Ron Boswell (Queensland, National Party) Share this | Hansard source

I join this debate not expecting to have to speak tonight, but I will proceed. We are debating the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) 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 fact is that Labor and the coalition in 1996 agreed that ministerial oversight of RU486 needed to be present in an explicit way. They decided this after a single TGA official caused flawed trials of RU486 to be undertaken in Australia without ministerial knowledge. The drug evaluation branch of the TGA at the time stated:

TGA has not carried out an assessment as 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 the parliament. At that time, 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 RU486. That inquiry is happening as we speak. It follows public health warnings, new medication guides and warning labels on the use of RU486 issued in 2005. As I told the Senate last year, the new medication guide of the drug manufacturer, Danco, 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.

…         …         …

• you cannot get emergency medical help in the two weeks after you take Mifeprex.

That is the drug company’s advice. And this drug is supposed to help rural and outback women. In Danco’s patient agreement form, the woman must sign her name to the following statements:

7. My provider gave me advice on what to do if I develop heavy bleeding or need emergency care due to treatment.

…         …         …

9. I know that, in some cases, the treatment will not work. This happens in about 5 to 8 women out of 100 who use this treatment.

This is on the label. It continues:

11. I understand that if the medicines I take do not end my pregnancy and I decide to have a surgical procedure to end my pregnancy, or if I need a surgical procedure to stop bleeding, my provider will do the procedure or refer me to another provider who will. I have that provider’s name, address and phone number.

There is also a congressional subcommittee looking into the original approval process used by the FDA and the FDA’s response to five deaths and hundreds of other adverse events related to RU486 abortions. As well, there is a bill calling for the suspension of RU486 sales until a complete safety review is done. That is in America.

In Italy, last month, the government announced it was restricting imports of RU486 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. RU486 has never been licensed in Canada, despite its liberal abortion laws. There is also a lot more information now in the medical literature pointing to the comparative dangers posed by chemical abortions as opposed to surgical abortions. 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 it all together, when you add into the equation all these inquiries and their results, the investigations, the suspensions of trials, the restrictions of imports and the medically adverse findings, RU486 is not performing well. In fact, it is performing like a dog. RU486 is doing worse than when parliament decided to put the decision about its use under its ministerial wing. A lot of the focus in this debate has been turned on to the current health minister. We would do well to remember that health ministers come and go. We have had several since Carmen Lawrence first stopped trials of RU486 in Australia. Health ministers come from a range of backgrounds. Who knows who the next health minister will be? Any bill aimed at getting around a particular minister would be a short-sighted affair and could even backfire on the bill’s supporters in times to come. I hope this bill is not aimed at one minister.

A lot of my work over my 23 years in the Senate has been chasing down bureaucratic decisions in estimates committees or approaching ministers with information about how their experts are not so expert after all. I can cite numerous examples—from Biosecurity Australia in the banana debate, which many here will be familiar with; to stem cell research; and to the distribution of various government assistance programs—where the experts have got it totally wrong. Experts do have an important place, but they are limited by the resources available to them and by their sources of funding, which may be based on a user pays approach such as the TGA depends on. They may be experts but they can only be experts within the guidelines they are given. For example, the TGA may rely on outdated international research because to update findings requires a drug company to fork out lots of money, which they will not want to do.

In important cases, where the community is much involved, such as with RU486, 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 expert analysis and thinks there should be more information, 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 a so-called expert.

The community has a stake in this decision. Who will be their expert and their representative? Who will adjudicate their interests, if not the democratically elected representative of a system of parliament and executive government? This bill asks senators to agree that the minister is not a fit and proper person to assess advice from a bureaucratic organisation that is funded by the industry it is set up 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 and the superannuation. If we duck the tough questions, what are we doing here? Every portfolio issue that comes across our desks is an invitation to use judgment and wisdom in assessing its pros and cons. No one person could possibly be qualified in all these areas on which we are called to cast our vote, so we use advice and we appoint specialists—geniuses in very narrow fields. But we will rue the day when we let those same unelected and unaccountable advisers run this country and weigh up all the issues that a minister must.

I believe the case for a ministerial role in approving RU486 is the same now as it was in 1996. I think it is even more necessary today. The bill’s advocates have not made the case that the current system is so bad that it needs to be changed. What evidence is there to support the prediction that the current system will not 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 for both the minister and the government. But has that happened? Are we at such a parlous stage that the only solution is to throw out the process and start all over again—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 us 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 for thinking that the existing system does not work. 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 trials of RU486? 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, the minister for health sought advice from experts, and that advice was promptly rejected out of hand by the movers of this bill. Why? It was expert advice, after all, and directly related to the issues 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. Here is why: it turned out that access to urgent medical care was an issue with RU486. 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. 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 five to eight per cent of cases, by the drug manufacturer’s own admission, there has to be emergency medical care on stand-by. What are we going to do—send in the Royal Flying Doctor Service, medivac them out?

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?

Debate interrupted.