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

I stand here today to oppose the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 and its repeal of ministerial responsibility for drugs, including abortion drugs, in the category of restricted goods. I believe we are taking a huge backward step in removing ministerial responsibility and accountability from the management of abortion drugs such as RU486, especially when we do not have to in order to get the best of all outcomes from this debate. The best of all outcomes would involve an improvement in the way responsibility for approval or rejection of the use of drugs, such as RU486, is managed. Such an option would pick up the best of technical and ethical advice in dealing with this issue together with the need for accountability to our bosses—the Australian people.

I oppose the bill because we are not dealing with just another prescription. This is not just another drug. RU486 is a killer drug. It is designed to terminate a pregnancy. A therapeutic drug, on the other hand, is designed to cure or treat an illness. Pregnancy is not an illness. Pro-abortionists want the drug for destroying the life of an unborn baby. It is what sets RU486 apart when advocates argue that we are dealing with just another drug. Even the drug company Pfizer—the manufacturer of the drug Cytotec, which must be used in tandem with RU486 to end the pregnancy and expel the foetus—says it cannot vouch for the safe use of Cytotec in an RU486 abortion.

The bill before the Senate is designed to remove the responsibility for approval of RU486 from the minister and substitute responsibility for that drug with the Therapeutic Goods Administration. I oppose this bill, but I do want to flag at the outset what I believe could be a better process in dealing with abortifacient drugs. Under the current process, the minister must table his notification of approval of an abortifacient drug on the restricted goods list in both houses of the parliament. This, in my view, is inadequate. It is inadequate in terms of ensuring parliamentary scrutiny.

The improved process, in my view, would require the minister to seek advice from the Australian Health Ethics Committee as a subcommittee of the National Health and Medical Research Council. The minister would then prepare a written statement of the reasons to support his approval or rejection. Under the current process, he is only required to notify an approval. So he would prepare a written statement of the reasons to support the approval or rejection of the drug and table these in both houses of parliament. This would then be subject to a parliamentary disallowance motion. That is a suggestion in terms of an improvement to the current process.

The inquiry into RU486 explored the concept of expert advice and the committee was advised that a committee of experts could be constituted to advise the minister if the current arrangements prevail. That is one of the options that was put to our committee by Dr Renate Klein. Given, as my colleagues have said, that we are not here to debate the merits and ethics of abortion but instead the administrative arrangements for dealing with abortion drugs, the improved process that I referred to earlier is something that should be considered very seriously.

The committee received 2,496 submissions and 2,292 additional pieces of correspondence—a total of 4,788 public contributions to the inquiry. The committee considered the bill at public hearings on 15 December, 3 February and 6 February. As a committee member, I want to thank the chair, Senator Gary Humphries, for his leadership. I also want to thank Elton Humphery and his team at the secretariat for the work they did under very considerable pressure to get the job done within the time available.

Members of the committee—and, no doubt, other senators and members—received an enormous amount of correspondence from all sides of the debate. We received hundreds and thousands of letters and emails, and that further demonstrated to me why this issue is too important to leave to the hands of technical experts.

Reproductive Choice Australia, the pro-abortion group, said to our committee of inquiry, ‘Politics has no place in medicine.’ What an extraordinary attitude. Every day, politicians have to assess and decide appropriate health policy. If this drug is of such profound consequence as to require a conscience vote of MPs in the federal parliament, then it surely logically follows that ultimate responsibility for management of the drug must reside with the elected government, which is in turn accountable to parliament. The role of the TGA, with its team of experts, would be as an advisory body and not sole arbiter. To date, no state or territory government has acquiesced and devolved its powers relating to abortion to bureaucrats.

It is worth quoting from remarks made by the Prime Minister today at lunchtime when he summed up the principle of accountability. 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 accountable directly to the community.

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.

That quote was sourced from an AAP site.

I am voting against the bill for the above and several other reasons. RU486 poses undue health risks for women. The use of RU486, or medical abortion, carries with it a 10 times higher risk of death than surgical abortion, according to the latest research by Dr Michael Greene from Harvard University in the United States. This is not a just a morning-after pill. In five to eight per cent of cases, women require a follow-up surgical abortion, which is particularly problematic in isolated and rural areas.

There have been eleven fatalities around the world, so far, associated with the use of RU486 as an abortifacient. These are known fatalities based on a voluntary reporting system in most of the countries. One occurred in France, one in Sweden, one in Canada, three in Britain, and five in the United States. Five of the fatalities were due to septic shock following clostridium sordellii infection; two resulted from haemorrhage, one of which was from a ruptured ectopic pregnancy; and one was from coronary thrombosis. The drug has been banned in Canada and, last week, restrictions similar to a ban were imposed in Italy.

In the United States, the congress is considering the RU486 Suspension and Review Act, which would suspend all sales of RU486, subject to an inquiry of the Food and Drug Administration. In addition, there is an investigation into the Food and Drug Administration’s handling of the approval process for RU486 following four deaths in California. For every woman who dies in association with an RU486 abortion, there are 70 women who suffer life-threatening complications, including severe haemorrhage, sepsis and ruptured ectopic pregnancy.

The Therapeutic Goods Administration is empowered by the act to consider the safety, quality and efficacy of a drug. Of course, ‘efficacy’ means that the drug does exactly what is stated on the tin: it achieves the purpose for which it was designed. In this instance, I believe that is not the case. The TGA has no power or competence to consider the broader social and ethical impacts that may follow if a drug is registered for import and use in Australia. It does not have that power.

Under the existing restricted goods provisions, the Minister for Health and Ageing can consider the social and ethical impact of an abortifacient drug. If the bill is passed and these provisions are removed then the social and ethical implications of introducing RU486 into Australia cannot be taken into consideration.

It is also worth considering the appropriateness and applicability of the Therapeutic Goods Administration to approve access to RU486. A number of submissions and correspondence argued, based on common dictionary definitions of ‘therapeutic’, that therapeutic goods are those which remediate or prevent an illness, and that mifepristone, RU486, should not be classed as a therapeutic good and not be monitored or regulated by the TGA. I agree with this view. RU486 is a drug designed to end a life, not to cure it. Pregnancy is not an illness, as I said earlier, and therefore it could be argued that the TGA regime has no legal jurisdiction over abortifacients.

On page 9 of our Senate committee report, it is stated that it needs to be clarified that, in the legislative context, the relevant definition of ‘therapeutic goods’ is that contained in the Therapeutic Goods Act. Section 3 of the act states that the term ‘therapeutic goods’ includes goods ‘for therapeutic use’. ‘Therapeutic use’ is also defined in section 3 of the act. I want to make it clear for everybody by putting on the record the definition of ‘therapeutic use’ according to the act:

(a)

preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or

(b)

influencing, inhibiting or modifying a physiological process in persons or animals; or

(c)

testing the susceptibility of persons or animals to a disease or ailment; or

(d)

influencing, controlling or preventing conception in persons; or

(e)

testing for pregnancy in persons; or

(f)

the replacement or modification of parts of the anatomy in persons or animals.

I subscribe to the view that the comprehensive list of therapeutic uses in the Therapeutic Goods Act makes no specific reference to causing an abortion.

It is also worth noting that if the TGA assumed responsibility for the evaluation and approval of RU486 it would also assume ultimate responsibility for several other abortion drugs and vaccines on the restricted goods list. Subsection 3(1) of the TGA Act 1989 states the definition of restricted goods. The bill will repeal this definition and remove the requirement for ministerial approval before restricted goods can be imported, evaluated, registered or listed.

Besides RU486, mifepristone, the following medicines are currently listed as restricted goods which cannot be imported without ministerial approval: alprostadil, carboprost, dinoprost, dinoprostone, gemeprost, misoprostol, prostaglandins and vaccines against human chorionic gonadotrophin. Advocates of the drug incorrectly state that RU486 is the only medicine that is subject to the restricted goods condition. This is set out in their explanatory memorandum. However, RU486 is just one of the class of medicines defined as restricted goods.

How can this cocktail of abortion drugs, together with the controversial drug RU486, which is currently under intense scrutiny around the world, be the sole province of a team of unelected officials who would have ultimate arbitrary powers? RU486 can be used in the early to mid stages of pregnancy, up to 20 weeks. What is stopping another drug being designed in the months or years ahead to kill an unborn baby late term? Nothing at all. It would be up to an unelected team of bureaucrats, no matter how expert, in the TGA. What a cop-out for federal members of parliament.

On this score it is worth quoting two senators who spoke in the debate 10 years ago, when the minister for health was given the power of veto over restricted goods under the TGA Act of 1996. Greens senator Christabel Chamarette said:

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

ALP senator Belinda Neal said:

... we acknowledge that this issue raises large concerns within the community. It raises issues beyond purely health issues. These issues need to be addressed by the executive of this government and addressed with absolute and direct accountability ...

What has changed in the last decade? Nothing. Abortion remains as emotive an issue as it has always been. It costs Medicare more than $11 million a year. Federal funding is provided without any requirement for independent counselling—and by ‘independent’ I mean from a non abortion provider—and without any requirement for informed consent or a cooling-off period. In my view, this is appalling public policy.

The majority of Australians believe that the estimated 91,000 abortions each year in this country are too many. I agree. What are we doing to fix the problem? One in four pregnancies aborted is far too many. What are we doing to help? By passing this bill we will send all the wrong messages to young Australians—that abortion is no big deal and that now there is a pill which somehow sanitises the experience and the trauma.

I wholeheartedly support the recommendation in the report concerning counselling, which I believe should be available in the prenatal period, especially where a woman is contemplating an abortion, and the postnatal period and that these counselling requirements be covered by Medicare. Medicare funding of abortion, as I indicated, costs $11 million a year. I cannot see why, if it is funded at all, counselling should not be included in that publicly funded process.

As noted by the committee chair, Senator Gary Humphries, in his report:

... the Committee is not making any recommendations relating specifically to the Bill. However, it notes that a number of groups and individuals both supporting and opposing the Bill expressed concern over the number—

in my view, the very high number—

of abortions in Australia and the critical need to address wider personal and social problems. They urged the implementation or enhancement of a range of programs and services aimed at reducing unwanted pregnancies and supporting women through pregnancy.

Finally, I would like to quote from the recommendation. It says:

The Committee recommends that increased financial support be provided to improve sex education, including better education on responsible human relationships; wider availability of information about and access to contraception and other fertility control techniques; ensure independent professional counselling for women considering a termination of pregnancy, counselling post termination and counselling for relinquishing mothers as required; greater social support for women who choose to continue with their pregnancy—

and I wish to emphasise the wonderful work of the pregnancy support services around Australia—

and increasing the availability and affordability of child care.

I thank the Senate.