An Act relating to the provision of pharmaceutical, sickness and hospital benefits, and of medical and dental services
Part I—Preliminary
1 Short title
This Act may be cited as the National Health Act 1953.
2 Commencement
(1) Parts I and II shall come into operation on the day on which this Act receives the Royal Assent.
(2) The remaining provisions of this Act shall come into operation on such dates as are respectively fixed by Proclamation.
4 Interpretation
(1) In this Act, unless the contrary intention appears:
Chief Executive Medicare has the same meaning as in the Human Services (Medicare) Act 1973.
Committee of Inquiry means a Committee of Inquiry established under Part VIII.
complying health insurance policy has the meaning given by section 63‑10 of the Private Health Insurance Act 2007.
de facto partner of a person means:
(a) another person (whether of the same sex or a different sex) with whom the person has a relationship that is registered under a law of a State or Territory prescribed for the purposes of section 2E of the Acts Interpretation Act 1901 as a kind of relationship prescribed for the purposes of that section; or
(b) another person (whether of the same sex or a different sex) who is living with the person on a genuine domestic basis although not legally married to the person.
designated vaccine has the meaning given by subsection 9B(2).
Finance Minister means the Minister administering the Public Governance, Performance and Accountability Act 2013.
friendly society means:
(a) a body that is a friendly society for the purposes of the Life Insurance Act 1995; or
(b) a body that is registered or incorporated as a friendly society under a law of a State or Territory; or
(c) a body that is permitted, by a law of a State or Territory, to assume or use the expression friendly society; or
(d) a body that, immediately before the date that is the transfer date for the purposes of the Financial Sector Reform (Amendments and Transitional Provisions) Act (No. 1) 1999, was registered or incorporated as a friendly society under a law of a State or Territory.
hospital has the meaning given by subsection 121‑5(5) of the Private Health Insurance Act 2007.
hospital‑substitute treatment has the same meaning as in the Private Health Insurance Act 2007.
hospital treatment has the meaning given by section 121‑5 of the Private Health Insurance Act 2007.
Human Services Minister means the Minister administering the Human Services (Medicare) Act 1973.
medicare program has the same meaning as in the Human Services (Medicare) Act 1973.
midwife means a person who is registered as a midwife, or authorised (however described) to practise midwifery, by or under a law of a State or an internal Territory that provides for the registration of midwives, or the authorisation of persons to practise midwifery.
nurse practitioner means a person who is registered, or authorised (however described) to practise, as a nurse practitioner by or under a law of a State or an internal Territory that provides for the registration of nurse practitioners, or the authorisation of persons to practise as nurse practitioners.
pharmacist means a person registered as a pharmacist or pharmaceutical chemist under a law of a State or Territory providing for the registration of pharmacists or pharmaceutical chemists, and includes a friendly society or other body of persons (whether corporate or unincorporate) carrying on business as a pharmacist.
premises includes a part of premises.
private health insurer has the same meaning as in the Private Health Insurance Act 2007.
public hospital means a hospital in respect of which there is in force a statement under subsection 121‑5(8) of the Private Health Insurance Act 2007 that the hospital is a public hospital.
public hospital authority means the governing body of a public hospital.
rules, in relation to a private health insurer, has the same meaning as in the Private Health Insurance Act 2007.
Secretary means the Secretary of the Department.
spouse includes a de facto partner.
Territory means an internal Territory.
vaccine means a vaccine for the purpose of immunising persons.
Veterans’ Affairs Department means the Department administered by the Veterans’ Affairs Minister.
Veterans’ Affairs Minister means the Minister administering the Veterans’ Entitlements Act 1986.
(1A) In this Act, unless the contrary intention appears, a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act.
(2) A reference in this Act to a prescription for the supply of a pharmaceutical benefit is a reference to a prescription written in accordance with subsection 88(1), (1A), (1C), (1D) or (1E).
(3) A reference in this Act to the supply of pharmaceutical benefits at premises is a reference to the supply of pharmaceutical benefits to people who are at the premises when the supply is made.
6 Delegation
(1) The Minister may, either generally or as otherwise provided by the instrument of delegation, by writing signed by the Minister, delegate to a person (including the Secretary) all or any of the Minister’s powers under this Act, the regulations or another legislative instrument under this Act, other than:
(a) this power of delegation; or
(ab) the Minister’s powers under sections 90A and 90B; or
(b) the Minister’s powers under section 95.
(2) A power so delegated under subsection (1), when exercised by the delegate, shall, for the purposes of this Act, the regulations or another legislative instrument under this Act, be deemed to have been exercised by the Minister.
(3) A delegate under subsection (1) is, in the exercise of a power so delegated, subject to the directions (if any) of the Minister.
(4) A delegation under subsection (1) does not prevent the exercise of a power by the Minister.
(5) The Secretary may, either generally or as otherwise provided by the instrument of delegation, by writing signed by the Secretary, delegate to a person all or any of the Secretary’s powers under this Act, the regulations or another legislative instrument under this Act other than:
(a) this power of delegation; or
(b) the Secretary’s powers under section 95.
(6) A power so delegated under subsection (5), when exercised by the delegate, shall, for the purposes of this Act, the regulations or another legislative instrument under this Act, be deemed to have been exercised by the Secretary.
(7) A delegate under subsection (5) is, in the exercise of a power so delegated, subject to the directions (if any) of the Secretary.
(8) A delegation under subsection (5) does not prevent the exercise of a power by the Secretary.
6A External Territories
This Act extends to the Territory of Cocos (Keeling) Islands and to the Territory of Christmas Island.
7A Application of the Criminal Code
Chapter 2 (other than Part 2.5) of the Criminal Code applies to all offences against this Act.
Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
Part II—National health services
8 Interpretation
In this Part, Territory includes an external Territory to which this Act extends.
9 Provision of certain medical and dental services
(1) The Governor‑General may provide, or arrange for the provision of:
(a) aerial medical and dental services;
(b) diagnostic and therapeutic services for medical practitioners and hospitals, and for patients of medical practitioners or hospitals;
(c) teaching, research and advisory services in relation to maternal and child health;
(d) teaching, research and advisory services for or in relation to the improvement of health or the prevention of disease; and
(e) anything incidental to a service referred to in paragraph (a), (b), (c) or (d).
(2) The Minister may disseminate information relating to health or the prevention of disease.
9A Provision of medical and surgical aids and appliances etc. by the Commonwealth
(1) The Minister may, on behalf of the Commonwealth, arrange for:
(a) the supply by the Commonwealth of such medical or surgical aids, equipment or appliances as are prescribed to persons who require them;
(b) the making of any modifications to a building, vehicle or equipment that are necessary for the treatment or rehabilitation of a sick or disabled person.
(2) Subject to the provisions of an arrangement made under subsection 9C(1), a hearing aid, or any other medical or surgical aid, equipment or appliance of a kind prescribed for the purposes of this subsection, that is supplied under this section remains the property of the Commonwealth notwithstanding any purported disposition or pledging of the aid, equipment or appliance by any person.
(3) The Minister may impose such conditions as the Minister thinks fit on the use or possession of aids, equipment or appliances supplied, or to be supplied, under subsection (1).
(4) The regulations may make provision with respect to the supply of aids, equipment or appliances, or the making of modifications, under subsection (1), including provision for offences with respect to the use or possession of aids, equipment or appliances so supplied.
9B Provision of vaccines
(1) The Minister may provide, or arrange for the provision of:
(a) designated vaccines; and
(b) goods or services that are associated with, or incidental to, the provision or administration of designated vaccines.
Designated vaccines
(2) The Minister may, by legislative instrument, determine that a specified vaccine is a designated vaccine for the purposes of this Act.
Note: For variation and revocation, see subsection 33(3) of the Acts Interpretation Act 1901.
(3) A vaccine may be specified by reference to any or all of the following:
(a) brand;
(b) formulation;
(c) active ingredient;
(d) strength;
(e) number and timing of doses in a course of immunisation.
(4) Subsection (3) does not limit the ways in which a vaccine may be specified.
(5) In addition to specifying a vaccine, a determination under subsection (2) may specify the circumstances in which the vaccine may be provided.
(6) If any such circumstances are specified, subsection (1) only authorises the provision of the vaccine in those circumstances.
(7) A vaccine must not be specified in a determination under subsection (2) unless:
(a) the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that the vaccine be a designated vaccine; or
(b) at any time during the 60‑day period ending immediately before the commencement of this subsection, the vaccine was provided under repealed section 9B of this Act.
(8) Before:
(a) revoking a determination under subsection (2); or
(b) varying a determination under subsection (2) in such a way that a vaccine ceases to be a designated vaccine;
the Minister must obtain the written advice of the Pharmaceutical Benefits Advisory Committee in relation to the proposed revocation or variation.
(9) An advice under subsection (8) is to be tabled in each House of the Parliament with the revocation or variation to which the advice relates.
(10) This section does not limit the vaccine‑related powers conferred on the Minister by the Quarantine Act 1908.
9BA The National HPV Vaccination Program Register
Establishment
(1) The Commonwealth must establish and keep a register known as the National HPV Vaccination Program Register.
Contents of the Register
(2) The Register may contain the following kinds of personal information:
(a) the name, address, date of birth and Medicare card number of any person to whom HPV vaccine has been administered;
(b) the indigenous status of such a person;
(c) the names and addresses of parents or guardians of such a person (if the person is a child or is incapable of managing the person’s affairs);
(d) information about when and where HPV vaccine was administered to such a person;
(e) information about who administered HPV vaccine to such a person;
(f) information about HPV vaccine that was administered to such a person.
Purposes of the Register
(3) The purposes of the Register are to ensure the successful implementation of the National Human Papillomavirus (HPV) Vaccination Program, and in doing so facilitate:
(a) establishment and maintenance of an electronic database of records for monitoring vaccination of participants in the HPV Program; and
(b) monitoring of the effectiveness of HPV vaccine in preventing certain cervical cancers by allowing for future cross referencing of data against Pap Smear and other cervical cytology or cervical cancer registers maintained by States and Territories; and
(c) establishment of mechanisms to advise eligible persons, or the parents or guardians of children, if doses of HPV vaccine have been missed or if booster doses are required in the future; and
(d) maintenance of a record of the HPV vaccination status of eligible persons for the purposes of certifying the completion of the course of vaccination; and
(e) promotion of the health and well being of persons by providing information on new developments associated with the Program to vaccination providers, eligible persons and parents or guardians of children; and
(f) payment of general practitioners for entering information in the Register.
Opting out of the Register
(4) A person may, in writing, request the Commonwealth to remove from the Register personal information relating to:
(a) the person; or
(b) a child of whom the person is a parent or guardian.
The Commonwealth must comply with any such request as soon as practicable.
Effect of the Privacy Act 1988
(5) The use by the Commonwealth of personal information for the purposes of the Register is taken to be authorised by this Act for the purposes of paragraph 6.2(b) of Australian Privacy Principle 6.
(6) The disclosure by the Commonwealth of personal information for the purposes of the Register is taken to be authorised by this Act for the purposes of paragraph 6.2(b) of Australian Privacy Principle 6 if:
(a) the disclosure is made to a body that is:
(i) prescribed by the regulations; or
(ii) included in a class of bodies prescribed by the regulations; or
(iii) a prescribed body within the meaning of Part IVA of the Health Insurance Act 1973; or
(b) the disclosure is made to a vaccination provider for the purpose of administering HPV vaccine.
Definitions
(7) In this section:
eligible person means a person who is eligible to receive vaccination under the National Human Papillomavirus (HPV) Vaccination Program.
HPV vaccine means Human Papillomavirus vaccine that the Minister has determined under section 9B to be a designated vaccine.
parent: without limiting who is a parent of a child for the purposes of this section, someone is the parent of a child if:
(a) the child is the person’s adoptive child or stepchild; or
(b) the child would be the person’s stepchild except that the person is not legally married to the person’s de facto partner; or
(c) the child is a child of the person within the meaning of the Family Law Act 1975.
personal information has the same meaning as in the Privacy Act 1988.
vaccination provider means:
(a) a general practitioner; or
(b) a nurse who is authorised by a State or Territory, or by an authority of a State or Territory, to administer HPV vaccine.
9C Arrangements with States for provision of surgical aids and appliances etc.
(1) The Minister may, on behalf of the Commonwealth, enter into an arrangement with a State, a Territory or a body corporate established for a public purpose under a law of a State or Territory for and in relation to:
(a) the supply of medical or surgical aids, equipment or appliances prescribed for the purposes of paragraph 9A(1)(a) to persons who require them; and
(b) the making of any modifications to a building, vehicle or equipment that are necessary for the treatment or rehabilitation of a sick or disabled person.
(2) Without limiting the generality of subsection (1), an arrangement entered into under that subsection with a State, a Territory or a body corporate may provide for:
(a) the payment by the Commonwealth of amounts to the State, Territory or body corporate, as the case may be, in connection with the carrying out of the arrangement; and
(b) the transfer to the State, Territory or body corporate, as the case may be, of medical or surgical aids, equipment or appliances owned by the Commonwealth.
(4) An arrangement entered into under subsection (1) may be expressed to have taken effect from a day earlier than the day on which the arrangement was entered into.
10 Arrangements with other Ministers
The Minister may make an arrangement with any other Minister for the performance by that other Minister of a service in connexion with a service, matter or thing for which provision is made by or under this Part.
11 Arrangements with States
(1) The Governor‑General may enter into an arrangement with the Governor of a State or the Administrator of a Territory for the performance by that State or Territory of a service in connexion with a service, matter or thing for which provision is made by or under this Part.
(2) An arrangement entered into under this section may provide for payments by the Commonwealth to the State or Territory in respect of capital expenditure or maintenance expenditure incurred by the State or Territory at the request of the Commonwealth in connexion with the service performed by the State or Territory.
(3) Any arrangement entered into under this section which provides for payments by the Commonwealth to a State or Territory in respect of expenditure referred to in subsection (2) shall provide for information to be supplied to the Minister by such persons, at such times and in such manner and form as the Minister requires.
(4) An arrangement entered into under this section shall provide:
(a) that property the cost of which, or part of the cost of which, has been paid by the Commonwealth to the State or Territory under the arrangement shall not, except with the approval of the Minister, be used otherwise than for the purpose for which the property was acquired; and
(b) for the indemnification of the Commonwealth:
(i) in the event of the acquisition by the Commonwealth of property the cost of which has been paid by the Commonwealth to the State or Territory under the arrangement—against payment by way of compensation for the acquisition of that property; and
(ii) in the event of the acquisition by the Commonwealth of property the cost of which was paid in part by the Commonwealth to the State or Territory under the arrangement—against payment by way of compensation proportionate to the cost so paid.
Part III—Continence Aids Payment Scheme
12 Continence Aids Payment Scheme
(1) The Minister may, by legislative instrument, formulate a Continence Aids Payment Scheme, under which the Commonwealth makes payments as a contribution towards the cost of buying products that help manage incontinence.
(2) A person who satisfies the eligibility criteria that are stated in the legislative instrument is eligible to participate in the scheme.
(3) Without limiting subsection (1), the legislative instrument may provide for:
(a) applications by persons who want to participate in the scheme; and
(b) the conditions that must be complied with in order for a person to participate in the scheme; and
(c) the amount of the contribution that is payable in each financial year in relation to a person who is participating in the scheme; and
(d) investigations to be conducted in order to ensure that persons who are participating in the scheme are eligible to do so; and
(e) the functions and powers of the Chief Executive Medicare in relation to the scheme.
13 Secretary or Chief Executive Medicare may request information
(1) This section applies if the Secretary or Chief Executive Medicare (the official) believes, on reasonable grounds, that a person is capable of giving information that is relevant to deciding:
(a) whether a contribution is payable to a person under the Continence Aids Payment Scheme; or
(b) the amount of a contribution that is payable to a person under the Continence Aids Payment Scheme.
(2) The official may request the person to give the information to the official.
(3) The request:
(a) must be made in writing; and
(b) must state what information must be given to the official; and
(c) may require the information to be verified by statutory declaration; and
(d) must specify a day on or before which the information must be given, which day must be at least 28 days after the day on which the request is made; and
(e) must contain a statement to the effect that a failure to comply with the request is an offence.
(4) The person commits an offence if the person fails to comply with the request.
Penalty: 30 penalty units.
(5) However, an individual is excused from complying with the request if the giving of the information might tend to:
(a) incriminate the individual; or
(b) expose the individual to a penalty.
Note: A defendant bears an evidential burden in relation to the matter in subsection (5). See subsection 13.3(3) of the Criminal Code.
(6) An offence against subsection (4) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
14 Reviewing decision whether applicant is eligible for the scheme
(1) This section applies if the Chief Executive Medicare decides that a person who has applied to participate in the scheme is not eligible to participate in the scheme.
(2) The Chief Executive Medicare must give the person a signed notice that states:
(a) the decision; and
(b) the day when the decision has effect; and
(c) the reasons for the decision; and
(d) that, within 28 days after receiving the notice, the person may apply to the Chief Executive Medicare for a review of the decision; and
(e) how the person may apply for the review.
(3) A person who is aggrieved by the Chief Executive Medicare’s decision may apply for a review of the decision in the way stated in the legislative instrument that sets out the scheme.
(4) If an application is made under subsection (3), the Chief Executive Medicare must review the decision and give the person a signed notice that states:
(a) the decision; and
(b) the day when the decision has effect; and
(c) if the decision is that the person is not eligible to participate in the scheme:
(i) the reasons for the decision; and
(ii) that, within 28 days after receiving the notice, the person may apply to the Administrative Appeals Tribunal for a review of the Chief Executive Medicare’s decision.
(5) An application may be made to the Administrative Appeals Tribunal for the review of the Chief Executive Medicare’s decision mentioned in subsection (4).
15 Reviewing decision whether participant is eligible for the scheme
(1) This section applies if the Chief Executive Medicare decides that a person who is participating in the scheme is not eligible to participate in the scheme.
(2) The Chief Executive Medicare must give the person a signed notice that states:
(a) the decision; and
(b) the day when the decision has effect; and
(c) the reasons for the decision; and
(d) that, within 28 days after receiving the notice, the person may apply to the Chief Executive Medicare for a review of the decision; and
(e) how the person may apply for the review.
(3) A person who is aggrieved by the Chief Executive Medicare’s decision may apply for a review of the decision in the way stated in the legislative instrument that sets out the scheme.
(4) If an application is made under subsection (3), the Chief Executive Medicare must review the decision and give the person a signed notice that states:
(a) the decision; and
(b) the day when the decision has effect; and
(c) if the decision is that the person is not eligible to participate in the scheme:
(i) the reasons for the decision; and
(ii) that, within 28 days after receiving the notice, the person may apply to the Administrative Appeals Tribunal for a review of the Chief Executive Medicare’s decision.
(5) An application may be made to the Administrative Appeals Tribunal for the review of the Chief Executive Medicare’s decision mentioned in subsection (4).
Part VII—Pharmaceutical benefits
Division 1—Preliminary
83Z Repeal and saving
(1) The Pharmaceutical Benefits Act 1947, the Pharmaceutical Benefits Act 1949, the Pharmaceutical Benefits Act (No. 2) 1949 and the Pharmaceutical Benefits Act 1952 are repealed.
(2) The National Health (Medicines for Pensioners) Regulations made under the National Health Service Act 1948–1949 are repealed.
(3) Notwithstanding the repeal effected by subsection (1):
(a) where immediately before the commencement of this Part, a person or body was under the Pharmaceutical Benefits Act 1947–1952:
(i) an approved pharmaceutical chemist approved in respect of one or more premises;
(ii) an approved medical practitioner approved in respect of an area; or
(iii) an approved hospital authority approved in respect of one or more hospitals;
that person or body shall be deemed to be an approved pharmacist in respect of those premises, an approved medical practitioner in respect of that area or an approved hospital authority in respect of that hospital or those hospitals under section 90, 92 or 94, as the case requires, and the provisions of this Act apply to and in relation to that person or body accordingly; and
(b) a special arrangement made in pursuance of section 15 of the Pharmaceutical Benefits Act 1947–1952 which was in force immediately before the commencement of this Part shall continue in force as if made in pursuance of section 100.
(4) The reference in subparagraph (3)(a)(i) to an approved pharmaceutical chemist includes a reference to a person who:
(a) owned, or was about to own, a business for the supply of pharmaceutical benefits at or from particular premises; and
(b) was purportedly approved under the Pharmaceutical Benefits Act 1947–1952 as an approved pharmaceutical chemist.
84 Interpretation
(1) In this Part, unless the contrary intention appears:
additional member means an additional member of the Tribunal.
agreed price means the amount in force under a price agreement.
applicable amount has the meaning given by subsection 84BA(4).
approved ex‑manufacturer price of a listed brand of a pharmaceutical item means:
(a) if a price agreement is in force in relation to the brand of the pharmaceutical item—the amount in force under the agreement as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item; or
(b) if a price determination is in force in relation to the brand of the pharmaceutical item—the amount in force under the determination as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.
approved hospital authority means a hospital authority for the time being approved, or deemed to be approved, under section 94.
approved medical practitioner means a medical practitioner for the time being approved, or deemed to be approved, under section 92.
approved pharmacist means a person for the time being approved under section 90 and includes:
(a) a person treated as having been so approved under any provision of a law of the Commonwealth other than section 91; and
(b) except so far as subsection 90(3) is concerned—a person treated as having been so approved under section 91.
approved supplier means an approved pharmacist, an approved medical practitioner or an approved hospital authority.
authorised midwife means an eligible midwife in relation to whom an approval is in force under section 84AAF, so far as the eligible midwife provides midwifery treatment in a collaborative arrangement or collaborative arrangements of a kind or kinds specified in a legislative instrument made by the Minister for the purposes of this definition, with one or more medical practitioners of a kind or kinds specified in the legislative instrument.
authorised nurse practitioner means an eligible nurse practitioner in relation to whom an approval is in force under section 84AAJ, so far as the eligible nurse practitioner provides nurse practitioner treatment in a collaborative arrangement or collaborative arrangements of a kind or kinds specified in a legislative instrument made by the Minister for the purposes of this definition, with one or more medical practitioners of a kind or kinds specified in the legislative instrument.
authorised optometrist means an optometrist in relation to whom an approval is in force under section 84AAB.
Authority means the Australian Community Pharmacy Authority established under section 99J.
brand of a pharmaceutical item means:
(a) the trade name under which the person who is or will be the responsible person supplies the pharmaceutical item; or
(b) if there is no trade name—the name of the person who is or will be the responsible person.
Chairperson means the Chairperson of the Tribunal.
child, in relation to a member of a friendly society, means:
(a) a child under the age of 16 years of that member; or
(b) a child of that member who:
(i) has attained the age of 16 years;
(ii) is receiving full‑time education at a school, college or university;
(iii) is wholly or substantially dependent on that member or on the spouse of that member; and
(iv) is a person who is to be treated as a child of that member in accordance with the rules of the friendly society.
Note: See also subsection (3B).
claimed price means the amount specified in a determination in force under subsection 85B(3).
co‑marketed brands has the meaning given by section 84AE.
combination item means a pharmaceutical item that has a drug that contains at least 2 other drugs or medicinal preparations, at least one of which is a listed drug.
combination item has a drug: see subsection 84ABA(2).
Commonwealth officer means:
(a) the Governor‑General; or
Note: See also section 16A of the Acts Interpretation Act 1901.
(b) a Minister; or
(c) a member of the Parliament of the Commonwealth; or
(d) the Administrator, an Acting Administrator, or a Deputy Administrator, of Norfolk Island; or
(e) a person who is in the employment of the Commonwealth; or
(f) a person who holds or performs the duties of any office or position established by or under a law of the Commonwealth; or
(g) a member of the Australian Defence Force; or
(h) the Commissioner of the Australian Federal Police, a Deputy Commissioner of the Australian Federal Police, an AFP employee, a special member or a special protective service officer (all within the meaning of the Australian Federal Police Act 1979).
Commonwealth price means:
(a) in relation to a pharmaceutical benefit supplied by an approved pharmacist—the Commonwealth price for the particular quantity or number of units of the pharmaceutical benefit worked out in accordance with a determination in force under subsection 98B(1); or
(b) in relation to a pharmaceutical benefit supplied by an approved medical practitioner—the Commonwealth price for the particular quantity or number of units of the pharmaceutical benefit worked out in accordance with a determination in force under subsection 98C(1); or
(c) in relation to a pharmaceutical benefit supplied by an approved hospital authority to a patient receiving treatment in or at a hospital in respect of which the authority is approved—the amount of the payment to which the authority is entitled under subsection 99(4) in respect of the supply of the particular quantity or number of units of the pharmaceutical benefit.
communicated, in relation to a prescription, means communicated directly or indirectly.
communicated prescription means a prescription that is communicated to an approved pharmacist in the circumstances and manner set out in regulations made for the purposes of paragraph 89(a).
concessional beneficiary means:
(a) a person who is the holder of a pensioner concession card, a seniors health card or a health care card under the Social Security Act 1991; or
(b) a person (other than the holder of the card) whose name is included in a card referred to in paragraph (a); or
(c) a person:
(i) who is an Australian resident within the meaning of the Health Insurance Act 1973; and
(ii) to whom, or in respect of whom, there is being paid a service pension under Part III, or income support supplement under Part IIIA, of the Veterans’ Entitlements Act 1986; or
(d) a person who is:
(i) an Australian resident within the meaning of the Health Insurance Act 1973; and
(ii) eligible, under subsection 86(1), (2) or (3) of the Veterans’ Entitlements Act 1986, to be provided with treatment under Part V of the last‑mentioned Act; or
(da) a person who is:
(i) an Australian resident within the meaning of the Health Insurance Act 1973; and
(ii) entitled to treatment under section 284 of the Military Rehabilitation and Compensation Act 2004; or
(e) a person who is:
(i) an Australian resident within the meaning of the Health Insurance Act 1973; and
(ii) the holder of a seniors health card within the meaning of the Veterans’ Entitlements Act 1986.
concessional benefit prescription means a prescription that, in accordance with section 84AA, is a prescription in respect of a concessional beneficiary or of a person who, in relation to the concessional beneficiary, is a dependant within the meaning of subsection (4) or (7).
concession card means a safety net concession card issued under section 84DA and includes an additional concession card, or a replacement concession card, issued under section 84H.
concession card prescription means a prescription that, in accordance with section 84AA, is a prescription for the supply of a pharmaceutical benefit to a person who is a holder of a concession card.
CTS claim means a claim made to the Chief Executive Medicare using the procedures of the Claims Transmission System provided for in section 99AAA of the National Health Act 1953.
dependant has the meaning given by subsections (4) and (7).
determined price means the amount specified in a determination in force under subsection 85B(2).
determined quantity of a listed brand of a pharmaceutical item: see subsection 84AK(3).
drug in a combination item means the drug referred to in paragraph 84AB(a) in the application of that paragraph to the pharmaceutical item that is the combination item.
drug in a pharmaceutical item means the drug referred to in paragraph 84AB(a) in the application of that paragraph to the pharmaceutical item.
drug is in Part A of F2 has the meaning given by section 84AD.
drug is in Part T of F2 has the meaning given by section 84AD.
drug is on F1 has the meaning given by section 84AC.
drug is on F2 has the meaning given by section 84AC.
early supply of a specified pharmaceutical benefit has the meaning given by subsection 84AAA(1).
eligible midwife has the meaning given by section 84AAE.
eligible nurse practitioner has the meaning given by section 84AAI.
entitlement card means a pharmaceutical benefits entitlement card issued under section 84E and includes an additional entitlement card, or a replacement entitlement card, issued under section 84H.
entitlement card prescription means a prescription that, in accordance with section 84AA, is a prescription for the supply of a pharmaceutical benefit to a person who is a holder of an entitlement card.
exempt item means a pharmaceutical item determined by the Minister under section 84AH to be an exempt item.
expiry date, in relation to a medicare number, means:
(a) if the number is recorded on a medicare card that specifies a particular date on which the card expires—that date; and
(b) if the number is recorded on a medicare card that does not specify a particular date on which the card expires but that has recorded on it the month at the end of which the card expires—the last day of that month; and
(c) if the number is not of a kind referred to in paragraph (a) or (b)—such date as the Minister specifies, in writing, in respect of the number.
friendly society body means a body (whether corporate or unincorporate) carrying on business for the benefit of members of a friendly society or friendly societies.
general benefit prescription means a prescription other than:
(b) a concessional benefit prescription; or
(c) an entitlement card prescription; or
(d) a concession card prescription.
general patient means a person who is an eligible person within the meaning of the Health Insurance Act 1973, but who is not a concessional beneficiary.
hospital means premises in which patients are received and lodged for the purpose of hospital treatment.
hospital authority means the governing body of a public hospital or the proprietor of a private hospital.
listed brand of a pharmaceutical item means a brand of the pharmaceutical item in relation to which a determination under subsection 85(6) is in force.
listed drug means a drug or medicinal preparation in relation to which a declaration under subsection 85(2) is in force.
medicare card means:
(a) a card issued by the Chief Executive Medicare and commonly known as a medicare card; or
(b) a card or written authorisation provided to a person that evidences a person’s eligibility for pharmaceutical benefits under:
(i) the scheme known as the Repatriation Pharmaceutical Benefits Scheme established under the Veterans’ Entitlements Act 1986; or
(ii) a scheme that applies under section 18 of the Australian Participants in British Nuclear Tests (Treatment) Act 2006; or
(c) any other card that is prescribed for the purposes of this definition.
medicare number means:
(a) in relation to a particular person covered by a medicare card—the particular combination of numbers, or letters and numbers, on the card that is applicable only to that person as a person covered by that card; and
(b) in relation to a person who the Chief Executive Medicare is satisfied is, or is entitled to be treated as, an eligible person within the meaning of the Health Insurance Act 1973 but who is not covered by a medicare card—the particular combination of numbers, or letters and numbers, that would be applicable to that person if that person were covered by a medicare card.
member means a member of the Tribunal, and includes the Chairperson.
nurse practitioner treatment, in relation to a nurse practitioner, means treatment that the nurse practitioner is authorised (however described) to provide under a law of a State or an internal Territory.
optometrist means a person registered or licensed as an optometrist or optician under a law of a State or an internal Territory that provides for the registration or licensing of optometrists or opticians.
out‑patient medication means a drug or medicinal preparation supplied through the out‑patient department of a public hospital.
pack quantity of a listed brand of a pharmaceutical item: see subsection 84AK(2).
participating dental practitioner means a dental practitioner in relation to whom an approval is in force under section 84A.
PBS prescriber means:
(a) a medical practitioner; or
(b) a participating dental practitioner; or
(c) an authorised optometrist; or
(d) an authorised midwife; or
(e) an authorised nurse practitioner.
pharmaceutical benefit means the following:
(a) if a declaration under subsection 85(2) is in force in relation to a drug or medicinal preparation (the drug) and paragraph (b), (c) and (d) do not apply—the drug;
(b) if a determination under subsection 85(3) is in force in relation to a form of the drug and paragraph (c) and (d) do not apply—the drug in that form;
(c) if a determination under subsection 85(5) is in force in relation to a manner of administration of that form of the drug and paragraph (d) does not apply—the drug in that form with that manner of administration;
(d) if a determination under subsection 85(6) is in force in relation to a brand of a pharmaceutical item that is the drug in that form with that manner of administration—that brand of the drug in that form with that manner of administration.
pharmaceutical benefit has a drug: see subsection 84ABA(3).
pharmaceutical item has the meaning given by section 84AB.
pharmaceutical item has a drug: see subsection 84ABA(1).
prescriber bag provisions means the following:
(a) section 93 (supplies by medical practitioners);
(b) section 93AA (supplies by authorised midwives);
(c) section 93AB (supplies by authorised nurse practitioners).
price agreement means an agreement under section 85AD.
price determination means a determination under subsection 85B(2).
pricing quantity of a listed brand of a pharmaceutical item: see subsection 84AK(1).
proportional ex‑manufacturer price of a listed brand of a pharmaceutical item: see section 85D.
record form means a pharmaceutical benefits prescription record form, or an out‑patient medication prescription record form, issued under section 84D.
refund agreement means an agreement or arrangement under which a payment may be made by or at the direction of a person to another person in the event of the other person being charged an amount in respect of the supply of a pharmaceutical benefit.
relevant entitlement period means:
(a) in the application of this Part before 1 January 1992:
(i) in relation to a pensioner—the period commencing on 1 November 1990 and ending on 31 December 1991; or
(ii) in relation to any other person—the year commencing on 1 January 1990 or 1 January 1991; or
(b) in the application of this Part on or after 1 January 1992:
(i) the year commencing on 1 January 1992; or
(ii) a succeeding year.
relevant price: see subsection 99ACF(5).
repatriation pharmaceutical benefit means a pharmaceutical benefit within the meaning of section 91 of the Veterans’ Entitlements Act 1986 or subsection 4(1) of the Australian Participants in British Nuclear Tests (Treatment) Act 2006.
responsible person for a brand of a pharmaceutical item means the person determined by the Minister under section 84AF to be the responsible person for the brand of the pharmaceutical item.
Schedule equivalent has the meaning given by section 84AJ.
special number, in relation to a particular person who is included within a class of persons identified by the Minister in a determination under subsection 86E(1)—the particular combination of numbers, or letters and numbers, allocated in accordance with a procedure set out in that determination, that is applicable to that person as a person included in that class.
special patient contribution has the meaning given by subsection 85B(5).
State or Territory officer means:
(a) the Governor of a State; or
Note: See also section 16B of the Acts Interpretation Act 1901.
(b) the Administrator, an Acting Administrator, or a Deputy Administrator, of the Northern Territory; or
(c) a Minister of a State, a Minister for the Australian Capital Territory or a Minister of the Northern Territory; or
(d) a member of the Parliament of a State, a member of the Legislative Assembly for the Australian Capital Territory or a member of the Legislative Assembly of the Northern Territory; or
(e) a person who is in the employment of a State or Territory; or
(f) a person who holds or performs the duties of any office or position established by or under a law of a State or Territory; or
(g) a member of the police force or police service of a State or Territory.
subject to a 12.5% price reduction: see subsection 99ACA(2).
subject to a 16% price reduction: see subsection 99ACA(2A).
subject to an outstanding staged reduction: see subsection 99ACA(1).
therapeutic group means a therapeutic group determined by the Minister under section 84AG.
Tribunal means the Pharmaceutical Benefits Remuneration Tribunal established by section 98A.
(1A) Where a refund agreement was entered into before 24 April 1964, and, on or after that date:
(a) the agreement was or is renewed on or before the date on which it would, but for that renewal, have expired;
(b) the period of operation of the agreement was or is extended on or before the date on which it would, but for that extension, have expired; or
(c) the rights and obligations under the agreement of the party by or at whose direction payments may be made under the agreement were or are transferred to another person;
the renewal, extension or transfer shall, for the purposes of this Act, be deemed not to have been or to be an entering into a new agreement.
(1B) If:
(a) a prescription directs a repeated supply of a pharmaceutical benefit (the specified benefit); and
(b) another pharmaceutical benefit (the supplied benefit) is supplied, on the repeated supply, in accordance with subsection 103(2A);
then, for the purposes of determining whether a repeated supply of the specified benefit has occurred, the supplied benefit is taken to be the repeated supply, upon the prescription, of the specified benefit.
(2) In this Part, a reference to the supply, obtaining or receipt of a pharmaceutical benefit shall, unless the contrary intention appears, be read as a reference to the supply, obtaining or receipt of that pharmaceutical benefit under this Part.
(2A) A reference in this Part to a prescription for the supply of a pharmaceutical benefit to a person who is a holder of a concession card or an entitlement card is a reference to a prescription for the supply of a pharmaceutical benefit to a person who is, at the time when the prescription is written or communicated, or becomes, after the prescription is written or communicated and before the benefit is supplied upon the prescription, a holder of a concession card or an entitlement card.
(3) If the Minister so determines, the Minister of State of a State administering the laws of that State relating to public hospitals shall, for the purposes of this Part, be deemed to be the governing body of the public hospitals in that State.
(3A) A reference in this Part to the governing body, in relation to a public hospital in the Territory of Cocos (Keeling) Islands or the Territory of Christmas Island, shall be read as a reference to the Administrator of the relevant Territory.
(3B) A reference in the definition of child in subsection (1) to a child of a member includes a reference to:
(a) an adoptive child or a stepchild of the person; and
(b) someone who would be the stepchild of the person except that the person is not legally married to the person’s de facto partner; and
(c) someone who is a child of the person within the meaning of the Family Law Act 1975.
(4) A dependant, in relation to a person to whom paragraph (c) or (d) of the definition of concessional beneficiary applies, is a person who is an Australian resident within the meaning of the Health Insurance Act 1973 and:
(a) the spouse of the person; or
(b) a child under the age of 16 years who is in the custody, care and control of the person or the spouse of the person; or
(c) a person who:
(i) has attained the age of 16 years but is under the age of 25 years; and
(ii) is receiving full time education at a school, college or university; and
(iii) is not being paid a disability support pension under the Social Security Act 1991; and
(iv) is wholly or substantially dependent on the person or on the spouse of the person.
(7) For the purposes of this Part, if:
(a) paragraph (e) of the definition of concessional beneficiary applies to a person (the seniors health card holder); and
(b) no other paragraph of the definition of concessional beneficiary applies to the seniors health card holder;
a person who, apart from this subsection, would be a dependant of the seniors health card holder is taken not to be a dependant of the seniors health card holder.
Note: A person who is the holder of a seniors health card within the meaning of the Veterans’ Entitlements Act 1986 is a person to whom paragraph (e) of the definition of concessional beneficiary applies.
(8) A reference in this Part to the provision to a person or body of a medicare number as a number applicable to a particular individual is a reference to:
(a) the production to that person or body of a medicare card having on it a medicare number as a number applicable to that particular individual; or
(b) the provision to that person or body of any other information, whether documentary or oral, that indicates a medicare number as a number applicable to that particular individual.
(9) A reference in this Part to the provision to a person or body of the expiry date in relation to a medicare number provided as a number applicable to a particular individual is a reference to:
(a) the production to the person or body of a medicare card that indicates the expiry date in relation to that medicare number; or
(b) the provision to the person or body of any other information, whether documentary or oral, that indicates the expiry date in relation to that medicare number.
(10) A reference in this Part to a medicare number, or a special number, ultimately supplied to the Chief Executive Medicare in relation to a prescription, is a reference to:
(a) if the number is not inserted in a CTS claim relating to that prescription—the number in the form in which it appears on the prescription (or in the case of a communicated prescription, the written version of the prescription), at the time when the prescription is sent to the Chief Executive Medicare by an approved supplier with a claim for payment; or
(b) if that number is inserted in a CTS claim relating to the prescription—the number so inserted.
84AAA Early supply of a specified pharmaceutical benefit
(1) A supply of a pharmaceutical benefit to a person (whether or not that supply is a supply of a kind described in paragraph 84C(4A)(a)) is an early supply of a specified pharmaceutical benefit if:
(a) the supply of the pharmaceutical benefit is made within 20 days after the day of a previous supply to the person of:
(i) the pharmaceutical benefit; or
(ii) another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit; or
(iii) another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit;
whether or not the previous supply was a supply of a kind described in paragraph 84C(4A)(a); and
(b) the pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection (2); and
(c) the supply does not result from a prescription originating from a hospital.
Note: For hospital see subsection 4(1).
(2) The Minister may, by legislative instrument, specify pharmaceutical items for the purposes of paragraph (1)(b).
Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.
(3) A pharmaceutical item may be specified in an instrument under subsection (2) by reference to:
(a) the circumstances in which a pharmaceutical benefit that has the pharmaceutical item is supplied; or
(b) any other circumstances in relation to a pharmaceutical benefit that has the pharmaceutical item.
84AA Concessional benefit prescriptions, concession card prescriptions and entitlement card prescriptions
(1) A prescription that is written by a PBS prescriber in accordance with the Act and the regulations shall not be taken, for the purposes of this Part, to be a prescription in respect of a concessional beneficiary or a person who, in relation to a concessional beneficiary, is a dependant of the beneficiary within the meaning of subsection 84(4) or (7) unless there is written or marked on the prescription, or there purports to be written or marked on the prescription, in such manner as is prescribed by regulations made for the purposes of this subsection, such information relating to the status of the person to whom the prescription relates as such a concessional beneficiary or dependant as is prescribed by those last‑mentioned regulations in relation to persons having that status.
(1A) A prescription that is written by a PBS prescriber in accordance with this Act and the regulations shall not be taken, for the purposes of this Part, to be a prescription for the supply of a pharmaceutical benefit to a person who is a holder of a concession card or an entitlement card unless there is written or marked on the prescription, or there purports to be written or marked on the prescription, in such a manner as is prescribed by regulations made for the purposes of this subsection, such information relating to the status of the person to whom the prescription relates as a holder of a concession card or an entitlement card as is prescribed by those last‑mentioned regulations.
(2) A prescription that is communicated to an approved pharmacist in pursuance of paragraph 89(a) in such circumstances as are prescribed for the purposes of that paragraph shall not be taken, for the purposes of this Part, to be a prescription in respect of a concessional beneficiary or a person who, in relation to a concessional beneficiary, is a dependant of the beneficiary within the meaning of subsection 84(4) or (7) unless, before supply of the pharmaceutical benefit upon that prescription, there is communicated, or there is purportedly communicated, to the pharmacist, in such manner as is prescribed by regulations made for the purposes of this subsection, such information relating to the status of the person to whom the prescription relates as such a concessional beneficiary or dependant as is prescribed by those last‑mentioned regulations in relation to persons having that status.
(3) A prescription that is communicated to an approved pharmacist in pursuance of paragraph 89(a) in such circumstances as are prescribed for the purposes of that paragraph shall not be taken, for the purposes of this Part, to be a prescription for the supply of a pharmaceutical benefit to a person who is a holder of a concession card or an entitlement card unless, before supply of the benefit upon that prescription, there is communicated, or there is purportedly communicated, to the pharmacist, in such manner as is prescribed by regulations made for the purposes of this subsection, such information relating to the status of the person to whom the prescription relates as a holder of a concession card or an entitlement card as is prescribed by those last‑mentioned regulations.
(4) Nothing in subsection (1), (1A), (2) or (3) shall be read as derogating from subsection 87(3A).
84A Participating dental practitioners
(1) A dental practitioner may give to the Secretary a notification, in writing, that the dental practitioner wishes to become a participating dental practitioner for the purposes of this Part.
(2) Where the Secretary receives a notification under subsection (1), the Secretary shall, by writing signed by the Secretary, approve the dental practitioner concerned as a participating dental practitioner for the purposes of this Part.
(3) The Secretary shall notify the dental practitioner concerned of the dental practitioner’s approval under this section.
84AAB Authorised optometrists
(1) An optometrist may apply to the Secretary, in writing, to be an authorised optometrist for the purposes of this Part.
(2) The Secretary may approve the application if satisfied that the optometrist meets the criteria determined under paragraph (3)(a). The approval is subject to any conditions determined under paragraph (3)(b).
(3) The Minister may, by legislative instrument, determine either or both of the following:
(a) criteria by which applications are to be considered under this section;
(b) conditions to which approvals under this section are subject.
(4) The Secretary must, as soon as is practicable, approve or reject an application under subsection (1) and notify the applicant in writing of the decision.
Note: Section 27A of the Administrative Appeals Tribunal Act 1975 requires the person to be notified of the person’s review rights.
84AAC Secretary may suspend or revoke approval of authorised optometrist
(1) The Secretary may suspend or revoke an approval under section 84AAB if satisfied that the optometrist to whom the approval relates:
(a) does not, at the time of the suspension or revocation, meet the criteria that would apply if the optometrist were to apply under subsection 84AAB(1) to be an authorised optometrist at that time; or
(b) has breached a condition to which the approval is subject under paragraph 84AAB(3)(b); or
(c) has breached a condition to which an approval would be subject under paragraph 84AAB(3)(b) if the person were to apply under subsection 84AAB(1) to be an authorised optometrist at that time.
(2) Before deciding to suspend or revoke the approval, the Secretary must notify the optometrist that suspension or revocation is being considered. The notice must:
(a) be in writing; and
(b) include the Secretary’s reasons for considering the suspension or revocation; and
(c) invite the optometrist to make written submission to the Secretary within the period of 28 days (the submission period) after being given the notice.
(3) In deciding whether to suspend or revoke the approval, the Secretary must consider any written submissions made by the optometrist during the submission period.
(4) The Secretary must give to the optometrist written notice of the decision. If the decision is to suspend an approval, the notice must specify the period for which the approval is suspended.
Note: Section 27A of the Administrative Appeals Tribunal Act 1975 requires the person to be notified of the person’s review rights.
(5) If the Secretary does not give the optometrist written notice of the decision within the period of 60 days after the end of the submission period, the Secretary is taken to have decided not to suspend or revoke the approval.
(6) If the Secretary suspends the approval, the Secretary may, by written notice at any time, further suspend or revoke the approval under subsection (1) or remove the suspension.
84AAD Review of decisions relating to authorised optometrists
(1) If the Secretary:
(a) decides not to approve an optometrist under section 84AAB; or
(b) suspends or revokes the approval of an optometrist under section 84AAC;
the optometrist may apply, in writing, to the Secretary for reconsideration by the Secretary of the decision.
(2) On receiving an application under subsection (1) relating to a decision not to approve an optometrist under section 84AAB, the Secretary must reconsider the decision and:
(a) affirm the decision; or
(b) approve the optometrist.
An approval under paragraph (b) is taken, for the purposes of this Act, to be an approval under section 84AAB.
(3) On receiving an application under subsection (1) relating to a suspension or revocation of the approval of an optometrist under section 84AAC, the Secretary must reconsider the decision and:
(a) affirm the suspension or revocation; or
(b) reinstate the approval of the optometrist.
A reinstatement under paragraph (b) has effect as if the approval had never been revoked.
(4) The Secretary must give to the applicant written notice of the Secretary’s decision under subsection (2) or (3).
Note: Sections 105AC of this Act and 27A of the Administrative Appeals Tribunal Act 1975 require the person to be notified of the person’s review rights.
(5) In this section:
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
84AAE Meaning of eligible midwife
(1) For the purposes of this Part, a person is an eligible midwife if the person:
(a) is a midwife; and
(b) meets the requirements set out in a determination made under subsection (3).
(2) However, if there is no determination in force under subsection (3), a person cannot be an eligible midwife for the purposes of this Part.
(3) The Minister may, by legislative instrument, determine one or more requirements that a specified person must meet in order to be an eligible midwife for the purposes of this Part.
(4) The requirements that may be determined under subsection (3), include (but are not limited to) one or more of the following:
(a) a requirement to hold particular qualifications in midwifery;
(b) a requirement to have particular experience in midwifery;
(c) a requirement to be credentialled by a particular body.
84AAF Authorised midwives
(1) An eligible midwife may apply to the Secretary, in writing, to be an authorised midwife for the purposes of this Part.
(2) The Secretary may approve the application if satisfied that the eligible midwife meets the criteria determined under paragraph (3)(a). The approval is subject to any conditions determined under paragraph (3)(b).
(3) The Minister may, by legislative instrument, determine either or both of the following:
(a) criteria by which applications are to be considered under this section;
(b) conditions to which approvals under this section are subject.
(4) The Secretary must, as soon as is practicable, approve or reject an application under subsection (1) and notify the applicant in writing of the decision.
Note: Section 27A of the Administrative Appeals Tribunal Act 1975 requires the person to be notified of the person’s review rights.
84AAG Secretary may suspend or revoke approval of authorised midwife
(1) The Secretary may suspend or revoke an approval under section 84AAF if satisfied that the person to whom the approval relates:
(a) is not, at the time of the suspension or revocation, an eligible midwife; or
(b) does not, at the time of the suspension or revocation, meet the criteria that would apply if the person were to apply under subsection 84AAF(1) to be an authorised midwife at that time; or
(c) has breached a condition to which the approval is subject under paragraph 84AAF(3)(b); or
(d) has breached a condition to which an approval would be subject under paragraph 84AAF(3)(b) if the person were to apply under subsection 84AAF(1) to be an authorised midwife at that time.
(2) Before deciding to suspend or revoke the approval, the Secretary must notify the person that suspension or revocation is being considered. The notice must:
(a) be in writing; and
(b) include the Secretary’s reasons for considering the suspension or revocation; and
(c) invite the person to make written submissions to the Secretary within the period of 28 days (the submission period) after being given the notice.
(3) In deciding whether to suspend or revoke the approval, the Secretary must consider any written submissions made by the person during the submission period.
(4) The Secretary must give to the person written notice of the decision. If the decision is to suspend an approval, the notice must specify the period for which the approval is suspended.
Note: Section 27A of the Administrative Appeals Tribunal Act 1975 requires the person to be notified of the person’s review rights.
(5) If the Secretary does not give the person written notice of the decision within the period of 60 days after the end of the submission period, the Secretary is taken to have decided not to suspend or revoke the approval.
(6) If the Secretary suspends the approval, the Secretary may, by written notice at any time, further suspend or revoke the approval under subsection (1) or remove the suspension.
84AAH Review of decisions relating to authorised midwives
(1) If the Secretary:
(a) decides not to approve an eligible midwife under section 84AAF; or
(b) suspends or revokes an approval under section 84AAG;
the person to whom the approval relates may apply, in writing, to the Secretary for reconsideration by the Secretary of the decision.
(2) On receiving an application under subsection (1) relating to a decision not to approve an eligible midwife under section 84AAF, the Secretary must reconsider the decision and:
(a) affirm the decision; or
(b) approve the eligible midwife.
An approval under paragraph (b) is taken, for the purposes of this Act, to be an approval under section 84AAF.
(3) On receiving an application under subsection (1) relating to a suspension or revocation of an approval under section 84AAG, the Secretary must reconsider the decision and:
(a) affirm the suspension or revocation; or
(b) reinstate the approval.
A reinstatement under paragraph (b) has effect as if the approval had never been revoked.
(4) The Secretary must give to the applicant written notice of the Secretary’s decision under subsection (2) or (3).
Note: Sections 105AC of this Act and 27A of the Administrative Appeals Tribunal Act 1975 require the person to be notified of the person’s review rights.
(5) In this section:
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
84AAI Meaning of eligible nurse practitioner
(1) For the purposes of this Part, a person is an eligible nurse practitioner if the person:
(a) is a nurse practitioner; and
(b) meets the requirements (if any) set out in a determination made under subsection (2).
(2) The Minister may, by legislative instrument, determine one or more requirements that a specified person must meet in order to be an eligible nurse practitioner for the purposes of this Part.
84AAJ Authorised nurse practitioners
(1) An eligible nurse practitioner may apply to the Secretary, in writing, to be an authorised nurse practitioner for the purposes of this Part.
(2) The Secretary may approve the application if satisfied that the eligible nurse practitioner meets the criteria determined under paragraph (3)(a). The approval is subject to any conditions determined under paragraph (3)(b).
(3) The Minister may, by legislative instrument, determine either or both of the following:
(a) criteria by which applications are to be considered under this section;
(b) conditions to which approvals under this section are subject.
(4) The Secretary must, as soon as is practicable, approve or reject an application under subsection (1) and notify the applicant in writing of the decision.
Note: Section 27A of the Administrative Appeals Tribunal Act 1975 requires the person to be notified of the person’s review rights.
84AAK Secretary may suspend or revoke approval of authorised nurse practitioner
(1) The Secretary may suspend or revoke an approval under section 84AAJ if satisfied that the person to whom the approval relates:
(a) is not, at the time of the suspension or revocation, an eligible nurse practitioner; or
(b) does not, at the time of the suspension or revocation, meet the criteria that would apply if the person were to apply under subsection 84AAJ(1) to be an authorised nurse practitioner at that time; or
(c) has breached a condition to which the approval is subject under paragraph 84AAJ(3)(b); or
(d) has breached a condition to which an approval would be subject under paragraph 84AAJ(3)(b) if the person were to apply under subsection 84AAJ(1) to be an authorised nurse practitioner at that time.
(2) Before deciding to suspend or revoke the approval, the Secretary must notify the person that suspension or revocation is being considered. The notice must:
(a) be in writing; and
(b) include the Secretary’s reasons for considering the suspension or revocation; and
(c) invite the person to make written submissions to the Secretary within the period of 28 days (the submission period) after being given the notice.
(3) In deciding whether to suspend or revoke the approval, the Secretary must consider any written submissions made by the person during the submission period.
(4) The Secretary must give to the person written notice of the decision. If the decision is to suspend an approval, the notice must specify the period for which the approval is suspended.
Note: Section 27A of the Administrative Appeals Tribunal Act 1975 requires the person to be notified of the person’s review rights.
(5) If the Secretary does not give the person written notice of the decision within the period of 60 days after the end of the submission period, the Secretary is taken to have decided not to suspend or revoke the approval.
(6) If the Secretary suspends the approval, the Secretary may, by written notice at any time, further suspend or revoke the approval under subsection (1) or remove the suspension.
84AAL Review of decisions relating to authorised nurse practitioners
(1) If the Secretary:
(a) decides not to approve an eligible nurse practitioner under section 84AAJ; or
(b) suspends or revokes an approval under section 84AAK;
the person to whom the approval relates may apply, in writing, to the Secretary for reconsideration by the Secretary of the decision.
(2) On receiving an application under subsection (1) relating to a decision not to approve an eligible nurse practitioner under section 84AAJ, the Secretary must reconsider the decision and:
(a) affirm the decision; or
(b) approve the eligible nurse practitioner.
An approval under paragraph (b) is taken, for the purposes of this Act, to be an approval under section 84AAJ.
(3) On receiving an application under subsection (1) relating to a suspension or revocation of an approval under section 84AAK, the Secretary must reconsider the decision and:
(a) affirm the suspension or revocation; or
(b) reinstate the approval.
A reinstatement under paragraph (b) has effect as if the approval had never been revoked.
(4) The Secretary must give to the applicant written notice of the Secretary’s decision under subsection (2) or (3).
Note: Sections 105AC of this Act and 27A of the Administrative Appeals Tribunal Act 1975 require the person to be notified of the person’s review rights.
(5) In this section:
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
84AB Pharmaceutical items
If:
(a) a declaration under subsection 85(2) is in force in relation to a drug or medicinal preparation (the drug); and
(b) a determination under subsection 85(3) is in force in relation to a form of the drug; and
(c) a determination under subsection 85(5) is in force in relation to a manner of administration of that form of the drug;
then the drug in that form with that manner of administration is a pharmaceutical item.
84ABA References to pharmaceutical items, combination items or pharmaceutical benefits having a drug
(1) A reference in this Part to a pharmaceutical item having a drug is a reference to the pharmaceutical item having the drug or medicinal preparation referred to in paragraph 84AB(a) in the application of that paragraph to the pharmaceutical item.
(2) A reference in this Part to a combination item having a drug is a reference to the combination item having the drug or medicinal preparation referred to in paragraph 84AB(a) in the application of that paragraph to the pharmaceutical item that is the combination item.
(3) A reference in this Part to a pharmaceutical benefit having a drug is a reference to the pharmaceutical benefit having the drug or medicinal preparation referred to in paragraph (a) of the definition of pharmaceutical benefit in subsection 84(1) in relation to the pharmaceutical benefit.
84AC When listed drug is on F1 or F2
F1
(1) A drug is on F1 if there is a determination in force under section 85AB or 99AEJ that the drug is on F1.
(2) A drug is on F1 if:
(a) the regulations prescribe that the drug is on F1; and
(b) there is not a determination under section 85AB in force that the drug is on F2.
F2
(3) A drug is on F2 if there is a determination in force under section 85AB that the drug is on F2.
(4) A drug is on F2 if the regulations prescribe that the drug is on F2.
Regulations
(5) On the day on which this section commences, the regulations may prescribe that a drug or medicinal preparation that is a listed drug on that day is on F1 or F2.
84AD When listed drug is in Part A or Part T of F2
Part A
(1) A drug is in Part A of F2 if there is a determination in force under section 85AC that the drug is in Part A of F2.
(2) A drug is in Part A of F2 if the regulations prescribe that the drug is in Part A of F2.
Part T
(3) A drug is in Part T of F2 if there is a determination in force under section 85AC that the drug is in Part T of F2.
(4) A drug is in Part T of F2 if the regulations prescribe that the drug is in Part T of F2.
Regulations
(5) Regulations made under subsection 84AC(5) that prescribe that a drug is on F2 may also prescribe that the drug is in Part A or Part T of F2.
(6) Regulations made for subsection (2) or (4) cease to be in force on 1 December 2010.
(7) Regulations made for subsection (5), to the extent that they prescribe that a drug is in Part A or Part T of F2, cease to be in force on 1 December 2010.
Note: Subsection (7) does not affect the regulations to the extent that they prescribe that a drug is on F1 or F2.
84AE Co‑marketed brands
When co‑marketed brands are to be treated as one brand
(1) For the purposes of section 85AB, 2 or more brands of a pharmaceutical item that are co‑marketed brands of the pharmaceutical item are to be treated as if they were only one brand of the pharmaceutical item.
Meaning of co‑marketed brands
(2) 2 or more brands of a pharmaceutical item are co‑marketed brands of the pharmaceutical item if:
(a) a determination is in force under subsection (3) that the brands are co‑marketed brands of the pharmaceutical item; or
(b) both of the following apply:
(i) the regulations prescribe under subsection (4) that the brands are co‑marketed brands of the pharmaceutical item;
(ii) there is no determination in force under subsection (3B) that the brands cease to be co‑marketed brands of the pharmaceutical item.
Ministerial determination
(3) The Minister may, by legislative instrument, determine that 2 or more brands (the co‑marketed brands) of a pharmaceutical item (the co‑marketed item) are co‑marketed brands of the co‑marketed item if the following paragraphs are satisfied:
(a) within 4 months of the first of the co‑marketed brands of the co‑marketed item being included on the Australian Register of Therapeutic Goods, applications are made to include the other co‑marketed brands of the co‑marketed item on the Register;
(b) the first determination that is made under subsection 85(6) in relation to a brand of the co‑marketed item is made only in relation to the co‑marketed brands of the co‑marketed item;
(c) each of the co‑marketed brands is a listed brand of the co‑marketed item;
(d) no other brand is a listed brand of the co‑marketed item;
(e) if there is another pharmaceutical item that has the same drug as the co‑marketed item:
(i) each of the co‑marketed brands is a listed brand of that pharmaceutical item; and
(ii) no other brand is a listed brand of that pharmaceutical item.
(3A) The Minister may, by legislative instrument, vary or revoke a determination under subsection (3) so that all brands (the co‑marketed brands) that are co‑marketed brands of a pharmaceutical item (the co‑marketed item) cease to be co‑marketed brands of the co‑marketed item if:
(a) any of the co‑marketed brands is not a listed brand of the co‑marketed item; or
(b) another brand is a listed brand of the co‑marketed item; or
(c) if there is another pharmaceutical item that has the same drug as the co‑marketed item:
(i) any of the co‑marketed brands is not a listed brand of that pharmaceutical item; or
(ii) another brand is a listed brand of that pharmaceutical item.
(3B) The Minister may, by legislative instrument, determine that all brands (the co‑marketed brands) that are prescribed by the regulations as being co‑marketed brands of a pharmaceutical item (the co‑marketed item) cease to be co‑marketed brands of the co‑marketed item if:
(a) any of the co‑marketed brands is not a listed brand of the co‑marketed item; or
(b) another brand is a listed brand of the co‑marketed item; or
(c) if there is another pharmaceutical item that has the same drug as the co‑marketed item:
(i) any of the co‑marketed brands is not a listed brand of that pharmaceutical item; or
(ii) another brand is a listed brand of that pharmaceutical item.
Regulations
(4) For the purposes of paragraph (2)(b), on the day on which this section commences, the regulations may prescribe that 2 or more brands that are listed brands of a pharmaceutical item on that day are co‑marketed brands of the pharmaceutical item.
84AF Responsible person for a brand of a pharmaceutical item
(1) The Minister may, by legislative instrument, determine that a person is the responsible person for a brand of a pharmaceutical item if:
(a) the person notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to:
(i) wholesalers; or
(ii) in the case of a supply where wholesalers are not involved—approved pharmacists directly; and
(b) the brand of the pharmaceutical item is a listed brand; and
(c) there is no determination in force under this section that another person is the responsible person for:
(i) the brand of the pharmaceutical item; or
(ii) the brand of any other pharmaceutical item.
(2) The notification referred to in paragraph (1)(a) may be made before or after the commencement of this section.
84AG Therapeutic groups
Determinations
(1) The Minister may, by legislative instrument, determine:
(a) one or more therapeutic groups; and
(b) that 2 or more listed drugs are in the same therapeutic group.
(1A) If the Minister proposes to make a determination under paragraph (1)(a), the Minister must obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee in relation to the proposed determination.
(2) A determination for the purposes of paragraph (1)(b) may specify the circumstances in which a listed drug is, or is not, in a therapeutic group.
(3) In making a determination for the purposes of paragraph (1)(b), the Minister may have regard to advice (if any) given (whether before or after the commencement of this section) to the Minister by the Pharmaceutical Benefits Advisory Committee to the effect that a drug or medicinal preparation should, or should not, be treated as interchangeable on an individual patient basis with another drug or medicinal preparation.
(4) If:
(a) section 99ADH has applied to a brand of a pharmaceutical item; and
(b) the Minister has determined, under paragraph (1)(b), that the drug in the pharmaceutical item is in a therapeutic group;
the Minister must, by legislative instrument, vary the determination to remove the drug from that group with effect on the day that section 99ADH applied to the brand of the pharmaceutical item.
(5) Without limiting the powers of the Minister under subsection (1), the Minister may, by legislative instrument, vary a determination to remove a drug from a therapeutic group that contains only 2 drugs. In that case, the group will contain only that remaining drug.
Regulations
(6) On the day on which this section commences, the regulations may prescribe one or more therapeutic groups.
84AH Exempt items
The Minister may, by legislative instrument, determine that a pharmaceutical item (the relevant item) is an exempt item if:
(a) there is only one listed brand of the relevant item; and
(b) there are no listed brands of other pharmaceutical items that are bioequivalent or biosimilar to the listed brand of the relevant item; and
(c) the relevant item and at least one listed brand of another pharmaceutical item have the same drug; and
(d) the Minister is satisfied, having regard to advice (if any) given to the Minister by the Pharmaceutical Benefits Advisory Committee (whether before or after the commencement of this section), that:
(i) the listed drug in the relevant item represents suitable therapy for a particular patient population; and
(ii) the relevant item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration of the drug in the item; and
(iii) no other pharmaceutical item that has that drug is suitable for use by that subgroup because of either or both of the form and manner of administration of the drug in that other item.
84AI Rounding amounts
If an amount worked out under this Part is not a number of whole cents, round the amount to the nearest cent (rounding 0.5 cents upwards).
84AJ When pharmaceutical benefits are Schedule equivalent
A pharmaceutical benefit (the first benefit) is Schedule equivalent to another pharmaceutical benefit (the second benefit) if the Schedule of Pharmaceutical Benefits referred to in paragraph 103(2A)(b) states that the first benefit and the second benefit are equivalent.
84AK Quantities of pharmaceutical items
Pricing quantity
(1) The pricing quantity of a listed brand of a pharmaceutical item is the lowest of any pack quantity of any listed brand of the pharmaceutical item.
Pack quantity
(2) The Minister may, by legislative instrument, determine for a listed brand of a pharmaceutical item that one or more quantities or numbers of units of the pharmaceutical item is a pack quantity of the brand of the pharmaceutical item.
Determined quantity
(3) The Minister may, by legislative instrument, determine for a listed brand of a pharmaceutical item that one or more quantities or numbers of units of the pharmaceutical item is a determined quantity of the brand of the pharmaceutical item.
Division 1A—Safety net concession cards and pharmaceutical benefits entitlement cards
84B Family relationships
(1) For the purposes of this Division, the following are the members of a person’s family:
(a) the person’s spouse;
(b) any dependent child of the person or the person’s spouse.
(2) For the purposes of this section, a person who is, at any time during a relevant entitlement period, a dependent child of another person shall be taken to be a dependent child of that other person throughout the remainder of that period.
(3) For the purposes of this section, a person shall not be taken to have the custody of a child unless the person, whether alone or jointly with another person, has the right to have, and to make decisions concerning, the daily care and control of the child.
(4) In this section:
child means a person who:
(a) is under the age of 16 years; or
(b) is a student child.
dependent child, in relation to a person, means:
(a) a child under the age of 16 years who is:
(i) in the custody, care and control of the person; or
(ii) where no other person has the custody, care and control of the child—is wholly or substantially in the care and control of the person; or
(b) a student child who is wholly or substantially dependent on the person.
spouse, in relation to a person, means:
(a) a person who is legally married to, and is not living, on a permanent basis, separately and apart from, that person; and
(b) a de facto partner of the person within the meaning of paragraph (a) of the definition of de facto partner in subsection 4(1), who is not living, on a permanent basis, separately and apart from the person;
(c) a de facto partner of the person within the meaning of paragraph (b) of the definition of de facto partner in subsection 4(1).
student child means a person who:
(a) has attained the age of 16 years but has not attained the age of 25 years; and
(b) is receiving full‑time education at a school, college or university.
(5) For the purposes of the definition of spouse in subsection (4):
(a) a person who is the spouse of another person (the person’s partner) under paragraph (a) or (b) of the definition is not taken to be living separately and apart from the person’s partner on a permanent basis, if the person is living apart from the person’s partner only because of the illness or infirmity of either or both of them; and
(b) a person who is the spouse of another person (the person’s partner) under paragraph (c) of the definition is not taken to have ceased to live with the person’s partner on a de facto basis, if the person is living apart from the person’s partner only because of the illness or infirmity of either or both of them.
84BA Supplies of out‑patient medication
(1) The purpose of this section is to make provision so that account may be taken of payments made by a person to a public hospital authority for supplies of out‑patient medication when it is being ascertained, for the purposes of this Part, whether the person is eligible to be issued with a concession card or an entitlement card.
(2) Before the beginning of a relevant entitlement period, the Minister must determine in writing the amounts that, for the purposes of this Part, will be taken to have been paid to a public hospital for supplies of out‑patient medication made, against payment, by the hospital during the relevant entitlement period.
(3) In making a determination, the Minister may determine:
(a) different amounts in respect of a supply of out‑patient medication, having regard to the State or Territory in which the hospital supplying the medication is situated; and
(b) different amounts in respect of:
(i) supplies made to concessional beneficiaries and persons who, in relation to concessional beneficiaries, are dependants within the meaning of subsection 84(4) or (7); and
(ii) supplies made to holders of a concession card; and
(iii) supplies made to general patients other than holders of a concession card.
(4) In this Part:
applicable amount, in relation to a supply of out‑patient medication made by a public hospital to a person during a relevant entitlement period, means the amount that, under the determination applicable for that period, is to be taken to have been paid to the hospital for the supply of medication.
84C Eligibility for concession and entitlement cards
(1AA) A person who is both a general patient and an eligible person at any time during a relevant entitlement period is eligible to be issued with a concession card if:
(a) the total of the amounts charged (otherwise than under subsection 87(2A)) to the person for supplies of pharmaceutical benefits (including supplies taken, because of subsection 99(2A) to be supplies otherwise than under this Part) and repatriation pharmaceutical benefits made to the person during the period and of the applicable amounts in relation to the supplies of out‑patient medication made to the person during the period; or
(b) the total of the amounts charged (otherwise than under subsection 87(2A)) to the person and to the person’s family for supplies for pharmaceutical benefits (including supplies taken, because of subsection 99(2A) to be supplies otherwise than under this Part) and repatriation pharmaceutical benefits made to the person and the person’s family during the period and of the applicable amounts in relation to the supplies of out‑patient medication made to the person and to the person’s family during the period;
is the amount of the general patient safety net (within the meaning of section 99F) or an amount that, together with the amount that the person may be charged under paragraph 87(2)(b), (c) or (e) (whichever is applicable) for the supply of a pharmaceutical benefit, would not be less than the amount of the general patient safety net.
Note: The figures expressed in this subsection in dollars are periodically adjusted under section 99G.
(1C) A person who is a concessional beneficiary during a relevant entitlement period commencing on or after 1 January 1992 is eligible to be issued with an entitlement card in respect of that period if either of the following paragraphs applies:
(a) the total of:
(i) the amounts charged (otherwise than under subsection 87(2A)) for supplies of pharmaceutical benefits and repatriation pharmaceutical benefits made to the person during that period when the person was a concessional beneficiary; and
(ia) the applicable amounts in relation to the supplies of out‑patient medication made to the person during that period when the person was a concessional beneficiary; and
(ii) where the person has, during that period, been a general patient—the transferred value of amounts (if any) charged for supplies of pharmaceutical benefits and repatriation pharmaceutical benefits made to the person, and of applicable amounts in relation to the supplies (if any) of out‑patient medication made to the person, during that period when the person was a general patient;
is the amount of the concessional beneficiary safety net (within the meaning of section 99F) or an amount that, together with the amount chargeable under paragraph 87(2)(a) for the supply of a pharmaceutical benefit would be not less than the amount of the concessional beneficiary safety net;
(b) the total of:
(i) the aggregate of amounts charged (otherwise than under subsection 87(2A)) for supplies of pharmaceutical benefits and repatriation pharmaceutical benefits made to the person and the person’s family during that period when the person was a concessional beneficiary; and
(ia) the applicable amounts in relation to the supplies of out‑patient medication made to the person and the person’s family during that period when the person was a concessional beneficiary; and
(ii) where the person has, during that period, been a general patient—the transferred value of amounts (if any) charged for supplies of pharmaceutical benefits and repatriation pharmaceutical benefits made to the person and the person’s family, and of applicable amounts in relation to the supplies (if any) of out‑patient medication made to the person and the person’s family, during that period when the person was a general patient;
is the amount of the concessional beneficiary safety net (within the meaning of section 99F) or an amount that, together with the amount chargeable under paragraph 87(2)(a) for the supply of a pharmaceutical benefit would be not less than the amount of the concessional beneficiary safety net.
(2) For the purposes of this section, a pharmaceutical benefit supply or a supply of out‑patient medication is taken to have been made, during a relevant entitlement period, to a person’s family if and only if the supply was made, during that period, to:
(a) a person who was, at the time when the person applied for the issue of a concessional card or an entitlement card in respect of that period, a member of the person’s family; or
(b) a person who was, at the time of supply, a member of the person’s family.
(3) Where:
(a) a prescription is for the supply of a pharmaceutical benefit or a repatriation pharmaceutical benefit to a person (in this subsection referred to as the patient); and
(b) upon the prescription, a pharmaceutical benefit or repatriation pharmaceutical benefit (the benefit) is given to another person, as agent for the patient, for supply to the patient;
the benefit shall, for the purposes of this section, be taken to have been supplied to the patient upon the prescription.
(4) The supply or repeated supply of a pharmaceutical benefit to a person shall not be taken into account for the purposes of this section unless:
(a) the pharmaceutical benefit is supplied:
(i) by an approved pharmacist, at or from premises in respect of which the pharmacist is for the time being approved, on presentation of a prescription written by a PBS prescriber in accordance with this Act and the regulations, or, in such circumstances as are prescribed for the purposes of paragraph 89(a), on communication to the pharmacist, in the manner prescribed for the purposes of that paragraph, of a prescription of a PBS prescriber; or
(ii) in accordance with section 92 or 94;
Note: Sometimes a supply can still be taken into account if the pharmacist is approved later. See subsection 99(3B).
(b) at the time of supply, the person:
(iii) was not a holder of an entitlement card;
(c) in a case where the supply is made upon a general benefit prescription, the Commonwealth price for the pharmaceutical benefit exceeds $28.60 and an approved pharmacist or approved medical practitioner is not entitled to be paid by the Commonwealth under subsection 99(2AA) an amount that is equal to the special patient contribution for a brand of a pharmaceutical item that is the pharmaceutical benefit—the amount received in respect of the supply is equal to or exceeds the aggregate of $28.60 and the special patient contribution (if any) for the brand of the pharmaceutical item;
(d) in a case where the supply is made upon a concessional benefit prescription, the Commonwealth price for the pharmaceutical benefit exceeds $4.60 and an approved pharmacist or approved medical practitioner is not entitled to be paid by the Commonwealth under subsection 99(2AA) an amount that is equal to the special patient contribution for a brand of a pharmaceutical item that is the pharmaceutical benefit—the amount received in respect of the supply is equal to or exceeds the aggregate of $4.60 and the special patient contribution (if any) for the brand of the pharmaceutical item; and
(e) in a case where the supply is deemed, by virtue of subsection 99(2A), (2AB) or (2B), to be a supply otherwise than under this Part:
(i) the amount demanded or received in respect of the supply does not exceed the aggregate of:
(A) the price worked out in accordance with a determination in force under subsection (7) for the pharmaceutical benefit;
(B) any charge demanded or received by reason only that the supply was made at a time outside normal trading hours; and
(C) any charge demanded or received in accordance with regulations made for the purposes of paragraph 87(4)(b).
Note: The figures expressed in this subsection in dollars are periodically adjusted under section 99G.
(4AA) The supply or repeated supply of a pharmaceutical benefit or repatriation pharmaceutical benefit to a person must not be taken into account for the purposes of this section if:
(a) it is an early supply of a specified pharmaceutical benefit; and
(b) it is not a supply of out‑patient medication.
(4A) The supply or repeated supply of a repatriation pharmaceutical benefit to a person is not to be taken into account for the purposes of this section unless:
(a) the repatriation pharmaceutical benefit is supplied:
(i) under the scheme established under section 91 of the Veterans’ Entitlements Act 1986; or
(ii) in accordance with a determination under paragraph 286(1)(c) of the Military Rehabilitation and Compensation Act 2004; or
(iii) under a scheme that applies under section 18 of the Australian Participants in British Nuclear Tests (Treatment) Act 2006; and
(b) at the time of supply the person was not a holder of an entitlement card.
(4B) A supply of out‑patient medication to a person is not to be taken into account for the purposes of this section if, at the time of the supply, the person is the holder of an entitlement card.
(7) The Minister may determine, by legislative instrument, the manner in which the price for particular quantities or numbers of units of all or any pharmaceutical benefits is to be ascertained for the purpose of this section.
(8) A manner determined under subsection (7) shall:
(a) in the case of a pharmaceutical benefit that is a listed brand of a pharmaceutical item—take as a basis the approved ex‑manufacturer price or a proportional ex‑manufacturer price of the brand of the pharmaceutical item that was in force on the first day of the month of the year in which the supply occurs; and
(b) in the case of other pharmaceutical benefits—take as a basis the basic wholesale price of each ingredient that is applicable on the day on which the supply occurs; and
(c) provide for the addition of such fees and other amounts as are determined by the Tribunal for the purposes of paragraph 98B(2)(c); and
(d) provide for the addition of such other fees and other amounts as are determined by the Minister.
(9) The Minister shall not determine an amount for the purpose of paragraph (8)(d) unless the Pharmacy Guild of Australia has agreed in writing to the making of that determination.
(11) In this section, unless the contrary intention appears:
basic wholesale price has the same meaning as in section 98B.
pharmaceutical benefit supply means a supply or a repeated supply of a pharmaceutical benefit or repatriation pharmaceutical benefit.
84CA Modification of amounts paid
For the purposes of subsection 84C(1C), the transferred value of amounts charged for, or applicable in relation to, supplies is worked out by multiplying $4.60 by the number of supplies.
Note: The figure expressed in this section in dollars is periodically adjusted under section 99G.
84D Pharmaceutical benefits prescription record forms etc.
(1) Upon application, the Secretary shall issue to a person a pharmaceutical benefits prescription record form in accordance with subsections (3) and (4).
(1A) Upon application, the Secretary must issue to a person an out‑patient medication prescription record form in accordance with subsections (3) and (4).
(2) An approved pharmacist, approved medical practitioner or approved hospital authority may issue to a person a pharmaceutical benefits prescription record form in accordance with subsections (3) and (4).
(2A) A public hospital authority may issue to a person an out‑patient medication prescription record form in accordance with subsections (3) and (4).
(3) A pharmaceutical benefits prescription record form and an out‑patient medication prescription record form must:
(a) be in accordance with the form approved by the Secretary; and
(b) include the prescribed particulars of the person to whom the form is issued.
(4) A pharmaceutical benefits prescription record form or an out‑patient medication prescription record form issued to a person may include the prescribed particulars of any person who is a member of the person’s family and:
(c) is not a holder of an entitlement card.
(5) Where a pharmaceutical benefits prescription record form or an out‑patient medication prescription record form is issued to a person, the person and each member of the person’s family whose particulars are included in the form in accordance with subsection (4) shall be taken, for the purposes of this section, to be a holder of the form.
(6) Where:
(a) an approved pharmacist, approved medical practitioner or approved hospital authority supplies a pharmaceutical benefit or repatriation pharmaceutical benefit to a holder of a pharmaceutical benefits prescription record form;
(b) the form is presented at the time of supply; and
(c) the supply is:
(i) a supply of a pharmaceutical benefit to be taken into account under subsection 84C(4) for the purposes of section 84C; or
(ii) a supply of a repatriation pharmaceutical benefit to be taken into account, under subsection 84C(4A), for the purposes of section 84C;
the pharmacist, medical practitioner or authority shall record the supply of that pharmaceutical benefit on the form.
(7) A record made for the purposes of subsection (6) shall include:
(a) the prescribed particulars of the prescription upon which the pharmaceutical benefit or repatriation pharmaceutical benefit is supplied;
(b) the date on which the pharmaceutical benefit or repatriation pharmaceutical benefit is supplied; and
(c) such other particulars in relation to the supply of the pharmaceutical benefit or repatriation pharmaceutical benefit as are prescribed;
and shall be signed by:
(d) in a case where the record is made by an approved pharmacist—the pharmacist;
(e) in a case where the record is made by an approved medical practitioner—the medical practitioner; or
(f) in a case where the record is made by an approved hospital authority—the medical practitioner or pharmacist by or under whose supervision the pharmaceutical benefit or repatriation pharmaceutical benefit is dispensed.
(8) An approved pharmacist may authorise a person to record, on behalf of the pharmacist, the supply of pharmaceutical benefits and repatriation pharmaceutical benefits for the purposes of subsection (6).
(9) A reference in subsection (7) to an approved pharmacist includes a reference to a person authorised by a pharmacist under subsection (8) to record, on behalf of the pharmacist, the supply of pharmaceutical benefits and repatriation pharmaceutical benefits.
(10) Where:
(a) an out‑patient medication is supplied to the holder of an out‑patient medication prescription record form; and
(b) the form is presented at the time of supply; and
(c) the supply is not excluded under subsection 84C(4B) from being taken into account for the purposes of section 84C;
the medical practitioner or pharmacist by whom, or under whose supervision, the medication is dispensed, or any person authorised under subsection (12) to do so, must record the supply of the medication on the form.
(11) A record made for the purposes of subsection (10) must include:
(a) the prescribed particulars of the prescription upon which the medication is supplied; and
(b) the date on which the medication is supplied; and
(c) any other particulars of the supply that are prescribed;
and must be signed by the person making the record.
(12) The public hospital authority of a public hospital may authorise in writing a person employed at the hospital to record, for the purposes of subsection (10), the supply of an out‑patient medication dispensed by, or under the supervision of, a medical practitioner or pharmacist.
84DA Issue of safety net concession card
(1) Where:
(a) a person applies, either personally or through the person’s agent, to the Secretary for a safety net concession card in respect of a relevant entitlement period; and
(b) the Secretary is satisfied that the person is eligible to be issued with such a card in respect of that period;
the Secretary must issue a safety net concession card to the person in respect of that period.
(2) Where:
(a) a person applies, either personally or through the person’s agent, to an approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority for a safety net concession card in respect of a relevant entitlement period; and
(b) the pharmacist, medical practitioner or authority is satisfied that the person is eligible to be issued with such a card in respect of that period;
the pharmacist, medical practitioner or authority may issue a safety net concession card to the person in respect of that period.
(3) An application under subsection (1) or (2) must:
(a) be in the form approved by the Secretary; and
(b) contain such particulars, and be accompanied by such documents, as are prescribed; and
(c) be signed by the person making the application or by the person’s agent.
(4) Where an application is made to a person for the issue of a safety net concession card, the person to whom the application is made must, in determining whether to issue a card, have regard to:
(a) the matters contained in the application;
(b) any record form or other document that accompanies the application; and
(c) such other matters as the person considers relevant.
(5) Where:
(a) a person applies, either personally or through the person’s agent, to an approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority for a safety net concession card in respect of a relevant entitlement period; and
(b) the pharmacist, medical practitioner or authority issues such a card to the person in respect of that period;
the pharmacist, medical practitioner or authority must submit the application, and all documents that accompanied the application, to the Secretary by lodging them at a prescribed office within one month (or such longer period as is prescribed) after the day on which the card is issued.
84E Issue of pharmaceutical benefits entitlement card
(1) Where:
(a) a person applies, either personally or through the person’s agent, to the Secretary for a pharmaceutical benefits entitlement card in respect of a relevant entitlement period; and
(b) the Secretary is satisfied that the person is eligible to be issued with a pharmaceutical benefits entitlement card in respect of that period;
the Secretary shall issue a pharmaceutical benefits entitlement card to the person in respect of that period.
(2) Where:
(a) a person applies, either personally or through the person’s agent, to an approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority for a pharmaceutical benefits entitlement card in respect of a relevant entitlement period; and
(b) the pharmacist, medical practitioner or authority is satisfied that the person is eligible to be issued with a pharmaceutical benefits entitlement card in respect of that period;
the pharmacist, medical practitioner or authority may issue a pharmaceutical benefits entitlement card to the person in respect of that period.
(3) An application under subsection (1) or (2) shall:
(a) be in accordance with the form approved by the Secretary;
(b) contain such particulars, and be accompanied by such documents, as are prescribed; and
(c) be signed by the person making the application or by the person’s agent.
(4) Where an application is made to a person for the issue of an entitlement card, the person to whom the application is made shall, in determining whether to issue an entitlement card, have regard to:
(a) the matters contained in the application;
(b) any record form or other document that accompanies the application; and
(c) such other matters as the person considers relevant.
(5) Where:
(a) a person applies, either personally or through the person’s agent, to an approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority for a pharmaceutical benefits entitlement card in respect of a relevant entitlement period; and
(b) the pharmacist, medical practitioner or authority issues a pharmaceutical benefits entitlement card to the person in respect of that period;
the pharmacist, medical practitioner or authority shall submit the application, and all relevant documents that accompanied or supported the application, to the Secretary by lodging them at a prescribed office within one month (or such longer period as is prescribed) after the day on which the entitlement card is issued.
(7) In subsection (5), relevant document means a document accompanying an application under subsection (1) or (2).
84F Form of cards
(1) A concession card must be in the form approved by the Secretary for that card.
(1A) An entitlement card must be in the form approved by the Secretary for that card.
(2) Without limiting the generality of subsections (1) and (1A), a concession card and an entitlement card shall include particulars of:
(a) the relevant entitlement period in respect of which the card is issued; and
(b) the person to whom the card is issued and each person who is, at the time when the card is issued, a member of the person’s family.
(3) The omission from a concession card or an entitlement card of particulars of a person who is, at the time when the card is issued, a member of the family of the person to whom the card is issued does not affect the validity of the card.
84G Persons covered by card
Subject to subsection 84H(3), where a concession card or an entitlement card is issued to a person, the person and each person who is, at the time when the card is issued, a member of the person’s family shall be taken, for the purposes of this Act, to be a holder of the card.
84H Additional and replacement cards
(1) Where a concession card or an entitlement card has been issued, an additional concession card or an additional entitlement card (as the case may be) may, in accordance with the regulations, be issued to a person who is a holder of the card.
(2) Without limiting the generality of subsection (1), regulations made for the purposes of that subsection may provide for the issue of an additional card to a person:
(a) who is or was a holder of a concession card or an entitlement card that has been lost, stolen, damaged or destroyed; or
(b) who is a holder of a concession card or an entitlement card but whose particulars are not included on the card.
(3) Where:
(a) a person (in this subsection called the original card holder) has been issued with a concession card, or an entitlement card, in respect of a relevant entitlement period; and
(b) a person (in this subsection referred to as the new family member) becomes, after the issue of the card and during that period, a member of the original card holder’s family;
a replacement concession card or a replacement entitlement card (as the case may be) may, in accordance with the regulations, be issued to the original card holder, being a card that includes particulars of the holders of the original card and of the new family member and, where such a replacement card is issued, each holder of the original card and the new family member shall be taken, from the time when the replacement card is issued, to be a holder of the replacement card.
(4) Regulations made for the purposes of subsection (1) or (3) may provide for application to be made to the Administrative Appeals Tribunal for review of a decision of a person refusing to issue an additional card or a replacement card.
84HA Fee to approved pharmacist etc. for issuing card
(1) An approved pharmacist, approved medical practitioner or approved hospital authority who issues a safety net concession card, a pharmaceutical benefits entitlement card or an additional or replacement card in relation to any of those cards is entitled to be paid by the Commonwealth, in respect of the issue of the card, the fee determined by the Minister, for the purposes of this section, for the issue of cards generally or for the issue of cards of that kind, as the case requires.
(2) The Minister shall not determine a fee for the purposes of this section unless the Pharmacy Guild of Australia has agreed in writing to the making of that determination.
(3) A determination under subsection (1) shall:
(a) be made by notice in writing published in the Gazette; and
(b) come into operation on such day as is specified in the determination.
84J Period of effect of card
A concession card or an entitlement card issued in respect of a relevant entitlement period commences to have effect on the day on which it is issued and ceases to have effect at the end of that period.
84K Return of card
Where a concession card or an entitlement card is issued to a person who is not eligible to be issued with the card, the Secretary may, by notice in writing to a holder of the card, require the holder to deliver the card, within such period (not being a period of less than 7 days) as is specified in the notice, to:
(a) the Secretary; or
(b) such other person as is specified in the notice;
for cancellation and the holder shall comply with the notice.
84L Offences
(1) An approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority shall not issue a concession card or an entitlement card to a person who is not eligible to be issued with such a card.
Penalty: $5,000 or imprisonment for 2 years, or both.
(2) An approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority shall not include in a concession card or an entitlement card, as the name of a member of a person’s family, the name of a person who is not a member of the person’s family.
Penalty: $5,000 or imprisonment for 2 years, or both.
(3) A person shall not fail to comply with a notice given to the person under section 84K.
Penalty: $2,000 or imprisonment for 12 months, or both.
(4) A person shall not fail to comply with subsection 84DA(5) or 84E(5).
Penalty for contravention of this subsection: $2,000 or imprisonment for 12 months, or both.
(5) Subsections (3) and (4) do not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (5). See subsection 13.3(3) of the Criminal Code.
Division 2—Supply of pharmaceutical benefits
85 Pharmaceutical benefits
Pharmaceutical benefits
(1) Benefits shall be provided by the Commonwealth, in accordance with this Part, in respect of pharmaceutical benefits.
Note 1: While most pharmaceutical benefits are generally available for supply under this Part, some pharmaceutical benefits (see sections 85AAA and 85AA) can only be supplied under this Part under the prescriber bag provisions or in accordance with special arrangements under section 100.
Note 2: Special arrangements under section 100 can modify the effect of this Part in relation to the supply of pharmaceutical benefits that are covered by the arrangements (see subsection 100(3)).
Drugs etc.
(2) The drugs and medicinal preparations in relation to which this Part applies are:
(a) drugs and medicinal preparations that are:
(i) declared by the Minister, by legislative instrument, to be drugs and medicinal preparations to which this Part applies; or
(ii) included in a class of drugs and medicinal preparations declared by the Minister, by legislative instrument, to be a class of drugs and medicinal preparations to which this Part applies; and
(b) medicinal preparations composed of:
(i) one or more of the drugs and medicinal preparations referred to in paragraph (a), being a drug or medicinal preparation that is, or drugs and medicinal preparations that are, included in a class of drugs and medicinal preparations declared by the Minister, by legislative instrument, to be a class of drugs and medicinal preparations to which this paragraph applies; and
(ii) one or more of such additives as are declared by the Minister, by legislative instrument, to be additives to which this paragraph applies.
Note 1: The Minister cannot make a declaration under this subsection in relation to a drug or medicinal preparation unless the Pharmaceutical Benefits Advisory Committee has recommended that the drug or medicinal preparation be declared (see subsections 101(4) and (4A)).
Note 2: If the Minister makes a declaration in relation to a drug or medicinal preparation under this subsection, the Minister cannot vary or revoke that declaration so as to delist the drug or medicinal preparation without first obtaining the Pharmaceutical Benefits Advisory Committee’s advice (see subsection 101(4AAB)).
Drugs etc. that can only be supplied under the prescriber bag provisions
(2AA) If:
(a) the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and
(b) the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AACA) that the drug be supplied only under one or more of the prescriber bag provisions;
then the Minister must, by legislative instrument, declare that the drug can only be supplied under that provision or those provisions.
Note: If the Minister makes a declaration in relation to a drug or medicinal preparation under this subsection, the Minister cannot vary or revoke that declaration without first satisfying the conditions set out in subsection 101(4AACC).
Drugs etc. that can only be supplied under special arrangements
(2A) If:
(a) the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and
(b) the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100;
then the Minister must, by legislative instrument, declare that the drug can only be supplied under such special arrangements.
Note: If the Minister makes a declaration in relation to a drug or medicinal preparation under this subsection, the Minister cannot vary or revoke that declaration without first satisfying the conditions set out in subsection 101(4AAF).
Forms
(3) The Minister may, by legislative instrument, determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a listed drug.
(4) A form of a listed drug as determined by the Minister under subsection (3) may be such as to require the addition of a substance or substances to the drug so that it will be suitable for administration in a particular manner or at a particular strength.
Manners of administration
(5) The Minister may, by legislative instrument, determine the manner of administration of a form of a listed drug, being a form of the drug in relation to which a determination under subsection (3) is in force.
Brands
(6) The Minister may, by legislative instrument, determine a brand of a pharmaceutical item.
Prescriptions of pharmaceutical benefits in certain circumstances
(7) The Minister may, by legislative instrument, determine:
(a) that a particular pharmaceutical benefit is to be a relevant pharmaceutical benefit for the purposes of section 88A; and
(b) the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written.
Pharmaceutical benefits that can only be supplied under the prescriber bag provisions
(7A) The Minister may, by legislative instrument, determine that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions.
Pharmaceutical benefits that can only be supplied under special arrangements
(8) The Minister may, by legislative instrument, determine that:
(a) a particular pharmaceutical benefit (other than a pharmaceutical benefit that has a drug covered by subsection (2A)) can only be supplied under special arrangements under section 100; or
(b) one or more of the circumstances in which a prescription for the supply of a pharmaceutical benefit may be written under paragraph (7)(b) are circumstances in which the benefit can only be supplied under special arrangements under section 100.
85AAA Pharmaceutical benefits that can only be supplied under the prescriber bag provisions
(1) If the Minister makes a declaration under subsection 85(2AA) in relation to a drug or medicinal preparation (the drug) declaring that the drug can only be supplied under one or more of the prescriber bag provisions, then every pharmaceutical benefit that has that drug can only be supplied under this Part under that provision or those provisions.
(2) If the Minister makes a determination under subsection 85(7A) that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions, then that pharmaceutical benefit can only be supplied under this Part under that provision or those provisions.
(3) Despite subsections (1) and (2), if:
(a) the Minister makes a declaration under subsection 85(2AA) declaring that a drug or medicinal preparation (the drug) can only be supplied under one or more (but not all) of the prescriber bag provisions (the drug prescriber bag provision); and
(b) the Minister makes a determination under subsection 85(7A) determining that a pharmaceutical benefit that has the drug can only be supplied under a different prescriber bag provision or different prescriber bag provisions (the pharmaceutical benefit prescriber bag provision);
then the pharmaceutical benefit can only be supplied under this Part under the drug prescriber bag provision and the pharmaceutical benefit prescriber bag provision.
85AA Pharmaceutical benefits that can only be supplied under special arrangements
(1) If the Minister makes a declaration under subsection 85(2A) in relation to a drug or medicinal preparation (the drug), then every pharmaceutical benefit that has that drug can only be supplied under this Part in accordance with special arrangements under section 100.
(2) If the Minister makes a determination under paragraph 85(8)(a) in relation to a pharmaceutical benefit, then that pharmaceutical benefit can only be supplied under this Part in accordance with special arrangements under section 100.
(3) If the Minister makes a determination under paragraph 85(8)(b) about the circumstances in which a pharmaceutical benefit can only be supplied under special arrangements under section 100, then, in those circumstances, the pharmaceutical benefit can only be supplied under this Part in accordance with those arrangements.
85A Determinations of forms of pharmaceutical benefits or pharmaceutical items with respect to classes of persons
(1) The Minister may determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a pharmaceutical benefit or pharmaceutical item that is or are allowable for the purposes of this Part for prescription by persons included in a class of persons specified in the determination.
(2) The Minister may, with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit:
(a) determine the maximum quantity or number of units of:
(i) if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or
(ii) in any other case—the pharmaceutical benefit;
that may, in one prescription, be directed to be supplied on any one occasion, either for all purposes or for particular purposes; and
(b) determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated, either for all purposes or for particular purposes; and
(c) determine the manner of administration that may, in a prescription, be directed to be used in relation to the pharmaceutical benefit.
(2A) The Minister may determine that particular conditions must be satisfied when writing a prescription to which a determination under paragraph (2)(a) or (b) applies.
(3) The regulations may make provision authorizing the variation of the application, in relation to persons included in a class of persons, of a determination under paragraph (2)(a) or (b) and, where such a variation is made, the determination shall be deemed to have effect as varied.
(3A) The Minister may determine rules that must be applied when deciding whether to authorise a variation under regulations made for the purposes of subsection (3).
(4) A determination made under subsection (1), (2), (2A) or (3A) is a legislative instrument.
85AB Minister may determine that a listed drug is on F1 or F2
(1) Subject to subsection (5), the Minister may, by legislative instrument, determine that a listed drug is on F1 or F2.
(2) The Minister may only determine that the drug is on F1 if the drug satisfies all the criteria for F1.
Note: For other circumstances in which the Minister may determine that a listed drug is on F1, see section 99AEJ.
(3) The Minister may only determine that the drug is on F2 if the drug does not satisfy one or more of the criteria for F1.
(4) The criteria for F1 are as follows:
(a) there are no brands of pharmaceutical items that:
(i) have the drug; and
(ii) are bioequivalent or biosimilar; and
(iii) are listed brands of the pharmaceutical items on any day in the relevant period;
(b) there are no brands of pharmaceutical items that:
(i) have another listed drug that is in the same therapeutic group as the drug; and
(ii) are bioequivalent or biosimilar; and
(iii) are listed brands of the pharmaceutical items on any day in the relevant period;
(c) the drug was not on F2 on the day before the determination under subsection (1) comes into force.
(5) This section does not apply to the drug if:
(a) the drug is in a combination item; and
(b) there are no brands of combination items that:
(i) have the drug; and
(ii) are bioequivalent or biosimilar; and
(iii) are listed brands of the combination items on any day in the relevant period.
(6) In this section:
relevant period means the period that consists of:
(a) the day before the day the determination under subsection (1) comes into force; and
(b) the day the determination under subsection (1) comes into force.
85AC Minister may determine that a listed drug is in Part A or Part T of F2
(1) If, under section 85AB, the Minister determines that a drug is on F2, the Minister may, by legislative instrument, determine that the drug is in Part A or Part T of F2.
(2) The Minister may only determine that the drug is in Part A if the drug satisfies neither of the criteria for Part T.
(3) The Minister may only determine that the drug is in Part T if the drug satisfies either or both of the criteria for Part T.
(4) The criteria for Part T are as follows:
(a) the drug is in the same therapeutic group as a drug that is in Part T;
(b) the drug was in Part T on the day before the determination under subsection (1) comes into force.
(5) A determination under this section ceases to be in force on 1 December 2010.
85AD Price agreements
(1) The Minister and the responsible person for a listed brand of a pharmaceutical item may, from time to time, agree, by reference to the pricing quantity of the brand of the pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.
Note: Section 85C and Division 3A limit the Minister’s power to agree to amounts for the purposes of subsection (1).
(2) It does not matter that at the time the agreement is made:
(a) the person is not yet the responsible person; or
(b) the item is not yet a pharmaceutical item; or
(c) the quantity or number of units of the item is not yet a pricing quantity; or
(d) the brand is not yet a listed brand.
However, those matters must be satisfied at the time the amount referred to in subsection (1) comes into force.
(3) The agreement must be in writing.
85B Price determinations and special patient contributions
Application
(1) This section applies to a listed brand of a pharmaceutical item.
Price determination
(2) If the Minister and the responsible person have been unable to make a price agreement for the brand of the pharmaceutical item, then the Minister may, by legislative instrument, determine, by reference to the pricing quantity of the listed brand of a pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.
Note: Section 85C and Division 3A limit the Minister’s power to determine amounts under subsection (2).
Claimed price determination
(3) The Minister may, by legislative instrument, determine, by reference to a pack quantity of the listed brand of the pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the price of the brand of the pharmaceutical item claimed by the responsible person for that quantity.
Special patient contribution
(4) If the Minister makes a determination under subsection (3), then the Minister may, by legislative instrument, determine the circumstances in which the Commonwealth is to pay the special patient contribution for the brand of the pharmaceutical item.
(5) The special patient contribution for a quantity or number of units of a listed brand of a pharmaceutical item is the amount that is the difference between:
(a) the price that would have been the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item if that Commonwealth price had been based on the claimed price for that quantity or number of units; and
(b) the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item.
85C Each brand of a pharmaceutical item is to have the same approved ex‑manufacturer price
If there are 2 or more listed brands of a pharmaceutical item, then the Minister must ensure, when agreeing an amount under subsection 85AD(1) or determining an amount under subsection 85B(2), that the approved ex‑manufacturer price of each listed brand of the pharmaceutical item is the same.
85D Proportional ex‑manufacturer price
The proportional ex‑manufacturer price for a pack quantity (other than the pricing quantity) of a listed brand of a pharmaceutical item on a day is the amount worked out as follows:
where:
AEMP means the approved ex‑manufacturer price of the brand of the pharmaceutical item in force on that day.
PkQ means the pack quantity of the brand of the pharmaceutical item on that day.
PQ means the pricing quantity of the brand of the pharmaceutical item on that day.
86 Entitlement to receive pharmaceutical benefits
(1) Subject to this Part, a person who:
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) is receiving:
(i) medical treatment by a medical practitioner; or
(ii) dental treatment by a participating dental practitioner; or
(iii) optometrical treatment by an authorised optometrist; or
(iv) midwifery treatment by an authorised midwife; or
(v) nurse practitioner treatment by an authorised nurse practitioner;
is entitled to receive pharmaceutical benefits under this Part without the payment or furnishing of money or other consideration other than a charge made in accordance with section 87.
Residency
(2) For the purposes of paragraph (1)(a), while a person is working outside Australia as a Commonwealth officer, he or she is taken to reside in Australia.
(3) For the purposes of paragraph (1)(a), while a person is working outside Australia as a State or Territory officer, he or she is taken to reside in Australia.
(4) For the purposes of paragraph (1)(a), while the spouse, or a dependent child, of a person covered by subsection (2) or (3) is outside Australia accompanying that person, the spouse or child is taken to reside in Australia.
Note: Paragraph (1)(a) refers to a person being an eligible person within the meaning of the Health Insurance Act 1973. Under that Act an Australian resident is an eligible person. A person must reside in Australia to be an Australian resident.
Definitions
(5) In this section:
dependent child has the same meaning as in section 84B.
spouse has the same meaning as in section 84B.
86A Pharmaceutical benefits not to be supplied in respect of persons reasonably believed not to be in Australia
(1) An approved supplier must not supply a pharmaceutical benefit in respect of a person if the approved supplier has reason to believe that the person is not in Australia at the time of the supply.
Commonwealth, State or Territory officers working outside Australia
(2) However, subsection (1) does not apply to the supply of a pharmaceutical benefit in respect of:
(a) a person working outside Australia as a Commonwealth officer; or
(b) a person working outside Australia as a State or Territory officer; or
(c) the spouse, or a dependent child, of a person covered by paragraph (a) or (b) if the spouse or child is outside Australia accompanying that person.
Definitions
(3) In this section:
dependent child has the same meaning as in section 84B.
spouse has the same meaning as in section 84B.
86B Approved supplier may request provision of medicare number
Approved supplier may request provision of medicare number
(1) If:
(a) an approved supplier is presented with a prescription for the supply of a pharmaceutical benefit to a person; and
(b) the person presenting the prescription claims to be, or to be the agent of, the person to whom the prescription relates; and
(c) the person presenting the prescription does not request that the drug or medicinal preparation to which the prescription relates not be supplied as a pharmaceutical benefit;
the approved supplier may request the person presenting the prescription to provide to the approved supplier a medicare number applicable to the person to whom the prescription relates and the expiry date in relation to the number.
Inclusion of medicare number in a prescription does not prevent later request
(2) The approved supplier may make the request under subsection (1) whether or not:
(a) the prescription already contains a medicare number as a number applicable to the person to whom the prescription relates; or
(b) the approved supplier’s records already contain such a number (whether with or without the expiry date in relation to that number) recorded and retained in accordance with section 86D.
Approved supplier’s powers if medicare number is provided
(3) If a medicare number is provided to the approved supplier as a number applicable to the person following a request under subsection (1), or is included as such a number in the approved supplier’s records in accordance with section 86D, the approved supplier may:
(a) if the prescription has already been endorsed with a medicare number as such a number, check the number so provided or included against the endorsed number and:
(i) confirm that they are the same; or
(ii) if they are not the same and the approved supplier considers the number so provided or included more reliable than the endorsed number—alter the endorsed number to the number so provided or included or insert the number so provided or included in the CTS claim relating to the prescription, noting the discrepancy; or
(iii) if they are not the same and the approved supplier considers the endorsed number more reliable than the number so provided or included—disregard the number so provided or included and, if making a CTS claim, insert the endorsed number in the CTS claim relating to that prescription; and
(b) if the prescription has not already been endorsed with a medicare number as such a number:
(i) endorse the prescription with the medicare number so provided or included as a number applicable to the person; or
(ii) insert the number so provided or included in the CTS claim relating to that prescription; and
(c) if the approved supplier has also been provided with, or has, in the approved supplier’s records, the expiry date in relation to the medicare number ultimately supplied to the Chief Executive Medicare—confirm that the supply of a pharmaceutical benefit authorised by the prescription is not being sought after the expiry date.
Approved supplier’s powers in respect of prescription (other than communicated prescription) covering person included in class determined under subsection 86E(1)
(4) If:
(a) the prescription for the supply of a pharmaceutical benefit that is presented to the approved supplier does not contain a medicare number as a number applicable to the person to whom the prescription relates; and
(b) despite a request under subsection (1), a medicare number is not provided to the approved supplier as such a number; and
(c) a medicare number is not retained in the approved supplier’s records in accordance with section 86D as such a number; and
(d) the approved supplier is satisfied that the person to whom the prescription relates is included within a class of persons identified by the Minister under subsection 86E(1);
the approved supplier may:
(e) endorse on the prescription the special number applicable to the person as a member of that class; or
(f) insert that number in the CTS claim relating to that prescription.
Approved supplier’s powers in respect of written version of communicated prescription not containing medicare number
(5) If:
(a) a prescription for the supply of a pharmaceutical benefit is not presented to an approved supplier as described in subsection (1) but is communicated to the approved supplier in circumstances set out in regulations made for the purposes of paragraph 89(a); and
(b) the approved supplier later receives a written version of the prescription that does not contain a medicare number as a number applicable to the person to whom the prescription relates;
the approved supplier may, after the written version of the prescription is received, endorse on the written version, or insert in the CTS claim relating to the prescription:
(c) if a medicare number is already retained in the approved supplier’s records in accordance with section 86D as a number applicable to the person to whom the prescription relates—that medicare number; or
(d) if a medicare number is not so retained as a number applicable to the person to whom the prescription relates—the special number applicable to the person under subsection 86E(1) as a person in respect of whom a prescription has been so communicated.
86C On and after 1 January 2001 approved supplier must request provision of medicare number in certain circumstances
Approved supplier must request provision of medicare numbers in certain circumstances
(1) If:
(a) an approved supplier is presented, on or after 1 January 2001, with a prescription for the supply of a pharmaceutical benefit to a person; and
(b) the pharmaceutical benefit is one in respect of the supply of which the approved supplier would, but for the operation of subsection 99(7), be entitled to receive a payment under subsection 99(2) or (4); and
(c) the person presenting the prescription claims to be, or to be the agent of, the person to whom the prescription relates; and
(d) the person presenting the prescription does not request that the drug or medicinal preparation to which the prescription relates not be supplied as a pharmaceutical benefit;
the approved supplier must, if:
(e) the prescription does not contain a medicare number as a number applicable to the person to whom the prescription relates; and
(f) the approved supplier’s records do not already contain a medicare number as such a number (whether with or without the expiry date in relation to that number) recorded and retained in accordance with section 86D;
request the person presenting the prescription to provide to the approved supplier a medicare number applicable to the person to whom the prescription relates and the expiry date in relation to that number.
Inclusion of medicare number in a prescription does not prevent later request
(2) Even if:
(a) the prescription presented to the approved supplier already contains a medicare number as a number applicable to the person to whom the prescription relates; or
(b) the approved supplier’s records already contain a medicare number as such a number (whether with or without the expiry date in relation to that number) recorded and retained in accordance with section 86D;
the approved supplier may request the person presenting the prescription to provide to the approved supplier a medicare number applicable to the person to whom the prescription relates and the expiry date in relation to that number.
Approved supplier’s obligations in relation to medicare number provided
(3) If:
(a) a medicare number is provided to the approved supplier as a number applicable to the person to whom the prescription relates following a request under subsection (1) or is included as such a number in the approved supplier’s records in accordance with section 86D; and
(b) the prescription has not already been endorsed with a medicare number as a number applicable to the person to whom the prescription relates;
the approved supplier must:
(c) endorse the prescription with the medicare number so provided or included; or
(d) insert the number so provided or included in the CTS claim relating to the prescription.
If medicare number is provided, approved supplier may check prescription endorsed by practitioner
(4) If:
(a) a medicare number applicable to the person to whom the prescription relates is provided to the approved supplier following a request under subsection (2) or is included in the approved supplier’s records in accordance with section 86D; and
(b) the prescription has already been endorsed with a medicare number as a number applicable to the person to whom the prescription relates;
the approved supplier may check the number so provided or included against the endorsed number and:
(c) confirm that they are the same; or
(d) if they are not the same and the approved supplier considers the number so provided or included more reliable than the endorsed number:
(i) alter the endorsed number to the number so provided or included; or
(ii) insert the number so provided or included in the CTS claim relating to the prescription, noting the discrepancy; or
(e) if they are not the same and the approved supplier considers the endorsed number more reliable than the number so provided or included—disregard the number so provided or included and, if making a CTS claim, insert the endorsed number in the CTS claim relating to that prescription.
Approved supplier may check to ensure that supply not being sought after relevant expiry date
(5) If the approved supplier has also been provided with, or has in the approved supplier’s records, the expiry date in relation to the medicare number ultimately supplied to the Chief Executive Medicare, the approved supplier may confirm that the supply of the pharmaceutical benefit authorised by the prescription is not being sought after the expiry date.
Requirement in respect of prescription (other than communicated prescription) covering person included in class determined under subsection 86E(1)
(6) If:
(a) the prescription for the supply of a pharmaceutical benefit that is presented to the approved supplier does not contain a medicare number as a number applicable to the person to whom the prescription relates; and
(b) despite a request under subsection (1), a medicare number is not provided to the approved supplier as such a number; and
(c) a medicare number is not retained in the approved supplier’s records in accordance with section 86D as such a number; and
(d) the approved supplier is satisfied that the person to whom the prescription relates is included within a class of persons identified by the Minister in a determination under subsection 86E(1);
the approved supplier must:
(e) endorse on the prescription the special number applicable to the person as a member of that class; or
(f) insert that special number in the CTS claim relating to the prescription.
Requirement in respect of written version of communicated prescription not containing medicare number
(7) If:
(a) a prescription for the supply of a pharmaceutical benefit is not presented to an approved supplier as described in subsection (1) but is communicated to the approved supplier in circumstances set out in regulations made for the purposes of paragraph 89(a); and
(b) the pharmaceutical benefit is one in respect of the supply of which the approved supplier would, but for the operation of subsection 99(7), be entitled to receive a payment under subsection 99(2) or (4); and
(c) the approved supplier later receives a written version of the prescription that does not contain a medicare number as a number applicable to the person to whom the prescription relates;
the approved supplier must, after the written version of the prescription is received, endorse on the written version, or insert in the CTS claim relating to the prescription:
(d) if a medicare number is already retained in the approved supplier’s records in accordance with section 86D as a number applicable to the person to whom the prescription relates—that medicare number; or
(e) if a medicare number is not so retained as a number applicable to the person to whom the prescription relates—the special number applicable to the person under subsection 86E(1) as a person in respect of whom a prescription has been so communicated.
Note 1: Subsection 99(7) sets out the consequences of a failure ultimately to supply a medicare number or special number to the Chief Executive Medicare or, in the case of a medicare number that is so supplied, of a discrepancy with a medicare number held in the records of the Chief Executive Medicare.
Note 2: If, because a medicare number is not provided and a special number is not applicable, a person pays the full amount to an approved supplier for the supply of a pharmaceutical benefit, the person may be entitled to an appropriate refund from the Commonwealth (see subsection 87A(2)).
86D Power of approved suppliers to record and retain medicare numbers and expiry dates
Approved supplier may record and retain medicare numbers and expiry dates supplied by or on behalf of patients
(1) If:
(a) an approved supplier is provided with a medicare number as a number applicable to a person (whether with or without the expiry date in relation to that number) either:
(i) as a result of a request under section 86B or 86C; or
(ii) to facilitate the supply of pharmaceutical benefits at a later time or times; and
(b) the approved supplier is satisfied that the person providing the number, or number and date, is:
(i) the person in respect of whom the number was provided; or
(ii) the legal guardian of that person; or
(iii) another person who, in accordance with a written determination made by the Minister for the purposes of this subsection, is capable of giving an authorisation under this subsection;
the approved supplier may, with the authorisation of the person providing the number, or number and date, undertake the permitted recording and retention activities in relation to that number, or number and date.
Supplier may record and retain medicare numbers and expiry dates supplied by PBS prescribers in respect of communicated prescriptions
(2) If:
(a) a prescription for the supply of a pharmaceutical benefit is communicated to an approved supplier in circumstances set out in regulations made for the purposes of paragraph 89(a); and
(b) at the time the prescription is communicated, the PBS prescriber communicating the prescription informs the approved supplier of a medicare number as a number applicable to the person to whom the prescription relates (whether with or without the expiry date in relation to that number);
the approved supplier may undertake the permitted recording and retention activities in relation to that number, or number and date.
Note: An approved supplier can only be informed of a medicare number under this section with the authority of the person whose number it is, or of another person on that person’s behalf (see subsection 88(3B)).
Persons not obliged to authorise recording and retention of particulars
(3) Nothing in this section implies that a person is under any obligation to authorise an approved supplier to undertake the permitted recording and retention activities in respect of a medicare number, or of a medicare number and the expiry date in relation to such a number, provided as a result of a request under section 86B or 86C.
Approved supplier responsible for storage and security
(4) An approved supplier who, under this section, records and retains medicare numbers, or medicare numbers and expiry dates in relation to those numbers, in the approved supplier’s records must ensure:
(a) that the record of those numbers, or numbers and dates, is protected, by such security safeguards as it is reasonable in the circumstances to take, against loss, against unauthorised access, use, modification or disclosure, and against other misuse; and
(b) if it is necessary for access to the record of those numbers, or numbers and dates, to be given to a person in connection with the provision of services to the approved supplier—that everything reasonably within the power of the approved supplier is done to prevent unauthorised use or disclosure of information contained in that record.
Determinations are disallowable instruments
(5) Ministerial determinations for the purposes of subsection (1) are disallowable instruments within the meaning of section 46A of the Acts Interpretation Act 1901.
Permitted recording and retention activities
(6) In this section:
permitted recording and retention activities, in relation to a medicare number provided to an approved supplier under subsection (1) or (2) as a number applicable to a person (whether with or without an expiry date in relation to that number), are:
(a) to record and retain that number, or that number and date, in the approved supplier’s records in relation to that person; or
(b) if the approved supplier has already recorded and retained either or both of those particulars in relation to that person by virtue of a previous operation of this section—to check the accuracy and completeness of the recorded particulars in respect of that person and, if the recorded particulars are inaccurate or incomplete, to modify those particulars appropriately.
86E Minister may determine certain persons to be special evidentiary categories
Determination of classes of persons whose entitlement to pharmaceutical benefits can be evidenced otherwise than by provision of medicare numbers
(1) The Minister may, by written instrument, determine that certain classes of persons are classes of persons in respect of whom an entitlement to pharmaceutical benefits can be evidenced otherwise than by provision of a medicare number.
Classes that may be the subject of a determination
(2) Without limiting the classes that may be so determined, those classes may include the following:
(a) persons who are not legally competent;
(b) persons requiring drugs or medicinal preparations in an emergency;
(c) foreign persons:
(i) who are entitled to be treated as eligible persons within the meaning of the Health Insurance Act 1973 under section 7 of that Act; and
(ii) who are able to produce evidence, of a kind specified in the determination, to prove that entitlement;
(d) persons in respect of whom a prescription is communicated in circumstances set out in regulations made for the purposes of paragraph 89(a).
Determinations may set out particulars of which suppliers must be satisfied
(3) In a determination under subsection (1), the Minister may set out:
(a) the particular matters in respect of which an approved supplier must be satisfied before being satisfied that a person is included within a particular class determined under that subsection; and
(b) the procedure to be followed by the approved supplier in establishing such matters.
Determinations under subsection (1) must establish procedure for allocation of special numbers
(4) The Minister must include, in each determination under subsection (1) that identifies a class of persons, a procedure for allocating a particular combination of numbers, or letters and numbers, that is to be the special number applicable to a person included within that class as a member of that class.
Determinations are disallowable instruments
(5) Ministerial determinations under subsection (1) are disallowable instruments within the meaning of section 46A of the Acts Interpretation Act 1901.
87 Limited charges for pharmaceutical benefits
(1) Subject to this section, an approved pharmacist, a medical practitioner or an approved hospital authority shall not demand or receive a payment (other than a payment from the Commonwealth) or other valuable consideration in respect of the supply of a pharmaceutical benefit.
(2) Subject to subsection (2A), an approved pharmacist or an approved medical practitioner acting in accordance with his or her approval may, in respect of each supply (including each repeated supply) by the approved pharmacist or approved medical practitioner, as the case may be, of a pharmaceutical benefit:
(a) upon:
(i) a concessional benefit prescription; or
(ii) an entitlement card prescription where the supply is an early supply of a specified pharmaceutical benefit; or
(iii) a concession card prescription (other than where the supply is an early supply of a specified pharmaceutical benefit);
charge the person to whom the pharmaceutical benefit is supplied $4.60; or
(b) upon a general benefit prescription if, during the relevant entitlement period in which the supply is made, the person supplied has previously been charged, for supplies of pharmaceutical benefits, an amount that is not less than the amount of the general patient safety net (within the meaning of section 99F)—charge the person $4.60; or
(c) upon a general benefit prescription if, during the relevant entitlement period in which the supply is made, the person supplied, together with the members of his or her family (within the meaning of Division 1A), has previously been charged, for supplies of pharmaceutical benefits, an amount that is not less than the amount of the general patient safety net (within the meaning of section 99F)—charge the person $4.60; or
(e) upon a general benefit prescription (other than one relating to a supply to which paragraph (b) or (c) applies), or a concession card prescription (where the supply is an early supply of a specified pharmaceutical benefit)—charge the person to whom the pharmaceutical benefit is supplied $28.60.
Note: The figures expressed in this subsection in dollars are periodically adjusted under section 99G.
(2AAA) Paragraphs (2)(b) and (c) do not apply to an early supply of a specified pharmaceutical benefit.
(2AA) For the purposes of paragraphs 2(b) and (c), a person is taken to have been charged the price worked out in accordance with a determination in force under subsection 84C(7) for each supply, during the relevant entitlement period, of a pharmaceutical benefit that is taken, because of subsection 99(2A), to be a supply otherwise than under this Part.
(2AB) In determining, for the purposes of paragraph (2)(b) or (c), an amount that has previously been charged for supplies of pharmaceutical benefits:
(a) supplies taken, because of subsection 99(2A), to be supplies otherwise than under this Part are taken to be supplies of pharmaceutical benefits; and
(b) supplies of repatriation pharmaceutical benefits are taken to be supplies of pharmaceutical benefits; and
(c) any additional amounts charged under subsection (2A) are to be disregarded; and
(d) the amount that would, apart from paragraph (2)(b) or (c) (as the case requires), be chargeable in respect of the particular supply in question is to be included; and
(e) any amount charged in respect of an early supply of a specified pharmaceutical benefit (other than a supply of out‑patient medication) is to be disregarded.
(2A) In addition to any amount that may be charged in accordance with subsection (2), an approved pharmacist or an approved medical practitioner acting in accordance with his or her approval may, in respect of each supply (including each repeated supply) of a pharmaceutical benefit that is a listed brand of a pharmaceutical item and in relation to which a determination under subsection 85B(3) is in force, charge the person to whom it is supplied an amount equal to the special patient contribution for the brand of the pharmaceutical item, unless the approved pharmacist or approved medical practitioner is entitled to be paid by the Commonwealth that special patient contribution under subsection 99(2AA).
(3) Where an approved pharmacist or an approved medical practitioner supplies a pharmaceutical benefit in accordance with a direction included in a prescription in pursuance of subsection 88(6) or (6A), the amount chargeable in accordance with subsection (2), of this section is, in lieu of whichever of the amounts referred to in subsection (2), of this section is applicable, an amount equal to the product of that applicable amount and the minimum number of occasions of supply that would have had to be directed if the medical practitioner, authorised midwife or authorised nurse practitioner had prescribed the same total quantity or number of units of the pharmaceutical benefit by way of repeated supplies.
(3A) An approved pharmacist, approved medical practitioner or approved hospital authority shall not supply a pharmaceutical benefit to a person on terms that are appropriate for the supply of the benefit to:
(ba) a holder of a concession card; or
(c) a holder of an entitlement card; or
(d) a concessional beneficiary; or
(e) a person who is a dependant of a concessional beneficiary within the meaning of subsection 84(4) or (7); or
(f) a general patient;
unless the pharmacist, medical practitioner or authority is satisfied that the person is entitled to receive the benefit on those terms.
(3B) Without limiting the generality of subsection (3A), an approved pharmacist, approved medical practitioner or approved hospital authority may refuse to supply a pharmaceutical benefit to a person on terms that are appropriate for the supply of the benefit to:
(ba) a holder of a concession card; or
(c) a holder of an entitlement card; or
(d) a concessional beneficiary; or
(e) a person who is a dependant of a concessional beneficiary within the meaning of subsection 84(4) or (7); or
(f) a general patient;
unless the person produces evidence (whether by way of the production of a card or evidence of identity or otherwise) to the pharmacist, medical practitioner or authority that the person is entitled to receive the benefit on those terms.
(4) The regulations may provide for the making of a charge, not exceeding an amount ascertained in accordance with the regulations:
(b) by an approved pharmacist or an approved medical practitioner in respect of the supply of a pharmaceutical benefit by delivery at or to a place other than premises in respect of which the approved pharmacist is approved, or premises at which the approved medical practitioner carries on practice, as the case may be.
(5) Subsection (1) does not prevent an approved hospital authority from charging, in respect of the supply of pharmaceutical benefits to a patient receiving treatment in or at a hospital, amounts not exceeding the sum of the charges that the patient could have been required to pay in accordance with subsections (2) and (2A), if the patient had obtained the pharmaceutical benefits from an approved pharmacist upon a prescription or prescriptions directing the supply of the maximum quantity or number of units applicable under a determination of the Minister under subsection 85A(2).
(5A) Subsection (5) does not apply to a supply if:
(a) the patient is the holder of an entitlement card; and
(b) the supply is not an early supply of a specified pharmaceutical benefit.
(6) The reference in subsection (1) to a payment or other valuable consideration in respect of the supply of a pharmaceutical benefit does not include a reference to a charge demanded or received by reason only that the supply is made at a time outside normal trading hours.
87A Entitlement to refund in certain circumstances
(1) If:
(a) an approved supplier did not supply a pharmaceutical benefit to a person on terms that are appropriate for the supply of a benefit to:
(i) the holder of a concession card or entitlement card; or
(ii) a concessional beneficiary; or
(iii) a person who is a dependant of a concessional beneficiary within the meaning of subsection 84(4) or (7);
because the supplier was not satisfied that the person was entitled to receive the benefit on those terms; and
(b) the Secretary is satisfied that the person was entitled at the time to receive the benefit on those terms;
the person is entitled to be paid by the Commonwealth an amount equal to the difference between:
(c) the amount payable for the supply of the benefit on those terms; and
(d) an amount equal to:
(i) if, because of subsection 99(2A), (2AB) or (2B), the supply of the benefit is taken to be a supply otherwise than under this Part—the Commonwealth price for the supply of the benefit; or
(ii) in any other case—the amount that the person was charged under section 87.
(2) A person is entitled to be paid by the Commonwealth an amount equal to the difference between the amount payable for the supply of a pharmaceutical benefit on terms that are appropriate for the supply of the benefit to a general patient and an amount equal to the Commonwealth price for the supply of the benefit if:
(a) an approved supplier did not supply the benefit to the person on those terms because the supplier was not satisfied that the person was entitled to receive the benefit on those terms; and
(b) the Secretary is satisfied that the person was entitled at the time to receive the benefit on those terms.
(3) Subsection (4) applies if:
(a) under this Act an approved supplier charged a person an amount in respect of a supply of a pharmaceutical benefit; and
(b) at the time of the supply, the person was eligible to be issued with a concession card or an entitlement card but was not the holder of such a card.
(4) If the Secretary is satisfied:
(a) that the failure to issue a concession card or entitlement card was not caused by some wilful action of the person; and
(b) that in the circumstances the person should be treated as if:
(i) the person had been at the time when the pharmaceutical benefit was supplied the holder of a concession card or entitlement card; and
(ii) the prescription upon which the pharmaceutical benefit had been supplied were a concession card prescription or entitlement card prescription (as the case may be);
the person is entitled to be paid by the Commonwealth an amount equal to any amount paid by the person that would not have been payable if the pharmaceutical benefit had been supplied on a concession card prescription or an entitlement card prescription (as the case may be).
88 Prescribing of pharmaceutical benefits
(1) Subject to this Part, a medical practitioner is authorized to write a prescription for the supply of a pharmaceutical benefit.
(1A) Subject to this Part, a participating dental practitioner is authorized to write a prescription for the supply of any pharmaceutical benefit determined from time to time by the Minister, for the purposes of this subsection, by legislative instrument.
(1C) Subject to this Part, an authorised optometrist is authorised to write a prescription on or after 1 January 2008 for the supply of any pharmaceutical benefit determined from time to time by the Minister for the purposes of this subsection, by legislative instrument.
(1D) Subject to this Part, an authorised midwife is authorised to write a prescription on or after 1 November 2010 for the supply of any pharmaceutical benefit determined from time to time by the Minister for the purposes of this subsection, by legislative instrument.
(1E) Subject to this Part, an authorised nurse practitioner is authorised to write a prescription on or after 1 November 2010 for the supply of any pharmaceutical benefit determined from time to time by the Minister for the purposes of this subsection, by legislative instrument.
(1F) When writing a prescription under subsection (1), (1A), (1C), (1D) or (1E) for the supply of a pharmaceutical benefit that has a pharmaceutical item, the PBS prescriber, in identifying the pharmaceutical benefit that he or she is directing to be supplied, need not specify:
(a) a listed brand of the pharmaceutical item in the pharmaceutical benefit; or
(b) the manner of administration of the pharmaceutical item in the pharmaceutical benefit.
(2) A PBS prescriber shall not, by writing a prescription or otherwise, authorize the supply of a pharmaceutical benefit, being a narcotic drug, for the purpose of the administration of that benefit to himself or herself.
(3) A prescription for the supply of a pharmaceutical benefit must not be written:
(a) by a medical practitioner otherwise than in relation to the medical treatment of a person requiring that pharmaceutical benefit; or
(b) by a participating dental practitioner otherwise than in relation to the dental treatment of a person requiring that pharmaceutical benefit; or
(c) by an authorised optometrist otherwise than in relation to the optometrical treatment of a person requiring that pharmaceutical benefit; or
(d) by an authorised midwife otherwise than in relation to the midwifery treatment of a person requiring that pharmaceutical benefit; or
(e) by an authorised nurse practitioner otherwise than in relation to the nurse practitioner treatment by the authorised nurse practitioner of a person requiring that pharmaceutical benefit.
(3A) A PBS prescriber, when writing or communicating a prescription for the supply of a pharmaceutical benefit to a person, may:
(a) request the provision of a medicare number applicable to the person and of the expiry date in relation to that number; and
(b) if a medicare number (whether with or without the expiry date in relation to that number):
(i) is so provided as a number applicable to the person; or
(ii) is retained as such a number in the PBS prescriber’s records in accordance with section 88AA;
endorse the medicare number on a prescription written for that person (including, in the case of a communicated prescription, a subsequent written version of that communicated prescription).
(3B) A PBS prescriber must not inform an approved supplier of a medicare number, or a medicare number and an expiry date in relation to that number, in the circumstances described in subsection 86D(2), unless:
(a) the person in respect of whom the number was provided; or
(b) the legal guardian of that person; or
(c) another person identified in a determination made by the Minister under section 86D or 88AA as capable of authorising the recording and retention of such number or number and date;
authorises the PBS prescriber to inform the approved supplier of that number, or number and date.
(3C) Nothing in this section implies that a person is under any obligation:
(a) to provide a medicare number, or a medicare number and the expiry date in relation to that number, to a PBS prescriber; or
(b) to authorise such a PBS prescriber to inform an approved supplier of such a number, or number and date, in the circumstances described in subsection 86D(2).
(4) Where a determination of the Minister under subsection 85A(1) is applicable to a PBS prescriber, the PBS prescriber shall not write a prescription for the supply of a pharmaceutical benefit except in accordance with that determination or any other determination that is applicable to him or her.
(5) Subject to subsection (6), a PBS prescriber is not authorized, in a prescription for the supply of a pharmaceutical benefit, to direct that:
(a) there be supplied on one occasion a quantity or number of units of:
(i) if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or
(ii) in any other case—the pharmaceutical benefit;
in excess of the maximum quantity or number of units (if any) applicable under a determination of the Minister under subsection 85A(2); or
(b) the pharmaceutical benefit is to be administered in a manner other than the manner (if any) applicable under a determination of the Minister under subsection 85A(2).
(6) Where a medical practitioner may, in accordance with this Part, direct a repeated supply of a pharmaceutical benefit, the medical practitioner may, in such circumstances and subject to such conditions as are prescribed, instead of directing a repeated supply, direct in the prescription the supply on one occasion of a quantity or number of units of the pharmaceutical benefit not exceeding the total quantity or number of units of:
(a) if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or
(b) in any other case—the pharmaceutical benefit;
not exceeding the total quantity or number of units that could be prescribed if the medical practitioner directed a repeated supply.
(6A) If a person who is an authorised midwife or authorised nurse practitioner may, in accordance with this Part, direct a repeated supply of a pharmaceutical benefit, the person may, instead of directing a repeated supply, direct in the prescription the supply on one occasion of a quantity or number of units of the pharmaceutical benefit not exceeding the total quantity or number of units of:
(a) if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or
(b) in any other case—the pharmaceutical benefit;
not exceeding the total quantity or number of units that could be prescribed if the person directed a repeated supply.
(6B) However, the person may only make a direction under subsection (6A) if:
(a) the regulations prescribe either or both of the following:
(i) circumstances in which the person may make such a direction;
(ii) conditions on the making of such a direction; and
(b) the direction is made in those circumstances and in accordance with those conditions.
(7) Except in accordance with a determination of the Minister under subsection 85A(2), a PBS prescriber is not authorized, in a prescription for the supply of a pharmaceutical benefit, to direct that the supply of the pharmaceutical benefit be repeated on one or more occasions.
(8) If, in one prescription:
(a) the supply of a pharmaceutical benefit (the first benefit) and another pharmaceutical benefit (the second benefit) is directed; and
(b) the second benefit is:
(i) Schedule equivalent to the first benefit; or
(ii) if the first benefit is a listed brand of a pharmaceutical item—another listed brand of the pharmaceutical item;
then the prescription is taken to direct the repeated supply of the first benefit.
88AA Power of PBS prescribers to record and retain medicare numbers and expiry dates
(1) If:
(a) a PBS prescriber is provided with a medicare number as a number applicable to a person (whether with or without the expiry date in relation to that number) either:
(i) as a result of a request under subsection 88(3A); or
(ii) to facilitate the writing of a prescription for the supply of pharmaceutical benefits at a later time or times; and
(b) the PBS prescriber is satisfied that the person providing the number, or number and date, is:
(i) the person in respect of whom the number was provided; or
(ii) the legal guardian of that person; or
(iii) another person who, in accordance with a written determination made by the Minister for the purposes of this subsection, is capable of giving an authorisation under this subsection;
the PBS prescriber may, with the authorisation of the person providing the number, or number and date:
(c) record and retain that number, or number and date, in the PBS prescriber’s records; or
(d) if the PBS prescriber has already recorded and retained either or both of those particulars by virtue of a previous operation of this section—check the accuracy and completeness of the recorded particulars and, if the recorded particulars are inaccurate or incomplete, appropriately modify those particulars.
(2) Nothing in subsection (1) implies that a person is under any obligation to authorise the recording and retention, in a PBS prescriber’s records, of a medicare number, or of the expiry date in relation to such a number, provided as a result of a request under subsection 88(3A).
PBS prescriber responsible for storage and security
(3) A PBS prescriber who, under this section, records and retains medicare numbers, or medicare numbers and expiry dates in relation to those numbers, in the PBS prescriber’s records must ensure:
(a) that the record of those numbers, or numbers and dates, is protected, by such security safeguards as it is reasonable in the circumstances to take, against loss, against unauthorised access, use, modification or disclosure, and against other misuse; and
(b) that if it is necessary for access to the record of those numbers, or numbers and dates, to be given to a person in connection with the provision of services to the PBS prescriber, everything reasonably within the power of the PBS prescriber is done to prevent unauthorised use or disclosure of information contained in that record.
(4) Ministerial determinations for the purposes of subsection (1) are disallowable instruments within the meaning of section 46A of the Acts Interpretation Act 1901.
88A Prescription of certain pharmaceutical benefits authorised only in certain circumstances
Where a pharmaceutical benefit is determined, under subsection 85(7), to be a relevant pharmaceutical benefit for the purposes of this section, the writing of a prescription for the supply of the benefit is authorised under this Part only in circumstances specified in the determination under subsection 85(7).
89 Pharmaceutical benefits to be supplied only on prescription etc.
A person is not entitled to receive a pharmaceutical benefit unless it is supplied:
(a) by an approved pharmacist, at or from premises in respect of which the pharmacist is for the time being approved, on presentation of a prescription written by a PBS prescriber in accordance with this Act and the regulations, or, in such circumstances as are prescribed, on communication to that pharmacist, in the prescribed manner, of a prescription of a PBS prescriber; or
Note: Sometimes the person will still be entitled to receive the pharmaceutical benefit if the pharmacist is approved later. See subsection 99(3B).
(b) in accordance with the provisions of section 89A, section 92, section 93, section 93AA, section 93AB, section 93A or section 94.
89A When pharmaceutical benefits may be supplied by approved pharmacists without prescription
(1) An approved pharmacist may, at or from premises in respect of which the pharmacist is for the time being approved, supply a pharmaceutical benefit without a prescription for that supply if:
(a) the pharmaceutical benefit is covered by an instrument made under subsection (3); and
(b) the supply is made in accordance with conditions that are specified in an instrument made under subsection (3).
(2) If an approved pharmacist makes a supply in accordance with subsection (1), then this Act (other than paragraph 89(a)) applies in relation to the supply as if:
(a) a person had presented the pharmacist with a prescription that:
(i) had been written by a PBS prescriber in accordance with this Act and the regulations; and
(ii) did not contain a medicare number; and
(b) a reference in this Part to a prescription for the supply of a pharmaceutical benefit to a person who is a holder of a concession card or an entitlement card included a reference to a supply made in accordance with subsection (1) to a person who is a holder of a concession card or an entitlement card on the day of the supply; and
(c) the following provisions were omitted:
(i) subsection 84(2A) and paragraph 84(10)(a);
(ii) section 84AA;
(iii) subparagraph 86B(3)(b)(i) and paragraph 86B(4)(e);
(iv) paragraphs 86C(3)(c) and (6)(e);
(v) paragraph 92A(1)(ca); and
(d) the words “, in accordance with section 84AA,” in the definitions of concessional benefit prescription, concession card prescription and entitlement card prescription in subsection 84(1) were omitted.
(3) The Minister may, by legislative instrument, determine:
(a) the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription; and
(b) the conditions that must be satisfied when making a supply of those pharmaceutical benefits.
(4) The Minister must publish statistics annually for each pharmaceutical item supplied under subsection (1).
(5) The Minister must:
(a) cause a written report to be prepared of a review of this section no more than two years from the commencement of the section; and
(b) cause a copy of the report to be laid before each House of the Parliament within six months of the commencement of the review.
90 Approved pharmacists
(1) Subject to this section, the Secretary may, upon application by a pharmacist for approval to supply pharmaceutical benefits at particular premises, approve that pharmacist for the purpose of supplying pharmaceutical benefits at those premises.
(2) Where a pharmacist desires to supply pharmaceutical benefits at more than 1 premises, a separate application shall be made in respect of each of the premises and, where approval is granted in respect of 2 or more premises, a separate approval shall be granted in respect of each of the premises.
(3) Subject to this section, where an approved pharmacist desires to supply pharmaceutical benefits at premises other than premises in respect of which approval has been granted, the Secretary may on application by the approved pharmacist, grant approval in respect of those other premises.
(3A) Subject to subsections (3AA) and (3AE), an application under this section must be referred to the Authority.
(3AA) Subsection (3A) does not apply to an application for an approval arising out of a change in the ownership of a pharmacy situated at particular premises if the change results or resulted from:
(a) the sale of the pharmacy; or
(b) the acquisition, following the death of a person who was the owner or one of the owners of the pharmacy, of that person’s interest in the business of the pharmacy; or
(c) a change in the constitution of a partnership that owned the pharmacy;
if the pharmacy is to continue to operate at the same premises.
(3AB) In subsections (3AA) and (3AE):
pharmacy means a business in the course of the carrying on of which pharmaceutical benefits are supplied.
(3AC) For the purposes of paragraph (3AA)(b), if a person who is the owner or one of the owners of the business of a pharmacy dies, another person will be taken to have acquired the interest of the deceased person only after:
(a) a grant of probate of the will, or letters of administration of the estate, of the owner who has died, by a court of a State or Territory having jurisdiction in relation to the owner; and
(b) the transfer to that other person of that interest.
(3AD) Despite the grant of that probate or those letters of administration being taken to have had effect from the date of death of the owner, any permission to supply pharmaceutical benefits at particular premises that is granted under section 91 in respect of:
(a) a period preceding that grant of probate or those letters of administration; or
(b) a period following that grant of probate or those letters of administration and preceding the subsequent transfer of the business;
is unaffected.
(3AE) Subsection (3A) does not apply to an application for an approval if:
(a) the application arises out of an expansion or contraction of particular premises (the original premises) at which a pharmacy is situated; and
(b) the expanded or contracted premises occupy any of the space occupied by the original premises.
(3AF) However, the Secretary may, at his or her discretion, refer to the Authority an application referred to in subsection (3AE).
(3B) An approval may be granted under this section in respect of an application that has been referred to the Authority under subsection (3A) or (3AF) only if the Authority has recommended the grant of the approval, but the Secretary may refuse to grant an approval even if the grant has been recommended by the Authority.
(3C) Unless sooner repealed, subsections (3A), (3AA), (3AB), (3AC), (3AD), (3AE), (3AF) and (3B) cease to have effect at the end of 30 June 2015.
(3D) The Secretary must not grant approval under this section to a pharmacist in respect of particular premises if the Secretary is satisfied that on or after the day the approval would otherwise be granted:
(a) the pharmacist would be unable to supply pharmaceutical benefits at the premises; or
(b) the premises would not be accessible by members of the public for the purpose of receiving pharmaceutical benefits at times that, in the opinion of the Secretary, are reasonable.
(4) Nothing in this section authorizes the Secretary to grant approval to a pharmacist in respect of premises at which that pharmacist is not permitted, under the law of the State or Territory in which the premises are situated, to carry on business.
(5) Where the Secretary makes a decision granting or rejecting an application made by a pharmacist under this section, the Secretary shall cause to be served on the pharmacist, notice in writing of that decision.
Note: In certain circumstances, the Minister may substitute for a decision of the Secretary rejecting an application for approval, a decision granting the approval (see section 90A).
(5AA) If, under this section, a pharmacist is granted approval to supply pharmaceutical benefits at particular premises, the pharmacist may also supply pharmaceutical benefits from those premises.
(5A) A pharmacist who:
(a) before 18 December 1990, was granted an approval to supply pharmaceutical benefits at or from particular premises; and
(b) supplied pharmaceutical benefits on or before 18 December 1990 from other premises without the Secretary having granted approval under subsection (3) in respect of those other premises;
is to be taken to have been granted in respect of those other premises, or whichever of those premises was the premises from which the pharmacist last supplied pharmaceutical benefits before 18 December 1990, an approval under subsection (3).
(5B) The reference in paragraph (5A)(b) to supplying pharmaceutical benefits includes a reference to supplying drugs and medicinal preparations for which payment was made as if they were pharmaceutical benefits.
(5C) Subsection (5A) does not apply if:
(a) the approval referred to in paragraph (5A)(a) was not in force immediately before the commencement of section 20 of the Health and Community Services Legislation Amendment Bill (No. 2) 1993; or
(b) the pharmacist is not permitted, under the law of the State or Territory in which the premises referred to in paragraph (5A)(b) are situated, to carry on business at those premises.
(6) For the purposes of this section, a reference to a pharmacist is taken to include a reference to a person who owns, or is about to own, a business for the supply of pharmaceutical benefits at particular premises.
(7) Subsection (6) does not permit an application to be made under subsection (1) by a beneficiary of a deceased approved pharmacist who is not himself or herself a pharmacist before the interest in the business of the deceased pharmacist is transferred to the beneficiary in the course of the administration of the estate of the deceased pharmacist.
(8) Nothing in this section prevents the approval of more than one pharmacist for the purpose of supplying pharmaceutical benefits at particular premises.
90A Minister may substitute decision approving pharmacist
(1) This section applies in relation to a decision of the Secretary under section 90 rejecting an application by a pharmacist for approval to supply pharmaceutical benefits at particular premises, if:
(a) the application was made on or after 1 July 2006; and
(b) the decision was made on the basis that the application did not comply with the requirements of the relevant rules determined by the Minister under section 99L.
(2) The Minister may substitute for the Secretary’s decision a decision approving the pharmacist for the purpose of supplying pharmaceutical benefits at the particular premises if the Minister is satisfied that:
(a) the Secretary’s decision will result in a community being left without reasonable access to pharmaceutical benefits supplied by an approved pharmacist; and
(b) it is in the public interest to approve the pharmacist.
(3) For the purposes of subsection (2):
community means a group of people that, in the opinion of the Minister, constitutes a community.
reasonable access, in relation to pharmaceutical benefits supplied by an approved pharmacist, means access that, in the opinion of the Minister, is reasonable.
(4) The power under subsection (2) may only be exercised:
(a) on request by the pharmacist made under section 90B; and
(b) by the Minister personally.
(5) Subject to subsection 90B(5), the Minister does not have a duty to consider whether to exercise the power under subsection (2) in respect of the Secretary’s decision.
(6) The power under subsection (2) does not authorise the Minister to approve a pharmacist for the purpose of supplying pharmaceutical benefits at particular premises at which the pharmacist is not permitted, under the law of the State or Territory in which the premises are situated, to carry on business.
(7) A decision by the Minister not to exercise the power under subsection (2) in respect of the Secretary’s decision does not prevent the pharmacist from making an application to the Administrative Appeals Tribunal under subsection 105AB(7) for review of the Secretary’s decision.
(8) For the purposes of this section (other than subsection (7)):
(a) a reference to a decision of the Secretary includes a reference to a decision of the Secretary that has been affirmed by a decision of the Administrative Appeals Tribunal or an order of a federal court; and
(b) a reference to a decision of the Administrative Appeals Tribunal includes a reference to a decision of the Administrative Appeals Tribunal that has been affirmed by an order of a federal court.
90B Request to Minister to approve pharmacist
(1) If section 90A applies to a decision of the Secretary under section 90 rejecting an application by a pharmacist, the pharmacist may, in writing, request the Minister to exercise the Minister’s power under subsection 90A(2) in respect of the Secretary’s decision.
(2) The Minister may determine the form in which a request under subsection (1) must be made and, if the Minister does so, such a request must be made in that form.
(3) A request under subsection (1) must be made:
(a) within 30 days after the pharmacist is notified of the Secretary’s decision; or
(b) if the pharmacist has applied to the Administrative Appeals Tribunal for review of the Secretary’s decision—within 30 days after:
(i) the pharmacist is given a copy of the Administrative Appeals Tribunal’s decision affirming the Secretary’s decision; or
(ii) the application has been discontinued, withdrawn or dismissed; or
(c) if the pharmacist has sought an order from a federal court in respect of the Secretary’s decision or a decision of the Administrative Appeals Tribunal affirming the Secretary’s decision—within 30 days after:
(i) the court has made an order affirming the Secretary’s decision or the Administrative Appeals Tribunal’s decision, as the case requires; or
(ii) the court proceeding has been discontinued, withdrawn or dismissed.
(4) The Minister must, within 3 months after receiving a request under subsection (1), personally decide whether to consider the request. If the Minister has not made a decision within this period, the Minister is taken to have decided not to consider the request.
(5) If the Minister decides to consider a request under subsection (1), the Minister must, within 3 months after making that decision, personally decide whether to exercise the power under subsection 90A(2) in respect of the Secretary’s decision. If the Minister has not made a decision within this period, the Minister is taken to have decided not to exercise the power under subsection 90A(2) in respect of the Secretary’s decision.
(6) The Secretary must, by notice in writing, advise the pharmacist of:
(a) the decision made, or taken to have been made, by the Minister under subsection (4); and
(b) if applicable, the decision made, or taken to have been made, by the Minister under subsection (5).
90C Circumstances in which request may not be made
(1) A request must not be made under subsection 90B(1) in relation to a decision of the Secretary to which section 90A applies if:
(a) the Secretary’s decision is the subject of a proceeding before the Administrative Appeals Tribunal or a federal court; and
(b) the proceeding has not been discontinued, withdrawn or dismissed, or otherwise finally determined.
(2) A request under subsection 90B(1) is taken to have been withdrawn if, before the Minister has made a decision in relation to the request under subsection 90B(4) or (if applicable) subsection 90B(5), the Secretary’s decision becomes the subject of a proceeding before the Administrative Appeals Tribunal or a federal court.
90D Provision of further information
(1) For the purpose of deciding whether to consider a request made by a pharmacist under subsection 90B(1) or whether to exercise the power under subsection 90A(2) in relation to such a request:
(a) the Minister may, by notice in writing given to the pharmacist, require the pharmacist to provide such further information, or produce such further documents, to the Minister as the Minister specifies, within the period specified in the notice; and
(b) the Minister may give a notice in writing to any other person:
(i) advising the person of the request; and
(ii) inviting the person to provide comments on, or information or documents relevant to, the request within the period specified in the notice.
(2) If:
(a) the Minister gives a notice to a pharmacist under paragraph (1)(a); and
(b) the pharmacist does not provide the information specified in the notice or produce the documents specified in the notice within the period specified in the notice;
the Minister may treat the request as having been withdrawn.
(3) If the Minister gives a notice to a person under paragraph (1)(b), the Minister:
(a) is only required to consider comments, information or documents provided by the person during the period specified in the notice; and
(b) if the person does not provide any comments, information or documents within that period—is not required to take any further action to obtain such comments, information or documents.
90E Effect of decision by Minister to approve pharmacist
If the Minister decides to substitute for a decision of the Secretary to which section 90A applies a decision approving a pharmacist for the purpose of supplying pharmaceutical benefits at particular premises:
(a) the pharmacist is to be treated for all purposes of this Act as if the pharmacist is approved under section 90 in respect of those premises; and
(b) references in this Act to an approval granted under section 90 include references to an approval treated as having been granted under section 90 by paragraph (a) of this section; and
(c) the conditions to which an approval granted under section 90 is subject (including any condition that is imposed by means of a determination under paragraph 92A(1)(f)) apply also to an approval that is treated as having been granted under section 90 by paragraph (a) of this section; and
(d) the rights conferred and obligations imposed on an approved pharmacist apply to the pharmacist in his or her activities as an approved pharmacist.
91 Application to supply pharmaceutical benefits following the death of approved pharmacist
(1) If:
(a) a person is an approved pharmacist in respect of a pharmacy at particular premises; and
(b) the approved pharmacist dies at any time on or after the commencement of this section; and
(c) another person claims to be:
(i) the executor, or one of the executors, of the will of the deceased pharmacist in respect of which probate has been granted; or
(ii) the executor, or one of the executors, of the will of the deceased pharmacist although probate has not yet been granted; or
(iii) a person, or one of the persons, to whom the administration of the estate of the deceased pharmacist has been granted; or
(iv) a person, or one of the persons, intending to apply for administration of the estate of the deceased pharmacist; and
(d) that other person applies to the Secretary for permission to supply pharmaceutical benefits at those premises;
the Secretary may, if the Secretary reasonably believes that the applicant is, or on the grant of probate of the will or letters of administration of the estate is likely to be, such an executor or administrator, grant the applicant permission to supply such pharmaceutical benefits at those premises.
(2) An application under subsection (1) in relation to the supply of pharmaceutical benefits at particular premises:
(a) must be made in writing in a form approved by the Secretary; and
(b) must be made as soon as reasonably practicable after the death of the pharmacist who previously supplied such pharmaceutical benefits at those premises; and
(c) must be accompanied by documentary evidence relating to:
(i) the identity of the applicant; and
(ii) the nature of the applicant’s claim to be a person referred to in a subparagraph of paragraph 91(1)(c);
of a kind determined in writing by the Secretary for the purposes of this paragraph.
(3) A determination made for the purposes of paragraph (2)(c) is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.
(4) For the purpose of considering an application under this section, the Secretary may, by notice in writing given to the applicant, require the applicant to provide such further information, or produce such further documents, to the Secretary as the Secretary specifies, within such period as the Secretary specifies.
(5) If the Secretary requires the provision of information or the production of documents within a specified period and the information or documents are not provided or produced within that period, the Secretary may treat the application as having been withdrawn.
(6) When the Secretary makes a decision to grant or refuse an application under this section, the Secretary must cause notice in writing of that decision to be given to the applicant. If the Secretary decides to refuse an application, the notice must include reasons for the refusal.
(7) If the Secretary grants an applicant permission to supply pharmaceutical benefits at premises the subject of the application:
(a) the person granted that permission is to be treated for all purposes of this Act as if the person is, and, since the referral day in relation to the permission, had been, approved under section 90 as an approved pharmacist in relation to the pharmacy at those premises; and
(b) any supply of pharmaceutical benefits at or from those premises by a pharmacist who is not an approved pharmacist after the referral day in relation to the permission and before the grant of that permission is to be treated as if it had been a supply of those pharmaceutical benefits by the person to whom the permission is granted; and
(c) references in this Act to an approval granted under section 90 include references to an approval treated as having been granted under section 90 by paragraph (a); and
(d) the conditions to which an approval granted under section 90 is subject (including any condition that is imposed by means of the Minister’s determination under paragraph 92A(1)(f)) apply also to an approval that is treated as having been granted under section 90 by paragraph (a); and
(e) the rights conferred and obligations imposed on an approved pharmacist apply to that person in his or her activities as such an approved pharmacist.
(8) For the purposes of subsection (7), the referral day, in relation to a permission granted under this section, is:
(a) unless paragraph (b) applies—the day following the date of death of the deceased pharmacist to whom the application for permission related; or
(b) if there has been a prior permission granted under this section in relation to the premises to which the permission relates—the day following the date the prior permission was revoked.
(9) A permission granted to a person under subsection (1) in relation to particular premises continues, unless it is sooner revoked, until that person or another person is approved by the Secretary under section 90 in respect of those premises.
(10) Nothing in this section authorises the Secretary to grant a permission under subsection (1) to a person to supply pharmaceutical benefits at particular premises at which the person is not permitted, under the law of the State or Territory in which the premises are situated, to carry on business.
(11) If:
(a) probate of the will, or administration of the estate, of a deceased approved pharmacist is granted; and
(b) the person granted a permission under subsection (1) in relation to the supply of pharmaceutical benefits at premises where that pharmacist carried on business is not, or is not included among persons who are, granted that probate or administration;
he or she must, as soon as he or she becomes aware of that fact, notify the Secretary in writing of that fact.
(12) If the Secretary becomes aware, either as a result of a notification under subsection (11) or otherwise, that:
(a) probate of the will, or administration of the estate, of a deceased approved pharmacist is granted; and
(b) the person granted a permission under subsection (1) is not, or is not included among persons who are, granted that probate or administration;
the Secretary must, by notice in writing given to the person granted that permission, revoke the permission.
(13) If a partnership agreement provides for the disposal of the pharmacy business of a deceased approved pharmacist to any surviving partner or partners, nothing in this section is to be taken to override the operation of the terms of that agreement.
92 Approved medical practitioners
(1) Where there is no pharmacist approved in respect of premises from which, in the opinion of the Secretary, a convenient and efficient pharmaceutical service may be supplied in a particular area and a medical practitioner is practising in that area, the Secretary may approve the medical practitioner for the purpose of supplying pharmaceutical benefits to persons in that area.
(1A) Where the Secretary makes a decision under subsection (1) approving or refusing to approve a medical practitioner, the Secretary shall cause to be served on the medical practitioner, notice in writing of that decision.
(2) Pharmaceutical benefits supplied by a medical practitioner so approved shall be supplied in accordance with such conditions as are prescribed.
92A Approvals to be subject to conditions
(1) The approval of a person as an approved pharmacist, or the approval of a medical practitioner, for the purposes of this Part (including an approval granted before the commencement of this section and an approval of a person or body referred to in section 83Z) is, by force of this section, subject to the following conditions:
(a) a condition that the approved pharmacist or approved medical practitioner will not, by advertisement, notice or otherwise, state or indicate that he or she is willing to supply all or any pharmaceutical benefits to all or any persons without charge or for a charge other than the charge that he or she may make without contravening section 87;
(b) a condition that, where the approved pharmacist or approved medical practitioner makes, by advertisement, notice or otherwise, a statement with respect to the charge for which he or she is willing to supply, or with respect to his or her willingness to supply without charge, drugs or medicinal preparations generally or a class of drugs or medicinal preparations, he or she will indicate in the statement whether or not the statement relates to the supply of pharmaceutical benefits;
(c) a condition that the approved pharmacist or approved medical practitioner will not follow a practice of supplying all or any pharmaceutical benefits to all or any persons without charge or for a charge other than the charge that he or she may make without contravening section 87;
(ca) a condition that where:
(i) the approved pharmacist supplies a pharmaceutical benefit upon a prescription that, in accordance with subsection 84AA(2) or (3), is a concessional benefit prescription, a concession card prescription or an entitlement card prescription; and
(ii) that prescription is subsequently reduced to a document in writing (in this paragraph referred to as the relevant document) and given to the approved pharmacist in pursuance of regulations in force for the purposes of this Part;
the approved pharmacist shall write or mark on the relevant document the information communicated, or purportedly communicated, to him or her under subsection 84AA(2) or (3) in such manner as would, if the relevant document were a written prescription, cause that prescription to be, in accordance with subsection 84AA(1) or (1A), a concessional benefit prescription, a concession card prescription or an entitlement card prescription, as the case requires;
(d) a condition that the approved pharmacist or approved medical practitioner will not enter into a refund agreement or become an agent of a party to a refund agreement for the purposes of the refund agreement;
(e) a condition that the approved pharmacist, being a friendly society or a friendly society body, will keep a record, in a form approved by the Secretary, of the names and addresses, being addresses last known to the pharmacist, of all members:
(i) where the pharmacist is a friendly society—of the friendly society; or
(ii) where the pharmacist is a friendly society body—of the friendly society, or of any of the friendly societies, for the benefit of the members of which the pharmacist is carrying on business;
who were, immediately before 24 April 1964, and have continued to be, parties to agreements or arrangements under which contributions were and are payable by those members or on their behalf to friendly societies, or to friendly society bodies, for the purpose of obtaining benefits in respect of medicines;
(f) any other condition (including, but not limited to, a condition relating to premises) determined by the Minister.
(1A) A determination under paragraph (1)(f) is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.
(2) The conditions specified in paragraphs 92A(1)(a), (b) and (c) do not apply in relation to:
(a) the supply, or a statement relating to the supply, of pharmaceutical benefits upon entitlement card prescriptions;
(b) the supply, or a statement relating to the supply, of pharmaceutical benefits by a friendly society or by a friendly society body to members:
(i) in the case of a friendly society—of the friendly society; or
(ii) in the case of a friendly society body—of the friendly society, or of any of the friendly societies, for the benefit of the members of which the friendly society body is carrying on business;
who were, immediately before 24 April 1964, and have continued to be, parties to agreements or arrangements under which contributions were and are payable by those members or on their behalf to friendly societies, or to friendly society bodies, for the purpose of obtaining benefits in respect of medicines; or
(c) the supply, or a statement relating to the supply, of pharmaceutical benefits by a friendly society or by a friendly society body to the spouses, or to the children, of members referred to in paragraph (b).
(3) For the purposes of section 95, any conduct of an approved pharmacist or an approved medical practitioner that is a contravention of the conditions specified in this section shall be deemed to be conduct that is an abuse of his or her approval.
(4) For all purposes in connection with the writing or marking on a document by an approved pharmacist of information of the kind referred to in paragraph (1)(ca), the communication, or purported communication, of the information referred to in subsection 84AA(2) or (3), as the case requires, shall be taken to afford full and sufficient grounds for the writing or marking of that information by the pharmacist on that document.
92B Persons not to enter into certain refund agreements
(1) Except as provided in subsection (2), a person who is an insurer must not enter into a contract of insurance that comprises or contains a refund agreement.
Penalty: 20 penalty units
(2) This section does not prevent a private health insurer from entering into a complying health insurance policy under which the insurer covers the cost of pharmaceutical benefits dispensed to a person as part of an episode of hospital treatment or hospital‑substitute treatment covered by the policy.
93 Prescriber bag supplies—medical practitioners
(1) Except as prescribed, a medical practitioner is authorized to supply such pharmaceutical benefits as the Minister, by legislative instrument, determines to persons who are entitled under this Part to receive those pharmaceutical benefits.
(2) For the purpose of this section, the Minister may, by legislative instrument, determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by a medical practitioner during a specified period and a medical practitioner shall obtain the pharmaceutical benefit as prescribed.
(3) Payment by the Commonwealth in respect of the supply of pharmaceutical benefits under this section shall be made as prescribed.
93AA Prescriber bag supplies—authorised midwives
(1) Except as prescribed by the regulations, an authorised midwife is authorised to supply such pharmaceutical benefits as the Minister, by legislative instrument, determines to persons who are entitled under this Part to receive those pharmaceutical benefits.
(2) For the purposes of this section, the Minister may, by legislative instrument, determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by an authorised midwife during a specified period.
(3) The regulations may make provision for or in relation to the obtaining of pharmaceutical benefits by an authorised midwife for the purposes of this section.
(4) The regulations may make provision for or in relation to payments by the Commonwealth in respect of the supply of pharmaceutical benefits under this section.
93AB Prescriber bag supplies—authorised nurse practitioners
(1) Except as prescribed by the regulations, an authorised nurse practitioner is authorised to supply such pharmaceutical benefits as the Minister, by legislative instrument, determines to persons who are entitled under this Part to receive those pharmaceutical benefits.
(2) For the purposes of this section, the Minister may, by legislative instrument, determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by an authorised nurse practitioner during a specified period.
(3) The regulations may make provision for or in relation to the obtaining of pharmaceutical benefits by an authorised nurse practitioner for the purposes of this section.
(4) The regulations may make provision for or in relation to payments by the Commonwealth in respect of the supply of pharmaceutical benefits under this section.
93A Supply of certain pharmaceutical benefits to patients in private hospitals or aged care facilities
(1) In this section:
prescribed institution means:
(a) a private hospital; or
(b) a residential care service within the meaning of the Aged Care Act 1997.
(2) For the purposes of this section, the Minister may determine:
(a) the pharmaceutical benefits or classes of pharmaceutical benefits that may be supplied under this section to patients receiving treatment in prescribed institutions; and
(b) the conditions under which such pharmaceutical benefits may be supplied to, and held by, prescribed institutions.
Note: Subsection 33(3A) of the Acts Interpretation Act 1901 applies to a determination under subsection (2). This means that, for example, a determination could determine conditions for private hospitals that are different from conditions that are determined for residential care services.
(3) A copy of each determination made by the Minister under subsection (2) is to be published in the Gazette.
(4) An approved supplier may supply to a prescribed institution, in accordance with determinations made under paragraph (2)(b), pharmaceutical benefits that are covered by a determination made under paragraph (2)(a).
(5) A medical practitioner may authorise a prescribed institution to supply pharmaceutical benefits covered by a determination made under paragraph (2)(a) to patients receiving treatment in the institution.
(6) Payment by the Commonwealth in respect of the supply of pharmaceutical benefits under this section is to be made as prescribed.
94 Approved hospital authorities
(1) Upon application by a hospital authority, the Minister may, in the Minister’s discretion but subject to subsection (5), approve a hospital authority for the purpose of its supplying pharmaceutical benefits to patients receiving treatment in or at the hospital of which it is the governing body or proprietor.
(2) The approval of a hospital authority under subsection (1) may be expressed to be subject to such terms and conditions as the Minister determines.
(3) Where a hospital authority desires to supply pharmaceutical benefits to patients receiving treatment in or at several hospitals:
(a) a separate application shall, unless the Minister otherwise allows, be made in respect of each hospital; and
(b) separate approval may be granted in respect of each hospital.
(4) Where an approved hospital authority desires to supply pharmaceutical benefits to patients receiving treatment in or at a hospital other than a hospital in respect of which approval has been granted, the Minister may, on application by the approved hospital authority, grant approval in respect of that other hospital.
(4A) Where the Minister makes a decision granting or rejecting an application made by a hospital authority under this section, the Minister shall cause to be served on the hospital authority, notice in writing of that decision.
(5) A hospital authority shall not be approved under this section in respect of a hospital unless the dispensing of drugs and medicinal preparations at that hospital is performed by or under the direct supervision of a medical practitioner or pharmacist.
(5A) The Minister may, in the Minister’s discretion, at any time, by notice in writing, vary, or suspend or revoke, an approval in force under this section (including an approval granted before the commencement of this subsection).
(5B) A suspension under subsection (5A) has effect for such period as the Minister determines and specifies in the notice of suspension.
95 Suspension or revocation of approval
(1) The Minister may, after investigation and report by the appropriate Committee of Inquiry, by notice in writing:
(a) reprimand an approved pharmacist; or
(b) suspend or revoke the approval of the pharmacist under section 90;
and may, at any time, by notice in writing, remove that suspension or restore that approval.
(3) A suspension under subsection (1) has effect for such period as the Minister determines and specifies in the notice of suspension.
(4) If the Secretary considers that it is necessary in the public interest so to do pending investigation and report by the appropriate Committee of Inquiry, the Secretary may suspend an approval referred to in subsection (1) and the Secretary may at any time remove the suspension.
(5) Where the approval of a pharmacist is suspended under subsection (4), the Secretary shall forthwith refer the matter to the appropriate Committee of Inquiry for investigation and report to the Minister.
(6) A suspension by the Secretary under subsection (4) has effect only until the Minister has dealt with the matter in accordance with subsection (7).
(7) On receipt of a report from a Committee of Inquiry on a matter referred to it in accordance with subsection (5), the Minister may, by notice in writing, further suspend the approval for such period as the Minister specifies in the notice, revoke the approval or remove the suspension.
(8) The Minister shall not suspend, further suspend or revoke an approval under the preceding provisions of this section unless, having regard to the evidence before the Committee of Inquiry and the report of the Committee, the Minister is satisfied that the pharmacist has, in relation to or arising out of the approval, been guilty of conduct which is an abuse of that approval or is an abuse or contravention of this Act or the regulations or shows the pharmacist, as the case may be to be unfit to continue to enjoy the approval.
(9) The suspension or revocation of the approval of a pharmacist under this section may be in respect of all of the premises in respect of which the approval was granted or may be in respect of particular premises.
(10) For the purposes of this section, a reference to a pharmacist is taken to include a person to whom subsection 90(6) applies.
98 Cancellation by Secretary of approval of pharmacists etc.
(1) Whenever:
(a) an approved pharmacist requests that his or her approval under section 90 in respect of all or any of the premises in respect of which he or she is approved be cancelled;
(aa) a participating dental practitioner requests that his or her approval as a participating dental practitioner under section 84A be cancelled; or
(b) an approved medical practitioner requests that his or her approval in respect of an area under section 92 be cancelled; or
(c) an authorised optometrist requests that his or her approval as an authorised optometrist under section 84AAB be cancelled; or
(d) an authorised midwife requests that his or her approval as an authorised midwife under section 84AAF be cancelled; or
(e) an authorised nurse practitioner requests that his or her approval as an authorised nurse practitioner under section 84AAJ be cancelled;
the Secretary shall cancel that approval.
(2) Where:
(a) an approved pharmacist gives the Secretary notice in writing that the pharmacist has ceased to carry on business as a pharmacist at premises in respect of which the pharmacist is approved; or
(b) an approved medical practitioner gives the Secretary notice in writing that the medical practitioner has ceased to practise in the area in respect of which the medical practitioner is approved;
the Secretary may (at his or her discretion) cancel the approval.
(3) If the Secretary is satisfied that:
(a) an approved pharmacist is not carrying on business as a pharmacist at premises in respect of which the pharmacist is approved; or
(b) the premises are not accessible by members of the public for the purpose of receiving pharmaceutical benefits at times that, in the opinion of the Secretary, are reasonable;
then the Secretary may (at his or her discretion), by notice in writing to the pharmacist, cancel the approval of the pharmacist under section 90.
(3A) Where the Secretary is satisfied that an approved medical practitioner is not practising in the area in respect of which the medical practitioner is approved, the Secretary may (at his or her discretion), by notice in writing to the medical practitioner, cancel the approval of the medical practitioner under section 92.
(4) If a person becomes an approved pharmacist in respect of premises in an area in respect of which a medical practitioner is approved under section 92, the Secretary shall cancel the approval of the medical practitioner in respect of that area or of that part of the area in relation to which that section no longer applies.
(4A) If a pharmacist:
(a) before 18 December 1990, was granted an approval to supply pharmaceutical benefits at or from particular premises; and
(b) because of the operation of subsection 90(5A), is taken to have been granted such an approval in respect of other premises;
the Secretary is taken, immediately after the commencement of section 20 of the Health and Community Services Legislation Amendment Act (No. 2) 1993, to have cancelled the approval in respect of the premises referred to in paragraph (a).
(5) A reference in this section to an approved pharmacist carrying on business as a pharmacist at premises is a reference, in the case of an approved pharmacist to whom subsection 90(6) applies, to an approved pharmacist carrying on a business for the supply of pharmaceutical benefits at the premises.
(6) For the purposes of this section, an approved pharmacist is taken not to be carrying on business as a pharmacist if the approved pharmacist is not supplying pharmaceutical benefits in the course of carrying on the business.
98AA Cancellation by Minister of approval of hospital
(1) Whenever an approved hospital authority requests that its approval under section 94 in respect of all or any of the hospitals in respect of which it is approved be cancelled, the Minister shall cancel that approval.
(2) Where an approved hospital authority gives the Minister notice in writing that the authority has ceased to conduct a hospital in respect of which it is approved, the Minister may (at his or her discretion) cancel the approval.
(3) Where the Minister is satisfied that an approved hospital authority is not conducting a hospital in respect of which it is approved, the Minister may (at his or her discretion), by notice in writing to the authority, cancel the approval of the authority under section 94.
98AB Notification by Department of alterations to pharmaceutical benefits scheme
The Secretary must cause to be made publicly available on the Department’s website information on the outcomes of the changes to the pharmaceutical benefits scheme resulting from the introduction of the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007.
98AC Information about supplies
(1) An approved supplier that supplies a pharmaceutical benefit (including a supply taken, because of subsection 99(2A), to be a supply otherwise than under this Part):
(a) must give to the Secretary, in relation to the supply of that benefit, the information specified in rules made by the Minister under paragraph (4)(a); and
(b) must give the information in accordance with the rules made by the Minister under paragraph (4)(b).
(2) Subsection (1) does not apply if the approved supplier makes, or proposes to make, a claim for payment in relation to the supply of the pharmaceutical benefit under section 99AAA.
(3) Subject to the rules made by the Minister under paragraph (4)(b), subsections 99AAA(4) and (5) and section 99AAB (about the procedures for giving information) apply in relation to the giving of information under this section in the same way as they apply in relation to the giving of information under section 99AAA.
(4) The Minister must, by legislative instrument, make:
(a) rules specifying the information to be given to the Secretary by approved suppliers in relation to the supply by them of pharmaceutical benefits; and
(b) rules defining the procedures to be followed by approved suppliers in giving information to the Secretary in relation to the supply by them of pharmaceutical benefits.
(5) In making rules for the purposes of paragraph (4)(b), the Minister may define different procedures:
(a) for the giving of information by electronic means; and
(b) for the giving of information otherwise than by electronic means.
(6) Rules made under this section may be set out in the same document as rules made under subsection 99AAA(8).
Division 3—Payment for supply of pharmaceutical benefits
98A Establishment of Pharmaceutical Benefits Remuneration Tribunal
(1) For the purposes of this Part, there is hereby established a Tribunal to be known as the Pharmaceutical Benefits Remuneration Tribunal.
(2) The Tribunal shall consist of:
(a) a Chairperson appointed by the Governor‑General; and
(b) 4 additional members appointed by the Minister.
(2A) The Minister:
(a) must appoint as an additional member at least one person who has been, but is no longer, engaged either directly or indirectly in community pharmacy; and
(b) is to make that appointment only after he or she has consulted with the Pharmacy Guild of Australia.
(3) An appointment under subsection (2) shall be on a part‑time basis.
(4) A person is not eligible to be appointed as Chairperson unless the person is a Deputy President of the Fair Work Commission.
98B Functions of Tribunal
(1) The functions of the Tribunal are:
(a) to determine the manner in which the Commonwealth price for particular quantities or numbers of units of all or any pharmaceutical benefits is to be worked out for the purpose of payments to approved pharmacists in respect to the supply by them of pharmaceutical benefits; and
(c) if an agreement referred to in section 98BAA provides for the Tribunal to perform functions under the agreement—those functions.
(2) A manner determined under paragraph (1)(a) shall:
(a) in the case of a pharmaceutical benefit that is a listed brand of a pharmaceutical item—take as a basis the approved ex‑manufacturer price or a proportional ex‑manufacturer price of the brand of the pharmaceutical item that was in force on the first day of the month of the year in which the supply occurs; and
(b) in the case of other pharmaceutical benefits—take as a basis the basic wholesale price of each ingredient that is applicable on the day on which the supply occurs; and
(c) provide for the addition of such fees and other amounts as are determined by the Tribunal.
(3) In subsection (2):
basic wholesale price in relation to an ingredient in a pharmaceutical benefit, means the amount that The Pharmacy Guild of Australia and the Minister agree from time to time is to be taken to be, for the purposes of this Part, the appropriate price for sales of that ingredient to approved pharmacists.
(4) The Tribunal may approve criteria that it considers to be appropriate for use in determining the nature or magnitude of fees or other amounts referred to in paragraph (2)(c), and may, at any time, vary or revoke such criteria.
(5) In determining fees or other amounts referred to in paragraph (2)(c), and in approving criteria under subsection (4), the Tribunal must have regard to national minimum wage orders of the Fair Work Commission, and, in particular, any statements by the Commission about the effect of wage increases on productivity, inflation and levels of employment.
98BA Inquiries by Tribunal
(1) The Tribunal shall, as soon as practicable after the commencement of this section, and at such subsequent intervals as are determined by the Chairperson, hold an inquiry to ascertain whether the Commonwealth price of all or any pharmaceutical benefits should be varied.
(2) The holding of an inquiry under subsection (1) shall be by means of proceedings before the Tribunal.
(3) A person interested in the subject matter of an inquiry under subsection (1) may seek the leave of the Tribunal to appear, or be represented, in the proceedings before the Tribunal for the purpose of making a submission, or presenting evidence or other material, to the Tribunal.
(4) The Tribunal shall ensure that its findings resulting from its second or any subsequent inquiry, and the reasons for them, are issued not later than 12 months after the date on which the Tribunal issued its findings resulting from its first inquiry or from the last inquiry held by it, as the case may be.
98BAA Tribunal must give effect to certain agreements
(1) Despite anything else contained in this Part, where the Minister (acting on the Commonwealth’s behalf) and the Pharmacy Guild of Australia or another pharmacists’ organisation that represents a majority of approved pharmacists have entered into an agreement in relation to the manner in which the Commonwealth price of all or any pharmaceutical benefits is to be ascertained for the purpose of payments to approved pharmacists in respect of the supply by them of pharmaceutical benefits, the Tribunal, in making a determination under subsection 98B(1) while the agreement is in force, must give effect to the terms of that agreement.
(2) Where:
(a) at the time an agreement referred to in subsection (1) is entered into, an inquiry under section 98BA is being held or such an inquiry has been completed but the Tribunal has not issued a statement under subsection 98BD(1); or
(b) such an agreement was in force immediately before the commencement of this section and at that time such an inquiry was being held or such an inquiry had been completed but the Tribunal had not issued a statement under subsection 98BD(1);
the Tribunal must terminate the inquiry or, in a case where the inquiry has been completed but a statement has not been so issued, take no further action for the purposes of that inquiry.
(3) Section 98BA does not apply while there is in force an agreement referred to in subsection (1) except so far as otherwise provided in that agreement.
98BB Constitution of Tribunal
(1) For all purposes, including the purposes of any proceeding before the Tribunal, the Tribunal is to be constituted by the Chairperson and at least 2 additional members.
(1A) The Chairperson may give directions as to the constitution of the Tribunal for the purposes of any inquiry.
(2) In this section:
additional member includes an acting additional member; and
Chairperson includes an acting Chairperson.
98BC Procedure of Tribunal
(1) Subject to this Part, in any proceeding before the Tribunal:
(a) the procedure of the Tribunal is within the discretion of the Tribunal;
(b) the Tribunal is not bound to act in a formal manner and is not bound by any rules of evidence but may inform itself of any matter in such manner as it thinks just; and
(c) the Tribunal shall act according to equity, good conscience and the substantial merits of the case, without regard to technicalities and legal forms.
(2) Subject to subsection (3), a proceeding before the Tribunal shall be conducted in public.
(3) If the Tribunal is satisfied, upon the application of a party to a proceeding before the Tribunal, that, by reason of the confidential nature of a submission, or other evidence or material, submitted to the Tribunal in the proceeding, or for any other reason, it is undesirable to conduct the proceeding or a part of the proceeding in public, the Tribunal may direct that the proceeding or the part of the proceeding, as the case may be, be conducted in private.
(4) A direction by the Tribunal under subsection (3) may:
(a) specify persons for the purpose of permitting them, but no other persons, to be present when the proceeding, or the part of the proceeding, concerned is conducted in private; or
(b) specify persons for the purpose of prohibiting them from being present when the proceeding, or the part of the proceeding, concerned is conducted in private.
(5) The Chairperson is to preside in any proceeding before the Tribunal and all questions to be decided by the Tribunal are to be decided by a majority of votes of the members and, for that purpose, the Chairperson has a deliberative vote and, in the event of an equality of votes, also has a casting vote.
98BD Findings etc. of Tribunal to be made public
(1) After the completion of an inquiry under section 98BA, the Tribunal shall issue, in a proceeding conducted in public, a statement, in writing, of its findings and the reasons for them.
(2) Where the Tribunal:
(a) determines fees or other amounts referred to in paragraph 98B(2)(c); or
(b) makes a decision approving criteria under subsection 98B(4) or varying or revoking such criteria;
the Tribunal shall issue, in a proceeding conducted in public, a statement, in writing, setting out the terms of that determination or decision and the reasons for making it.
(3) Where the Tribunal issues a statement under subsection (1) or (2), the Tribunal shall:
(a) submit to the Minister a report setting out the terms of the statement so issued; and
(b) cause to be published in the Gazette a notice setting out the terms of the statement so issued.
98BE Date of operation of determination of the Tribunal
A determination of the Tribunal under subsection 98B(1) shall come into operation on a date specified in the determination, not being a date earlier than the date on which a statement setting out the terms of the determination is issued by the Tribunal in accordance with section 98BD.
98C Determinations by Minister
(1) The Minister may, from time to time, determine:
(a) the manner in which the Commonwealth price for particular quantities or numbers of units of all or any pharmaceutical benefits is to be ascertained for the purpose of payments to approved medical practitioners in respect of the supply of pharmaceutical benefits, including any fees or other amounts that are to be taken into account in determining that price; and
(b) the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
(2) The Minister may, before making a determination with respect to the conditions referred to in paragraph (1)(b), request the Tribunal to make a report with respect to the matters in respect of which the determination is to be made and, where such a request is made, the Tribunal shall comply with the request.
98D Form, and date of operation, of determinations under section 98C
A determination under section 98C shall:
(a) be in writing; and
(b) come into operation, or be deemed to have come into operation, on such date, being a date not earlier than 1 July 1976, as is specified in the determination.
98E Secrecy
(1) The Chairperson may, if he or she thinks it desirable to do so, give a direction in writing that any document, or evidence or other material, presented to the Tribunal in a proceeding before the Tribunal shall be treated as confidential.
(2) Where a direction is given under subsection (1) in relation to any document or evidence or other material:
(a) a person who, by virtue of the person’s office or employment under or for the purposes of this Act, has acquired any information obtained from that document or evidence or other material shall not, either directly or indirectly, except in the performance of a duty or the exercise of a function under or in connection with this Act, make a record of, or divulge or communicate to any person, that information; and
(b) a person who, by virtue of the person’s office or employment under or for the purposes of this Act, has access to that document or a record of that evidence or other material shall not be required to produce in a court, or to permit a court to have access to, that document or record, except when it is necessary to do so for the purposes of, or of a prosecution under or arising out of, this Act.
99 Payment for supply of benefits
(2) An approved pharmacist or approved medical practitioner who has supplied a pharmaceutical benefit is, subject to section 99AAA and to the conditions determined under section 98C and applicable at the time of the supply, entitled to be paid by the Commonwealth:
(a) where the prescription for the supply of the pharmaceutical benefit was an entitlement card prescription, and the supply was not an early supply of a specified pharmaceutical benefit—an amount equal to the Commonwealth price of the pharmaceutical benefit as at the time of the supply; and
(b) in any other case—the amount (if any) by which the Commonwealth price of the pharmaceutical benefit, as at the time of the supply, exceeded the amount that the pharmacist or approved medical practitioner was entitled to charge under subsection 87(2) or (3).
(2AA) If:
(a) an approved pharmacist or approved medical practitioner is entitled to be paid an amount by the Commonwealth under subsection (2) in relation to the supply of a pharmaceutical benefit; and
(b) a determination under subsection 85B(4) is in force in relation to a listed brand of a pharmaceutical item that is the pharmaceutical benefit; and
(c) the brand of the pharmaceutical item was supplied in the circumstances specified in that determination;
then, subject to section 99AAA and the conditions determined under section 98C and applicable at the time of the supply, the approved pharmacist or approved medical practitioner is entitled to be paid by the Commonwealth an amount that is equal to the amount of the special patient contribution for the brand of the pharmaceutical item.
(2A) Where a pharmaceutical benefit is supplied upon a general benefit prescription (other than in a case to which subsection (2AB) applies), or a supply of a pharmaceutical benefit is an early supply of a specified pharmaceutical benefit upon a concession card prescription, and:
(a) the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner otherwise than as referred to in paragraph (b) and the Commonwealth price of the pharmaceutical benefit does not, at the time of the supply, exceed $28.60; or
(aa) the pharmaceutical benefit is supplied by an approved hospital authority and the amount that would have been the Commonwealth price of the pharmaceutical benefit if it had been supplied by an approved pharmacist does not, at the time of the supply, exceed $28.60; or
(b) the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner in accordance with a direction included in a prescription in pursuance of subsection 88(6) or (6A) and the Commonwealth price of the maximum quantity or number of units of the pharmaceutical benefit that could, but for that subsection, have been directed to be supplied on any one occasion does not, at the time of the supply, exceed $28.60;
the supply and receipt of that pharmaceutical benefit shall, for all purposes of this Part (other than for the purposes of Division 1A), be deemed to be a supply and receipt otherwise than under this Part.
Note: The figures expressed in this subsection in dollars are periodically adjusted under section 99G.
(2AB) Where a pharmaceutical benefit is supplied upon a general benefit prescription to a person referred to in paragraph 87(2)(b) or (c) and:
(a) the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner otherwise than as referred to in paragraph (c) and the Commonwealth price of the pharmaceutical benefit does not, at the time of the supply, exceed $4.60; or
(b) the pharmaceutical benefit is supplied by an approved hospital authority and the amount that would have been the Commonwealth price of the pharmaceutical benefit if it had been supplied by an approved pharmacist does not, at the time of the supply, exceed $4.60; or
(c) the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner in accordance with a direction included in a prescription under subsection 88(6) or (6A) and the Commonwealth price of the maximum quantity or number of units of:
(i) if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or
(ii) in any other case—the pharmaceutical benefit;
that could, apart from that subsection, have been directed to be supplied on any one occasion does not, at the time of the supply, exceed $4.60;
the supply and receipt of that pharmaceutical benefit is, for all purposes of this Part (other than the purposes of Division 1A), taken to be a supply and receipt otherwise than under this Part.
Note: The figures expressed in this subsection in dollars are periodically adjusted under section 99G.
(2B) Where a pharmaceutical benefit is supplied upon a concessional benefit prescription and:
(a) the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner otherwise than as referred to in paragraph (c) and the Commonwealth price of the pharmaceutical benefit does not, at the time of the supply, exceed $4.60; or
(b) the pharmaceutical benefit is supplied by an approved hospital authority and the amount that would have been the Commonwealth price of the pharmaceutical benefit if it had been supplied by an approved pharmacist does not, at the time of the supply, exceed $4.60; or
(c) the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner in accordance with a direction included in a prescription in pursuance of subsection 88(6) or (6A) and the Commonwealth price of the maximum quantity or number of units of:
(i) if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or
(ii) in any other case—the pharmaceutical benefit;
that could, apart from that subsection, have been directed to be supplied on any one occasion does not, at the time of the supply, exceed $4.60;
the supply and receipt of that pharmaceutical benefit shall, for all purposes of this Part (other than for the purposes of Division 1A), be deemed to be a supply and receipt otherwise than under this Part.
Note: The figures expressed in this subsection in dollars are periodically adjusted under section 99G.
(3) Nothing in this section shall be deemed to authorize payment in respect of the supply of a drug or medicinal preparation:
(a) to a person who is not entitled under this Part to receive that drug or medicinal preparation as a pharmaceutical benefit;
(b) by an approved pharmacist at or from premises in respect of which he or she is not approved or otherwise than in accordance with the terms of his or her approval; or
(c) by an approved medical practitioner outside the area in respect of which he or she is approved or otherwise than in accordance with the terms of his or her approval.
(3A) Despite paragraph (3)(b), if:
(a) a pharmacist is an approved pharmacist in respect of particular premises; and
(b) the pharmacist supplies a pharmaceutical benefit (the pre‑approval benefit) at or from other premises before obtaining approval under section 90 in respect of those other premises; and
(c) the pharmacist later obtains approval (the later approval) under that section to supply pharmaceutical benefits at those other premises;
then, because of the later approval:
(d) the pharmacist is entitled to a payment of 90% of the amount that the pharmacist would have been entitled to be paid in respect of the supply of the pre‑approval benefit had the later approval been in force at the time of its supply; and
(e) if the amount already received by the pharmacist in respect of the pre‑approval benefit exceeds the amount that the pharmacist is entitled to under paragraph (d), the amount of the excess is to be set off against future entitlements under this section.
(3B) The pre‑approval benefit is taken to have been supplied in accordance with subparagraph 84C(4)(a)(i) and paragraph 89(a) if, under subsection (3A) of this section, the pharmacist is entitled to an amount in respect of the supply.
(4) An approved hospital authority is, subject to this Part, entitled to payment from the Commonwealth, at such rates and subject to such conditions as the Minister determines, in respect of the supply of particular quantities or numbers of units of pharmaceutical benefits to patients receiving treatment in or at a hospital in respect of which the approved hospital authority is approved.
(5) A payment to which an approved hospital authority in a State is entitled under this section may be paid to that State, or to an authority of that State, on behalf of the approved hospital authority.
(6) After the commencement of this section a payment in pursuance of subsections (4) and (5) may be made as if those subsections had come into operation on the date upon which an agreement between the Commonwealth and the State under section 5 of the Hospital Benefits Act 1951 came into force.
(7) Subject to subsection (8), an approved supplier is not entitled:
(a) if the supplier is an approved pharmacist or an approved medical practitioner—despite subsection 99(2); and
(b) if the supplier is an approved hospital authority—despite subsection 99(4);
to be paid by the Commonwealth for the supply of a pharmaceutical benefit to a person on a prescription presented to the approved supplier on or after 1 July 2001 or such later date as is prescribed for the purposes of this subsection unless:
(c) there is ultimately supplied to the Chief Executive Medicare a medicare number, or a special number, as a number applicable to the person to whom the prescription relates; and
(d) if the number so supplied is such a medicare number—that medicare number corresponds with a medicare number that is held in the records of the Chief Executive Medicare as a number applicable to that person.
(8) The Minister may, by written determination, identify circumstances in which subsection (7) does not prevent an approved supplier being paid by the Commonwealth for the supply of a pharmaceutical benefit in respect of a person to whom a prescription relates although a medicare number ultimately supplied to the Chief Executive Medicare in relation to the prescription does not correspond with a medicare number that is held in the records of the Chief Executive Medicare as a number applicable to that person.
(9) Ministerial determinations for the purposes of subsection (8) are disallowable instruments within the meaning of section 46A of the Acts Interpretation Act 1901.
99AAA Claim for payment relating to supply of benefits
(1) In this section:
Claims Transmission System means the procedures defined in the rules made by the Minister under paragraph (8)(c).
manual system means the procedures defined in the rules made by the Minister under paragraph (8)(d).
(2) An approved supplier who wants to receive payment from the Commonwealth in relation to the supply of a pharmaceutical benefit must make a claim for payment to the Secretary in accordance with the rules made by the Minister under paragraph (8)(a).
(3) An approved supplier who makes, or proposes to make, a claim for payment in relation to the supply of a pharmaceutical benefit must give to the Secretary, in relation to the supply of that benefit, the information specified in the rules made by the Minister under paragraph (8)(b).
(4) Except as provided by section 99AAB, an approved supplier must use the Claims Transmission System to give information to the Secretary in relation to the supply of pharmaceutical benefits.
(5) If an approved supplier does not use the Claims Transmission System to provide information to the Secretary in relation to the supply of pharmaceutical benefits, the approved supplier must use the manual system to provide that information to the Secretary.
(6) The Secretary must process and determine claims made under subsection (2), and make any payments relating to those claims, in accordance with the rules made by the Minister under paragraph (8)(e).
(7) Where the Secretary decides not to approve a claim made by an approved supplier under subsection (2), the Secretary must, in writing, inform the approved supplier of the decision and give reasons for the decision.
(8) The Minister must, by legislative instrument, make:
(a) rules defining the procedures to be followed by approved suppliers in making claims for payment in relation to the supply of pharmaceutical benefits; and
(b) rules specifying the information to be given to the Secretary by approved suppliers in relation to the supply by them of pharmaceutical benefits; and
(c) rules defining the procedures to be followed by approved suppliers in providing information by electronic means to the Secretary in relation to the supply by them of pharmaceutical benefits; and
(d) rules defining the procedures to be followed by approved suppliers in providing information otherwise than by electronic means to the Secretary in relation to the supply by them of pharmaceutical benefits; and
(e) rules defining the procedures to be followed by the Secretary in:
(i) processing and determining claims by approved suppliers for payment relating to the supply of pharmaceutical benefits; and
(ii) making the payments.
(10) In making rules for the purposes of paragraph (8)(a), the Minister may define different procedures:
(a) for the making of claims for payment supported by information provided by electronic means; and
(b) for the making of claims for payment supported by information provided otherwise than by electronic means.
99AAB Certain suppliers exempted from requirement to use the Claims Transmission System
(1) An approved supplier specified in subsection (2) is not required to comply with subsection 99AAA(4) but the approved supplier may do so if the approved supplier so wishes.
(2) For the purposes of subsection (1), the following approved suppliers are specified:
(a) an approved medical practitioner;
(e) an approved supplier in respect of whom a declaration under section 99AAC is in force.
99AAC Declaration by Secretary exempting approved supplier from using Claims Transmission System
(1) The Secretary may, subject to the guidelines determined by the Minister under subsection (2), declare in writing that an approved supplier is exempted from the operation of subsection 99AAA(4).
(2) The Minister must determine, in writing, guidelines in accordance with which the Secretary is to exercise his or her functions under subsection (1).
(3) A determination under subsection (2) is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.
(4) Where the Secretary decides:
(a) not to make a declaration under subsection (1) in respect of an approved supplier; or
(b) to revoke such a declaration;
the Secretary must, in writing, inform the approved supplier of the decision and give reasons for the decision.
99AA Unauthorised payments etc.
(1) Where:
(a) a pharmaceutical benefit has been supplied to a person (in this subsection referred to as the patient) by an approved pharmacist, approved medical practitioner or approved hospital authority;
(b) the pharmacist, medical practitioner or authority is paid an amount (in this subsection referred to as the relevant amount) by the Commonwealth in respect of the supply of the benefit to the patient; and
(c) the patient obtained the benefit on terms that were appropriate for the supply of the benefit to:
(i) a holder of a concession card; or
(iii) a holder of an entitlement card; or
(iv) a concessional beneficiary; or
(v) a person who was a dependant of a concessional beneficiary within the meaning of subsection 84(4) or (7);
knowing, or in circumstances such that he or she ought reasonably to have known, that he or she was not entitled to receive the benefit on those terms;
the Secretary may, by notice in writing to the patient, require the patient to pay to the Commonwealth an amount equal to the relevant amount.
(2) Where:
(a) a pharmaceutical benefit is supplied to a person by an approved pharmacist, approved medical practitioner or approved hospital authority;
(b) the pharmacist, medical practitioner or authority is paid an amount (in this subsection referred to as the relevant amount) by the Commonwealth in respect of the supply of the benefit to that person; and
(c) the pharmacist, medical practitioner or authority obtained the relevant amount knowing, or in circumstances such that he or she ought reasonably to have known, that it was not payable;
the Secretary may, by notice in writing to the pharmacist, medical practitioner or authority, require the pharmacist, medical practitioner or authority to pay to the Commonwealth an amount equal to the relevant amount.
(3) Where:
(a) the conditions referred to in paragraphs (1)(a), (b) and (c) or (2)(a), (b) and (c) are satisfied in relation to an amount paid by the Commonwealth; and
(b) the Secretary gives a person notice under subsection (1) or (2) as the case may be, requiring the person to pay to the Commonwealth an amount equal to the amount referred to in paragraph (a) of this subsection;
the Commonwealth may recover the amount referred to in the notice as a debt due to the Commonwealth by action in a court of competent jurisdiction.
(4) Where a person is liable to pay an amount to the Commonwealth under this section, an amount not exceeding that amount may be deducted from any other amount that is payable to the person under this Part and, where an amount is so deducted, the other amount shall, notwithstanding the deduction, be deemed to have been paid in full to the person.
99AB Advances
(1) An advance, on account of an amount that may become payable to a person under section 99 in relation to the supply of a pharmaceutical benefit, may be made to the person on such terms and conditions (if any) as are approved by the Secretary in writing.
(2) If a person receives, by way of advances on account of an amount that may become payable to the person under section 99 in relation to the supply of a pharmaceutical benefit, an amount that exceeds the amount that becomes payable to the person under section 99 in relation to the supply of the pharmaceutical benefit, the person is liable to repay to the Commonwealth the amount of the excess.
(3) If:
(a) a person receives an amount by way of advances on account of an amount that may become payable to the person under section 99 in relation to the supply of a pharmaceutical benefit; and
(b) no amount becomes payable to the person under section 99 in relation to the supply of the pharmaceutical benefit;
the person is liable to repay to the Commonwealth the amount so received.
(4) Where a person is liable to repay an amount to the Commonwealth under this section, the Commonwealth may recover the amount as a debt due to the Commonwealth by action in a court of competent jurisdiction.
(5) Where a person is liable to repay an amount to the Commonwealth under this section, an amount not exceeding that amount may be deducted from any other amount that is payable to the person under this Part and, where an amount is so deducted, the other amount shall, notwithstanding the deduction, be deemed to have been paid in full to the person.
Division 3A—Price reductions
Subdivision A—Preliminary
99AC What this Division is about
This Division is about price reductions for listed brands of pharmaceutical items.
Subdivision B requires there to be at least a 16% price reduction in the price of a new brand of a pharmaceutical item (other than a combination item) when it lists. The listing of the new brand of the pharmaceutical item also provides a trigger for price reductions to occur under Subdivision D (see section 99ACH) for:
(a) other existing brands of the pharmaceutical item; and
(b) existing brands of pharmaceutical items that have the same drug and manner of administration; and
(c) existing brands of pharmaceutical items that have a drug in the same therapeutic group and the same manner of administration.
Subdivision C sets out the circumstances in which price reductions are required for combination items.
Subdivision CA sets out the circumstances in which price reductions are required for new brands of pharmaceutical items that have the same drug as an existing brand of a pharmaceutical item that is subject to an outstanding staged reduction under section 99ACK. The listing of the new brand or brands also provides a trigger for price reductions to occur under Subdivision D (see sections 99ACM and 99ACN) for existing brands of pharmaceutical items that have that drug.
Subdivision D provides for other price reductions for pharmaceutical items (including for combination items in some cases). These price reductions:
(a) are triggered when Subdivision B applies to require a 16% price reduction to a new brand of a pharmaceutical item; or
(b) are triggered when Subdivision CA applies to a new brand of a pharmaceutical item that has the same drug as an existing brand of a pharmaceutical item that is subject to an outstanding staged reduction; or
(c) arise if the pharmaceutical item has a drug on F2 on a particular day.
99ACA Definitions etc.
(1) In this Division:
component drug, in relation to a drug in a combination item, means a drug or medicinal preparation that is contained in that drug.
listed component drug means a component drug in relation to which a declaration under subsection 85(2) is in force.
relevant price: see subsection 99ACF(5).
subject to an outstanding staged reduction: a brand of a pharmaceutical item is subject to an outstanding staged reduction on a day if:
(a) on any day before that day, section 99ACK had applied to the brand of the pharmaceutical item; and
(b) on the day before that day, the agreed price, or the determined price and claimed price, of the brand of the pharmaceutical item had not been reduced, because of the application of section 99ACF in relation to section 99ACK or 99ACM, by 25% of the relevant price of the brand of the pharmaceutical item.
(2) A listed component drug contained in a drug in a combination item has been subject to a 12.5% price reduction if:
(a) any of the following has applied before 1 February 2011 to a brand of a pharmaceutical item that has the listed component drug and has the same manner of administration as the combination item:
(i) section 99ACB;
(ii) subsection 99ACF(1) or (2) because of item 1 of the table in section 99ACF; or
(b) a pharmaceutical item that has the listed component drug and has the same manner of administration as the combination item is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied.
(2A) A listed component drug contained in a drug in a combination item has been subject to a 16% price reduction if:
(a) any of the following has applied to a brand of a pharmaceutical item that has the listed component drug and has the same manner of administration as the combination item:
(i) section 99ACB;
(ii) subsection 99ACF(1) or (2) because of item 1 of the table in section 99ACF; or
(b) a pharmaceutical item that has the listed component drug and has the same manner of administration as the combination item is in a class of pharmaceutical items to which a 16% administrative price reduction has applied.
(3) The Minister may, by legislative instrument, determine that a 12.5% administrative price reduction has applied to a class of pharmaceutical items.
Subdivision B—16% price reductions for new brands of pharmaceutical items that are not combination items
99ACB 16% price reduction for new brands of pharmaceutical items that are not combination items
When section applies to new brands
(1) Subject to subsections (2) and (3), this section applies to a brand (the new brand) of a pharmaceutical item (the trigger item) that is not a combination item if:
(a) a determination under subsection 85(6) comes into force in relation to the new brand of the trigger item on a day (the determination day); and
(b) on the day before the determination day, the new brand of the trigger item was not a listed brand of the trigger item; and
(c) on the day before the determination day:
(i) a brand (the existing brand) of a pharmaceutical item (the existing item) was a listed brand of the existing item; and
(ii) the new brand of the trigger item is bioequivalent or biosimilar to the existing brand of the existing item; and
(iii) the trigger item and existing item have the same drug and manner of administration.
Note: For the purposes of paragraph (c), the new brand and the existing brand may be the same brand, or the trigger item and the existing item may be the same pharmaceutical item.
Circumstances in which section does not apply
(2) This section does not apply in relation to the new brand of the trigger item if:
(a) the trigger item is in a class of pharmaceutical items to which a 12.5% or 16% administrative price reduction has applied; or
(b) another pharmaceutical item that has the same drug and manner of administration as the new brand of the trigger item is in a class of pharmaceutical items to which a 12.5% or 16% administrative price reduction has applied; or
(c) if the drug that is in the trigger item is in a therapeutic group—a pharmaceutical item that:
(i) has another drug that is in that group; and
(ii) has the same manner of administration as the new brand of the trigger item;
is in a class of pharmaceutical items to which a 12.5% or 16% administrative price reduction has applied.
(3) This section does not apply in relation to the new brand of the trigger item if:
(a) any of the following has applied:
(i) subsection (1);
(ii) subsection 99ACF(1) or (2) because of item 1 of the table in section 99ACF;
in relation to:
(b) the new brand, or another listed brand, of the trigger item; or
(c) a listed brand of another pharmaceutical item that has the same drug and manner of administration as the new brand of the trigger item; or
(d) if the drug that is in the trigger item is in a therapeutic group—a listed brand of a pharmaceutical item that:
(i) has another drug that is in that group; and
(ii) has the same manner of administration as the new brand of the trigger item.
Note: For the purposes of subparagraph (a)(i), subsection (1) is taken not to have applied in relation to a brand of a pharmaceutical item in some cases: see section 99AEI.
16% price reduction
(4) The Minister:
(a) may, under section 85AD, make a price agreement for the new brand of the trigger item; and
(b) must not make a determination under section 85B in relation to the new brand of the trigger item.
(5) Subject to subsection (6), the agreed price for the new brand of the trigger item that comes into force on the determination day must not exceed the approved ex‑manufacturer price, on the day before the determination day, of the existing brand of the existing item, reduced by 16%.
Apportioning if pricing quantity changes
(6) If the pricing quantity of the existing brand of the existing item on the day before the determination day is different from the pricing quantity of the existing brand of the existing item on the determination day, then, for the purposes of subsection (5), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day is taken to be the amount worked out as follows:
where:
AEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day.
PQ1 means the pricing quantity of the existing brand of the existing item on the day before the determination day.
PQ2 means the pricing quantity of the existing brand of the existing item on the determination day.
Section does not limit Minister’s powers
(7) This section does not limit the Minister’s powers, after the determination day, to make:
(a) further price agreements; or
(b) determinations under section 85B;
for the new brand of the trigger item.
Subdivision C—Price reductions for combination items
99ACC Price reductions for single brands of combination items
When section applies
(1) This section applies if:
(a) subsection 85AB(5) applies to the drug in a combination item; and
(b) there is only one listed brand (the single brand) of the combination item; and
(c) an agreed price (the existing agreed price) is in force for the single brand of the combination item; and
(d) after the day on which the existing agreed price came into force for the single brand of the combination item:
(i) if the drug in the combination item contains only one listed component drug—that listed component drug becomes subject to a statutory price reduction on a day (the reduction day); or
(ii) if the drug in the combination item contains 2 or more listed component drugs—one of the listed component drugs becomes subject to a statutory price reduction on a day (the reduction day); or
(iii) if the drug in the combination item contains 2 or more listed component drugs—2 or more of the listed component drugs become subject to a statutory price reduction on the same day (the reduction day); and
(e) on the reduction day, or on the day before that day, no listed brand of another combination item that has a drug that contains the same component drugs as the combination item:
(i) is bioequivalent or biosimilar to the single brand of the combination item; and
(ii) has the same manner of administration as the single brand of the combination item.
Price reduction
(2) The existing agreed price ceases to have effect at the end of the day before the reduction day.
(3) The Minister may, under a price agreement, agree on a new price for the single brand of the combination item that comes into force on the reduction day.
Note: The new price for the single brand of the combination item may be the same as the existing agreed price.
(4) If the Pharmaceutical Benefits Advisory Committee gives advice to the Minister under subsection 101(4AC) in relation to the combination item, then, in working out the new price of the single brand of the combination item, the Minister may have regard to that advice in considering the extent (if any) to which to reduce the existing agreed price.
(4A) If:
(a) subsection (4) applies; and
(b) the Minister decides to reduce the existing agreed price;
then, in agreeing the new price of the single brand of the combination item, the Minister:
(c) may have regard to the advice referred to in subsection (4) in relation to the combination item; and
(d) must take into account, in relation to the listed component drug, or each listed component drug, that became subject to statutory price reduction:
(i) the approved ex‑manufacturer price, on the reduction day, of each brand of a pharmaceutical item that has the drug that is the listed component drug; and
(ii) the quantity of the listed component drug contained in the combination item.
(4B) If subsection (4) does not apply, then, in agreeing the new price of the single brand of the combination item, the Minister must take into account, in relation to the listed component drug, or each listed component drug, that became subject to statutory price reduction:
(a) the approved ex‑manufacturer price, on the reduction day, of each brand of a pharmaceutical item that has the drug that is the listed component drug; and
(b) the quantity of the listed component drug contained in the combination item.
Section does not limit Minister’s powers
(5) This section does not limit the Minister’s powers, after the reduction day, to make further price agreements in relation to the single brand of the combination item.
Subject to statutory price reduction
(6) A listed component drug contained in a drug in a combination item becomes subject to statutory price reduction if:
(a) section 99ACB, subsection 99ACF(1) or (2) (because of item 1 in the table in section 99ACF) or section 99ADH has applied to a listed brand of a pharmaceutical item that:
(i) has the listed component drug; and
(ii) has the same manner of administration as the combination item; or
(b) subsection 99ACF(1) or (2) (because of any of the items (other than item 1) in the table in section 99ACF) has applied to a listed brand of a pharmaceutical item that has the listed component drug.
99ACD 16% price reduction for new brands of combination items
When section applies to new brands
(1) Subject to subsections (1A) and (2), this section applies to a brand (the new brand) of a pharmaceutical item (the trigger combination item) that is a combination item if:
(a) a determination under subsection 85(6) comes into force in relation to the new brand of the trigger combination item on a day (the determination day); and
(b) on the day before the determination day, the new brand of the trigger combination item was not a listed brand of the trigger combination item; and
(c) on the day before the determination day:
(i) a brand (the existing brand) of a pharmaceutical item (the existing item) was a listed brand of the existing item; and
(ii) the new brand of the trigger combination item is bioequivalent or biosimilar to the existing brand of the existing item; and
(iii) the drug in the trigger combination item and existing item contain the same component drugs; and
(iv) the trigger combination item and the existing item have the same manner of administration.
Note: For the purposes of paragraph (c), the new brand and the existing brand may be the same brand, or the trigger combination item and the existing item may be the same pharmaceutical item.
Circumstances in which section does not apply to new brands
(1A) This section does not apply in relation to the new brand of the trigger combination item if:
(a) the trigger combination item is in a class of pharmaceutical items to which a 12.5% or 16% administrative price reduction has applied; or
(b) another combination item that has the same drug and manner of administration as the new brand of the trigger combination item is in a class of pharmaceutical items to which a 12.5% or 16% administrative price reduction has applied; or
(c) if the drug in the trigger combination item is in a therapeutic group—a combination item that:
(i) has another drug that is in that group; and
(ii) has the same manner of administration as the new brand of the trigger combination item;
is in a class of pharmaceutical items to which a 12.5% or 16% administrative price reduction has applied.
(2) This section does not apply in relation to the new brand of the trigger combination item if subsection (1) or section 99ACE has applied in relation to:
(a) the new brand, or another listed brand, of the trigger combination item; or
(b) a brand of another combination item that:
(i) has a drug that contains the same component drugs as the new brand of the trigger combination item; and
(ii) has the same manner of administration as the new brand of the trigger combination item; or
(c) if the drug in the trigger combination item is in a therapeutic group—a combination item that:
(i) has another drug that is in that group; and
(ii) has the same manner of administration as the new brand of the trigger combination item.
Note: For the purposes of this subsection, subsection (1) is taken not to have applied in relation to a brand of a pharmaceutical item in some cases: see section 99AEI.
16% price reduction
(4) The Minister:
(a) may, under a price agreement, agree an agreed price for the new brand of the trigger combination item that comes into force on the determination day; and
(b) must not make a determination under section 85B for the new brand of the trigger combination item.
(5) Subject to subsections (6), (6A), (6B) and (7), the agreed price of the new brand of the trigger combination item must not exceed the approved ex‑manufacturer price, on the day before the determination day, of the existing brand of the existing item, reduced by 16%.
Adjustment for prior price reductions to component drugs
(6) If, on a day before the determination day:
(a) one or more of the listed component drugs (the component) contained in the drug in the existing item had been subject to one of the following (the prior price reduction of the component):
(i) a 12.5% price reduction;
(ii) a 16% price reduction; and
(b) because of the prior price reduction of the component, the approved ex‑manufacturer price of the existing brand of the existing item was reduced;
then the reduction referred to in subsection (5) is to be adjusted to reflect:
(c) the percentage (the flowed‑on percentage) of the prior price reduction of the component that was taken into account in working out the amount of the reduction to the approved ex‑manufacturer price of the existing brand of the existing item; and
(d) the quantity of the component contained in the drug in the existing item.
(6A) For the purposes of subsection (6), if:
(a) the prior price reduction of the component was a 12.5% price reduction; and
(b) the flowed‑on percentage was 100%;
then the reduction referred to in subsection (5) is to be adjusted so that there is no further reduction in relation to the component.
(6B) For the purposes of subsection (6), if:
(a) the prior price reduction of the component was a 12.5% price reduction; and
(b) the flowed‑on percentage was less than 100%;
then the reduction referred to in subsection (5) is to be adjusted so that the percentage worked out as follows is taken into account in relation to the component:
Apportioning if pricing quantity changes
(7) If the pricing quantity of the existing brand of the existing item on the day before the determination day is different from the pricing quantity of the existing brand of the existing item on the determination day, then, for the purposes of subsection (5), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day is taken to be the amount worked out as follows:
where:
AEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day.
PQ1 means the pricing quantity of the existing brand of the existing item on the day before the determination day.
PQ2 means the pricing quantity of the existing brand of the existing item on the determination day.
Section does not limit Minister’s powers
(8) This section does not limit the Minister’s powers, after the determination day, to make:
(a) further price agreements; or
(b) determinations under section 85B;
for the new brand of the trigger combination item.
99ACE Flow‑on of 16% price reduction to related brands of combination items
When section applies
(1) This section applies if:
(a) section 99ACD has applied to a brand (the new brand) of a combination item (the new combination item); and
(b) the new agreed price for the new brand of the combination item comes into force on a day (the reduction day); and
(c) on that day, a price agreement or a determination under section 85B is in force in relation to any of the following listed brands (the related brand) of a combination item (the related item):
(i) another listed brand of the new combination item;
(ii) a brand of another combination item that has a drug that contains the same component drugs as the new brand of the new combination item and that has the same manner of administration as the new brand of the new combination item;
(iii) if the drug in the new combination item is in a therapeutic group—a combination item that has another drug that is in that group and has the same manner of administration as the new brand of the new combination item; and
(d) the related item is not an exempt item.
Note: For the purposes of paragraph (c), the new brand and the related brand may be the same brand, or the new combination item and the related item may be the same pharmaceutical item.
16% price reduction
(2) The approved ex‑manufacturer price of the related brand of the related item ceases to be in force at the end of the day before the reduction day. Each claimed price (if any) for the related brand of the related item ceases to be in force at the end of the day before the reduction day.
(3) If a price agreement was in force on the day before the reduction day for the related brand of the related item, the Minister may:
(a) in a price agreement, specify an agreed price for the related brand of the related item that:
(i) comes into force on the reduction day; and
(ii) subject to subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price in force, on the day before that day, for the related brand of the related item, reduced by 16%; or
(b) in a price determination, specify a determined price for the related brand of the related item that:
(i) comes into force on the reduction day; and
(ii) subject to subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price in force, on the day before that day, for the related brand of the related item, reduced by 16%.
(4) If a price determination was in force for the related brand of the related item on the day before the reduction day, the Minister may:
(a) in a price determination, specify a determined price for the related brand of the related item that:
(i) comes into force on the reduction day; and
(ii) subject to subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price in force, on the day before that day, for the related brand of the related item, reduced by 16%; or
(b) in a price agreement, specify an agreed price for the related brand of the related item that:
(i) comes into force on the reduction day; and
(ii) subject to subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price in force, on the day before that day, for the related brand of the related item, reduced by 16%.
(4A) If a determination under subsection 85B(3) was in force for a particular pack quantity of the related brand of the related item on the day before the reduction day, the Minister may, in a determination under subsection 85B(3), specify a claimed price for that pack quantity of the related brand of the related item that:
(a) comes into force on the reduction day; and
(b) subject to subsections (5), (5A) and (5B), does not exceed the claimed price in force for that pack quantity of the related brand of the related item on the day before that day, reduced by 16%.
Apportioning if pricing quantity changes
(4B) If the pricing quantity of the related brand of the related item on the day before the reduction day is different from the pricing quantity of the related brand of the related item on the reduction day, then, for the purposes of subparagraphs (3)(a)(ii), (3)(b)(ii), (4)(a)(ii) and (4)(b)(ii), the approved ex‑manufacturer price of the related brand of the related item on the day before the reduction day is taken to be the amount worked out as follows:
where:
AEMP1 means the amount that was the approved ex‑manufacturer price of the related brand of the related item on the day before the reduction day.
PQ1 means the pricing quantity of the related brand of the related item on the day before the reduction day.
PQ2 means the pricing quantity of the related brand of the related item on the reduction day.
Adjustment for prior price reductions to component drugs
(5) If, on a day before the reduction day:
(a) one or more of the listed component drugs (the component) contained in the related item had been subject to one of the following (the prior price reduction of the component):
(i) a 12.5% price reduction;
(ii) a 16% price reduction; and
(b) because of the prior price reduction of the component, the approved ex‑manufacturer price of the related brand of the related item was reduced;
then the reduction referred to in subsection (3) or (4) is to be adjusted to reflect:
(c) the percentage (the flowed‑on percentage) of the prior price reduction of the component that was taken into account in working out the amount of the reduction to the approved ex‑manufacturer price of the related brand of the related item; and
(d) the quantity of the component contained in the drug in the related item.
(5A) For the purposes of subsection (5), if:
(a) the prior price reduction of the component was a 12.5% price reduction; and
(b) the flowed‑on percentage was 100%;
then the reduction referred to in subsection (3) or (4) is to be adjusted so that there is no further reduction in relation to the component.
(5B) For the purposes of subsection (5), if:
(a) the prior price reduction of the component was a 12.5% price reduction; and
(b) the flowed‑on percentage was less than 100%;
then the reduction referred to in subsection (3) or (4) is to be adjusted so that the percentage worked out as follows is taken into account in relation to the component:
Section does not limit Minister’s powers
(6) This section does not limit the Minister’s powers, after the reduction day, to make:
(a) further price agreements; or
(b) further determinations under section 85B;
for the related brand of the related item.
Subdivision CA—New brands of pharmaceutical items having drugs with outstanding staged reductions
99ACEA Price reduction for new brand of pharmaceutical item having drug with outstanding staged reductions—new brand bioequivalent or biosimilar to existing listed brand
When this section applies
(1) Subject to subsection (2), this section applies to a brand (the new brand) of a pharmaceutical item (the trigger item) on a day (the reduction day) if:
(a) on the reduction day, a determination under subsection 85(6) comes into force in relation to the new brand of the trigger item; and
(b) on the day before the reduction day:
(i) the new brand of the trigger item was not a listed brand of the trigger item; and
(ii) a brand (the existing brand) of a pharmaceutical item (the existing item) was a listed brand of the existing item; and
(c) the new brand of the trigger item is bioequivalent or biosimilar to the existing brand of the existing item; and
(d) the trigger item and existing item have the same drug and manner of administration; and
(e) on the reduction day, either or both of the following are subject to an outstanding staged reduction:
(i) the existing brand of the existing item;
(ii) a brand (the related brand) of a pharmaceutical item (the related item) that has the same drug as the existing item and the trigger item.
Note 1: For the purposes of this subsection, the new brand and the existing brand may be the same brand, or the trigger item and the existing item may be the same pharmaceutical item.
Note 2: For the purposes of this subsection, the new brand and the related brand may be the same brand, or the trigger item and the related item may be the same pharmaceutical item.
Note 3: For the purposes of this subsection, the existing brand and related brand may be the same brand, or the existing item and related item may be the same pharmaceutical item.
When this section does not apply
(2) This section does not apply if, before the reduction day, this section applied to:
(a) the new brand, or another listed brand, of the trigger item; or
(b) a listed brand of another pharmaceutical item that has the same drug as the new brand of the trigger item.
Note: Subsection (1) is taken not to have applied in relation to a brand of a pharmaceutical item in some cases: see section 99AEI.
Price reduction
(3) The Minister:
(a) may, under section 85AD, make a price agreement for the new brand of the trigger item; and
(b) must not make a determination under section 85B in relation to the new brand of the trigger item.
(4) Subject to subsection (5), the agreed price of the new brand of the trigger item that comes into force on the reduction day must not exceed the approved ex‑manufacturer price, on the day before the reduction day, of the existing brand of the existing item, reduced by the same amount that the approved ex‑manufacturer price of the existing brand of the existing item is reduced by on the reduction day under item 6 or 7 of the table in section 99ACF.
Apportioning if pricing quantity changes
(5) If the pricing quantity of the existing brand of the existing item on the day before the reduction day is different from the pricing quantity of the existing brand of the existing item on the reduction day, then, for the purposes of subsection (4), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the reduction day is taken to be the amount worked out as follows:
where:
AEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the reduction day.
PQ1 means the pricing quantity of the existing brand of the existing item on the day before the reduction day.
PQ2 means the pricing quantity of the existing brand of the existing item on the reduction day.
This section does not limit Minister’s powers
(6) This section does not limit the Minister’s powers, after the reduction day, to make:
(a) further price agreements; or
(b) determinations under section 85B;
for the new brand of the trigger item.
99ACEB New brands of pharmaceutical items having drug with outstanding staged reductions—new brands not bioequivalent or biosimilar to existing listed brand
When this section applies
(1) Subject to subsection (2), if:
(a) on a day (the reduction day), a determination under subsection 85(6) comes into force in relation to 2 or more brands (the new brands) of pharmaceutical items (the trigger items); and
(b) the new brands of the trigger items:
(i) are bioequivalent or biosimilar; and
(ii) have the same drug and manner of administration; and
(c) on the day before the reduction day, the new brands of the trigger items were not listed brands of the trigger items; and
(d) on the day before the reduction day, there was not a listed brand of a pharmaceutical item that:
(i) is bioequivalent or biosimilar to the new brands of the trigger items; and
(ii) has the same drug and manner of administration as the new brands of the trigger items; and
(e) on the reduction day, a listed brand (the existing brand) of a pharmaceutical item (the existing item):
(i) has the same drug as the trigger items; and
(ii) is subject to an outstanding staged reduction;
then this section applies to the new brands of the trigger items.
Note 1: For the purposes of this subsection, the new brands may be the same brand, or the trigger items may be the same pharmaceutical item.
Note 2: For the purposes of this subsection, any of the new brands and the existing brand may be the same brand, or any of the trigger items and the existing item may be the same pharmaceutical item.
When this section does not apply
(2) This section does not apply if, before the reduction day, this section applied to:
(a) the new brands, or another listed brand, of the trigger items; or
(b) a listed brand of another pharmaceutical item that has the same drug as the new brands of the trigger items.
Note: Subsection (1) is taken not to have applied in relation to a brand of a pharmaceutical item in some cases: see section 99AEI.
Price reduction
(3) The Minister:
(a) may, under section 85AD, make a price agreement for the new brands of the trigger items; and
(b) must not make a determination under section 85B in relation to the new brands of the trigger items.
This section does not limit Minister’s powers
(4) This section does not limit the Minister’s powers, after the reduction day, to make:
(a) further price agreements; or
(b) determinations under section 85B;
for the new brands of the trigger items.
Subdivision D—Other statutory price reductions
99ACF Statutory price reductions
Reduction equal to percentage or amount
(1) Subject to section 99ACG, if:
(a) a section referred to in column 2 of the table in this subsection applies to a listed brand of a pharmaceutical item on a day specified in the section (the reduction day); and
(b) subsection (2) does not apply to the listed brand of the pharmaceutical item on the reduction day; and
(c) on the day before the reduction day, an approved ex‑manufacturer price was, or one or more claimed prices were, in force for the listed brand of the pharmaceutical item;
then, subject to subsection (2A), the approved ex‑manufacturer price is, and (if applicable) each of the claimed prices are, taken to be reduced, on the reduction day, by the percentage or amount specified in column 3 of the table for the section referred to in column 2.
Statutory price reductions table |
Item | Section | Percentage or amount for section |
1 | 99ACH | 16% |
2 | 99ACI | 2% |
2A | 99ACIA | 2% |
3 | 99ACJ | 25% |
4 | 99ACK | the amount that equals the staged percentage, on the reduction day, of the relevant price for the brand of the pharmaceutical item |
5 | 99ACL | the reduction percentage specified in subsection 99ACL(2) |
6 | 99ACM | the amount that equals the outstanding staged percentage, on the reduction day, of the relevant price for the brand of the pharmaceutical item |
7 | 99ACN | the reduction percentage specified in subsection 99ACN(2) |
8 | 99ACO | 5% |
9 | 99ACP | the reduction amount specified in subsection 99ACP(2) |
10 | 99ACQ | the reduction percentage specified in subsection 99ACQ(2) |
Note: Subsection (1) does not apply if there is no determination under subsection 85(6) in respect of the pharmaceutical item in force on the specified day (whether or not the determination was revoked following a request by the responsible person for the pharmaceutical item).
Reduction more than percentage or amount
(2) This subsection applies if:
(a) a section referred to in column 2 of the table in subsection (1) applies to a listed brand of a pharmaceutical item on a reduction day; and
(b) subject to subsection (2A), on the reduction day the approved ex‑manufacturer price of the listed brand of the pharmaceutical item does not exceed the approved ex‑manufacturer price of the brand of the pharmaceutical item in force on the day before the reduction day, reduced by more than:
(i) the percentage specified in column 3 of the table for the section referred to in column 2; or
(ii) if there is a staged percentage for the listed brand of the pharmaceutical item for the reduction day—the amount specified in column 3 of the table for the section referred to in column 2; and
(c) if, on the day before the reduction day and on the reduction day, a determination under subsection 85B(3) was in force in relation to a particular pack quantity of the listed brand of the pharmaceutical item—the claimed price for that pack quantity of the brand of the pharmaceutical item does not exceed the claimed price for the same pack quantity of the brand of the pharmaceutical item in force on the day before the reduction day, reduced by more than the percentage or amount specified in column 3 of the table for the section referred to in column 2.
Apportioning if pricing quantity changes
(2A) If the pricing quantity of the listed brand of the pharmaceutical item on the day before the reduction day is different from the pricing quantity of the listed brand of the pharmaceutical item on the reduction day, then, for the purposes of subsection (1) and paragraph (2)(b), the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the day before the reduction day is taken to be the amount worked out as follows:
where:
AEMP1 means the amount that was the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the day before the reduction day.
PQ1 means the pricing quantity of the listed brand of the pharmaceutical item on the day before the reduction day.
PQ2 means the pricing quantity of the listed brand of the pharmaceutical item on the reduction day.
Sequence of application of 2 or more price reductions
(3) If 2 or more items of the table in subsection (1) apply to a listed brand of a pharmaceutical item on the same day:
(a) apply the items in the order they appear in the table; and
(b) apply the second and later items as if the approved ex‑manufacturer price, and (if applicable) each claimed price, (as the case requires) were those prices as affected by the operation of the item or items that have already been applied.
Section does not limit Minister’s powers
(4) This section does not limit the Minister’s powers, after the reduction day, to make:
(a) further price agreements; or
(b) further determinations under section 85B;
for the listed brand of the pharmaceutical item.
(5) In this section:
outstanding staged percentage for a listed brand of a pharmaceutical item on a reduction day, means 25% less each staged percentage that has applied under item 4 of the table in subsection (1) to the brand of the pharmaceutical item on a day before the reduction day.
relevant price of a listed brand of a pharmaceutical item means:
(a) for the agreed price or determined price—the amount that was the agreed price or determined price in force in relation to the brand of the pharmaceutical item on 31 July 2008; and
(b) for the claimed price—the amount that was the claimed price in force in relation to the brand of the pharmaceutical item on the day before the reduction day.
staged percentage on a reduction day for a listed brand of a pharmaceutical item, means the percentage that is prescribed for the purposes of paragraph 99ACK(3)(b) for the reduction day.
99ACG Other price reductions do not apply if 12.5% or 16% statutory price reduction or price disclosure reduction applies
2% reduction on 1 August 2008, 2009 or 2010 does not apply if a 12.5% reduction has applied
(1) If:
(a) any of the following applies to a listed brand of a pharmaceutical item on 1 April or 1 August in a year:
(i) section 99ACB;
(ii) section 99ACD or 99ACE;
(iii) subsection 99ACF(1) or (2) because of item 1 of the table in section 99ACF; and
(b) apart from this subsection, item 2 of the table would apply in relation to the brand of the pharmaceutical item, or another listed brand of the pharmaceutical item, on 1 August in that year;
item 2 of the table does not apply on 1 August in that year in relation to the brand of the pharmaceutical item or the other brand of the pharmaceutical item.
2% reduction on 1 February 2011 does not apply if a 12.5% reduction has applied
(1A) If:
(a) on 1 December 2010, a 12.5% administrative price reduction or any of the following applies to a listed brand of a pharmaceutical item:
(i) section 99ACB;
(ii) section 99ACD or 99ACE;
(iii) subsection 99ACF(1) or (2) because of item 1 of the table in section 99ACF; and
(b) apart from this subsection, item 2A of the table would apply in relation to the brand of the pharmaceutical item, or another listed brand of the pharmaceutical item, on 1 February 2011;
then item 2A of the table does not apply on 1 February 2011 in relation to the brand of the pharmaceutical item or the other brand of the pharmaceutical item.
Other price reductions do not apply if a price disclosure reduction has applied
(2) If:
(a) section 99ADH has applied to a listed brand of a pharmaceutical item (the first item) on a day; and
(b) apart from this subsection, any of the following provisions would apply on or after that day to a listed brand of a pharmaceutical item that has the same drug and manner of administration as the first item:
(i) section 99ACB;
(ii) section 99ACD or 99ACE;
(iii) subsection 99ACF(1) or (2) because of any item (other than item 4, 5, 6 or 7) of the table in section 99ACF;
then none of the provisions mentioned in paragraph (b) apply, on or after that day, to:
(c) the first item; or
(d) a listed brand of the pharmaceutical item that has the same drug and manner of administration as the first item.
99ACH 16% statutory price reduction flow‑on to related brands
(1) If:
(a) section 99ACB has applied to the agreed price for a brand (the new brand) of a pharmaceutical item (the new item); and
(b) that price comes into force on a day (the reduction day); and
(c) on the reduction day, a price agreement or a determination under section 85B is in force in relation to any of the listed brands (the related brand) of a pharmaceutical item (the related item) mentioned in subsection (2); and
(d) the related item is not a combination item; and
(e) the related item is not an exempt item;
then this section applies to the related brand of the related item on the reduction day.
(2) For the purposes of paragraph (1)(c), a related brand of a related item is any of the following:
(a) another listed brand of the new item;
(b) a listed brand of another pharmaceutical item that has the same drug and manner of administration as the new item;
(c) if the drug in the new item is in a therapeutic group—a listed brand of a pharmaceutical item that:
(i) has another drug that is in that group; and
(ii) has the same manner of administration as the new brand of the trigger item.
Note: For the purposes of subsection (2), the new brand and the related brand may be the same brand, and the new item and the related item may be the same pharmaceutical item.
99ACI 2% statutory price reduction on 1 August 2008, 2009 and 2010
(1) If:
(a) on the day before a 2% price reduction day, a price agreement or a determination under section 85B is in force in relation to a listed brand of a pharmaceutical item; and
(b) the drug in the pharmaceutical item is in Part A of F2 on the 2% price reduction day; and
(c) the pharmaceutical item is not an exempt item on the 2% price reduction day;
this section applies to the listed brand of the pharmaceutical item on the 2% price reduction day.
Note: Section 99ACG may affect the operation of this section.
(2) In this section, each of the following is a 2% price reduction day:
(a) 1 August 2008;
(b) 1 August 2009;
(c) 1 August 2010.
99ACIA 2% statutory price reduction on 1 February 2011
If:
(a) on 31 January 2011, a price agreement or a determination under section 85B is in force in relation to a listed brand of a pharmaceutical item; and
(b) on 11 October 2010, the drug in the pharmaceutical item was in Part A of F2; and
(c) on 1 February 2011, the pharmaceutical item is not an exempt item;
then this section applies to the listed brand of the pharmaceutical item on 1 February 2011.
99ACJ 25% statutory price reduction on single day
(1) If:
(a) on 31 July 2008, a price agreement or a determination under section 85B is in force in relation to a listed brand of a pharmaceutical item that is not a prescribed brand of that item; and
(b) the drug in the pharmaceutical item is in Part T of F2 on 1 August 2008; and
(c) the pharmaceutical item is not an exempt item on 1 August 2008;
this section applies to the listed brand of the pharmaceutical item on 1 August 2008.
(2) In this section:
prescribed brand means a brand of a pharmaceutical item prescribed for the purposes of subsection 99ACK(2).
99ACK 25% statutory price reduction staged over 2 or more days
(1) Subject to subsection (1A), this section applies to a listed brand of a pharmaceutical item on a reduction day if:
(a) on the day before that day, a price agreement or a determination under section 85B is in force in relation to the brand of the pharmaceutical item; and
(b) the drug in the pharmaceutical item is in Part T of F2 on 1 August 2008; and
(c) the pharmaceutical item is not an exempt item on the reduction day.
(1A) This section does not apply to a brand of a pharmaceutical item on a reduction day if, on that day, section 99ACM applies or had previously applied to the brand of the pharmaceutical item.
(2) The regulations may prescribe, for the purposes of this Division, a listed brand of a pharmaceutical item.
(3) For each brand of a pharmaceutical item prescribed under subsection (2), the regulations may prescribe:
(a) 2 or more reduction days; and
(b) for a reduction day:
(i) a percentage of the determined price, or agreed price, in force in relation to the brand of the pharmaceutical item on 31 July 2008; and
(ii) if, on the day before the reduction day concerned and on the reduction day concerned, a determination under subsection 85B(3) was in force in relation to a particular pack quantity of the brand of the pharmaceutical item—a percentage of the claimed price in force in relation to that pack quantity of the brand of the pharmaceutical item on the day before the reduction day concerned.
(4) The percentages prescribed for each brand of the pharmaceutical item must not total more than 25%.
99ACL Staged price reduction: staged reductions under section 99ACK causing statutory price reductions for other brands of pharmaceutical items having the drug
(1) This section applies to a listed brand (the existing brand) of a pharmaceutical item (the existing item) on a day (the reduction day) if, on the reduction day:
(a) the existing brand of the existing item is not subject to an outstanding staged reduction; and
(b) a listed brand (the staged brand) of a pharmaceutical item (the staged item) is subject to an outstanding staged reduction; and
(c) section 99ACK applies to the staged brand of the staged item; and
(d) the existing item and the staged item have the same drug.
Note: For the purposes of paragraphs (b) and (d), the existing brand and the staged brand may be the same brand, or the existing item and the staged item may be the same pharmaceutical item.
(2) For the purposes of item 5 of the table in section 99ACF, the reduction percentage for the existing brand of the existing item is the percentage that is worked out as follows:
Method statement
Step 1. See column 3 of item 4 of the table in section 99ACF to work out the amount (the staged brand’s reduction amount) by which the agreed price or determined price of the staged brand of the staged item is reduced on the reduction day.
Step 2. Work out what percentage the staged brand’s reduction amount represents of the agreed price or determined price of the staged brand of the staged item on the day before the reduction day.
The reduction percentage is the percentage worked out at step 2.
99ACM Staged price reduction: new brand listing bringing forward outstanding staged reductions
This section applies to a listed brand (the staged brand) of a pharmaceutical item (the staged item) on a day (the reduction day) if, on the reduction day:
(a) the staged brand of the staged item is subject to an outstanding staged reduction; and
(b) section 99ACEA or 99ACEB applies to a brand (the new brand) of a pharmaceutical item (the trigger item); and
(c) the staged item and the trigger item have the same drug.
Note: For the purposes of paragraphs (b) and (c), the staged brand and the new brand may be the same brand, or the staged item and the trigger item may be the same pharmaceutical item.
99ACN Staged price reduction: bringing forward outstanding staged reductions causing statutory price reduction for other brands of pharmaceutical items having the drug
(1) This section applies to a listed brand (the existing brand) of a pharmaceutical item (the existing item) on a day (the reduction day) if, on the reduction day:
(a) the existing brand of the existing item is not subject to an outstanding staged reduction; and
(b) section 99ACM applies to a listed brand (the staged brand) of a pharmaceutical item (the staged item) on the reduction day; and
(c) the existing item and the staged item have the same drug.
Note: For the purposes of paragraphs (b) and (c), the existing brand and the staged brand may be the same brand, or the existing item and the staged item may be the same pharmaceutical item.
(2) For the purposes of item 7 of the table in section 99ACF, the reduction percentage for the existing brand of the existing item is the percentage that is worked out as follows:
Method statement
Step 1. See column 3 of item 6 of the table in section 99ACF to work out the amount (the staged brand’s reduction amount) by which the agreed price or determined price of the staged brand of the staged item is reduced on the reduction day.
Step 2. Work out what percentage the staged brand’s reduction amount represents of the agreed price or determined price of the staged brand of the staged item on the day before the reduction day.
The reduction percentage is the percentage worked out at step 2.
99ACO 5% statutory price reduction for brands of pharmaceutical items having a drug that is not subject to outstanding staged reductions
If:
(a) on 31 January 2011, a price agreement or a determination under section 85B is in force in relation to a listed brand (the relevant brand) of a pharmaceutical item (the relevant item); and
(b) on 11 October 2010, the drug in the relevant item was in Part T of F2; and
(c) on 1 February 2011, the relevant item is not an exempt item; and
(d) on 1 February 2011, the relevant brand of the relevant item is not subject to an outstanding staged reduction; and
(e) on 1 February 2011, there is not another listed brand of a pharmaceutical item that:
(i) is subject to an outstanding staged reduction; and
(ii) has the same drug as the relevant item;
then this section applies to the relevant brand of the relevant item on 1 February 2011.
99ACP 5% statutory price reduction for brands of pharmaceutical items subject to outstanding staged reductions
(1) If:
(a) on 31 January 2011, a price agreement or a determination under section 85B is in force in relation to a listed brand (the relevant brand) of a pharmaceutical item (the relevant item); and
(b) on 11 October 2010, the drug in the relevant item was in Part T of F2; and
(c) on 1 February 2011, the relevant item is not an exempt item; and
(d) on 1 February 2011, the relevant brand of the relevant item is subject to an outstanding staged reduction;
then this section applies to the relevant brand of the relevant item on 1 February 2011.
(2) For the purposes of item 9 of the table in section 99ACF, the reduction amount for the relevant brand of the relevant item is the amount that is worked out as follows:
Method statement
Step 1. Work out the relevant price of the relevant brand of the relevant item.
Step 2. Work out the amount (the comparison amount) that equals 25% of the relevant price.
Step 3. Subtract the comparison amount from the relevant price.
The reduction amount is 5% of the amount worked out at step 3.
99ACQ 5% statutory price reduction for brands of pharmaceutical items having a drug that is subject to outstanding staged reductions
(1) If:
(a) on 31 January 2011, a price agreement or a determination under section 85B is in force in relation to a listed brand (the relevant brand) of a pharmaceutical item (the relevant item); and
(b) on 11 October 2010, the drug in the relevant item was in Part T of F2; and
(c) on 1 February 2011, the relevant item is not an exempt item; and
(d) on 1 February 2011, the relevant brand of the relevant item is not subject to an outstanding staged reduction; and
(e) on 1 February 2011:
(i) another listed brand (the staged brand) of a pharmaceutical item (the staged item) is subject to an outstanding staged reduction; and
(ii) the relevant item and the staged item have the same drug;
then this section applies to the relevant brand of the relevant item on 1 February 2011.
(2) For the purposes of item 10 of the table in section 99ACF, the reduction percentage for the relevant brand of the relevant item is the percentage that is worked out as follows:
Method statement
Step 1. See column 3 of item 9 of the table in section 99ACF to work out the amount (the staged brand’s reduction amount) by which the agreed price or determined price of the staged brand of the staged item is reduced on the reduction day.
Step 2. Work out what percentage the staged brand’s reduction amount represents of the agreed price or determined price of the staged brand of the staged item on the day before the reduction day.
The reduction percentage is the percentage worked out at step 2.
Division 3B—Price disclosure
Subdivision A—Preliminary
99AD What this Division is about
This Division requires the responsible person for certain brands of pharmaceutical items to comply with the price disclosure requirements for each supply of those brands of pharmaceutical items.
• Subdivision B has the price disclosure requirements. It provides for regulations to set out the kind of information that is required to be provided for the brand of the pharmaceutical item, the form and manner in which that information is to be provided and when that information is to be provided.
• The price disclosure requirements generally apply in relation to brands of pharmaceutical items that have a drug on F2.
• Subdivision D provides for the consequences of failing to comply with the price disclosure requirements.
In addition, this Division reduces the approved ex‑manufacturer price of the brand of the pharmaceutical item in specified circumstances (see Subdivision E). This reduction happens as a result of the price being adjusted based on information collected about brands of pharmaceutical items.
99ADA Division does not apply to exempt items
This Division does not apply to brands of exempt items.
99ADB Definitions etc.
(1) In this Division:
adjusted approved ex‑manufacturer price of a brand of a pharmaceutical item is the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item.
applicable approved ex‑manufacturer price: see subsection (3A).
price disclosure requirements has the meaning given by section 99ADC.
relevant day means the day after the end of the period in respect of which the weighted average disclosed price of the brand of the pharmaceutical item is determined.
unadjusted price reduction for a brand of a pharmaceutical item is the difference between:
(a) the applicable approved ex‑manufacturer price of the brand of the pharmaceutical item; and
(b) the weighted average disclosed price of the brand of the pharmaceutical item;
expressed as a percentage of that applicable approved ex‑manufacturer price.
weighted average disclosed price of a brand of a pharmaceutical item is the weighted average disclosed price of the brand of the pharmaceutical item determined by the Minister under subsection (4).
Applicable approved ex‑manufacturer price
(3A) The applicable approved ex‑manufacturer price of a brand of a pharmaceutical item is the approved ex‑manufacturer price of the brand on the relevant day.
(3B) For the purposes of subsection (3A), if:
(a) apart from this subsection, the brand of the pharmaceutical item would not have an approved ex‑manufacturer price on the relevant day; and
(b) the brand of the pharmaceutical item has an approved ex‑manufacturer price before the first reduction day that:
(i) is determined under paragraph 99ADH(1)(aa) in relation to the brand of the pharmaceutical item; and
(ii) occurs after the relevant day;
then:
(c) the regulations may prescribe the approved ex‑manufacturer price, or a method or formula for working out the approved ex‑manufacturer price, of the brand of the pharmaceutical item on the relevant day; and
(d) if the regulations do so, the amount so worked out is taken to be the approved ex‑manufacturer price of the brand of the pharmaceutical item on the relevant day.
Weighted average disclosed price
(4) The Minister may, by legislative instrument, determine the weighted average disclosed price of a brand of a pharmaceutical item in accordance with the regulations.
(6) Without limiting subsection (4), the regulations may prescribe a method or formula for determining the weighted average disclosed price of a brand of a pharmaceutical item. The method or formula prescribed may take into account information (if any) that has been provided in compliance with the price disclosure requirements, and any other information, about:
(a) the brand of the pharmaceutical item; and
(b) other brands of the pharmaceutical item; and
(c) all brands (including the brand) of all pharmaceutical items that have the same drug and manner of administration as the pharmaceutical item.
(7) A determination made under subsection (4) in relation to a brand of a pharmaceutical item may include the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item.
Subdivision B—Price disclosure requirements
99ADC The price disclosure requirements
(1) The price disclosure requirements for a supply of a brand of a pharmaceutical item are:
(a) to provide information prescribed by the regulations in relation to the supply of the brand of the pharmaceutical item by the responsible person to a person or entity prescribed by the regulations; and
(b) to provide that information in the manner and form prescribed by the regulations; and
(c) to provide that information at the times prescribed by the regulations.
(2) Without limiting subsection (1), the regulations may prescribe information relating to:
(a) the price of the brand of the pharmaceutical item supplied, which may be by reference to the quantity or number of units of the pharmaceutical item supplied; and
(b) the volume of the supply; and
(c) the person to whom the supply was made; and
(d) when the supply was made; and
(e) the type and value of any benefit (whether monetary or otherwise) provided to persons by the responsible person in relation to the supply, whether or not the benefit also relates to another supply of a product (the related product) that is:
(i) the brand of the pharmaceutical item; or
(ii) any other pharmaceutical item available in the brand or any other brand; or
(iii) any other product; and
(f) if the benefit referred to in paragraph (e) also relates to a supply of the related product—information relating to the supply of the related product (including the price and volume of the supply); and
(g) any other matter that is relevant in determining the weighted average disclosed price of the brand of the pharmaceutical item.
99ADD When the price disclosure requirements apply
The responsible person for a listed brand of a pharmaceutical item that has a drug on F2 is required to comply with the price disclosure requirements for each supply of the brand of the pharmaceutical item.
Subdivision D—Consequences for failing to comply with the price disclosure requirements
99ADF Offence for failing to comply with the price disclosure requirements
(1) A person commits an offence if:
(a) the person is required to comply with the price disclosure requirements for a supply of a brand of a pharmaceutical item; and
(b) the person fails to comply with those requirements for the supply of the brand of the pharmaceutical item.
Penalty: 60 penalty units.
(2) Subsection 4K(2) of the Crimes Act 1914, which creates daily or continuing offences, does not apply to an offence against subsection (1).
99ADG Other consequences for failing to comply with the price disclosure requirements
(1) This section applies if:
(a) a responsible person is required to comply with the price disclosure requirements for a supply of a brand (the disclosure brand) of a pharmaceutical item (the disclosure item); and
(b) the responsible person does not comply with those requirements for the supply of the disclosure brand of the disclosure item.
(2) Without limiting any power the Minister may otherwise have under this Part, the Minister may do any or all of the following:
(a) by legislative instrument, revoke or vary a determination under subsection 85(6) in relation to the disclosure brand of the disclosure item;
(b) by legislative instrument, revoke or vary a determination under subsection 85(6) in relation to any brand of any pharmaceutical item of the responsible person;
(c) refuse to make a determination under subsection 85(6) in relation to any brand of any pharmaceutical item of the responsible person;
(d) if the only listed brand of a pharmaceutical item would be a brand of the pharmaceutical item of the responsible person—refuse to make:
(i) a declaration under subsection 85(2) in relation to the drug in the pharmaceutical item; or
(ii) a determination under subsection 85(3) in relation to the form of the pharmaceutical item; or
(iii) a determination under subsection 85(5) in relation to the manner of administration of the pharmaceutical item.
Note: For the purposes of paragraphs (b), (c) and (d), a brand mentioned in those paragraphs may be the disclosure brand, or a pharmaceutical item mentioned in those paragraphs may be the disclosure item.
(3) Without limiting the powers of the Minister under subsection (2), in exercising a power under that subsection, the Minister may have regard to:
(a) the number of times the responsible person did not comply with the price disclosure requirements for:
(i) the disclosure brand of the disclosure item; and
(ii) if, in addition to the disclosure brand of the disclosure item, the person was also required to comply with the price disclosure requirements for a brand of a pharmaceutical item—the brand of the pharmaceutical item; and
(b) the period in which the non‑compliances occurred; and
(c) the duration of each non‑compliance; and
(d) the reasons for the non‑compliances; and
(e) whether those reasons are, in the Minister’s opinion, reasonable; and
(f) any other matter the Minister thinks is relevant.
Note: For the purposes of subparagraph (a)(ii), a brand mentioned in that subparagraph may be the disclosure brand, or a pharmaceutical item mentioned in that subparagraph may be the disclosure item.
(4) The refusals referred to in paragraphs (2)(c) and (d) are not legislative instruments.
Subdivision E—Price reduction
99ADH Price reduction based on information provided under the price disclosure requirements
When this section applies
(1) This section applies if:
(a) under section 99ADB, the Minister determines the weighted average disclosed price of a brand of a pharmaceutical item; and
(aa) the Minister, by legislative instrument, determines a day (the reduction day) for the purposes of this section in relation to the brand of the pharmaceutical item; and
(b) a price agreement or price determination is in force in relation to the brand of the pharmaceutical item on the reduction day; and
(c) the unadjusted price reduction for the brand of the pharmaceutical item is at least 10%.
(2) For the purposes of paragraph (1)(aa), the reduction day must be:
(a) 1 April or 1 October in any year; or
(b) another prescribed day.
Price reduction
(3) If, on the reduction day, the approved ex‑manufacturer price of the brand of the pharmaceutical item would, apart from this section, be higher than the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item, then, on the reduction day, the amount of the approved ex‑manufacturer price is taken to be reduced to the amount of the adjusted approved ex‑manufacturer price for the purposes of the price agreement or price determination.
Note: If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity on the reduction day, then, for the purposes of subsection (3), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is worked out under subsection (4A).
Claimed price reduction
(4) If, on the reduction day:
(a) a determination under subsection 85B(3) is in force in relation to a particular pack quantity of the brand of the pharmaceutical item; and
(b) the approved ex‑manufacturer price of the brand of the pharmaceutical item is reduced because of subsection (3);
then, on the reduction day the claimed price for that pack quantity of the brand of the pharmaceutical item is taken to be reduced by the percentage worked out as follows:
where:
AAEMP means the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item.
AEMP means the amount that would have been the approved ex‑manufacturer price of the brand of the pharmaceutical item on the reduction day if the reduction under subsection (3) had not occurred.
Note: If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity on the reduction day, then, for the purposes of subsection (4), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is worked out under subsection (4A).
Apportioning if pricing quantity changes
(4A) If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity of the brand of the pharmaceutical item on the reduction day, then, for the purposes of subsections (3) and (4), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is taken to be the amount worked out as follows:
where:
PQ1 means the pricing quantity of the brand of the pharmaceutical item on the relevant day.
PQ2 means the pricing quantity of the brand of the pharmaceutical item on the reduction day.
WADP means the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item.
Section not to limit Minister’s powers
(5) This section does not limit the Minister’s powers, after the reduction day, to make:
(a) other price agreements; or
(b) further determinations under section 85B;
for the brand of the pharmaceutical item.
99ADHA Price reduction for brands listing after end of data collection period
When this section applies
(1) This section applies if:
(a) a determination under subsection 85(6) is in force on the reduction day in relation to a brand (the new brand) of a pharmaceutical item (the existing item); and
(b) the determination came into force:
(i) after the last day of the period in respect of which the weighted average disclosed price is determined for another brand (the existing brand) of the existing item; and
(ii) before the reduction day; and
(c) the approved ex‑manufacturer price of the existing brand of the existing item is reduced on the reduction day under subsection 99ADH(3).
Price reduction
(2) On the reduction day, the approved ex‑manufacturer price of the new brand of the existing item is taken to be reduced to the same amount as the approved ex‑manufacturer price of the existing brand of the existing item on that day.
Claimed price reduction
(3) If, on the reduction day:
(a) a determination under subsection 85B(3) is in force in relation to a particular pack quantity of the new brand of the existing item; and
(b) the approved ex‑manufacturer price of the new brand of the existing item is reduced because of subsection (2);
then, on the reduction day the claimed price for that pack quantity of the new brand of the existing item is taken to be reduced by the percentage worked out as follows:
where:
AEMP1 means the amount that would have been the approved ex‑manufacturer price of the new brand of the existing item on the reduction day if the reduction under subsection (2) had not occurred.
AEMP2 means the approved ex‑manufacturer price of the new brand of the existing item on the reduction day.
Division 3C—Guarantee of supply
Subdivision A—Preliminary
99AE What this Division is about
This Division is about guaranteeing the supply of certain brands of pharmaceutical items.
Subdivision B requires the responsible person for certain brands of pharmaceutical items to supply those brands of pharmaceutical items during a specified period.
Subdivision C sets out which brands of pharmaceutical items are required to be supplied, and the period in which they are required to be supplied.
Subdivision D provides for when the responsible person is considered to have failed to supply, or been unable to supply, the brand of the pharmaceutical item.
Subdivision E requires the responsible person to notify the Minister if the person will fail or be unable to supply, or has failed or been unable to supply, the brand of the pharmaceutical item.
Subdivision F sets out the possible consequences for the responsible person if the person fails, or is unable, to supply the brand of the pharmaceutical item.
Subdivision G sets out the possible consequences for other brands of pharmaceutical items that were affected by the brand of the pharmaceutical item, if the brand of the pharmaceutical item is delisted under Subdivision F.
99AEA Definitions
In this Division:
fails to supply has the meaning given by section 99AEE.
guaranteed brand of a guaranteed item has the meaning given by sections 99AEC and 99AED.
guaranteed period, for a guaranteed brand of a guaranteed item, has the meaning given by:
(a) if the guaranteed brand of the guaranteed item is a brand of a pharmaceutical item to which subsection 99AEC(2) applies—subsection 99AEC(3); or
(b) if the guaranteed brand of the guaranteed item is a brand of a pharmaceutical item to which subsection 99AED(2) applies—subsection 99AED(3).
unable to supply has the meaning given by section 99AEF.
Subdivision B—Guarantee of supply
99AEB Guarantee of supply
The responsible person for a guaranteed brand of a guaranteed item must supply the guaranteed brand of the guaranteed item during the guaranteed period for the guaranteed brand of the guaranteed item.
Note 1: For the circumstances when a responsible person fails to supply, or is unable to supply, in the guaranteed period, see sections 99AEE and 99AEF.
Note 2: For the consequences for the responsible person for failing to supply, or being unable to supply, in the guaranteed period, see Subdivision F.
Subdivision C—Brands that are guaranteed brands
99AEC Guaranteed brand: new brand
(1) A brand of a pharmaceutical item is a guaranteed brand of a guaranteed item for the purposes of this Division (other than section 99AED) if subsection (2) applies to the brand of the pharmaceutical item.
(2) This subsection applies to a brand (the guaranteed brand) of a pharmaceutical item (the guaranteed item) if:
(a) a determination under subsection 85(6) comes into force in relation to the guaranteed brand of the guaranteed item on a day (the determination day); and
(b) on the day before the determination day, the guaranteed brand was not a listed brand of the guaranteed item; and
(c) on the determination day, or on the day before that day:
(i) a brand (the existing brand) of a pharmaceutical item (the existing item) is a listed brand of the existing item; and
(ii) the guaranteed brand of the guaranteed item is bioequivalent or biosimilar to the existing brand of the existing item; and
(iii) the guaranteed item and the existing item have the same drug and manner of administration.
Note: For the purposes of paragraph (c), the guaranteed brand and the existing brand may be the same brand, or the guaranteed item and the existing item may be the same pharmaceutical item.
Guaranteed period
(3) The guaranteed period for the guaranteed brand of the guaranteed item is the period that commences on the determination day and ends on the earliest of the following days:
(a) the last day of the 24 month period beginning on the determination day;
(b) if, after the determination day:
(i) a determination under subsection 85(6) comes into force on a day (the later determination day) in relation to a brand (the later brand) of a pharmaceutical item (the later item); and
(ii) the later brand of the later item is bioequivalent or biosimilar to the guaranteed brand of the guaranteed item; and
(iii) on the day before the later determination day, the later brand was not a listed brand of the later item;
the later determination day;
(c) if, after the determination day, subsection 99AED(2) applies to:
(i) a brand of the guaranteed item; or
(ii) a brand of a pharmaceutical item that is bioequivalent or biosimilar to the guaranteed brand of the guaranteed item;
the new price day referred to in paragraph 99AED(2)(d);
(d) the day that is the first whole day on which the guaranteed brand is not a listed brand of the guaranteed item.
Note 1: For the purposes of paragraph (b), the later brand and the guaranteed brand may be the same brand, or the later item and the guaranteed item may be the same item.
Note 2: For the purposes of paragraph (c), the brand mentioned in that paragraph and the guaranteed brand may be the same brand, or the pharmaceutical item mentioned in that paragraph and the guaranteed item may be the same pharmaceutical item.
99AED Guaranteed brand: first brand to offer a lower price
(1) A brand of a pharmaceutical item is a guaranteed brand of a guaranteed item for the purposes of this Division (other than section 99AEC) if subsection (2) applies to the brand of the pharmaceutical item.
(2) This subsection applies to a brand (the guaranteed brand) of a pharmaceutical item (the guaranteed item) if:
(a) the drug in the guaranteed item is on F2; and
(b) the guaranteed brand is a listed brand of the guaranteed item; and
(c) the Minister and the responsible person for the guaranteed brand of the guaranteed item agree, in a price agreement, an agreed price (the new price) of the guaranteed brand of the guaranteed item; and
(d) on the day (the new price day) the new price comes into force, the new price is less than what the approved ex‑manufacturer price of the guaranteed brand of the guaranteed item would have been on that day if the new price had not come into force; and
(e) the responsible person was the first responsible person for a brand of the guaranteed item to offer the Minister the new price.
Guaranteed period
(3) The guaranteed period for the guaranteed brand of the guaranteed item is the period that commences on the new price day and ends on the earliest of the following days:
(a) the last day of the 24 month period beginning on the new price day;
(b) if, after the new price day:
(i) a determination under subsection 85(6) comes into force on a day (the later determination day) in relation to a brand (the later brand) of a pharmaceutical item (the later item); and
(ii) the later brand of the later item is bioequivalent or biosimilar to the guaranteed brand of the guaranteed item; and
(iii) on the day before the later determination day, the later brand was not a listed brand of the later item;
the later determination day;
(c) if, after the new price day, subsection (2) applies, in another application of that subsection, to:
(i) a brand of the guaranteed item; or
(ii) a brand of a pharmaceutical item that is bioequivalent or biosimilar to the guaranteed brand of the guaranteed item;
the day the new price referred to in that subsection under the other application comes into force;
(d) the day that is the first whole day on which the guaranteed brand is not a listed brand of the guaranteed item.
Note 1: For the purposes of paragraph (b), the later brand and the guaranteed brand may be the same brand, or the later item and the guaranteed item may be the same item.
Note 2: For the purposes of paragraph (c), the brand mentioned in that paragraph and the guaranteed brand may be the same brand, or the pharmaceutical item mentioned in that paragraph and the guaranteed item may be the same pharmaceutical item.
Subdivision D—Meaning of fails to supply and unable to supply
99AEE Meaning of fails to supply
(1) A responsible person for a guaranteed brand of a guaranteed item fails to supply the guaranteed brand of the guaranteed item if:
(a) a wholesaler or an approved pharmacist requests the responsible person to supply the wholesaler or pharmacist with an amount of the guaranteed brand of the guaranteed item; and
(b) the responsible person fails to supply that amount to the wholesaler or pharmacist within:
(i) a reasonable period; or
(ii) if the regulations prescribe a period—that period;
after receiving the request.
(2) The responsible person fails to supply the guaranteed brand of the guaranteed item on the day after the end of that period.
99AEF Meaning of unable to supply
A responsible person for a guaranteed brand of the guaranteed item is unable to supply the guaranteed brand of the guaranteed item on a day if the responsible person would be unable to supply any amount of the guaranteed brand of the guaranteed item within a reasonable period of being requested by a wholesaler or an approved pharmacist, on that day, to supply the guaranteed brand of the guaranteed item.
Subdivision E—Requirement to notify Minister of failure or inability to supply etc.
99AEG Requirement to notify Minister of failure to supply etc.
Notification of belief that responsible person will fail to supply or be unable to supply
(1) If, during the guaranteed period for a guaranteed brand of a guaranteed item, the responsible person for the guaranteed brand of the guaranteed item forms the belief that the person will fail to supply, or will be unable to supply, the guaranteed brand of the guaranteed item in the period, then, as soon as practicable after the person forms the belief, the person must notify the Minister, in writing, of that belief.
Notification of failure to supply or inability to supply
(2) If, during the guaranteed period for a guaranteed brand of a guaranteed item, the responsible person for the guaranteed brand of the guaranteed item fails to supply, or is unable to supply, the guaranteed brand of the guaranteed item, then, as soon as practicable after the failure or inability occurs, the person must notify the Minister, in writing, of that failure or inability unless the person notified the Minister about that supply under subsection (1).
Offence
(3) A person commits an offence if:
(a) the person is required to notify the Minister under subsection (1) or (2); and
(b) the person fails to do so.
Penalty: 60 penalty units.
(4) Subsection 4K(2) of the Crimes Act 1914, which creates daily or continuing offences, does not apply to an offence against subsection (3).
Subdivision F—Consequences for guaranteed brands of failure or inability to supply
99AEH Minister’s powers if responsible person fails to supply, or is unable to supply, guaranteed brand
(1) This section applies if, during the guaranteed period for a guaranteed brand of a guaranteed item, the responsible person for the guaranteed brand of the guaranteed item fails to supply, or is unable to supply, the guaranteed brand of the guaranteed item on one or more occasions.
(2) Without limiting any power the Minister may otherwise have under this Part, the Minister may do any or all of the following:
(a) by legislative instrument, revoke or vary a determination under subsection 85(6) in relation to the guaranteed brand of the guaranteed item;
(b) by legislative instrument, revoke or vary a determination under subsection 85(6) in relation to any brand of any pharmaceutical item of the responsible person;
(c) refuse to make a determination under subsection 85(6) in relation to any brand of any pharmaceutical item of the responsible person;
(d) if the only listed brand of a pharmaceutical item would be a brand of the pharmaceutical item of the responsible person—refuse to make:
(i) a declaration under subsection 85(2) in relation to the drug in the pharmaceutical item; or
(ii) a determination under subsection 85(3) in relation to the form of the pharmaceutical item; or
(iii) a determination under subsection 85(5) in relation to the manner of administration of the pharmaceutical item.
Note: For the purposes of paragraphs (b), (c) and (d), a brand mentioned in those paragraphs may be the guaranteed brand, or a pharmaceutical item mentioned in those paragraphs may be the guaranteed item.
(3) Without limiting the powers of the Minister under subsection (2), in exercising a power under that subsection, the Minister may have regard to:
(a) the number of times the responsible person failed to supply, or was unable to supply:
(i) the guaranteed brand of the guaranteed item; and
(ii) if, in addition to the guaranteed brand of the guaranteed item, the person was also required to supply other guaranteed brands of guaranteed items—those other guaranteed brands of guaranteed items; and
(b) the period in which those failures or inabilities occurred; and
(c) the duration of those failures or inabilities; and
(d) the reasons for those failures or inabilities; and
(e) whether those reasons are, in the Minister’s opinion, reasonable; and
(f) any other matter the Minister thinks is relevant.
(4) The refusals referred to in paragraphs (2)(c) and (d) are not legislative instruments.
Subdivision G—Consequences for other brands
99AEI Minister may increase approved ex‑manufacturer price if guaranteed brand delisted
(1) This section applies if, under section 99AEH, the Minister revokes or varies a determination under subsection 85(6) in relation to a brand (the delisted brand) of a pharmaceutical item (the existing item).
(2) Without limiting any power the Minister may otherwise have under this Part, the Minister may:
(a) under section 85AD, make or vary a price agreement to increase the agreed price; or
(b) under subsection 85B(2), make or vary a determination to increase the determined price; or
(ba) under subsection 85B(3), make or vary a determination to increase one or more claimed prices;
for a brand of a pharmaceutical item that has an approved ex‑manufacturer price that was reduced because the delisted brand of the existing item was:
(c) the new brand of the trigger item referred to in section 99ACB; or
(d) the new brand of the trigger combination item referred to in section 99ACD; or
(da) the new brand of the trigger item referred to in section 99ACEA; or
(db) one of the new brands of the triggers items referred to in section 99ACEB; or
(e) the guaranteed brand of the guaranteed item under subsection 99AED(2).
(3) If the Minister exercises the power referred to in subsection (2), then the Minister may, by legislative instrument, determine that:
(a) if subsection 99ACB(1) applied to the delisted brand of the existing item—for the purposes of subsection 99ACB(3), subsection 99ACB(1) is taken not to have applied to the delisted brand of the existing item; or
(b) if subsection 99ACD(1) applied to the delisted brand of the existing item—for the purposes of subsection 99ACD(2), subsection 99ACD(1) is taken not to have applied to the delisted brand of the existing item; or
(c) if subsection 99ACEA(1) applied to the delisted brand of the existing item—for the purposes of subsection 99ACEA(2), subsection 99ACEA(1) is taken not to have applied to the delisted brand of the existing item; or
(d) if subsection 99ACEB(1) applied to the delisted brand of the existing item—for the purposes of subsection 99ACEB(2), subsection 99ACEB(1) is taken not to have applied to the delisted brand of the existing item.
(4) If the Minister makes a determination under subsection (3), the determination has effect on the day specified in the determination, being a day on or after the determination comes into force.
99AEJ Minister may determine drug is on F1 if guaranteed brand delisted
The Minister may, by legislative instrument, determine that a listed drug is on F1 if:
(a) under section 99AEH, the Minister revokes or varies a determination under subsection 85(6) in relation to a brand (the delisted brand) of a pharmaceutical item (the existing item); and
(b) before the revocation or variation came into force, subsection 99AEC(2) applied to the delisted brand of the existing item; and
(c) after the revocation or variation comes into force, there is only one listed brand of a pharmaceutical item (the remaining item) that is bioequivalent or biosimilar to the delisted brand of the existing item; and
(d) apart from paragraph 85AB(4)(c), the drug in the remaining item satisfies the criteria for F1 referred to in subsection 85AB(4); and
(e) the drug in the remaining item was on F1 on the day before subsection 99AEC(2) began to apply to the delisted brand of the existing item.
99AEK Minister may revoke or vary formulary determination if guaranteed brand delisted
Without limiting the power of the Minister under section 85AB, the Minister may, by legislative instrument, revoke or vary a determination under section 85AB if:
(a) under section 99AEH, the Minister revokes or varies a determination under subsection 85(6) in relation to a brand (the delisted brand) of a pharmaceutical item (the existing item); and
(b) before the revocation or variation came into force, subsection 99AEC(2) applied to the delisted brand of the existing item; and
(c) after the revocation or variation comes into force, there is only one listed brand of a pharmaceutical item (the remaining item) that is bioequivalent or biosimilar to the delisted brand of the existing item; and
(d) the remaining item is a combination item; and
(e) the drug in the remaining item was not on F1 or F2 on the day before subsection 99AEC(2) began to apply to the delisted brand of the existing item.
Division 4—Provisions relating to members of the Pharmaceutical Benefits Remuneration Tribunal
99A Terms and conditions of appointment
(1) Subject to this Part, a member holds office for such period (not exceeding 3 years) as is, and on such terms and conditions as are, specified in the instrument of his or her appointment, but is eligible for re‑appointment.
(2) If the holder of the office of Chairperson ceases to be a Deputy President of the Fair Work Commission he or she ceases to hold the office of Chairperson.
99B Remuneration and allowances
(1) The Chairperson shall not be paid remuneration or allowances in his or her capacity as Chairperson but, for the purposes of the payment of travelling expenses to him or her, his or her duties as Deputy President of the Fair Work Commission shall be deemed to include his or her duties as Chairperson of the Tribunal.
(2) An additional member shall be paid such remuneration as is determined by the Remuneration Tribunal, but, if no determination of that remuneration by that Tribunal is in operation, the additional member shall be paid such remuneration as is prescribed.
(3) An additional member shall be paid such allowances as are prescribed.
(4) Subsections (2) and (3) have effect subject to the Remuneration Tribunal Act 1973.
99C Resignation and removal from office
(1) A member may resign office by writing signed by the member and delivered:
(a) in the case of the Chairperson—to the Governor‑General; or
(b) in any other case—to the Minister.
(2) The Governor‑General may remove the Chairperson from office for misbehaviour or physical or mental incapacity.
(3) The Minister may remove an additional member from office for misbehaviour or physical or mental incapacity.
(4) If an additional member becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit, the Minister shall remove the member from office.
99D Acting Chairperson
(1) The Governor‑General may appoint a person who holds office as a Deputy President of the Fair Work Commission to act as Chairperson of the Tribunal:
(a) during a vacancy in the office of Chairperson; or
(b) during any period, or during all periods, when the Chairperson is unavailable to perform the duties of Chairperson.
Note: For rules that apply to acting appointments, see section 33A of the Acts Interpretation Act 1901.
(4) Where the Tribunal as constituted for the purpose of a proceeding includes a person acting or purporting to be appointed under this section, or a person so acting or purporting to be appointed has done any act, the validity of any decision of, or of any direction given or other act done by, the Tribunal as so constituted, or of the act done by the person so acting or purporting to be appointed, shall not be called in question in any proceeding on the ground that the occasion for the person to act or for the appointment of the person had not arisen or that the occasion for the person’s appointment had passed or the person’s appointment had ceased to have effect.
(7) Where, by virtue of an appointment under subsection (1), a person is acting as Chairperson during the unavailability of the Chairperson, the Governor‑General may, by reason of the pending consideration of a matter by the Tribunal or other special circumstances, direct that the person so acting shall continue so to act until otherwise directed by the Governor‑General notwithstanding that the Chairperson has ceased to be unavailable.
(8) Where a person is acting as Chairperson by virtue of a direction under subsection (7), the Chairperson shall take no part in the operations of the Tribunal.
(9) A person shall not continue to act as Chairperson by virtue of a direction under subsection (7) for a period of more than 12 months.
(10) The appointment of a person under subsection (1) and a direction in relation to a person under subsection (7) cease to have effect if the person ceases to hold office as a Deputy President of the Fair Work Commission.
99E Acting additional member
(1) The Minister may appoint a person to act as an additional member of the Tribunal:
(a) during a vacancy in an office of an additional member; or
(b) during any period, or during all periods, when an additional member is unavailable to perform his or her duties.
Note: For rules that apply to acting appointments, see section 33A of the Acts Interpretation Act 1901.
(4) Where the Tribunal as constituted for the purpose of a proceeding includes a person acting or purporting to be appointed under this section, or a person so acting or purporting to be appointed has done any act, the validity of any decision of, or of any direction given or other act done by, the Tribunal as so constituted, or of the act done by the person so acting or purporting to be appointed, shall not be called in question in any proceeding on the ground that the occasion for the person to act or for the appointment of the person had not arisen or that the occasion for the person’s appointment had passed or the person’s appointment had ceased to have effect.
Division 4A—Indexation
99F Definitions
In this Division, unless the contrary intention appears:
concessional beneficiary charge means each amount of $4.60 referred to in paragraph 84C(4)(d), section 84CA, paragraph 87(2)(a) or subsection 99(2B).
concessional beneficiary safety net means the amount worked out by multiplying the concessional beneficiary charge by 60.
general patient charge means each amount of $28.60 referred to in paragraph 84C(4)(c) or 87(2)(e) or subsection 99(2A).
general patient reduced charge means each amount of $4.60 referred to in paragraph 87(2)(b), or (c) or subsection 99(2AB).
general patient safety net means the amount that was the general patient safety net immediately before 31 December 2009.
index number, in relation to a quarter, means the All Groups Consumer Price Index number that is the weighted average of the 8 capital cities and is published by the Australian Statistician in respect of that quarter.
99G Indexation
(1) An amount referred to in an item in the CPI Indexation Table below is to be indexed under this section in each year after 2005 on the indexation day in that item, using the reference quarter in that item and rounding to the nearest multiple of 10 cents. However, if the amount is not a multiple of 10 cents but it is a multiple of 5 cents, the amount is to be increased by 5 cents.
CPI INDEXATION TABLE |
Item | Amount | Indexation day | Reference quarter |
1. | General patient charge | 1 January | September |
2. | General patient reduced charge | 1 January | September |
3. | Concessional beneficiary charge | 1 January | September |
4. | General patient safety net | 1 January | September |
(2) Where an amount is to be indexed on an indexation day, this Act has effect as if the indexed amount were substituted for that amount on that day.
Note: The Department can tell you what the current indexed amounts are.
(3) Subject to this section, the indexed amount for an amount to be indexed is worked out using the formula:
where:
Current figure, as at a particular time in relation to an amount to be indexed, means:
(a) if the amount has not yet been indexed under this section before that time—the amount; and
(b) if the amount has been indexed under this section before that time—the amount most recently substituted for the amount under this section before that time.
Indexation factor means the figure worked out under subsection (4).
(4) Subject to subsections (5) and (6), the indexation factor for an amount to be indexed on an indexation day is worked out using the formula:
where:
Most recent index number means the index number for the most recent reference quarter for the amount ending before the indexation day.
Previous index number means the index number for the reference quarter for the amount immediately preceding the most recent reference quarter for the amount ending before the indexation day.
(5) Subject to subsections (6) and (7), an indexation factor is to be worked out to 3 decimal places.
(6) If an indexation factor worked out under subsection (5) would, if it were worked out to 4 decimal places, end in a number that is greater than 4, the indexation factor is to be increased by 0.001.
(7) If an indexation factor worked out under subsections (4), (5) and (6) would be less than 1, the indexation factor is to be increased to 1.
(8) Subject to subsection (9), if at any time (whether before or after the commencement of this section), the Australian Statistician publishes an index number for a quarter in substitution for an index number previously published by the Statistician for that quarter, the publication of the later index number is to be disregarded for the purposes of this section.
(9) If at any time (whether before or after the commencement of this section) the Australian Statistician changes the reference base for the Consumer Price Index, regard is to be had, for the purposes of applying this section after the change takes place, only to index numbers published in terms of the new reference base.
Division 4B—Australian Community Pharmacy Authority
99H Interpretation
In this Division:
Chairperson means the Chairperson of the Authority.
member means a member of the Authority.
99J Establishment of Authority
(1) An Authority is established.
(2) The name of the Authority is the Australian Community Pharmacy Authority.
99K Functions
(1) The functions of the Authority are:
(a) to consider applications under section 90; and
(b) to make, in respect of an application under section 90:
(i) a recommendation whether or not the applicant should be approved under that section in respect of particular premises; and
(ii) if an approval is recommended—recommendations as to the conditions (if any) to which the approval should be subject; and
(2) In making a recommendation under subsection (1), the Authority must comply with the relevant rules determined by the Minister under section 99L.
(3) All recommendations of the Authority under subsection (1) are to be made to the Secretary.
99L Determination of rules by Minister
(1) The Minister must, by writing, determine the rules subject to which the Authority is to make recommendations under subsection 99K(1).
(2) A determination under subsection (1) is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.
99M Powers
The Authority has power to do all things necessary or convenient to be done for, or in connection with, the performance of its functions.
99N Membership
(1) The Authority consists of the following part‑time members:
(a) a Chairperson;
(b) 2 pharmacists who are to be chosen from 4 pharmacists nominated by the Pharmacy Guild of Australia;
(c) one pharmacist who is to be chosen from 2 pharmacists nominated by the Pharmaceutical Society of Australia;
(d) an officer of the Department;
(e) a person who, in the Minister’s opinion, is an appropriate person to represent the interests of consumers.
(2) The member referred to in paragraph (1)(d) is to be appointed by the Secretary.
(3) The other members are to be appointed by the Minister.
(4) The member referred to in paragraph (1)(d) holds office, subject to this Division, during the pleasure of the Secretary.
(5) Each member referred to in paragraph (1)(a), (b), (c) or (e) holds office, subject to this Division, for the period of 2 years from the date of his or her appointment, but is eligible for re‑appointment.
99P Terms and conditions not provided for by this Act
A member holds office on such terms and conditions (if any), in respect of matters not provided for by this Act, as are determined in writing by the Minister.
99Q Defective appointment not invalid
The appointment of a person as a member is not invalid because of a defect or irregularity in connection with the appointment.
99R Remuneration and allowances
(1) A member is to be paid such remuneration as is determined by the Remuneration Tribunal, but, if no determination of that remuneration by the Tribunal is in operation, a member is to be paid such remuneration as is prescribed.
(2) A member is to be paid such allowances as are prescribed.
(3) Subsections (1) and (2) have effect subject to the Remuneration Tribunal Act 1973.
(4) In this section:
member means a member other than the member referred to in paragraph 99N(1)(d).
99S Leave of absence
The Minister may grant to a member appointed by the Minister leave of absence on such terms and conditions as to remuneration or otherwise as the Minister determines.
99T Disclosure of interests
(1) A member who has a direct or indirect pecuniary interest in a matter being considered by the Authority must, as soon as possible after the relevant facts have come to the member’s knowledge, disclose the nature of the interest at a meeting of the Authority.
(2) A disclosure under subsection (1) must be recorded in the minutes of the meeting of the Authority and the member may not, unless the Minister otherwise determines:
(a) be present during any deliberation of the Authority with respect to that matter; or
(b) take any part in any decision of the Authority with respect to that matter.
99U Resignation
A member may resign by writing signed and delivered:
(a) if the member was appointed by the Secretary—to the Secretary; or
(b) otherwise—to the Minister.
99V Termination of appointment
(1) The Minister may terminate the appointment of a member for misbehaviour or physical or mental incapacity.
(2) If a member:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with creditors or makes an assignment of remuneration for the benefit of those creditors;
(b) fails, without reasonable excuse, to comply with an obligation imposed by section 99T; or
(c) is absent, except on leave of absence granted under section 99S, from 3 consecutive meetings of the Authority;
the Minister may terminate the appointment of the member.
(3) In this section:
member means a member appointed by the Minister.
99W Meetings
(1) The Chairperson may convene such meetings of the Authority as the Chairperson considers necessary for the efficient performance of the Authority’s functions.
(2) Meetings are to be held at such places as the Chairperson determines.
(3) The Chairperson presides at all meetings at which he or she is present.
(4) Where the Chairperson is not present at a meeting, the members present must appoint one of their number to preside at the meeting.
(5) Subject to this Act, the person presiding at a meeting may give directions regarding the procedure to be followed at or in connection with that meeting.
(6) At a meeting:
(a) 3 members constitute a quorum; and
(b) all questions are to be decided by a majority of votes of the members present and voting; and
(c) the person presiding has a deliberative vote and, if necessary, also has a casting vote.
(7) The Authority must keep records of its meetings.
99X Committees
(1) The Authority:
(a) may, with the approval in writing of the Minister, establish committees to assist it in performing its functions; and
(b) must, if the Minister so requires in writing, establish a committee to assist it in advising the Minister on a particular matter referred to it by the Minister.
(2) A committee consists of the persons (whether or not members of the Authority) appointed by the Minister to be its members.
(3) An appointment under subsection (2) is on a part‑time basis.
(4) For the purposes of section 99R, the members of a committee who are not members of the Authority are taken to be members of the Authority.
99Y Cessation of operation
Unless sooner repealed, this Division ceases to have effect at the end of 30 June 2015.
Division 4C—Cost recovery
Subdivision A—Preliminary
99YB What this Division is about
This Division enables fees to be charged for certain services provided by the Commonwealth in order to recover the cost to the Commonwealth of providing those services. Those services relate to the exercise of certain powers of the Minister under this Act.
Subdivision B provides for regulations to set out the fees that are payable for those services, as well as other matters relating to the payment of those fees and the provision of those services (including some consequences of failing to pay a fee).
Subdivision C sets out another possible consequence of failing to pay a fee by providing for the Minister to refuse to exercise certain powers until the fee is paid.
Subdivision D provides that the Minister must cause a review to be undertaken of the impact of cost‑recovery measures provided for under this Division and any regulations made under this Division, and must table an annual report on related processes.
Subdivision B—Payment of fees etc. for certain services
99YBA Payment of fees etc. for certain services
(1) The regulations may make provision in relation to services provided by the Commonwealth in relation to the exercise of a power by the Minister under any of the following:
(a) section 9B;
(b) a provision in Part VII (other than a provision in that Part prescribed by the regulations).
(2) Without limiting subsection (1), the regulations may make provision in relation to the following:
(a) the making of applications for those services;
(b) prescribing fees for those services;
(c) the time that prescribed fees are due and payable (including extending the time for payment of the fees);
(d) the manner of payment of prescribed fees (including payment by instalments);
(e) the payment of penalties in respect of late payment of prescribed fees;
(f) exemptions from prescribed fees;
(g) the waiver, remission or refund of prescribed fees;
(h) the refusal to provide those services until a prescribed fee is paid;
(i) the review of decisions made under the regulations.
(3) A prescribed fee must not be such as to amount to taxation.
(4) A prescribed fee is payable to the Commonwealth.
(5) A prescribed fee that is due and payable may be recovered by the Commonwealth as a debt due to the Commonwealth.
Subdivision C—Consequences if fees not paid
99YBB Minister may refuse to exercise certain powers if prescribed fees not paid
(1) If:
(a) a person applies for a service referred to in subsection 99YBA(1) in relation to the exercise of a power by the Minister; and
(b) either:
(i) a fee prescribed under paragraph 99YBA(2)(b) is payable by the person for the service; or
(ii) a fee prescribed under paragraph 99YBA(2)(b) is payable by the person for another service referred to in subsection 99YBA(1) that the person has applied for;
then, without limiting any power the Minister may otherwise have under section 9B or this Part, the Minister may refuse to exercise the power until the prescribed fee is paid.
(2) A refusal referred to in subsection (1) is not a legislative instrument.
Subdivision D—Review of cost‑recovery measures
99YBC Review of impact of cost‑recovery measures
Review
(1) The Minister must cause an independent review of the impact of cost‑recovery measures provided for under this Division and any regulations made under this Division to be undertaken as soon as possible after the second anniversary of the commencement of this Division and completed within 4 months of that anniversary.
(2) The review must report on:
(a) the average number of times a submission is presented before gaining approval and the reasons provided for requiring applicants to resubmit;
(b) the average fee for submissions by type of submission (major/minor/generic according to the Department’s classifications);
(c) the number of applications where the population is likely to be small and utilisation of the drug, medicinal preparation or vaccine is likely to be highly targeted;
(d) the number of reviews requested by applicants;
(e) the number of fee waivers given to applicants and the reasons why waivers were given;
(f) the length of time taken for submissions to be approved;
(g) the number of applications that fail to gain a listing, the reasons why and the types of drugs concerned;
(h) any increase in operating costs of the Pharmaceutical Benefits Advisory Committee;
(i) any increase in the cost of pharmaceutical benefits scheme medications to patients;
(j) any other matters considered relevant.
(3) The review must be conducted by a panel which must comprise not less than five persons, including:
(a) a medical professional nominated by the Minister;
(b) a nominee of the Consumers Health Forum of Australia;
(c) three other persons nominated by the Minister, each of whom must have relevant professional qualifications and must not be employed within the pharmaceuticals industry.
(4) The panel must give the Minister a written report of the review, and the Minister must cause a copy of the report to be tabled in each House of the Parliament within 15 sitting days of receiving the report.
Annual report on processes
(5) The Secretary must, as soon as practicable after 30 June in each year, prepare and give to the Minister a report on processes leading up to the Pharmaceutical Benefits Advisory Committee consideration, including:
(a) the extent and timeliness with which responsible persons are provided copies of documents relevant to their submission to the Pharmaceutical Benefits Advisory Committee;
(b) the extent to which responsible persons exercise their right to comment on these documents, including appearing at hearings before the Pharmaceutical Benefits Advisory Committee;
(c) the number of responsible persons seeking a review of a Pharmaceutical Benefits Advisory Committee recommendation.
(6) The Minister must cause a copy of each report prepared under subsection (5) to be tabled in each House of the Parliament within 15 sitting days of receiving the report.
Division 4D—Export restriction
99ZH Definitions
(1) In this Division, unless the contrary intention appears:
CEO of Customs means the Chief Executive Officer of Customs.
Commonwealth benefit means benefit paid or payable by the Commonwealth to an approved supplier of substances to which this Part applies.
consign for export, in relation to an article containing drug like substances, means the initial act of placement of that article by one person in the physical possession of another person with the intention that the other person will, either directly or indirectly, arrange for the export of that article from Australia to a place outside Australia.
Customs declaration, in relation to an article that is consigned for export and that contains drug like substances, means:
(a) an export entry within the meaning of the Customs Act 1901; or
(b) a declaration that is attached to the article in accordance with the requirements of section 99ZK.
Customs documentation purposes means the purposes of enabling Customs to deal with any complaint made, or proceeding taken, against Customs officers in respect of their activities under this Division.
Customs officer means an officer of Customs within the meaning of subsection 4(1) of the Customs Act 1901.
drug like substance means a substance:
(a) that is in the form of a tablet, capsule, or other similar preparation apparently suitable for taking by mouth; or
(b) that is apparently suitable for introduction into the nose or throat as an aerosol; or
(c) that is contained in an ampoule or vial apparently suitable for injection; or
(d) that is a cream, suppository, pessary, foam or other preparation apparently suitable for insertion in the rectum or vagina; or
(e) that is contained in a patch or other vehicle apparently suitable for the introduction of a medication through the skin;
and includes the packaging (if any) in which the substance, or the ampoule, vial, patch or other vehicle containing the substance, is contained.
exporter, in relation to drug like substances, means a person who:
(a) leaves Australia or attempts to leave Australia, carrying such substances; or
(b) consigns an article containing such substances for exportation.
PBS monitoring purposes means monitoring by the Chief Executive Medicare of the operation of the pharmaceutical benefits scheme.
PBS regulatory purposes means:
(a) the purpose of enabling the Chief Executive Medicare to perform his or her functions in relation to drug like substances detained under this Division; and
(b) PBS monitoring purposes.
pharmaceutical benefits scheme means the scheme for the supply of pharmaceutical benefits established under this Part.
prescription drug means a substance for the supply of which the prescription of a medical or dental practitioner is required:
(a) if the State or Territory in which the substance was supplied is known—under the law of that State or Territory relating to drugs or poisons; or
(b) in any other case—under the law of any State, of the Australian Capital Territory, or of the Northern Territory, relating to drugs or poisons.
prohibited export means a thing the exportation of which from Australia is prohibited under the Customs Act 1901 or under any other law of the Commonwealth.
(2) In this Division, a reference to the making of a copy of a document means, in relation to a document that is in electronic form, the making of a hard copy of the text of the original document.
99ZI Restrictions on carriage or consignment of drug like substances
(1) A person must not leave Australia carrying drug like substances unless they:
(a) are not prescription drugs; or
(b) are prescription drugs but no Commonwealth benefit has been paid or is payable in respect of those drugs; or
(c) are prescription drugs but for the personal use of the person, of another person travelling in the company of the person or of a person covered by paragraph 86A(2)(a), (b) or (c).
(2) A person must not consign for export an article that contains drug like substances unless the substances:
(a) are not prescription drugs; or
(b) are prescription drugs but no Commonwealth benefit has been paid or is payable in respect of those drugs; or
(c) are prescription drugs but for the personal use of the person, of another person accompanying the person or of a person covered by paragraph 86A(2)(a), (b) or (c).
(3) For the purposes of subsection (1), a person who attempts to leave Australia is taken to be carrying drug like substances if the substances are in baggage to which the person’s documents for travel relate, whether or not that baggage is under the person’s immediate physical control.
(4) The restriction imposed by subsections (1) and (2) on the carriage or consignment of drug like substances are in addition to, and not in derogation from, any other prohibition or restriction imposed on such activities, in relation to those substances, under any other law of the Commonwealth or any law of a State or Territory.
(5) The reference in subsection (3) to a person’s documents for travel that relate to the person’s baggage includes a reference to any document relating to the person’s travel that contains information for use by the person in reclaiming that baggage.
99ZJ Detention of certain drug like substances being carried out of Australia and retention of related documents
(1) If:
(a) a person is attempting to leave Australia; and
(b) a Customs officer finds that the person is carrying drug like substances in the person’s baggage; and
(c) the person cannot satisfy the officer of a matter referred to in paragraph 99ZI(1)(a), (b) or (c) in relation to the substances;
the officer may, in accordance with guidelines issued under section 99ZS, detain the substances for transfer to the Chief Executive Medicare for PBS regulatory purposes.
(2) If the drug like substances are claimed by the exporter not to be prescription drugs, the exporter may satisfy a Customs officer of that claim by providing to the officer:
(a) a signed declaration by the exporter to that effect; or
(b) any other evidence sufficient to satisfy the officer to that effect.
(3) If the drug like substances are claimed by the exporter to be prescription drugs, the exporter may satisfy a Customs officer that no Commonwealth benefit has been paid or is payable in respect of the substances by providing to the officer:
(a) an approved supplier’s letter to that effect; or
(b) a signed declaration by the exporter to that effect; or
(c) any other evidence sufficient to satisfy the officer to that effect.
(4) If the drug like substances are claimed by the exporter to be prescription drugs, the exporter may satisfy a Customs officer that they are for the personal use of the exporter (the applicable person), of another person (the applicable person) accompanying the exporter or of a person (the applicable person) covered by paragraph 86A(2)(a), (b) or (c), by providing to the officer:
(a) a medical or dental practitioner’s letter to that effect; or
(aa) an optometrist’s letter signed on or after 1 January 2008 to that effect; or
(ab) a letter from an authorised midwife or an authorised nurse practitioner signed on or after 1 November 2010 to that effect; or
(b) a signed declaration by the exporter:
(i) stating that the substances are for the personal use of the applicable person; and
(ii) setting out the name and address of the medical or dental practitioner, or the optometrist, authorised midwife or authorised nurse practitioner, who prescribed the substances; and
(iii) setting out the name and address of the approved supplier of the substances; and
(iv) stating the quantity of the substances intended for export; and
(v) setting out the daily dosage of the substances for the applicable person and the time the applicable person is expected to be outside Australia; or
(c) any other evidence sufficient to satisfy the officer that the substances are for the personal use of the applicable person.
(4A) For the purposes of subparagraph (4)(b)(ii), the substances must have been prescribed:
(a) for substances prescribed by an optometrist—on or after 1 January 2008; or
(b) for substances prescribed by an authorised midwife or an authorised nurse practitioner—on or after 1 November 2010.
(5) Nothing in subsection (2), (3) or (4) is intended to imply that the tendering to a Customs officer of a document of the kind described in paragraph (2)(a), (3)(a) or (b) or (4)(a), (aa), (ab) or (b) will necessarily be sufficient to satisfy the officer as required by that subsection.
(6) If drug like substances are detained by a Customs officer under subsection (1), the officer must:
(a) if a signed declaration is given to the officer under subsection (2), (3) or (4):
(i) make 2 copies of the declaration; and
(ii) retain the original declaration for transfer to the Chief Executive Medicare for PBS regulatory purposes; and
(iii) retain one copy of the declaration for Customs documentation purposes; and
(iv) return the other copy of the declaration to the exporter; and
(b) if any other document is given to the officer under that subsection:
(i) make 2 copies of that document; and
(ii) retain one copy for transfer to the Chief Executive Medicare for PBS regulatory purposes; and
(iii) retain the other copy for Customs documentation purposes; and
(iv) return the original document to the exporter.
(7) Subject to subsection (8), if a drug like substance is not detained by a Customs officer under subsection (1), the officer must return to the exporter any document, including any signed declaration, given to the officer.
(8) If, on examination of a document, if any, given to a Customs officer under subsection (2), (3) or (4), the officer decides not to detain the drug like substances, but, having regard to:
(a) the quantity of the substances; or
(b) the manner of packaging or carrying of the substances; or
(c) any other circumstances relating to the carriage of the substances;
the officer considers it appropriate to retain information relating to the substances for transfer to the Chief Executive Medicare for PBS monitoring purposes, the officer must:
(d) if a signed declaration is given to the officer under that subsection:
(i) make 2 copies of the declaration; and
(ii) retain the original declaration for transfer to the Chief Executive Medicare for those monitoring purposes; and
(iii) retain one copy of the declaration for Customs documentation purposes; and
(iv) return the other copy of the declaration to the exporter; and
(e) if any other document is given to the officer under that subsection:
(i) make 2 copies of that document; and
(ii) retain one copy for transfer to the Chief Executive Medicare for those monitoring purposes; and
(iii) retain the other copy for Customs documentation purposes; and
(iv) return the original document to the exporter.
Note: The manner of dealing with documents, and copies of documents, retained under subsection (6) or (8) is dealt with in section 99ZN.
99ZK Detention of certain drug like substances consigned for export and retention of related documents
(1) If:
(a) a person consigns an article for export; and
(b) a Customs officer finds drug like substances in the article; and
(c) the article:
(i) is not covered by a Customs declaration that discloses the substances; or
(ii) is covered by a Customs declaration disclosing the substances but the declaration is not sufficient to satisfy the officer of a matter referred to in paragraph 99ZI(2)(a), (b) or (c) in relation to the substances;
the officer may, in accordance with guidelines issued under section 99ZS, detain the substances for transfer to the Chief Executive Medicare for PBS regulatory purposes.
(2) If a person consigns an article containing drug like substances for export and the person is not required, under subsection 113(1) of the Customs Act 1901, to enter the goods for export, the exporter must attach to the article in which the substances are consigned a signed declaration stating:
(a) his or her name and address; and
(b) any one of the following:
(i) that the substances are not prescription drugs;
(ii) that they are prescription drugs but no Commonwealth benefit has been paid or is payable in respect of them;
(iii) that they are prescription drugs but for the personal use, outside Australia, of the exporter, of a person who travels from Australia in the company of the exporter or of a person covered by paragraph 86A(2)(a), (b) or (c).
(3) To satisfy a Customs officer of a matter referred to in paragraph (2)(b), the exporter may:
(a) in the case of a statement under subparagraph (2)(b)(i)—include in the article any documentary evidence in support of that statement; or
(b) in the case of a statement under subparagraph (2)(b)(ii)—include in the article an approved supplier’s letter or other evidence to support that statement; or
(c) in the case of a statement under subparagraph (2)(b)(iii)—include in the article:
(i) a medical practitioner’s letter; or
(ii) a dental practitioner’s letter; or
(iii) an optometrist’s letter signed on or after 1 January 2008; or
(iiia) a letter from an authorised midwife or an authorised nurse practitioner signed on or after 1 November 2010; or
(iv) any other documentary evidence to support that statement.
(4) Nothing in subsection (3) is intended to imply that the inclusion within the article of a document of the kind described in paragraph (3)(a), (b) or (c) will necessarily be sufficient to satisfy the officer as required by that subsection.
(5) If drug like substances contained within an article consigned for export are detained by a Customs officer under subsection (1), the officer must:
(a) make a copy of the Customs declaration relating to that article; and
(b) retain that copy for transfer to the Chief Executive Medicare for PBS regulatory purposes; and
(c) retain the original declaration for Customs documentation purposes; and
(d) if the article is found to contain a document in support of a statement relating to the substances in the Customs declaration:
(i) make 2 copies of the document; and
(ii) retain one copy for transfer to the Chief Executive Medicare for PBS regulatory purposes; and
(iii) retain the other copy for Customs documentation purposes; and
(iv) return the original document to the article.
(6) If, on examination of a declaration referred to in subsection (2) or any other document referred to in subsection (3), the Customs officer decides not to detain the drug like substances, but having regard to:
(a) the quantity of the substances; or
(b) the manner of packaging the substances; or
(c) any other circumstances in which the substances are being exported;
the officer considers it appropriate to retain information relating to the substances for transfer to the Chief Executive Medicare for PBS monitoring purposes, the officer must:
(d) make a copy of the Customs declaration relating to that article; and
(e) retain the copy for transfer to the Chief Executive Medicare for those monitoring purposes; and
(f) retain the original declaration for Customs documentation purposes; and
(g) if the article is found to contain a document in support of a statement relating to the substances in the Customs declaration:
(i) make 2 copies of the document; and
(ii) retain one copy for transfer to the Chief Executive Medicare for those monitoring purposes; and
(iii) retain the other copy for Customs documentation purposes; and
(iv) return the original document to the article.
Note: The manner of dealing with documents, and copies of documents, retained under subsection (5) or (6) is dealt with in section 99ZN.
99ZL Examination and inspection powers
(1) A Customs officer may, in an examination place and with such assistance and using such force as is reasonable and necessary in the circumstances, examine, and inspect the contents of:
(a) any item of baggage, in that place, that is carried, or taken to be carried, by an exporter; or
(b) any article, in that place, that is consigned for export;
in order to determine, for the purposes of section 99ZJ or 99ZK:
(c) whether or not the baggage or article contains drug like substances; or
(d) if the presence of drug like substances in the baggage or article has been disclosed by the exporter—whether or not the drug like substances in the baggage or article are as so disclosed.
(2) A Customs officer must, in exercising the powers of examination and inspection referred to in subsection (1), act in accordance with guidelines issued under section 99ZS.
(3) In this section:
examination place means:
(a) a port, airport, wharf or boarding station appointed under section 15 of the Customs Act 1901; or
(b) a place that is the subject of a permission under section 58 of that Act; or
(c) an international mail centre approved for the purposes of subsection 77F(1) of that Act; or
(d) a place appointed under section 77G of that Act.
99ZM Customs may detain some drug like substances and not others
The power in section 99ZJ or 99ZK to detain drug like substances contained in an item of baggage, or in an article consigned for export, includes a power to detain some such substances while not detaining others, including others of the same kind as the substances that are detained.
99ZN Customs treatment of detained substances and retained documents
(1) Drug like substances detained under section 99ZJ or 99ZK must, pending their transfer to the Chief Executive Medicare, be taken to a place of security specified by the CEO of Customs.
(2) If a Customs officer detains drug like substances under section 99ZJ or 99ZK, the officer must:
(a) give to the exporter a notice of such detention in accordance with subsections (4) and (5); and
(b) give to the Chief Executive Medicare a copy of that notice; and
(c) in accordance with the guidelines issued under section 99ZS, transfer to the Chief Executive Medicare, for PBS regulatory purposes:
(i) the substances so detained; and
(ii) any documents that relate to the substances and that were retained by the officer under subsection 99ZJ(6) or 99ZK(5) for such transfer; and
(d) in accordance with the guidelines issued under section 99ZS, transfer to a place of security specified by the CEO of Customs, for Customs documentation purposes, any documents relating to the substances that were retained by the officer under subsection 99ZJ(6) or 99ZK(5) for such purposes.
(3) If a Customs officer does not detain drug like substances under section 99ZJ or 99ZK but retains information relating to the substances under that section, the officer must, in accordance with the guidelines issued under section 99ZS:
(a) transfer to the Chief Executive Medicare, for PBS regulatory purposes, any documents that relate to the substances and that were retained by the officer under subsection 99ZJ(8) or 99ZK(6) for such transfer, accompanied by a brief statement of the circumstances in which the substances were being exported; and
(b) transfer to such place of security as the CEO of Customs directs, for Customs documentation purposes, any documents relating to the substances that were retained by the officer under subsection 99ZJ(8) or 99ZK(6) for such purposes, accompanied by a copy of the statement referred to in paragraph (a).
(4) For the purposes of this Division, a notice of detention of drug like substances is taken to have been duly given to the exporter if the notice is:
(a) given to the exporter, if the exporter is present at the time of the detention; or
(b) if the exporter is not present but a postal address of the exporter is known—sent by post to the last known such address; or
(c) if the postal address of the exporter of a consignment is not known but the address of the consignee is known—sent
