The European Union plans to introduce an SPC waiver for Generics and Biosimilars intended for export to countries without patent protection. The laudable aim is to minimize counterfeit medicines in developing countries and to promote more competition and earlier access to generics and biosimilars in Europe. But many challenges remain, including potential conflict with international treaty obligations, enforcement difficulties, and business decisions that could undermine a fundamental assumption of the new policy. This presentation will describe the proposal and discuss how it relates to US positions.