Media release
Australian Law Reform Commission/Australian Health Ethics Committee
Wednesday, 28 August 2002
Human genetics revolution - safeguards require major upgrade
The revolution in genetic science means that Australia now requires a careful mix of strategies - stronger ethical oversight, stiffer regulations, industry codes, education campaigns, an independent expert advisory body, revised privacy and discrimination laws, and perhaps even new criminal laws - to ensure human genetic information is well protected and intelligently used.
After 18 months of investigation and wide public consultation, the Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee (AHEC) of the National Health and Medical Research Council have today released ALRC Discussion Paper 66, containing 105 proposals and 40 further questions, together with extensive supporting research and commentary.
ALRC President Professor David Weisbrot said rapid advances in genetic science mean these issues now impact on every Australian. "Today a person's DNA can be used for identification, to test for illness, and to help predict that person's future health and well-being. Your DNA can talk about you, your family and your community, so the implications of this are almost endless," he said. "We hear about using DNA for health and medical research, and for law enforcement. However, we also need to consider the activities of insurance companies, employers, sporting associations, government authorities, and in the courts."
The Inquiry, which began in February 2001, has had to find a sensible path between the beneficial uses of genetic information, and protecting people's privacy, rights and interests.
Dr Kerry Breen, Chair of AHEC, said: "We have found that in such a complex environment, you cannot simply pass a set of new laws. It will take action on many levels across many sectors to develop an effective and comprehensive system of regulation. We have consciously avoided one-size-fits-all solutions. For example, the way we deal with genetic material for research should be different from regulating its use by insurers or employers."
Among the Inquiry's key proposals:
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A broad-based, independent body-a Human Genetics Commission of Australia (HGCA)- should be established to provide high-level advice to governments and industry about human genetics, and to assist in developing and harmonising the existing "patchwork" of laws, guidelines and practices.
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Privacy laws should be revised to cover genetic samples as well as genetic information, and authorisation should be given to health professionals to disclose otherwise confidential personal genetic information to a genetic relative, where failure to disclose would place at serious risk the health or life of that relative.
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The Disability Discrimination Act 1992 (Cth) should be amended to ensure that it covers unlawful discrimination based on a person's (real or perceived) genetic status.
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The ethical oversight of all genetic research should be strengthened, by prohibiting any genetic research that does not comply with NHMRC's standards, by tightening reporting requirements and better supporting Human Research Ethics Committees (HRECs).
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Model research protocols and consent forms should be developed by AHEC to provide guidance to HRECs, researchers, and research participants about Best Practice.
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New rules should be developed to govern the operation of human genetic research databases, to ensure that due attention is given to ethical issues and privacy protection.
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As a matter of priority, all Australian governments should develop strategies to assess and respond to the growing need for more genetic counselling services.
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The TGA should be empowered to regulate home use (DIY) genetic testing kits.
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Employers should be prohibited from gathering and using genetic information, except in very limited circumstances - such as when it is necessary for occupational health and safety reasons, and the action complies with stringent standards.
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Existing genetic test information should continue to be available to insurers for the purpose of underwriting, but only where the test has been approved by the HGCA. The polices and practices of the insurance industry regarding the use of genetic information should be improved by enhancing industry education and training; providing reasons for unfavourable underwriting decisions; and ensuring that genetic information only is used in a scientifically reliable and actuarially sound manner, as required by law.
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Government should develop policies on the use of predictive genetic testing for assessing the health requirement under migration legislation, and should review policies about the provision of information to migration applicants regarding kinship testing.
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DNA parentage testing should be conducted only with the consent of each person sampled and, in the case of a child who is unable to make an informed decision, only with the consent of both parents or pursuant to a court order. Also, DNA parentage testing only should be conducted by NATA-accredited laboratories in accordance with accreditation requirements, for ethical and quality assurance reasons.
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ATSIC should consider the appropriate test or tests to be applied in determining Aboriginal or Torres Strait Islander identity, including the appropriateness or otherwise of using genetic testing and genetic information for this purpose.
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A new criminal offence should be created to prohibit a person or a corporation from submitting a person's sample for genetic testing, knowing that this is being done without the consent of the individual concerned, or without other lawful authority.
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All Australian governments should work together to harmonise Australian forensic procedures legislation, in particular in relation to the collection, use, storage, destruction and index matching of forensic material and the DNA profiles created from such material.
In developing these proposals, the Inquiry conducted 15 public forums around Australia, held more than 100 meetings with interested parties and received 168 written submissions. A number of overseas jurisdictions currently grappling with these issues were also considered.
"It is important for people to realise that these proposals are not final. We believe that these proposals represent a careful and sensible balance in each area of use, since there are almost always competing or conflicting interests involved. Before we finalise our thinking, we want the community to have an opportunity to consider these proposals in detail and to provide us with their views," Professor Weisbrot said.
The final report and recommendations will be given to the federal Attorney-General and the Minister for Health and Ageing by 31 March 2003.
"Because of the pace of developments in genetic research we must establish a flexible system which can react to rapid change," said Dr Breen. "Many of our proposals are related to improved education about human genetics for doctors, researchers, lawyers and judges, insurers, employers and others. People dealing with sensitive genetic information must understand the full ramifications of what they are doing."