EFPIA response to the Council's position on the draft regulation which introduces a manufacturing waiver to the protection granted by an SPC
16.01.19
EFPIA notes the outcome of today’s EU ambassadors meeting on the Council's position on a draft regulation which introduces an exception for manufacturing for export purposes (manufacturing waiver) to the protection granted to an original medicine by a supplementary protection certificate (SPC).
Although, the draft regulation undoubtedly sends a signal to the world that Europe is weakening its commitment to IP incentives and innovation, Member States’ current support of the original scope of the Commission’s proposal could go some way to prevent further erosion of Europe’s IP framework as a consequence of its implementation and must be maintained. The innovative pharmaceutical industry represented by EFPIA is also very concerned about the trend in reducing a realistic transition period for the application of the regulation and calls on decision makers to consider what is at stake.
In order to ensure that Europe remains a competitive and attractive investment destination for innovative healthcare despite the SPC manufacturing waiver proposal, it is important that the final text of the regulation has:
• 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.
It is critical to note that implementation of the regulation will be at the cost of high-value research and development jobs in Europe.