Genetic testing, ethical concerns, and the role of patent law

Abstract

This article examines the changing debate over gene patenting and the possible connection between patent law and the ethical and policy concerns associated with the use of genetic testing technologies (e.g. the premature implementation and inappropriate marketing of genetic tests). Arguably, patent law helps to form the market forces that lead to these concerns. It is suggested that existing safeguards fail to control these concerns because of, for example, a lack of provider knowledge and an absence of an adequate regulatory framework. While patent law can be associated with a number of ethical and policy concerns, the article also suggests that patent law may have a positive role in reducing them. Patent law provides policy makers and the public with a focal point - the patent holder - upon which to attach accountability for ethical and legal conduct. The article concludes by inviting policy makers to consider the ways in which patent law could be modified in order to optimize its constructive influence.

Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: Comparing breast and ovarian cancers with colon cancers

“…This contrasts sharply with the Working Group with Stanford’s Program in Genomics, Ethics and Society, which recommends that ‘for most people, testing for BRCA1 and BRCA2 mutations is not appropriate.’ While all genetic testing policies are undoubtedly motivated by a degree of self-interest, it is hard to deny the strong, and possibly adverse, impact of the profit motive in this context. (p. 371)80…”

Modern Advances in Genetic Testing: Ethical Challenges and Training Implications for Current and Future Psychologists

“…Others argue that it will result in a modern “eugenics,” with efforts to “purify” the gene pool (Lemke, 2002). Further concerns center on the patenting and ownership of genetic material (Caulfield & Gold, 2000) and the ability of children to consent to genetic testing (Geller, Tambor, Bernhardt, Fraser, & Wissow, 2003). The debate over genome sequencing is both politically and ethically charged, and clients and psychologists are likely to have strong viewpoints about the merits and psychological costs of predictive testing.…”

“…Transferring genetic data requires that samples have been securely coded and deidentified and that proper technical and organizational measures prevent against unauthorized access, alteration, loss, and accidental or illegal data destruction (Godard, Schmidtke, Cassiman, & Aymé, 2003). In addition to issues of data transfer, organizations may have legal ownership of clients’ genetic material (Caulfield & Gold, 2000). Such ownership is likely to entail more detailed descriptions from practitioners of how and why genetic data will be used.…”

Where There’s a Web, There’s a Way: Commercial Genetic Testing and the Internet

“…For example, in the US the Clinical Laboratory Improvement Amendments (CLIA) regulate laboratories and the Food and Drug Administration (FDA) controls test kits; in Canada, laboratories are accredited provincially while the federal government, through its Therapeutics Products Directorate and the Biologics and Genetic Therapies Directorate, oversees pharmaceuticals and diagnostic test kits. However, a hole exists in Canadian [50, 51]and American [52, 53]regulations. In contrast to over-the-counter test kits (which are considered products), there is currently no direct oversight of ‘home-brew’ or in-house laboratory-based tests which constitute the majority of commercial genetic tests.…”