European Commission Steps Further Towards ‘Ambitious’ Pharma Legislation Reform

Considering Proposals To Allow Earlier Market Entry For Generics And Biosimilars

The incentives system, access to medicines, future proofing for novel products and antimicrobial resistance are just some of the topics included in a new consultation.

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The European Commission Is Consulting On Ambitious Reform

In another step towards what looks set to be a major revision of the EU’s pharmaceutical legislation, the European Commission has published a consultation touching on a wide range of areas that are potentially ripe for reform. It is seeking opinions on measures to improve the incentives system, such as linking incentives to how well a company reports R&D costs, and to drive access to medicines by obliging companies to launch their products in most EU markets.

The commission says that the consultation is “the latest step towards an ambitious reform” and is part of its wider Pharmaceutical Strategy for Europe, which was adopted in November 2020. This strategy aims “at creating a future proof regulatory framework and at supporting industry in promoting research and technologies that actually reach patients in order to fulfil their therapeutic needs while addressing market failures

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