European Industry Proposes Incentive To Develop New Antimicrobials
EFPIA Urges Care Over Definition Of ‘Unmet Medical Need’
With proposals for an overhaul of the EU medicines legislation due at the end of this year, EFPIA has published its formal response to the European Commission’s consultation with suggestions for facilitating new antibiotic development, testing new regulatory approaches to novel medicines, and tackling medicine shortages.
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Proposals for an EU voucher that would encourage the development of “game-changing” antimicrobials are accompanied by plans for procurement mechanisms to guarantee revenues for companies regardless of sales volumes. But one law firm said the conditions attached to the voucher were so strict that the scheme appeared “unworkable.”
The European Commission’s vision for a more agile and streamlined drug development and assessment framework includes the use of controlled regulatory environments for testing innovative new drugs and technologies.
A group of EU member states has written to the European Commission saying that an exclusivity voucher scheme intended to stimulate R&D into new antimicrobials will stifle innovation by competitor companies and push up costs for national health systems.