Senate debates

Wednesday, 8 February 2006

Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005

Second Reading

5:34 pm

Photo of Steve FieldingSteve Fielding (Victoria, Family First Party) Share this | Hansard source

Everyone has an opinion about abortion. It is one of those controversial issues that sparks great community debate. We have seen that in the last few weeks in relation to the abortion drug RU486. This debate has been prompted by a private member’s bill introduced by a National Party senator, Fiona Nash. The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is designed to shift responsibility for approving the drug from the health minister to the Therapeutic Goods Administration—that is, the TGA—a body which examines the safety of drugs. Put simply, the question is: who decides on RU486? Do we want our elected leaders deciding whether this drug should be approved in Australia or do we want to give that decision-making power to unelected bureaucrats?

Family First believes that this is a unique drug which raises major social policy and ethical issues as well as medical and safety issues. We cannot consider the social policy issues without taking into account community attitudes. That is not the job of the Therapeutic Goods Administration; that is the job of elected politicians. That is, after all, why people elect us. That is why we are paid. The TGA itself told the Senate parliamentary committee inquiry, on 15 December, that it cannot consider social and ethical issues, only the technical questions around the quality and safety of drugs.

Family First strongly believes that policy decisions should never be made by unelected bureaucrats; their job is to advise on policy and implement policy decisions. As I said earlier, in discharging our responsibility, we as elected politicians must consider community attitudes when we make decisions.

So, in the case of RU486, if a doctor sought approval from the health minister to use the drug, you would expect the minister to seek advice from the TGA, as they are the drug safety experts. However, you would also expect the minister to take into account many other issues, including community attitudes. That way the minister would be carrying out his or her duty of gathering all the information and then making a decision.

We know where the community is at on the abortion issue. Regardless of whether Australians support or oppose abortion, we know that the overwhelming majority of them are concerned about it and want the numbers reduced. An editorial in the Sydney Morning Herald on 4 January this year summed it up well. It said:

A substantial majority supports abortion on demand—but at the same time an even greater majority is uneasy with the number of procedures carried out and wants the abortion rate cut somehow.

The latest research from the Southern Cross Bioethics Institute reveals that Australians think that the number of abortions in Australia each year—90,000—is too high and should be reduced. They want their elected leaders to find ways to reduce the number of abortions. We also know from research that many women who have abortions do not feel they have a choice. Many have abortions due to a lack of financial or emotional support and do not feel they will be able to cope if they have their baby. Family First believes that as a community we have an obligation to offer women alternatives to abortion. For example, governments should fund agencies that provide practical support to pregnant women both before and after the birth of the child.

The Southern Cross Bioethics Institute’s research into RU486 is interesting. It found that 75 per cent of Australians had ‘little or no knowledge’ of the drug. Once people were told about the drug, only 17 per cent supported introducing it. The majority, 59 per cent, said they wanted the decision delayed.

We all know that abortion is a subject of national interest. That is why the RU486 issue was referred to the Senate Community Affairs Legislation Committee, of which I am a member. Family First has labelled the inquiry a farce. Given the importance of this issue, it is a joke that the committee reported to the parliament only today, the debate started just a few hours later and the vote will be tomorrow. What a waste of thousands of dollars of taxpayers’ money, flying committee members and staff around the country to public hearings, when politicians will have less than a day to examine the report. Think about this: late last year when the government was ramming through its industrial relations changes and the Telstra bill, members of the Democrats, the Greens and the Labor Party were all howling with rage about the abuse of the Senate process. Family First felt the same. Just a few months later, here we are with another bill that is being rammed through, but, because it is one that most of the Democrats, Greens and Labor senators support, suddenly concern about ramming bills through seems to have disappeared.

Another reason the minister should retain control over approvals of RU486 is because he or she is accountable to the community for what he or she does. The TGA is not. When the TGA originally approved the morning-after pill, the manufacturer said it must be available only with a doctor’s prescription. Just 12 months later, a TGA committee removed this restriction and the morning-after pill became available over the counter at chemists. And no-one batted an eyelid. Within six months of that decision, a newspaper investigation found that only two out of 10 pharmacies it visited were following proper guidelines when selling the pill. The TGA was not called to account for its backflip. Had the minister been responsible for that decision, you can be sure there would have been much greater public accountability.

Family First is pro women, which is why we must also consider the potentially serious medical and psychological effects, and the deaths overseas, associated with RU486. Doctors and pharmacists are not required to report adverse effects of a drug to the TGA. This means the TGA cannot monitor the effects of a drug, which is a serious issue. On the other hand, the health minister could ensure that mandatory monitoring was a condition of approving its use.

Supporters of the bill say that we should trust the doctors. We are told they will devise safeguards and protection. But, in the United States, the Food and Drug Administration—the equivalent of the TGA—admits that doctors ignore its conditions, such as limiting the use of RU486 to the first 49 days of gestation. We also know that the FDA has received reports that more than a dozen women have taken RU486 while having an ectopic pregnancy. In theory, none of this is supposed to happen.

Supporters of the bill also want us to take comfort from the fact that more than 30 countries have approved RU486. But given that it cannot be used effectively without a prostaglandin like misoprostol, you would think they would tell you that no countries have approved use of this drug for abortion. In fact, it is used off-label and against the manufacturer’s advice. The reason the manufacturer of the prostaglandin wants nothing to do with this is that it could cause possible malformation to any surviving unborn child.

Let us look back. It was 10 years ago, back in 1996, that the parliament decided that the health minister should be responsible for approving RU486 by passing the Therapeutic Goods Amendment Bill 1996. At the time, Labor senator Belinda Neal said:

These issues need to be addressed by the executive of this government ... with absolute and direct accountability ...

Greens senator Christabel Chamarette said:

We deserve to have parliamentary scrutiny of decisions. We deserve to have a voice on issues and not simply leave them to boards of experts.

Nothing has changed. The onus is on those who seek to repeal that bill to show there has been sufficient change since 1996 to warrant such action. Not only have they failed to do so, they have not even attempted to do so. We all know RU486 is like no other drug. It is designed to cause an abortion and end the life of an unborn child. Family First believes this is a major policy issue of social, moral and ethical importance. The community elects, and pays, politicians to do their job, and that includes tackling tough issues like abortion and considering the community’s views as well. For Australia’s elected politicians to wash their hands of this, to pass off their decision-making power on a policy issue like RU486 to unelected bureaucrats, would be a gross dereliction of our duty and a real insult to the people who put us here in the first place.

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