EFPIA statement on the Commission’s proposal to introduce an SPC manufacturing waiver, weakening Europe’s knowledge based economy

EFPIA, the organisation representing 40 of the biggest investors in life science research and development is deeply concerned with the European Commission’s proposal to open the SPC legislation with a view to introducing a manufacturing waiver.

People all over Europe are living longer, healthier and more productive lives thanks to the innovative medicines developed by our members. As an industry we invest more than 35 billion euros in R&D every year in Europe alone. We employ over 700,000 people across the continent, of which 118,000 are employed in research and development.

The Commission’s proposal reduces IP rights and thereby jeopardises patient access to innovative treatments. It also sends a global signal that Europe is weakening its commitment to IP, putting this investment, these jobs, this opportunity for economic growth and the advancement of patient care in Europe at serious risk.

Talking about the proposal, Nathalie Moll, EFPIA’s Director General said: “Europe has long benefited from being a global leader in medical innovation based on a framework of IP & incentives that has given investors and companies the assurance they need to invest in the region and grow an industry dedicated to the long, complex and risky process of developing new treatments. The Commission’s proposal to de-value this framework puts Europe at a serious disadvantage in the global race to attract life science investments.”

General Counsel at EFPIA, Kristine Peers said: “The EU introduced Supplementary protection certificates (SPCs) to attract and drive research in Europe. Approximately half the patent life of a new treatment is lost during the research, development and regulatory processes and the SPC went some way to restoring some of that patent life. Changing any part of this carefully constructed framework destabilises the IP incentives system in Europe. Granting an SPC manufacturing waiver, erodes the foundations of medical research, putting the future of medical research in Europe at risk.”

Koen Berden, EFPIA’s leading trade expert said, “The research-based biopharmaceutical industry is playing a critical role in Europe’s export performance and is one of the most competitive pillars of the EU economy, helping to restore Europe to growth. It is one of the industries that is key when discussing Europe’s strategy to remain a knowledge-economy, investing an estimated €35 billion in R&D in Europe. Unfortunately, the Commission’s proposal is inconsistent with its own ‘innovation-driven economy’ vision, jeopardising long-run innovation potential and dynamic benefits for uncertain short-term (and low-value) gains. The proposal to introduce an SPC manufacturing waiver is all the more striking given the extent to which other geographies, notably China, are moving in the opposite direction by strengthening their IP frameworks; aiming to become the Europe of tomorrow.”

Magda Chlebus, EFPIA’s Executive Director of Science & Regulatory Policy highlighted that “With more than 80 medicines approved every year, including around 30 new active substances and over 7000 medicines currently in development, it is clear to see that the existing Intellectual Property incentives system is working to deliver new and improved treatments to patients who need them.”

EFPIA has a very real concern that this proposal to de-value the IP and incentives framework will be detrimental to patient access to innovative medicines and lead to a greater percentage of the R&D of those treatments moving to other parts of the world that value and are strengthening the knowledge based economy.