兰德-通过欧盟生物技术法案保护创新-兰德欧洲公司提交的证据（英）-2025_10页_201kb

Summary of RAND Europe's Submission to the EU Biotech Act

Core Content

RAND Europe has submitted evidence to the European Commission's EU Biotech Act initiative, outlining key opportunities and potential actions to strengthen the European biotechnology landscape. The submission emphasizes the need for a coordinated, science-informed, and innovation-supportive governance approach that addresses the unique challenges and potential of the biotechnology sector.

Main Opportunities

RAND Europe identifies six key opportunities for the EU Biotech Act to enhance biotechnology leadership and responsible innovation:

1. Developing Adaptive and Secure Governance Frameworks

• Objective: Create governance structures that integrate security considerations and enable responsible innovation across convergent technologies.
• Challenges: Current regulatory systems are fragmented and do not support cross-sectoral reuse of biotechnology.
• Recommendation: Implement platform-based regulation that allows foundational approval for core technologies and streamlined pathways for sector-specific applications. Use mutual recognition agreements and shared databases to support this.

2. Building a Strong Workforce and Streamlining Commercialisation Routes

• Objective: Improve workforce mobility and talent retention in the biotechnology sector.
• Challenges: Regulatory and legal barriers limit cross-border and cross-sector collaboration.
• Recommendation: Establish harmonized qualification requirements for key biotechnology roles. Support training, secondments, and R&D funding to foster collaboration and innovation.

3. Establishing Shared Data Governance Approaches

• Objective: Address data governance barriers to enable cross-sectoral innovation.
• Challenges: Data sharing is hindered by lack of regulation-driven incentives and fragmented frameworks.
• Recommendation: Develop sector-specific data governance provisions with harmonized standards for access, interoperability, and security. Promote federated data architectures for secure, cross-border analysis.

4. Supporting Access to Capital

• Objective: Facilitate investment in biotechnology and biomanufacturing.
• Challenges: Small and medium-sized companies face difficulties in securing funding, especially during the "translation gap."
• Recommendation: Encourage funding into different biotechnology sectors and organizations. Address regulatory barriers through a whole-systems approach involving fiscal incentives and regulatory reform.

5. Creating Flexible and Strong Supply Chains

• Objective: Enhance the resilience of biotechnology supply chains during health emergencies.
• Challenges: Current frameworks lack specific provisions for rapid deployment of biotechnology products.
• Recommendation: Establish pre-defined emergency regulatory pathways for biotechnology applications. Promote coordination mechanisms between sectors to enable rapid repurposing of manufacturing capacity.

6. Supporting the Development of Physical Infrastructure

• Objective: Invest in physical infrastructure to enable innovation and scalability.
• Challenges: Limited infrastructure hampers the production of advanced therapies and medical countermeasures.
• Recommendation: Support the development of biofoundries and other facilities for advanced manufacturing. Encourage public-sector investment in clinical trials infrastructure.

Key Recommendations

The following recommendations are proposed to guide the EU Biotech Act:

• Establish Cross-Cutting Clarity of Priorities: Define shared goals and outcomes to ensure alignment and collaboration across the biotechnology sector.
• Adaptive Governance and Regulation: Implement flexible and adaptive governance that supports the convergent nature of biotechnology. Embed security considerations from the outset and promote regulatory sandboxes.
• Workforce and Commercialisation Support: Develop appropriate skills mixtures and fast-track procedures for biotechnology applications to support workforce development and commercialisation.
• Sector-Specific Data Governance: Implement harmonized data standards and address dual-use risks through legislative and voluntary measures.
• Enhanced Access to Capital: Encourage investment in the biotechnology sector and reduce regulatory barriers to funding.
• Supply Chain Resilience: Strengthen regulatory mechanisms to support rapid deployment and coordination during health emergencies.
• Infrastructure Development: Invest in physical infrastructure such as biofoundries and clinical trial facilities to support innovation and scalability.

Conclusion

The EU Biotech Act has the potential to drive transformative innovation in biotechnology while ensuring responsible development and deployment. By addressing governance, workforce, data, capital, supply chain, and infrastructure challenges, the Act can support the EU in becoming a global leader in biotechnology, balancing scientific progress with societal and security considerations.