European Council Advances SPC Waiver For Generics; Negotiations Coming

The European Union Council of member states has approved a mandate for negotiations with the EU Parliament concerning a draft regulation aimed at boosting EU-based generic and biosimilar manufacturing for export by providing an exception to the extended intellectual property protection granted by special protection certificates (SPCs). The mandate brings the draft regulation a step closer to adoption, and it also suggests that Parliament’s recent amendments to the regulation are likely be key areas of debate in the negotiations, which are expected to begin in the coming weeks.







