The international trend towards standing advisory bodies

5.17 The Inquiry noted in DP 66^[20]—and it was remarked upon in many public meetings, consultations and written submissions—that it is somewhat ironic that the regulation of gene technology with respect to plants and animals has been formalised, providing the government with a source of high level advice in this area, but the same is not yet true with respect to human genetics.

5.18 In DP 66, the Inquiry referred to the clear international trend towards the establishment of standing bodies to advise governments on human genetics and biotechnology.^[21] These developments provide a number of different models for consideration—although care is needed in making direct comparisons, since each body has its own particular set of functions and priorities, relationships with other public authorities, pattern of membership, level of resources, and so on.

5.19 In DP 66, the Inquiry described the nature and functions of a number of overseas standing advisory bodies operating in the area of bioethics and biotechnology. These included the European Union’s Life Sciences High Level Group,^[22] the US President’s Council on Bioethics,^[23] and the Canadian Biotechnology Advisory Committee.^[24] Having considered the various models, the Inquiry believes that the two most relevant ones for Australian purposes are the UK Human Genetics Commission and the Ontario (Canada) Advisory Committee on Genetics, which are described more fully below.

UK Human Genetics Commission

5.20 The United Kingdom Human Genetics Commission (HGC) was established following a comprehensive review by the British government in May 1999 of the regulatory and advisory framework for biotechnology, and replaces an earlier advisory committee. While that review indicated that the then existing system for regulating individual products and processes was operated satisfactorily, it was concluded that changes were needed to make the advisory framework:

• more transparent, in order to gain public and professional confidence;
• more streamlined, in order to avoid gaps, overlaps and fragmentation; and
• capable of dealing with rapid developments, and to be able take broad social and ethical issues fully into account.

5.21 The HGC now plays a key role in the UK’s advisory and regulatory framework, including:

• assisting in the identification of gaps, overlaps, fragmentation or other problems, and ways of addressing them, by promoting coordination between bodies in the advisory and regulatory framework for human genetics;
• developing an overview of the regulatory and advisory framework, enabling the HGC to advise Ministers as needed on issues relevant to the framework as a whole;
• managing change, by providing information that will inform Ministers’ decisions on the practical implications of advances, by identifying current and potential developments in human genetics and their implications for the National Health Service (NHS) and providing guidance as needed on general issues about the introduction and use of novel technologies, including in the NHS; and
• providing advice to Ministers, to inform decisions on broad social and ethical issues, in particular information on the current situation, likely developments and the views, wishes and concerns of the public and other stakeholders.

5.22 The HGC already has published a number of useful research and information documents, commissioned a survey of public opinion, and engaged in a significant level of public consultation.^[25]

5.23 The 22 part-time members of the HGC cover a wide range of expertise, interests and experience, including clinical genetics, genetic research, general medical practice, law, bioethics, theology, disability advocacy, nursing, pharmaceutical research, consumer protection, journalism, and family studies. The members include the chair of the Human Fertilisation and Embryology Authority and the nominees of the Chief Medical Officers from each of the four home counties. Appointments are usually for three years and may be renewed. The current Chair of the HGC is Baroness Helena Kennedy, a leading barrister, and the Deputy Chair is Professor Alexander McCall Smith, a leading authority on health and medical law.

5.24 In order to develop its projects, the HGC has operated through a number of Working Groups and Sub-Groups (comprised of HGC members and co-opted experts). These include the Working Group on the Storage, Protection and Use of Genetic Information (six HGC members plus one co-opted); the Working Group on Genetic Testing Services Supplied Direct to the Public (ten HGC members); the Public Involvement in Genetics Sub-Group (six HGC members plus three co-opted); and the Horizon-Scanning Sub-Group (four HGC members plus three co-opted).

5.25 In a particularly interesting initiative, the HGC also has set up a Community Consultative Panel of 106 people to provide the direct insights and experiences of people with a genetic disorder and to act as a sounding board for the HGC’s reports and recommendations. The Panel includes people who have experience of single gene, chromosomal and multifactorial disorders, and of early and late onset disorders. Some Panel members are themselves affected, others are carriers or have experience as a parent of a child affected by a genetic disorder or as a carer for someone in the family who is affected.^[26]

5.26 The Secretariat for the HGC is provided by officials of the Department of Health and the Office of Science and Technology, and is based (and physically housed) within that Department.^[27]

Ontario Advisory Committee on Genetics

5.27 In April 2000, the Ministry of Health and Long-Term Care of the Canadian Province of Ontario established an Advisory Committee on New Predictive Genetic Technologies in order ‘to help Ontario navigate the new frontier of human genetic medicine and science’.^[28] Its mandate is to

develop a policy framework for introducing new genetic predictive testing and services into Ontario’s health care system. This framework would help ensure that the provincial health system promotes wellness and improves health outcomes in advance of the appearance of disease. The Committee would also develop guidelines, principles, broad criteria and advice to guide decisions on how new genetic services should be incorporated into the province’s health care system.^[29]

5.28 The multidisciplinary Advisory Committee included geneticists; a genetic counsellor; family physicians; genetic researchers; laboratory directors; academics in law, ethics and medicine; educators; a clinical epidemiologist; an expert in psychosocial issues; and representatives from the Canadian Cancer Society, the Heart and Stroke Foundation, the Huntington Society of Canada, the Ontario Association of Medical Laboratories, the Ontario College of Family Physicians, the Ontario Hospital Association, and officers of the Ministry of Health and Long-Term Care.

5.29 The work of the Committee was divided among six sub-committees, which were able to co-opt additional expertise, as needed: education; evaluation; clinical practice; psychosocial issues; laboratory practice; and legal and ethical issues.

5.30 The Report has a number of interesting things to say about the impacts of the new genetic technology on health systems, clinical practice, patients and the general community. However, the central recommendation was that:

the need for further consultation and implementation be recognized through an ongoing process. With this in mind, it is recommended that Ontario establish a Provincial Genetics Advisory Committee.^[30]

5.31 The suggested areas of coverage for this proposed permanent advisory committee include:

• new developments in the genetic sciences;
• evaluation of existing genetic services;
• recommendations on the timely provision of new genetic tests and services following formal evaluation of proposed genetic testing by the committee;
• legal and social issues;
• human and infrastructure resource requirements for genetic services;
• educational needs for Ontarians, including professions involved in all aspects of the provision of genetic services;
• a process for the implementation of new genetic services that includes both public and private laboratories; and
• any other areas as requested by the provincial government.

5.32 The Report also recommended that the permanent advisory committee’s membership should be broadly constituted:

reflective of the broad based expertise necessary to achieve its mandate including geneticists, genetic counsellors, health economists, legal/ethical experts, epidemiologists, laboratory scientists, mental health professionals, and community representatives, including members of health related voluntary organizations.^[32]

5.33 Another issue considered was to whom the permanent advisory committee should report. Although it was acknowledged that many of the issues that will arise for the committee would fall within the jurisdiction of other departments, such as Education, Finance, and Consumer and Commercial Relations, it was decided that it would be best for the committee to be situated in the Ministry for Health and Long-Term Care, since its core responsibilities would be connected to patient interests and the improvement of the publicly funded health care system. The Report also sensibly proposed that the permanent advisory committee maintain close liaison with other relevant committees, such as those that deal with the nature and quality of laboratory services.^[33]

5.34 On 24 July 2002, the Minister for Health and Long-Term Care announced the establishment of the Ontario Advisory Committee on Genetics, with a brief to

provide advice to the government about the newest developments in genetic sciences and new genetic tests to benefit the people of Ontario. … The committee’s mandate will also include clinical evaluation of existing genetic services and recommendations on the timeliness of new genetic tests and services following formal evaluation of proposed genetic testing by the committee.^[34]

5.35 The foundation Chair of the Advisory Committee on Genetics is Dr Ronald Carter, President of the Canadian College of Medical Geneticists, and Head of Cancer Genetics for the Regional Genetic Services of South Central Ontario.