Senate debates

Thursday, 9 February 2006

Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005

In Committee

Bill—by leave—taken as a whole.

12:58 pm

Photo of Guy BarnettGuy Barnett (Tasmania, Liberal Party) Share this | | Hansard source

I, and on behalf of Senator Humphries, foreshadow that I will move:

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

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

(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.

(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.

(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”.

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.

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.

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”.

Photo of John HoggJohn Hogg (Queensland, Deputy-President) Share this | | Hansard source

I have had questions privately from people interested in the debate in the chamber as to how the matter would proceed. Senator Barnett, I am looking for some guidance and some input from the other participants in the debate as to the process that will be followed for the committee stage. It would seem to me that there are two sets of amendments before the chair, those on sheet 4828, revised 1, standing in the names of Senator Barnett and Senator Humphries, and those on sheet 4830, standing in the names of Senators Colbeck and Scullion. I want to clarify that there are no more amendments to be considered before the committee. The second thing is that it seems reasonable to me that the amendments of Senators Barnett and Humphries be dealt with and disposed of, and then, if the first amendments fail, the amendments of Senators Colbeck and Scullion be dealt with and disposed of. Is there any objection to that process?

1:00 pm

Photo of Judith TroethJudith Troeth (Victoria, Liberal Party) Share this | | Hansard source

Will the amendments of Senators Barnett and Humphries be dealt with together?

Photo of John HoggJohn Hogg (Queensland, Deputy-President) Share this | | Hansard source

Yes, except for amendment (2), which is schedule 1, items 1 to 5 on page 3 to be opposed. That will need to be put separately. But it is subject to the wishes of Senators Barnett and Humphries and whether they seek leave to move amendments (1), (3), (4), (5), R(6), R(7) and R(8) together. That has not happened at this stage. I note that it is past one o’clock and that sessional requirements require me to report progress.

Photo of Lyn AllisonLyn Allison (Victoria, Australian Democrats) Share this | | Hansard source

If I could make a point: it may be necessary for you to allocate times to those amendments, given the short time frame within which we must debate the amendments.

Photo of John HoggJohn Hogg (Queensland, Deputy-President) Share this | | Hansard source

I hear your point, and that is why I was interested to take the chair. It is not within my province to allocate time. I suggest that the interested parties get together during the next hour and work out a time allocation as a guide to the chair and the clerks. We have always held to the guidance from interested parties. I am sure it can be worked out in a reasonable and mutually advantageous way for all parties.

Progress reported.