Therapeutic Goods Amendment Act (No. 3) 2000

No. 120, 2000

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

[Assented to 12 September 2000]

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the Therapeutic Goods Amendment Act (No. 3) 2000.

2 Commencement

(1) Subject to this section, this Act commences on the day on which it receives the Royal Assent.

(2) Schedule 1 commences on the 28th day after the day on which this Act receives the Royal Assent.

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Subject to section 2, each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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

Therapeutic Goods Act 1989

1 Subsection 3(1)

Insert:

ethics committee means a committee:

(a) constituted and operating as an ethics committee in accordance with guidelines issued by the National Health and Medical Research Council as in force from time to time; and

(b) which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.

2 Subsection 3(1) (definition of exempt goods)

Repeal the definition, substitute:

exempt goods, in relation to a provision of Part 3, means therapeutic goods that are exempted from the operation of that Part (except section 31A and sections 31C to 31F) by the regulations.

exempt goods, in relation to a provision of Part 4, means therapeutic goods that are exempted from the operation of that Part by the regulations.

3 At the end of subsection 18(1)

Add “(except section 31A and sections 31C to 31F)”.

4 Saving

(1) Regulations in force for the purposes of subsection 18(1) of the Therapeutic Goods Act 1989 immediately before the commencement of the amendment of that subsection made by this Schedule have effect, after that commencement, as if they had been made for the purposes of that subsection after that commencement.

(2) Subitem (1) does not prevent the amendment or repeal of the regulations.

5 After subsection 19(1)

Insert:

(1A) An approval for the purpose mentioned in paragraph (1)(b) is subject to the conditions (if any) specified in the regulations. Those conditions (if any) are in addition to any conditions imposed on the approval under subsection (1).

6 Application

Conditions specified in regulations made for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989 apply to an approval for the purpose mentioned in paragraph 19(1)(b) of that Act granted before or after the commencement of subsection 19(1A).

7 After subsection 19(4)

Insert:

(4A) The use by a person for experimental purposes in humans of specified therapeutic goods that are the subject of an approval granted to someone else under paragraph (1)(b) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:

(a) the preconditions on the use of the goods for those purposes;

(b) the principles to be followed in the use of the goods for those purposes;

(d) the circumstances in which the person must cease the use of the goods for those purposes.

8 Application

Conditions specified in regulations made for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989 apply to an approval for the purpose mentioned in paragraph 19(1)(b) of that Act granted before or after the commencement of subsection 19(4A).

9 After subsection 19(5)

Insert:

(5A) An authority may be given subject to the conditions (if any) specified in the authority.

(5B) The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (5) by giving to the person written notice of the conditions (or further conditions).

10 Application

Subsection 19(5B) of the Therapeutic Goods Act 1989 applies to an authority given under subsection 19(5) of that Act before or after the commencement of subsection 19(5B).

11 After paragraph 19(6)(a)

Insert:

(aa) to a medical practitioner who has the approval of an ethics committee to supply the specified therapeutic goods or the specified class of such goods; and

12 At the end of subsection 19(6)

Add “Paragraph (aa) does not apply in the exceptional circumstances (if any) prescribed by the regulations for the purposes of this subsection.”.

13 Subsection 22(7)

Repeal the subsection, substitute:

(7) A person is guilty of an offence if:

(a) the person intentionally does an act or omits to do an act; and

(b) the person was reckless as to whether the act or omission would breach:

(i) a condition of an exemption applicable under regulations made for the purposes of subsection 18(1); or

(ii) a condition of an approval under section 19; or

(iii) a condition applicable under regulations made for the purposes of subsection 19(4A); or

(iv) a condition of an approval under section 19A.

(7AA) An offence against subsection (7) is punishable on conviction by a fine of not more than 60 penalty units.

14 After paragraph 22(7A)(a)

Insert:

(aa) the conditions (if any) to which the authority is subject; and

15 Subsection 22(8)

Omit “section 19.”, substitute “ section 19 or a condition applicable under regulations made for the purposes of subsection 19(4A).”.

16 After section 31

Insert:

31A Secretary may require information etc. about exempt goods

Exempt goods for use for experimental purposes in humans

(1) If therapeutic goods are exempt under subsection 18(1) from the operation of this Part (except this section and sections 31C to 31F) to allow for their use for experimental purposes in humans, the Secretary may give the sponsor of the goods a written notice requiring the sponsor to give to the Secretary specified information or documents relating to one or more of the following:

(a) the supply of the goods;

(b) the handling of the goods;

(d) the results of the supply of the goods;

(e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

Statement by medical practitioner about medicine

(2) If a medicine is exempt under subsection 18(1) from the operation of this Part (except this section and sections 31C to 31F) because a medical practitioner has signed a statement in accordance with regulation 12A of the Therapeutic Goods Regulations 1990, the Secretary may give the medical practitioner a written notice requiring the medical practitioner to give to the Secretary specified information or documents relating to one or more of the following:

(a) the condition of the person to whom the medicine is to be given or is given;

(b) the supply of the medicine;

(d) the monitoring of the supply of the medicine;

(e) the results of the supply of the medicine;

(f) any other matter prescribed by the regulations for the purposes of this paragraph in relation to medicines of that kind.

Compliance period

(3) A notice under subsection (1) or (2) must specify a reasonable period within which the person to whom the notice is given must comply with it. The period must be at least 14 days starting on the day on which the notice is given.

31B Secretary may require information relating to approvals and authorities under section 19

Approval under subsection 19(1)

(1) The Secretary may give to a person who is granted an approval under subsection 19(1) in relation to specified therapeutic goods a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

(a) the supply of the goods;

(b) the handling of the goods;

(d) the results of the supply of the goods;

(e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

Approval under subsection 19(1)—use by another person

(2) The Secretary may give to a person using specified therapeutic goods that are the subject of an approval granted to someone else under paragraph 19(1)(b) a written notice requiring the person to give to the Secretary specified information or documents relating to either of both of the following:

(a) the use of the goods;

(b) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

Authority under subsection 19(5)

(3) The Secretary may give to a person who is granted an authority under subsection 19(5) in relation to specified therapeutic goods, or a specified class of therapeutic goods, a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

(a) the supply of the goods;

(b) the handling of the goods;

(d) the results of the supply of the goods;

(e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

Compliance period

(4) A notice under subsection (1), (2) or (3) must specify a reasonable period within which the person to whom the notice is given must comply with it. The period must be at least 14 days starting on the day on which the notice is given.

31C Requirements in relation to information or documents sought under section 31A or 31B

When information or documents must be given etc.

(1) A person to whom a notice is given under section 31A or 31B must give the Secretary:

(a) the information or documents specified in the notice within the period specified in the notice; and

(b) the information specified in the notice in the form (if any) specified in the notice.

Way in which information given

(2) A notice mentioned in subsection (1) may require information to be given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

Offence

(3) A person mentioned in subsection (1) is guilty of an offence if the person fails to comply with that subsection.

Note: The privilege against self incrimination is not a reasonable excuse for the purposes of subsection (3). However, the information given, and the fact that a document was given under this section (and other information, documents or things obtained because of giving the information or document) generally cannot be used in a prosecution (see section 31F).

Penalty

(4) An offence against subsection (3) is punishable on conviction by a fine of not more than 60 penalty units.

31D False or misleading information

(1) A person to whom a notice is given under section 31A or 31B is guilty of an offence if:

(a) the person gives information to the Secretary in compliance or purported compliance with subsection 31C(1); and

(b) the person does so knowing that the information:

(i) is false or misleading; or

(ii) omits any matter or thing without which the information is misleading.

Maximum penalty: Imprisonment for 12 months.

(2) Subsection (1) does not apply as a result of subparagraph (1)(b)(i) if the information is not false or misleading in a material particular.

Note: A defendant bears an evidential burden in relation to the matter in subsection (2).

(3) Subsection (1) does not apply as a result of subparagraph (1)(b)(ii) if the information did not omit any matter or thing without which the information is misleading in a material particular.

Note: A defendant bears an evidential burden in relation to the matter in subsection (3).

31E False or misleading documents

(1) A person is guilty of an offence if:

(a) the person produces a document to the Secretary; and

(b) the person does so knowing that the document is false or misleading; and

Maximum penalty: Imprisonment for 12 months.

(2) Subsection (1) does not apply if the document is not false or misleading in a material particular.

Note: A defendant bears an evidential burden in relation to the matter in subsection (2).

(3) Subsection (1) does not apply to a person who produces a document if the document is accompanied by a written statement signed by the person or, in the case of a body corporate, by a competent officer of the body corporate:

(a) stating that the document is, to the knowledge of the first‑mentioned person, false or misleading in a material particular; and

(b) setting out, or referring to, the material particular in which the document is, to the knowledge of the first‑mentioned person, false or misleading.

Note: A defendant bears an evidential burden in relation to the matter in subsection (3).

31F Self‑incrimination

(1) A person is not excused from giving information or a document under section 31C on the ground that the giving of the information or document would tend to incriminate the person or expose the person to a penalty.

(2) However, in the case of an individual:

(a) the information given; or

(b) the giving of the document; or

(c) any information, document or thing obtained as a direct or indirect consequence of giving the information or document;

is not admissible in evidence in criminal proceedings against the individual (except proceedings under, or arising out of, section 31D or 31E).

17 Application

(1) Subsections 31B(1) and (2) of the Therapeutic Goods Act 1989 apply to an approval granted under subsection 19(1) of that Act before or after the commencement of section 31B of that Act.

(2) Subsection 31B(3) of the Therapeutic Goods Act 1989 applies to an authority given under subsection 19(5) of that Act before or after the commencement of section 31B of that Act.

18 After subsection 61(3)

Insert:

(3A) The Secretary may release information obtained in response to a notice under section 31A or 31B to:

(a) the head of an authority, or an authority, of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods; and

(b) the body in a State or Territory responsible for the registration of medical practitioners in that State or Territory; and

Schedule 2—Product tampering

Therapeutic Goods Act 1989

1 Subsection 3(1)

Insert:

actual or potential tampering has the meaning given by section 42U.

2 Subsection 3(1)

Insert:

National Manager of the Therapeutic Goods Administration means:

(a) the person holding the position of National Manager of the Therapeutic Goods Administration; or

(b) if the position of National Manager of the Therapeutic Goods Administration ceases to exist, or ceases to be referred to by that name—the person holding a position determined in writing by the Secretary.

3 Subsection 3(1)

Insert:

tamper: therapeutic goods are tampered with if:

(a) they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and

(b) the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.

4 After Part 4B

Insert:

Part 4C—Product tampering

42T Notifying of actual or potential tampering

(1) A person is guilty of an offence if:

(a) the person supplies, manufactures or is a sponsor of, or proposes to supply, manufacture or become a sponsor of, therapeutic goods; and

(b) either:

(i) the person knows that some or all of those therapeutic goods, or any other therapeutic goods, are or have been subject to actual or potential tampering; or

(ii) some or all of those therapeutic goods, or any other therapeutic goods, are or have been subject to actual or potential tampering, and the person is reckless as to that fact; and

(c) the person fails, within 24 hours after becoming aware of, or becoming aware of a substantial risk of, the actual or potential tampering, to notify the Secretary or the National Manager of the Therapeutic Goods Administration.

Maximum penalty: 400 penalty units.

(2) A person is guilty of an offence if:

(a) the person supplies, manufactures or is a sponsor of, or proposes to supply, manufacture or become a sponsor of, therapeutic goods; and

(b) the person receives information or a demand; and

(i) the person knows that the information or demand relates (either expressly or by implication) to actual or potential tampering with some or all of those therapeutic goods, or any other therapeutic goods; or

(ii) the information or demand relates (either expressly or by implication) to actual or potential tampering with some or all of those therapeutic goods, or any other therapeutic goods, and the person is negligent as to that fact; and

(d) the person fails to notify the Secretary or the National Manager of the Therapeutic Goods Administration of the information or demand within 24 hours after receiving it.

Maximum penalty: 240 penalty units.

(3) For the purposes of subparagraph (2)(c)(ii), the person is only taken to be negligent as to the fact that the information or demand is of the kind referred to in that subparagraph if:

(a) the person’s acts or omissions involve such a great falling short of the standard of care that a reasonable person would exercise in the circumstances; and

(b) there is such a high risk that the information or demand is of that kind;

that the acts or omissions merit criminal punishment.

(4) For the purposes of this section, it does not matter whether, at the time of receipt of the information or demand:

(a) the person has possession or control of the therapeutic goods to which the information or demand relates; or

(b) the therapeutic goods are in existence.

42U Meaning of actual or potential tampering etc.

Actual or potential tampering, in relation to therapeutic goods, means:

(a) tampering with the therapeutic goods; or

(b) causing the therapeutic goods to be tampered with; or

(d) proposing to cause the therapeutic goods to be tampered with.

42V Recovery of therapeutic goods because of actual or potential tampering

(1) The Secretary may, in writing, impose requirements under this section on a person if:

(a) the person supplies or has supplied therapeutic goods of a particular kind, or a particular batch of therapeutic goods of that kind; and

(b) the Secretary is satisfied that therapeutic goods of that kind, or included in that batch, are, have been or could possibly be, subject to actual or potential tampering.

(2) The requirements may be one or more of the following:

(a) to take specified steps, in the specified manner and within such reasonable period as is specified, to recover therapeutic goods of that kind, or included in that batch, that the person has supplied;

(b) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, that therapeutic goods of that kind, or included in that batch, are, or have been, subject to actual or potential tampering;

(c) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, that therapeutic goods of that kind, or included in that batch, could possibly be subject to actual or potential tampering.

(3) Requirements referred to in paragraph (2)(a) do not apply to therapeutic goods that cannot be recovered because they have been administered to, or applied in the treatment of, a person or animal.

(4) The Secretary must cause to be published in the Gazette, as soon as practicable after imposing such requirements, a notice setting out particulars of the requirements.

(5) The Secretary may impose requirements under this section whether or not the Secretary has been notified under section 42T.

(6) A person who intentionally refuses or fails to comply with a requirement under subsection (1) is guilty of an offence.

Maximum penalty: 240 penalty units.

(7) This section does not prevent the Secretary from taking action under section 30.

42W Supply etc. of therapeutic goods that are subject to recovery requirements

(1) A person is guilty of an offence if:

(a) the person supplies therapeutic goods in Australia; and

(b) either:

(i) the person knows that the therapeutic goods are of a kind, or are included in a batch, in respect of which requirements have been imposed under section 42V, on that person or another person, to recover therapeutic goods; or

(ii) the therapeutic goods are of such a kind, or are included in such a batch, and the person is reckless as to that fact; and

Maximum penalty: 240 penalty units.

(2) A person is guilty of an offence if:

(a) the person exports therapeutic goods from Australia; and

(b) either:

(ii) the therapeutic goods are of such a kind, or are included in such a batch, and the person is reckless as to that fact; and

Maximum penalty: 240 penalty units.

(3) The Secretary must not give consent relating to an exportation unless satisfied that there are exceptional circumstances that justify giving the consent.

42X Saving of other laws

This Part is not intended to exclude or limit the operation of any other law of the Commonwealth or any law of a State or Territory.

5 After subsection 61(4)

Insert:

(4A) The Secretary may release to:

(a) the head of an authority of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods, health or law enforcement; or

(b) the head of a national regulatory authority of another country that has national responsibility relating to therapeutic goods, health or law enforcement;

therapeutic goods information relating to one or more of the following:

(d) action taken by the Secretary under Part 4C;

(e) contraventions, or possible contraventions, of Part 4C;

(f) any cases, or possible cases, of actual or potential tampering with therapeutic goods.

[Minister’s second reading speech made in—

Senate on 29 June 2000

House of Representatives on 6 September 2000]

(111/00)