Nies Lecture Number
Prof. Reichman describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as 'market exclusivity' and in Europe as 'data exclusivity,' these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers’ undisclosed test data.
Reichman, Jerome, "Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach. Law: From Private to Public Good?" (2008). The Honorable Helen Wilson Nies Memorial Lecture. Paper 6.