Answer given by Ms Bieńkowska on behalf of the European Commission

8.10.2018

The Commission proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products[1] balances the interests of the whole spectrum of stakeholders, including patients as well as generic and originator companies.

While the first objective of the proposal is to foster competitiveness of EU-based manufacturers of generics and biosimilars, the proposal will also benefit EU patients. Supplying the EU market as soon as the SPC expires will be facilitated by the existence of manufacturing facilities in the EU, set up in order to produce and export medicinal products during the term of the SPC.

The Commission considers that the approach to applicability in time of the proposal represents a suitable compromise between the need for, on the one hand, legal certainty for SPC holders and respect of the Charter of Fundamental Rights of the European Union and, on the other, for swift applicability of the waiver so as to avoid delaying benefits for EU-based manufacturers of generics and biosimilars and for patients.

• [1] COM(2018) 317 — Proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, https://ec.europa.eu/docsroom/documents/29462