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Europe’s gamble with the future of medical innovation

EFPIA notes the gamble on Europe’s future in medical innovation taken by the EU institutions in today’s trilogue meeting on the SPC manufacturing waiver. If adopted in the final text, the amendments risk impacting on European patients living with unmet medical needs. They will significantly weaken Europe’s research and development offering risking investment and jobs from our SMEs, our companies, our academic institutions and our healthcare systems. 

These unbalanced and disproportionate amendments allowing the stockpiling of generic medicines for 6 months, an early implementation date and a lack of safeguards recalibrates the European economy from a knowledge-based region at the cutting edge of research, development and medical innovation to a Europe that is not competitive on the global R&D stage and fails to attract future investments for the benefit of patients.

EFPIA Director General, Nathalie Moll said. “Stockpiling without adequate safeguards risks the further erosion of IP rights beyond the waiver itself, sending the wrong signal to global investors and innovators. The need for adequate safeguards should be of paramount importance to anyone that believes in medical innovation in Europe”.