The terms of reference directed the ALRC and the Australian Health Ethics Committee (AHEC) to consider, with respect to human genetic information and the samples from which such information is derived, how best to:
- protect privacy;
- protect against unfair discrimination; and
- ensure the highest ethical standards in research and practice.
The experience of the inquiry, mirrored overseas, is that the rapid pace of scientific change has produced two powerful, but conflicting, social reactions. On the one hand, there is very strong public support for breakthroughs promising better medical diagnosis and treatments, and for assisting with law enforcement (including identification of missing or deceased persons). On the other hand, there are anxieties about loss of privacy and the potential for genetic discrimination, as well as about the capacity to regulate genetic science in the public interest.
The major challenge for the inquiry was to find a sensible path that meets twin goals: to foster innovation in genetic research and practice that serve humanitarian ends, and to reassure the community that such innovations will be subject to proper ethical, legal and other controls.
This two-year inquiry, involving extensive research and widespread public consultation was the most comprehensive inquiry ever undertaken into these issues in Australia or overseas.
- 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 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 permitted under anti-discrimination laws (as amended) or 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 for 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.
The recommendations of ALRC Report 96 are addressed to a wide range of parties and not merely to the Australian Government. For this reason, the report contains an Implementation Schedule, making clear the lines of responsibility for implementing the recommendations.
The Australian Government issued a formal response to the recommendations of ALRC 96 on 9 December 2005, accepting many of the recommendations of the report: The full text of the government response is available on this website.
A number of recommendations have been acted on.
Human Genetics Advisory Commitee
The Human Genetics Advisory Commitee (HGAC) was established as a principal committee of the National Health and Medical Research Council (NHMRC) in November 2005, with its first members appointed from 1 January 2006. The HGAC is to provide on-going advice to the government on high-level technical and strategic issues in human genetics, and on the social, ethical and legal implications of human genetics and related technologies. The establishment of the HGAC implements the central recommendations of ALRC Report 96 (Recommendations 5–1 to 5–9).
Information and health privacy law
The Privacy Legislation Amendment Act 2006 (Cth) was passed by Parliament on 7 September 2006 and commenced operation on 14 September 2006. The Act implements the following recommendations ALRC Report 96:
- amendment of the definitions of ‘health information’ and ‘sensitive information’ in the Privacy Act 1988 (Cth) to expressly refer to genetic information (Recommendations 7–4, 7–5);
- amendment of the Privacy Act 1988 (Cth) to permit disclosure of genetic information by health professionals to the genetic relatives of the patient where there is a serious threat to an individual’s life, health or safety, but not necessarily an imminent threat (Recommendation 21–1);
- and provision for the development by the National Health and Medical Research Council, with approval by the Privacy Commissioner, of guidelines in relation to the disclosure of genetic information by health professionals to the genetic relatives of the patient (Recommendation 21–2).
A draft National Health Privacy Code has been developed by the National Health Privacy Working Group (a sub-group of the Australian Health Ministers’ Advisory Council). The aim of the Code is to provide a set of health-specific privacy principles that can be implemented nationally, harmonising health privacy protection. The draft code includes genetic information in its definition of ‘health information’. The Code is currently under consideration by the Health Ministers. The adoption of such a code would effectively implement Recommendations 7-1 to 7–3.
In ALRC Report 96, the ALRC recommended that the National Health and Medical Research Council (NHMRC), in consultation with the Office of the Federal Privacy Commissioner (OPC), should develop guidelines for health professionals dealing with disclosure of genetic information to the genetic relatives of their patients (Recommendation 21-2).
On 16 December 2009, the NHMRC, in cooperation with the OPC released The Use and Disclosure of Genetic Information to a Patient’s Genetic Relative under Section 95AA of the Privacy Act 1988 (Cth): Guidelines for Health Practitioners in the Private Sector. The Guidelines are designed to assist health practitioners in making decisions about disclosing genetic information to their patient’s genetic relatives, including the circumstances in which genetic information may be used and disclosed for the purposes of lessening or preventing a serious threat to the life, health or safety of an individual.
In 2008, the ALRC completed its review of the Privacy Act 1988 (Cth) with the release of the report For Your Information: Australian Privacy Law and Practice (ALRC 108). Part H of the report considers health services and research, including the harmonisation of health privacy protection. The Australian Government response to For Your Information accepted the majority of the ALRC’s recommendations relating to health privacy protection.
In July 2004 the Productivity Commission completed a review of the Disability Discrimination Act 1992 (Cth). As a part of the review, the Productivity Commission supported Recommendation 9–3 from ALRC Report 96 to amend the definition of ‘disability’ in the Act to clarify that the legislation applies to discrimination based on genetic status. The Government accepted the recommendations of the ALRC and the Productivity Commission on this issue.
The Disability Discrimination and Other Human Rights Legislation Amendment Act 2009 (Cth) received Royal Assent on 8 July 2009 (entry in force 5 August 2009) implementing two key recommendations of Essentially Yours:
- the amendment of the definition of ‘disability’ in the Disability Discrimination Act 1992 (Cth) to address discrimination on the basis of genetic status where a person may have the genetic markers for a condition but is presently asymptomatic (Recommendaton 9–3);
- the amendment of the Disability Discrimination Act to prohibit an employer from requesting or requiring information, including genetic information, from a job applicant or employee, except where the information is reasonably required for purposes that do not involve unlawful discrimination (Recommendation 31–3).
The ALRC made a submission to the Senate Standing Committee on Legal and Constitutional Affairs Inquiry into the legislation.
Medical genetic testing
In 2007, the National Pathology Accreditation Advisory Council (NPAAC) published Classification of Human Genetic Testing 2007 Edition, which is a supplementary guide to the Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis (2006). The new supplement took effect from 1 January 2008.
Non-consensual genetic testing
The ALRC’s Recommendation 12–1 provided that the ‘Standing Committee of Attorneys-General should develop a model criminal offence relating to non-consensual genetic testing, for enactment into Commonwealth, state and territory law. 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’.
This recommendation was suported in the December 2005 Whole of Government response, and the matter was referred to the Standing Committee of Attorneys-General (SCAG) for further development and consultation. In April 2007, SCAG asked the Model Criminal Law Officers’ Committee (MCLOC)—comprised of senior law officers from the Commonwealth, states and territories—to consider the merits of a draft model offence to criminalise non-consensual genetic testing.
On 7 November 2008, the Home Affairs Minister, the Hon Bob Debus MP, released for public consultation a Discussion Paper entitled ‘Non-Consensual Genetic Testing’. The Discussion Paper draws heavily on the ALRC’s thinking and discussion contained in Chapter 12 of Essentially Yours: The Protection of Human Genetic Information in Australia.
The Discussion Paper proposes three draft model offences for consideration:
- Offence of obtaining bodily material for genetic testing;
- Offence of the use of bodily material for genetic testing; and
- Offence of the disclosure or use of results from genetic testing.
Each of these offences has been developed along the lines of the ALRC’s Recommendation 12–1, requiring proof that the accused knew (or was recklessly indifferent to the fact) that the person concerned had not consented to the taking or testing of the DNA sample, and acted without other lawful authority (such as a court-ordered paternity test, or a police officer investigating a crime scene under forensic procedures legislation, or a scientist engaged in ethics-approved research). The Discussion Paper suggests that each of these offences should carry a maximum penalty of two years imprisonment.
The ALRC made a submission in response to the Discussion Paper, noting the ALRC’s recommendations in Essentially Yours (November 2008).
Human genetic research and databases
In March 2007, the National Health and Medical Research Council endorsed and published the revised National Statement on Ethical Conduct in Human Research. The revision incorporates a number of recommendations made in ALRC 96, including improved waiver of consent and unspecified consent provisions, clearer guidance on identifiable, re-identifiable and non-identifiable data, more stringent conditions for the establishment and running of biobanks and genetic registers, and ethical issues specific to genetic research. (Recommendations 15–1, 15–2, 15–4, 16–1, 17–1, 18–1, 18–2, 18–3).
Human tissue collections
The report recommends the development of nationally consistent rules in relation to the collection, storage, use and disclosure of, and access to, newborn screening cards (also known as ‘Guthrie Cards’) (recommendation 19-1). The Australian Health Ministers’ Advisory Council’s Advisory Group on Human Gene Patents and Genetic Testing is considering this issue. While Victoria supports national guidelines, there was concern about delays in their development, and a separate review on these issues was undertaken in that state. The Victorian Newborn Screening Review Committee presented its report to the Victorian Minister for Health in August 2006.
Genetic counselling and medical education
The Australian Health Ministers’ Advisory Council’s Advisory Group on Human Gene Patents and Genetic Testing is considering the development of guidelines for the appropriate delivery of genetic counselling services, and for the appropriate qualifications of those counsellors (see recommendations 23-2 and 23-3).
The Investment and Financial Services Association (IFSA) has undertaken a number of activities directly related to recommendations from ALRC 96 concerning insurance:
- In December 2005, IFSA implemented policy standards No 11 Genetic Testing and No 16 Family Medical History, implementing Recommendations 27–2, 27-4 and 27-6.
- Brochures for IFSA members on insurance and genetic testing have been reviewed to clarify how insurers use the results of genetic tests in applications received from a family member, and training sessions conducted around Australia to ensure that underwriters understand their roles and responsibilities under the new genetic information standards. These activities go towards fulfillment of Recommendation 27-10.
- IFSA is seeking a Public Interest Determination under the Privacy Act 1988 (Cth) in relation to the practice of collecting genetic information from applicants about their genetic relatives for use in underwriting insurance policies (Recommendation 28-3).
The HGAC has established communications with the insurance industry in order to monitor developments in the use of human genetic information in that industry.
The Family Law Regulations 2004 (Cth), which commenced operation on 23 December 2004, implemented a number of recommendations from ALRC 96 in relation to forms required for parentage testing under the Family Law Act 1975 (Cth). In particular, the amending Regulations prescribe that a recent photograph of the donor of a bodily sample must be attached to the affidavit that is to be provided to the sampler under the parentage testing procedures prescribed in the principal Regulations. The amending Regulations also prescribe that the relevant adult must swear or affirm that they consent to the taking of a sample from a child. This amendment addresses the concerns raised in ALRC 96 about substitution of a donor with the aim of avoiding a positive parentage result (Recommendation 35–6).
Genetic information and sport
In direct response to recommendations 38–1 and 38–2, a Protocol on the Ethical Use of Genetic Testing and Information in Sport was developed, and endorsed by the Australian Sports Commission. Final approval rests with the federal Minister for Sport.
In its response to ALRC Report 96, the Australian Government noted that many of the recommendations relating to law enforcement and forensic procedures legislation overlapped with the recommendations of the Report of the Independent Review of Part 1D of the Crimes Act 1914 – Forensic Procedures (the Part 1D Report) which was released in May 2003. The Government indicated that it had referred the recommendations raised by both reports to the Standing Committee of Attorneys-General (SCAG). There have been no significant amendments to Part ID of the Crimes Act except in relation to inter-jurisdictional sharing of DNA profiles.
Recommendations 40–1 and 40–2 sought the development of adequate national minimum standards in Australian forensic procedures legislation with respect to the collection, use, storage, destruction and index matching of forensic material and the DNA profiles created from such material, and to have those standards reflected in arrangements for inter-jurisdictional sharing of genetic information for law enforcement purposes.
The Crimes Act Amendment (Forensic Procedures) Act 2006 (Cth), which commenced operation in November 2006, clarified the legality of arrangements for inter-jurisdictional sharing of DNA profiles between the Commonwealth, states and territories. The legislation does not, however, adopt national minimum standards as recommended in ALRC 96.
Identification of deceased pPersons
An amendment contained in the Crimes Legislation Enhancement Act 2003 (Cth) gives effect to Recommendation 42-4 of the report. A provision of the Crimes Act, which regulates inter-jurisdictional sharing of information, has been amended to include the identification of missing or deceased persons. Previously, the law was limited to cross-border cooperation for the purposes of criminal investigations and proceedings.