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France Implements New Early Access Pathway For Innovative Medicines

Current Procedures Have Become Too Complex, Says Health Ministry

 
• By Ian Schofield

Reforms to the French early access processes will make reimbursement decisions more predictable and bring greater consistency into the medicinal product pathway says the French pharmaceutical industry body Leem. Others, though, say the system is too complicated and lacks clarity in a number of areas.

The concept of France-the hand gives a thumbs up with the flag of France.
France will have a new scheme for OKing early access to medicines • Source: Alamy

A new simplified system for giving patients early or exceptional access to medicines for serious or rare disorders is to be put in place in France following the publication of a decree outlining the procedures to be followed when access applications are submitted.

The new system will offer two schemes: early access and compassionate use, according to the decree (No

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