EFPIA strongly support the ambition to foster a world-class innovation environment for biotechnologies. To make the EU more attractive for researching, developing and manufacturing new technologies, we urge coordinated and urgent action across several areas.   

• Reinforce internationally competitive Intellectual Property (IP) protection rules. 

This might mean: reforming the Supplementary Protection Certificate (SPC) framework to fully compensate innovators for time lost due to regulatory burdens and the pricing and reimbursement process; enhancing Regulatory Data Protection (RDP) protection for medicines for which patent protection is insufficient or unavailable; enacting a patent enforcement system with early resolution mechanisms to provide clarity for generic entry and treble damages for launches at risk. Predictable, strong and enforceable IP underpins a competitive EU, enhancing patients’ health and access to innovative medicines.  

• Simplify, speed up and harmonise the EU framework for clinical trials. 

This might mean: pragmatic implementation of the Clinical Trials Regulation avoiding requirements beyond its scope; faster, harmonised, and coordinated processes for multi-country trials, including ethics reviews, with the use of reliance mechanisms; enabling parallel submissions of substantial modifications; resources and a dedicated platform for continued regulator/innovator dialogue beyond Clinical Trials Information System (CTIS), and a shift towards a product-based approach that optimises efficiency. Regulatory pathways should be aligned across frameworks such as Medical Device Reguation/In Vitro Diagnostics Regulation/Genetically Modified Organisms legislation/etc to reduce duplication. 

• Establish a center of excellence for manufacturing innovation. 

This might mean: establish a center of excellence for manufacturing innovation (e.g. via a more empowered EMA-QIG “v2.0”) underpinned by resources, confidentiality and sandbox principles; future proof enabling regulations, like Annex 2 of the Medicines Directive (currently being negotiated) and the variations guideline; implement changes with minimal additional regulatory burden; address cumulative impact of chemical/environmental legislations on medicine manufacturing; streamline permitting and auditing processes to tap into the potential of the EU in terms of scale of production.   

• Modernise the EU regulatory ecosystem.  

The EU regulatory framework must apply better regulation principles to truly function as enabler of biopharmaceutical innovation. The reform of the pharmaceutical legislation should simplify processes, while the Biotech Act can drive further progress e.g. by accelerating digital transformation; enhancing regulators’ capacity through sustainably ensuring resources and expertise; and enabling the EU to lead in shaping global standards, especially for platform technologies and Advanced Therapy Medicinal Products.  

• Unlock broader use of private investments. 

Access to capital should be facilitated. We urge policymakers to consider reforms to pension fund regulations that would unlock private investment by increasing liquidity for venture capital and SME financing. The creation of an EU-backed guarantee mechanism would play a vital role in de-risking large-scale investments in biotech innovation. Robust funding for collaborative Research and Innovation, including public-private partnerships and clusters of excellence to maintain and scale up Research and Development infrastructures, is essential to strengthen Europe’s biotech ecosystem.  

• Boost digitalisation for biotech development. 

This might mean: a balanced data-sharing framework aligned with the Data Act and TRIPS Agreement to protect sensitive commercial information and underpinned by a harmonised approach to data use that avoids fragmentation and legal uncertainty; secure and efficient access to high-quality datasets across sectors and borders to support innovation at scale; a framework allowing for AI integration in life science R&D across the medicine lifecycle; leverage data already submitted by Marketing Authorisation Holders (e.g. during registration process) and tools like European Medicines Verification System and European Shortages Monitoring Platform to minimise duplication and burden in meeting reporting requirements. 

The full submission is available here