Biotech CEOs Urge EU for Urgent Reforms to Boost Cell and Gene Therapy Competitiveness

More than 30 biotech CEOs are calling on European Union lawmakers to implement new incentives and legislative changes to accelerate the development and commercialization of cell and gene therapies, particularly by increasing early-stage capital. This push comes as the EU aims to regain its competitiveness in the advanced therapies sector.

Key Demands from Biotech Leaders:

• Increased Early-Stage Capital: CEOs emphasize the need for dedicated EU funds to support the transition of cell and gene therapies from preclinical stages to first-in-human trials. They also advocate for member states to provide more tax incentives, risk-sharing mechanisms, and support for spinouts, citing that European companies secure significantly smaller financing rounds at early stages compared to other regions.
• Reduced Regulatory Burdens: The policy brief, supported by the executives, calls for a reduction in duplicative regulatory submissions.
• Improved EU-Level Coordination: Proposals include adopting new pilot programs for better EU-wide coordination in commercializing cell and gene therapies, especially those targeting ultra-rare conditions.
• Streamlined Clinical Trials: The brief highlights that adjustments to clinical trials in Europe can take up to 90 days to process, compared to approximately 30 days elsewhere. This delay slows patient recruitment, data generation, increases investor uncertainty, and diminishes Europe’s appeal for multi-center trials.

Driving the Push for Change:

• Fredrik Wessberg, CEO of CCRM Nordic, stressed the “sense of urgency” for “quick wins and solutions.”
• Miguel Forte, President of the International Society for Cell & Gene Therapy, underscored the need for policies that ensure products can be “commercially viable,” addressing challenges faced by therapies in both the EU and US.
• The upcoming Biotech Act, expected to be released next year, along with an overhaul of Europe’s pharmaceutical legislation (finalizing within two years), presents a “particular moment of time that has a lot of opportunity” for these changes.
• The European Commission recently sought comments on its Biotech Act proposal, aiming to accelerate the transition of advanced therapies “from laboratory to factory and to the market, while maintaining the highest safety standards.”

German biopharma giants like Bayer and Boehringer Ingelheim have also submitted comments, advocating for IP reforms, accelerated biotech and biomanufacturing scale-up, and other regulatory adjustments.