on ENVI reports on the EU Pharmaceutical Package

Today, 19 March 2024, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) adopted the two reports on the so-called EU Pharmaceutical Package, namely 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. The reports build on the proposal made by the European Commission to reform the EU pharmaceutical landscape to improve access, affordability and availability, while maintaining an innovative and competitive framework for pharmaceutical companies.

EUCOPE appreciates the ENVI committee’s recognition of the importance of a strong and predictable incentive framework for innovative companies, particularly small and mid-sized biotech. Proposals to future-proof and streamline the regulatory framework will reduce administrative barriers for all stakeholders and contribute to accelerated access to novel and safe therapies. EUCOPE commends the ENVI committee for considering the nuance of access and recognising pharmaceutical companies as only one of the partners involved. More efforts are needed to improve access across the EU, many of which require reflections beyond the current legislation.

EUCOPE’s initial reflections

EUCOPE believes the revision of the pharmaceutical legislation should build on the success of the past two decades and ensure that the EU remains globally competitive and an attractive place for investments and innovation.

The ENVI committee’s reports represent a step in the right direction to maintain the EU’s competitiveness, which should be characterised by a predictable incentive framework and a robust regulatory ecosystem. Reforms such as the Regulatory Sandbox and the introduction of Platform Technology signal to pharmaceutical companies the EU’s intention to remain attractive for innovation.

It is fundamental to appropriately reward innovative biotech companies with an adequate number of years of regulatory data protection (RDP) and orphan market exclusivity (OME). These incentives offset risks, encourage further innovation, and reward research. While the ENVI committee’s report has strengthened RDP compared to the Commission’s proposal, the baseline duration of RDP remains below the levels offered under the current system.

In the context of rare diseases, modulation of market exclusivity needs to be done in a way that is clear and predictable, an example of which is outlined by the Orphan Drug Expert Group. Further reflection is needed on the global orphan marketing authorisation (GOMA) as a tool to stimulate further research and encourage companies to find additional applications for existing, on-patent compounds, especially if this opens the door for treatments for those patients with no other options. It is regrettable that this principle is not further strengthened to support further innovation.

Questions remain regarding the definition and interpretation of unmet medical needs (UMN) and high unmet medical needs (HUMN). These concepts risk overlooking patient populations and will have implications on innovation, as well as on market access decisions.

EUCOPE urges avoiding unrealistic requirements, especially on medicine shortages and environmental risk assessment (ERA), as recommended by the ENVI committee. Increased administrative barriers will be extremely burdensome for smaller companies and can delay marketing authorization and patients’ access. A balanced approach is needed, addressing the roles and responsibilities of all parties involved.

Next steps

The Plenary vote in the European Parliament is scheduled for 11 April 2024. In parallel, discussions are ongoing in the Council. When both the European Parliament and the Council have adopted their positions, trialogue negotiations can begin.

The Pharmaceutical Package must be seen as one important part of the legislative framework shaping the EU pharmaceutical landscape. By itself, it will not be able to address all the challenges, but it will have far-reaching consequences, including beyond its immediate scope.