SPC manufacturing waiver : consequences for a generic and innovative Bioteh company.

Abstract

As compensation for the time invested during preclinical and clinical studies and to continue to encourage European pharmaceutical companies to invest in the research and innovation, the EU proposed a uniform and communal solution, called the « Supplementary Protection Certificate» (SPC). Unfortunately, this extension of protection accorded to patented medicines presents unintended side effects, by conferring « time » advantages to generic or biosimilar companies, located in countries outside the EU, where a SPC does not exist or in which the SPC duration is shorter. The SPC manufacturing waiver aims to restore a level playing field between manufacturers of generic and biosimilar products located inside and outside EU and to enhance the competitiveness of the UE. The SPC manufacturing waiver allows manufacturers, located within the EU, to produce generic and biosimilar during the protection period covered by the SPC of a patented medicine, and to export them to « third countries ». In addition to the exportation, the EU-based manufacturers can produce and store generic products, in order to serve the EU markets quickly and immediately, as soon as the SPC expires. Thus, generic and biosimilar companies, located in EU compete directly, based on the, so called, «EU Day-1 entry» concept. The SPC manufacturing waiver is perceived positively or negatively according to several actors of pharmaceutical industry sector.