EFPIA calls for revisions to Pharmaceutical Regulation 28 Jun 2023

The leaders of the European Federation of Pharmaceutical Industries and Associations (EFPIA) have warned that the proposed reforms to the European Commission’s (EC) Pharmaceutical Legislation should be revised as they believe they risk damaging Europe’s capacity for innovation and international competitiveness.

Speaking in Brussels on 21 June 2023, the freshly elected presidency team said they were keen to collaborate with the EC to improve the regulation.

They set out five amendments that EFPIA believed would help drive access to new medicines and support the region’s ability to compete globally. These are:

1. Deliver on the core purpose of Europe’s pharmaceutical legislation by further optimising the regulatory framework and ensuring maximum use of expedited pathways in support of patient needs.
2. In line with the European Council Conclusions (March 2023), strengthen, rather than cut, the region’s regulatory data protection baseline and orphan drug market exclusivity, as well as creating separate incentives to drive innovation and meet health care challenges.
3. Jointly address barriers and delays to access to new treatments based on a shared understanding of the evidence generated by the recently published Industry European Access Hurdles Portal.
4. Include a patient-centred, broad definition of unmet medical need that would incentivise avenues of research to meet the needs of people living with rare diseases and chronic conditions and appropriately value incremental innovation.
5. Ensure that supply chain and environmental requirements are proportionate and fit for purpose, to best support our shared objectives of increasing supply of medicines and reducing our sector’s environmental impact.

EFPIA and its members stated that they remained committed to working with Members of the European Parliament (MEPs), Member States and other stakeholders to close the R&D and clinical trials gap between the EU and the US and Asia.