Additional comments on
the Inquiry into the Therapeutic Goods Amendment (repeal of Ministerial
responsibility for approval of RU486) Bill 2005
Senator Judith Adams
LIB, Western Australia
Senator Lyn Allison
AD, Victoria
Senator Jan McLucas
ALP, Queensland
Senator Claire Moore
ALP, Queensland
Senator Fiona Nash
NAT, New South Wales
Senator Kerry Nettle
AG, New South Wales
Senator Ruth Webber
ALP, Western Australia
“If the Parliament wishes to stop terminations
from happening then it should legislate to stop them. If it is not prepared to
do that, it should not limit the options that women may have when they make the
terrible decision to have the pregnancy terminated.”
Ian Pettigrew.
Associate Professor of Rural Obstetrics and
Gynaecology,
Monash School of Rural Health,
MILDURA. (204)
It is our view that issues concerning the
legality, morality and desirability of abortion in Australia are outside the terms
of reference of this inquiry, being the responsibility of the various state and
territory governments to decide. Of the remaining submissions received into the
inquiry – those which address the terms of reference – opposition to the
removal of Ministerial veto can be summed up by five main arguments:
- That the drug does
not have “therapeutic value”; hence it does not come under the
jurisdiction of the TGA (eg. 93, 420, 635);
- That
the drug is unsafe, and that conflicting reports on the safety of the drug
suggest that it is better to keep the drug out of the country until
further research is done (eg. 74, 210, 1014);
- That the use of
RU486 in the termination of a pregnancy is more traumatic for the woman
than surgical abortion (eg. 11, 975, 1083);
- That
allowing the drug to be made available will lead to an increase in the
abortion rate (eg. 950, 975, 1012); and
- That
the Health Minister should be responsible for making the decision because it
encompasses more than just the safety of the drug (eg. 412, 628, 720).
That the drug does not have “therapeutic
value”, as pregnancy is not a disease; hence it does not come under the
jurisdiction of the TGA
Ms
Jill Michelson of Marie Stopes International writes (918):
“The
Therapeutic Goods Administration (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.
The
TGA is well resourced and positioned to make an evidence-based assessment based
on clinical and professional criteria as to the efficacy of, as well as any
risks pertaining to, the use of RU486.
As
a member of the World Health Organisation (WHO) Collaborating Centre the TGA
has access to counterpart bodies throughout the world, including in countries
where RU486 has been approved and is currently in use, ensuring that the TGA
has access to the most up-to-date information when making an assessment in
relation to RU486.
Australia
is well served by the TGA and the integrity and competence of their world’s
best practice standards.”
The
TGA assesses and monitors therapeutic goods that are available in Australia, to
ensure that they are of an acceptable standard. Its purpose is to ensure that
the Australian community has access to therapeutic advances. It is a highly
respected body, and as a member of the World Health Organisation (WHO)
Collaborating Centre, the TGA has access to counterpart bodies in countries
where RU486 has been assessed and approved for use.
The role of the TGA is to monitor the safety,
quality and efficacy of medicines coming into Australia; its function does not
rely on everyday usage of the word “therapeutic”. Rather, the role of the TGA
is defined by the Therapeutic Goods Act. From the TGA’s own website:
A 'therapeutic good' is
broadly defined as a good which is represented in any way to be, or is likely
to be taken to be, for therapeutic use (unless specifically excluded or
included under Section 7 of the Therapeutic Goods Act 1989).
Therapeutic use means use
in or in connection with:
- preventing,
diagnosing, curing or alleviating a disease, ailment, defect or injury;
- influencing
inhibiting or modifying a physiological process;
- testing the susceptibility
of persons to a disease or ailment;
- influencing,
controlling or preventing conception;
- testing for
pregnancy; or
- replacement or
modification of parts of the anatomy.
The TGA is responsible for assessing
the safety, quality and efficacy, and this role is not limited only to
medically essential treatments. The TGA has a role in approving such goods as
breast implants and some cosmetics, neither of which is used to prevent or
treat disease.
Furthermore, it is clear that the
decision to terminate a pregnancy is often taken for medical reasons. In the
interests of these women, it is important that they should not be denied
alternative methods of doing so, should they be deemed safe.
That the drug is unsafe, and that
conflicting reports on the safety of the drug suggest that it is better to keep
the drug out of the country until further research is done
The evidence that has been presented has
demonstrated that, while no medical procedure is without risk, the risks of
this particular drug are minimal. However, we assert that it should be the
qualified professionals at the TGA that make the final assessment.
More importantly, that the evidence that has been
provided by both sides of the argument is coming from the same sources,
suggests to us that this is in fact a question of interpreting the data and
assessing the risks – a job we are confident in leaving to health professionals
at the TGA.
It is important to acknowledge that the
Australian Medical Association (AMA) (1003), The Royal Australian and New Zealand
College of Obstetricians and Gynaecologists (RANZCOG) (401, 401a, 401b, 401c, 401d) and Rural Doctors Association of
Australia (RDAA) (911) all endorse the use of RU486 for
medical termination of pregnancy.
Further questions about the circumstances under
which RU486 may be administered should also be determined by the relevant
professionals. In recommending that the Health Minister’s veto power be removed
we do not assert that there should be any less regulation of this drug than
with any other.
Therefore, we support the move to remove the
Health Minister’s veto power, so that the safety of the drug, and
recommendations for its correct use, can be determined by those most qualified
to do so. In doing so, we do not make any claims as to the safety or otherwise
of this drug. Rather, we recognise that this is a technical question that
should remain outside the realm of politics.
That the use of RU486 in the termination
of a pregnancy is more traumatic for the woman than surgical abortion
Some submissions have argued that this method of
termination is more traumatic for the woman, while others have argued that this
is a preferable option.
From the research we have been presented with, it
seems that the choice between surgical and medical abortion is a matter of
personal preference and control. Despite the varying results of research into
the effects of abortion on the woman, there seems to be a universal recognition
of the fact that abortion is always more traumatic when it is not freely chosen
and fully informed.
For this reason alone, it is clear that, should
the TGA declare the drug safe, providing women with another option for her to
consider will be a positive move.
Furthermore, it has been argued that for women
who cannot get access to surgical abortion, and those for whom privacy and
control are primary considerations, being forced to make costly and conspicuous
visits to abortion clinics, often being accosted by protestors, is in itself a
highly traumatic experience (204, 606, 901, 911).
That allowing the drug to be made
available will lead to an increase in the abortion rate
This claim has been made in a number
of the submissions to the inquiry, however no supporting evidence has been
provided to show that this has been the case in any of the many countries where
RU486 has been made available. Evidence was presented that suggested that the
introduction of RU486 in countries such as the UK, US, Germany and Sweden, the
overall abortion rates remained stable or actually declined (402, 917, 1003).
The evidence also indicates an
increase in the number of early terminations, as medical abortions can be
performed earlier in the pregnancy than surgical abortions can. Some countries
have recorded a steady rise in the numbers of medical abortions, however this
has coincided with a decrease in the number of surgical abortions being
performed, suggesting that for many women this is the preferred option.
There is no evidence, however, to
suggest that allowing RU486 into Australia will in any way conflict with the
important policy goal of reducing the total number of terminations.
Further to this, it remains our view
that if the concern is for women’s physical and mental health, then making it
more difficult to obtain appropriate medical care is not an acceptable
response.
That the Health Minister should be
responsible for making the decision because it encompasses more than just the
safety of the drug
Questions of the legality and
availability of abortion fall to the state and territory governments. Allowing
the Federal Government to exert control over the availability of RU486 for
reasons other than safety gives is allowing it to override the laws of the
majority of states and territories, which have ruled that abortion be allowed
under certain circumstances (705, 1005).
It has been argued that the Federal
Government should not be required to “rubber stamp” the decisions made by state
and territory governments (729). However
this is not the question that we are being asked to address. Although the
current Health Minister has made it clear that he will not allow abortifacients
into the country, the Ministerial veto will continue to apply to all subsequent
Health Ministers.
There are many medications the uses
of which have social and ethical implications, for example Viagra, birth
control pills and medications involved in IVF. However, the need for
ministerial approval is limited to abortifacients, and it is our view that this
additional level of scrutiny provides the Health Minister with a level of power
that should be outside of his or her role.
Conclusion
To summarise, while there have been
plenty of reasons offered as to why RU486 should not be made available in
Australia, we remain unconvinced that the Health Minister should have the
unique power to make that decision. In order to determine the safety of the
drug, it is clear that the health of Australian women depends on appropriately
qualified professionals making such decisions based on an ongoing, careful
assessment of the evidence-based research, and therefore we recommend the Bill
be passed to allow this to take place.
Senator Judith AdamsSenator Lyn Allison
LIB, Western Australia AD, Victoria
Senator Jan McLucasSenator Claire Moore
ALP, Queensland ALP, Queensland
Senator Fiona NashSenator Kerry
Nettle
NAT, New South Wales AG, New South Wales
Senator Ruth Webber
ALP, Western Australia
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