Mal Washer (Moore, Liberal Party) Share this | Hansard source

I move:

That this bill be now read a second time.

The history important to this debate on RU486 (mifepristone) comes about because this drug belongs to the special category of drugs under the Therapeutic Goods Act 1989 (the act) known as restricted goods, which cannot be evaluated, listed, registered or imported without the written approval of the minister for health.

Further, any such written approval must be laid before each house of parliament by the minister within five sitting days of being given.

Restricted goods only apply to abortifacients—that is, exclusively to medicines intended to induce an abortion.

All other medicines are evaluated and regulated by the Therapeutic Goods Administration (TGA) without any requirement for approval from the minister.

A sponsor seeking to market an abortifacient such as RU486 would need to submit an application with supporting data demonstrating quality, safety and effectiveness of the drug through the same process as all prescription medicines in Australia. The key difference is that in the case of RU486 ministerial written approval is required before evaluation by the TGA can occur.

The restricted goods provision was incorporated into the act in 1996 as a result of amendments introduced in the Therapeutic Goods Amendment Bill 1996 by Senator Brian Harradine.

The amendments were supported by both the Liberal-National Party government and the Labor opposition.

This made the minister for health, rather than the TGA, ultimately responsible for decisions in relation to evaluation, registration, listing or importation of abortifacients.

Senator Meg Lees argued at the time that this would effectively deter sponsors from seeking to bring RU486 into Australia, an argument that has proven to be true. Please do not confuse authorised prescribers as changing the restricted goods status of this drug.

Sponsors often face significant costs in putting together supporting evidence for an application to the TGA, which demands full cost recovery.

The TGA is a globally respected organisation and is the appropriate authority to assess and evaluate the risks posed by therapeutic goods, applying any measures necessary for treating the risks posed and monitoring and reviewing the risks over time. So far the TGA has been entrusted by government to evaluate more than 50,000 therapeutic goods. Therefore, it would be reasonable to assume that it is also qualified to manage the risks associated with medicines such as RU486.

In 2005 two Queensland based gynaecologists, Caroline de Costa and Michael Carrette, submitted an application to become authorised prescribers of RU486. This was referred to the TGA by the minister.

A TGA bill before the Senate gave Senators Lyn Allison, Judith Troeth, Fiona Nash and Claire Moore the opportunity to change this ministerial control in the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005.

This bill will ensure all medications for use in Australia are appropriately evaluated by the TGA and the Australian Drug Evaluation Committee, the group of independent experts appointed by the health minister.

The member for Murray, Dr Sharman Stone, supports this position, as she has experienced the plight of disadvantaged people in her electorate in having only a ‘surgical requiring anaesthetic’ option for termination of pregnancy.

Clearly this debate is not about one’s views on abortion, as this is a legal procedure determined by state and territory laws. There should be no difficulty in separating the issue of abortion from the question of method.

Currently this parliament sanctions and Medicare rebates surgical—that is, suction curettage with anaesthesia termination of pregnancy—a procedure with many similar risk factors to RU486.

The reasons for abortion are an unwanted or unviable pregnancy. Unwanted pregnancies occur in multiple situations such as foetal abnormality, serious maternal health problems and severe psychological and social problems, to mention a few.

This debate is not about increasing the incidence of abortion, as careful research in many of the 35 countries where RU486 is used has not demonstrated this trend.

In the Netherlands, where abortion is legal and both surgical and medical—RU486—methods are available, and contraception and sex education are widely promoted, there exists one of the world’s lowest abortion rates.

In Australia, where RU486 is not available, the incidence of abortion is far too high, and we should take some lessons from the Netherlands.

As Dr Stone and I have advocated, we need to put in place better education and information programs that more effectively inform young people about their own sexuality, that empower them with better life skills and that teach them about responsible parenting and contraception. There is an urgent need to identify world’s best practice, with a view to our government implementing a national health and wellbeing program that is available in all schools.

As the highest rates of abortions occur in women between 20 and 24 years of age, there is also a need for media education similar to our highly successful tobacco Quit program.

This debate is not about parliamentarians rightly being entitled to different views on abortion, as there are many members with religious and moral views who oppose abortion.

Nevertheless, politicians are not entitled to use the power of the state and legislation to impose their own personal moral positions on the entire community.

We do have a political responsibility to ensure the safety and quality of health care and to ensure equitable access to lawful services and procedures.

There can be no excuse in this debate to confuse separating the issue of abortion from the method of abortion, particularly when the surgical method receives Medicare funding.

I would have thought that Christian belief would extend compassion to women confronted with unwanted pregnancy, particularly with gross foetal abnormality and serious maternal illness including cancer, and in cases of nonviable pregnancy and to at least allow the dignity of a thorough evaluation of a medical alternative.

This is not a debate about confidence or lack of confidence in the health minister, a man whom I believe has excelled in the job. We may have had a few minor differences but that is expected in any mature political relationship.

The debate should not be influenced by extreme minority groups targeting marginal seats, aimed at intimidating people in these seats to confuse the debate as a debate about the pros and cons of abortion, which is a total lie.

The debate is certainly not about giving parliament greater levels of scrutiny and accountability by ministerial retention, now or in the future, of the power that requires his or her written approval for TGA assessment.

Under the current arrangements the health minister is simply required to notify the parliament of a decision to approve the application for evaluation of an abortifacient by the TGA.

Given the fact that such a decision is not disallowable, this would not amount to a significant level of parliamentary scrutiny.

Further, the minister is not required to table decisions not to approve such applications, meaning that the parliament would neither necessarily be informed nor have the capacity of any oversight of such a decision.

A proposition put by some that the bill, if approved, would abandon parliamentary responsibility to grapple with difficult social and ethical questions instead of leaving this to scientists, doctors, ethicists and officials specialising in the field but who are not as accountable for contentious decisions is, to say the least, ludicrous.

How many times have we rightly heard statements like, ‘I will take advice and report back to parliament,’ or, ‘We will await the outcome of an expert inquiry,’ or, ‘This is just a download from Google and not properly researched policy’?

Specialised scientific and medical advice built on evidence based research and expertise is the only way to determine appropriate methods of treatment.

These methods also need to be followed or reviewed on a regular basis to ensure safety, and funded by a sponsor.

Further evidence to confirm this absurd position will be ‘cherry-picking’ of risk factors of RU486 to suit an argument to effectively prevent proper evaluation by the TGA.

For example, I am sure one will be clostridium sordellii, which can cause septic shock. It is an organism found in soil and in the human gut and in 10 per cent of women’s vaginas. This will no doubt get a mention.

The four deaths in the USA and one in Canada associated with abortion are factual, but the FDA is not convinced that they are directly related to RU486 or prostaglandin usage.

Infection from this bacterium has occurred in people undergoing liver, colon, bowel and prostate procedures and has been associated with ear infection, wound infections and caesarean section. These types of infections are certainly not beyond our medical ability to prevent by the use of appropriate prophylaxis if deemed necessary, no doubt a job for the TGA to assess.

A number in this debate will talk of the drug in the light of medical misadventure or incompetence, a problem that makes any medication look dangerous if inappropriately administered or managed but of course not the fault of the drug itself.

Others will claim this drug is evil because it is designed to kill a foetus, but so of course is the Medicare rebatable surgical procedure of suction curettage with anaesthesia.

It is interesting to note that maternal death from pregnancy giving live birth is almost seven times greater than medical or surgical abortion, yet few of us would discourage women from having children.

I have no intention of pretending expertise in RU486 and prostaglandin combination usage, as it has never been utilised in this country, although of course prostaglandins have been extensively utilised on their own for a number of purposes.

There seems no doubt, however, from overseas experience that in the period of pregnancy before eight weeks gestation, when suction curettage can be used without greater risk of cervical and uterine damage, RU486 is a much safer option.

We almost all agree that, if abortion is deemed necessary, earlier rather than later is preferable.

Abortifacients like RU486 are already used in this country for termination of ectopic and intra-uterine pregnancy.

Methotrexate, a drug readily available, a folate antagonist, is used in certain cancers, psoriasis and rheumatoid arthritis and is one of these drugs. However, methotrexate lacks the efficacy and safety of RU486 for intra-uterine abortion.

I have always believed, like the majority of people in this place, that freedom of choice should be a right of all, within the constraints of the law. Women undergoing legal procedures should have the opportunity to have proper assessment of the medical alternative to surgery, otherwise there would be a lingering doubt that this is more about punishment than the responsibility of ensuring the best care possible.

The best care possible is determined by the TGA, with informed consent and, I emphasise, appropriate counselling between the patient and doctor, a view supported by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Australian Medical Association, the World Health Organisation and the Public Health Association of Australia, to mention but a few.

The TGA will enable us, as politicians, to ensure that the best scrutiny is given to RU486.

It is anticipated that adequate funding by a sponsor will be offered to introduce the medication to Australia if the current ministerial requirements and impediments are lifted. Not removing these impediments is an exercise in gross negligence to a section of our constituencies.

It is time for us to minimise the trauma to women undergoing a legal procedure for an unwanted or non-viable pregnancy. This debate is about method and definitely not about abortion, so we have no need to take the place of our state or territory politicians who have already legislated on the matter of abortion. Please also remember that women would not be pregnant without at least some assistance from a male and that the trauma associated with abortion extends beyond the individual to family and friends. A very significant part of that trauma is related to the method of the procedure. This is where this debate should remain acutely focused.

Any amendments presented in an attempt to politically dilute or pervert the findings of the TGA should be vigorously rejected.

Would anyone in this House seriously believe that any CEO of a sponsor company would sanction the very significant time and money to seek approval for a drug to be TGA assessed when this parliament could reject it out of hand?

See this speech in context