EUCOPE statement on the political agreement on the EU General Pharmaceutical Legislation

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) acknowledges the provisional political agreement reached on the EU General Pharmaceutical Legislation (GPL) and recognises the efforts of the EU Institutions to modernise the pharmaceutical framework for the first time in over 20 years. This revision will have a significant impact on the innovative pharmaceutical sector, especially on small and mid-sized companies.

The revision of the GPL will have far-reaching implications for the EU’s ability to attract investment, support innovation, and ensure timely patient access to new therapies. The potential reduction of incentives has already influenced investment and development decisions. EUCOPE considers the conclusion of negotiations an important step in providing clarity for developers, patients, and healthcare systems. Significant and important work remains ahead as the Union develops the scientific guidelines, implementing, and delegated acts which will further set the direction of the GPL.

Initial reflections on the agreement

EUCOPE commends the EU Institutions for their work in strengthening the EU’s already robust regulatory environment, namely through:

• speeding up regulatory processes with the reduction of EMA CHMP opinion timeline from 210 to 180 days;
• the inclusion of regulatory sandboxes;
• introduction of a voluntary subscription model for novel antimicrobials;
• protecting patient voting rights in the EMA.

These measures have the potential to support a more efficient, future-proof, and predictable regulatory environment for innovative pharma and biotech companies.

Avoiding the reduction of the baseline duration of the Regulatory Data Protection (RDP) per the Commission’s initial proposal, is a step in the right direction; yet, the potential reduction of incentives remains. The various conditionalities especially with a shortened baseline market protection period will still weaken the EU’s global competitiveness in attracting life sciences investment.

Several provisions could have negative consequences for innovation and decrease patient access in the Union, especially when it comes to rare diseases. EUCOPE is concerned about the environment for rare disease companies which will see a reduction in baseline orphan market exclusivity (OME) as well as the retention of Article 72.2 (the Global Orphan Marketing Authorisation, GOMA principle). The impact of the proposed OME extension through ‘breakthrough’ designation will depend on its further clarification.

Overall, modulation of incentives, together with the proposed access obligations, extended Bolar exemption and newly introduced regulatory requirements (e.g., linked to shortages and supply), will reduce predictability and increase administrative burdens for innovators. This adds another layer of uncertainty to existing global challenges such as tariffs and the most favored nation (MFN) policy.

EUCOPE stands ready to work with the European Commission to provide the expert industry perspective on delegated acts and implementation guidance, to ensure that the legislation enhances the EU’s attractiveness for innovation and pharmaceutical investment. Fundamentally, the GPL must be seen as part of a wider effort to improve the pharmaceutical ecosystem. The upcoming Biotech Act and the MDR / IVDR revision as well as other simplification and industrial policy proposals both at EU and national levels, must support a competitive ecosystem.

Quote from Alexander Natz, EUCOPE Secretary General

“The agreement on the General Pharmaceutical Legislation marks a significant milestone for the EU health and industrial landscape. We welcome the constructive efforts of all Institutions to reach a compromise. At the same time, it is essential that the new rules will be implemented in a way that truly strengthens the EU’s competitiveness and maintains incentives for companies developing innovative therapies, particularly in rare diseases.

Our initial assessment shows positive steps in streamlining the regulatory framework, but also areas of concern that could affect long-term investment. The ability of small and mid-sized companies to bring life-changing treatments to patients could be hampered by modulation of incentives and access obligations. We look forward to working with policymakers to ensure that implementation reflects the EU’s ambition to remain a global leader in biopharmaceutical innovation.”