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

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5901 -Revised 2

2008-2009

 

The Parliament of the

Commonwealth of Australia

 

THE SENATE

 

 

 

 

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

 

(1)     Schedule 1, item 7, page 4 (after line 15), after subsection 52A(2), insert:

             (3)  Before the Secretary makes a legislative instrument under subsection (2):

                     (a)  the Secretary must ensure that adequate consultation has been undertaken with consumer health and therapeutic goods industry stakeholders; and

                     (b)  having regard to that consultation, the Secretary must be satisfied that the proposed instrument will not have a negative impact on the therapeutic goods industry or on access by consumers to therapeutic goods.

             (4)  Before the Governor-General makes a regulation for the purposes of any provision in this Part:

                     (a)  the Minister must ensure that adequate consultation has been undertaken with consumer health and therapeutic goods industry stakeholders; and

                     (b)  having regard to that consultation, the Minister must be satisfied that the proposed regulation will not have a negative impact on the therapeutic goods industry or on access by consumers to therapeutic goods.

[consultation]

(2)     Schedule 1, item 8, page 4 (after line 25), after subsection 52B(3), insert:

          (3A)  The regulations must provide:

                     (a)  for the Minister to appoint to the Committee a person with expertise in complementary medicines; and

                     (b)  for that person to be a member of the Committee only for the purpose of the committee undertaking functions in relation to substances which are, or which contain, complementary medicines.

          (3B)  In this section:

complementary medicines has the same meaning it has in Part 6-4.

[membership of medicines scheduling committee]

(3)     Schedule 1, item 12, page 7 (after line 32), at the end of section 52E, add:

             (6)  Before exercising a power under subsection 52D(2):

                     (a)  the Secretary must ensure that adequate consultation has been undertaken with consumer health and therapeutic goods industry stakeholders; and

                     (b)  having regard to that consultation, the Secretary must be satisfied that the proposed exercise of power will not have a negative impact on the therapeutic goods industry or on access by consumers to therapeutic goods.

[consultation]

(4)     Schedule 1, page 9 (after line 16), at the end of the Schedule, add:

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, including a person with expertise in complementary medicines.

             (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.

[review of scheduling regime]