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At least 19 recordsLinked to original sources
PubMed2004

The human genome: lessons for life, love and the law.

In 2003, the Australian Law Reform Commission and the Australian Health Ethics Committee (of the National Health and Medical Research Council) completed a major inquiry into the Protection of Human Genetic Information, focusing on privacy protection; protection against unlawful discrimination based on genetic status; and the establishment and maintenance of high ethical standards. The joint inquiry considered these matters across a wide range of contexts, with the final report, Essentially Yours, making 144 recommendations in such diverse areas as medical research; clinical genetic services; genetic research databases; employment; insurance; immigration; sport; parentage testing; and law enforcement. This article discusses some of the major themes that emerged in the course of the inquiry and underpinned the broad-based strategy adopted to prepare Australia for the challenges of the "New Genetics".

Australia↗
PubMed2003

The Australian joint inquiry into the Protection of Human Genetic Information.

The Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee are currently engaged in an inquiry into the Protection of Human Genetic Information. In particular, the Attorney-General and the Minister for Health and Ageing have asked us to focus, in relation to human genetic information and tissue samples, on how best to ensure world's best practice in relation to: privacy protection; protection against unlawful discrimination; and the maintenance of high ethical standards in medical research and clinical practice. While initial concerns and controversies have related mainly to aspects of medical research (e.g. consent; re-use of samples) and access to private insurance coverage, relevant issues arise in a wide variety of contexts, including: employment; medical practice; tissue banks and genetic databases; health administration; superannuation; access to government services (e.g. schools, nursing homes); law enforcement; and use by government authorities (e.g. for immigration purposes) or other bodies (e.g. by sports associations). Under the Australian federal system, it is also the case that laws and practices may vary across states and territories. For example, neonatal genetic testing is standard, but storage and retention policies for the resulting 'Guthrie cards' differ markedly. Similarly, some states have developed highly linked health information systems (e.g. incorporating hospitals, doctors' offices and public records), while others discourage such linkages owing to concerns about privacy. The challenge for Australia is to develop policies, standards and practices that promote the intelligent use of genetic information, while providing a level of security with which the community feels comfortable. The inquiry is presently reviewing the adequacy of existing laws and regulatory mechanisms, but recognizes that it will be even more important to develop a broad mix of strategies, such as community and professional education, and the development of official standards and industry codes that reflect emerging international best practice in the area.

Advisory Committees↗
PubMed2005

Balancing innovation and access to healthcare through the patent system--an Australian perspective.

This article examines the enforcement of gene and other research tool patents in Australia. An empirical analysis of patenting practices in the Australian medical biotechnology industry showed heightened concern about the impact of patents on research and diagnostic testing, but provided little evidence to support these concerns at that time. Since then, the Australian company Genetic Technologies Ltd. has been enforcing its patents for non-coding DNA sequences. The governments of Australia are encouraging the biotechnology industry to better protect and enforce intellectual property rights, but recognize these needs to be balanced against access to healthcare. The article discusses proposals made by the Australian Law Reform Commission to adjust the balance, both by tightening the requirements for obtaining patents and by introducing various options to assist providers of diagnostic services and others in using patented inventions, but at the same time maintaining the incentive to innovate.

Australia↗
PubMed2004

The human genome, property of all: opportunities under the ALRC inquiry into gene patenting and human health.

This article highlights the revolutionary and dramatic implications brought about by the advances in genetics. Among the myriad of legal problems involved, gene patenting is regarded as one of the most controversial. In a critical evaluation of the current inquiry into gene patenting and human health, the author argues that the Australian Law Reform Commission falls short of a thorough recommendation by failing to grant due recognition to the Universal Declaration on the Human Genome and Human Rights. Starting with the fundamental premise that the human genome is the 'heritage of humanity', it is argued that the fruits of genetic research must flow back to humankind, and any law reform process must thereby ensure that the economic and health benefits of genetic research are available to all. Specifically, the Patents Act 1990 (Cth) should be amended to include the 'medical treatment' defence to patent infringement, following the lead of overseas jurisdictions. It should also incorporate an 'experimental use' defence to ensure an unhindered approach to research and development. In doing so, the patent law regime will be truly balancing the interests at stake, which will accommodate more fully Australia's domestic needs and international obligations.

Advisory Committees↗
PubMed1983

Law reform, politics and mental health.

A major problem of democratic government is to get lawmakers to address controversial and sensitive subjects such as mental health law reform. By reference to current and past projects in the Australian Law Reform Commission, its Chairman outlines the way in which permanent law reform agencies can mobilise expert and community opinion to help the lawmaking process address sufficiently the needs of law reform. After outlining briefly the history of mental health law reform in English-speaking countries, the author suggests that moves for reform tend to come in 'cycles' or 'waves'. This is especially so in federations such as Australia. Reforms introduced in South Australia in 1976 are now working their way into the laws of other jurisdictions of Australia, where mental health law is basically a state concern. The reforms deal with such matters as legal representation for persons involuntarily committed and stricter definitions of circumstances for and objectives of hospitalisation of the mentally ill. Some comments are offered on new approaches to the defence of insanity in criminal trials following the jury verdict in the Hinkley case arising out of an attempt on the life of a President of the United States. The implications of this and other cases for the 'anti-psychiatry' movement are referred to and discussed. The author concludes with comments on the implications of mental health law reform for democracies. He suggests a law for law reform agencies in reconciling needs for law reform and community tolerance of change.

Advisory Committees↗
PubMed2004

Investigating genetic discrimination in Australia: opportunities and challenges in the early stages.

Genetic discrimination, defined as the differential treatment of individuals or their relatives on the basis of actual or presumed genetic differences, is an emerging issue of interest in academic, clinical, social and legal contexts. While its potential significance has been discussed widely, verified empirical data are scarce. Genetic discrimination is a complex phenomenon to describe and investigate, as evidenced by the recent Australian Law Reform Commission inquiry in Australia. The authors research project, which commenced in 2002, aims to document the multiple perspectives and experiences regarding genetic discrimination in Australia and inform future policy development and law reform. Data are being collected from consumers, employers, insurers and the legal system. Attempted verification of alleged accounts of genetic discrimination will be a novel feature of the research. This paper overviews the early stages of the research, including conceptual challenges and their methodological implications.

Australia↗
PubMed2006

Diagnostic testing of genetic disorders: limiting the scope of patent claims through disclosure requirements.

The breadth of claims in patents relating to genetic inventions has been controversial for some time. Possible adverse effects of broad claims include inhibiting research and higher costs, restricting patient access to genetic testing. The Australian Law Reform Commission's Report on Genes and Ingenuity--Gene Patenting and Human Health examined this issue, and concluded that the existing disclosure requirements contained in s 40 of the Patents Act 1990 (Cth) provide adequate mechanisms to control the breadth of claims. However, application of these requirements may be problematical in practice due to lack of relevant case law to provide guidance to patent examiners. It has been suggested that this deficit in direct judicial guidance can be obviated by developing appropriate analogies with other chemical systems in decided cases. This article focuses on gene-based diagnostic patents for human diseases, such as those held by Myriad Genetics for testing predisposition towards breast and ovarian cancer using the gene BRCA1. By examining the application of disclosure requirement by courts in genetic and non-genetic chemical inventions, it is possible to provide insight into how this might be applied by courts considering the validity of patent claims for diagnostic testing methods based on mutations in a gene such as BRCA1.

Australia↗
PubMed2006

Reforming the Human Tissue Acts.

The Human Tissue Acts of the various States and Territories that were enacted following the 1977 Report of the Australian Law Reform Commission on Human Tissue Transplants are in need of an overhaul as a result of rapid advances in medical science and biotechnology, as well as growing public expectations regarding the ethical use of tissues and organs obtained from autopsies and other sources. The author argues that the time is ripe for a comprehensive review and revision of the Acts throughout the country in order to maintain a consistent approach.

Australia↗
PubMed2005

Exploring the concept of genetic discrimination.

The issue of genetic discrimination has attracted growing attention and has been the focus of a recent major Australian inquiry. It is, however, a complex and loaded notion, open to interpretation. This paper explores the concept of genetic discrimination in both its theoretical and practical dimensions. It examines its conceptual underpinnings, how it is understood, and how this understanding fits within the legal framework of disability discrimination. The paper also examines the phenomenon in practice, including the 'fear factor' and the resulting implications for the development of regulatory policy. The paper argues that we need to be discerning in our interpretation of this term, and differentiate between discriminatory conduct which is legal and illegal. Further, it is argued that a concerted societal response to the 'problem' of genetic discrimination is needed involving targeted legal reforms as well as broader non-legal strategies.

Advisory Committees↗