EFPIA statement on the implementation of the SPC manufacturing waiver
Cutting edge, innovative treatments and generic medicines both play a critical role in advancing patient care and ensuring the long-term sustainability of our healthcare systems. For patients, the European research-base and wider economy, it is vital to maintain and develop Europe’s IP framework, the foundation on which all medical innovation is based. The SPC manufacturing waiver sends a worrying global signal that the EU is weakening its IP framework, in that context it is critical that the implementation of the waiver carries the appropriate safeguards to avoid further erosion of the European IP framework, ensuring that Europe can continue to be a leading source of medical innovation for patients around the world.
The SPC is part of an incentives framework that helps to generate the 35 billion in investment in R&D in Europe by the research-based industry. It helps to safeguard over 750,000 jobs directly employed by biopharmaceutical companies and critically facilitates, research into unmet medical needs, finding treatments and cures for patients across Europe and beyond.