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Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009

Authoritative Version
  • - C2009A00096
  • In force - Latest Version
Act No. 96 of 2009 as made
An Act to amend the Therapeutic Goods Act 1989, and for related purposes
Administered by: Health
Originating Bill: Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009
Registered 08 Oct 2009
Date of Assent 29 Sep 2009
Table of contents.

 

 

 

 

 

 

Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009

 

No. 96, 2009

 

 

 

 

 

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

  

  


Contents

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

2............ Commencement................................................................................... 2

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

Schedule 1—Scheduling of substances                                                                      3

Therapeutic Goods Act 1989                                                                                     3

Schedule 2—Medical devices                                                                                         11

Therapeutic Goods Act 1989                                                                                   11

Schedule 3—Other amendments                                                                                 12

Part 1—Amendments commencing on day after Royal Assent            12

Therapeutic Goods Act 1989                                                                                   12

Part 2—Amendments commencing on day to be fixed by Proclamation               14

Therapeutic Goods Act 1989                                                                                   14

 


 

 

Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009

No. 96, 2009

 

 

 

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

[Assented to 29 September 2009]

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  Commencement

             (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.

 

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.

29 September 2009

2.  Schedule 1

1 July 2010.

1 July 2010

3.  Schedule 2

The day after this Act receives the Royal Assent.

30 September 2009

4.  Schedule 3, Part 1

The day after this Act receives the Royal Assent.

30 September 2009

5.  Schedule 3, Part 2

A single day to be fixed by Proclamation.

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

29 March 2010

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.


 

Schedule 1Scheduling of substances

  

Therapeutic Goods Act 1989

1  Part 6‑3 (heading)

Repeal the heading, substitute:

Part 6‑3Scheduling of substances

2  Before section 52A

Insert:

52AA  Overview

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:

                     (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);

                     (c)  to reconsider a recommendation made under paragraph (a) or (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 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);

                     (c)  to reconsider a recommendation made under paragraph (a) or (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.

             (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:

52E  Secretary to take certain matters into account in exercising powers

             (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;

                     (c)  the toxicity 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).

52EAA  Application for amendment 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

                     (c)  be delivered to an office of the Department specified in the 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;

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

                     (c)  before that commencement, that Committee had not proposed 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.

14  At the end of Part 6‑3

Add:

52EC  Review of scheduling regime

             (1)  The Minister must cause an independent review of the operation of this Part to be conducted, with particular reference to the amendments to this Part made by the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (the amendments).

             (2)  The review must:

                     (a)  start not later than 1 July 2013; and

                     (b)  be completed within 6 months.

             (3)  The review must report on:

                     (a)  the system of access controls for goods containing scheduled substances established by this Part;

                     (b)  the outcomes of the administration of scheduled substances by the Secretary and by the committees established by this Part;

                     (c)  the effect of the amendments on the therapeutic goods industry and on individual parties within the industry;

                     (d)  whether there are adequate avenues for review of decisions made by the Secretary and by the committees established by this Part;

and may make recommendations for further changes to the scheduling regime.

             (4)  The review must be conducted by a panel which must comprise not less than three, and not more than five, persons with relevant expertise.

             (5)  As part of the review, the panel must invite and consider public submissions.

             (6)  The panel must give the Minister a written report of the review.

             (7)  The Minister must cause a copy of the report to be laid before each House of the Parliament within 15 sitting days of that House after the day on which the Minister receives the report.


 

Schedule 2Medical 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 Register in relation to the person if the Secretary is satisfied that 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.


 

Schedule 3Other amendments

Part 1Amendments 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

                     (c)  the indication is not an indication accepted in relation to that 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.

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

                     (c)  the purpose is not a purpose accepted in relation to that 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.


 

Part 2Amendments 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.


 

 

 

 

[Minister’s second reading speech made in—

House of Representatives on 24 June 2009

Senate on 20 August 2009]

(128/09)