The ALRC Report into the Protection of Human Genetic Information
In brief: This feature article provides an overview of the discussion paper on genetic information, recently released by the Australian Law Reform Commission.
- Background
- Basis of the Inquiry and summary outcomes
- A major proposal – establishment of HGCA
- Other issues
- Significant questions
- Significant proposals
Background
As reported in the last edition of Biotech News, on 28 August 2002 the joint Inquiry of the Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee released Discussion Paper no. 66, entitled 'Protection of Human Genetic Information'.
The origin of DP 66 dates back to 5 February last year, when Attorney General Daryl Williams and (then) Health Minister Dr Michael Wooldridge framed terms of reference for the joint Inquiry. These included how best to protect privacy, to safeguard against unfair dismissal and to ensure the highest ethical standards in Australian genetic research and clinical practice.
Due to the number and importance of issues raised by DP 66 for Australia's biotech industry, Biotech News will discuss several aspects of DP 66 over the next three editions:
- 24 September Recommendations/implications as to genetic testing
- 8 October Implications of the report for medical research and genetic databases
- 22 October Implications of the report for: insurance; employment; and privacy.
This edition's article provides a background to, and overview of, DP 66.
Basis of the Inquiry and summary outcomes
The Inquiry was prompted by ethical concerns over rapid advances in human genetic technology and their potentially detrimental applications, including inappropriate and/or discriminatory use of human genetic information. A key aspect of the Terms of Reference is whether (and to what extent) changes to Australia's existing regulatory framework are required to protect human genetic samples and information and prevent inappropriate use thereof.
The Inquiry has undertaken an exhaustive review of all legal and ethical aspects of genetic testing, from research use and databases, through to employment, OH&S, insurance, parentage, aboriginality, intellectual property/ownership and the forensic use of genetic material.
As the discussion paper notes,
"Careful consideration of the legal and policy issues thrown up by the use of genetic samples and information requires a wide range of interests to be balanced... [A]chieving the proper balance is difficult in practice, since various interests will compete and clash across the spectrum of activity. For example, employers may wish to discover and use genetic information since they must fulfil common law and statutory duties to provide a healthy and safe work environment for their employees. Employers also have direct economic incentives to reduce insurance premiums and sick leave, and to guard against future lawsuits by employees whose genetic predisposition to an illness may have been triggered by environmental factors present in the workplace. At the same time, employees have a strong interest in preserving their privacy and being protected against unfair discrimination based on their genetic status.
The current methods of regulation and conflict resolution involve a patchwork of federal, state and territory laws; official guidelines; personal and professional ethics; institutional restraints; peer review and pressure; oversight by public funding authorities and professional associations; supervision by public regulatory and complaints-handling authorities; private interest; and market pressures."
The Inquiry stresses that its proposals do not represent the final views or recommendations of the Inquiry, and are subject to revision – the final report and recommendations inevitably will be influenced by subsequent submissions, consultations and research.
A major proposal – establishment of HGCA
The Inquiry's major regulatory proposal is the establishment of a Human Genetics Commission of Australia (HGCA), following the lead of the United Kingdom, the United States and Canada. If established, the Commission will have a principal role of providing on-going, high-level technical advice to Australian governments about existing and emerging issues in human genetics, in addition to the ethical, legal and social implications arising from these developments.
The HGCA would also play a leadership role at the national level, by promoting harmonisation of laws and practices; promoting public engagement and community and professional education; and developing policy statements and national guidelines in this area. The HGCA would work closely with other government agencies, or relevant industries and organisations.
One example proposed by the Inquiry of work the HGCA could perform is to become responsible for approving particular genetic (and related) tests for use by the insurance industry for risk-rating purposes, or perhaps for use by employers where there are compelling occupational health and safety reasons to do so.
Other issues
A major emphasis of DP 66 is the need for informed consent to genetic testing and the lack of adequate safeguards against non-consensual testing. However, the Inquiry recognises that genetic testing cuts across many areas and no single solution can adequately address all issues.
In an earlier era, the centrepiece of any significant law reform effort often was the recommendation of a major new piece of legislation. However, in a more complex environment in which authority is much more diffused, modern law reform efforts are likely to involve a mix of strategies and approaches, including legislation and regulations; official standards and codes of practice (such as those promulgated by the National Health and Medical Research Council and the Privacy Commissioner); industry codes and best practice standards; education and training programs; better coordination of governmental and intergovernmental programs; and so on. Thus, the proposals contained in DP 66 are addressed to a range of parties and not merely to the Commonwealth Government.
Accordingly, DP 66 proposes greater controls over the collection and
use of genetic information.
Forthcoming editions of
Biotech News will discuss these issues in further detail in the specific
contexts noted above. At this stage, we have listed below the key
proposals/questions posed by DP 66.
Significant questions
- Should laboratories that conduct genetic testing be accredited by the National Association of Testing Authorities (NATA)?
- Should accreditation standards only permit genetic testing to be conducted on samples collected with appropriate consent of the individual or a Human Research Ethics Committee (HREC)?
- Should HRECs be accredited?
- Should human genetic databases be licensed or registered?
Significant proposals
- Conducting genetic testing on any sample without consent should be a criminal offence unless permitted prior, such as research on de-identified samples approved by HRECs.
- The Privacy Act should be amended to define 'personal information' to include bodily samples from an individual whose identity is readily apparent or reasonably ascertainable.
- Federal anti-discrimination legislation should be amended to prohibit discrimination based in genetic status and to clarify the applicability of the legislation to a disability that may exist in the future.
- Human genetic research that does not comply with the NHMRC National Statement should be prohibited.
- Full property rights in genetic samples should not be granted; rather the common law rights to possession of preserved samples (currently enjoyed by hospitals and researchers) should continue to be recognised.
- Insurers should not use a predictive genetic test in underwriting mutually rated insurance unless the HGCA has approved the test for that purpose.
- Insurers who refuse insurance on the basis of genetic information should give clear and meaningful reasons explaining the actuarial or statistical basis for the decision.
- Genetic screening of potential employees for susceptibility to work-related conditions should only be conducted where (i) there is strong evidence of a clear connection between the working environment and the development of the condition; (ii) the condition may seriously endanger that person's health or safety; and (iii) that danger cannot be eliminated or significantly reduced by reasonable measures.
- DNA parentage testing should only be conducted by laboratories accredited by NATA.
- Results of DNA parentage testing should only be admissible in family law proceedings where the test was conducted with the signed consent of each adult donor; and the child should also be involved in the decision to undergo a parentage test if aged above 12 and has sufficient maturity to make a free and informed decision.
Public comment on DP 66 closes on 29 November 2002 – the ALRC encourages written submissions on any aspect of the DP. Further information on making a submission may be obtained by contacting the ALRC. The Inquiry's final report and recommendations are to be announced by 31 March 2003.
