There is no shortage of attorneys involved in legal issues related to the pharmaceutical and health care industries. There is, however, a shortage of law schools examining those issues. Since its founding, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics has aimed to rectify that problem. Established in 2005 at Harvard Law School by founding faculty director Einer Elhauge ’86, the Petrie-Flom Center has produced works of scholarship and hosted events focused on health care and the law, including several specifically on the pharmaceutical industry.
Among its events, the center held a conference in 2009 on pharmaceutical research, development, and markets, which featured sessions on mergers and antitrust, drug research and safety, intellectual property, pricing and marketing, and generics. Another conference that year, focused on health metrics, addressed clinical trials as well as pricing and accessibility of pharmaceuticals in the developing world. Last year, the center hosted a two-day summit attended by top executives from the major pharmaceutical firms which considered ethical standards and practices related to multiregional clinical trials, especially those that involve the developing world.
That world is also the focus of a forthcoming book by Professor William Fisher ’82 and Talha Syed, former Petrie-Flom Fellow. Called “Drugs, Law, and the Health Crisis in the Developing World,” the book addresses what the authors call the largely preventable deaths from infectious diseases of about 9 million people a year in developing countries. The problem, they contend, stems from the holders of patents pursuing pricing strategies to maximize profits and pharmaceutical firms concentrating research and development on diseases prevalent in developed countries but not common in developing nations. Among possible reforms, the authors propose a system of financial incentives that would induce pharmaceutical firms to develop drugs to fight disease in developing countries and to adopt pricing practices that would facilitate their greater distribution.
This spring, Fisher and William W. Chin, executive dean for research at Harvard Medical School, convened a meeting of experts from across the university to look at just the sort of problems explored in Fisher and Syed’s book, but in the context of the government systems that regulate and fund the development of pharmaceuticals. The first meeting of the Working Group on Governmental Management of Pharmaceutical Products in April brought together researchers at the medical school with HLS faculty—including Elhauge and Petrie-Flom co-directors I. Glenn Cohen ’03 and Benjamin Roin ’05—and others from across the university. Fisher and Chin hope it was the beginning of collaborations that will yield solutions.