THERAPEUTIC GOODS AMENDMENT (REPEAL OF
MINISTERIAL RESPONSIBILITY FOR APPROVAL OF RU486) BILL 2005
Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval
of RU486) Bill 2005 (the Bill)
is a private Senators' bill that was introduced into the Senate on 8
December 2005 by Senator Nash and also on behalf of Senators Troeth, Allison and Moore. On the
same day, 8 December 2005, the Bill was referred on the motion of Senator Troeth to the Committee for inquiry and report by
the second sitting day in 2006 (effectively 8 February 2006).
majority of the Committee (Senators Adams and Moore dissenting) agreed that a short extension to the reporting date should
be sought. Following the receipt of advice relating to Senate business
programming, the Committee subsequently agreed (Senator Fielding dissenting) that it would not formally seek
an extension from the Senate.
expresses as its purpose 'to remove the responsibility for approval of RU486
from the Minister and to provide responsibility for approval of RU486 to the
Therapeutic Goods Administration'.
achieves this purpose through the amendment of the Therapeutic Goods Act 1989 by repealing subsection 3(1) (definition
of restricted goods), section 6AA (importation of restricted goods), section
6AB (exempt goods), section 23AA (ministerial approval of evaluation,
registration or listing of exempt goods) and subsection 57(9) (delegation).
the title and stated purpose of the Bill
refer only to RU486, the provisions to be repealed by the Bill
deal with abortifacient drugs, not specifically RU486. Subsection 3 (1) of the Therapeutic Goods Act 1989 states that:
restricted goods means medicines (including progesterone
antagonists and vaccines against human chorionic gonadotrophin) intended for
use in women as abortifacients.
The Bill will
repeal this definition and remove the requirement for Ministerial approval
before restricted goods can be imported (section 6AA), evaluated, registered or
listed (section 23AA). Besides RU486 (Mifepristone) the following medicines are
currently listed as restricted goods which cannot be imported without
Ministerial approval: Alprostadil, Carboprost, Dinoprost, Dinoprostone,
Gemeprost, Misoprostol, Prostaglandins and Vaccines against human chorionic
received that medicines on the list are used in Australia
under approval. Dr Edith Weisberg
The hCG vaccine has
stopped being developed. That is what it says in the legislation—‘such as
vaccines’. The human chorionic gonadotrophin vaccine could be used as a
contraceptive but it has not proved to be effective and is no longer being
developed, so that is not relevant anymore. Gemeprost is on the market. If you
look at MIMS, Gemeprost is actually approved for use to induce labour, but it
is also approved in MIMS for use for induction of second trimester abortion.
Misoprostal is also on the market as Cytotec for the treatment of gastric
ulcers. So these drugs are not really restricted as such, and prostaglandins
are available for the induction of labour. They are not totally restricted.
acknowledged that in accordance with Senate procedures the inquiry should be
restricted to the stated purpose of the Bill,
which is to remove the responsibility for approval of RU486 from the Minister
and to provide responsibility for approval of RU486 to the Therapeutic Goods
Administration. However, the Committee was of the view that it was inevitable
that the nature of the debate on the subject would open the issue to the wider
consideration of RU486 and abortion generally.
While accepting that the debate would become wider than
the specific purpose of the Bill, in accordance with Senate procedures the
Committee processed and received as public submissions only those that were
relevant to the Bill. However, the Committee agreed to receive
and publish all correspondence it received that expressed opinions on the
general subjects of RU486 and abortion that did not refer to the Bill or were not relevant to the actual Bill that had been referred to the Committee.
The Committee received 2496 submissions and 2292
additional pieces of correspondence, a total of 4788 public contributions to
the inquiry. A listing of the individual submissions received and a statistical
breakdown of the submissions and correspondence received is at Appendix 1. The
Committee considered the Bill at public hearings on 15
December 2005, 3 and 6
February 2006. Details of the public hearings are referred
to in Appendix 2. Submissions and the Hansard transcript of evidence may be
accessed through the Committee's website at http://www.aph.gov.au/senate_ca
Complete volumes of submissions and correspondence received by the
Committee are available in CD format from the Committee secretariat.
this inquiry the Committee has been mindful that it is in circumstances where
the political parties have given their Senators a ‘free vote’ on the Bill
when it is considered by the Senate. Thus, in conducting the inquiry and in the
preparation of its report, the Committee considered that its primary role
was to gather information to assist Senators to make an informed decision on
The report has been prepared by describing the approval processes in question
and the pharmacological properties of RU486, and then providing an outline of
the issues and arguments raised in evidence by those groups and individuals
supporting the Bill and
those opposing the Bill.
has not been requested nor will it be making a judgement on the particular
drug. The single issue for the inquiry as contained in the Bill was
whether the Minister for Health or the TGA should have the responsibility for
making that judgement. As was the case with the Committee's previous inquiry
into a Bill for which Senators had been given a 'free vote', the
report does not formulate conclusions or make recommendations because the
Committee considers that should be the prerogative of individual Senators in
exercising a 'free vote'.
memorandum describes the current approval process for RU486 and the change that
is proposed by the Bill:
In 1996 amendments to
the Therapeutic Goods Act were passed that placed medications such as RU486 in
a special group of drugs known as 'restricted goods'. According to the 1996
amendments restricted goods cannot be evaluated, registered, listed or imported
without the written approval of the Minister for Health and Ageing. In
addition, any such written approval must be laid before each House of the Parliament
by the Minister within 5 sitting days of being given. RU486 is the only
medicine that is subject to the restricted goods condition.
Medicines used for any
purpose other than abortion are evaluated and regulated by the Therapeutic
Goods Administration (TGA) alone and do not require additional approval from
the Minister for Health and Ageing...
Removal of the
restricted goods provisions in the Act would mean that RU486 could be evaluated
within the same framework as applies to all other medicines.
In a recent
Research Note the Parliamentary Library explained that:
the restricted goods
provisions do not amount to a direct ban on RU486 or other abortifacients. A
sponsor seeking approval to market an abortifacient can apply through the same
process as exists for all prescription medicines in Australia—that is, an application would need to be
submitted with supporting data to demonstrate the quality, safety and
effectiveness of the drug. The key difference as a result of the restricted
goods provisions is that, in addition to the supporting data, written
ministerial approval is required before a restricted good, such as RU486, can
be evaluated by the TGA.
Dr David Graham,
National Manager of the TGA, explained to the Committee the approval process
used by the TGA for therapeutic goods, other than restricted goods.
Therapeutic goods must be entered onto the Australian Register of Therapeutic
Goods (ARTG). Goods on the ARTG are entered at different levels, depending on
the risk associated with the product. Prescription drugs, which have the
highest level of control, are evaluated on the basis of quality, safety, and
The entry and
categorisation of therapeutic goods on the ARTG is determined by the Secretary
of the Department of Health (or his or her delegate), on the basis of advice
provided by expert advisory committees within the TGA. In the case of
prescription drugs the relevant expert advisory committee is the Australian
Drug Evaluation Committee (ADEC). The expert advisory committees provide the
advice to the Secretary on the basis of an evaluation by the TGA, which in turn
is based on submissions made by the sponsor of the therapeutic good.
Secretary decides that the therapeutic good is suitable for marketing, then the
good is entered into the ARTG. The Secretary may determine that the marketing
of a therapeutic good is subject to certain conditions.
Parliamentary Library made the following conclusion in relation to the two
Removal of the
restricted goods provisions would mean that RU486 could be evaluated within the
same framework as applies to all other medicines. It is reasonable to assume
that this may provide potential sponsors of the drug with greater confidence
that an application for approval would be worth pursuing—in that the
determining factor in the process would be an evidence-based evaluation by the
TGA of the merits and risk profile of the drug.
At the same time,
removal of the restricted goods provisions would mean that the additional layer
of scrutiny (that is, the requirement for Ministerial approval and notification
of Parliament) that currently exists in relation to applications for marketing
of RU486 would no longer exist.
However, this is not
the same as saying that the process for evaluating applications for
abortifacients would become less transparent or accountable. Under current
arrangements, the Minister is simply required to notify the Parliament of a
decision to approve an application for evaluation by the TGA. Given the fact
that such a decision would not be disallowable by the Parliament, this does 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 is neither necessarily informed of these, nor does it have
the capacity for any oversight of such decisions.
arrangements mean that the Minister for Health alone decides whether
applications for evaluation of abortifacients such as RU486 can proceed through
the usual processes of the TGA. It could be argued that this situation is at
odds with the evidence-based framework generally used to assess other medicines
While it could also be
also be argued that special arrangements are necessary in the case of RU486,
given community sensitivity to the issue of abortion, it should be noted that
the current arrangements do not necessarily provide for significant
parliamentary scrutiny of applications to evaluate, register, list or import
RU486 for use in medical abortion. Rather, this power currently resides
entirely with the Minister for Health.
THE DRUG RU486
received submissions and evidence on the operation and functions of
mifepristone (the generic name for RU486). The generic and common names for the
drug are used almost interchangeably in submissions. Mifepristone, also known
by the trade name Mifeprex in the USA and
Mifegyne in Europe and New
was developed in the early 1980s by the French pharmaceutical Roussel Uclaf.
progesterone is made in large quantities during pregnancy. Progesterone
stimulates and maintains the development of the endometrium – the lining of the
uterus. Mifepristone is a synthetic anti-progesterone – it blocks the action of
progesterone in the body by occupying progesterone receptors on cells. By
blocking the action of progesterone, mifepristone causes the endometrium to
degenerate so that a pregnancy cannot be sustained.
terminations (as distinct from surgical terminations), mifepristone can be used
in conjunction with prostaglandin, a drug that stimulates uterine contractions.
The combination of mifepristone and prostaglandin is the most effective method
of termination for pregnancies of less than 7 weeks. Mifepristone
is mainly used during the first nine weeks of pregnancy, though is also
effective for second trimester termination up to 20 weeks, again in conjunction
with a prostaglandin.
Mifepristone is widely used internationally, including in the United
States, Europe and New
protocols for its use vary between countries. However, the process can briefly
be summarised as follows: a specified dose of mifepristone is administered
orally under medical supervision in a licensed facility, after which in most
cases the woman is able to return home. Two to 3 days later she returns to the
facility and prostaglandin is administered under medical supervision, usually
misoprostol, which causes the uterus to contract thereby expelling the products
of conception that consist of the tiny embryo, placental tissue, membrane and
stressed to the Committee the importance of ultrasound prior to administering
mifepristone to establish how far advanced the pregnancy is and that the
pregnancy is not ectopic.
adverse effects of RU486 include infection and septic shock, haemorrhage and
ruptured ectopic pregnancies. Other side effects include abdominal pain and
nausea. In clinical trials in the United
surgical abortion was needed after medical abortion with mifepristone and
misoprostol failed in 6-8 per cent of cases.
There have been
eleven known fatalities associated with the use of RU486 as an abortifacient.
One in France, one in Sweden, one in Canada, three in Britain, and five in the
United States. Five of these fatalities were due to septic shock following
Clostridium sordellii infection, two resulted from haemorrhage (one of which
was from a ruptured ectopic pregnancy) and one from coronary thrombosis. The
maternal mortality rate for an RU486 abortion has been estimated to be ten
times the rate for a surgical abortion carried out at the same period of
number of these fatalities needs to be viewed against Mifepristone having been
used by some twelve million women worldwide.
correspondence received by the Committee indicated considerable confusion by
many who thought that mifepristone was the 'morning after pill'. Dr Page of
the Rural Doctors Association of Australia clarified the difference between
mifepristone and the morning after pill:
The morning-after pill is
a medication that needs to be taken within 72 hours of unprotected intercourse.
So, for example, if somebody has used a condom for contraception and the condom
broke, they need to be able to purchase the medication quickly and to take it.
It is basically a dose of
medication that is very like the contraceptive pill, but you take it in a
higher dose and then repeat the dose 12 hours later...
The intent of the
morning-after pill is to change the lining of the womb so that, when the egg is
trying to implant, the uterus is not of the right hormonal nature to allow
implantation to happen and so the fertilised egg flushes out with the normal period
for that woman...
received submissions and heard evidence on non-abortifacient uses for
can be used to prevent pregnancy by inhibiting ovulation or preventing
implantation, depending on the time in a woman's menstrual cycle the drug is
well as being a means of emergency contraception, mifepristone can be used as a
regular method of contraception for women unable to use contraception
containing oestrogen. Aside from contraceptive uses, mifepristone can be used
to manage gynaecological conditions such as endometriosis and uterine fibroids.
has also been used in the treatment of breast and prostate cancer, meningiomas
(a type of brain tumour), and Cushing's Syndrome (a disorder of the adrenal
gland). There are indications that mifepristone may be useful in the management
and treatment of glaucoma, depression, HIV/AIDS and dementia.
These uses are
all investigational/unlabelled as specified in the Mifepristone Drug
Information for the United
Under the current restricted goods provisions the Minister has given approval
for the importation and use of RU486 for some of these uses. The
investigational/unlabelled status of these uses would not be affected by the
passage of the Bill.
Misoprostol use in
conjunction with mifepriston
In the United
States, Europe and New
prostaglandin most commonly used to bring about the expulsion of the fetus
following the use of RU486 in a medical abortion is misoprostol (Cytotec ®).
A spokesman for
Pfizer Australia, the
Australian distributor of Cytotec ®, has reportedly said that "We would
not recommend use outside TGA-endorsed indication and at this stage that just
involves stomach ulcers. To get any other use of the drug would involve major
clinical trials and that can take years."
Director of Searle, the previous manufacturer of Cytotec ® since acquired by
Pfizer, warned in a "Dear Health Care Provider" letter dated 23 August 2000 that
“Cytotec is not approved for the induction of labor or abortion. Serious
adverse events reported following off-label use of Cytotec in pregnant women
include maternal or fetal death; uterine hyperstimulation, rupture or
perforation requiring uterine surgical repair, hysterectomy or
salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding,
retained placenta, shock, fetal bradycardia and pelvic pain.”
Product Information states that "Congenital anomalies sometimes associated
with fetal death have been reported subsequent to the unsuccessful use of
misoprostol as an abortifacient... Several reports in the literature associate
the use of misoprostol during the first trimester of pregnancy with skull
defects, cranial nerve palsies, facial malformations, and limb defects."
Australian and New Zealand College of Obstetricians and Gynaecologists noted in
its November 2005 statement on the "Use of Misoprostol in obstetrics and
gynaecology" that "the company which markets an oral formulation of
Misoprostol (Cytotec) has not researched and does not support its use in
pregnancy, nor does it intend to do so". The RANZCOG statement also
observes that studies of Misoprostol in obstetrics and gynaecology “have not
been large enough to exclude low risks of serious adverse events".
Dr Elvis Seman gave
evidence that medical defence organisations would not indemnify doctors for the
off-label use of misoprostol.
Dr Edith Weisberg
gave evidence that a lot of drugs are used off-label with peer support:
I think off-label
prescribing is very common because the companies often do not believe that it
is worthwhile changing the indication for a drug through the TGA if a new
indication becomes apparent through research. It is very expensive for a company
to do that and they often do not think the commercial gain from it would be
adequate to make that worthwhile.
The definition of
A number of
submissions and correspondence argued, based on common dictionary definitions
of 'therapeutic', that therapeutic goods are those which remediate or prevent
an illness, and that mifepristone should not be classed as a therapeutic good,
and not be monitored or regulated by the TGA.
It needs to be
clarified that in the legislative context the relevant definition is that
contained in the Therapeutic Goods Act. Section 3 of the Act defines a
'Therapeutic good' to include goods for (or presented for) a 'therapeutic use'.
Therapeutic use is also defined in section 3 of the Act to mean use in or in
diagnosing, curing or alleviating a disease, ailment, defect or injury in
persons or animals; or
inhibiting or modifying a physiological process in persons or animals; or
(c) testing the
susceptibility of persons or animals to a disease or ailment; or
controlling or preventing conception in persons; or
(e) testing for
pregnancy in persons; or
(f) the replacement or
modification of parts of the anatomy in persons or animals.
submissions noted that this comprehensive list of 'therapeutic uses' makes no
specific reference to causing an abortion.
Factually flawed claims
Claims made in
several submissions by supporters of the Bill were
admitted to be without substance during the public hearings.
Three of these
claims originated in a pro forma submission placed on the website of
Reproductive Choice Australia. Submissions substantially utilising this
material included those from the Public Health Association (Submission 10), the
National Union of Students (Submission 1000), Women’s Health NSW (Submission
402) and the Bankstown Women’s Health
Centre (Submission 95). The misinformation in these submissions also appears on
the Public Health Association website on a page headed “USE AND SAFETY OF
RU486: THE INTERNATIONAL EVIDENCE” [at:http://www.phaa.net.au/sig/Women's_Health/useandsafetyofru486.htm]
presented by the groups mentioned above were developed in good faith based on
information and evidence represented by Reproductive Choice Australia and NARAL
Pro Choice America.
1. The adverse drug event rate for RU486 is
very low at 0.137%. In the USA, the adverse
drug event rate for mifepristone is very low – only 0.137%. This includes minor
complications such as headaches and nausea (NARAL 2004). Claritin (sold over
the counter at pharmacies as Claratyne in Australia) has an
adverse drug event rate of 12% - over 87 times higher than mifepristone (NARAL
2. In the December 1st Edition of the New
England Journal of Medicine Dr Robert Greene, a Professor of Obstetrics,
Gynaecology, and Reproductive Biology at Harvard Medical School, Boston and the
Director of Obstetrics at Massachusetts General Hospital, Boston, has argued
that the overall mortality rate associated with medical abortion is small
(1:100,000) and no different to that posed by surgical abortion.
3. The US FDA
recently reaffirmed the safety of medical abortion for American women and
authorised its continued use.
Each of these
claims is factually incorrect.
figures given for adverse drug event rates improperly compare serious adverse
events requiring hospital treatment for RU486 with all reported adverse events
for Claratyne, including minor side-effects such as dry mouth and headache. The
figure of 0.137% for adverse events rate for mifepristone is referenced by the
PHA to NARAL 2004. However, the bibliography refers to: NARAL Pro-choice
America. Mifepristone is a Safe Choice, Fact Sheet 20 December 2005. Available
at: http://www.prochoiceamerica.org (accessed Nov 2005). This Fact Sheet uses
the standard Physicians Desk reference 2003 to derive the adverse events rate
for Claratin as 12%. However, it derives the adverse events rate for
mifepristone (which it gives as 0.022%, presumably a typographical error for
0.22%) from Henderson et al. “Safety of Mifepristone Abortions in Clinical Use”
published in Contraception in October 2005 which gives a figure of 2.2 per
1,000, which is of course 0.22%, for “reportable complications requiring
inpatient or outpatient hospital treatment, most commonly heavy bleeding”.
This, of course, leads to a misleading and totally inappropriate comparison.
Comparing all reported adverse events for each drug would give a 96% rate for
RU486, based on the US Clinical trials which is 8
times higher than the12% adverse event rate for Claratyne. The claim that
Claratyne has an adverse event rate 87 times higher than Mifepristone is that
incorrect by a factor of 696.
2. Dr Michael
[not Robert] Greene in fact states in the NEJM article that the overall
mortality rate associated with medical abortion is 10 times higher than the
mortality rate for surgical abortions at 8 weeks’ gestation, the most
“The overall maternal mortality rate associated with
induced abortion in the United
approximately 1 per 100,000. That overall rate is a "blended" rate
including all the procedures performed in the United
States at all
gestational ages. The gestational-age–specific rate increases exponentially
from 0.1 per 100,000 at 8 weeks' gestation to 8.9 per 100,000 at 21 or more
weeks' gestation. Mifepristone is approved for the termination of pregnancies
at less than seven weeks' gestation. Therefore, the appropriate comparison is
with a risk of 0.1 per 100,000 for surgical abortions performed at less than
eight weeks' gestation.”
3. The US Food and Drug
Administration has in fact increased its warnings about the risks of medical
abortion, most recently on 4 November 2005, in response
to the series of deaths from RU486 abortions. As
these claims have been widely promoted and quoted it is important to record
that they have been demonstrated to be factually flawed.
SUPPORT OF THE BILL
submissions supporting the Bill
noted that in considering the Bill the
Committee was only being asked to consider whether the Minister for Health or
the TGA should have the responsibility for approval of RU486. They stressed
that the Committee was not being asked to consider whether a woman should be
able to receive medical assistance to terminate a pregnancy nor was the
Committee being asked to make a determination about the efficacy and relative
medical risks associated with RU486. It was their view that the issue in
question was essentially a question of good governance arrangements. Dr Cockburn
The Bill before the Parliament is about governance.
However it is contentious because of its relation to abortion. There is a vocal
minority who seek to reduce access to all abortions and they cloud this Bill with emotive anecdotes, and unscientific
arguments...Those in favour of the Bill believe in principles of good governance
and accountable, transparent, scientific drug evaluation in Australia.
provided a detailed outline of the governance argument:
and probity are well accepted features of good governance. When governments are
faced with decisions that require expert consideration of technical matters, it
is common practice to establish bodies that operate at arm’s length. By
selecting widely respected experts for these bodies, and by ensuring that they
use clearly articulated criteria and processes for decision-making - as well as
for the detection and handling of any conflict of interest that might arise -
these bodies can make decisions on complex matters in a manner that can
generate a high level of public confidence in the outcomes. Making the process
highly accountable – with a clear decision-trail – increases this level of
does not necessarily have the same characteristics. A minister is not
necessarily an expert on the subject matter of the portfolio. The advice
received by a minister, or the considerations used to reach a particular
decision, are not necessarily transparent. Where electoral sensitivities are
involved a minister may be tempted to, or rather expected to, take these
considerations into account. Ministerial decisions influenced in this way may
well result in different outcomes from those reached by disinterested experts
making decisions on the basis of publicly stated criteria...
The Committee needs to
consider whether the public interest in good governance is better served in
this instance by maintenance of the Ministerial discretion, or by its removal.
Removal would appear to permit a more transparent and directly accountable
process of deliberation on the medical indications and contra-indications for
the use of RU486.
submissions argued that as Australia is
a democratic, secular society and not a theocracy, public policy decisions including
medical decisions must be based on rational, scientific and independent inquiry
isolated from the potential for individuals in political power to subvert such
decisions to political and religious belief.
Abortion in Australia
While the Bill and
the inquiry are not about abortion many submissions both supporting and opposed
to the Bill made
reference to the issue. Those supporting the Bill
argued that access to an abortion is a settled issue in Australia
noting that abortion is a legal and safe procedure in all Australian States and
However, it was also noted that there are legal variations operating across
jurisdictions and this remains a concern for those performing the procedure:
It needs to be remembered
that whilst abortion is legal in all states and territories (either by common
law ruling or by statute) there are still provisions in the respective
state/territory Crimes Acts or Criminal Codes (with the exception of the ACT – the ACT is the only state which has repealed provisions from its Crimes Act)
which relate to abortion.
The existence of these
provisions, even though they and their interpretation have been clarified
either by common law ruling (Victoria, NSW and Qld) or by statute (NT, SA, WA and
Tasmania) make doctors nervous. The possibility of
being arrested and charged with performing a so-called ‘unlawful’ abortion is
still present for all doctors who perform abortions in Australia, except doctors in the ACT.
are performed in Australia
using surgical techniques. Submissions argued that because abortion is a legal
procedure in Australia,
both surgical and medical options to provide this procedure should be available
in Australia, as
they are in many countries of the world. Every drug which has an abortifacient
effect, in terms of their approval process, should be evaluated like all other
drugs are. There is no case for the continued singling out of abortifacient
drugs. As the Australasian Chapter of Sexual Health Medicine said 'It is
anomalous that current restrictions mean that surgical abortion is available
and legal, while medical abortion, while legal, is not available'.
This issue was
summarised by Professors Rogers, Ankeny and
Induced abortion is a
legal, albeit heavily regulated, procedure in Australia; the licensing of RU486 will not alter this
situation. What will change if RU486 is licensed is that Australian women and
their medical practitioners will have an increased range of options from which
to select the safest and most efficacious treatment for any particular patient.
Women's Right of Choice
submissions strongly advocated women's right of choice; firstly that all women
should have access to safe and affordable pregnancy termination services should
this be their chosen option and secondly, that women should be entitled to
choice in regard to pregnancy termination options.
The view that
women do not give sufficiently serious consideration in making these decisions
was strongly refuted. It was emphasised that women do not make such decisions
lightly and give great deliberation to reaching an informed decision – and they
certainly do not need interference from external sources. It was considered
'highly inappropriate' that 'the current legal situation means that the Health
Minister of the day has power over aspects of women’s reproductive choices'.
Women are fully human and
capable of fully moral decisions. They do not require the oversight or
supervision of Parliament (or anyone else) to ensure that they make ethically
sound decisions about mothering. It is an old ethical principle that decisions
should be made by those most directly affected by them... Women who are mothers
are the same women who have abortions. They do not require a public debate or
Parliamentary or ministerial oversight regarding their decision to mother, and
neither do they for their decision to terminate a pregnancy.
In our experience women
are very careful in the consideration of their choices with regard to a
pregnancy, and the availability of RU486/Misoprostol will not change how they
view these choices. We envisage that the same degree of counselling and
discussion would be involved in providing a woman with an RU486/Misoprostol
termination as a surgical termination, and the same legal requirements will
The RANZCOG and
the AMA expressed the opinion that if a woman has chosen to have an abortion,
she should not only have available to her accurate and appropriate information
about abortion, but she should also be provided with sufficient information to
make an informed choice about having a safe medical abortion rather than a
surgical abortion if that is her preference.
groups emphasised the need for legal terminations to be performed safely and to
the highest possible standard to ensure that women who choose this option do
not suffer unnecessary harm. RANZCOG indicated that 'there is clear evidence
that some women would prefer not to have a surgical procedure if that could be
avoided and also clear evidence that this is a safe if not safer option for
pregnancy termination up to nine weeks gestation'. The
Royal Women's Hospital also expressed a belief that:
for many women a medical
abortion, which can be performed earlier in pregnancy than surgical abortion,
would be preferable... Some women undergoing a termination of pregnancy want a
safe alternative to surgery and to avoid being anaesthetised, which can cause a
sense of a loss of control... Nevertheless, some women will continue to want
surgery, and both options should be made available. Several other studies have
shown that women value choice, have a strong preference for one or other
approach, and are more likely to be satisfied with a method they choose.
The AMA advised that its review of the present
ead us to the same position
as the [RANZCOG], that non-surgical forms of abortion based on the use of RU486
are sufficiently safe that they should be made available to Australian women
within, of course, a therapeutic relationship and with all necessary services
and support. There is no expectation that the rigorous service provision that
ensures surgical abortions are very safe would be relaxed when the medical
option is available...
fundamental role of a medical practitioner in assisting a woman reach an
informed decision was referred to in a number of submissions. Reference was
made to survey findings that the overwhelming majority of Australians support a
women’s right to choose and believe that abortion is a matter solely between a
woman and her doctor. Many
emphasised this point including WHNSW who, as the peak body representing
women's health centres throughout NSW, 'understand from the experience of our
member centres, that the best decisions regarding pregnancy termination are
those made by a woman in consultation with her medical practitioner'.
addition to the other medical groups, the RACGP also noted that 'General
practitioners are trusted members of the health care community who are well
placed to provide advice on options available to women contemplating a termination
and management of a termination, counselling, ongoing care and contraception'.
Therapeutic Goods Administration
raised a number of arguments as to why they considered that the TGA should have
responsibility for the approval of RU486 rather than the Minister for Health.
The Minister for Health
While a number
of submissions included an argument against the Minister based on the
particular beliefs of the current Minister, others argued against the position
of the Minister rather than a particular individual retaining the
responsibility. They argued that Ministerial responsibility for approving RU486
was inappropriate on a number of grounds:
The Minister for Health does not have the
capacity for or specific expertise in assessing the safety and efficacy of
Singling out abortifacients for Ministerial
approval does not improve the safety of drug regulation and prescribing in
Australia. The democratic political process requires that the government act in
the interest of the constituency it represents and should not rely on the
decision of one person, while denying the advice of a properly constituted
expert body. It is not appropriate that the availability of any drug should
rest on the decision of a single individual. This process is in conflict with
evidence based medicine;
Seeking Ministerial approval for each use of the
drug potentially breaches the confidentiality of the patient for whom its use
is sought. There are no other medical procedures or treatments for which such
an approval process is required, and as it is essential to avoid breaches of
patient confidentiality, it is not morally acceptable and potentially
discriminatory to require such approval for RU486.
The Therapeutic Goods
argument asserted by the supporters of the Bill is
that the Therapeutic Goods Administration
is the specialist statutory body in Australia
authorised to evaluate, approve and regulate therapeutic drugs in the public
interest, after a rigorous and robust assessment of scientific evidence and an
examination of the risks inherent in any drug proposed for marketing in Australia. The
TGA has been provided through legislation with all the necessary powers,
authority and resources to evaluate and assess research results regarding the
quality, safety and efficacy of a specific drug and to advise practitioners and
the community on its safe and effective use.
It was pointed
out that the TGA’s approval process is subject to clear standards of
accountability and transparency for evaluating clinical evidence. The approval
process is based on scientific evidence, and examines and evaluates the
quality, safety and effectiveness of drugs on this evidence. The TGA takes a
risk management approach to drug evaluation. Its risk assessment procedures
provide clarity and transparency of process and ensure that decisions about
access to unproven drugs are protected from vested interests, whether from
consumers with chronic or life threatening illnesses, or manufacturers mindful
of profit margins, who may seek to influence decisions on access to drugs. The
public’s interests are also protected by the TGA’s governance structure and
accountability process, which require reporting through the Minister to parliament.
the role and assessment processes of the TGA in delivering a considered
judgement about the risk/benefit profile of a drug, the question was
rhetorically posed: 'If the evidence exists to support claims that the drug is
unsafe, shouldn’t those expressing concern about risk welcome the vindication
likely to come from a proper evidence-based evaluation by the TGA?'
the TGA, an expert advisory committee, the Australian Drug Evaluation
Committee, undertakes assessments and provides independent, scientific advice
on all drugs to the TGA. ADEC is entrusted with making significant decisions
and has provided sound judgements that have served Australia
well over many years.
supporting the Bill hold
the view that Australia is
well served by the professional competence and integrity of the TGA. With an
evidence based, risk management approach to the consideration of therapeutic
goods, they consider that the TGA is the appropriate body to address the safety
and efficacy of all drugs to be used in Australia. The
supporters argue that the TGA should be the approving body for ALL medicines
and medical devices. There is no reason to exclude one group of therapeutic
agents from the Act by having a separate process for the drug RU486.
SH&FPA believes that
ADEC’s advice constitutes an appropriate, objective, apolitical conclusion
based on the efficacy, quality and safety of a drug and its suitability for use
by Australians. That this expert body is not trusted to provide adequate advice
on this matter seems to refute the whole proposition of evidence based
scientific scrutiny in the provision of appropriate drug supply to the
SH&FPA believes that ADEC’s advice constitutes an
appropriate, objective, apolitical conclusion based on the efficacy, quality
and safety of a drug and its suitability for use by Australians. That this
expert body is not trusted to provide adequate advice on this matter seems to
refute the whole proposition of evidence based scientific scrutiny in the provision
of appropriate drug supply to the Australian community.
Istar Ltd, the
company formed specifically to import mifepristone into New
provided information about the use of the drug in New
including the approval process and tightly restricted distribution and access
arrangements, operation of protocols for early medical abortion and the
oversight of abortion procedures by an Abortion Supervisory Committee. Istar
In New Zealand mifepristone has been assessed and its use
monitored by Medsafe, the New Zealand equivalent of the TGA. The drug has been
satisfactorily regulated using the same procedures and controls that are
available for other prescription medicines.
The 1996 amendments to
the Act and their impact
that the 1996 amendments to the Therapeutic Goods Act created a significant
inconsistency in the administration established under the Act for the
evaluation, approval and regulation of therapeutic goods. They imposed an
exception to the agreed standards and criteria for assessing drugs for use in Australia
thereby undermining the integrity of the system established by the TGA to
protect and promote public health through safe and effective use of high
quality, therapeutic drugs in Australia.
By reducing the
powers of the TGA and shifting the absolute power over access to these drugs,
the amendments to the Act meant that the safety and efficacy of these drugs
could not even be evaluated without the Minister's written approval. The Act
does not require the Minister to seek advice, give any reasons or follow any
protocol, when making a decision regarding an application relating to these
drugs. Dr Cockburn
No other drugs have this
layer of ministerial micromanagement. Every other drug is evaluated solely on
its scientific merits by the TGA, free from ministerial interference, using
accountable methods to assess its safety and efficacy.
submissions noted that there were wider medical implications because the Act
has effectively banned the entry of RU486 into Australia not only for use as an
abortifacient but also for the number of other possible uses such as an
emergency contraceptive, in the treatment of some breast and brain tumours, and
as treatment for endometriosis and irregular bleeding.
Others put the impact of effectively banning RU486 in stronger terms:
It is unconscionable to
indicate (by effectively banning the scientific examination of a therapeutic
agent in Australia) that Australia’s scientific and medical community are not capable
or responsible enough to use a drug appropriately. There is no evidence to believe
that Australian doctors would act in an irresponsible manner with this, or any other
Professor David Healy,
Chairman of the Monash University Department of Obstetrics and Gynaecology,
described his decades of experience in the medical use of Mifepristone
including studies commenced in 1988 and 1994 in conjunction with the World
Health Organisation. Professor Healy
Therefore, before the 1996
amendment to the Therapeutic Goods Act, it seems that Mifepristone had already
been approved twice by the Australian Government, including on one occasion by
It therefore is
bewildering to me, that medication such as RU486 and other restricted goods
cannot be evaluated, registered, listed or imported without the written
approval of the Minister for Health and Ageing in 2006.
The 1996 amendment has
damaged the health of Australian women by creating a climate of reproductive
hostility. This has resulted in a lack of interest by pharmaceutical companies
in applying for sponsorship and registration of such medicines in Australia. 
RU486 and International
evidence and approval
Approval and use as a
safe and effective drug
supporting the Bill,
while recognising that no medication or medical procedure is risk-free,
referred to the substantial body of literature establishing the safety and
efficacy of RU486 when used in conjunction with a prostaglandin (usually
misoprostol) to induce early abortion. With the evidence reporting extremely
low levels of adverse incidents, the health risks associated with RU486 are
considered to fall within acceptable limits, which has enabled an extensive
list of prestigious Australian, International and World Health Bodies to
formally support RU486 including:
The World Health Organisation
The Royal Australian New Zealand College of
Obstetricians and Gynaecologists
The Australian Medical Association
The Rural Doctors Association of Australia
The Public Health Association of Australia
The Royal College of Obstetricians and
American College of Obstetricians and
The American Medical Association
American Association for Advancement of Science
US Federal Drug Administration
Federation of International Gynaecology and
It was argued
that the safety of RU486 could be demonstrated by the 35 countries that had
approved the use of the drug as an alternative to surgical abortion most
commonly in the first 49 days of pregnancy. These countries include the UK, USA,
many in Europe and Scandinavia, India, South
There have been an estimated 500 000 early medical terminations in North
America since the drug was approved as an abortifacient in 2000 and over one
million in Europe.
noted, submissions recognised that no intervention is without risk and drugs do
have side effects. It
is important to determine that associated health risks fall within acceptable
limits. RANZCOG argued that 'as surgical termination is accepted as a safe
procedure, it is pertinent to compare the side effects and maternal mortality
of medical termination with surgical termination'. The College noted that there
had been few randomised trials comparing early medical and surgical termination
but the data they presented was a compilation of the best available evidence.
Serious complications are rare and occur in
approximately 4/1 000 procedures with either method. Mortality and serious
morbidity occurs less frequently than if a pregnancy went to term;
Maternal mortality rates relating to surgical
termination in Australia and North America are of the order of
0.3-0.8/100 000 and most recent data indicates the commonest cause was
related to anaesthesia;
Serious complications with medical terminations
are rare with overall rates due to haemorrhage infection of 2.7-3.0/100 and
2.0/100 requiring surgical evacuation of retained tissue.
The risk of
death from any cause associated with attempting to carry a pregnancy to term is
8 to 10 times the risk of death from a termination. Pregnancy related deaths in Australia
still occur at the rate of 8.2 per 100 000 confinements.
of Reproductive Health Professionals stated that:
From 1993 to 2000, the
U.S. Food and Drug Administration received over 4,000 adverse event reports,
including 55 reports of death, involving loratadine [sold over the counter at
pharmacies in Australia as Claratyne] a drug which recently gained
over-the-counter status. Among users of sildenafil [Viagra], there have been
approximately five deaths for every 100,000 prescriptions provided. According
to the manufacturer, Pfizer, more than 23 million men worldwide have been
prescribed the erectile dysfunction medication Viagra and more than 1 billion
prescriptions have been written.
A number of
submissions commented upon the recent deaths in the USA
associated with the use of RU486. The women had died from infection of the
uterus by clostridium sordellii. Dr Christian Fiala,
FIAPAC, commented that:
As tragic as these cases
are, one has to see them in perspective. Nothing of this kind has been reported
in Europe in the last 15 years and more than 1.5
million women being treated. And it is safe to assume that tragic cases like
these ones would have been reported, given the high public awareness on this
sordellii infections have also occurred following childbirth (vaginal delivery
and caesarean section) and pelvic and abdominal surgery. All such cases have
been fatal. Additionally, this infection is not restricted to women of
reproductive age. Other known cases of Clostridium sordellii have occurred in
males and females of varying ages and under non-obstetric conditions, including
umbilical infection, deep skin infection, tendon transplant surgery,
orthopaedic surgery and following motor vehicle accidents. No causal link has
been established between the US
deaths and infection and the use of RU486.
While the FDA has clarified its warnings on the use of RU486, the FDA has not
withdrawn RU486 from sale in the US and
it continues to be available for use for medical abortions.
about death rates in the US for
surgical abortion in the first 8 weeks and the death rate from infection
associated with RU486 contained in a recent review article by Dr Michael Greene and
an accompanying editorial in the New England Journal of Medicine was referred
to in many submissions. The editorial noted that in either case these are
extremely rare events and do not justify banning the drug. The author goes on
to warn about overreacting to scant data, although he recognises that this is
difficult in relation to any discussion that touches on abortion.
As tragic as the deaths
of these young, healthy women are, they remain a small number of rare events
without a clear pathophysiologic link to the method of termination. Patients
should be informed of this risk before they consent to the procedure and should
be vigilant for symptoms after the procedure. Providers must be aware of this
potential complication and not be reassured by the absence of fever. Regulators
should keep this rare complication in perspective and not overreact to scant
data by prematurely foreclosing the only approved medical option for pregnancy
termination. It may be difficult, however, to maintain equipoise on this issue
in the wake of recent perceived regulatory lapses and amid the turbulence
created by any discussion about abortion.
Parliamentary Library Research Note made the following comment in relation to
the debate over the efficacy and possible side-effects of RU486:
Broadly, this Note
suggests that there has been very little dispute in the current debate over the
substantive ‘clinical facts’ of RU486 (such as its efficacy and possible
side-effects). Rather, much of the debate has involved alternative
characterisations of the risk associated with this form of medical abortion.
This suggests that one of the key questions in the debate over RU486 is about
who is the appropriate authority to evaluate the risk associated with this
medicine and determine its appropriateness for authorised use in Australia.
Mental health issues
raised by the Christchurch Health and Development Study
Dr Robyn Seth-Purdie
referred to the Christchurch
study on abortion and subsequent mental health problems published in January
2006 and commented on what relevance the CHDS study had for the Committee's
consideration of the Bill.
The study was also referred to by some opposing the Bill. Dr Seth-Purdie, who
had been provided with analysis of the CHDS data during the course of the
study, submitted that it is important to appreciate the limitations on the
study published and to be aware that the paper published by CHDS on its web
site is careful to make the following points:
First, the study did not
collect the data that would permit comparison of the personal circumstances or
the attitudes towards their own pregnancy of the two groups of young women who
were identified as having been pregnant... [Factors that] might be expected to
have some impact on decisions about pregnancy, and on subsequent mental health...
Second, based on whole
population figures, the incidence of terminations reported in the study group
was too low – only 80% of the expected level. Given that the group that
reported never having been pregnant exhibited much lower rates of mental
illness than both pregnant groups, under-reporting could have had a significant
impact on the results...
Thus, the elevated risk
associated with pregnancy termination reported by the CHDS cannot be unequivocally
attributed to the termination. However, the paper certainly highlights the need
for further study in this area. It also indicates the need to ensure adequate
support for young women who become pregnant, regardless of whether they decide
to proceed with or to terminate their pregnancy.
Availability of RU486
should it be approved
A number of
submissions responded to comments that should RU486 be approved the drug would
become easily available and its use uncontrollable. Dr Cockburn
reflected many expressed views when she wrote:
Maybe you are concerned
that passing this Bill will automatically make abortifacients
available to the general public. This is not the case. The drugs still need to
be fully evaluated by the TGA whose experts who will employ the same
accountable criteria and protocols that all other medications in this country
are put through. Only then, if these drugs pass the tests; and, after
appropriate clinical protocols and restrictions are put in place would they be
licensed for prescription use by Medical Practitioners in appropriate clinical
and legal circumstances. It is inconceivable that there would be any intention
of over the counter or unrestricted supply of these drugs. RU486 is NOT
Postinor (commonly called the Morning After Pill.).
correspondence received by the Committee indicated considerable confusion by
many who thought that RU486 was the 'morning after pill'.
No evidence that
abortion rates would increase
Concern at the
number of abortions performed every year in Australia was
expressed in many submissions supporting the Bill.
However, they argued that there is no evidence to support the contention that
making RU486 available will result in an increase in the number of women
seeking an abortion, nor will it have a significant impact on the number of
abortions performed. Rather, it was anticipated that the availability of RU486
would provide women and the medical profession with an additional choice in the
method of termination resulting in medical abortions replacing a proportion of
the surgical abortions currently undertaken.
noted that medical abortion, like surgical, would require appropriate medical
supervision and women in most States will still need to persuade a medical
practitioner that their abortion is 'necessary' for them to comply with
relevant State criminal codes regulating the procedure.
cited overseas experience and studies which had demonstrated that the
availability of medical abortion does not increase the overall number of
abortions that take place. Reference was made to the introduction of RU486 in
the UK, USA, Germany and Sweden
where the proportion of abortions performed using this method steadily
increased while the overall abortion rates remained stable or actually declined.
Istar Ltd provided New Zealand statistics which indicated that 'since the
introduction of medical abortion there has not been an increase in the number
of abortions, in fact in 2004 there was a small decrease for the first time in
by opponents of the Bill
portrayed a possible situation where a patient could be left on their own while
undertaking a medical termination procedure. This was countered by the
supporters who argued that, with the introduction of RU486, women undertaking a
medical termination will still require appropriate medical supervision as is
currently required with a surgical termination. Furthermore, in order to comply
with relevant State laws regulating the procedure, many women will still need
to explain to a medical practitioner why a pregnancy termination is 'necessary'
in their situation, and must still receive detailed information regarding the
procedure and its associated risks in order to provide informed consent.
practitioners emphasised that they have the expertise and would be involved
with all stages of the medical procedure. The RACGP noted that if a woman
chooses a medical termination, this service should be provided in accordance
with evidence based guidelines and protocols when the risk to the woman is
small. Many women internationally have chosen medical terminations, especially
those who want to avoid anaesthetics or surgery. The RACGP expressed confidence
that Australian general practitioners have adequate training and capacity to
care for patients, including support for women who choose a medical termination
if this becomes available in the future.
noted that gynaecologists are suitably trained to supervise medical abortion
and to recognise and manage any complications. Care may be delivered in
partnership with midwives, counsellors and General Practitioners according to
appropriate protocols. Protocols would be established regarding all of the
steps required for medical abortion.
argued that as with many other medical procedures, protocols can be developed
to ensure that women have access to medical care, according to the level of
risk, following administration of the drugs. RANZCOG advised that a doctor must
be trained to undertake a surgical termination safely and, for mifepristone to
be used safely, training and education of practitioners and the development of
best practise guidelines is essential. RWH indicated that it would establish
protocols and train relevant staff to make this treatment available to women,
as appropriate. Approaches to counselling and decision-making about abortion
would not change. Clinical practice, information and support would be informed
by international evidence about best practice.
was made to international guidelines and protocols that are already operative,
for example New
developed comprehensive guidelines for the use of mifepristone for medical
Both RANZCOG and the British Royal College of Obstetricians and Gynaecologists have
developed position papers for the use of RU486, the latter being evidence-based
as they have access to the drug.
the medical representatives, women's hospitals and groups indicated that they
would wish to be involved in the development of Australian guidelines and
the Women’s Clinic and Family General Practice on Richmond
currently offer a range of family planning and other medical services
including, termination of pregnancy stressed that:
If the drug was to be
introduced there are issues to be addressed around the training and experience
of the practitioners prescribing and monitoring it. For instance it is
imperative, when performing a surgical TOP, that the possibility of an ectopic
pregnancy be considered and excluded in the course of management. Ectopic
pregnancy is a life-threatening emergency and is a significant cause of
maternal deaths if undiagnosed and not treated. Experience in the diagnosis and
management of ectopic pregnancy is thus essential and protocols for the use of
RU486 must have interruption of the pregnancy and exclusion of an ectopic
pregnancy as an assured end point.
submissions were received representing views from regional, rural and remote
areas of Australia.
The argument common to these submissions was summarised by a group of doctors
working in Broome, WA:
As doctors practising
in a remote part of Australia, we regularly witness the disadvantage of
rural and remote women in accessing early and safe termination of pregnancy
compared with their urban peers.
disadvantage described in submissions covered issues such as lack of choice in
accessing services, difficulties imposed by distance travel, transport and
accommodation costs away from home, and loss of family support and other
assistance. The submissions argued that the limited access to timely legal
termination services in rural and remote Australia
could be safely addressed by supporting access to RU486 used under appropriate
medical supervision. The RDAA noted:
abortion is unavailable in many rural and remote areas. Women who have to
travel to larger centres for this service may lose both the personal emotional
support and the continuity of medical care they would have in their own
community. It could be argued that medical termination under the supervision of
their local doctor would be the safer alternative for many of them and they
should have the right to this option.
Association for Australian Rural Nurses noted that nurses and midwives are the
major group of health professionals outside metropolitan cities providing
health care to rural and remote women. The AARN asserted that:
The availability of a
range of reproductive choices is especially important for rural and remote
women. Time delays in gaining a safe abortion can have a dramatic impact on
rural women’s health and wellbeing. The medical complications of a delayed
termination of pregnancy are the direct result of a dearth of services being
available in rural and remote areas. The long distances women need to travel
must be taken into consideration when making decisions about women’s
In supporting the
amendment it is anticipated that rural and remote women will cease to be
disadvantaged in relation to available, accessible, appropriate and affordable
submissions took strong exception to the argument that the use of RU486 in
rural areas would place women at significant risk because the argument
disregards the fact that the drug would always be administered under medical
supervision. The RDAA stated that:
The concern that this supervision
may not be available to women in rural Australia is unfounded. Doctors in rural and remote Australia are keenly aware of their duty to ensure that
their patients are provided with the safest treatment options possible. They
have the advanced skills needed to manage complex conditions and to deal with
medical emergencies without the support systems available to their urban
colleagues. They know the range of treatment they and their nearest hospital
can provide, and they are used to assessing which treatment options are safest
for their patients in a wide range of conditions.
The argument was also seen to contain inferences about
medical capability with one submission asserting that 'these arguments, in
essence, are an attack on the integrity of the rural and remote medical
workforce'. The RDAA emphasised that rural doctors have
the expertise and experience to offer women who decide on the termination of a
pregnancy the option of safe medical abortion under their supervision. The
Association also noted that the specialist obstetricians and generalist and
procedural GPs who provide reproductive care are required to maintain and
enhance their skills by Continuing Professional Development through courses
such as those offered by the Australian College of Rural and Remote Medicine.
further noted that many rural areas have small hospitals equipped to deal with
pregnancy and spontaneous abortion and these hospitals could also provide back
up for women needing assistance with medical abortions.
A number of
submissions gave detailed examples of the issues faced within rural and remote
communities in a number of States. These are described below:
In Far North Queensland – surgical abortion is available only in Cairns, where a small number are done in the public
system, and the remainder in a private clinic. Women from Cape York or the Atherton Tablelands need to travel
vast distances to access the service and are required to pay $750 up front for
a surgical abortion. However excellent hospital facilities for the care of women
suffering spontaneous miscarriage or other complications of pregnancy,
including the availability of ultrasound, exist in all the small towns
throughout the region, including Atherton, Mareeba, Innisfail, Mossman,
Cooktown, Weipa and Thursday Island, and hence the necessary back-up for the
small number of women needing medical intervention in medical abortion could
potentially be provided in all these places.
TGA approval of RU486 is
an important issue in Queensland because there’s very limited access to
surgical termination for regional women. Provision of RU486 would provide a way
for medical abortions to be provided without the great disruption to women’s
lives and the cost of having to travel to centres such as Brisbane, Rockhampton, Townsville and Caboolture
where surgical termination services are available. The latest abortion figures
released by the Australian Institute of Health and Welfare showed that Queensland women are more likely to travel interstate
for an abortion than women in other states... These figures highlight the
geographical disadvantage thousands of Queensland women face when obtaining abortions... It is
clear from the statistics provided by the Australian Institute of Health and
Welfare that women living in regional Queensland are seeking termination services but are
disadvantaged in terms of time and cost by issues of distance.
Of particular significance
to Tasmania is the history of irregularity of access to
and provision of surgical abortion in our state. For decades, Tasmanian women
seeking to terminate an unwanted pregnancy have been subjected to the whim of
public hospitals and individual surgeons as to whether they can access this
procedure or not. Similarly, there has
been very limited access to private services, which are often prohibitively
expensive or inaccessible from outside of the capital. As a consequence,
hundreds of women over this time have had to travel to mainland cities to
access this service, resulting in significant expense, time away from work or
families, lack of support at the time of the procedure, a delay in accessing
the procedure and lack of aftercare in the weeks following... Having access to a
medical alternative to surgical abortion, such as RU486 would eliminate this
disadvantage, by allowing women to access this service via a general
practitioner in their local area.
VCOSS members in regional
Victoria have reported that women living in regional
and rural areas face restricted access to abortion services due to limited
service providers, the financial cost of seeing a private practitioner, the
lack of public transport, and the lack of privacy that can exist in smaller
communities. Many women in regional and rural Victoria must currently travel to access safe
termination services, which generally entails two to three days away from their
family, friends and work – from their support networks... Access to RU486, or a
medical abortion, would significantly assist in removing these barriers for
women, as well as enabling them to access their support networks.
requesting a termination of pregnancy in the Kimberley are often required to wait several weeks for
the procedure to be performed locally or when unable to be accommodated on our
limited surgical lists, required to travel up to 3000 km to Perth... Obviously, the decision to terminate an
early pregnancy is a difficult and emotional one for most women. Despite this
many women are having to endure this procedure alone, far from home and
supports and liable for extra financial expenses.
Working to reduce
Many groups and individuals supporting the Bill acknowledged the high rate of abortion and
urged the implementation or enhancement of a range of programs and services
aimed at reducing unwanted pregnancies. These included putting more resources
into improved sex education with expanded programs for better education of boys
and girls on responsible human relationships, wider availability of information
about and access to contraception and other fertility control techniques, and
appropriate counselling. The AMA and National Foundation for Australian Women
summed up the views expressed by many:
The AMA supports actions
the government is proposing and should consider to take others to reduce the
demand for abortions, such as better sex education in primary and secondary schools, improving access to
effective modern contraception and emergency contraception on the PBS, making
the work environment more conducive to having children by increasing the
availability of child care and making it more affordable by allowing childcare
costs to be claimed as an expense and therefore paid pre-tax and mandating 6
months paid maternity leave and a whole raft of other supports that are not
relevant to this inquiry.
[NFAW called upon the
Commonwealth to] develop and provide funds, in consultation with the
governments of States and Territories, health professionals, education
professionals and representatives of women’s organisations, for a national
program of sexual health education which includes relationships counselling,
ready affordable access to appropriate means of contraception including
emergency contraception, an appropriate range of independent professional
counselling for girls and women considering termination of a pregnancy,
counselling after a termination, and counselling for relinquishing mothers.
TO THE BILL
Effect of the Bill
broader than stated purpose
the Bill argued that the very purpose of the drug RU486 meant that the debate
over the Bill could not only be restricted to the question of who should have
responsibility for making a decision concerning the drug's approval, it must
also be viewed in the context of a much broader community debate over abortion.
The last few years have seen community disquiet grow over abortion and RU486
cannot be viewed in isolation from this. The argument was summed up by the
Queensland Bioethics Centre:
It is well nigh
impossible to comment upon this Bill without raising the question of abortion.
After all the legislation as it stands is
primarily concerned with RU486 as an abortifacient. The use of RU486 for other
genuine medical purposes is, all things being equal, not problematic. A
particular feature of RU486 is that it can be used for a non-therapeutic
purpose, namely the ending of a new human life.
Federation of Right to Life Associations contend that the Bill has a much
broader legal effect than the short title and purpose clause would suggest by
stating that the Bill's only effect would be to remove Ministerial
responsibility for approval of RU486. The Bill
proposes to repeal section 6AA of the Act that deals with the importation of
restricted goods and repeal the definition of restricted goods in subsection
3(1) which currently states 'restricted goods means medicines (including
progesterone antagonists and vaccines against human chorionic gonadotrophin)
intended for use in women as abortifacients'. AFRTLA argued that the repeals
mean that if the amendment Bill is passed, it would remove from Ministerial
responsibility approval of the importation of all abortifacient drugs/vaccines,
not only of RU486, and therefore the short title and purpose clause were
RU486 is unique
spoke with a single voice that RU486 is not like any other drug. They argued
that because the drug is designed to end the life of a human being, it thereby
makes this drug a matter of unique public concern demanding a unique level of
public scrutiny and accountability. The nature of this drug and its intended
use has profound social and ethical significance. For this reason the Catholic
Archdiocese of Sydney and others argued that:
The 1996 amendments to
the [TGA Act] placed substances such as RU486 in a special group of drugs known
as ‘restricted goods’ on grounds that they are drugs which are intended for use
in women as abortifacients. This is an appropriate designation for
abortifacient drugs. A substance is ‘therapeutic’ if it relates to the
treatment or curing of disease. Abortifacients, however, are not administered
to women with the intention of treating or curing a disease. Abortifacients are
administered with the intention of ending the life of a human embryo or foetus...
As abortifacients are not genuine ‘therapeutic goods’, drugs intended for use
in women as abortifacients should continue to be regarded as ‘restricted
developed a further argument beyond specifically referring to the purpose of
combination of RU486 with [prostaglandin] is one reason why RU486 is not like
any other drug and cannot simply be assessed (eg by the TGA) on its quality,
safety and efficiency. RU486 does not
work on its own, it needs the prostaglandin component.
limitations and the moral dilemma
drew attention to the legislative requirement that in evaluating an application
for registration and listing of a therapeutic good the Therapeutic Goods Administration is bound to consider 'whether the
quality, safety and efficacy of the goods for the purposes for which they are
to be used have been satisfactorily established'. There is no legislative
authority or other requirement for the TGA to consider or assess the deeper
social and ethical issues related to a therapeutic good. The TGA is quite
simply not equipped nor intended to deal with the morality of any drug and its
resultant action. It is these issues that for opponents of the Bill are at the heart of concerns about RU486 and
extensive, and costly, research that would be required in assessing RU486 in
association with the prostaglandin by or on behalf of the TGA was also
It is clear that drugs are assessed only based on their quality,
safety and effectiveness. Interactions of two drugs - Mifepristone and
Misoprostol - let alone the myriad of regimens, complications, contradictions,
multiple sites of actions, as well as social and ethical components of chemical
abortion would be a considerable challenge for the TGA. Of course, long-term
research studies, originated in Australia
- clinical trials as well as laboratory studies - could be requested by the
TGA. However the problem arises as to who would fund the extensive work that is
required. The TGA could not fund it
because since 1998-99 the Australian Government has required the TGA to operate
on a full cost-recovery basis.
concern raised in many submissions was that the Bill proposes to shift responsibility to an
unelected, and therefore unaccountable, group of anonymous bureaucrats and
scientists in the TGA who have no statutory role to deal with complex social
and ethical matters.
There is no reason to doubt that the TGA has sufficient medical
knowledge and expertise to conduct the evaluation of RU486 and other
abortifacients for quality, safety and efficacy.
However, drugs such as RU486 do not only carry the usual medical
risks associated with standard ‘therapeutic goods’. Because they are designed
to end very young human lives, allowing or disallowing access to abortifacients
has serious social implications. The TGA does not have the knowledge, expertise
or the mandate, to make a judgment about the ethical and social impact of
abortifacient drugs. Judgments and decisions about ‘restricted goods’ call for
an additional level of scrutiny and accountability by elected community
Concerns at TGA research and public safety
many submissions recognised the experience and good standing of the TGA, others
raised concerns relating to its approval processes and research performance,
noting that the robustness of its processes had been questioned in recent times.
TGA approval process is most often based upon research developed
by the drug companies. aa RU486 shares the view of prominent bioethicists, like
that RU486 research to date has been less than adequate in its controls and its
Federation of Right to Life Associations referred to problems which have
featured in a series of audits of the TGA conducted by the Australian National
Audit Office in the last decade into the efficiency, effectiveness and
accountability of the TGA’s performance in evaluating and approving
prescription and non-prescription drugs for public use. The Federation argued
that 'the outcomes of these audits do reveal the need for substantial
improvement in TGA processes for the sake of public safety'.
Minister should retain responsibility
opposing the Bill argued that the serious social and ethical issues which
surround abortion and the use of abortifacients, which make them unsuitable for
evaluation within the same TGA framework as therapeutic goods, require that the
Minister for Health and Ageing should retain ultimate responsibility for
decisions in relation to the importation, trial, registration and listing of
RU486 and other abortifacients in order to ensure that regulation is via the appropriate
scrutiny and accountability of elected community representatives. The
Australian Catholic Bishops Conference referred to the social policy issues:
Abortion is a sensitive and complex community issue. It is not
appropriate for any consideration of abortion to be merely about the
technicalities or the efficiency of different methods of abortion. It is for
that reason that it is not appropriate for the TGA to be the sole body to
consider an abortifacient such as RU486. The social policy aspects of such a
product must be taken into account.
Currently, consideration of the social policy implications of
RU486 is undertaken by the relevant Minister. There is no reason for that
arrangement to change.
of submissions also quoted Senator Christabel Chamarette during the debate on the 1996 amendments to the Act:
There is not only a health issue in the narrow sense – that is,
whether the drug is safe – but also a question of whether the availability
should be limited for ethical or policy reasons in the context of social
policy. This debate is yet to be heard...I affirm the right of this parliament to
have scrutiny over such issues.
Responsibility should be broadened to involve
cabinet and/or Parliament
submissions noted that concerns had been expressed about a particular Minister
having responsibility for making the policy decision on RU486 and proposed that
the matter could become one for Cabinet rather than the individual Minister for
Health. This would ensure that the
decision remained in the hands of elected politicians accountable through the
ballot box. Others, such as the CWLA who concluded that 'this awesome
responsibility rightly belongs to the Minister for Health, the Parliament and
the people', broadened the options
for responsibility to include Parliament:
There are alternative methods by which parliamentary scrutiny
for approval of abortifacient drugs could be achieved that might ensure more
objective, considered debate... [including] approval by a panel of Ministers
holding relevant portfolios; approval by Cabinet; approval given in a
disallowable instrument. The Association submits that the essential principle
is to retain parliamentary accountability for approval of this particular class
A Committee of Experts
Renate Klein proposed the establishment of a Committee of Experts consisting of
informed community members including social and natural scientists, doctors,
pharmacists and ethicists whose research should go beyond aspects of quality,
safety and effectiveness of these restricted goods and investigate their
complex interactions with Australian women’s lives. The Committee of Experts
would have an important role in aiding the Minister for Health in her/his
deliberations. Even if the Bill is
passed Dr Klein suggested that such an independent Committee of Experts should
nevertheless be established immediately, and, parallel to the TGA, conduct its
own broader investigation into the question of the availability of RU486 as an
abortifacient in Australia. Dr Klein explained:
I make this suggestion...because the brief of the TGA does not
enable it to fully canvass the range of social and ethical issues emanating
from RU486 abortions. Further, as the TGA is financed on a full cost-recovery
basis, it is unreasonable to believe that it has the capacity – and indeed the
RU486 licensee who is applying for registration would be willing to pay for it
– to perform an in depth inquiry into all aspects of chemical abortion.
I suggest that in fact independent of whether the Bill is rejected
or accepted, such a multidisciplinary Committee of Experts may be essential to
alleviate community concerns about either the wisdom of an individual’s (the
Minister for Health) decision, or the narrowness of the TGA’s investigation
that assesses RU486 as if it were a drug like any other.
Abortion in Australia
earlier opponents of the Bill
argued that it is impossible to comment upon this Bill without raising the question of abortion.
Abortion remains an issue of grave moral and social significance and is still
governed by legal constraints in all Australian jurisdictions with the
exception of the ACT. In three States at least abortion remains a criminal
offence and is 'legal' only under the conditions set forth by the decisions of
a few individual judges in what have become landmark, but untested, judgments.
emphasised that although abortion is widely practised in Australia, it is a mistake to think that Australians
favour abortion on demand and argued that passage of the Bill would send conflicting messages about the
It is one thing for legislators to accept the legal status quo
on abortion, but it is another thing altogether to ignore the fact that
Australians are deeply conflicted about the status quo, with fewer than one in
four people believing that abortion is morally justified outside of certain ‘hard cases’ involving disability or a danger to the mother’s health, and only
15% believing that abortion is morally acceptable when the foetus is healthy
and there is no abnormal risk to the mother. To legislate for the removal of
the current special status of RU486 as a drug requiring ministerial approval
sends the message that our federal representatives are intent on consolidating
and strengthening abortion practices despite the views of the community.
Rather than basing a decision on the fact that surgical abortion
is currently available, any decision should reflect the reality that abortion
itself is of great moral concern to the Australian public.
Safety of RU486
Can be pro-choice and anti-RU486
of submissions highlighted that those who oppose changing the current approval
process surrounding RU486 can be pro-life and pro-choice. Dr Klein who is in full support of a woman's right to have access to safe and
legal abortion argued strongly against the introduction of RU486. Australians Against RU486 said that
it is erroneous to simply label all those who may oppose RU486 as
This submission confirms that you can be pro-choice and anti
RU486, a feminist and anti RU486, pro-life and anti RU486. These are not
Their reasons are varied but their focus is singular.
The broad coalition of individuals and organisations within aaRU486
have differing views: some believe that abortion is wrong; while others view
abortion as a viable option but worry about the signals a pill promoted by its
advocates as a ‘simple solution’ sends; still others believe that the RU486
debate isn’t about a woman’s right to choose but rather that it’s about women’s
Complications arising from RU486 procedure
of safety were argued in many submissions by referring to the complications
that can arise from undertaking an abortion using a procedure involving RU486
and prostaglandin. Some submissions referred to this as chemical abortion
rather than medical abortion. The procedure, as described earlier in the
report, is a drawn out multi-step procedure that involves a number of visits to
a licensed practitioner's premises.
complications that occur with abortions that arise from the use of RU486 have
been documented in research and include, but are not limited to: heavy and
often prolonged bleeding including the need for blood transfusions, incomplete
abortions necessitating surgical intervention, moderate or severe physical
pain, and considerable mental anguish.
Adverse events, associated deaths and FDA
submissions raised fears over the safety of RU486 referring to adverse events
and deaths associated with the use of the drug and concerns within the United
States Food and Drug Administration
(FDA). They considered that a medical abortion was not safer than, or even as
safe as, a surgical abortion.
argued that although the FDA approved the use of RU486 in 2000 the decision was
highly controversial and remains far from settled. Approval was given, despite
warnings that procedural and scientific requirements had been bypassed and that
adequate clinical trials had not taken place. They pointed to the FDA reporting
in November 2004 that it had received 676 adverse events, following 350 000
applications from 2000 to October 2004, ranging in severity from minor symptoms
such as nausea and dizziness to serious complications such as blood loss,
ectopic pregnancy, and rare bacterial infections which have been fatal in some
was made to at least 10 deaths having been associated with the use of RU486
across Europe and the US since its introduction, though submissions
focussed on the death of four young women in California over the past two years. They each died
within a week of taking RU486 of the same overwhelming infection of the uterus
(clostridium sordellii). Three of the
families are suing the manufacturer, Danco. The company says it has ‘no
answers’ as to how this has occurred.
A death of a third British woman in association with a
mifepristone/misoprostol abortion was confirmed in January 2006 by the United
Kingdom’s Medicines and Health Products
Regulatory Agency. Senator
Joyce asked about the Australian context:
Senator JOYCE—So it
would be a fair statement that women who otherwise would have had a surgical
abortion but who take RU486 will—if these things play out in Australia—die.
review article published in The New England Journal of Medicine on 1 December
2005 described these four deaths of previously healthy women due to fatal toxic
shock syndrome and called for “further study of its association with medical
abortion”. An accompanying editorial noted that while the death rate in the US for surgical abortion in the first 8 weeks
is around 0.1 in 100,000 the death rate from infection associated with RU486
for similar early abortions is close to 1 in 100,000 or ten times higher.
is investigating recently reported serious adverse events associated with RU486
(trade name Mifeprex in the US) and, as a result, issued a public health
advisory on 19 July 2005 highlighting the risk of sepsis or blood
infection when undergoing medical abortion using Mifeprex and misoprostol in a
manner that is not consistent with the approved labelling. The FDA is
reportedly convening a high-level scientific meeting with the Centre for
Disease Control early in 2006 over these recent deaths linked to RU486.
United States Congressional Subcommittee on Criminal Justice Drug Policy and
Human Resources is currently investigating the handling of the approval process
for RU486 by the FDA, as well as its response to the five deaths and other
adverse events related to RU486 abortions.
February 2006 Congressman Roscoe Bartlett announced that he had seventy nine (79) co-sponsors for the RU486
Suspension and Review Act, a bill that would require the Food and Drug
Administration to suspend sales of RU486 until a complete review of its safety
is conducted following the deaths of five American women after RU486 abortions.
The Bill is also known as “Holly’s Law” with the support of Monty and Helen Patterson, the parents of 18 year old Holly Patterson one of these five women.
January 2006 the
Italian Minister for Health Francesco Storace announced that the Italian
Government was restricting imports of RU486. "From now on doctors will
have to justify every individual request on precise clinical and
epidemiological grounds" he said.
This move follows the suspension of a trial use of RU486 in Turin last September after one in twenty women
being given RU486 were having partial abortions at home followed by excessive
In Canada, a trial of RU486 was suspended after a 26
year old Canadian woman died of toxic shock syndrome on 1
September 2001. RU486 has never been licensed for
use in Canada despite it being a nation with extremely liberal abortion laws.
argued that, given these emergent safety concerns, at this point in time it
would be premature and imprudent for any Australian authority to make a
determination about the safety of RU486. As Dr van Gend noted 'the the jury appears to have been sent out again on the safety
aspects of RU486'.
Use and Monitoring if made available
argued that given the high risk of medical complications associated with RU486
it is important to consider how this drug would be monitored if it were to be
made available through the TGA. Reference was made to different procedures in Europe and the US. Of particular issue was that trends seen in
American since the introduction of RU486 demonstrate that there is little or no
follow up care for women. Whilst it is recommended that women have access to
medical treatment for a period of time after taking RU486, it is left up to the
discretion of the individual who is taking the drug. The Council for Marriage
and the Family addressed this issue:
There is therefore reason for serious concern regarding how
women will be protected and cared for after taking this drug if it becomes readily
available through the TGA... If this drug were to be made accessible through the
TGA it is recommended that there ought to be some strict regulation regarding
its use such as supervised administration of the drug in a hospital setting and
appropriate follow up (as is conducted in some countries in Europe).
It is also recommended that RU486 be accessible only through a specialist such
as a gynaecologist, who is able to take responsibility for the follow up care
submissions commented on psychological issues associated with determining to
have and then carrying through with an abortion. Drs Stephen and Dianne
Grocott, consultant psychiatrists described the
issues raised in many submissions:
The fact that the vast majority of Australian abortions are
performed for social reasons implies that many women would bear and raise their
child, if they had financial and relationship support instead of perceiving
that the child threatens the survival of their individuality, their relationship,
their career or the wellbeing of their other children. Women frequently decide
to keep their children if they believe that they will have the support they
need to do so. A medical abortion, marketed as an easy option, would have the
effect of making it harder for women to ask for help when they are in crisis
about their pregnancy...
Dianne has first-hand experience
of the psychological consequences to women, men, grandparents and siblings of
abortion decisions. Many researchers have documented increased rates of
depression, suicidal behaviour, substance abuse and relationship dysfunction
that have variously been labelled “post-abortion syndrome”... There is a great
need for public recognition of the psychological consequences of abortion so
individuals can be correctly diagnosed and treated. There is also need for
research in this area.
RU486 is marketed as “easier” than surgical abortion. The
initiation of a medical abortion is easier, but the consequences of delivering
a dead foetus at home, or of pain and bleeding for up to weeks would further
increase psychological trauma to women and their families. There is a need for
independent research into the true psychological consequences of RU486,
especially the consequences for women who decline to attend for follow-up.
of submissions also referred to the recently published Christchurch Health and
Development Study undertaken by Professor Fergusson in New Zealand on abortion and subsequent mental health
problems. Professor Fergusson found that women who had had at least one
abortion were twice as likely as others to drink alcohol at dangerous levels
and three times as likely to use illicit drugs. The study reportedly found that
at age 25, 42 per cent of women in the study group who had had an abortion also
experienced major depression at some stage during the previous four years. This
was nearly double the rate of those who had never been pregnant and 35 per cent
higher than those who had chosen to continue a pregnancy. They also found that those
having an abortion had elevated rates of subsequent mental health problems
including anxiety, suicidal behaviours and substance use disorders.
Impact on medical practitioners and medicine
also argued that the introduction of RU486 will negatively impact on medical
practitioners and the practice of medicine:
The introduction of RU 486 will extend the reach of abortion and
its culture and ethos further into the mainstream of medical practice,
involving more and more doctors, healthcare workers and medical students.
Bringing abortion into the domain of primary
care will further erode the practice and values of authentic healthcare which
is founded on respect and care for all human beings and the principle of “first
do no harm”... If it is successful it will have a profoundly negative effect on
medical practice and medical practitioners alike.
Use of RU486 for other medical indications
of submissions acknowledged the potential medical benefits of RU486 other than
as an abortifacient. Dr Klein noted that, contrary to some comments, the
1996 amendments to the TGA Act did not ban RU486 and advised:
it is indeed being trialled in Australia
for other indications including as emergency contraception, and, since 2003 in
conjunction with the contraceptive implant Implanon, to counter unacceptable
bleeding and study RU486s action on ovulatory function and cervical mucus.
Cancer research is also ongoing. The rejection of [this Bill]
would not jeopardise these projects, nor indeed preclude further research. However, it is precisely these many other
sites of actions of RU486 that make it eminently unsuitable as an abortifacient
as it is not specific enough in its action to stop a developing pregnancy.
Dr van Gend proposed that if RU486 is found by the TGA to be safe, then valid
medical indications for its use, including certain cancers, hormonal diseases
and medically essential termination of pregnancy, should be authorised. He
What the Government should be doing, in consultation with
medical authorities, is to establish valid medical indications for RU486 –
whether in certain cancers, hormonal diseases, or medically essential abortions
– and approve the drug for those uses...
RU486 is already available for certain medical conditions.
Further, if medical authorities can define situations where abortion is
medically essential, and where RU486 is safe and preferable to surgical
abortion, then the drug should be authorised for such situations. In this way,
RU486 could be accessed readily for these approved conditions through the
current system of Authority prescriptions, used for many special drugs (such as
narcotics) where strict prescribing conditions must be met for their use.
But the Government will have set the policy limits of this
Authorisation – not on the elementary criteria of ‘safety and efficacy’ which
the TGA exists to assess, but on more complex and significant criteria
including the issue of justice to the unborn child. That is why the Government
needs to keep a policy watch over the lower levels of administration like the
TGA, which quite properly make their assessment on simpler technical criteria,
appropriate for most drugs, but ethically inadequate for RU486.
the submissions opposing the Bill
argued against the view that making RU486 available in Australia could possibly alleviate problems of unequal
access to abortion by women in rural areas and those for whom privacy is an
issue for religious, ethnic or other reasons.
Those promoting the use of the drug in Australia
often refer to the lack of availability of abortion in rural areas and suggest
that this might provide an alternative. However, the drug requires repeated
medical treatments and at least three visits to a doctor... If rural women have
difficulty getting to a doctor – or obtaining medical appointments – this will
not be a suitable treatment for them.
Doctors commenting in an article in The Age, noted that it would
be very unsuitable relating to privacy concerns – many people including the
doctor, nurses, emergency services and pharmacists all knowing what you are
submissions referred to reviews which suggest that safe medical abortion, like
surgical abortion, requires the availability of an appropriate level of back-up
medical care to address possible complications arising from the procedure. They
noted that in cases where there has not been a successful medical abortion, the
abortion will need to be completed surgically by a qualified physician and in
some cases, women will require urgent medical care for side-effects such as
internal bleeding and infection of the retained products of conception. Access
to such urgent medical care is not readily available in many rural areas. A
pharmacist in rural NSW described her situation:
I am a rural pharmacist, who works in larger rural centres such
as Wagga Wagga
and Albury. I also work in smaller communities, and my most recent placement
was at Condobolin, a town of about 3,500 thousand people, with one pharmacy and
a small hospital. Although there are currently 4 doctors in Condobolin, there
are no facilities for women to have their babies there. So they must go at
least an hour away to Parkes or Forbes, where there is not
always an obstetrics specialist available, or to Orange,
Dubbo or Wagga Wagga,
which are a minimum of 2 hours away.
These larger, more distant centres could deal with a medical
emergency at any time; however a patient may live as far as one and a half
hours away from Condobolin. So the best case scenario would be a minimum of two
hours for townsfolk, or three and a half hours, for some Australians, to reach
How do we place the supply of RU486 in this context?
issue of distance in rural areas was also referred to by Dr Buist from Women's
Hospitals Australasia and Dr Piercy of RTLA:
Senator Barnett - In
your submission you stress the need for ready access to hospital facilities and
include the ability to conduct an emergency surgical evacuation of the uterus.
I would like to know how close to a fully equipped hospital would a woman need
to be and for how long before being able to get to such a facility after she
takes mifepristone or misoprostol?
Dr Buist - I do not think I used the word ‘hospital’, but I accept the point. I did not specifically say ‘hospital’ and I
am not necessarily suggesting that. Nonetheless, I am talking about within four
hours or less—and perhaps even a shorter time—of being able to get to such a
facility. That is why I have been very clear, hopefully, that I do not see this
as a solution for a woman who is a long way from at least a district general
Senator JOYCE—We seem
to have problems at the moment getting doctors out into regional areas of Australia
because of the debacle in the health system. Nonetheless, do you think RU486
has a special application to regional Australia
that is going to be of great advantage to those people?
Dr Piercy—I think it
would be far more dangerous in regional areas.
Submissions argued that the implications of such a
scenario for women in rural and remote Australia
is what was envisaged within the written advice from the Chief Medical Officer
to the Health Minister dated 15
November 2005, which stated inter alia:
believes the introduction of medical abortion using mifepristone would require extensive
coordination and backup arrangements, and would be appropriate only in
circumstances in which there was an established relationship with an obstetric
service that could deal with emergency complications outside normal clinic
hours. It[s] use more broadly, for example by GP’s in rural and remote areas,
would substantially increase the risks to women undergoing termination...
For some women seeking pregnancy termination a medical abortion
may be preferable, but is unsafe in circumstances in which appropriate
supervision and follow-up may not be available. It is therefore unsuitable for
women in rural and remote areas who may have limited access to obstetric
to the Bill concluded their argument that, as women in
rural areas and those for whom privacy is an issue for religious, ethnic or
other reasons are more likely to be unable or unwilling to access urgent
medical care than women in urban areas, RU486 could seriously endanger the
health of these women. As the Catholic Doctors Association of Victoria argued:
'There is a considerable risk to women in rural and isolated areas because of
the lack of emergency surgical and medical backup that is necessary to deal
with the known complications of RU486 use'.
1996 Amendments to TGA Act
of submissions referred to the background and parliamentary debate when in 1996
Senator Brian Harradine's amendments to the TGA Act received bipartisan support. They argued
that for the same reasons of public accountability, parliamentary scrutiny and
monitoring these amendments should be respected and retained by the current
Parliament. The Catholic
Archdiocese of Sydney noted that:
[The 1996 amendments ensured] that abortifacients were subject
to an additional layer of scrutiny. These amendments were supported by both the
Liberal-National government and the Labor opposition, and based upon specific
concerns about the safety of the drug RU486, as well as broader concerns about
the ethical and societal impact of abortifacient drugs. Those who spoke in
support of the amendments suggested that it is not sufficient to assess the
appropriateness of such drugs only in relation to scientific criteria such as
safety and efficacy because abortion is a sensitive community issue.
Abortion continues to be a ‘sensitive community issue’ in 2006.
New research suggests that there exists a significantly high degree of disquiet
within the community over the acceptability of abortion on demand.
History of the ‘restricted goods’ provisions
in the 1996 Amendments
of the history of the 'restricted goods' provisions being placed into the Act
in the 1996 Amendments was given in the submission from Women’s Forum Australia.
The current requirement for Ministerial scrutiny can only be
understood in light of events which were precipitated by the decision of an
unidentified official within the TGA to authorise the importation of RU486 in
1994 for clinical trials in Australia.
That action set in train a series of events culminating in the halting of a
Victorian trial of the drug and four separate departmental investigations into
the trials ordered by the then Minister for Health and Human Services, the Hon
Dr Carmen Lawrence MP.
As an abortifacient, RU486 was a prohibited import unless
exempted by the Department of Human Services and Health pursuant to the Customs
(Prohibited Imports) Regulations. It was understood that no such exemption
would be given unless the Minister was consulted. Neither the Minister for
Human Services and Health nor the Minister for Family Services, who had
responsibility for the Therapeutic Goods Authority (TGA), were consulted prior
to the exemption by the departmental delegate...
Senator Graham Richardson,
the Health Minister at the time the exemption was granted, acknowledged that
official parliamentary undertakings had been "breached" and said the
Government would see whether it could rectify the situation...
Despite claims that the TGA had rigorously scrutinised and
strictly evaluated the drug prior to authorising approval3 during Senate Estimates
hearings on May 25, 1994, Dr
head of the Drug Evaluation Branch of the TGA, demonstrated that this was not
“We do not evaluate ...TGA has not carried out an assessment to
the quality, safety and efficiency of this product in connection with this
notification...The only brake on the system is that the trial cannot commence
until we send them, in effect, a receipt saying that we have had their letter.
There is no evaluation carried out and it is not built into the process...That is
why the fee is $90. It is just the clerical fee for doing it, fixing it,
keeping the record.”
The TGA hadn’t rigorously scrutinised anything. It had merely
sent out a receipt. There was no independent control or scrutiny of drug trials
on human subjects...
When asked for information about the trials and the approval
process, the researchers involved in the trials complained to the National
Health and Medical Research Council (NHMRC) that parliament's demands for trial
details and consent forms were a threat to academic freedom. Health
Minister Dr Carmen Lawrence
responded, saying private ethics committees had "a very, very substantial
responsibility , and we have to get past the time ... where it's left to medical
experts”. “It is incumbent upon us all to ensure that women are fully informed
about drugs [they volunteer to trial]."
There had been no independent assessment of legality and
questions were raised about whether the trials were actually within the law.
trial was halted after questions were raised about the adequacy of the consent
form given to women... The forms failed to mention cardiovascular risks and the
fact that if the chemical abortion failed, there was the possibility of birth
defects and a surgical termination was required...
Trials were suspended August
This was the background against which the amendment to the TGA
Act was introduced and passed, requiring ministerial scrutiny over any
application for the importation of RU486 or any other prostaglandin antagonist.
Then ALP Senator Belinda Neal,
“We acknowledge that this issue raises large concerns within the
community. It raises issues beyond purely health issues. These issues need to
be addressed by the executive of this government and addressed with absolute
and direct accountability.”
Then 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
Availability of RU486 and increased abortion
submissions commented critically upon the very high number of abortions that
are known to be performed in Australia each year. Arguments were made in
submissions and correspondence that the availability of RU486 and 'easier'
medical abortions would result in an increase in the number of abortions
Pre-Abortion counselling is often provided by representatives of
abortion providers who minimize the research evidence about long-term physical
and psychological effects on women, and relationship effects with their
partners and subsequent live children. As mainstream Australian society has yet
to acknowledge and address this research, the consequences of providing an
additional abortion method which is marketed as making abortion easier may increase
further the rate of abortions and subsequent individual and societal damage.
At present, there is no substantial evidence that the
availability of abortifacients increases, or decreases, a nation's overall
abortion rates. However, it is hard to see how access to medical abortion will
do anything to address public concern about the high incidence of abortion in Australia.
Prima facie, the more methods of abortion and the greater the access, the more 'mainstream'
abortion may seem and the more likely the abortion rate is to increase. Social
arguments in favour of abortifacient use in Australia,
on grounds that women should have a 'choice of abortion methods' would seem to
support the current culture of high abortion rates.
associated with unwanted pregnancies
Submissions argued that the availability of RU486 would
not address the many social and personal issues that are at the root of Australia's
abortion problem. It would merely offer young healthy Australian women a
less-safe abortive solution to the profound social, moral, economic and
financial problems that women face when choosing how to deal with unplanned,
unwanted or difficult pregnancies.
There is a need to focus on offering counselling and
support for women with unwanted pregnancies. The Southern Cross Bioethics
Institute noted the Government's recent plan to provide Medicare funding for
pregnancy counselling and establish an independent national pregnancy
counselling hotline and referred to its research showing that the Australian
public is nearly unanimous in its support for the provision of counselling to
pregnant women and for ways of reducing the overall abortion rate.
The SCBI also referred to the recent 'Christchurch
study' which found that abortion increases the likelihood of young women
developing mental health problems and concluded that this research 'implicitly
supports the need for independent counselling for pregnant women. It also
provides impetus for reducing the abortion rate and strengthening alternatives,
rather than providing more ways of having an abortion.'
Seman and David
van Gend were hopeful that the debate on
RU486 would have one very positive outcome:
The RU486 debate has allowed us to “take stock” of where we are
with abortion in Australia.
The only people who dislike terminations more than the doctors doing them are
the 90,000 Australian women who each year feel they have no other alternative.
After this inquiry, and irrespective of the outcome, we need to focus our
attention on the pressures causing Australian women to seek abortion &
start providing viable alternatives. Selena Ewing’s 2005 evidence-based review
of termination of pregnancy proposes a research agenda worthy of our attention.
The debate on RU486 provides an opportunity for the profession
to reaffirm the ethical distinction between medically essential termination of
pregnancy and abortion for non-medical reasons. RU486, if considered safe,
should be authorised for the former, while for the latter the [medical] profession
must join with Government in the urgent policy task of reconstructing social
supports for women distressed by unplanned pregnancy.
social supports were discussed in a number of submissions, for example:
Australian women, men and children deserve more choices other
than abortion. Effort should be invested in education, couple counselling and
support of pregnant women. When families or communities in which an unplanned
pregnancy occurs can support the mother so that she can support her child, they
allow that child an opportunity to be born and raised to attain his or her
potential and contribute to the wellbeing of Australian society, rather than
instead becoming yet another abortion statistic.
earlier, the Committee is not making any recommendations relating specifically
to the Bill. However, it notes that a number of groups
and individuals both supporting and opposing the Bill expressed concern over the number of
abortions in Australia and the critical need to address wider personal
and social problems. They urged the implementation or enhancement of a range of
programs and services aimed at reducing unwanted pregnancies and supporting
women through pregnancy.
Committee recommends that increased financial support be provided to improve
sex education, including better education on responsible human relationships;
wider availability of information about and access to contraception and other
fertility control techniques; ensure independent professional counselling for
women considering a termination of pregnancy, counselling post termination and
counselling for relinquishing mothers as required; greater social support for
women who choose to continue with their pregnancy; and increasing the
availability and affordability of child care.
Navigation: Previous Page | Contents | Next Page