Feature
The ALRC report into the protection of genetic information - the implications for genetic testing
In brief: Lawyer Caroline Ryan discusses how the recent Australian Law Reform Commission Discussion Paper on the protection of human genetic information could affect the provision of genetic testing in Australia.
Background
As reported in previous editions of Biotech News, the joint Inquiry of the Australian Law Reform Commission and the Australian Health Ethics Committee released Discussion Paper No. 66, "Protection of Human Genetic Information", on 28 August 2002. This edition's article focuses on the Inquiry's preliminary comments in relation to access to genetic testing, accreditation of test service providers, and proposed reforms to regulate aspects of non-consensual genetic testing.
During the course of the Inquiry, it was acknowledged that the regulation of genetic testing in Australia is currently made up of a patchwork of regimes. The existing framework includes federal, state and territory regulations, official guidelines and a variety of institutional and ethical (both professional and personal) restraints. With this in mind, the Inquiry's brief includes scrutinising the existing regimes and, where possible, tailoring the existing framework to the particular demands of genetic testing. Where appropriate, the Inquiry has proposed new forms of regulation to address existing gaps in the current legal framework.
The scope of "genetic testing"
Different views emerged during the Inquiry as to what the definition of genetic test should be for the purposes of the Discussion Paper. Without being able to provide a comprehensive definition appropriate to all contexts, the Inquiry acknowledges that the term genetic testing includes the direct testing of genetic material and the biological products of genes.
Access and accreditation
Access to genetic testing in Australia is affected by a number of factors, such as the availability of a particular test, the cost involved and the protocol in providing such services which can vary depending on the particular laboratory approached.
Australian laboratories are currently accredited by a national scheme overseen by the National Association of Testing Authorities, Australia (NATA). Non-accredited genetic testing may be conducted in Australia by non-accredited laboratories, or by accredited laboratories that do not comply with the accreditation criteria in respect of a particular test or category of tests, provided these laboratories do not hold themselves out as being accredited for the purpose of the particular test.
Traditionally, medical practitioners have been the primary means of
accessing genetic tests. This more traditional path had a number of safeguards,
such as referral procedures and counselling for the patient by the practitioner,
in addition to the legal and professional protocol involved in conducting such
tests.
The Discussion Paper highlights the growth of alternative pathways to
genetic testing, such as direct access to laboratories by individuals, access to
overseas facilities via the Internet and over the counter (or "do it yourself")
genetic testing kits. The reliability of these forms of genetic testing are of
serious concern to the Inquiry, as are the ramifications of results supplied
from fraudulently obtained samples.
The Inquiry has proposed that:
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"do it yourself" style test kits be regulated by the Therapeutic Goods Administration, with a Code of Practice to be developed by the proposed Human Genetics Commission of Australia;
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in the interests of accurate and reliable paternity testing, NATA accreditation should be mandatory for all Australian laboratories conducting DNA parentage testing; and
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consideration be given to enacting legislative restrictions in relation to the use of non-accredited genetic testing in evidence for court proceedings.
It was also suggested that the accreditation process should ensure that samples are only collected by laboratories with the appropriate consent of the individual to whom the sample relates, or as approved by the Human Research Ethics Committee in some research situations.
The issue of regulating test services offered via the Internet by overseas laboratories was acknowledged in a number of submissions as having merit, but as being difficult to implement in practice. The Inquiry has invited further public comment on whether legislation should be enacted to prohibit Internet advertising of "do it yourself" style test kits.
Non-consensual genetic testing
A major emphasis of the Discussion Paper was the need for informed consent to genetic testing, and the lack of safeguards in the existing legal framework against non-consensual testing.
In light of the accessibility to testing services and the difficulties in regulating access to and conduct of laboratories overseas, the Inquiry has formed the tentative view that a criminal offence in relation to non-consensual genetic testing should be introduced.
The current proposal suggests that criminal liability should attach to any individual or corporation that, without lawful authority, submits a sample for genetic testing, or conducts genetic testing on a sample, knowing (or recklessly indifferent to the fact) that the individual from whom the sample has been taken did not consent to such testing. It was noted that the UK Human Genetics Commission recently made a similar recommendation.
This proposed offence would not apply to authorised non consensual testing, such as where a law enforcement officer acts with statutory authority under forensic procedure laws, or where the HREC approves testing of samples for research purposes under the existing regulatory framework.
The Discussion Paper stresses that these proposals do not represent the final view or recommendation of the Inquiry and may be subject to revision. Public comment on the issues raised in the Discussion Paper will close on 29 November 2002. Written submissions are encouraged and further information can be obtained by contacting the ALRC.
For further information, please contact Peter Allen on +61 7 3354 3351.
