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Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 [2006]

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4828-

REVISED 1

2004-2005-2006

 

The Parliament of the

Commonwealth of Australia

 

THE SENATE

 

 

 

 

Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005

 

 

(1)     Clause 1, page 1 (line 6), omit “ Repeal of Ministerial responsibility for approval of RU486 ”, substitute “ Ministerial responsibility ”.

[short title]

(2)     Schedule 1, items 1 to 5, page 3, TO BE OPPOSED .

[removal of ministerial discretion]

(3)     Schedule 1, page 3 (after line 13), at the end of the bill, add:

6  After subsection 6AA(2)

Insert:

          (2A)  Before giving written approval in accordance with subsection (2), the Minister must:

                     (a)  seek written advice from the Australian Health Ethics Committee; and

                     (b)  consider that advice; and

                     (c)  prepare a written statement of reasons for the approval or refusal to approve the importation.

[advice from the AHEC]

(4)     Schedule 1, page 3 (after line 13), at the end of the bill, add:

7  After subsection 6AA(2)

Insert:

          (2B)  The Minister must give written notice to a person seeking approval in accordance with this section of the approval of, or of the refusal to approve, the importation.

[Ministerial notification of response to all applications]

(5)     Schedule 1, page 3 (after line 13), at the end of the bill, add:

8  Subsection 6AA(4)

After “approval”, insert “together with the written advice received by the Minister from the Australian Health Ethics Committee and the written statement of reasons by the Minister for the approval of, or of the refusal to approve, the application”.

[Minister to confer with AHEC—reasons to be tabled]

R(6)  Schedule 1, page 3 (after line 13), at the end of the bill, add:

9  At the end of section 6AA

             (6)  A written approval or refusal to approve in accordance with this section is a disallowable legislative instrument for the purposes of the Legislative Instruments Act 2003 .

             (7)  Where the Minister issues a written refusal to approve an importation and that instrument is disallowed pursuant to subsection (6), the importation of the restricted good to which the instrument referred is taken to be approved by the Minister.

[disallowance of ministerial approval]

R(7)  Schedule 1, page 3 (after line 13), at the end of the bill, add:

10  Subsection 23AA(2)

Repeal the subsection, substitute:

             (2)  Before giving written approval in accordance with subsection (1), the Minister must:

                     (a)  seek written advice from the Australian Health Ethics Committee; and

                     (b)  consider that advice; and

                     (c)  prepare a written statement of reasons for the approval or refusal to approve.

             (3)  The Minister must give written notice together with the statement of reasons for the approval of, or for the refusal to approve, the evaluation, registration or listing of restricted goods in accordance with this section.

             (4)  A written approval, or refusal to approve, the evaluation, registration or listing of restricted goods shall be laid before each House of the Parliament by the Minister within 5 sitting days of being given.

             (5)  A written approval or refusal to approve in accordance with this section is a disallowable legislative instrument for the purposes of the Legislative Instruments Act 2003.

             (6)  Where the Minister issues a written refusal to approve the evaluation, registration or listing and that instrument is disallowed pursuant to subsection (5), the evaluation, registration or listing of the restricted good to which the instrument referred is taken to be approved by the Minister.

[ministerial notification re evaluation, registration or listing of restricted goods—disallowance procedures]

R(8)  Title, page 1 (lines 1 and 2), omit “ repeal Ministerial responsibility for approval of RU486 ”, substitute “ provide conditions for the exercise of Ministerial responsibility in relation to certain therapeutic goods ”.

[title]