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RU486 (mifepristone): the Australian debate

Country: 
Australia
Partner Institute: 
Centre for Health, Economics Research and Evaluation (CHERE), University of Technology, Sydney
Survey no: 
(7)2006
Author(s): 
Marion Haas
Health Policy Issues: 
Pharmaceutical Policy
Current Process Stages
Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no yes yes no no

Abstract

Abortion drug RU486 (mifepristone) has been removed from the ?restricted goods? category of drugs in Australia. Such drugs cannot be evaluated, registered, listed or imported without the written approval of the Minister for Health. Since 1986, restricted goods status has applied exclusively to medicines intended to produce abortions. The restrictions were imposed because opponents of abortion were concerned about the safety of the drugs. The use of RU486 has been effectively banned in Australia.

Purpose of health policy or idea

The objective of the recent policy debate was to decide whether to remove the drug RU486 (mifepristone) from the "restricted goods" category of drugs in the Therapeutic Goods Act and treat it in the same way as all other drugs assessed by the Therapeutic Goods Administration. In introducing the original act, independent Senator Brian Harradine and his supporters stated that they were concerned about the safety of the drug. The impact of the legislation has been to effectively ban the use of RU486 in Australia because potential sponsors such as manufacturers, clinicians or clinical researchers have been deterred from seeking to import RU486 into Australia for the purposes of abortion. The renewal of the debate has occurred because Senator Harradine has now retired from politics and a group of women politicians from all parties decided to re-open the issue before Parliament. Supporters of the use of the drug claim that its availability will increase women's choices, particularly those in rural and remote Australia, regarding the methods of abortion available to them.

Main points

Main objectives

  • to decide whether to remove RU486 from the restricted goods list for drugs
  • to improve access to abortion for women, particularly residents of rural and remote

Groups affected

women who desire an abortion, medical practitioners

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Characteristics of this policy

Degree of Innovation traditional rather traditional innovative
Degree of Controversy consensual highly controversial highly controversial
Structural or Systemic Impact marginal marginal fundamental
Public Visibility very low very high very high
Transferability strongly system-dependent rather system-neutral system-neutral

Using legislation is a traditional way of changing policy and the only way this particular issue was able to be resolved as the Minister's power was enshrined in legislation. Abortion is always a controversial issue and even though this particular piece of legislation was not about abortion per se, the debate concentrated on it, rather than the change to the Minister's powers. As yet, no individual or pharmaceutical company has applied to the TGA to have RU486 approved for use in Australia. Even if it is approved, there is likely to be very little change in the number of abortions performed, but there may be a shift to medical abortions by women who are not able to undergo a surgical abortion or those who, because they reside in rural areas, wish to avoid the travel time and associated costs of a surgical abortion.

All debates about abortion have high public visibility. This debate was made even more visible by the fact that a group of women from across the Parliament were the joint sponsors of the bill. The innovation is specific to Australia as the legislation it proposed to amend is Australian. However, the broader issue of separating scientific and ethical decisions and allowing bodies such as the TGA to make scientific decisions is an international one.

Political and economic background

Surgical abortion is available in all States of Australia, although its legal status varies. However, medical abortion has not been available due to action at the national level of government, which control the use of drugs across the country. In 1986, Senator Brian Harradine (independent) introduced an amendment to the Therapeutic Goods Amendment Bill which made the Minister for Health, rather than the Therapeutic Goods Administration (TGA, the statutory body usually responsible for approval of medicines in Australia) ultimately responsible for decisions in relation to the evaluation, registration, listing or importation of abortifacients. This was on the grounds that abortifacients were a special category of drugs for which additional scrutiny was required. At the time, the Senator raised concerns about the short and long term effects of the drug on women's health.

However, opponents argued that the intent of the amendments was to ban RU486 as the creation of the additional stage of the evaluation process would deter sponsors from seeking permission to import the drug. The 1986 amendments were supported by both the Liberal (conservative) and the Labor parties. With the retirement of Senator Harradine, members of both sides of Parliament (particularly women members) agreed that it was time to re-open the debate. It appears that the move was also motivated by the anti-abortion stance of the current Minister for Health (Tony Abbott) and the assurance by all parties that they would allow members of parliament a conscience vote on the issue.

Purpose and process analysis

Current Process Stages

Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no yes yes no no

Origins of health policy idea

The idea of amending the legislation came from

  • providers who, now that Senator Harradine had resigned, were interested in testing whether the Parliament would agree to remove the responsibility for RU486 from the Minister for Health and
  • from a group of women parliamentarians who believed that women should have access to all the safe and effective methods of abortion available.

The main purpose of the amendment is to treat RU486 in the same way as all other drugs ie to allow the Therapeutic Goods Administration to assess its efficacy and safety.

Initiators of idea/main actors

  • Parliament: A group of women parliamentarians from all parties were the sponsors of the amended legislation. In the end, although there were positions taken on all sides of the debate, the amendments were passed by a large majority.
  • Providers: Some providers have lobbied politicians to change the law
  • Civil Society: This is an issue of high importance to civil society as the debate on abortion divides society. However, most people accept that if abortion is available then all safe means should also be available.

Approach of idea

The approach of the idea is described as:
renewed: This debate has been held before, in the context of the original amendment proposed by Senator Harradine in 1986.

Stakeholder positions

The key point about this debate is the argument is about the evaluation of risk - that is, whether the potential benefits of making RU486 available are outweighed by the potential harms to the health of women. In Australia, the TGA is the body specifically charged with evaluating the risks of medicines proposed for use in Australia. Thus, the notion that the Minister for Health was additionally qualified to assess risk is an unusual notion within the Australian context. This, and the fact that the Ministers refused applications to import the drug in the years since 1986, add weight to the argument that the issue was not really risk but abortion itself. This was reinforced during the most recent debate. Supporters of the new amendment to remove the Minister's powers were able to show that RU486 is available for use in many countries and is a safe and effective alternative to surgical abortion whilst its opponents claimed that its use would lead to more abortions- they tried to shift the debate to one about how many abortions there "should" be in Australia.

The debate also utilised a recent innovation in social debates in Australia - the on-line petition. Both sides of the debate formed specific supporter groups and targeted potential supporters on-line - requesting them to email Ministers' and parlimentarians' offices and to sign an on-line petition requesting that members support or not support the proposed amendment. During the parlaimentary debate, opponents of the amendment lined the route to Parliament House with placards etc. This is a fairly unusual tactic to adopt and probably reflects the fact that a free vote was available to members.

The Senate held an inquiry into the proposed amended legislation. The committee conducting the inquiry considered that its primary role was to gather information to assist Senators to make an informed decision about the bill. The committee did not make a judgement on the drug in question. However, it received many submissions from those both supportive of and opposed to the proposed legislation who expressed concern about the number of abortions which occured in Australia (despite the fact that the data available does not distinguish between induced or spontaneous abortions). However, in recognising that this issue was a critical one personally and socially, the committee recommended that increased financial support be provided for programs and services aimed at reducing unwanted pregnancies and supporting women throughout pregnancy.

One of the most interesting aspects of the recent debate was the cross-political alliance of women parliamentarians who lead the debate and championed the successful amendment. This was made possible by 1) a change in community attitudes to abortion  and 2) the recognition of this by the political parties who allowed members a conscience vote.

The Parliamentary deliberations were also remarkable for the high level of debate displayed by those speaking on both sides and for the civility opponents displayed towards each other. The continuing role for the group of women is illustrated by their voices in the next issue arising from this debate - the provision of professional and independent counselling to women considering having an abortion. The government has introduced regulations aimed at making such counselling mandatory and more widespread.

Actors and positions

Description of actors and their positions
Parliament
Parliamentvery supportivesupportive strongly opposed
Providers
Providersvery supportivevery supportive strongly opposed
Civil Society
Civil societyvery supportiveneutral strongly opposed

Influences in policy making and legislation

The debate centred on proposed amendments to the Therapeutic Goods Amendment Bill which succeeded. A group of women from all political parties were the leaders of the amendments. The Senate (upper house) held an inquiry into the issues prior to the legislation being introduced and produced a report which described the positive and negative aspects of the proposal in detail without making specific recommendations (because all parties had indicated that they were allowing members a conscience vote). However, a number of the members of the committee provided "additional comments" which are appended to the report. These comments are in line with each groups' attitudes to abortion.

The Prime Minister and the Minister for Health were prominent opponents of the new Bill whilst the leaders of the other two parties, Labor and the Democrats, were supporters. Medical experts were generally supportive. FPA Health (Family Planning Association) and Sexual Health and Family Planning Australia generated a supporters' group and website whilst their opponents did the same.

Legislative outcome

success

Actors and influence

Description of actors and their influence

Parliament
Parliamentvery strongvery strong none
Providers
Providersvery strongstrong none
Civil Society
Civil societyvery strongnone none
ProvidersParliamentCivil society

Positions and Influences at a glance

Graphical actors vs. influence map representing the above actors vs. influences table.

Adoption and implementation

Any change in practice requires an individual or company to apply to the TGA for permission to import RU486 for use in abortions. No such application has yet been made, or whether it is likely to. Such a request will trigger the TGA's evaluation process. An attempt to appease opponents was the government's regulation that proposed abortions should be preceded by independent, professional counselling. The debate about this proposal has centred around the attitudes of the organisations being considered as recipients of government funding for the provision of counselling services. The government has explicitly stated that it will not fund any organisations connected with abortion providers but will considered a range of other groups, including church-based counselling services (who may be prevented by their religious affiliations from providing information about abortions).

Monitoring and evaluation

It will be possible to monitor the number of applications made to the TGA for importation of RU486. However, it will not be possible to monitor the use of the drug for two reasons: 1) women undergoing medical abortions monitored by a doctor will have their consultations recorded but not the reason for the consultation 2) the way that information is recorded currently means that it is not possible to distinguish between medically or surgically induced abortions and spontaneous abortions (commonly referred to as miscarriages).

Results of evaluation

There has been no evaluation as yet.

Expected outcome

The legislation has achieved its short term aim of removing RU486 from  the "restricted drug" category, thus eliminating the Minister for Health from the decision making process about its risks and benefits. It is not possible to know whether the policy will achieve its long-term objective of making RU486 available to women because they currently still have to request permission to import the drug and the TGA will be required to evaluate it.

If the drug is approved for use in Australia, it is likely that a small proportion of women having an abortion will choose to use RU486 (currently in the US, approximately 4% of abortions are medical, rather than surgical). It is possible that some women will become ill and a very small number may die due to infection following the use of RU486. It is unlikely to have impact on costs and quality of care but it may improve access to care for women living in rural and remote parts of Australia.

Impact of this policy

Quality of Health Care Services marginal neutral fundamental
Level of Equity system less equitable system more equitable system more equitable
Cost Efficiency very low neutral very high

The amended legislation removes an anomaly where surgical but not medical abortion was available in rural areas. Thus, if RU486 becomes available, it will increase equity of access to abortion for rural residents. However, because it is unlikely to change the overall number of abortions performed and because relatively small numbers of medical abortions will be performed, it is not likely to have a major impact on either the quality of services delivered or the efficiency of the Australian health system.

References

Sources of Information

Buckmaster, L. RU486 for Sexual Health and Family Planning Australia.

The facts- Mifepristone/RU486 - Abortion. www.shfpa.org downloaded 18/1/06.

FPA Health. RU4Choice? State Newsletter FPA Health. February 2006.

Inquiry into Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. www.aph.gov.au/Senate/committee/clac_ctte/ru486/report/index.htm accessed April 3, 2006.

Author/s and/or contributors to this survey

Marion Haas

Suggested citation for this online article

Marion Haas. "RU486 (mifepristone): the Australian debate". Health Policy Monitor, RU486 in Australia. Available at http://www.hpm.org/survey/au/a7/5