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

Order of the day read for the adjourned debate on the motion of the Minister for Climate Change and Water (Senator Wong)—That this bill be now read a second time.

Debate resumed.

Question put and passed.

Bill read a second time.

The Senate resolved itself into committee for the consideration of the bill.

In the committee

Bill, taken as a whole by leave, debated.

Senator Xenophon moved the following amendments together by leave:

 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.

 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.

Debate ensued.

Question—That the amendments be agreed to—put and negatived.


Senator Xenophon moved the following amendment:

 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.

Debate ensued.

Question—That the amendment be agreed to—put and negatived.

Senator Xenophon moved the following amendment:

 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.

Debate ensued.


The Minister for Broadband, Communications and the Digital Economy (Senator Conroy) moved the following amendment to Senator Xenophon's proposed amendment:

 Subsection 52EC(4), omit ", including a person with expertise in complementary medicines".

Debate ensued.

Question—That Senator Conroy's amendment to Senator Xenophon's proposed amendment be agreed to—put and passed.

Question—That the amendment, as amended, be agreed to—put and passed.

Bill, as amended, agreed to.

Bill to be reported with an amendment.

The Acting Deputy President (Senator Trood) resumed the chair and the Temporary Chair of Committees reported accordingly.

On the motion of Senator Conroy the report from the committee was adopted and the bill read a third time.