EVENT RECAP – What Drives Life Sciences Investment in the EU and the Future Impact of the Pharma Package?

On November 14th, EUCOPE together with FTI Consulting EU hosted the event “What Drives Life Sciences Investment in the EU and the Future Impact of the Pharma Package”, to mark the launch of the report, ‘’The Economic Lens: Understanding What Makes the EU Attractive for Life Sciences Investments’’.

This report provides an analysis of the EU’s current environment for attracting life sciences investments and examining the potential influence of the revision of the General Pharmaceutical Legislation (GPL) on investors’ confidence and industry growth.

The event kicked off with a presentation of insights from the report and was followed by a lively panel discussion, delving into the key drivers of life sciences investment in the EU and the broader implications of the Pharma Package. Discussions revolved around challenges and opportunities for life sciences investments in the EU, emphasising competitiveness, funding, regulatory frameworks, and the Pharma Package’s impact on innovation. The event highlighted the EU’s potential to remain a global leader in life sciences, provided its investment and regulatory ecosystems evolve to address critical barriers.

 

 

Key takeaways from the Report

The session began with a presentation by Katja Murray, Senior Director of Strategic Communication, Healthcare & Life Science at FTI Consulting EU, who detailed the report’s findings. Based on extensive literature research and interviews with ten life sciences investors, the report outlines the EU’s strengths, including world-class research institutions, high academic standards, and cost-effective early-stage research. However, it contrasts these strengths with the growing trend of investments and late-stage clinical trials shifting to the US, citing easier access to capital, regulatory efficiency, and stronger commercialisation expertise as primary drivers. Recommendations to make the EU more attractive to investors include improving access to funding, streamlining regulatory processes, providing a robust baseline in terms of market exclusivity and regulatory data protection, and fostering a predictable investment environment.

Main discussion

The discussion opened with remarks from Alexander Natz, Secretary General at EUCOPE, who stressed the importance of incorporating investors’ perspectives into policy discussions. He emphasised the need for the EU to remain competitive and predictable, particularly in areas such as rare diseases, where innovation thrives but requires long-term investments. He noted that investors often make decisions a decade before a product reaches the market, and uncertainty about market conditions could deter these critical investments. As Alexander pointed out, the report emphasises that having a strong baseline is crucial for investors.

Raúl Martín-Ruiz, Investor and partner at Ysios Capital, expressed scepticism about whether the proposed Pharma Package would address the EU’s investment challenges. He shared that his firm often invests in companies targeting unmet needs, noting that such ventures involve high risks due to scientific and clinical uncertainties. He explained that the US system, with its larger investor base and smoother transition from early-stage to Initial Public Offering (IPO) funding, offers more predictable returns. He stressed the importance of maintaining regulatory data protection and exclusivity incentives to encourage investment in the EU, especially for rare and complex diseases.

Kim Jørgensen, Director General, Permanent Representation of the European Investment Bank (EIB), described the EIB’s increasing role in financing high-risk life sciences projects, particularly from small and medium-sized enterprises (SMEs). He acknowledged that the EU faces significant challenges in scaling companies beyond seed funding stages. Jørgensen called for innovative funding mechanisms to bridge this gap, emphasising the need to derisk investments to attract private capital. He highlighted the importance of collaboration between public and private sectors, sharing examples of successful COVID-era initiatives that could serve as models for the future.

Florian Schmidt, Deputy Head of Unit “Medicines: Policy, Authorisation and Monitoring” of DG SANTE (European Commission), offered insights into the Pharma Package objectives, particularly its focus on reducing regulatory uncertainty and incentivising innovation. He acknowledged investors’ concerns about baseline protections but pointed out new proposals such as early engagement with the European Medicines Agency (EMA), regulatory sandboxes and the use of real-world evidence. Schmidt argued that these measures could streamline processes and enhance the attractiveness of the EU for high-risk biotech investments. However, he admitted that further dialogue was needed to fully address investors’ concerns.

MEP Stine Bosse, Vice-Chair of the European Parliament’s Subcommittee on Public Health (SANT), argued for a comprehensive European Life Sciences Strategy that integrates the pharmaceutical, biotech and medical devices sectors. She emphasised the critical importance of access to capital, and she suggested leveraging public funding to mitigate risks for private investors, which is particular important in antimicrobial resistance (AMR) and in certain rare diseases. She also underlined the urgency of addressing Europe’s decline in competitiveness, noting that the region has been falling behind for the past 10-15 years – despite Europe’s strong intellectual capital, there are still significant gaps in creating the right environment for innovation, highlighting the importance of ensuring the necessary prerequisites are in place to support startups and businesses. MEP Bosse stressed that the EU must act decisively to retain its leadership in life sciences, drawing attention to Denmark’s success in biotech, which she attributed to a mix of public strategies and strong private sector leadership.

Toon Digneffe, Head of Public Affairs & Public Policy Europe & Canada at Takeda Europe, and EUCOPE Board Vice Chairman, highlighted the importance of partnerships between large companies and SMEs in advancing innovation. He praised the Pharma Package for addressing regulatory inefficiencies but expressed concern that conditional incentives tied to market access could deter innovation. He emphasised the need for a stronger foundational case for incentives. He also called for the establishment of a dedicated EU Life Sciences Office to oversee and streamline policy initiatives across the sector.

Conclusions

The event provided a shared understanding of the urgent need to enhance the EU’s competitiveness in the global life sciences market.

EUCOPE believes it is essential that the EU remains globally attractive for investments, to encourage innovation and access. The Pharma Package, while a step in the right direction, requires further refinement to address funding gaps, streamline regulatory processes, and provide stronger incentives for innovation.