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Stakeholders Attack European Commission’s Plans To Define ‘Unmet Medical Need’

 
• By Ian Schofield

Narrow, restrictive, unclear, ambiguous, challenging to achieve, and likely to hamper innovation and deter R&D investment. Just some of the comments that have been leveled at EU proposals for a formal definition of unmet medical need.

assortment of pills and capsules of colors in plastic jars isolated in white - Image
Deciding which drugs fulfil an unmet need is not always easy • Source: Shutterstock

Defining “unmet medical need” where new medicines and vaccines are concerned might seem a straightforward enough concept, but the definition of the term proposed in the European Commission’s overhaul of the EU pharmaceutical legislation has drawn a barrage of criticism and comment from the pharma and vaccine industries.

There is currently no agreement on the meaning of unmet medical need (UMN) or high unmet medical need (HUMN), so...

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