EHA response to the EU’s Pharma Revision

Last week, the European Affairs team finalised EHA's response to the proposed revision of the EU (European Union) Pharmaceutical Legislation.

In April 2023, the European Commission published a proposed Directive and Regulation to replace the current, outdated legal framework. Its objectives are, among others, increasing the availability, accessibility, and affordability of medicines, through the creation of a single market for medicines, whilst stimulating the industry’s innovation and competitiveness. This package also envisages a reduction of the administrative burden on health systems and the introduction of environmental sustainability measures.

EHA's response to the proposed legislation was submitted to the European Commission on November 8, and is being shared with policymakers working on the file to inform positions taken in the Parliament and Council.

This document is the result of several fruitful discussions with the European Affairs Committee (EAC) and their written feedback, as well as a survey circulated to all EHA members, regarding the definition of Unmet Medical Need (UMN). Fully in line with EHA's advocacy priorities and past position papers on access and affordability, it addresses six core topics: hospital exemption, UMN, transparency requirements, shortages, drug repurposing and incentives.

The response, in a nutshell:

On UMN, EHA advocates for a patient-centric and inclusive definition that encompasses, among others, quality of life and burden of disease. Secondly, drug repurposing was highlighted as a means to speed up R&D (Research & Development) and save costs, conducive to more and lower priced innovative therapies. EHA furthermore endorsed the transparency and shortages requirements foreseen in the proposal and expressed support for lower baseline regulatory protection, coupled with conditions for additional incentives. On the provision regarding hospital exemptions, EHA reiterated its importance for patient access to innovative therapies and asked for harmonisation, given current Member State discrepancies.


In addition, EHA has also contributed to collective positioning on the pharma revision by the BioMed Alliance, European Cancer Organisation and Rare Cancers Europe. 

Last Updated on Monday 13 November 2023.