EU Pharma Revision – Position Paper

EU Pharma Strategy Revision Position Statement-Post Static

Recently, the European Commission published revision of the EU pharma legislation. A first in two decades, this sweeping reform promises to leave a deep imprint in the European medical landscape. One of the main goals of the revision is to balance pharma incentives and accessibility to ensure that all EU patients have timely and equitable access to safe and effective medicines, regardless of which member state they live in. The legislation introduces measures to reduce red tape and incentivize drug development that society needs.

Publishing the proposal is only the beginning. It is now up to the European Parliament and Council of the EU to find a common ground ahead of trilogues (co-legislative process of those three key EU institutions). Given that the file is highly political, the negotiations will be long and heated and it is not clear whether they will be concluded before the next EU elections in June, 2024.

EFNA has issued a statement regarding the pharma revision. Read on to find out the key issues we are raising.

We support the Commission’s patient-centred approach, which could enhance accessibility to affordable medicines, stimulate development of drugs for children and rare diseases, and amplify patient representation.

We believe that the strategy’s revision is particularly vital in addressing neurological conditions, which currently suffer from unmet needs due to their complexity and high clinical trial failure rates.

We note that the proposed changes in the pharmaceutical strategy are expected to stimulate research and development for innovative therapeutic solutions, fostering an environment conducive to advancements in neurological treatments. Schemes such as PRIME, aimed at expediting the development and review of drugs for unmet needs, may, however, require further refinement for neurology applications. Moreover, revised incentives and regulatory protections, alongside the extension of data protection to repurposed medicines, could foster innovation in treatments for complex neurological conditions.

We underline the importance of patient engagement, emphasizing that incorporating patient insights can enhance the quality of healthcare development and delivery.

We also note the strategy’s embrace of real-world evidence (RWE) in regulatory decision-making, which can offer transformative insights into treatment effectiveness and safety.

Addressing gender disparities in neurological research forms an integral part of EFNA’s advocacy. Despite women being disproportionately affected by brain disorders, their symptoms are often overlooked or misdiagnosed due to inadequate understanding of female-specific indicators. The revision process should work towards equitable representation in clinical trials and research.

EFNA supports discussions on greater transparency in pharmaceutical R&D costs, as this could help in pricing discussions and potentially make treatments more affordable.

Furthermore, EFNA supports the establishment of an EU database on medicine shortages and the transition to electronic product information, emphasizing the need for it to complement rather than replace paper-based information.