Senate debates

Thursday, 9 February 2006

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

In Committee

3:46 pm

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

by leave—I move Barnett-Humphries amendments (1) and (3) to R(8) on sheet 4828 revised together:

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

(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”.

The intent behind these amendments is to take on board the views that were put to the Senate committee of inquiry as well as some of the views expressed during the speeches in the second reading debate. The amendments are designed to improve the process for approving an abortifacient or other drug on the restricted goods list.

There are three main objections that were expressed during the inquiry and by a number of senators in their speeches in this place that I wish to acknowledge. Firstly, they said, ‘Why just the minister? Why not the parliament? Why isn’t there parliamentary scrutiny of the decision by the minister? As members of parliament we are accountable and responsible to our electors.’ Secondly, they wanted to know: ‘Where does the minister get his advice from? From where does it come?’ Thirdly, they objected to the fact that the text is ‘the minister lays on the table of both houses of parliament notification of his approval,’ not ‘his approval or disapproval’. Also, under the current arrangements, as senators are aware, the minister is not required to state his reasons when he provides that notification.

I want to acknowledge that during the debate Senators Payne, Stott Despoja and Conroy noted that our amendment—that was the first amendment put out, the one distributed last night—referred to the tabling of only the minister’s approval. You will see that the amendment before you refers to tabling of both approvals and rejections of approval by the minister. So that particular point has been addressed and I acknowledge the work of those senators. I also want to thank all senators for their efforts during this debate. It is emotionally draining, as it was for the senators who were involved in the committee inquiry. It is a conscience vote, which is unusual, and that is one of the reasons why we are standing here today.

Those are some of the inadequacies in the current process. We want to improve that, so what Senator Humphries and I have suggested in these amendments is that, before the minister gives written approval or disapproval of the drug, the minister must seek written advice from the Australian Health Ethics Committee. And I have details on the Australian Health Ethics Committee: it is a principal committee of the NHMRC; its membership is specified in the act; it consults extensively with individuals, community organisations, health professionals and governments; and it undertakes formal consultations on these sorts of very important moral and ethical issues. So the minister must take that advice. He must seek that advice and consider that advice and then prepare and table in both houses a written statement of the reasons for the approval or the disapproval of the drug, along with the Australian Health Ethics Committee advice.

So the minister’s decision, whichever way it goes, would then be subject to disallowance by either house of parliament. I think this really addresses a key point that has been raised over the last few weeks and in the last 48 hours with regard to this debate. It says that the ultimate say-so is with the people in the federal parliament—in this chamber and in the House of Representatives. A lot of people have said that the Minister for Health and Ageing, Mr Abbott, has certain strong views about abortion; well, in years to come there may be another minister who has perhaps pro-abortion views or totally different views. We accept that. The point is that the ultimately say-so rests with the members of this parliament. That is because the licensing and management of abortion drugs does not just raise health issues. Yes, the health issues must be addressed by the TGA—the safety, the quality and the efficacy of the drug. That is entirely appropriate. But the community, social and ethical issues must be addressed by the parliament. We believe this suggestion will improve the process.

So I have explained the process and our recommendations about it. I did just want to make an observation with regard to Senators Colbeck and Scullion’s amendments. It appears from the amendment that I have seen that there is an omission with respect to section 6AA, referring to the import of the drug. There are two types of decisions that can be made by the minister: one relates to the evaluation, registration and licensing of that particular drug; the other relates to the importation of the drug. There are two separate processes. Our amendment addresses both, and the minister’s decision on either is disallowable in the parliament. Under the amendment circulated by Senators Colbeck and Scullion, it appears that that second approval process for the importation of the drug is not there, so I just draw that to the senators’ attention. I think that sums it up and I would like to leave time for my co-sponsor of the amendments, Senator Humphries, to make some comments.

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