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European SPC waiver proposed to promote pharmaceutical manufacturing | PING

The European Commission has put forward plans for a waiver of supplementary protection certificates (SPCs) to stimulate pharmaceutical manufacturing in Europe. The proposal would remove obstacles to the competitiveness of EU industry by allowing the manufacture for export of generics and biosimilars, which are protected by SPCs in Europe, but not in the non-EU country of destination.

In the European Economic Area, SPCs extend the term of patents protecting certain pharmaceutical products. The rationale for the system is to remedy (or reduce) the problem for rights holders that the patent term for many medicinal products is eroded whilst the patentee awaits the grant of a marketing authorisation.

The EGA (the European Generic and Biosimilar Medicines Association) has described the proposal as essential to increasing manufacturing in Europe, creating new high-skill pharmaceutical jobs and stimulating economic growth. Under the current system, European manufacturers must outsource production to supply countries without SPCs or where SPCs expire earlier than in Europe.

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