Thursday, 9 February 2006
Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005
I move the Scullion-Colbeck amendment (3) on sheet 4830:
(3) Schedule 1, item 4, page 3 (lines 10 and 11), omit the item, substitute:
4 Section 23AA
Repeal the section, substitute:
23AA Evaluation, registration and listing of restricted goods
(1) Subject to subsections (2) and (3), restricted goods may be evaluated, registered and listed in accordance with the provisions of this Division as they apply to therapeutic goods.
(2) A certificate of:
(a) registration of restricted goods under section 25; and
(b) listing of restricted goods under section 26;
is a disallowable legislative instrument of the purposes of the Legislative Instruments Act 2003.
(3) A certificate mentioned in subsection (2) does not take effect before the expiration of the time within which a House of Parliament may disallow the certificate.
I will be speaking on behalf of Senator Scullion so that we can ensure we get through this and that those who want to have the opportunity to speak on this particular amendment will get the opportunity to do so. Although, as many have said during their contributions, this could strictly be seen as a debate on the process of approval of RU486, it is completely inevitable that other emotions, other elements and other sensitivities will be brought into the debate. It is from that perspective that Senator Scullion and I have developed our amendment.
We do not agree that this is just another drug. There is no doubt in my mind that this is more than just another drug that should be before the Therapeutic Goods Administration through the usual process. We believe though that it should proceed to the Therapeutic Goods Administration unfettered. If a company wants to make application to register RU486 or a similar drug for a similar purpose, it should have the opportunity to do so and the Therapeutic Goods Administration, which is rightly recognised as a very competent authority operating on behalf of the Australian government and the Australian people, should have the opportunity to make an assessment of the drug.
We also believe that the Australian community see that as elected representatives we should have some oversight of that process. It is unfortunate that some submissions have called into question the work and processes undertaken by the Therapeutic Goods Administration. Senator Scullion and I believe that there should be some parliamentary oversight of the process in cases such as this, recognising that RU486 is not just another drug. That is the premise of the amendment that we put forward. Any application that goes to the Therapeutic Goods Administration for a drug of this nature should be assessed through the usual process but approval of such a drug should then come back to the parliament as a disallowable instrument so that the parliament, the representatives of the people, have the opportunity for oversight of that process.
I know that in that occurrence other things will be brought into the debate, just as there have been at this time. It could be said that we are now having the debate that should be had, but in my view it needs to go further. Certainly that view is shared by Senator Scullion. A lot of excellent work has been done as part of the process of going through the Senate committee inquiry into this drug. There are a whole range of perspectives. I do not necessarily come to this with a pro-life perspective. In fact, I have had long discussions with my wife about this. In essence, I think I come to this from a pro-choice perspective. But Senator Scullion and I believe that, as this is not just another drug, the parliament should have some oversight of the process.
Senator Barnett, in his contribution earlier, intimated that there might be some flaw in the amendment that we are considering. I have researched that and I do not believe that to be the case. Senator Barnett is referring to a specific variety of drug. The purpose of our amendment is to take the process away from any one individual. We do not believe that any one individual should have the opportunity to restrict the process going forward. From our perspective, this is a very simple process. An application is made, it goes to the TGA and then, in the event of approval, it is overseen by the parliament. In my view, the reference that Senator Barnett made essentially leaves in place another de facto method for one person to stymie the opportunity for women in Australia to have access to this drug, if it is approved by the TGA. We do not believe that that is appropriate as part of this process. Essentially, this amendment supports the proposed process but leaves the final oversight of the approval of this drug in the place where Senator Scullion and I believe it should be left, and that is in the hands of the elected representatives of the Australian people in the Australian parliament.