EFPIA notes with concern the ENVI Committee’s adoption of the Compromise Amendments on its draft opinion relating to the SPC manufacturing waiver proposed regulation

The proposal to introduce an export manufacturing waiver to the SPC regulation sends a signal to the world that Europe is weakening its commitment to IP incentives and innovation. If the proposal is implemented, then the safeguards to mitigate potential spill-over effects that would further erode IP rights are vitally important.  
The compromise Amendments adopted by the ENVI Committee do not provide such safeguards and risk further disincentivising investment in Europe, putting jobs and economic growth at risk, as well as the advancement of patient care.
Specifically, allowing the stockpiling of generic medicines while the innovator medicine is still under SPC protection and failing to guarantee a robust system for notifying innovator companies of applications for a manufacturing waiver makes Europe a less attractive destination for life science investment.
As discussions evolve around the SPC manufacturing waiver proposal, our call to policy-makers in the European Parliament and the Council is to protect medical innovation in Europe.  They can do this by ensuring clarity and legal certainty on what the waiver entails, the conditions under which it applies, and that it does not further reduce IP incentives for innovation. In practical terms that means:
  • Ensuring transparency & legal certainty for all parties.
  • A timely and fair notification system.
  • Labelling measures which prevent products manufactured under the manufacturing waiver for export from being re-directed back to the EU or being launched on the EU market before SPC expiry.
  • Non-retroactive implementation.
EFPIA believes these are fundamental provisions to ensure the protection of Europe’s IP framework, particularly in today’s context of intense global competition for pharmaceutical research and development investment.