The Petrie-Flom Center at Harvard Law School is happy to announce the penultimate session of this year’s Health Law Policy, Biotechnology and Bioethics Workshop in the Spring 2013 semester. We’re delighted to welcome a stellar lineup of leading researchers and opinion-makers in the fields at the intersection of health and law. Professors Elhauge and Cohen lead the 2012-13 workshop series.
This spring’s next presenter is Petrie-Flom Academic Fellow Nicholson Price. He will be presenting his paper “Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing” on Monday, April 8th at 5pm in Hauser 105. The full text of the paper is available here, and the abstract is copied below the “read more”
The workshop will conclude on Monday, April 15th with a lecture from WilmerHale Professor of Intellectual Property Law at HLS and Faculty Director of the Berkman Center, Terry Fisher. Workshops are open to the public and copies of papers will generally be posted a week in advance on the Petrie-Flom Website: http://www.law.harvard.edu/programs/petrie-flom/workshop/index.html.
Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing
W. Nicholson Price II
Innovation policy succeeds at promoting advances in drug discovery and development, but the need for innovation in the pharmaceutical industry does not stop with a drug‘s approval. Drug manufacturing comprises 15-50% of costs in the pharmaceutical industry, and poor manufacturing contributes to major problems including drug shortage, recalls, and contamination-based outbreaks. As a result of academic and policy shortchanging, innovation in pharmaceutical manufacturing struggles, resulting in significant monetary and human costs. This lack of innovation is at least partially due to a regulatory structure that creates significant procedural and substantive barriers for innovative change and a lack of sufficient incentives, grounded in either regulatory structures or intellectual property, to overcome those barriers. In particular, the patent system which performs well in incentivizing drug discovery performs poorly in promoting manufacturing innovation, leading to an emphasis on trade secrecy and opaque procedures instead. To address these major challenges, pharmaceutical innovation policy should pursue some combination of lowering regulatory barriers to innovation and increasing the incentives available for meaningful manufacturing innovation.