SENATOR BOSWELL - Speech to the Senate prior to the vote on RU486

The Senate is debating the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for approval of RU-486) Bill 2005.

The movers of this bill had to prove one thing. They had to show there was a good reason to undo what both sides of Parliament had agreed on in 1996.

They have failed to do this. They have not put up a convincing argument to justify turning the original approach on its head.

The facts are that Labor and the Coalition in 1996 agreed that Ministerial oversight of RU 486 needed to be present in an explicit way.

They decided this after a single TGA official caused flawed trials of RU 486 to be undertaken in Australia without Ministerial knowledge.

The Drug Evaluation branch of the TGA at the time stated that “TGA has not carried out an assessment to the quality, safety and efficiency of this product.” The Melbourne trial was stopped when the Consent Forms were exposed as being totally inadequate.

Carmen Lawrence as Health Minister suspended the trials in August 1994. In 1996, the TGA Act was amended with the support of both sides of Parliament.

As then Labor Senator Belinda Neal noted:- “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.”

Even Greens Senator Chamarette agreed, saying, “We deserve to have a voice on issues and not simply leave them to boards of experts.”

What significant event has happened since that time of unity across the board to change the approach to dealing with this abortion drug?

If anything, the intervening time has allowed more information to come forward which actually reinforces the wisdom of the Parliament’s earlier decision. Already this year we have seen major international developments that go to the heart of public policy on RU486.

The US Food and Drug Administration is revisiting the safety issues of RU486 with a special investigation with the Centre for Disease Control into recent deaths linked to RU 486. That inquiry is happening as we speak.

It follows public health warnings and new medication guides and warning labels on the use of RU486 issued in 2005. As I told the Senate last year, the drug manufacturer Danco’s new medication guide states:-

“About 5-8 out of 100 women taking Mifeprex will need a surgical procedure to end the pregnancy or to stop too much bleeding….

“Some women should not take Mifeprex. Do not take it if you cannot return for the next 2 visits …(and) you cannot get emergency medical help in the two weeks after you take Mifeprex”.  That is the drug company’s own advice.

In Danco’s patient agreement form, the woman must sign her name to the following statements:-

There is also a Congressional Subcommittee looking into the original approval process used by the FDA and the FDA’s response to 5 deaths and hundreds of other adverse events related to RU 486 abortions. As well, there is a bill calling for the suspension of RU 486 sales until a complete safety review is done.

In Italy last month, the government announced it was restricting imports of RU 486 after a trial was suspended following one in 20 women experiencing partial abortions at home with excessive bleeding.



In Canada a trial was also suspended after a death. RU 486 has never been licensed in Canada despite their liberal abortion laws.

There is also a lot more information now in the medical literature pointing to the comparative dangers posed by chemical abortion as opposed to surgical abortion. As the Senate Committee pointed out in the body of its report, “the overall mortality rate associated with medical abortion is 10 times higher than the mortality rate for surgical abortions at 8 weeks gestation.”

So when you put all these inquiries and investigations, these suspensions of trials, these restrictions of imports and these medically adverse findings into the equation, RU486 is not performing well.

RU 486 is in fact doing worse than when the Parliament decided to put the  decision of its use under the Ministerial wing.

A lot of focus has been turned onto the current Health Minister in this debate. We would do well to remember that Health Ministers come and go. We have had several since Carmen Lawrence first stopped trials on RU 486 in Australia.

Health Ministers come from a range of backgrounds. Who knows who the next Health Minister will be? Any bill aimed at getting round a particular Minister would be a shortsighted affair – and could even backfire on the bill’s supporters in times to come. I hope this bill is not aimed at any one Minister.

A lot of my work over the years has been chasing down bureaucratic decisions in Estimates Committees or approaching ministers with information about how their experts are not so expert afterall.

I can cite numerous examples from Biosecurity Australia to stem cell research to the distribution of various government assistance programs where the experts have got it wrong.

Yes they have an important place, but they are limited by the resources available to them and the source of funding which may be a user pays approach such as the TGA depends on.

They may be experts but they can only be expert within the guidelines they are given.

For example, the TGA may rely on outdated international research because to update the findings requires the drug company to fork out lots of money which they won’t want to do. 

In important cases where the community is much involved such as with RU 486, I believe it is most important for the portfolio Minister to have a role in the final decision.

It may be that he or she will accept the experts’ findings. It may be that he or she sees that there are limitations on the expert analysis and thinks there should be more information or more studies or a delay in order to await the outcomes of overseas investigations. All these matters are duly weighed by a Minister but can have no place in a limited and narrow analysis by so-called experts.

The community has a stake in this decision. Who will be their expert, their representative – who will adjudicate their interests if not the democratically elected representative system of Parliament and executive government?

This bill asks Senators to agree that a Minister is not a fit and proper person to assess advice from a bureaucratic organisation funded by the industry they are setup to regulate.

If that is to be the way of good governance in Australia, why do we need Ministers at all? Why don’t we all go home and leave it to the experts? We are not elected to leave it to others, precisely when issues of great public interest such as this come along. This is when we really earn the Comcars, the first class seats, the salary, the superannuation.

If we duck the tough questions, what are we doing here?

Every issue in every portfolio that comes across our desks is an invitation to use judgement and wisdom in assessing its pros and cons.

No one person could possibly be qualified in all the areas on which we are called to cast our vote. So we use advice, we appoint specialists, geniuses in a very narrow field.

But we will rue the day we let those same unelected and unaccountable advisers run the country and weigh up all the issues that a Minister must.

I believe the case for a Ministerial role in RU 486 is the same now as it was in 1996 – perhaps it is even more necessary today.

This bill’s advocates have not made out the case why the current system is so bad that it needs to be changed. What evidence is there to support the prediction that the current system won’t work?

If the drug had been approved by the TGA with widespread support around the country and the Minister failed to recommend the same, then that would be a poor Ministerial decision that would have many consequences both for the Minister and the government.

But has that happened? Are we at such a parlous stage that the only solution is throw out the process and start all over again, and  replace an open process with one that is not transparent, not accountable and presided over by unelected specialists?

The current system has not failed anyone to date. Let’s be clear about that. The movers of this bill are convinced that a religious-based prejudice will prevail. Perhaps this bill is really about the movers’ own prejudices because there is no basis to think that the existing system has not worked. It is the same system that has worked under other health Ministers – to Australia’s benefit.

Does anyone here think that Carmen Lawrence was wrong to stop the trials of RU 486?

Does anyone think that Michael Wooldridge somehow let the side down. What has the current Health Minister ever said on this issue that would make it urgent to bring in a private member’s bill to redress some terrible failing?

Following the announcement of this bill, he sought advice from experts and that advice was promptly rejected out of hand by the movers of this bill. Why? It was expert advice afterall and directly related to the issue raised by the movers of this bill who argued that rural women needed access to chemical abortion drugs because surgical abortion services were not too readily available.

Then it turned out that access to urgent medical care was an issue with RU 486.

No one denies this – it is on the drug manufacturer’s own medication guides.

We all know that it is often difficult to access medical services in the bush, particularly for the more remote communities.

And yet here is a drug which requires several follow-up visits to a doctor with ultrasound equipment  - plus - if something goes wrong – as it does in 5 to 8% of cases as admitted by the drug manufacturer, there has to be emergency medical care on standby.

These are facts, not fiction. Any Health Minister who failed to release this information would be grossly negligent.

I urge Senators to think about whether the current system has failed.

If it has not, should we abandon the Westminster principle of Ministerial oversight for the tyranny of unelected experts funded by the drug companies they must judge?

 

ENDS