Senate debates

Wednesday, 8 February 2006

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

Second Reading

6:05 pm

Photo of Judith AdamsJudith Adams (WA, Liberal Party) Share this | Hansard source

I rise this evening to speak to the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I wish to preface my remarks by stating that this bill is not a personal attack on the current minister for health or those who have gone before him. I am a member of the committee that did the inquiry and, as a midwife and someone who has worked for a very long time in rural Western Australia and also in New Zealand, I found the inquiry very interesting. I thank all those people who put forward submissions. Over my break—as it was termed; it was not really a break—from Christmas and New Year through until the end of January I did look at most of the submissions. We had over 1,000 presented to us, along with other correspondence, which was put into another category. A number of submissions were put forward that did not address the terms of reference, so they were put into a different category.

In terms of the process, as a committee we looked at the number of submissions and we were all allowed to put forward types of submissions that we would really like to hear about. There were 2,400 submissions in all, and it was a great honour for those who came to present to us, because their submissions were considered to be of such relevance and importance to such an important issue. Those supporting the bill—as I certainly am—were able to invite the people they wished to appear.

As a result of my own area of expertise, I tried to get a very practical debate. The first people I asked to appear were the administrators, including the Therapeutic Goods Administration, the Department of Health and Ageing, the Australian Medical Association and the Rural Doctors Association of Australia. The Association for Australian Rural Nurses, a number of health care people, people who work in the consultancy area and people who have been involved in research appeared later. During the whole program, some excellent people appeared on that side of the debate, as they did on the other side. I would like to put on the record that as a committee we looked very carefully at which people and organisations we asked to appear before us.

I will speak later about rural women and our rural doctors, but I would like to state now, as a woman and as a midwife, that I am absolutely appalled at the number of abortions that occur. I do not think anyone who took part in the inquiry would not be. I agree wholeheartedly with the recommendation at the end of our committee report, which Senator Barnett has just read, and I think that education is really the only way that we will be able to reduce these abortions or terminations of pregnancy.

The purpose of the bill is to move the responsibility for approval of RU486 from the Minister for Health and Ageing to the Therapeutic Goods Administration, known as the TGA. The drug RU486 belongs to a special category of drugs under the Therapeutic Goods Act 1989 known as ‘restricted goods’, which cannot be evaluated, registered, listed 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. Under the act, the minister does not have to report to the parliament the number of applications for RU486.

Restricted goods are defined under the act as:

... medicines ... intended for use in women as abortifacients.

It is important to note that medicines used for any purpose other than abortion are evaluated and regulated by the TGA without any requirement for approval from the minister. The restricted goods provisions were incorporated into the act in 1996 as a result of amendments introduced to the Therapeutic Goods Amendment Bill 1996 by Senator Brian Harradine, known as the Harradine amendments.

The Therapeutic Goods Administration does not comprise faceless and nameless bureaucrats, as has been stated by a number of individuals. That has really annoyed me because, being a health professional, I regard these people as very, very special. They are a team of highly respected experts in their fields of expertise. The TGA has to date overseen the evaluation and approval of over 50,000 therapeutic goods and therapies in Australia, making it the most experienced and qualified entity in the country to evaluate this category of drugs.

The TGA, as a member of the World Health Organisation and the World Health Organisation Collaborating Centre, has access to other countries where RU486 is being used. I know those countries have been put on the record today, so I will not read out the list of those countries. Of interest to me, as a former New Zealander, is that the TGA has a memorandum of understanding with its New Zealand counterpart, Medsafe. It was signed in 1993 and an agreement has since been signed, in 2003, for the establishment of a joint scheme for the regulation of therapeutic products. I believe the TGA and its respective advisory committees are the correct group of people to make the decision as to whether this drug is safe and to provide the relevant guidelines to ensure that Australian women and their medical practitioners have the opportunity to make an informed decision on whether they can have a medical rather than a surgical termination.

I know from listening to some of the speakers before me that there has been sceptical comment about the guidelines. I visited New Zealand in the last few weeks and would like to speak tonight about its guidelines and the way that they are organised. I know it is getting away from the bill, but our whole inquiry has gone to the issue of the termination, how it works, what is safe and what is not and all of the rest. I would like to bring forward the guidelines that are used in New Zealand to give people an understanding of how they work. New Zealand has special GPs who have been trained in termination procedures, in counselling and in how to deal with affected people. If a woman, for her own reasons, presents to her GP and says she wishes to terminate her pregnancy, under law that GP, if they have not done that training, must refer the woman to one of these specialist GPs.

Women do not go to the pharmacy and get RU486 over the counter. It is prescribed to a clinic and the medical termination must be done at a clinic. The women must have access to trained psychologists, counsellors and people like that who form part of the clinic staff as well as the specialist GPs. If the women are approved as being medically fit to undergo this termination, rather than a surgical termination, and it is their wish to have a medical termination, they are then advised and given every piece of information that they need to make the decision. They are then given the drug at the surgery or clinic and allowed to go home for two days. They have 24-hour access to that clinic and they are not allowed to go any further than four hours away from it in case of any problems. On the third day they come back to the clinic and have their misoprostol. Often, within four hours, they will abort or miscarry at the clinic. So with these guidelines the woman’s safety is absolutely paramount and there is no way that that person will be left without support.

When the process is finished, if they are fit enough and healthy, they are allowed to go home, but they must return in two weeks time. I have been told and we heard at the hearing that, women being women, they might forget to come back or they might forget to do this or that. No medical practitioner is going to allow a woman to go through this type of termination if they do not consider that they are suitable candidates for it. That is just not going to happen. I would like people to really think about that. The minister asked the Chief Medical Officer from the department to provide him with information about the drug, and there was a comment included about rural doctors. As a rural person and a midwife, as I said, I have worked everywhere—right out in remote areas. These medical professionals, especially rural doctors, have a terrific lot of knowledge and expertise. They have to do an extra two years of training before they are even allowed to have a Medicare number in a rural area. As far as having a surgical procedure to back this up, that must happen. They are not going to allow anyone to go through this without that.

There was a very good submission to the inquiry from the Broome Regional Aboriginal Medical Service. There have been many comments that Aboriginal women might not be the right people to have this drug if it were approved in Australia. These six doctors from Broome were saying that they are 3,000 kilometres from Perth and that at the present time, because of the elective surgery waiting list in Broome, Kununurra and Derby where they do elective surgery, there is no way that they can do their terminations. They may be able to but it is very difficult. It means that the woman has to go to Perth on an aircraft, stay in Perth to have her termination, if they can get her in somewhere—by herself, usually, because of the expense of an escort going with her—and then go back again. These doctors know their patients very well and they would be very happy to treat them in their own community. In the Kimberley there are about 10 different areas where they have surgical backup. As they said, one in four pregnancies miscarry. They are always dealing with miscarriages so they have to treat these people all the time.

I think rural doctors do have the expertise. I really thank the Rural Doctors Association for putting forward such a good submission to prove just where they feel they can deal with these issues. I feel, as far as our report goes, we have really done very well. There are very good arguments for and against. I recommend the report to anyone who has doubts about what is going on. I commend the bill.

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