The SPC manufacturing waiver: Good for patients, good for jobs, good for Europe

Abstract

The European Commission is currently considering an important legislative proposal which is supported by the generic pharmaceutical industry. Following the introduction of supplementary protection certificates in the 1990s, an unintended consequence has been felt by European generic manufacturers, whom are very often the last group to be able to commence commercial production, due to earlier expiry of rights in other parts of the world. This puts European pharmaceutical manufacturers at a competitive disadvantage, seeing as they are not able to manufacture product for export to countries in which no patent rights exist, or in readiness for day 1 launches in Europe. The supplementary protection certificate manufacturing waiver has been independently assessed to represent €7.3–9.5b of revenue to European industry by 2025, to generate 20,000–25,000 jobs, to lead to €1.6–3.1b in healthcare cost-savings and to improve patient access to healthcare. However, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and other innovator pharmaceutical groups have been lobbying against the proposal. In this paper, I examine the arguments against the supplementary protection certificate manufacturing waiver, particularly those set out in EFPIA’s White Paper that was published in 2017. The conclusions of the White Paper are found to be unsupported. It is hoped that the supplementary protection certificate manufacturing waiver will be implemented, and provide a valuable stimulus for the manufacture of pharmaceuticals in Europe.