European Parliament Passes Landmark Pharmaceutical Package: What’s Next?

Overview

• On April 10, 2024, Members of the European Parliament (EP) adopted their position on the revision of the two reports that make the EU General Pharmaceutical Legislation: The?Directive on medicinal products for human use and the?Regulation on authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency. This vote comes a year after the introduction of the Commission proposal and constitutes the first major overhaul to the EU’s medicines regulatory environment in over two decades.
• The file now sits with the Council of the European Union where Member States are expected to adopt their position in 2026, with an entry into force expected for 2028. ?

A quickfire deal ahead of the EU elections

Aimed at ensuring availability, accessibility and affordability of medicines and fostering a competitiveness across the bloc, the Pharma Package breezed through the Parliamentary vote with relative ease as anticipated, leaving the next legislative mandate with a foundation from which to work.

The broad consensus reached by the EP’s political groupings has been met with mixed reactions, with stakeholders still acknowledging the various compromises achieved since the original Commission proposal: regulatory data protection (RDP) was increased from 6 to 7.5 years, while the launch-conditionality was disconnected from incentives. Transferable exclusivity vouchers, granting additional RDP to boost research in antimicrobial resistance, were introduced alongside a new method (regulatory sandbox) that would allow experimenting with new regulatory approaches for novel therapies.

However, this quickfire deal leaves many technical files still open for COREPER and trilogues to settle, a few of which:

• Unmet medical needs: The European Parliament reports retained the notions of unmet medical needs and high unmet medical needs, with the latter aiming to incentivise company investment in ultra rare disease areas. Despite some specifications, this dichotomy continues to spark concerns on these definitions’ implication for national pricing and reimbursement discussions.
• Regulatory data protection: The Parliament reports have increased the baseline of RDP by 1.5 years for all manufacturing companies, with the incentive for high unmet medical needs also been elevated. However, this means that the position adopted in the Plenary reduces regulatory data protection by six months compared to the current legislation.
• Environmental risk assessment: Another hot iron is related to mandatory environmental risk assessment which has been made part of the marketing authorisation process; potentially leading to marketing authorisations being revoked or refused based on environmental concerns. A final pending point is this provision’s interactions and implication for standards applicable to third countries.
• Anti-microbial resistance: Although the European Parliament kept transferable exclusivity vouchers in the text, it is already clear that several Member States will have some strong objections against it, as it could imply uncertainties for their health-budgets.

To be continued...

The Member States face a monumental task ahead and major changes are expected from the Council given the weight of some dispositions for national access and pricing decisions. The next Council Presidency Trio – Hungary, Poland and Denmark – will play a fundamental role in steering the negotiations and defining Council lines. These countries interestingly embody the visible divides between capitals, with the two Eastern Member States expected to emphasize access across the EU27, pricing and access to generics, while the Scandinavian nation is set to focus on innovation and incentives.

While the Pharma Legislation is deemed a huge step forward for the pharma ecosystem, there are clear challenges to draw a parallel to avoid implementation issues going forward. The current hurdles being faced in the context of the Health Technology Assessment (HTA) Regulation implementation should serve as a reminder of the diversity of health systems across the European Union and recall the need for a comprehensive balancing of all stakeholders’ expectations to ensure feasibility in implementation and effective patient access in practice.