HANSARD EXTRACT
|
Therapeutic Goods Amendment (Repeal of Ministerial
Responsibility for Approval of RU486) Bill 2005: Second
Reading |
| 15 February 2006 |
Mr HAYES
(Werriwa)
(8.50
p.m.)—I
know there are many and varied views about the issue of abortion,
and it would be unrealistic to think these views can be easily
quarantined from the considerations in the
Therapeutic Goods Amendment (Repeal of
Ministerial responsibility for approval of RU486) Bill 2005
before us today. From the outset, I should indicate that my personal
view and strongly held belief is that life begins at conception.
Whether growing up in a Catholic family or being the product of a
Catholic education has influenced my view in this regard I am not
sure, but I know I hold so deeply to that view that for me not to
admit it would amount to gross dishonesty on my part. I accept that
among my colleagues and the public there are many who hold equally
strong views, but views which are opposed to mine. I respect all
these views but, as I believe that life begins at conception and I
cannot be persuaded otherwise, I concede that there is no prospect
of reconciling these contrary views when it comes to such a critical
issue of moral belief.
I recognise that the bill before the House is not about the
illegality of abortion. I am aware that some have already raised the
issues associated with the criminal codes that apply in the various
states and territories. I believe there is little point being
pedantic on the legal position of abortion. There is broad
acceptance that abortion is both legal and indeed readily accessible
throughout
Australia. It would be wrong to say that this bill is just about
changing the approval process of a particular class of drug. This
bill is about parliament relinquishing its responsibility to
consider all matters associated with the approval of an
abortifacient, including ethical and moral issues—that is,
relinquishing the responsibility in favour of the TGA, which in
general is an unelected administrative board which is partly funded
by the pharmaceutical industry. The truth is that this debate is
about abortion and, in particular, the type and extent of access
women have to terminations. We would not be having this debate if
that were not the case.
The reason why RU486 is a restricted drug and subject to section
23AA of the Therapeutic Goods Act is that its primary intended use
is as an abortifacient. As such, for any drug of this type, there
are always going to be issues in addition to the scientific and
technical evaluations to be considered in any approval process.
Abortion will always involve questions as to when life begins;
therefore, there will always be issues of a moral, ethical and
philosophical nature to be considered. This is why the Therapeutic
Goods Amendment Bill was passed in its current form in 1996. It
provided legislative support to ensure that drugs such as RU486 were
not imported into
Australia
without the express approval of the minister for health, being a
person directly responsible to this parliament. At the time,
Senator
Harradine aptly summarised the position when he said:
People on both sides of the abortion debate agree that the
importation, trials, registration and marketing of such agents ...
should not be left in the hands of bureaucrats and science
technologists. There should be ministerial responsibility ...
The legislation established direct ministerial responsibility as a
mechanism to ensure that an issue such as the importation of an
abortifacient is subject to thorough consideration, not simply a
technical evaluation of the effectiveness of the drug to induce a
termination but also consideration of the broader range of social
policy and ethical issues.
I do not believe anything has materially changed since the passage
of the 1996 amendment that would warrant the removal of ministerial
or parliamentary responsibility in the approval of a drug of this
type. If passed, this bill would make the abortifacient drug RU486
subject to the ordinary approval processes of the Therapeutic Goods
Administration under section 25 of the Therapeutic Goods Act. The
act provides that, before any pharmaceutical drug can be marketed in
Australia, it must first be evaluated and approved by the TGA
against the criteria of quality, safety and effectiveness. The
passage of this bill would in effect remove RU486 from the class of
restricted goods which currently serves to prevent the evaluation,
registration or sale of the drug without the approval of the
minister. If the debate were simply about the technical evaluation
of a drug and a consequential approval process, clearly the TGA
would be the appropriate organisation to undertake this role. The
technical and scientific competence of the TGA is not in question.
RU486 is not a medicine or a therapeutic drug because its intended
use is not primarily for therapeutic purposes. The proposed purpose
of RU486 is to chemically induce terminations. Clearly, we are not
debating whether this drug should be made available for a
therapeutic application. We know that mifepristone has already been
used in
Australia to treat brain tumours and the drug was obtained under the
Special Access Scheme. This is a debate about whether or not the
availability of RU486 for non-therapeutic use for abortions should
appropriately remain with the minister, a person responsible to this
parliament.
It is not possible to hide from the fact that there are significant
ethical and moral issues associated with this class of drug. But
leaving that to one side for the moment, there is also a real and
genuine concern as to the longer term effects on women, both
physically and mentally, as a consequence of medicated abortions.
The Commonwealth’s Chief Medical Officer has already expressed the
view that, as a procedure, medicated abortions carry a significant
higher risk of later adverse effects. That being the case, it adds
to the argument that any assessment of a drug of this type should
not be left to a single faceted and technical approval system and
must be subject to the most rigorous of evaluations, including the
consideration of relevant social policy.
Some have argued that RU486 is simply a chemical way of doing what
can already be achieved surgically, and that this medical means of
termination provides women with a choice that will make abortion
easier for them and more readily available. In all honesty, I must
admit that, for me, ‘more’ and ‘easier’ does not necessarily mean
better. It is inescapable that a drug of this type will always
involve ethical considerations, as it raises issues beyond purely
health issues. Therefore, I believe that as a parliament we would be
abrogating our responsibilities to relegate this consideration to
the TGA.
I would like to conclude by agreeing with the views of
Senator
Neal,
expressed in the 1996 debate when she said:
These issues need to be addressed by the Executive of this
government and addressed with absolute and direct accountability and
absolute and complete transparency.
I oppose the bill.
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