Therapeutic Goods Amendment Bill (No. 3) 2000
First Reading

1998-1999-2000

The Parliament of the

Commonwealth of Australia

THE SENATE

Presented and read a first time

Therapeutic Goods Amendment Bill (No. 3) 2000

No. , 2000

(Health and Aged Care)

A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes

ISBN: 0642 439001

Contents

A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes

The Parliament of Australia enacts:

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

2 Commencement This Act commences on the 28th day after the day on which it receives the Royal Assent.

3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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--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

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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;

(c) the monitoring of the use, and the results of 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;

(c) the monitoring of the supply 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:

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

(b) the supply of the medicine;

(c) the handling 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;

(c) the monitoring of the supply 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;

(c) the monitoring of the supply 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.

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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

(c) the document is produced in compliance or purported compliance with subsection 31C(1).

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

(c) the body in a State or Territory responsible for the registration of pharmacists in that State or Territory.