Jackie Kelly (Lindsay, Liberal Party) Share this | Hansard source

Last week when the Prime Minister was asked for his views on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 he said:

I think there are a number of issues that have to be considered, not only the medical implications of it but also the principle that important decisions affecting the community should be made by people who are directly accountable to the community.

The Prime Minister went on:

I’ve never been one, incidentally, who believes it makes much sense to devote an enormous amount of time and energy and commitment of one’s life to win election to parliament, and to the high office of decision-making, and then to spend the next stage of life busily handing over decisions to people who are not accountable.

I agree with the Prime Minister. I did not become a member of parliament because I thought the business of government is a spectator sport. The Prime Minister also said that RU486 was not an ordinary drug. That was why it was not automatically under the control of the Therapeutic Goods Authority, like other medicines. The Prime Minister said:

Self evidently this is not an ordinary drug. You don’t have a question at a news conference involving the Prime Minister of Australia and the Prime Minister of another country about a flu tablet.

Again, I agree with the Prime Minister. RU486 is different. It involves social issues and policy matters as well as technical issues, and it involves taking into account community standards.

As others have said, this is not a debate about abortion. It is about the approval of a particular class of drugs. The Prime Minister is not the only person who thinks that RU486 is not an ordinary drug. Back in 1996, when both houses of parliament passed the bill establishing the current regime, then Labor Senator Belinda Neal said:

These issues need to be addressed by the executive of this government ... with absolute and direct accountability ...

Then Greens Senator Christabel Chamarette said:

We deserve to have a voice on issues and not simply leave them to boards of experts.

One of the problems with this bill is that it does not address the call for greater transparency and accountability. All it does is substitute the TGA for the minister and leave the process as opaque as it is currently. Another problem is that the bill has generated a debate in which we are being called upon to choose between the minister and the TGA. In my view, this is an artificial choice that we do not need to make. There is a need to involve both the minister and the TGA.

The TGA has an important part to play in the approval process. It is an expert body and the most appropriate body to deal with health, safety and efficacy issues. But these are not the only issues involved in a decision about approving the use of this drug. The use of this drug involves policy issues and social considerations, and these issues are the responsibility of elected representatives and not unelected bodies. As Belinda Neal said, there is a role for the executive of the government. It is not the responsibility of the TGA to determine social and policy issues or to assess community attitudes. This is the role of elected politicians answerable to the people. Nor is it appropriate or practical for issues to be first considered by way of a disallowance motion, particularly a disallowance motion after the decision has already been made.

However, I do agree that the minister should not be the final judge of these issues. There should be a transparent process in which the minister is accountable for his or her decision. That accountability includes making available the TGA’s assessment of an application and the minister’s decision. Such a process would ensure that a minister would not disregard advice that he or she received without very good reason to do so. In such a case, there should be a means of reviewing the minister’s decision since these issues involve matters of judgment—and none of us gets it right all the time. It is our role to review the decisions of ministers—that is the role of elected parliamentarians.

Consequently, I am moving a principled amendment which sets out these matters. This procedure will facilitate debate about detailed amendments to give effect to these principles. I believe the process for approving drugs such as RU486 should be as follows: applications for approval of the drug are sent to the minister; the minister refers the application to the TGA for its assessment; upon receipt of the assessment, the minister makes a decision, giving reasons, and publishes it; the minister attaches the TGA’s assessment to the decision; and the decision, whether it be positive or negative, together with the TGA’s assessment, becomes a disallowable instrument which can be disallowed by either House.

I believe that these principles would give us the best practical system. It is a compromise between those who say that the existing system has not been tested and should not be fixed until we know it is broken and those who say that RU486 should be subjected to the same regime as any other drug. It also enables the parliament to discharge its responsibilities to the community by either affirming or rejecting the minister’s decision should members of parliament wish to call it into question. Because a number of issues relating to approving RU486 involve matters of judgment, it is appropriate that there should be this capacity to review the minister’s decision. It is our role as elected representatives to undertake that review.

Of course governments and parliamentarians must consult and consider carefully the assessments and views of experts in their fields of competence. Still, the community expects governments and parliaments to determine policy and weigh the variety of issues relevant to important decisions. The issue before us is to decide upon an approval process. The current system is flawed, but the system proposed by this bill does not address the flaws and even makes matters worse by removing elected representatives from the decision-making process.

I am proposing a regime which incorporates the principle that the views of experts must be known and heard and the principle that it is the role of elected representatives to make final decisions which involve social and policy issues and to take responsibility for them. It also represents a fair compromise between those who believe the current system is not flawed and those who want a transparent process which involves experts in the decision-making process and in which the various participants in that process are accountable. I commend these views to the House and move:

That all words after “That” be omitted with a view to substituting the following words: “ the House is of the opinion that the bill is unacceptable in its current form and the preferred policy approach should be:

(1)

the Minister for Health and Ageing continuing to have the decision making role in relation to the approval of restricted goods as defined in the Therapeutic Goods Act 1989;

(2)

the Minister being required to obtain written advice from the Therapeutic Goods Administration prior to giving written approval or refusal to approve; and

(3)

the Minister’s decision being subject to disallowance by each House of Parliament”.

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