EUCOPE Response to Council Agreement on Pharma Package: Innovation must remain a priority

Brussels, 5 June 2025 – Following the negotiators in the Council having agreed their General Approach yesterday (4 June), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) acknowledges the step forward in the legislative process and urges EU policymakers to safeguard the EU’s innovation-driven life sciences ecosystem as trilogue negotiations begin.

The reform of the General Pharmaceutical Legislation (GPL) is a pivotal opportunity to strengthen the EU’s ability to attract investment, foster pharmaceutical innovation, and address the pressing needs of patients across the EU. Small and mid-sized pharmaceutical companies, the main drivers of innovation in the sector and key developers of transformative therapies, such as orphan medicinal products (OMPs) and advanced therapy medicinal products (ATMPs), need a supportive and predictable regulatory environment for their investments, especially in high-risk areas. Investors similarly need a predictable environment and robust regulatory authority to just their investments.

The Council’s agreement preserves the 8-year baseline regulatory data protection (RDP), as in the current legislative framework. This provides the needed predictability, improving the initial Commission proposal; yet, the modulation of incentives remains. The shift of modulation, and related conditionalities, from RDP to market protection (MP), especially with a shortened baseline MP period, will still weaken the EU’s global competitiveness in attracting life sciences investment. In fact, the incentives’ total 9-year baseline (RDP + MP) remains lower than under the current framework (10-year RDP + MP). Regulatory incentives as a whole must remain strong and predictable if the EU wants to foster innovation and address unmet needs.

The Council’s approach includes measures aimed at improving access. EUCOPE remains concerned that these proposals may impose disproportionate burdens on smaller developers without addressing the underlying challenges; instead, efforts should focus on optimising existing access pathways to ensure timely and equitable patient access.

EUCOPE supports the inclusion of tools like PRIME and regulatory sandboxes, and sees potential in strengthening forward-looking elements such as the potential for marketing authorisations for platform technologies. However, the return to a 210-day timeline for marketing authorisation, rather than the Commission’s proposed 180 days, lacks ambition and risks delaying patient access to innovative therapies. Careful attention will need to be paid to the assessment of certain products in the future, with the decision to retain the current expertise of CAT, COMP, and PDCO by way of working groups, parties, and through pools of, without any explicit call to obligate the establishment of such groups.

Alexander Natz, EUCOPE Secretary General, stated:

“The proposed approach to rare diseases illustrates an understanding of the importance of this sector. EUCOPE applauds the Council for building on the success of the past 20 years and safeguarding the 10-year Orphan Marketing Exclusivity (OME), which has served as an important contributing factor to the development of over 260 OMPs since the OMP Regulation was adopted. OMP developers need predictability. In this context, we continue to express concern about the approach taken to implementing the new ‘Global Orphan Marketing Authorisation’ or GOMA principle.” 

EUCOPE calls on inter-institutional negotiators to ensure a holistic and forward-looking incentives framework, that contributes to building a predictable and future-proofed ecosystem for innovation, ensuring EU’s competitiveness and allowing small and mid-sized enterprises to deliver novel therapies to patients in the EU and beyond.

Download the press release: EUCOPE PR – Response to Council Agreement on Pharma Package.