Leslie Cannold: Writer, Commentator, Ethicist, Researcher
ARTICLES

THE RU486 DEBATE: Death by Amendment

As I write, the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU86) Bill 2005 may be sliding towards defeat in the House of Representatives. Designed to undercut 1996 amendments to the Therapeutic Goods Act that have effectively banned RU486 and other abortifacient drugs from Australia, the Bill – having passed through the Senate last Thursday – is now the subject of an amendment that, if successful, will see the ban remain firmly in place.

The amendments – one introduced by Queensland Liberal Andrew Laming and a another by NSW Liberal Jackie Kelly – are similar to those advanced in the Senate by Tasmanian Richard Colbeck and the Northern Territory’s Nigel Scullion. However, unlike the Colbeck/Scullion amendment, which attracted minimal support, some members of the Lower House – those in marginal seats or who relied on Family First preferences at the last election and have swallowed the ‘we will target you at the next election’ bluster of pro-life lobbyists – are now seriously considering throwing their support behind the Laming amendment.

This is a disastrous outcome for those hoping for a quick resolution to the divisive debate about abortion that has accompanied the introduction of the Bill. It is also a blow to those hoping that the passage of the unamended Bill would mean that the Therapeutic Goods Administration (TGA) would finally get a chance to conduct an impartial and thorough evaluation of the safety and efficacy of the medication and – should they give the go ahead – approve the registration of the drug in Australia.

Successful amendment of the Bill in the Lower House could mean Australians are in for ‘the abortion debate that time forgot.’ Indeed, this may be the intention of the amendment. A fax sent to all MPs urges them to vote for the amendment to ensure an ‘all-encompassing debate’ on the ‘moral and ethical’ – as well as the ‘safety’ – issues is had this time, and every time, the TGA approves such drugs.

MPs who vote for the current amendments will condemn the rest of us to weeks, if not months, of further discussion on RU486 because the amended Bill must return to the Senate for consideration and a vote. If the Senate refuses to accept the amended Bill, the House of Representatives can either insist on their amendment or vote to pass the original. If they go the former route then the Bill will return to the Senate which can either vote to accept the amended one or return the original to the House of Represenatatives … and on and on it goes.

Indeed, the Bill can become a football, passing back and forth between the two Houses until – unable to reach agreement – both agree to set it aside, meaning that the current untenable situation, where the Health Minister decides on drugs like RU486, prevails.

There are both principled and practical problems with the Laming amendment. While it allows the TGA to evaluate the drug without prior approval of the Minister – the Parliament would have the power to override the TGA’s decision to register the drug. This replicates – indeed multiplies – the current problem of non-experts making critical decisions based on heaven-knows-what information about life-altering and life-saving medications.

Liberal MP Danna Vale’s plea to her colleagues to vote against the current Bill because the drug’s availability could lead to Australia being dominated by Muslims – a claim not only replete with racist overtones but also based on the false assertion that making RU486 available will increase the abortion rate – offers an insight into the sort of ‘logic’ that some MPs might apply to decisions about drugs like RU486 if given the chance by passing of the amendment.

This principled problem leads to the practical problem already facing women and patients desperately seeking access to the drug: no pharmaceutical company is willing to go through the expensive and time-consuming process of seeking TGA registration for RU486, despite reams of high-quality evidence that it is both safe and effective. This is because of the uncertainty created by the current arrangements, which allow the Minister to veto the TGA’s ruling.

The Laming amendment multiplies this uncertainty by allowing the TGA’s evidence-based decision to be overturned by Parliament and in so doing, virtually assures a continued absence of applications by drug companies to register and market the drug in Australia.

Indeed, if the amendment passes, this could be the situation not just for abortifacient drugs but for all drugs a small, vociferous minority deems controversial. The pro-amendment fax states:

RU486 is just the first of many highly controversial drugs which the TGA will confront over the next decade … The TGA Act 1989 should be amended to ensure that any controversial drug is not listed in Australia purely because it is safe and effective.

Drug approval by popular opinion, it seems, is just around the corner.

So close, yet so far. It is the face of Mary Lander – the Australian woman diagnosed around this time last year with an inoperable brain tumour who is still struggling to import RU486 to treat her condition – that swims before my eyes as I consider the possibility that having passed the Senate with such overwhelming support, this Bill may still be defeated.

Mary’s face, and faces of the Australian women who – having made the difficult decision to terminate – are so determined to carry out this decision without undergoing surgery and without delay (medical abortion using RU486 can be done earlier than surgical abortion) that they hop on a plane to New Zealand or the UK to gain access to the drug.

MPs considering the Laming amendment should not kid themselves that it represents a reasonable compromise position. In fact, the amendments undermine the fundamental intention of the Bill, which is to remove medical and scientific decisions from the hands of politicians, and place them in the hands of the experts at the TGA.

Yes, RU486 procures early non-surgical abortion, but it also has the capacity to save the lives of countless Australians suffering from serious diseases. And insofar as MPs believe decisions relating to abortion needs to be regulated by politicians, they can rest assured that they are. Every State in Australia has criminal or medical regulations overseeing abortion and State MPs, like their Federal counterparts, come up for regular re-election, too. It has been argued more than once that, given the availability of legal abortion in Australia, the push by Federal parliamentarians to constrain the legitimate role of the TGA is illegitimately interfering with State laws and policies.

Supporting the Laming amendment means affirming the dubious principle that politicians, rather than medical and scientific experts, are the right people to make critical decisions about one particular class of drugs. In practice, it means denying Australian women with an unplanned and unwanted pregnancy – and other Australian patients with life-threatening tumours and cancers – ready and affordable access to a pharmaceutical that is used safely and legally by millions of patients around the globe each year.

Politicians have been afforded a conscience vote on this issue. They have a moral obligation to use it to ensure women, in consultation with their doctors, get one too.

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Email: leslie@cannold.com Mobile: 0417 114 859 Fax: +61 3 9348 2015 - PO Box 1337, St Kilda South VIC 3182 Australia