Phase changes in the BRCA policy domain.

ABSTRACT

The recent US Supreme Court ruling against gene patenting has been accompanied by the passage at the federal level of the Patient Protection and Affordable Care Act, both events representing a thawing or phase change in policies that will now make preventive techniques, such as BRCA genetic testing to predict risk for familial breast and ovarian cancer, more affordable and accessible. Authors including Yun-Han Huang in this journal have noted the judicial ruling is one step--a significant one--in the process of patent system reform. This commentary links such changes with policy formation and action taken by members of diverse religious communities in the aftermath of the Human Genome Project and continuing in today's genome sequencing area. Religious engagement has acted as a catalyzing force for change in the creation and dissemination of genetic developments. Religious perspectives are needed to solve the new ethical dilemmas posed by population screening for BRCA mutations and the rise of direct-to-consumer and provider marketing of such genetic tests, which have far-reaching consequences at the individual, family, and societal levels.