Genetics and the law

Australia must act now to establish the pattern of laws, institutions and policies needed to guide us through the age of the 'New Genetics', according to a landmark report into the protection of human genetic information released recently.

The report, Essentially Yours: The Protection of Human Genetic Information in Australia, is the product of a two-year inquiry by the Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee (AHEC) of the NHMRC, involving extensive research and widespread public consultation.

Launched in Canberra by Attorney-General Daryl Williams and the Minister for Health and Ageing, Senator Kay Patterson, the report covers an extensive range of activities in which genetic testing and information does - or soon will - play an important role. The two-volume, 1200 page report makes 144 recommendations about how we should deal with the ethical, legal and social implications of the New Genetics.

ALRC President, Prof David Weisbrot, who chaired the inquiry, said it was the most comprehensive inquiry ever undertaken into these issues here or overseas, and very timely.

"The enormous promise of genetic research for improving human health is well known. However, it is also permeating and influencing many other aspects of Australian society, such as employment, insurance, law enforcement, family and kinship relations, immigration, sports and the delivery of clinical genetic services," he said.

Prof Weisbrot said that genetic science is developing so rapidly that it is leaving major gaps and shortfalls in the legal protections for human genetic information.

"Now is the time to lay down the basic rules and regulatory mechanisms in this area. This will require some additions and amendments to existing law. However, the challenges of the New Genetics demand a broader mix of strategies, involving stronger ethical guidance and oversight, industry codes, community and professional education, and - recognising the complexities and the fast pace of change - a new standing advisory body, to be called the Human Genetics Commission of Australia.

"Genetic testing is an area that is so personal and so sensitive that it's critical we get this right - and do so now - to avoid the crisis of confidence and the public backlash that inevitably would follow from poor or unethical practices."

"Australia has an opportunity to be an international leader in the protection of human genetic information. This inquiry has attracted significant interest overseas, and this report will be keenly studied by governments and policymakers around the world," Prof Weisbrot said.

AHEC Chair Dr Kerry Breen said: "Our basic brief was to encourage the beneficial and intelligent uses of genetic information while considering how best to protect privacy, protect against unfair discrimination, and ensure that we maintain high ethical standards.

"We have gone to great lengths to engage the public, and have been gratified by the large number of people who attended meetings and provided written submissions. We have benefited greatly from their insights and experiences and have taken their views very seriously. In general, we found strong public support for continued research aimed at providing better medical diagnosis and treatments - but there is also some general anxiety about how we might regulate such rapid scientific advances in the public interest.

"In response, we have made recommendations targeted at improving the system for ethical oversight of genetic research, as well as suggesting improvements for the quality and delivery of medical genetic services," Dr Breen said.

The Inquiry's key recommendations include:

• The establishment of a standing Human Genetics Commission of Australia (HGCA) to provide high-level, technical and strategic advice about current and emerging issues in human genetics, as well as providing a consultative mechanism for the development of policy statements and national guidelines in this area.
• Discrimination laws should be amended to prohibit unlawful discrimination based on a person's real or perceived genetic status.
• Privacy laws should be harmonised and tailored to address the particular challenges of human genetic information, including extending protection to genetic samples, and acknowledging the familial dimension of genetic information. For example, doctors might be authorised to disclose confidential information to a genetic relative where it is necessary to avert a serious threat to an individual's life, health, or safety.
• Ethical oversight of genetic research should be strengthened by: ensuring that all genetic research complies with NHMRC standards; better supporting Human Research Ethics Committees; providing more guidance to researchers and research participants about best practice; developing new rules to govern the operation of human genetic research databases; and tightening reporting requirements.
• Employers should not be permitted to collect or use genetic information - except in those rare circumstances where this is necessary to protect the health and safety of workers or third parties, and the action complies with stringent HGCA standards.
• The insurance industry should be required to adopt a range of improved consumer protection policies and practices with respect to its use of genetic information (including family history) for underwriting purposes. New laws and practices should ensure that: genetic information is only used in a scientifically reliable and actuarially sound manner; reasons are provided for any unfavourable underwriting decision; industry complaints-handling processes are strengthened and extended to cover underwriting decisions; and industry education and training about genetics are improved.
• A new criminal offence should be created to prohibit someone submitting another person's sample for genetic testing knowing that this is done without consent or other lawful authority (eg, a court order, or the statutory authority given to police officers).
• Lack of harmonisation is threatening the effectiveness of any national approach to sharing DNA information for law enforcement purposes. Australian governments should develop national minimum standards on the collection, use, storage, destruction and matching of DNA samples and profiles. No inter-jurisdictional sharing of information should be permitted except in accordance with these minimum standards.
• DNA parentage testing should be conducted only with the consent of each person sampled, or pursuant to a court order. Where a child is unable to make an informed decision, testing should proceed only with the consent of both parents, or a court order.