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France Refines Early Access System Again

Significant Benefits Seen For Patients With No Other Options

 
• By Ian Schofield

Following last year’s reform of the scheme that allows early access to unapproved or non-reimbursed medicines, the rules are being changed again, including the criteria used to determine whether an “appropriate treatment” is already available.

hand with a rare key, on the background of the
Early access schemes open the door to unapproved medicines • Source: Shutterstock

The French health authorities have refined the criteria for deciding whether an unapproved medicine should be made available under the early-access mechanism, including by making changes to the factors to be taken into account when deciding whether a product is “presumed innovative.”

The move follows a review of the scheme's operation during the 10 months since it was overhauled in July last year. The review showed the reformed system had brought significant...

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