EFPIA notes with concern the INTA Committee’s draft opinion on the SPC manufacturing waiver proposal

Many of the medicines available to patients today and those in the R&D pipeline would not be there without the EU’s robust standards of IP protection.

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. Weakening IP means less investment in new medicines which ultimately limits patients’ access to new treatments and cures.

Adequate and robust safeguards are vitally important to mitigate potential spill-over effects of the proposed waiver that would further erode IP rights.The opinion adopted by the INTA Committee does not provide appropriate safeguards and risks further disincentivising investment in Europe, putting jobs and economic growth at risk, as well as the advancement of patient care. 

Secondly, allowing the stockpiling of generic medicines while the innovator medicine is still under SPC protection extends the scope of the exemption beyond Commission’s intention, further reducing innovators’ intellectual property rights. 

Thirdly, applying the waiver to SPCs for which the basic patent expires after the entry into force of the Regulation shifts the goal posts for those who have already invested in life sciences in Europe under the existing IP framework. If Europe wants to be at the forefront of medical innovation and be taken seriously as a destination for life sciences investment any waiver should only apply to SPCs applied for after the amended regulation comes in to force. This is critical, not only to mitigate the negative impacts of the waiver but also to send a signal to the global investor community that investors in Europe, can be certain of the conditions under which they invest. Devaluing investments half way through their life-cycle via ill-thought out policy changes will drive investment to other locations around the world.

As discussions on the SPC manufacturing waiver proposal evolve, we call on policy-makers in the European Parliament and the Council to protect patients and medical innovation in Europe. It is essential to ensure transparency & legal certainty for all parties, clarify the conditions under which the waiver applies, and that it does not further reduce IP incentives for innovation. In practical terms that means:

• No stockpiling of generic/biosimilar medicines while the innovative medicine is still under SPC protection.
• A timely, effective and transparent notification system.
• Effective 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 requirements to protect Europe’s IP framework, particularly in today’s context of intense global competition for investment in pharmaceutical research and development.