Supplementary protection certificate for medicinal products

Key points

The EESC:

• supports the proposed amendment of Regulation (EC) No 469/2009, proposing modifications in line with Option 4, i.e. legislation on both export and stockpiling waivers;
• welcomes that this proposal leaves SPC protection intact as regards placing products on the EU market;
• welcomes the market exclusivity of EU SPC holders in the Member States during the full period of SPC protection;
• 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;
• strongly supports those safeguards that ensure transparency and protect against a possible diversion onto the Union market of generics and biosimilars (G/Bs) in respect of which the original product is protected by an SPC;
• supports the Commission's stance on SMEs, since they play an important role in manufacturing generics and developing biosimilars.

For more information please contact the INT Section Secretariat.