INTRODUCTION
The Council of Australian Governments (COAG) today held its 11th meeting in Canberra. The Council, comprising the Prime Minister, Premiers and Chief Ministers and the President of the Australian Local Government Association (ALGA), had wide ranging discussions on important areas of national interest.
This Communique sets out the agreed outcomes of the discussions.
HUMAN CLONING, ASSISTED REPRODUCTIVE TECHNOLOGY (ART) AND RELATED MATTERS
The Council agreed that the Commonwealth, States and Territories would introduce nationally-consistent legislation to ban human cloning and other unacceptable practices. The Council noted the Commonwealth intends to introduce legislation by June 2002.
The Council agreed that research involving the use of excess assisted reproductive technology (ART) embryos that would otherwise have been destroyed is a difficult area of public policy, involving complex and sensitive ethical and scientific issues. Having noted the range of views across the community, including concerns that such research could lead to embryos being created specifically for research purposes, the Council agreed that research be allowed only on existing excess ART embryos, that would otherwise have been destroyed, under a strict regulatory regime, including requirements for the consent of donors and that the embryos were in existence at 5 April 2002. Donors will be able to specify restrictions, if they wish, on the research uses of such embryos.
The regulation restricting the use of embryos created after 5 April 2002 will cease to have effect in three years, unless an earlier time is agreed by the Council. The Council also agreed to establish an Ethics Committee with membership jointly agreed by the Council to report to the Council within 12 months on protocols to preclude the creation of embryos specifically for research purposes, with a view to reviewing the necessity for retaining the restriction on embryos created on or after 5 April 2002. The Council also agreed to request the National Health and Medical Research Council (NHMRC) to report within 12 months on the adequacy of supply and distribution for research of excess ART embryos which would otherwise have been destroyed.
The Council agreed that research involving the destruction of existing excess ART embryos be permitted under a strict regulatory regime to enable Australia to remain at the forefront of research which may lead to medical breakthroughs in the treatment of disease. It was further agreed that the regulatory regime governing the use of excess ART embryos that would otherwise have been destroyed will be reviewed within three years. Research would need to have approval from an ethics committee and be in accordance with NHMRC and Australian Health Ethics Committee guidelines. This arrangement will be administered by the NHMRC as the national regulatory and licensing body.
Details of the agreed arrangements on the bans on human cloning and other unacceptable practices and the regulatory regime governing research involving the destructive use of existing excess ART embryos are attached.
FOOT AND MOUTH DISEASE
The Council considered a report from its Foot and Mouth Disease (FMD) Taskforce that had been commissioned in June 2001. The report noted that Australia is free from major exotic animal diseases such as FMD and bovine spongiform encephalopathy (BSE or ‘mad cow disease';) but that, if there was an outbreak of one of these diseases in Australia, there would be a major impact on the agricultural sector, rural and regional Australia and the national economy.
The Council agreed that major animal disease emergencies, and their consequences, must be tackled on a national basis. COAG agreed a national coordination framework to ensure close integration of responsibilities and actions within and across jurisdictions which builds on existing animal disease and emergency management plans. The detailed arrangements would be settled in a Memorandum of Understanding between Heads of Government, by mid 2002.
COAG agreed that further work is required to improve national prevention, preparedness and response capability. This high priority activity is being coordinated through the Primary Industries Ministerial Council.
COAG considers it important for industry to continue to develop and implement as soon as possible industry-wide and farm-level measures which would reduce the likelihood of disease establishment, rate and extent of spread and impact.
A full-scale national simulation will be held in September 2002 to test peak-level arrangements across and within jurisdictions and emergency roles and linkages across all relevant agencies. The simulation will not involve any substantial field operations.
COAG also agreed that a further report be submitted to COAG by December 2002 which draws together the key matters arising from the national simulation, progress on improving prevention, preparedness and response capacity, an assessment by each jurisdiction of its preparedness status against agreed performance criteria, and an assessment of funding implications for each level of government. A report would also be prepared on managing relief and recovery arrangements. NATIONAL ACTION PLAN FOR SALINITY AND WATER QUALITY, AND PROPERTY RIGHTS
The Council reviewed progress in implementing the National Action Plan for Salinity and Water Quality (NAP) in Australia agreed on by COAG on 3 November 2000. The Council noted that all jurisdictions except Western Australia have signed the Intergovernmental Agreement that sets out the overarching commitments and obligations of the NAP.
The Council noted that Bilateral Agreements are in place with South Australia, Victoria, Tasmania and Queensland, that the Bilateral Agreement with New South Wales is ready for signing, and that a range of key policy tools to support the implementation of the NAP have either been agreed or substantially progressed. These include national criteria for accrediting integrated regional Natural Resource Management plans, a national framework for Natural Resource Management standards and targets and a national monitoring and evaluation framework. Council noted that although regional planning is progressing well in South Australia, Victoria and New South Wales, there was a need for a greater urgency in this task with the objective of achieving accreditation of a significant number of plans by June this year.
The Council noted that funding for priority projects in South Australia totalling $15.1 million had been provided and that foundation funding, priority actions and capacity building activities totalling $15.8 million were approved by Commonwealth and Victorian Ministers in February 2002.
Council members emphasised their ongoing commitment to working with communities to undertake an integrated approach to natural resource management on a regional scale.
The Council agreed to accelerate the implementation of the NAP including by:
signing of the Intergovernmental Agreement by all parties that have not yet done so; concluding the remaining Bilateral Agreements by the end of June 2002, including progress on foundation funding, capacity building and priority projects; and making substantial progress on regional plans in all jurisdictions by the end of 2002.
The Council agreed to support arrangements that include adequate:
local government representation on regional bodies; local government involvement in the development of integrated natural resource management regional plans; and awareness of regional objectives in local planning.
The Council noted water has been a key driver in regional and national development and, in recognition of the need to address adverse economic and environmental consequences of past water management policies and practices, in 1994 COAG adopted a strategic framework for reforms to national water governance. A key part of these reforms has been the development of a system of water property rights on a jurisdiction by jurisdiction basis.
The Council also noted that substantial progress is being made on the national water reforms. Water management is currently in a transition phase as jurisdictions implement new water allocation arrangements. There have been a number of calls for clarification to water property rights.
Council reaffirmed the importance of water property rights issues in dealing with the nation';s salinity and water quality problems. Council further noted that during this transitional period, there may be a lack of information in the community about the nature of property rights, including responsibilities of water users. There also needs to be consideration of the implications of changes to water property rights for investment and the impacts of the changes on water users, particularly farmers.
In order to clarify these issues jurisdictions agreed to report to COAG by September 2002 on opportunities and impediments to better define and implement water property rights regimes (including water trading markets and where appropriate the responsibilities of water users); and how they are addressing uncertainties.
RECONCILIATION
The Council reaffirmed its continuing commitment to advance reconciliation and address the social and economic disadvantages experienced by many indigenous Australians.
The Council considered a report on progress in implementing the reconciliation framework agreed by the Council in November 2000 (will be available at www.dpmc.gov.au/docs/comm_state_index.cfm). The report shows that all governments have made progress in addressing the COAG priorities of leadership, reviewing and re-engineering programmes to assist indigenous families and promoting indigenous economic independence. Ministerial councils have also made progress in developing action plans and performance reporting strategies, although this has been slower than expected.
To underpin the commitment to reconciliation and to drive future work, the Council agreed to a trial of a whole-of-governments cooperative approach in up to 10 communities or regions. The aim of these trials will be to improve the way governments interact with each other and with communities to deliver more effective responses to the needs of indigenous Australians. The lessons learnt from these cooperative approaches will be able to be applied more broadly. This approach will be flexible in order to reflect the needs of specific communities, build on existing work and improve the compatibility of different State, Territory and Commonwealth approaches to achieve better outcomes. The selection of communities and regions will be discussed between the Commonwealth, States and Territories, the communities and the Aboriginal and Torres Strait Islander Commission and be announced by mid 2002.
The Council also agreed to commission the Steering Committee for the Review of Commonwealth/State Service Provision to produce a regular report against key indicators of indigenous disadvantage. This report will help to measure the impact of changes to policy settings and service delivery and provide a concrete way to measure the effect of the Council';s commitment to reconciliation through a jointly agreed set of indicators.
The Council noted that it would continue to review progress under the reconciliation framework, and that the next detailed report on progress achieved by governments and ministerial councils would be provided to the Council no later than the end of 2003.
PUBLIC LIABILITY INSURANCE
Recent developments in the provision of insurance for public liability, medical indemnity and terrorism risks have raised a number of issues for all levels of government. The Council noted that the Commonwealth has initiated a number of processes for examining these issues.
A Commonwealth-State ministerial meeting on public liability insurance took place on 27 March and will meet again in May 2002.
A national Medical Indemnity Forum, to be chaired by the Commonwealth Minister for Health and Ageing, Senator the Hon Kay Patterson, will be held on 23 April.
The Commonwealth has been undertaking consultations with key stakeholders, including the States and Territories, on the withdrawal of insurance cover for terrorist acts.
The Council noted the responsibility of the insurance industry to act transparently and responsibly in setting insurance premium rates. The Council asked the Australian Competition and Consumer Commission and the Australian Prudential Regulation Authority to examine the situation with a view to ensuring that these objectives are achieved.
The Council also noted that a number of States and Territories have taken action to address issues within their own jurisdictions in relation to public liability insurance, medical indemnity insurance and the withdrawal of insurance for terrorism risk.
The Council agreed that it is important to address concerns about public liability, medical indemnity and terrorism insurance in a nationally-coordinated way and from a whole-of-government perspective. Accordingly, the chair of the Heads of Treasuries, in consultation with the chair of the Australian Health Ministers'; Advisory Council and the secretary to the Standing Committee of Attorneys-General, will brief Commonwealth-State senior officials in July 2002 on progress in addressing issues associated with public liability, medical indemnity and terrorism insurance.
In relation to public liability insurance, the Council endorsed the outcomes of the 27 March Commonwealth-State ministerial meeting on public liability insurance, as set out in the joint communique released following that meeting, and noted that:
a Heads of Treasuries Insurance Working Group has been asked to consult with each jurisdiction's operational areas affected by public liability insurance with a view to developing practical measures for consideration by governments by 30 April 2002;
each jurisdiction will delegate a minister to represent the interests of its jurisdiction; and
the relevant Commonwealth, State and Territory ministers and the President of ALGA will meet again in May 2002.
The Council places a high priority on constructive tort law reform. It was agreed that the law reform proposals considered by the 27 March ministerial meeting on public liability insurance and any additional proposals arising from the Medical Indemnity Forum should be progressed as a matter of priority. This will be progressed by Heads of Treasuries in consultation with departments of Attorneys-General.
In relation to medical indemnity insurance, there are two separate, but interrelated issues: rapidly rising premiums; and the financial viability of the medical defence organisations (MDOs). Both threaten the withdrawal of medical services. The Council noted that, in relation to the MDOs, the Commonwealth has announced assistance to help stabilise the financial position of Australasian Medical Insurance Limited. It was agreed that the Commonwealth and the States and Territories should work together with the medical profession and medical indemnity insurance industry to find ways to address the financial difficulties confronting the medical indemnity industry.
Issues associated with rising premiums for medical indemnity insurance will be examined by the Medical Indemnity Insurance Forum, to be chaired by the Commonwealth Minister for Health and Ageing, on 23 April. The Council agreed that solutions in this area will require coordinated and comprehensive reforms by all jurisdictions.
The possible withdrawal of insurance cover for terrorism events could have implications for a wide range of insurance products. The Commonwealth has been consulting with key stakeholders on the impact of the changed practices in this area and is currently considering the issues arising from these consultations. The Commonwealth will be concerned not to stifle the re-emergence of market provision of terrorism risk insurance, and will consult the States and Territories regarding what action may be needed to address the withdrawal of terrorism cover in the immediate term.
FUTURE MEETINGS
The Council agreed they would have a strategic discussion of one broad issue of national public policy at each of their future meetings, in addition to its normal agenda. It further agreed to meet at least annually and, depending on the circumstances, would meet more often if required.
Council of Australian Governments5 April 2002
ATTACHMENT
ARRANGEMENTS FOR NATIONALLY-CONSISTENT BANS ON HUMAN CLONING AND OTHER UNACCEPTABLE PRACTICES, AND USE OF EXCESS ASSISTED REPRODUCTIVE TECHNOLOGY (ART) EMBRYOS
The Council agreed that the Commonwealth, States and Territories would introduce nationally-consistent legislation to ban human cloning and other unacceptable practices. The Council noted the Commonwealth intends to introduce legislation by June 2002. It is also intended that this legislation establish a national regulatory regime in relation to the use of excess ART embryos. Given the pace of scientific developments in this area, the Council also agreed that arrangements for research using excess ART embryos will be reviewed within three years. The arrangements agreed by the Council are as follows. A nationally-consistent ban on the cloning of a human being
1. The following wording is to be used as the basis for a nationally-consistent ban on the cloning of a human being: 1.1 A person must not: a) create, or attempt to create, a human clone by means of a technological or other artificial process; or b) cause a human embryo clone to be placed in the body of a human or animal for any period of gestation.
1.2 For the purposes of establishing that a human clone or human embryo clone is a genetic copy: a) it is sufficient to establish that the set of genes in the nucleus of the human cell has been copied; and b) it is not necessary to establish that the copy is an identical genetic copy.
1.3 It is not a defence that the human clone or human embryo clone did not or could not survive. “Human clone” means a human that is a genetic copy of another living or dead human. “Human embryo clone” means a human embryo that is a genetic copy of a living or dead human. “Embryo” is a developing organism from the completion of fertilisation, or initiation of development by any other means, until eight weeks when the organism becomes known as a foetus. Nationally-consistent regulation of certain unacceptable practices 2. The following practices are unacceptable and should be prohibited in Australia . 2.1 A person must not create or develop an embryo outside the body of a woman: a) for purposes other than assisted reproduction; or b) by a process other than the fertilisation of a human ovum by human sperm. 2.2 A person must not create or develop an embryo for assisted reproduction that contains genetic material from more than two people. 2.3 A person must not create or develop an embryo for assisted reproduction that uses any precursor cells of eggs or sperm from an embryo or foetus. 2.4 A person must not maintain an embryo outside the body of a woman after the 14th day of its development excluding any time in which its development has been suspended. 2.5 A person must not alter the genome of a cell of a human being or in vitro embryo such that the alteration is inheritable. 2.6 A person must not conduct embryo flushing. 3. A person must not: a) create or develop a hybrid embryo; or b) place a hybrid embryo in the body of a human or animal for any period of gestation. “Hybrid embryo” means a single living organism which has a mixed genetic origin as a consequence of combining cells derived from humans and other species. 3.2 A person must not: a) place a human embryo in an animal or in any human body cavity other than the female human reproductive tract; or b) place an animal embryo in a human for any period of gestation.
3.3 A person must not give or offer valuable consideration to any person for donation of gametes or embryos of that person or of any other person. “Valuable consideration” includes a discount or priority in the provision of a service but does not include the disbursement of any reasonable expense incurred by a person in connection with a donation of his or her reproductive material. 4. The prohibited practices will be comprehensively reviewed within three years of nationally consistent legislation taking effect, taking into account changes in technology, the potential therapeutic uses for such technology and any changes in community standards. A nationally-consistent approach to research involving human embryos 5. Research involving human embryos should be regulated through nationally-consistent legislation. 6. The following principles should underpin nationally-consistent legislation: 6.1 legislation should ensure appropriate ethical oversight of research involving embryos based on nationally-consistent standards; 6.2 the nationally-consistent standards should be clear, detailed and describe the ethical issues to be taken into account, research which may be permitted and the conditions upon which it may be permitted (that is, the “rules” to be observed by researchers undertaking work with embryos) and should be based on National Health and Medical Research Council (NHMRC) guidelines as devised by the Australian Health Ethics Committee (AHEC);
6.3 these national standards should be applied consistently throughout Australia, recognising that jurisdictions may use different mechanisms to establish that proposals comply with the national standards; 6.4 the system should provide for public reporting of research involving embryos so as to improve transparency and accountability to the public; and 6.5 the system should enable appropriate monitoring of compliance with the national standards and provide legislated penalties for non-compliance.
7. There is a range of legislative options that could meet these principles including systems of accreditation, licensing or mandating of compliance with the revised AHEC guidelines. A nationally-consistent approach to the development and/or use of embryos for the derivation of stem cells 8. Research with existing stem cell lines will be permitted to continue in Australia subject to observance of conditions set by NHMRC/AHEC. 9. Research and possible therapeutic applications which involve the destruction of existing excess ART embryos (or which may otherwise not leave the embryo in an implantable condition) will be permitted in accordance with the regulatory regime at Appendix 1. 10. The ban on the development of embryos for purposes other than for assisted reproduction will be maintained and reviewed within three years taking into account the implications for therapeutic use of embryonic stem cells (as detailed in the Health Ministers'; report, Chapter 4).
A nationally-consistent approach to ART 11. Accreditation by the Reproductive Technology Accreditation Committee (RTAC) of the Fertility Society of Australia should provide the basis for a nationally-consistent approach to the oversight of ART clinical practice in Australia, noting that compliance with the NHMRC/AHEC Ethical Guidelines on ART is a key requirement of RTAC accreditation. 12. Individual jurisdictions may choose to mandate RTAC accreditation in legislation or supplement requirements for RTAC accreditation with an additional layer of oversight (for example, through a system of licensing or accreditation of ART service providers). 13. Non-legislative measures should be implemented to improve clarity regarding the role of Human Research Ethics Committees in relation to innovative practice and to increase public reporting of research and innovative practice (as detailed in the Health Ministers'; report, Chapter 5). APPENDIX 1
REGULATORY REGIME CRITERIA FOR RESEARCH USES OF EXCESS ASSISTED REPRODUCTIVE TECHNOLOGY (ART) EMBRYOS
Governments agree to put in place a strict regulatory regime under nationally-consistent legislation and administered by the National Health and Medical Research Council (NHMRC) as the national regulatory and licensing body. The NHMRC would issue a licence for a person to use an excess embryo from an ART programme for research or therapy that damages or destroys the embryo. A licence would only be issued where that project has the approval of an ethics committee established, composed and conducted in accordance with NHMRC guidelines, and that the approval is given on a case by case basis that: there is a likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the proposed procedure; the significant advance in knowledge or improvement in technologies could not reasonably be achieved by other means; the procedure involves a restricted number of embryos and a separate account of the use of each embryo is provided to the ethics committee and the national licensing body; all tissue and gamete providers involved and their spouses or domestic partners, if any, have consented to research for each embryo used, including by specifying restrictions, if they wish, on the research uses of such embryos; and the embryo had been created prior 5 April 2002. These regulations will be reviewed within three years. The regulation restricting the use of embryos created after 5 April 2002 will cease to have effect in three years, unless an earlier time is agreed by the Council.
The Council also agreed to establish an Ethics Committee with membership jointly agreed by the Council to report to the Council within 12 months on protocols to preclude the creation of embryos specifically for research purposes, with a view to reviewing the necessity for retaining the restriction on embryos created on or after 5 April 2002. The Council also agreed to request the NHMRC to report within 12 months on the adequacy of supply and distribution for research of excess ART embryos which would otherwise have been destroyed.
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