Thursday, 9 February 2006
Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005
I would like to respond, on behalf of the sponsors of the bill, to the amendments that we are looking at—that is, amendments (1) and (3) to (8) on sheet 4828. On the surface these amendments respond to some of the criticisms of the current arrangement, but when you look at them in detail they are little more than tinkering around the edges and, indeed, they place further hurdles in the way of assessment and approval of RU486.
Amendments (1) and (8) simply change the title of the bill and they require no comment. Amendments (3) to (5) put in place further requirements on the health minister in relation to applications to import RU486. Amendment (3) requires the minister to seek the advice of the Australian Health Ethics Committee before approving the importation of any restricted good. Amendment (4) requires the minister to let the applicant know whether their request has been approved or not, and amendment (5) requires the health minister to provide the parliament with a copy of the advice from the Australian Health Ethics Committee, along with a statement of the minister’s reasons for approving or rejecting an application to import RU486.
Amendment (6) makes any decision by the minister to allow or not allow the importation of RU486 disallowable. Amendment (7) puts in place similar requirements on the health minister in relation to applications to evaluate, list or register RU486, just as I have outlined for the importation. That is, the minister must seek the advice from the ethics committee, provide parliament with a written approval or refusal and so on.
There are many, many problems with what is being suggested. Firstly, the minister still has, in the first instance, the power—on his or her own—to approve or disapprove any application to evaluate, register, list or import RU486, and there are still no specified criteria that must be used. It is unclear what the purpose of involving the Australian Health Ethics Committee is. If that committee is supposed to comment on the safety and efficacy of RU486, how is this committee better qualified to do this than the TGA? And, of course, the minister still does not have to follow the advice; it just has to be considered.
The Senate might consider this: in amendment (6) it would seem that, if the minister refused an application to import RU486 and this was overturned by the parliament, then RU486 would automatically be allowed to be imported without the TGA having any chance to evaluate its safety. In amendment (7) part (3) it is unclear who is getting the written notice—the parliament or the applicant. If it is the applicant, there seems to be no way that the parliament gets a statement of the reasons behind the minister’s decisions. And finally—and this is probably the key issue—making the approval notice disallowable still leaves the key problem that decisions on the use of RU486 are left to politicians who are not experts on the safety and efficacy of RU486, and it still leaves the TGA and their expert advice out of the approval process.
This morning I listened to Senator Stephens recite what I am sure she believed was expert scientific advice. Those of us on both sides of the debate, if we were to go through this process proposed by Senator Barnett, could equally gather volumes of scientific advice in order to put our case—and who would know whether we were right? Nobody would know; no individual member of parliament, or a subgroup of parliamentarians or the parliament as a whole has the necessary skills, knowledge or resources to evaluate the safety of a drug. This is what this debate is about. The TGA is the group that should be making this decision, not parliamentarians or an ethics committee.