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Efpia’s position on the Spc manufacturing waiver issue

December 19, 2018

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The Efpia position on the Spc manufacturing waiver issue is summarized in a post signed by the Efpia Director General, Nathalie Moll, and published on the Federation website on 25 October.

A weakening signal of IP protection in Europe

According to Moll, the European Commission’s proposal for a derogation from export-related complementary protection certificates could send a negative signal that Europe is weakening its commitment to incentives for intellectual property and innovation. “However – writes Moll – we also recognize efforts to clarify the purpose of the proposal and introduce safeguards, mitigate possible spill-over effects that would further erode IP rights and could have (the perverse effect) of discouraging investment in Europe, putting work and economic growth at risk, as well as advancing patient care”.

Legal clarity and certainty required

The points proposed by Efpia reflect the original proposal of the European Commission:

  • Ensuring transparency & legal certainty for all parties
  • A timely and fair notification system
  • Labelling measures which prevent products manufactured under the Waiver for export from being re-directed back to the EU or being launched on the EU market before SPC expiry
  • Non-retroactive implementation
  • Limited scope as per the European Commission proposal

Nathalie Moll also remembers how the SPC allows to compensate the development time of a new product, which “burn” around half of the useful patent life of a pharmaceutical product. The European innovative drug industry invests 35 billion euros each year in research and development (Efpia data) and assures over 750 thousand jobs in the Old Continent.

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