Ms Julie Bishop (Curtin, Liberal Party, Minister Assisting the Prime Minister for Women's Issues) Share this | Hansard source

The debate we are having here today on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is not about whether RU486 is a good drug or a bad drug. It is not an opportunity to reconsider the legality of abortion. It is not about the number of abortions that take place every year in Australia. I expect that most if not all people in this place regret deeply the number of abortions undertaken in this country each year. Indeed, most people regret the difficult and profoundly disturbing decision some women make to bring a pregnancy to an end, whether for personal or medical reasons.

A broader community debate perhaps should take place on our high rate of teen pregnancy and whether we need more responsible contraception or sex education that is early, sensible, appropriate and thorough; more counselling for women who are pregnant; or a greater emphasis on adoption. These are all matters that should exercise the minds of thinking members of our society and a broader debate may well trigger a change in social attitudes or a change in community expectations.

But let us not confuse the issue. This debate is not whether abortion should be allowed. This country’s laws permit abortion in specified and regulated circumstances, and there is no proposal by any state, territory or federal government to change these laws. Put simply, abortion is legal, subject to restrictions. Let us make it as safe as it can possibly be. There are health risks associated with drugs. There are health risks associated with pregnancy. There are health risks associated with a surgical abortion, which involves extremely delicate procedures inside the uterus, with small but real risks of perforation, infection or haemorrhage. It is performed under general anaesthetic, which has its own risks, including death.

In the triennium 1997-99 there were 90 maternal deaths from pregnancy complications in Australia. There were no deaths from terminations for the same period. If there is another way, a safer way, with risks lower than surgical abortions, should not that option be available to a woman on the advice of and supervised or monitored by her medical adviser? If that safer way or that other option is a drug, should there not be a consistent, reliable assessment procedure to determine its safety and efficacy? Or should a woman have to place her reproductive health and risks to her health in the hands of one politician, albeit a minister of the Crown? The debate we are having today is whether the power to evaluate, approve and register an abortifacient is ultimately one which rests with the Therapeutic Goods Administration or whether the minister for health of the day should retain an effective power of veto over this drug, as is currently the case. This is a question of control over and access to a treatment widely available in 22 countries in the world but not available to medical practitioners to prescribe for their female patients in Australia.

Over the last few months the debate on this bill has extended well beyond its remit of the minister’s power and the TGA’s role. The original precept of the bill—that is, the need for a ministerial power of veto over RU486—has sometimes been lost in what has become an extremely emotional and often very personal debate. The debate has also moved to an area of particular concern to me, that of scrutiny and accountability. There has been comparison of the scrutiny or perceived scrutiny of a decision made by an elected member of parliament and minister contrasted with decisions made by the TGA or, as some have suggested, ‘faceless bureaucrats’ within the Department of Health and Ageing.

I want to make a few comments which I trust will be of assistance to the debate on this issue of scrutiny—both public and parliamentary—of the decision as to whether to permit an evaluation, listing or registration of RU486. At present, there is minimal public or parliamentary scrutiny of a decision of a health minister to approve or otherwise the evaluation, listing or registration of RU486 as an abortifacient. Some will say in response, ‘Oh well, the minister is answerable to the public.’ Well, yes, he or she will face a general election every three years, but that is not the level of scrutiny that this issue demands.

The only scrutiny, if you can call it that, is contained under section 23AA of the Therapeutic Goods Act 1989, whereby the minister is required to notify the parliament of a decision to approve an application for the evaluation, registration or listing of RU486 by the TGA within five sitting days of that approval. The minister is not required to seek advice and is not required to follow any protocol when making a decision regarding an application for listing or registration of RU486. The minister is not required to give any reasons when making a decision regarding the evaluation, listing or registration of RU486. The minister’s decision is not disallowable by the parliament. The minister’s decisions cannot be challenged in the Administrative Appeals Tribunal. Theoretically, a minister’s decision may be challenged under the Administrative Decisions (Judicial Review) Act, the only way a statement of reasons can be acquired compulsorily. However, this would not provide for a review on the merits of that decision. Rather, it would make available a review only on legal grounds, including error of law and irrelevant considerations. So let us be clear: under the current provisions of the Therapeutic Goods Act there is no requirement for the minister to give reasons and no opportunity for review on the merits of the minister’s decision.

By contrast, the Therapeutic Goods Administration is subject to considerable public and parliamentary scrutiny in the exercise of its functions and is accountable for them. The TGA does not itself carry out the assessment of prescription drugs. It is not accurate to say that these tasks are performed by bureaucrats in the Department of Health and Ageing. The task of assessing prescription drugs is in fact carried out by the Australian Drug Evaluation Committee, which was established in 1963 and has the role of providing independent, scientific advice to the federal government on new drugs. This body consists of six or seven core members of experts and up to 20 associate members. Of the core members, at least three must be eminent medical practitioners with at least two specialists in clinical medicine and one must be a pharmacologist or hold a degree in science, specialising in pharmaceutical science. The associate members must include at least one pharmaceutical chemist with recent manufacturing experience in therapeutic goods, at least one toxicologist and a medical practitioner in general practice. All of them are appointed by the Minister for Health and Ageing. They are health experts who are working in medical and clinical settings every day.

The Australian Drug Evaluation Committee’s recommendations for approval of new drugs or changes to registration of existing drugs are publicly available on their website and their recommendations are published in the Gazette. The committee, ADEC, makes its recommendations to the delegate of the Secretary to the Department of Health and Ageing, who is in fact a senior medical officer of the TGA. The delegate’s decision ultimately to approve or not to approve may be challenged in the Administrative Appeals Tribunal, and this provides the option of a review on the merits. The AAT stands in the position of the original decision maker and determines if the decision was in fact the right one. If the TGA determines to approve a drug, it is then listed on the Australian Register of Therapeutic Goods, a publicly available document.

Any drug approved by the TGA then goes through the further process of an evaluation by the National Drugs and Poisons Schedule Committee, which comprises state and territory government members and other persons appointed by the Minister for Health and Ageing—such as technical experts and representatives of various sectional interests, such as the professional colleges. This body makes determinations, decisions and recommendations pertaining to a drug’s retail supply and can restrict its use. Further, reports of serious reactions, for example, are forwarded to the Adverse Drug Reactions Advisory Committee for further assessment. This committee is composed of independent medical experts who have expertise in areas of importance to the evaluation of a medicine’s safety. This committee can make any of several decisions for a report, including that there be publication of the reaction to raise awareness, through to recommending the restriction or even the removal of the drug from the market.

Finally, the TGA is accountable to the parliament, first, through the provision of annual reports provided to government. The TGA is considered to be part of the Department of Health and Ageing for this purpose. Secondly, the TGA appears before the Senate estimates committee and is regularly interrogated by senators on specific drug evaluations and approvals. Parliament can hold inquiries into issues of public concern, including into the functions of the TGA, if it so wishes. The function or act of delegation under the Therapeutic Goods Act can be changed by legislation. It is subject to the scrutiny of our National Audit Office.

The situation which our current laws have produced is perverse. Under the current laws, RU486 is currently being trialled and used in Australia for other indications under the clinical trials and the special access schemes provided for in the Therapeutic Goods Act 1989. In the Senate Community Affairs Committee inquiry we heard evidence that RU486 is currently used for the purposes of emergency contraception, the control of unacceptable bleeding and in cancer research. Those who obtain approval to test a drug for the purposes of a clinical trial not related to an abortifacient function are not required to seek the approval of the Minister for Health and Ageing. By contrast, a range of drugs listed as restricted goods for the purposes of the Customs (Prohibited Imports) Regulations 1956 which can have an abortifacient effect are currently in use, including as abortifacients.

Misoprostol, a prostaglandin, is approved in this country to be used in the treatment of gastric or duodenal ulcers. However, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists has recognised the use of misoprostol as an aid to medical abortions. The drug is used under controlled circumstances in teaching hospitals where there are protocols and ethics committees to ensure it is used in appropriate and safe circumstances.

The medical profession, led by experts with solid clinical and pharmacological expertise and experience, has had to find ways of providing women—for example, those who cannot tolerate anaesthetics—with a medically essential choice to overcome the perverse situation which the 1996 amendments to the Therapeutics Goods Act created. I ask my colleagues: if you or your wife or partner or sister or daughter were facing a termination, for whatever reason, would you want her to have access to what health experts may consider the best, most appropriate medical treatment as prescribed by her doctor for her particular circumstances?

Under our parliamentary system ministers come and ministers go. It is time to recognise the value of the system this parliament put in place in 1989. It is a system of expert evaluation of proposed prescription drugs subject to significant public and parliament scrutiny: the expert Drug Evaluation Committee, whose findings are public; the decision of the TGA, whose findings are public; the national drugs body, comprising state and territory representatives, whose findings are public; and the Adverse Drug Reaction Advisory Committee, whose findings are public. At each level it is subject to scrutiny and, overall, subject to administrative appeals review. The evaluation of all drugs through this rigorous process is a system worthy of our trust and our support. For these reasons, I support this bill.

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