Several clusters of significant public policy issues mark the pathway to the growth and acceptance of personalized medicine. While none of these issues is unique to personalized medicine, government regulation of clinical trials, intellectual property rights, licensing practices, health care reimbursement, and privacy are among the areas that may need to be re-examined.

Currently, public policy decisions in the health care arena are made in a fragmented and uncoordinated way, without consideration of the impact one decision could have on other policy issues. For providers of products and services to be able to deliver on the promise of personalized medicine, policymakers must intelligently and comprehensively review the array of issues that affect the science and clinical practice of personalized medicine. The PMC exists because there is real risk that public health and medical practice will suffer unintended consequences unless policymakers coordinate their efforts. The next generation of medical practice - personalized medicine - demands a coherent, integrated approach to the legal, financial, social and professional issues that will shape its development and application.