Timothy Caulfield is at the Health Law Institute at the University of Alberta, Canada.

For years, commentators have been speculating on the potential adverse implications of market forces on the implementation and use of genetic services. Although the involvement of industry is both necessary and desirable for developing and disseminating genetic technologies, the resulting commercialization process is associated with social, ethical and health policy concerns.

In this issue, for example, Lori Andrews comments on the potential adverse implications of gene patents on the research environment and on the public's access to important genetic testing services. Myriad Genetics' recent decision to actively enforce its patents on the technologies associated with two breast cancer genes, BRCA1 and BRCA2 (as discussed by Andrews), highlights the impact that gene patents have on this access. According to a recent survey in Canada, the public generally support gene patents, but they have serious concerns about equity and access1.

In addition to such concerns, gene patents might also contribute to the “overselling” of a given technology. Patent holders have a natural and understandable desire to see their inventions used rapidly and by as large a market as possible. But might this market pressure lead to the premature implementation of genetic services? Some have speculated that this might be so, and that financial interests and professional enthusiasm led to the premature commercialization of the tests for the APOE4 and the BRCA mutations2. For example, it has been suggested that “commercial interests” led to the marketing of APOE4 genotyping for “predicting the future development of [Alzheimer disease] in asymptomatic individuals”3, despite uncertainty about the clinical utility of the test. Market pressures might also cause commercial labs to market their services to an inappropriately broad sector of the population (the broader the definition of “at risk”, the larger the market). Indeed, it can be argued that creating a demand is a natural consequence of private sector involvement.

To maximize the health care benefits promised by the genetic revolution, we need policies that mitigate the inevitable ramifications of market forces in this context. For example, governments must develop systems to allow for the independent evaluation of the efficacy and utility of genetic services. The marketing of genetic services, as with other health care products, should also be carefully monitored. In addition, the international community needs to give serious consideration to the reform of the existing patent system, including the possible adoption of new patent licensing schemes, as discussed by Andrews.

By fostering public trust and a high quality of care, the appropriate regulation of genetic technologies will benefit both the public and, in the long term, the biotech industry.