THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 2) BILL 2009

i Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009

Contents

Short title ............................................................................................ 1

Commencement .................................................................................. 1

Schedule(s) ......................................................................................... 2

Schedule 1--Scheduling of substances

Therapeutic Goods Act 1989

Schedule 2--Medical devices

Therapeutic Goods Act 1989

Schedule 3--Other ame ndments

Part 1--Amendments commencing on day after Royal Assent

Therapeutic Goods Act 1989

Part 2--Amendments commencing on day to be fixed by

Proclamation

Therapeutic Goods Act 1989

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009 1

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 (2009

Measures No. 2) Act 2009.

2 Commence ment

(1) Each provision of this Act specified in column 1 of the table

commences, or is taken to have commenced, in accordance with

column 2 of the table. Any other statement in column 2 has effect

according to its terms.

2 Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1. Sections 1 to 3

and anything in

this Act not

elsewhere covered

by this table

The day on which this Act receives the

Royal Assent.

2. Schedule 1

1 Ju ly 2010.

1 Ju ly 2010

3. Schedule 2

The day after this Act receives the Royal

Assent.

4. Schedule 3,

Part 1

The day after this Act receives the Royal

Assent.

5. Schedule 3,

Part 2

A single day to be fixed by Proclamation.

However, if any of the provision(s) do not

commence with in the period of 6 months

beginning on the day on which this Act

receives the Royal Assent, they commence

on the first day after the end of that period.

Note:

This table relates only to the provisions of this Act as originally

passed by both Houses of the Parliament and assented to. It will not be

expanded to deal with provisions inserted in this Act after assent.

(2) Column 3 of the table contains additional information that is not

part of this Act. Information in this column may be added to or

edited in any published version of this Act.

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.

Scheduling of substances Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009 3

Schedule 1

Scheduling of substances

Therapeutic Goods Act 1989

1 Part 6-3 (heading)

Repeal the heading, substitute:

Part 6-3--Scheduling of substances

2 Before section 52A

Insert:

52AA Overvie w

This Part provides the basis for a uniform system in Australia of

access controls for goods containing scheduled substances.

The scheduling of substances allows restrictions to be placed on

their supply to the public, in the interests of public health and

safety. This is aimed at minimising the risks of poisoning from,

and the misuse and abuse of, scheduled substances.

3 Section 52A

Before "In this", insert "(1)".

4 Section 52A (definition of Committee)

Repeal the definition.

5 Section 52A (at the end of paragraph (b) of the definition of

current Poisons Standard)

Add "(including as amended)".

6 Section 52A (definition of substance)

Repeal the definition, substitute:

substance means:

Schedule 1 Scheduling of substances

4 Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009

(a) an ingredient, compound, material or preparation which, or

the use of which, may cause death, illness or injury to

persons or animals; or

(b) an ingredient, compound, material or preparation specified

under subsection (2);

and includes any ingredient, compound, material or preparation

referred to in a schedule to the current Poisons Standard (as in

force immediately before 1 July 2010).

7 At the end of section 52A

Add:

(2) The Secretary may, by legislative instrument, specify an

ingredient, compound, material or preparation for the purposes of

paragraph (b) of the definition of substance in subsection (1).

Note:

For specification by class, see subsection 13(3) of the Legislative

Instruments Act 2003.

8 Sections 52B and 52C

Repeal the sections, substitute:

52B Advisory Committee on Medicines Scheduling

(1) The Advisory Committee on Medicines Scheduling is established

by this section.

(2) Subject to subsection (3), the Committee is to be constituted, and

to hold meetings, in accordance with the regulations.

(3) The Commonwealth, each State, the Australian Capital Territory

and the Northern Territory are each entitled to nominate a member

of the Committee in accordance with the regulations.

(4) The functions of the Committee are as follows:

(a) subject to subsection (5), to make recommendations to the

Secretary in relation to the classification and scheduling of

substances that are, or are included in, therapeutic goods;

(b) to make recommendations to the Secretary in relation to other

changes to the current Poisons Standard (other than the

schedules);

(b) at the request of the Secretary;

Scheduling of substances Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009 5

(d) subject to subsection (5), to provide advice to the Secretary in

relation to the restrictions (including restrictions as to

accessibility and availability) to be imposed in respect of

particular substances that are, or are included in, therapeutic

goods;

(e) to provide advice to the Secretary in relation to any matter

referred to it by the Secretary;

(f) any other functions that are prescribed by the regulations.

(5) Paragraphs (4)(a) and (d) do not apply in relation to substances to

the extent that the substances are included in goods other than

therapeutic goods.

52C Advisory Committee on Chemicals Scheduling

(1) The Advisory Committee on Chemicals Scheduling is established

by this section.

(2) Subject to subsection (3), the Committee is to be constituted, and

to hold meetings, in accordance with the regulations.

(3) The Commonwealth, each State, the Australian Capital Territory

and the Northern Territory are each entitled to nominate a member

of the Committee in accordance with the regulations.

(4) The functions of the Committee are as follows:

(a) subject to subsection (5), to make recommendations to the

Secretary in relation to the classification and scheduling of

substances;

(b) to make recommendations to the Secretary in relation to other

changes to the current Poisons Standard (other than the

schedules);

(b) at the request of the Secretary;

(d) subject to subsection (5), to provide advice to the Secretary in

relation to the restrictions (including restrictions as to

accessibility and availability) to be imposed in respect of

particular substances;

(e) to provide advice to the Secretary in relation to any matter

referred to it by the Secretary;

(f) any other functions that are prescribed by the regulations.

Schedule 1 Scheduling of substances

6 Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009

(5) Paragraphs (4)(a) and (d) do not apply in relation to substances to

the extent that the substances are, or are included in, therapeutic

goods.

52CA Joint meetings

The Advisory Committee on Medicines Scheduling and the

Advisory Committee on Chemicals Scheduling may hold joint

meetings in accordance with the regulations.

9 Subsection 52D(1)

Omit "Committee", substitute "then National Drugs and Poisons

Schedule Committee".

10 Subsections 52D(2) to (4)

Repeal the subsections, substitute:

(2) Subject to this Act and the regulations, the Secretary may:

(a) amend the current Poisons Standard; or

(b) prepare a document (including schedules containing the

names or descriptions of substances or classes of substances),

in substitution for the current Poisons Standard.

(3) The Secretary may exercise a power under subsection (2) on the

Secretary's own initiative or following an application under

section 52EAA.

11 After subsection 52D(4A)

Insert:

(4B) Despite subsection 14(2) of the Legislative Instruments Act 2003,

an instrument made under paragraph (2)(a) or (b) of this section

may make provision in relation to a matter by applying, adopting

or incorporating any matter contained in an instrument or other

writing as in force or existing from time to time.

12 Section 52E

Repeal the section, substitute:

Scheduling of substances Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009 7

52E Secretary to take certain matters into account in exercising

powe rs

(1) In exercising a power under subsection 52D(2), the Secretary must

take the following matters into account (where relevant):

(a) the risks and benefits of the use of a substance;

(b) the purposes for which a substance is to be used and the

extent of use of a substance;

(d) the dosage, formulation, labelling, packaging and

presentation of a substance;

(e) the potential for abuse of a substance;

(f) any other matters that the Secretary considers necessary to

protect public health.

(2) In exercising a power under subsection 52D(2), the Secretary must

comply with any guidelines of:

(a) the Australian Health Ministers' Advisory Council; and

(b) the subcommittee of the Council known as the National

Coordinating Committee on Therapeutic Goods (or any

replacement subcommittee);

notified to the Secretary for the purposes of this section.

(3) In exercising a power under subsection 52D(2), the Secretary must

have regard to any recommendations or advice of the Advisory

Committee on Medicines Scheduling or the Advisory Committee

on Chemicals Scheduling.

(4) In exercising a power under subsection 52D(2), the Secretary may

seek advice from either or both of the following:

(a) any committee that the Secretary considers appropriate

(whether or not the committee is established under this Act or

the regulations);

(b) any person.

(5) Subsections (2) to (4) do not limit the information the Secretary

may consider in exercising a power under subsection 52D(2).

Schedule 1 Scheduling of substances

8 Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009

52EAA Application for ame ndment of the Poisons Standard

(1) A person may apply to the Secretary for an amendment of the

current Poisons Standard.

(2) An application under subsection (1) must:

(a) be made in accordance with a form approved by the

Secretary; and

(b) set out the amendment sought; and

form; and

(d) be accompanied by the prescribed application fee.

Further information

(3) The Secretary may, by notice in writing given to the person,

require the person to give to the Secretary, within such reasonable

time as is specified in the notice, such further information

concerning the application as is specified in the notice.

Applications or information may be given electronically

(4) An approval of a form mentioned in paragraph (2)(a), or a notice

mentioned in subsection (3), may require or permit an application

or 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.

13 Saving and transitional

(1)

The amendment made by item 10 does not affect the validity of an

instrument made under paragraph 52D(2)(a) or (b) of the Therapeutic

Goods Act 1989 before the commencement of that item.

(2)

If:

(a) on or after 1 January 2010 and before the commencement of

this item, the Committee referred to in section 52B of the

Therapeutic Goods Act 1989 had proposed an amendment of

the current Poisons Standard; and

(b) before that commencement, that Committee had not amended

the current Poisons Standard as a result of that proposal;

Scheduling of substances Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009 9

then the Secretary must have regard to that proposal in relation to

making the first instrument under subsection 52D(2) of that Act on or

after that commencement.

(3)

If:

(a) on or after 1 January 2010 and before the commencement of

this item, an application was made to the Committee referred

to in section 52B of the Therapeutic Goods Act 1989 for an

amendment of the current Poisons Standard; and

(b) the application had not been refused by that Committee

before that commencement; and

an amendment of the current Poisons Standard as a result of

the application;

then the application has effect on and after that commencement as if it

were an application made to the Secretary in accordance with

section 52EAA of that Act.

Schedule 2 Medical devices

10 Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009

Schedule 2

Medical devices

Therapeutic Goods Act 1989

1 After section 41BE

Insert:

41BEA Excluded purposes

The Secretary may, by legislative instrument, specify purposes for

the purposes of paragraph 41FD(ia) and subsection 41FF(1A).

2 After paragraph 41FD(i)

Insert:

(ia) devices of that kind are not to be used exclusively for one or

more of the purposes specified under section 41BEA; and

3 After subsection 41FF(1)

Insert:

(1A) However, the Secretary must not include the kind of device in the

the kind of device is to be used exclusively for one or more of the

purposes specified under section 41BEA.

4 Application

The amendments made by items 2 and 3 apply in relation to

applications made after the day on which the first instrument made

under section 41BEA of the Therapeutic Goods Act 1989 takes effect.

Note:

Section 12 of the Legislative Instruments Act 2003 deals with when a legislative

instrument takes effect.

Other amend ments Schedule 3

Amend ments commencing on day after Royal Assent Part 1

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009 11

Schedule 3

Other amendments

Part 1

Amendments commencing on day after

Royal Assent

Therapeutic Goods Act 1989

1 Subsection 3(1)

Insert:

genetically modified organism has the same meaning as in the

Gene Technology Act 2000.

2 Subsection 22(5)

Repeal the subsection, substitute:

(5) A person commits an offence if:

(a) the person, by any means, advertises therapeutic goods for an

indication; and

(b) the therapeutic goods are included in the Register; and

inclusion.

Penalty: 60 penalty units.

3 At the end of subsection 30C(1)

Add "or a genetically modified organism".

4 Subsection 30D(1)

Repeal the subsection, substitute:

(1) The Secretary may request advice from the Gene Technology

Regulator in relation to:

(a) therapeutic goods that consist of, or that contain, a GM

product belonging to a class of GM products specified in the

request; or

(b) therapeutic goods that consist of, or that contain, a

genetically modified organism belonging to a class of

genetically modified organisms specified in the request.

Schedule 3 Other amendments

Part 1 A mend ments commencing on day after Royal Assent

12 Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009

Note:

The heading to section 30D is altered by adding at the end "or genetically modified

organisms".

5 Section 41ML

Repeal the section, substitute:

41ML False advertising about medical devices

A person commits an offence if:

(a) the person, by any means, advertises a medical device as

being for a purpose; and

(b) the device is of a kind included in the Register; and

inclusion.

Penalty: 60 penalty units.

6 Paragraph 57(8)(b)

Repeal the paragraph, substitute:

(b) a person who holds, occupies or performs the duties of a

position in the Therapeutic Goods Administration prescribed

by the regulations for the purposes of this paragraph.

7 Application and saving

(1)

The amendments made by items 2 and 5 apply in relation to

advertisements occurring on or after the commencement of those items.

(2)

The amendment made by item 3 applies in relation to applications made

on or after the commencement of that item.

(3)

The amendment made by item 4 does not affect the validity of a request

made under subsection 30D(1) of the Therapeutic Goods Act 1989

before the commencement of that item.

Other amend ments Schedule 3

Amend ments commencing on day to be fixed by Proclamation Part 2

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 No. , 2009 13

Part 2

Amendments commencing on day to be

fixed by Proclamation

Therapeutic Goods Act 1989

8 After paragraph 3(5)(c)

Insert:

(ca) if the therapeutic goods are medicine included in a class of

medicine prescribed by the regulations for the purposes of

this paragraph--if the medicine's label does not contain the

advisory statements specified under subsection (5A) in

relation to the medicine; or

9 After subsection 3(5)

Insert:

(5A) The Minister may, by legislative instrument, specify advisory

statements in relation to medicine for the purposes of

paragraph (5)(ca).

(5B) For the purposes of subsection (5A), the Minister may specify

different advisory statements for different medicines or different

classes of medicine.

10 Application

The amendment made by item 8 applies in relation to applications for

the registration or listing of medicine made on or after the

commencement of this Part.

Commonwealth of Australia Bills

THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 2) BILL 2009