EFPIA notes yesterday’s EP plenary debate and today’s vote on the SPC Manufacturing Waiver Regulation. The adoption of the SPC manufacturing waiver will ultimately impact on our capacity to develop new treatments for patients living with diseases like cancer, diabetes and dementia. It sends a negative signal to the world that Europe is devaluing its intellectual property framework, making Europe a less attractive location for research and development, impacting on jobs and investment.

This decision to introduce the waiver creates a significant challenge for the next mandate. There is no doubt that the introduction of the waiver has weakened Europe’s research and development offering, in the face of increasing competition from other global regions. If Europe wants to realise its potential to be a leader in medical research and development then the next Commission will need to look for opportunities to redress the balance, supporting research, development and innovation more broadly. 

It can do this by; improving the position of Europe in fast-tracking breakthrough therapies which meet unmet health needs, by maintaining and developing Europe’s incentives and reward mechanisms for research and development to drive the discovery of new treatments in areas of unmet medical need and by supporting a flexible legal framework for a Public Private Partnership’s in health to foster medical R&D activities and modernised manufacturing to tackle the health challenges of the future.

As the waiver will hit innovation in Europe, the research-based industry stands ready to work with policy makers across Europe to see how we can restore international confidence in Europe as a research destination and deliver a number of practical initiatives that can once again make Europe a global leader in medical research and development.