Ahead of the discussions on the EU future Framework Programme for Research and Innovation (FP10), EFPIA is putting forward nine recommendations to help maximise its impact. “Implementing these recommendations would not only optimise the investment in R&I but also position the EU at the forefront of health R&I globally”, said Magda Chlebus, Executive Director Science Policy and Regulatory Affairs at EFPIA. 

FP10 in support of a competitive life science R&D ecosystem in Europe 

Our recommendations focus on three overarching priorities: 

Improving continuity of funding, from drug discovery to healthcare delivery 

1) Design instruments for impact: the programme should cover the whole spectrum of research, including late-stage  

2) Increase and ringfence the FP10 budget for health challenges, and fund large-scale projects

3) Involve the best world experts in EU projects prioritising scientific excellence over geographical limits  

Strengthening industry participation, in collaborative research and public-private partnerships 

4) Coordinate FP10 with industrial policies, under the steering of an EU Office of Life Sciences for health challenges  

5) Strengthen collaborative research and European competitiveness via an adequate budget for Societal challenges, including public-private partnerships 

6) Participation rules adapted to the R&I lifecycle, e.g. further opening to large companies in Pillar III – Innovative Europe  

Embracing flexibility instead of one-size-fits-all and reduce administrative burdens 

7) Model Grant Agreement with simplified rules for participants not requesting EU funding  

8) Build public-private partnerships on in-kind contributions with minimised administrative burden  

9) IP rules enabling the fast uptake and deployment of results by industry 

The recent Draghi report highlighted the importance of the pharmaceutical sector in Europe and the emerging competitiveness gap between the EU, the US and China. The report underlined the need for an urgent mobilisation of R&D efforts and more supportive and coherent policies [1]. FP10 is an opportunity to support the EU’s competitiveness, especially in health and life sciences.  

Europe has the potential to lead in the development of new technologies that benefit patients, society and the economy, but faces challenges in scaling up and translating research into new medicines. Despite health being a priority for the EU through Framework Programmes, only 10.3% of Horizon Europe funds are earmarked for health R&I, lower than FP7 nearly two decades ago. FP10 is an opportunity for Europe to set financial and administrative conditions that attract key players in the research and innovation ecosystem, ensuring Europe remains a hub for innovation rather than merely a consumer of innovation developed elsewhere. 

EFPIA believes that public-private collaborative research and innovation should remain central to the Framework Programme.  This will not only contribute to addressing health challenges but also strengthen the translational research ecosystem in Europe [2].  As an illustration of this ambition, EFPIA co-founded with the European Commission the Innovative Medicines Initiative (IMI) and its successor, the Innovative Health Initiative (IHI) also involving the medical technologies’ sector [3]. EFPIA members committed nearly EUR 3 billion across IMI1, IMI2, and IHI. The final evaluation of IMI2 and interim evaluation of IHI recognised IMI as “a world-first public-private partnership in the field of health research and innovation” and IHI as continuing to drive innovation “ahead of the curve"[4].  

EFPIA’s detailed recommendations for FP10 can be found here, and are summarised below. 

Improve continuity of funding for a globally competitive and impactful FP10, supporting research from discovery to delivery of healthcare products and services to increase Europe’s competitiveness 

1) The EU should create funding instruments and resources for impact by identifying and supporting high-priority projects 

Increased funding is needed across the innovation journey to bridge all “valleys of death” and enhance Europe’s global competitiveness in research. Specific tools or programmes should be designed to support late-stage development (in particular for biopreparedness), translational research, implementation science such as regulatory acceptance processes, and upscaling of innovations. 

2) Increase and ringfence the FP10 budget to meet the needs of patients and health challenges, and fund large-scale projects. 

Health priorities should be supported by 20% of the overall FP10 budget and be exempt from cuts during the funding cycle. The programme should also encourage larger-scale and transformative projects, and allow for budget adjustments in response to crisis. 

3)  FP10 should attract and involve the best world experts in EU projects prioritising scientific excellence over geographical limits  

Global cooperation is critical to ensuring scientific excellence in the current geopolitical context and the need for strategic autonomy. FP10 should focus on a science-based approach rather than a geography-based approach, allowing non-EU entities that actively contribute to FP projects to become full participants even without requesting EU funding. 

Strengthen industry participation across FP10 to boost Europe’s innovation capacity and meet Europe’s long-term needs 

4) Coordinate FP10 programming with industrial policies, under the steering of an EU Office of Life Sciences, to accelerate R&D and benefit patients and society

Strategic planning and programme co-creation should be aligned with industrial policies across all relevant Directorate General (DGs) and Agencies. In the Life Sciences sector, this should be coordinated by a dedicated EU Office of Life Sciences [5]. 

5) Strengthen collaborative research and European competitiveness via an adequate budget in Pillar II, including public-private partnerships

Collaborative research under Horizon Europe’s ‘Pillar II – Global Challenges’ is key to enabling large-scale and impactful collaborations, as shown by the Innovative Medicines Initiative (IMI) and the Innovative Health Initiative (IHI). FP10 should maintain and strengthen this Pillar with its relevant clusters and instruments: these support an attractive and competitive EU R&I ecosystem involving all key stakeholders, which no other Pillar can achieve. 

6) Tailor participation requirements to different stages of the R&I lifecycle to support translational and late-stage research, particularly for large companies in Pillar III – Innovative Europe

FP10’s rules need to be tailored to the requirements of different stages of research. Translational research or late-stage development of critical health solutions require the participation of larger companies, who can contribute valuable expertise. This should be encouraged and facilitated under FP10’s revised Pillar III and any other instruments covering late-stage R&I. 

Embrace flexibility instead of one-size-fits-all and reduce administrative burdens to improve collaboration and maximise European investment.   

The Commission’s corporate approach under Horizon Europe has brought a high administrative burden on companies and significant rigidity in programme implementation. FP10 should be built on a trust-based system to minimise administrative burdens on companies. 

7) The FP10 Model Grant Agreement should also respond to industry operational reality, with a specific status and simplified rules for participants not requesting EU funding 

To alleviate administrative burdens, enhance project efficiency, and enable the industry involvement, it is essential to move away from the single corporate Model Grant Agreement approach or broader allowance for derogations or specific rules. The status of participants not requesting EU funding should be embedded in the FP10 legislation and applicable grant agreements, which should accept companies’ usual accounting principles in line with international standards. 

8) Build public-private partnerships on in-kind contributions with fit-for-purpose reporting rules, with reporting and certification of in-kind based on companies’ usual practices, aligned with business operations and commercial accounting requirements

FP10 should continue building on in-kind contributions as the cornerstone of public-private partnerships: this fosters solid connections between industry and academia, helps codesigning solutions, and enables translational work which would otherwise not be possible in a solely academic set-up. 

Adjustments should be made to the costing approaches to align them with business operations and commercial accounting requirements, and contributions via additional activities should be maintained to ensure the uptake, sustainability, and impact of project results.  

9) Intellectual property rules should enable the fast uptake, exploitation, and deployment of research results by industry, avoiding far-reaching additional obligations

FP10 rules on IP should differentiate between further “research use” and “direct exploitation” of results. Specific exploitation obligations imposed on participants should be applicable for public health emergencies, and should not be implemented broadly, or they risk to create legal uncertainty which is a deterrent for companies, and in particular SMEs, to join projects. 

References:

1.  European Commission, EU Competitiveness: Looking ahead, 2024,
   https://commission.europa.eu/topics/strengthening-european-competitiveness/eu-competitiveness-looking-ahead_en
   
   
2. European pharmaceutical industry calls for Competitiveness Strategy and dedicated Office for European Life Sciences, 2024,
   https://efpia.eu/news-events/the-efpia-view/statements-press-releases/european-pharmaceutical-industry-calls-for-competitiveness-industrial-strategy-and-dedicated-office-for-life-sciences
   
   
3. IHI builds on the successes of earlier European public-private partnerships in health research and innovation,
   https://www.ihi.europa.eu/about-ihi/history
   
   
4. ‘Ahead of the curve’ – new study confirms relevance and value of IHI,
   https://www.ihi.europa.eu/news-events/newsroom/ahead-curve-new-study-confirms-relevance-and-value-ihi
   
   
5. European pharmaceutical industry calls for Competitiveness Strategy and dedicated Office for European Life Sciences,
   https://efpia.eu/news-events/the-efpia-view/statements-press-releases/european-pharmaceutical-industry-calls-for-competitiveness-industrial-strategy-and-dedicated-office-for-life-sciences/