STAT+: Europe’s pharma policy shakeup moves forward toward enactment

LONDON — European policymakers on Thursday unveiled a compromise framework for the biggest shakeup to E.U. pharmaceutical policy in two decades, as they try to strike a balance between expanding faster access to drugs across the continent while encouraging drugmakers to invest. 

A key point of contention during the years of negotiations has been how long drugs should have the market to themselves before generic competition is allowed. Currently, new drugs in the E.U. generally have 10 years of baseline exclusivity. Under the agreement, the period would drop to nine years, but drugmakers could win additional years if they tick certain boxes — for example, by filling an unmet medical need or running trials in European countries. The maximum protection period is capped at 11 years. 

Certain orphan drugs that address a high unmet medical need would also get 11 years.

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