Political Debate on RU486
A private members bill is before the Senate Committee on whether the ability to allow the abortificant, RU486 should be placed in the hands of the TGA, instead of via the authority of the Health Minister (which was put in place in 1996).

As this bill has been tabled over christmas, it certainly seems to be a stealth move by Democrats to push this bill through in a time when many senators are not available and many Australians are distracted.

You can view the transcript for an initial committee meeting on the 15th of December online. One part I would like to highlight is the well thought out presentation (pg 50) of Dr Van Gend (Doctors for Life) who has done some great research on this issue. It is long, but worth reading. In summary, some senators want to remove the safeguard and accountability for allowing a drug whose purpose is morally debated after such safeguards were put in place in 1996 with bipartisan support (Question: Why is it okay for pro-abortion senators to try to sto any discussion on the legality of abortion as 'we have already had that debate', yet in this case they think discussion is merited?). The end result of this push (if successful) would be that the pro-abortion side benefits, so claims to it being 'neutral' are somewhat self-serving.

You can send a submission to the committee by the 16th of January attached to an email to mailto:community.affairs.sen@aph.gov.au

If you want more information on the dangers of RU486, specifically those ignored by the AMA in their talking to the committee, you can view Renate Kleins work on the facts and myths about RU486. Suffice to say, a lot more countries than Italy have taken issue with the drug, including Canada.

Dr Van Gend's speech

let me give these summary points if I may. Abortifacient drugs such as RU486 are unique in that no other drugs are designed to end a human life. Therefore their use demands a unique level of public scrutiny and accountability. The current regulatory arrangements in Australia for abortifacient drugs were instituted in 1996 with bipartisan support to ensure proper accountability by government on a matter of great public concern, and they should remain. However, if RU486 is found by the Therapeutic Goods Administration, the TGA, to be safe then valid medical indications for its use, including certain cancers, hormonal diseases and medically essential termination of pregnancy should be authorised by government.
Other uses for RU486 which are medically unjustifiable, such as taking the life of healthy offspring to relieve the social distress of parents should have no place in government policy or medical advocacy. Instead, the compelling policy task for both government and the medical profession together is to strengthen social supports for women distressed by unplanned pregnancy.

That is the shape of our concerns. May I focus closely on the key point: why the parliament should retain policy oversight of the conditions under which RU486 legitimately be used, rather than delegating it to a body such as the TGA, which has a narrow brief to assess drugs on the basis of efficacy, safety and quality, which is
entirely proper to their official role but which has not got the brief to deal with the broader questions of our dealings with an innocent life—the justification of taking a life, the medical situations where abortion may be entirely necessary and justifiable. It is not for the TGA. Those policy parameters are for our elected members to guide the lower levels of assessment, like the TGA.
I focus on that one point. The essential question facing MPs and senators is: why should RU486 require special approval by government when all other drugs are simply assessed by the TGA? The answer is that abortifacients like RU486 are unique as drugs designed to take life. That fact is of obvious public concern. It explains why this drug demands the special attention of those elected to deal with such matters of public concern. Australians will differ on whether the life of a very young human being matters but there is no dispute that, after using RU486, where there was once a dynamic living creature and an unfolding human destiny, there is now death. So RU486 is uniquely contentious in its action, raising serious moral issues and obviously therefore requiring a special level of scrutiny and accountability by our elected representatives.
The current regulation of RU486, I remember very well, was established in 1996 on exactly this principle of accountability and with bipartisan support. On behalf of Labor, former senator Belinda Neal spoke with a moral seriousness that we need to get back into this debate. She 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 ...
The parliament in 1996 thereby aimed to prevent the recurrence of the debacle in 1994 where an anonymous official in the Department of Health approved the importation of RU486 without the minister being aware. AsSenator Neal concluded:
We wish to ensure that, in circumstances where this drug is to be imported or supplied in Australia, the minister berequired to approve the drug and that notification of this approval be given in this chamber.
For the government, senator Bob Woods, who was Parliamentary Secretary to the Minister for Health and Family Services reassured the public and the AMA in these words:
In terms of the AMA’s perception that we are in some way banning a drug ... that is not the case. We are making theminister sign off, if you like, and making sure that public accountability is raised.
So the amendment put forward in 1996 by Senator Harradine was a professionally sound response to a health department lapse. It received bipartisan support. It has never banned RU486. It is being used, as we speak, in medical trials for cancer therapy in Australia—it has never been banned. It is allowed for valid medical indications. As Senator Harradine explained in his explanatory notes in 1995:
People on both sides of the abortion debate agree that the importation, trials, registration and marketing of such agents ... should not be left to bureaucrats and science technologists. There should be ministerial accountability ... The amendments
go no further than this.
Parliament is again to debate the regulation of RU486, but this time the stated aim is to remove this professional proper accountability. So once more a departmental official can approve RU486 without the minister taking policy responsibility or the parliament knowing. With this amendment bill for repeal of ministerial responsibility for approval of RU486, the parliament is being asked to support an amendment
which undermines, for ideological reasons, proper ministerial accountability on a matter of public importance.
It would be a triumph of underhandedness over transparency in public life. If this bill were passed, it would be an abandonment by parliament of their responsibility to grapple with difficult social and ethical questions, instead hiving the issues off to unelected scientists and officials who are not accountable for contentious decisions.
The TGA has a vital, proper but secondary role which is:
... to ensure the quality, safety and efficacy of medicines.
It has no brief to take into account the moral status of the life to be ended by RU486 or the justifiable conditions upon which that life may be ended. That is not in its brief. But without such ethical considerations no serious and responsible decisions can be made. That outcome, of course, is what supporters of unrestricted
abortion want—an assessment devoid of the moral dimension, free from consideration of justice or medical justifiability, just assessing this abortion bill as if it were a headache tablet. If this parliament votes to dodge responsibility, it will have lost an opportunity to make a vital, ethical distinction between abortions which are
medically necessary and which we must support and provide RU486 for, if that is appropriate, and abortions which have no medical justification which are done for complex social, financial or personal reasons but which require a different policy approach. This parliament will, by default, give its imprimatur to the current
practice of unrestricted abortion for non-medical reasons. The federal government has never had to commit itself one way or the other on the question of abortion for non-medical reasons. It is a matter for the states.
Now, with this question, it is unavoidable that it will have to commit itself one way or the other, even if the commitment is by merely washing its hands of the lives in question. If, however, this parliament recognises the need to retain policy responsibility on the use of this uniquely contentious drug, it will need to set parameters as to when the taking of life may be medically justifiable. And
that is where the medical profession must help. The government and the profession should be establishing all valid medical indications for RU486—whether in certain cancers, hormonal diseases or medically essential abortions—and approve the drug for those uses. RU486 is already available for certain medical conditions, as
the current cancer trials show.
Further, if authorities can define situations where abortion is medically essential and where RU486 is approved as safe by the TGA and considered preferable to surgical abortion by the O&G specialists, then the drug should be authorised for such situations. In this way, RU486 could be accessed appropriately for these
approved conditions through, for instance, the current system we have of authority prescriptions, which we use regularly for special drugs, such as narcotics, and where strict prescribing conditions must be met for their use.
That is practically how it could be done.
But it is the government who has to set the policy parameters for this authorisation, but not by using base level criteria of safety, efficacy and quality, which the TGA properly exists to assess. The government must bring in more complex and significant criteria, including the issue of justice to the unborn child, the prohibition against intentional killing without due cause, and the medical justifications for necessary abortion.
That is why the government needs to keep a policy watch over the lower levels of administration like the TGA, which quite properly make its assessment on simpler, technical criteria appropriate for most drugs butentirely inadequate for RU486.

- posted by Alan Grey @ Monday, December 19, 2005