National Health Amendment Act (No. 1) 1999

No. 35, 1999

An Act to amend the National Health Act 1953, and for related purposes

[Assented to 31 May 1999]

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the National Health Amendment Act (No. 1) 1999.

2 Commencement

(1) Subject to subsections (2) and (3), this Act commences on the day on which it receives the Royal Assent.

(2) The items of Schedule 1 commence on a day or days to be fixed by Proclamation.

(3) If an item to which subsection (2) applies does not commence within 6 months after the day on which this Act receives the Royal Assent, that item commences on the first day after the end of that period.

3 Schedule(s)

Subject to section 2, each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1—Amendment of the National Health Act 1953

1 After Division 4C of Part VII

Insert:

Division 4D—Export restriction

99ZH Definitions

(1) In this Division, unless the contrary intention appears:

CEO of Customs means the Chief Executive Officer of the Australian Customs Service.

Commission means the Health Insurance Commission established under the Health Insurance Commission Act 1973.

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 the Australian Customs Service 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

(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.

Managing Director means the Managing Director of the Commission.

PBS monitoring purposes means monitoring by the Commission of the operation of the pharmaceutical benefits scheme.

PBS regulatory purposes means:

(a) the purpose of enabling the Commission to perform its 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 or of another person travelling in the company of the person.

(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

(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 Commission 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

(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, or of another person accompanying the exporter, by providing to the officer:

(a) a medical or dental practitioner’s letter to that effect; or

(b) a signed declaration by the exporter:

(i) stating that the substances are for the personal use of the exporter or of that other person; and

(ii) setting out the name and address of the medical or dental 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 person to whom they were supplied and the length of the person’s expected stay outside Australia; or

(c) any other evidence sufficient to satisfy the officer that the substances are for the personal use of the exporter or of another person accompanying the exporter.

(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) 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 Commission 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 Commission 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

the officer considers it appropriate to retain information relating to the substances for transfer to the Commission 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 Commission 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 Commission 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

(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 Commission 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, or of a person who travels from Australia in the company of the exporter.

(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 a medical or dental practitioner’s letter, or 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 Commission for PBS regulatory 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 Commission 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

the officer considers it appropriate to retain information relating to the substances for transfer to the Commission 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 Commission 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 Commission 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:

(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

(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 Commission, 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 Commission a copy of that notice; and

(c) in accordance with the guidelines issued under section 99ZS, transfer to the Commission, 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 Commission, 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 by post to the address of the consignee; or

(d) in any other situation—published in the Gazette.

(5) The notice of detention of drug like substances must:

(a) set out a description of the substances detained; and

(b) provide a brief statement of the reasons for detention; and

(i) if the Commission is satisfied that they are not prescription drugs and not prohibited exports—return the substances to the exporter or reconsign them for export, as the case requires; and

(ii) if the Commission is satisfied that they are prohibited exports—pass the substances to the agency nominated in the guidelines issued under section 99ZS to deal with prohibited exports of that kind; and

(iii) if the Commission is satisfied that they are prescription drugs but not prohibited exports—notify the exporter in writing to that effect and invite the exporter to apply in writing to the Commission, within 60 days after the notification, for their return on the basis that paragraph 99ZI(1)(b) or (c) or (2)(b) or (c) applies in relation to the substances; and

(d) inform the exporter that, if the exporter is notified by the Commission in accordance with subparagraph (c)(iii) but no application for the return of the substances is received within 60 days after the notification, then, in accordance with subsection 99ZO(5), the Commission will be taken to have seized the substances and the substances will have been taken to have been condemned as forfeited to the Commonwealth; and

(e) inform the exporter that, if the exporter is notified by the Commission in accordance with subparagraph (c)(iii) and an application for the return of the substances is made within 60 days after the notification, the Commission will consider the application and, within 120 days after the notification, will either:

(i) return the substances to the exporter or reconsign them for export; or

(ii) seize the substances and then seek an order of a magistrates court for their condemnation as forfeited to the Commonwealth; and

(f) inform the exporter of the possible implications of a criminal prosecution of the exporter in relation to the substances.

(6) If a copy of a document or statement is transferred by a Customs officer under subsection (3) to a place of security, the Australian Customs Service must ensure:

(a) that the copy is not used for any other purposes than the purposes for which it was retained; and

(b) that, at the end of 12 months, or on completion of any complaint or proceeding initiated against Customs officers, whichever last occurs, the copy is destroyed.

99ZO Treatment by the Commission of detained substances and retained documents

(1) As soon as practicable after the Commission takes possession of detained substances, they must, pending their return, reconsignment or disposal, be taken to a place of security specified by the Managing Director.

(2) If the Commission establishes, on examining detained substances, that they are not prescription drugs and not prohibited exports, the Commission must, as soon as practicable:

(a) return the substances and any documents relating to the substances to the exporter; or

(b) reconsign the substances, and those related documents, for export;

as the case requires.

(3) If the Commission establishes, on examining detained substances, that they are prohibited exports, the Commission must forthwith pass the substances, and any documents relating to the substances, to the agency nominated in the guidelines issued under section 99ZS to deal with prohibited exports of that kind.

(4) If the Commission establishes, on examining detained substances, that they are prescription drugs but not prohibited exports, the Commission must:

(a) notify the exporter, in writing, to that effect; and

(b) invite the exporter to apply in writing to the Commission, within 60 days after the notification, for the return of the substances on the basis that paragraph 99ZI(1)(b) or (c) or (2)(b) or (c) applies in relation to them.

(5) If the exporter does not make an application for their return within that period, then, at the end of that period and subject to subsection (6):

(a) the Commission is taken to have seized the substances; and

(b) the substances are taken to have been condemned as forfeited to the Commonwealth.

(6) If, before the day when substances would be taken to have been condemned as forfeited to the Commonwealth under subsection (5), proceedings for an offence involving those substances have been commenced, the substances are not to be taken to have been so condemned.

(7) If:

(a) the Commission establishes, on examining detained substances, that they are prescription drugs but not prohibited exports; and

(b) within 60 days after notification to that effect was given to the exporter, an application is made for the return of the substances;

the Commission must consider the application and, not later than 120 days after the notification was so given:

(c) if it decides that it is satisfied that paragraph 99ZI(1)(b) or (c) or (2)(b) or (c) applies to the substances—must return the substances to the exporter or reconsign them for export; and

(d) if it decides that it is not so satisfied—must seize the substances as forfeited to the Commonwealth.

(8) Despite the fact that substances are seized under subsection (7) as forfeited to the Commonwealth, the Commission must, subject to subsection (9) and to any other law of the Commonwealth requiring their retention, destruction or disposal, return the substances to the exporter or reconsign them for export unless:

(a) not later than 60 days after the seizure, proceedings are commenced in a magistrates court for the condemnation of the substances as forfeited goods; and

(b) on completion of the proceedings, that court makes an order that the substances are condemned as forfeited to the Commonwealth.

(9) A court must not make an order for condemnation of substances under subsection (8) if proceedings for an offence involving the substances have been commenced.

(10) In any proceeding for the condemnation of substances as forfeited to the Commonwealth, a certificate by the Commission to the effect that the substances are prescription drugs within the meaning of this Division is prima facie evidence of that matter.

99ZP Right of compensation in certain circumstances for substances destroyed

(1) Despite the destruction of drug like substances that are taken to be condemned as forfeited to the Commonwealth under subsection 99ZO(5) because no application for their return was made, a person may apply to a court of competent jurisdiction under this section for compensation in respect of those substances.

(2) A right to compensation exists if:

(a) the substances are not prohibited exports; and

(b) the substances were not used or otherwise involved in the commission of an offence; and

(i) that he or she would have had an entitlement to the return of the substances; and

(ii) that there were circumstances providing a reasonable cause for the failure to apply for that return within 60 days after the notice was given to the exporter.

(3) If a right to compensation exists under subsection (2), the court must order the payment by the Commonwealth to the person of an amount equal to the market value of the substances at the time of their destruction.

99ZQ Disposal of forfeited substances

(1) If drug like substances:

(a) are taken to have been seized and condemned as forfeited to the Commonwealth under subsection 99ZO(5); or

(b) are actually seized under subsection 99ZO(7) and condemned as forfeited to the Commonwealth under subsection 99ZO(8);

the title to the substances vests in the Commonwealth to the exclusion of all other interests and cannot be called into question.

(2) Substances to which subsection (1) applies must be destroyed in accordance with the guidelines issued under section 99ZS.

99ZR Liability for acts done in good faith

(1) Subject to subsection (2), neither the Commonwealth, the Commission nor any person performing duty as a Customs officer or as a member of, or of the staff of, the Commission is liable for any act done in good faith by such a Customs officer, by the Commission, or by such a member of, or of the staff of, the Commission in the performance of functions or duties, or the exercise of powers, under this Division.

(2) If drug like substances that the Commission would, but for the operation of this subsection, be obliged under subsection 99ZO(2) or (7) to return or reconsign:

(a) have ceased to be usable because of effluxion of time or otherwise; or

(b) have been lost;

the Commission is not required to return or reconsign the substances but, if the exporter seeks compensation under this subsection, must pay the exporter such amount as is agreed between the exporter and the Commission, or, failing agreement, as is determined by a court of competent jurisdiction, to cover the cost to the exporter:

(d) if the substances would, but for their detention, have been carried or sent by the exporter to a place outside Australia and the exporter continues to require that the substances are sent to that place—of sending the substances to that place.

99ZS Guidelines for detention of, dealing with, and disposal of, substances

(1) The CEO of Customs may, by notice in writing, issue guidelines for the performance of functions and duties, and for the exercise of powers, by Customs officers, in relation to matters arising under this Division including, in particular, matters relating to:

(a) the examination and inspection of items of baggage, and articles consigned for export, in the circumstances, and for the purposes, set out in subsection 99ZL(1); and

(b) the detention of some or all of the drug like substances found in the exercise of those powers of examination and inspection; and

(d) copying, retaining, transferring and otherwise dealing with, documents (including Customs declarations) provided in respect of drug like substances or in respect of items of baggage, or articles consigned for export, that are found to contain such substances.

(2) The Commission may, by notice in writing, issue guidelines for the performance of functions and duties, and for the exercise of powers, by the Commission, or by members of, or of the staff of, the Commission, in relation to matters arising under this Division including, in particular, matters relating to:

(a) dealing with drug like substances transferred to the Commission by Customs officers; and

(b) dealing with claims for the return of such substances; and

(d) if such substances are found on examination to be prohibited exports—the transfer of those substances, and any documents relating to them, to the agency nominated in the guidelines to deal with prohibited exports of that kind.

(3) At any time, the CEO of Customs or the Commission may, by written notice, issue further guidelines that vary or revoke the existing guidelines.

(4) Guidelines are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.

(5) Despite section 46A and paragraph 48(1)(b) of the Acts Interpretation Act 1901, guidelines take effect from:

(a) the first day on which they are no longer liable to be disallowed; or

(b) if the guidelines provide for their commencement after that day—in accordance with that provision.

99ZT Forfeiture of substances detained under section 99ZJ or 99ZK

All drug like substances that are transferred to the Commission under section 99ZJ or 99ZK following their detention are forfeited to the Commonwealth unless:

(a) the substances are not prescription drugs; or

(b) the substances are prescription drugs and the exporter establishes:

(i) that no Commonwealth benefit has been paid or is payable; or

(ii) that the substances are for the personal use of the exporter or of a person accompanying the exporter.

2 After subsection 103(4)

Insert:

(4AA) A person must not have in his or her possession, or consign for export, a quantity of a pharmaceutical benefit that exceeds the designated quantity of that pharmaceutical benefit unless:

(a) that first‑mentioned quantity was supplied to the person (whether on prescription or otherwise) by an approved supplier for the medical or dental treatment of the person; or

(b) the person has some other reasonable excuse for possessing or consigning for export that first‑mentioned quantity.

Penalty: Imprisonment for 2 years.

(4AB) In a prosecution for an offence against subsection (4AA), the defendant bears the evidential burden of proving the exception set out in paragraph (a) or (b) of that subsection.

(4AC) For the purposes of subsection (4AA), the designated quantity of a pharmaceutical benefit is the quantity of that pharmaceutical benefit worked out using the formula:

where:

MQ is the quantity or number of units of that pharmaceutical benefit that is determined by the Minister, under paragraph 85A(2)(a), to be the maximum quantity, or the maximum number of units, of that pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion.

RA is the number (if any) that is determined by the Minister, under paragraph 85A(2)(b), to be the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.

(4AD) In proceedings for an offence against subsection (4AA), a certificate by the Commission to the effect that:

(a) a substance specified in the certificate is a particular pharmaceutical benefit; and

(b) the quantity of the substance to which the offence relates exceeds the designated quantity in relation to a pharmaceutical benefit of that kind;

is prima facie evidence of those matters.

(4AE) A person is not liable to be convicted of an offence against subsection (4) and subsection (4AA) in respect of the same action.

[Minister’s second reading speech made in—

Senate on 17 February 1999

House of Representatives on 13 May 1999]

(12/99)