EFPIA reveals ‘deep concern’ over proposal to introduce SPC manufacturing waiver
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has revealed its deep concern over the European Commission’s proposal to open the supplementary protection certificates (SPC) legislation to introduce a manufacturing waiver.
The proposal from the European Commission will reduce the intellectual property (IP) rights, which according to the EFPIA will jeopardise patient access to innovative treatments. Additionally, the organisation believes that this move weakens Europe’s commitment to IP, putting investment, jobs, opportunity for economic growth and the advancement of patient care in Europe at risk.
“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,” explained Nathalie Moll, EFPIA’s director general. “The commission’s proposal to de-value this framework puts Europe at a serious disadvantage in the global race to attract life science investments.”
“The EU introduced 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,” added general counsel at EFPIA, Kristine Peers. “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.”
“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,” said Koen Berden, EFPIA’s leading trade expert. “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: “With more than 80 medicines approved every year, including around 30 new active substances and over 7,000 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.”