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This has been another fantastic year for the Petrie-Flom Center and for health law, health policy, bioethics, and biotechnology at Harvard Law School.

The Affordable Care Act was a major focal point for the Center, and is likely to be next year as well, as we contemplate the impact of the Supreme Court’s ruling on the constitutionality of the law. Our affiliated faculty led public discussion of this issue, publishing commentary in a variety of news outlets from The New Republic and The New York Times to The New England Journal of Medicine. We also hosted a number of events discussing aspects of the Act, its legal status, and its current and future implementation.

The Center’s Annual Conference also took on a topic of substantial relevance and urgency, although one that has received far less media attention than health care reform: the regulation of human subjects research. In response to a number of signals that this issue was ripe for reconsideration, we brought together more than 80 leading thinkers on the subject to provide reflections and advice to the Department of Health and Human Services as it undertakes a revision of the main federal rules governing such research.

Other events addressed such wide-ranging issues as the ethics of embryo-destructive research, resource allocation to identified versus “statistical” persons, non-gendered parenting, and the constitutional foundations of bioethics. In addition, we were fortunate to work again with the Federal Judicial Center to provide training to federal judges, this time by focusing on health policy aspects of offender re-entry and reducing recidivism. We also partnered with the Autism Self-Advocacy Network on ethical, legal, and social implications of autism research. And our Health Law Policy Workshop continued to provide the premiere forum to develop new scholarship in this field, while exposing students to cutting-edge ideas and leading academics from around the country.

Once again this year, Center faculty and fellows have successfully placed their scholarship with a number of prestigious law reviews (at Cornell, Minnesota, Georgetown, Virginia, and Yale); top medical, bioethics, public health, and science journals (The American Journal of Transplantation, Developing World Bioethics, The American Journal of Public Health, The Hastings Center Report, The Journal of Medical Ethics, Genome Research, Genetics in Medicine, and Nature Reviews Genetics); and leading academic presses (Oxford University Press). Their published work covered everything from regulating reproduction and medical tourism, to organ sale and unethical research with human subjects, to ethical issues in genetic research and conflicts of interest in biomedical academic-industry relationships.

Ongoing faculty projects include work on medical tourism, patent settlements between innovators and generics, human enhancement, patent law, and pharmaceutical innovation. Meanwhile, the Center’s Academic Fellows are currently working on projects focused on anonymity in various legal domains, reproductive ethics, and several issues related to human subjects research. We look forward to supporting these fellows
on the academic job market this fall, and to welcoming a new fellow this summer.

Finally,our student fellows continue to produce top-notch scholarship, with papers on diverse subjects including the commercialization of health technology, the organization and regulation of surrogacy brokerages, conflicts of interest in pharmaceutical marketing, distracted driving laws, and genetically modified crops.

We are expecting another outstanding year in 2012 -2013. On November 2, 2012, we will host a major event on Institutional Financial Conflicts of Interest in Research Universities, featuring among others NIH Director Francis Collins and former Harvard President Derek Bok. With the help of our new Executive Director, Holly Fernandez Lynch, we plan to launch several new initiatives that we hope will further extend the great work done by our students, faculty, and university.

This report describes this year’s accomplishments in greater detail, and briefly outlines plans for next year’s programming and potential areas of expansion.

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