Program on Personalized Medicine, Law and Policy

Exploring legal, policy, and ethical challenges in the transition to genetic- and molecular-based medicine

The Program on Personalized Medicine, Law & Policy is the nation's first law-school program on personalized medicine that fosters the study of personalized medicine through the collaborative, multidisciplinary evaluation of critical issues at the intersection of law, science, and policy. These include regulatory hurdles to implementation of personalized medicine, ethical implications of targeted therapies, potential increase in liability for physicians, manufacturers, pharmacists, and others, creative solutions to existing pricing models and reimbursement, and evolving challenges in intellectual property in molecular diagnostics and genetic discoveries.

The Program addresses these issues through conferences and workshops, research projects, and a speakers program. Several conferences and workshops have been organized over the past decade on legal and policy issues relating to personalized medicine, and presentations made to many legal, medical, and public audiences, including presentations on genetics and law issues to more 20 judicial conferences. Research projects address liability relating to personalized medicine, biobanking, molecular diagnostics regulation and reimbursement, toxicogenomics in environmental regulation, genetics and toxic torts, autism genetics, and Alzheimer’s biomarkers.

Past Events

Workshop on Molecular Diagnostics / April 4, 2012

This roundtable discussion gathered leading government, industry, and academic experts to explore innovative solutions to current regulatory and reimbursement barriers for molecular and other diagnostics.

Personalized Medicine in the Clinic: Policy, Legal, and Ethical Implications / March 8-9, 2010

In partnership with the American Association for the Advancement of Science, a major conference was sponsored on the ethical, legal, and ethical implications of personalized medicine in the clinic, attended by more 200 participants and featuring many of the leading experts in the nation.

Personalized Medicine & Molecular Diagnostics: Legal, Regulatory, and Ethical Perspectives / March 2, 2007

This groundbreaking conference brought together leading scholars, practitioners, and policymakers in law, science, and medicine to explore the early development of personalized medicine and looking forward to its many legal, regulatory, and ethical implications.

Notable Accomplishments

  • A multi-year research project, funded in part by the National Institutes of Health, was coordinated on liability implications of personalized medicine for physicians and other health care providers.
  • The Center established the nation’s first LL.M. degree program specializing in genetics and biotechnology law.