Pharmaceutical Market Exclusivity Issue Briefs

The research team will prepare two issue briefs that describe the main components of drug market exclusivity and current points of controversy and future directions for reform. One brief will focus on the basic principles of regulatory exclusivity and patent-based exclusivity, while the second will focus on the possibility of reforms that can better balance the need for market exclusivity to provide adequate returns on investment in pharmaceutical research and development with the goal of timely generic entry at the conclusion of the market exclusivity period. The team will identify potential policy interventions and discuss the level at which the changes need to be made (state vs. federal, law vs. regulation, etc.). As part of the project, they will also conduct a review of peer-reviewed literature. This project will produce two issue briefs for wide-spread dissemination in a peer-reviewed journal and concurrently published on the Commonwealth Fund site.