Implications of genetic testing: discrimination in life insurance and future directions

This article examines the possibility of genetic discrimination in life insurance and discusses the inability of current Australian legislation to deal adequately with genetic test result information. Genetic information has certain features that distinguish it from other medical information and thus a specialist legislative package is required to regulate its use. This article outlines how current practices in the life insurance industry are inconsistent with notions of human rights. Several legislative options are suggested and examined. Given the negative and damaging impact that adverse selection is likely to have on the life insurance industry should the use of all genetic test results be prohibited, an approach which modifies the current regime is recommended. This includes a comprehensive review scheme and the introduction of additional insurance products tailored to individuals suffering from various genetic illnesses or predispositions to future disease.     

PGTandMe: social networking-based genetic testing and the evolving research model

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.     

商业化基因检测的法律规制

商业化基因检测有别于医疗服务行为,是主要面对消费者提供的检测服务.由于其发展较快,行业内未形成规范化的标准,使得检测市场较为混乱.介绍了商业化基因检测的现状和问题,论述了对商业化基因检测加以规制的必要性并提出了相关的对策建议.     

A threat or a promise: acquisition of teaching hospitals by investor-owned chains

In the early 1980s, acquisition of a small number of teaching hospitals by investor-owned chains raised the spectre of a for-profit takeover of teaching institutions. Drawing on experience to date, as well as interviews with affected parties, this article assesses the likely scope of such acquisitions and their impact on the education, research, and indigent care that teaching hospitals provide. Our assessment concludes that relatively few teaching hospitals are likely to satisfy the financial criteria chains apply to acquisitions; that hospitals with modest rather than extensive commitments to education and research are most likely to satisfy these criteria; and that terms of sale typically enhance, rather than undermine, these institutions' resources for research, education, and, to a lesser extent, indigent care, at least in the short run. In the long run, continuation of these activities is more likely to be a function of third-party payment policies than of proprietary versus nonprofit hospital ownership.     

Prenatal genetic testing and screening: constructing needs and reinforcing inequities

This Article considers the influence and implications of the application of genetic technologies to definitions of disease and to the treatment of illness. The concept of "geneticization" is introduced to emphasize the dominant discourse in today's stories of health and disease and the social construction of biological phenomenon is described. The reassurance, choice and control supposedly provided by prenatal genetic testing and screening are critically examined, and their role in constructing the need for such technology is addressed. Using the stories told about prenatal diagnosis as a focus, the consequences of a genetic perspective for and on women and their health care needs are explored.     

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.     

Putting together the pieces: recent proposals to fill in the genetic testing regulatory puzzle

The idea that genetic information is different from other medical information and therefore needs special protection has led to a regulatory puzzle where genetic testing is currently regulated under three separate schemes. Although genetic tests for over 2,000 diseases are available, less than 10% of these tests have been reviewed for clinical validity or utility. Recent action by some genetic testing companies has prompted the federal government to propose changes to the current regulatory scheme. This article discusses the current framework and the recent developments before examining some of the concerns and challenges that face the implementation of these proposed changes. The author evaluates the proposals and competing interests in order to suggest how genetic testing may best be regulated to meet the needs of the industry, clinicians, researchers, patients, and consumers.