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RU486 - something to be said for considered debate

By Andrew Laming - posted Thursday, 16 February 2006

Thanks to the Private Member’s Bill in Federal Parliament, RU486 is likely to be a medical abortion option for Australian women by year’s end. Such approval means additional choices for some, but ironically closes down a chance to debate the ethics of new medications.

The Therapeutic Goods Administration (TGA) is a unit of the Department of Health and Ageing in Canberra. It performs the tough job of evaluating safety and efficacy with proficiency and thoroughness. But its mandate explicitly ignores moral and ethical considerations.

Australia has already used Parliament to set the corridors of tolerability for issues like abortion, embryo collection and stem cell research. On the horizon is gene technology, therapeutic cloning, pharmacogenetics and pharmaceuticals in food: each worthy of broad community consultation well beyond the quantitative analysis of whether each are safe and effective. For many, RU486 is more akin to these challenges than it is a mere pill. That is why the community deserves some say via Parliament when major changes to issues like abortion are proposed.


Where substantive community concerns around pharmaceuticals run counter to safety and efficacy, MPs have three options: accept controversial registrations; disallow those registrations with a vote; or write legislation to overrule the TGA every time it happens.

No methodology can hope to satisfy all in such polarised ethical debate. Once the science of safety and effectiveness stacks up, parliamentary scrutiny is probably the closest we can get to having all views heard. After all, it is best to inform community debate using TGA evidence than have uninformed debate in isolation. Worse still is the risk of an unamended Bill - to bypass that consideration completely.

With clear parliamentary support for RU486 in both Houses, a vote on the drug should present no threat to registration. Criticism that politicians can’t make the tough calls on philosophy leaves us in an awkward predicament. Democracy must either allow every therapy deemed safe to be sorted out by patients and therapists or hold a referendum.

Currently, the sovereignty of Parliament on pharmaceutical listings is delegated to the Therapeutic Goods Administration. My preference is that where substantial ethical concerns exist, Parliament should retain the option to resume that delegation when required. There is little value in airbrushing concerns away to a scientific panel. Another benefit of parliamentary scrutiny is that community views on termination of pregnancy arrangements change over time. It is disappointing that we view 1970s legislation as immutable and disturbing that we would deny Parliament a philosophical debate on the grounds that we don’t share those concerns.

A disallowance instrument is one option to facilitate that debate: a parliamentary mechanism which overturns a decision or regulation. It would only be applied where the safety of specific classes of controversial drugs, deemed safe and effective by the TGA, but where community concern remained. Disallowances must be lodged within 15 days and voted upon within a similar period or it takes immediate effect.

Interestingly, only one Chamber needs to support the disallowance in order to overturn the regulation and block the drug. Currently, RU486 would survive such a disallowance in either House. That is why it is a fiction to say such parliamentary scrutiny would dissuade applications to the TGA or scuttle RU486 altogether.


Another claim is that disallowance would bury Parliament under an avalanche of applications. In reality, RU486 is the only abortifacient seeking approval. There have been no analogues developed in a decade. Further disallowances could only be moved if new safety or effectiveness issues warranted reapplication (unlikely with such an old drug) or if a new drug sought to register. That is precisely why we need the option to disallow in the future.

There is a final channel for new drugs through the TGA called the Special Access Scheme. This mechanism provides unlisted drugs for exceptional circumstances like medical research. Such options would not be compromised by having a disallowance option in Parliament.

No solution suits everyone, but there is something to be said for considered debate and the finality of a parliamentary vote that tells me it is as close as we will get to meeting community expectations. Removing such an option burdens a scientific body like the TGA unfairly. As morally challenging therapies blindside the TGA exponentially, the ethical void will become obvious.

This Bill has successfully removed ministerial intervention from drug evaluation. But in the rush to unravel former Senator Harradine’s blatantly pro-life legislation, we have lost some vital parliamentary accountability.

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About the Author

Andrew Laming is the Federal Member for Bowman in Queensland and the Shadow Spokesperson Regional Health and Indigenous Health.

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