EU to test disputed incentive scheme to develop novel antibiotics

The revamp of the bloc’s regulatory framework for pharmaceuticals, presented by the European Commission on Wednesday (26 April), features a new and somewhat controversial system of incentives to promote the development of new antimicrobials. 

The development of novel antibiotics is seen as a solution to this ‘silent pandemic’ that claims more than 35,000 lives per year in Europe.

In its reform of the EU pharma rules, the Commission proposed a 15-year trial of a ‘transferable data exclusivity voucher scheme’ for novel antibiotics to incentivise their developers.

In practice, the voucher will grant an additional year of regulatory data protection to the developer of the novel antibiotics, which can either be used for one of its own products or sold to another marketing authorisation holder.

Smart Innovations   Back