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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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.
A European public health NGO has disputed the suggestion that a transferable exclusivity extension is the answer to the lack of innovative antimicrobial drugs in company pipelines.
The EU regulator says it supports a globally aligned approach to the development of new antimicrobial medicines.