Pharmaceutical strategy - Related Opinions

With this opinion the EESC welcomes the Commission's approach to    leave SPC protection intact as regards placing products on the EU market, as well as the market exclusivity of EU SPC holders in the Member States during the full period of SPC protection. Furthermore the EESC deems it to be most important that, on those non-EU markets where protection does not exist or has expired, there be fair competition for EU-based manufacturers who bring generics and biosimilars to these markets. The EESC also supports the Commission's stance on SMEs, since they play an important role in manufacturing generics and developing biosimilars.

The EESC agrees that the aim of sustainable cooperation on health technology assessment (HTA) at EU level is to ensure that all the EU countries can benefit from efficiency gains, thus maximising added value; and believes that the proposal should benefit SMEs, as well as social economy enterprises operating in the sector, by reducing the current administrative burden and compliance costs linked to submissions of multiple dossiers to meet different national HTA requirements.