Bills Digest no. 96 2005–06
Therapeutic Goods Amendment (Repeal of Ministerial
responsibility for approval of RU486) Bill
2005
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage History
Purpose
Background
Main Provisions
Concluding Comments
Endnotes
Contact Officer & Copyright Details
Passage History
Therapeutic
Goods Amendment (Repeal of Ministerial responsibility for approval
of RU486) Bill 2005
Date
introduced: 8
December 2005
House: House of Representatives
Portfolio: Health and Ageing
Commencement:
On Royal
Assent
This Bill proposes to amend the
Therapeutic Goods Act 1989 to make it possible to
evaluate, register, list or import abortifacients (medicines
intended to induce an abortion) such as RU486 (mifepristone) for
use in Australia without the approval of the Minister for Health
and Ageing.
RU486 is the common name for the drug mifepristone, a synthetic
steroid that can be used to induce what is known as medical
abortion an alternative method to surgical termination of
pregnancy.(1)
RU486 works by blocking the effects of the hormone progesterone,
which is crucial to starting and maintaining pregnancy. Without
progesterone, the lining that covers the walls of the uterus breaks
down. In the absence of progesterone, the uterus cannot hold onto
the fertilised egg, making it impossible for pregnancy to
continue.
According to one recent estimate, RU486 has been approved for
use in 35 countries, including the United Kingdom, the United
States, much of Western Europe, Russia, China, Israel, India, New
Zealand and Tunisia.(2)
A more detailed overview of RU486 and issues related to its use
in medical abortion can be found in the Parliamentary Library
Research Note RU486 for Australia?,
available at http://www.aph.gov.au/library/pubs/rn/2005-06/06rn19.htm.
Therapeutic goods such as medicines are regulated under
Therapeutic Goods Act 1989 (the Act). The purpose of the
Act is to ensure the quality, safety, efficacy (where appropriate)
and timely availability of therapeutic goods.(3)
Regulatory arrangements for therapeutic goods under the Act are the
responsibility of the Therapeutic Goods Administration (TGA), a
unit of the Department of Health and Ageing.(4)
Any medicine available for general sale in Australia must be
included on the Australian Register of Therapeutic Goods (ARTG).
There are also a range of programs whereby conditional access can
be granted to products not listed on the ARTG, including the
Special Access Scheme, the Authorised Prescriber Scheme and
exemptions under clinical trials schemes.(5)
The TGA is responsible for administering the provisions of the
Act and maintaining the ARTG and the various conditional access
programs.
TGA
regulatory approach
Therapeutic goods on the ARTG are
regulated according to a risk management approach. This means that
the evaluated risk associated with a particular medicine or
medicinal ingredient determines the type of assessment process used
by the TGA. The concept of risk is based on an assessment of the
potential of a product to do harm to those it is intended to help,
or to others (such as children) who may come into contact with it
regardless of whether the harm results from following or
disregarding the directions for use .(6)
Higher risk
therapeutic goods (Registered medicines), such as those used to
treat serious conditions, or which need to be used under a doctor s
supervision, are subject to a high level of scrutiny and evaluation
by TGA to determine their quality, safety and efficacy.
Lower risk therapeutic goods (Listed medicines)
are assessed by the TGA for quality and safety but not
efficacy. That is, the TGA does not evaluate Listed medicines prior
to supply to determine whether they are
effective.(7)
RU486 belongs to a special category of drugs under the Act,
known as restricted goods , which cannot be evaluated, registered,
listed or imported without the written approval of the Minister for
Health and Ageing.(8) Medicines used for any purpose
other than abortion can be regulated by the TGA and (if approved)
imported by a manufacturer or distributor (known as the sponsor)
without any requirement for approval from the Minister.
The restricted goods provisions were incorporated into the Act
in 1996 as a result of amendments introduced in the Therapeutic
Goods Amendment Bill 1996 by Senator Brian
Harradine (the Harradine amendments ). Senator Harradine and others
speaking in support of the amendments argued that these provisions
were necessary because abortifacients amounted to a special
category of drugs for which an additional layer of public scrutiny
was required.(9)
Refer to the Parliamentary Library Research Note RU486
for Australia?, available from http://www.aph.gov.au/library/pubs/rn/2005-06/06rn19.htm
for further details.
Through the amendments in this Bill, Senators Allison, Moore,
Nash and Troeth are seeking to make it possible for abortifacients
such as RU486 to be evaluated, registered, listed or imported
without the written approval of the Minister for Health and Ageing.
If successful, ultimate responsibility for approving RU486 would be
taken from the Minister and returned to the TGA.
In her Second Reading speech, Senator Nash argued that the TGA,
rather than the Minister, is the appropriate body for making such a
decision:
The [TGA] has the knowledge and expertise to
conduct the evaluation of RU486 for quality, safety and efficacy.
That is why the TGA has been entrusted to evaluate more than 50,000
therapeutic goods that have already come before
it.(10)
Further, the Explanatory Memorandum to the Bill noted that the
TGA s role in regulating the risks associated with medicines make
it the appropriate body for evaluating RU486:
The TGA is specifically charged with identifying,
assessing and evaluating the risks posed by therapeutic goods that
come into Australia, applying any measures necessary for treating
the risks posed, and monitoring and reviewing the risks over
time.
The TGA is regarded by the government as being
qualified to manage the risks associated with any therapeutic good
that is used (or proposed for use) in Australia. It is therefore
reasonable to assume that it is also qualified to manage the risks
associated with medications such as RU486. (11)
It is also evident that an underlying purpose of the Bill is to
remove what some see as an impediment created by the current
arrangements to sponsors making an application for approval of
RU486. According to the Explanatory Memorandum, it is reasonable to
assume that [the amendments in the Bill] 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 .(12)
The debate about the possible use of RU486 for medical abortion
in Australia has been strongly contested by numerous members of
parliament, interest groups and press commentators both prior to,
and since, the introduction of this Bill in December 2005. Much of
this debate has been conducted as part of the Senate Inquiry
into Therapeutic Goods Amendment (Repeal of Ministerial
responsibility for approval of RU486) Bill
2005.(13) This debate has not been restricted
to the substantive issue raised by this Bill that is, who is the
appropriate authority to decide whether RU486 should be available
in Australia? Rather, it has been, to some extent a debate about
the legitimacy of abortion, in which RU486 has come to play a
symbolic role.
The debate surrounding the Bill has been conducted around three
main questions:
-
is RU486 when used in medical abortion safe enough to be used by
women in Australia?,
-
is the Minister or the TGA the most appropriate authority for
deciding whether RU486 should be made available in Australia for
use in medical abortion?
-
is there an established relationship between availability of
RU486 for medical abortion and an increase in the overall abortion
rate in countries where it has become available?
As noted above, the debates surrounding each of these questions
have been underpinned by existing assumptions about the legitimacy
of abortion in general (rather than restricted to particular issues
associated with RU486).
As noted in the in the Parliamentary Library Research Note
RU486 for Australia?, 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). Indeed, there appears to be continuing agreement
over the following:
- medical abortion using the RU486/misoprostol combination will
lead to a successful abortion in between 92 and 98 per cent of
cases
- in the five to eight per cent of cases in which there has not
been a successful abortion, the abortion will need to be completed
surgically by a qualified physician
- in some cases, women will require urgent medical care for
side-effects such as internal bleeding and infection of the
retained products of conception, and
- 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.(14)
Rather the key point of dispute has been over whether the above
constitutes an acceptable or unacceptable level of risk to the
safety of women.
While the issue of safety is clearly important, the debate over
the level of risk associated with RU486 when used in medical
abortion tends to reinforce the argument that the TGA should have
some role in determining whether the drug should become available
in Australia for that purpose. A similar point was made by Dr David
van Gend, Secretary of the World Federation of Doctors Who Respect
Human Life, in the Senate Inquiry into the Bill. In response to
concerns about the safety of RU486 raised by Senator Joyce, Dr van
Gend, who while being opposed to the Bill, stated that he did not
want to get into an auction of side effects. That is for the TGA.
That is for the [Obstetrics and Gynaecological] College. It is
nothing to do with politicians, respectfully .(15)
The issue of whether the TGA is sufficiently accountable to the
public to be charged with ultimate decision-making power in
relation to abortifacients has been raised by a number of
participants in the debate over this Bill. For example, Federal
Minister for Health and Ageing, Mr Tony Abbott, has argued that the
issue of access to RU486 is such an important thing that it shouldn
t be left in the hands of the unaccountable bureaucrats
.(16) Further, Dr van Gend has argued that:
Parliament is again to debate the regulation of
RU486, but this time the stated aim is to remove this professional
proper accountability. So, once more a departmental official can
approve RU486 without the Minister taking policy responsibility or
the parliament knowing. With this amendment Bill for repeal of
Ministerial authority for approval of RU486, the parliament is
being asked to support an amendment which undermines, for
ideological reasons, proper ministerial accountability on a matter
of public importance. It would be a triumph of underhandedness over
transparency in public life. If this Bill were passed, it would be
an abandonment by parliament of their responsibility to grapple
with difficult social and ethical questions, instead hiving the
issues off to unelected scientists and officials who are not
accountable for contentious decisions.(17)
Arguments about the need for greater accountability through
parliamentary scrutiny of decisions related to RU486 were also
prominent in the debates surrounding the 1996 amendments to the Act
that brought about the current legislative arrangements in relation
to abortifacients. To what extent, though, can the current
arrangements be said to provide for such accountability?
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, this would not amount
to a significant level of parliamentary scrutiny. Further, the
Minister is not required to table decisions not to
approve such applications, meaning that the Parliament would
neither necessarily be informed nor have the capacity for any
oversight of such a decision. As Senator Allison has argued, at the
present time:
the Minister can decide to refuse an application
and not indicate to the parliament that he has done so and that he
can agree to grant exemptions or approval without providing the
reasons to parliament There is no way that the parliament can
disallow his decision. There is no way the parliament can debate it
or have a vote on it.(18)
Thus, while there may be sound arguments for having greater
accountability in relation to decisions to evaluate, register, list
or import abortifacients, it is reasonable to argue that the
current arrangements provide for greater restrictions but only
limited parliamentary accountability. Greater parliamentary
accountability could, however, be provided through changes such as
requiring the Minister to table decisions not to approve
applications and/or making any decisions in relation to
abortifacients disallowable. Such changes may even have been
contemplated recently by Mr Abbott when he recently argued that in
relation to abortifacients there should be the accountability of a
ministerial decision and the possibility of subsequent
parliamentary disallowance.(19)
The possibility of increased availability of abortion following
any decision to approve RU486 for use in medical abortion in
Australia has also figured prominently in the recent debate.
For example, some in favour of approving RU486 have argued that
it may make abortion more accessible to women who have
traditionally not had such access (such as women in rural areas).
This has led to concerns being raised about the health risks this
might present to women in these areas and the subsequent emphasis
by medical experts on the need to ensure that there is an
appropriate level of back-up medical care to address possible
complications arising from medical abortion using RU486.
Others have raised concerns about the possibility
that availability of RU486 for medical abortion could lead to an
increase in the overall abortion rate. It should be noted, however,
that there is very little evidence available from which to draw
conclusions about the connection between availability of medical
abortion and the overall abortion rate. However, the very few
studies that have addressed this question appear to indicate that,
in the countries assessed, the availability of medical abortion has
not led to an increase in the abortion rate.
For example, one study considered trends in abortion rates
across France, Great Britain and Sweden (as measured as the number
of abortions (at all gestations) per 1,000 women aged between
15-44).(20) The study found that the abortion rate in
France, England and Wales remained stable from the date of approval
of RU486, to the most recent year data was available. In France the
abortion rate of 13 per 1,000 women in 1987 was the same as the
abortion rate in 1997. In England and Wales, the rate of abortion
of 16 per 1,000 women in 1990 was the same in 2000. In Sweden, the
abortion rate fell slightly from 21 per 1,000 women in 1990 (the
year before its introduction) to 18 per 1,000 women in 1999. In
Scotland the rate rose slightly from 9 per 1,000 in 1990 to 11 per
1,000 in 2000.
Unlike the 1996 amendments to the Act that brought in the
current restrictions relating to abortifacients, the government and
the opposition have both declared a free vote in relation to this
Bill.(21) As such, none of the major parties have
officially declared positions on the Bill.
Members of the government to have stated positions on the Bill
include Deputy Prime Minister, Mr Mark Vaile (opposed), Mr Abbott
(opposed), Government Leader in the Senate, Senator Nick Minchin
(opposed), Dr Sharman Stone (in favour) and Dr Mal Washer (in
favour).(22) The Prime Minister, Mr Howard, has said
that he remains undecided.(23)
Members of the opposition reported to have declared positions on
the Bill include Opposition Leader in the Senate, Senator Chris
Evans (in favour), Senator Jan McLucas (in favour), Senator Steve
Hutchens (opposed) and Senator Helen Polley
(opposed).(24) The Leader of the Opposition, Mr Kim
Beazley, and the Shadow Minister for Health and Ageing, Ms Julia
Gillard, do not appear to have publicly declared positions on the
Bill though, Ms Gillard has stated that the base Labor position and
my position on this is that RU486 ought to be treated like every
other medication and that is [that] the safety and the
circumstances in which it can be used should be determined by the
Therapeutic Goods Administration .(25)
The Greens and Democrats support the Bill, while Family First
Senator Steve Fielding is opposed.(26)
One issue not dealt with in the Bill, is the fact that under the
Customs (Prohibited Imports) Regulations 1956 (the
Regulations), abortifacients may not be imported without the
written permission of the Secretary of the Department of Health and
Ageing.
The relevant regulation is 5H(2), which says importation of any
good listed in Schedule 8 is prohibited unless it is authorised in
writing by the Secretary or a person authorised by the Secretary.
Schedule 8 of the regulations lists Abortifacients, that
is, substances that purport to produce abortion .
This suggests that, even if the RU486 Bill was to pass through
the Parliament (thereby removing the restricted goods provisions
relating to abortifacients from the Act and the TGA was to approve
an application from a sponsor to include RU486 on the ARTG, the
sponsor would still require the permission of the Secretary (or
authorised officer) of the Department of Health and Ageing before
importation of the drug could occur.
It is unclear from the regulations whether permission from the
Secretary (or authorised officer) requires only one (open-ended)
instrument giving permission or whether, alternatively, the sponsor
needs to obtain permission every time the drug is imported.
A further issue to be aware of, is that under regulation 5H(3)
the Secretary (or authorised officer) could potentially impose
conditions on the permission which make importation difficult.
One way of addressing the above issues would be to amend
the Act (through an amendment to the RU486
Bill) to ensure that the reference to
abortifacients in Schedule 8 of the above Regulations did not apply
to abortifacients approved for use in
Australia by the TGA. A possible
wording for the amendment could be:
notwithstanding anything in the Customs
(Prohibited Imports) Regulations 1956, if approved for use in
Australia by the TGA, abortifacients will not require the
permission of the Secretary of the Department of Health or
authorised officer prior to importation.
This would mean that, if the TGA decided to include RU486 on the
ARTG, there would be no additional requirement for permission to
import the drug.
Subsection 3(1) repeals the definition of
restricted goods .
Section 6AA repeals the section relating to
importation of restricted goods.
Section 6AB repeals the section stating that
Regulations exempting restricted goods from the operation of a Part
of this Act must not take effect before the expiration of the time
within which a House of the Parliament may disallow the
regulations.
Section 23AA repeals the section relating to
evaluation or registration or listing of restricted goods.
Subsection 57(9) repeals the subsection stating
that the Minister must not delegate his or her powers or functions
under section 6AA or 23AA.
Concluding comments
This Bill is particularly controversial, especially given its
broader association with the sensitive social issue of abortion and
the fact that many people on either side of the abortion debate
have views that are strongly held. Those who support the Bill
believe that the appropriate body for making decisions in relation
to the evaluation, registration, listing or importation of
abortifacients is the TGA, rather than the Minister for Health and
Ageing. In other words, they argue that abortifacients should be
treated like all other medicines in Australia. Those against the
Bill argue that decisions about abortifacients, like RU486, require
an additional layer of accountability of the kind currently
provided by the restricted goods provisions in the Act. As argued
above, however, while the current arrangements provide restrictions
on abortifacients, it is questionable whether they could be said to
offer a significant degree of parliamentary accountability (given
that they are not disallowable and that the Minister is not
required to table decisions not to approve such drugs).
-
While RU486 can potentially be used for the purposes of
emergency (or morning after ) contraception, it is not
what is commonly known as the morning after pill . In this country,
the term morning after pill is generally used to refer to the drug
Postinor-2 (levonorgestrel), a post-coital emergency
contraceptive.
-
List
of mifepristone approval, Gynuity Health Products website
http://www.gynuity.org/index.html
-
Medicines Regulation
and the TGA, Therapeutic Goods Administration, Department
of Health and Ageing, September 2004, p. 1.
-
This responsibility is exercised in cooperation with State and
Territory Governments and industry. There are five main processes
used by the TGA in regulating therapeutic goods: pre-market
evaluation and approval; development, maintenance and monitoring of
the systems for listing medicines; licensing of manufacturers;
post-market monitoring; and assessment of medicines for export.
-
In 2005, two Queensland-based gynaecologists, Caroline de Costa
and Michael Carrette, submitted an application to become Authorised
Prescribers of RU486. See, for example, M. Price, Doctor s push for
abortion drug , Australian, 20 October 2005. The
Authorised Prescriber program enables the TGA to grant medical
practitioners authority to prescribe a specified unapproved
therapeutic good or class of unapproved therapeutic goods to
specified recipients or classes of recipients (identified by their
medical condition). The medical practitioner can prescribe that
product for that condition to individual patients in their
immediate care without further TGA approval.
-
Medicines Regulation
and the TGA, op. cit., p. 4.
-
ibid, p. 4.
-
Therapeutic Goods Act 1989, sections 23AA(1) and
6AA.
-
For example, in explaining why the ALP would not be opposing the
amendments, ALP Senator Belinda Neal argued in Committee that Labor
wished to ensure that each house of parliament and the public at
large are notified . Senator Belinda Neal, In committee speech:
Therapeutic Goods Amendment Bill 1996 (No. 2) , Senate,
Debates, 9 May 1996, p. 623.
-
Senator Fiona Nash,
Therapeutic Goods Amendment (Repeal of Ministerial responsibility
for approval of RU486) Bill 2005: Second Reading Speech,
Senate, Debates, 8 December 2005, p. 1.
-
Therapeutic Goods Amendment (Repeal of Ministerial responsibility
for approval of RU486) Bill 2005: Explanatory Memorandum, p.
1.
-
ibid.
-
Submissions to the Inquiry can be accessed from
http://www.aph.gov.au/Senate/committee/clac_ctte/ru486/submissions/sublist.htm,
accessed 6 February 2006. Transcripts from the Inquiry hearings can
be accessed from
http://www.aph.gov.au/Senate/committee/clac_ctte/ru486/hearings/index.htm,
accessed 6 February 2006.
-
See, for example, World Health Organisation (WHO), Safe
abortion: technical and policy advice for health systems, WHO,
Geneva, 2003, pp. 35 39; Royal College of Obstetricians and
Gynaecologists (RCOG), The care of women requesting induced
abortion, Evidence-based Clinical Guideline No. 7, RCOG,
London, September 2004, pp. 51 54. Available online: see
http://www.rcog.org.uk/resources/Public/pdf/induced_abortionfull.pdf
(accessed 27 November 2005); Department of Health and Ageing,
RU-486 (mifepristone) medical abortion, Minute to the
Minister, November 2005; C. de Costa, Medical abortion for
Australian women: it s time , Medical Journal of
Australia, vol. 183, no. 7, 2005, pp. 378 80.
-
Inquiry into Therapeutic Goods Amendment (Repeal of
Ministerial responsibility for approval of RU486) Bill
2005, p. 75.
-
Abortion drug issue one of principle: Abbott , Australian
Associated Press, 1 February 2006.
-
Inquiry into Therapeutic Goods Amendment (Repeal of
Ministerial responsibility for approval of RU486) Bill
2005, p. 66.
-
Inquiry into Therapeutic Goods Amendment (Repeal of
Ministerial responsibility for approval of RU486) Bill
2005, p. 71.
-
Abortion drug issue one of principle: Abbott , Australian
Associated Press, 1 February 2006.
-
R. Jones and S. Henshaw, Mifepristone for Early Medical
Abortion: Experiences in France, Great Britain and Sweden ,
Perspectives on Sexual and Reproductive Health, Volume 34,
Number 3, May/June 2002, p. 156.
-
M. Grattan and N. Khadem, Howard cautious as vote on abortion
drug nears , The Age, ^ Febraury 2006.
-
See L. Wright, Vaile says no to pill , Sunday Herald
Sun, 5 February 2006; Abbott stand on abortion pill ,
Daily Telegraph, 2 February 2006; N. Khadem, 2006: the
issues to watch , The Age, 2 February 2006; S. Peatling,
Lobbying storm in abortion pill debate , Sydney Morning
Herald, 7 February 2006.
-
M. Grattan and N. Khadem, op. cit.
-
See J. Topsfield and N. Khadem, Fear and fury on eve of RU486
vote , The Age, 7 February 2006; H. Low Choy, Polley
defies poll majority , Hobart Mercury, 3 February
2006.
-
J. Gillard, Shadow Minister for Health, TRANSCRIPT DOORSTOP
INTERVIEW 8:15am Parliament House,
Canberra. Monday 6 February
2006, media release, 6 February 2006.
-
J. Topsfield and N. Khadem, op. cit.
Dr Luke Buckmaster
8 February 2006
Bills Digest Service
Parliamentary Library
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