The next EU Multiannual Financial Framework for 2028-2034, including the envisaged Competitiveness Fund, is an opportunity to align the EU budget with the key strategic priorities as set out in the Competitiveness Compass and related initiatives in order to close the innovation gap, implement a roadmap for competitiveness and decarbonisation, and increase the EU economic security. As highlighted in the Draghi report, the pharmaceutical industry is a key strategic sector for Europe, and the next MFF could play an important role in strengthening core capacities that will support Europe’s competitiveness in pharmaceuticals as well as life sciences and healthcare more broadly.

The future MFF should support the life sciences research and innovation ecosystem, ensure the competitiveness of the EU regulatory system and foster the development and conduct of multi-country clinical trials. As a complement to national policies, the EU should also facilitate the modernisation of health systems, creating efficiencies and freeing up resources to improve the uptake of innovation in health systems, as well as protect the health security of EU citizens by supporting strong immunisation and surveillance systems. The next MFF should in this regard consider resilient health systems and health security as part of the broader EU defence and preparedness agenda, as robust, resilient and agile health systems are necessary for supporting European societies in a crisis or conflict scenario. Future funding for defence should therefore include a health component, and should not deprioritise other EU programmes supporting health priorities. The implementation of greening and sustainability legislation, and investment in the upskilling of the EU workforce are also essential areas requiring adequate resources from the EU.

Increased and stable long-term investment is therefore needed for health in the future budget of the Union, as this is a key driver of strategic autonomy, innovation, and resilience. This requires dedicated and earmarked EU-level funding across a broad range of objectives and instruments.

Health Research and Innovation should be a central pillar of the MFF

The next MFF should support world-class life sciences research and its translation into products and services that improve health of citizens and bring value to the economy. This requires programmes supporting and facilitating the upscaling of large infrastructures and enabling public-private collaborations between all relevant stakeholders. A comprehensive approach to Life Sciences is needed across the continuum of EU programmes (today organised in Horizon / FP10, EU4Health, Digital Europe).

SMEs, start-ups and biotech companies play a key role in the medicines R&D cycle. Investment in early-stage development is particularly risky in medicines R&D given the complex science, high attrition rates and long timespans until return on investment (10-15 years), which is why European biopharma SMEs and biotech companies need tailor-made solutions in order to close the translational R&D gap with US and China.

The next MFF should support the following key priorities across the landscape of EU programmes:

• Collaborative research and PPPs: dedicate appropriate funding in framework programmes to collaborative research including public-private partnerships to break silos between players in the R&I process from discovery, through translation to development and deployment. This also requires a dedicated ambitious budget for the health area specifically.
• R&D infrastructure: maintain and scale up Europe’s main infrastructures funded since FP7 (data infrastructures, clinical trial networks, large biobanks). In particular, EU programmes should leverage the value of data infrastructures to develop future research and innovation in health.
• Translation, scale up and deployment: specific budget should support translating, scaling up and deploying results of precompetitive research in research and healthcare practice.
• Clusters: Fund programmes like European Cluster Collaboration, establishing a limited number of excellent clusters supported by pan-European networks/research infrastructures will support the competitiveness of the whole European ecosystem.
• Establish a guarantee fund in collaboration with EIB that de-risks the operation of large, European life-science VC funds to support access to growth capital for European biopharma SMEs and biotech companies.
• Secure funding and create adapted instruments in order to prepare Europe for future global pandemic threats as well as for the growing threat of Anti-microbial Resistance (AMR) enabling late-stage development of medical countermeasures for biopreparedness require adapted funding.
• Crisis preparedness including protection against biomedical threats, including in a context of protecting both the general population and military personnel.

Resourcing the EU Medicines Agency and the EU Regulatory Framework

The ambitious reforms of the regulatory framework for medicines set out in the revision of the General Pharmaceutical Legislation needs to be matched by resources for the European Medicines Agency and regulatory network to ensure that the EU's regulatory system maintains its global competitiveness and that resource constraints are not a blocker for new initiatives. The next MFF should therefore provide sufficient financial resources for activities which are not service-related (and funded through the fee system) but are necessary to ensure a well-resourced and future-proof regulatory system, including:

• Upskilling of staff to cope with advances in science and technology and ensure effective oversight of future innovation
• Greater collaboration with regulators from other countries to align on evidence requirements and to find efficiencies in regulatory oversight activities
• Invest in advanced analytics and solutions enabling experimentations of the use of AI in medicine lifecycle to increase efficiency and productivity.
• Enhance data and technology infrastructure to support the European Medicines Regulatory Network Strategy, ensuring seamless regulatory information flow and full participation across countries.

Modernise clinical trials

Clinical trials are the most expensive and time-consuming part of the drug development process. An enabling ecosystem and an effective regulatory framework for conducting these trials are essential for maintaining the competitiveness of the EU’s most innovation-intensive pharmaceutical sectors while providing opportunities for patients with important unmet health needs to access the latest breakthroughs in medical science.

• Resources for organisation of a single approval process for multi-country trials (including for combination products): Multi-country or EU-wide trials should be facilitated: today, they remain burdensome and time-consuming, due to ongoing regulatory fragmentation and a lack of coordination.
• EU platform for ethical reviews: the Commission needs sufficient resources to enable continued exchange of good practices, standardisation where possible or convergence of ethical review processes, including reliance mechanisms.
• Set up programmes to integrate clinical trials into medical care across Europe (infrastructure, trainings and resources). Adequately funded European Research Networks (ERNs) will be instrumental for rare diseases.
• Support for clinical trial design is also intended to be provided by Joint (EMA-HTA) Scientific Consultations as foreseen by the EU HTA Regulation. At the moment, capacity for such joint advice is severely limited both in terms of availability of qualified assessors and financial support.

Health systems readiness and resilience for healthy populations

Given Europe’s ageing population and increased burden of chronic disease, Europe’s future growth and economic security depends on a healthy population both in working age and after retirement. Implementing evidence-based primary and secondary prevention strategies can save considerable costs for health systems and improve economic productivity, creating headroom for needed investments in innovation. Strategic EU investments can complement national health policies to help achieve these objectives across Member States, guided by the European Semester, and support modernisation and uptake of innovation in health systems.

• Prevent and manage the burden of chronic disease through primary and secondary prevention, including immunisation, screening, early detection and intervention, including in support of actions in the EU Beating Cancer Plan and future EU Cardiovascular Health Plan.
• Support health systems transformation towards a people-centric care model, including strengthened primary care and integrated care models for patients with multimorbidity and complex conditions, also utilising digital tools for monitoring and self-management.
• Investment in precision medicine including precision oncology (via building on European Union initiatives such as the Beating Cancer Plan, Horizon Europe/FP10 or Digital Europe Programmes) can significantly improve health systems in Europe by: enhancing patient outcomes with targeted treatments, reducing healthcare costs through early detection and intervention, supporting preventive healthcare and risk management and driving innovation in medical research and pharmaceuticals.
• Sufficient funds for Member States for harmonised implementation of the European Health Data Space to foster balanced data sharing and exchange environment to improve patients' control over their health data, advancing research, and enhancing health outcomes.
• Support patient organisations as independent voices of patients in health system decision-making and collaboration, in order to drive efficiency through patient-centred healthcare models.
• Secure adequate funding of EMA, ECDC and HERA to conduct robust infectious diseases surveillance, vaccine effectiveness monitoring and digitalisation of immunisation information systems, which will in particular boost the performance of national immunisation systems.
• Measures to improve health systems’ resilience against external shocks, as part of Europe’s broader defence and preparedness agenda.

Implementation of greening and sustainability legislations

Many new regulations will soon take effect as part of the Commission’s new and revised chemical, environment, animal and food legislations - many at the same time and this will create pressures on industry and regulators. Incentives and resource aid would help in ensuring development of sustainable practices:

• Facilitate collaborations between pharma companies, research institutions, and regulators to develop sustainable pharmaceutical production.
• Enhance sustainable supply chains & circular economy.
• Help companies adapt to the new legislations regarding compliance, costs, sustainability audits, and technology transitions, in particular for SMEs via co-funded instruments.
• Allocate funding for training programs that help pharmaceutical professionals adapt to green chemistry principles, digitalized energy-efficient manufacturing, and ESG reporting compliance.

Skills

Ensuring a highly skilled and adaptable workforce is critical to maintaining Europe's leadership in pharmaceutical innovation, supporting economic growth, and addressing emerging health challenges. A forward-looking EU MFF must prioritize investments in skills, talent development, and workforce resilience. To achieve this, we recommend to:

• Invest in STEM education, strengthening EU-wide funding for pharmaceutical sciences, bioinformatics, and digital health technologies while fostering industry-academia collaboration to attract, develop, and retain high-skilled talents.
• Promote reskilling and upskilling for a changing workforce, recognising the rapid pace of technological advancement. Ensure dedicated funding for training in automation, digitalization, AI, and green technologies and facilitate professional certifications across EU Member States.

Fit-for-for purpose legal framework

As part of the simplification package prepared by the Commission, the MFF should come up with a revised flexible set of rules for EU programmes, instead of the current one-size-fits-all approach implemented the Commission. These rules might not be directly part of the MFF itself and would be covered either in the EU Financial Regulation or specific programmes’ rules. Future instruments should provide simple and flexible rules, in particular by reducing the administrative burdens for participants not receiving funding and by providing intellectual property protection scenarios, to facilitate collaborations and increase the impact of EU projects.

APPENDIX – FURTHER RECOMMENDATIONS

More specific and detailed recommendations are available in the following EFPIA publications:

Input specific to Competitiveness:

• A Competitiveness Strategy for European Life Sciences: https://efpia.eu/media/fzkbhzoe/a-competitiveness-strategy-for-european-life-sciences.pdf
• Thematic review on the cumulative impacts of environment and chemical legislations on the healthcare sector: https://www.efpia.eu/media/i0ihfkys/efpia-cumulative-legislative-impacts.pdf

Input specific to Clinical Trials in Europe

• Improving EU Clinical Trials: Proposals to Overcome Current Challenges and Strengthen the Ecosystem https://www.efpia.eu/media/pl0nag0s/efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf

Input related to R&I Programmes / FP10

• EFPIA’S recommendations for Framework Programme 10: https://www.efpia.eu/media/ae1frswv/building-on-horizon-europe-efpia-recommendations-for-fp10.pdf

Input specific to the needs of start-up and scale-ups:

• An Agenda for Action: Expanding Funding Options for Small and Medium-Sized Pharma companies in Europe:
  https://efpia.eu/media/ufrpw0ee/an-agenda-for-action-expanding-funding-options-for-small-and-medium-sized-pharma-companies-in-europe.pdf