EFPIA believes the proposals for overhauling the EU pharmaceutical legislation, as currently worded, will hit innovative R&D and fail to halt the decline in European clinical trials.
While the industry federation concedes the proposals go some way towards improving the regulatory system, it has criticized plans to reduce data protection and market exclusivity periods.
EFPIA wants to see “maximum use” of expedited pathways and a broad, patient-centered definition of “unmet medical need.”
It wants to work on the proposals with policymakers to secure a globally competitive industry that ensures the long-term health of Europeans and works for national health care systems.

Pharma Revision Will Hasten EU’s R&D Decline, Says EFPIA’s New Presidency Team

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