European Commission touts proposed Biotech Act in new staff report
The European Commission has published an analysis detailing the benefits of enacting the European Biotech Act, which was proposed last year as a means of increasing the EU’s competitiveness in the sector, in part by simplifying regulations.
The Commission noted that the proposed legislation would help to achieve several key objectives, including making the region more attractive to medical product manufacturers and increasing access to new treatments.
On 27 May, the Commission published a staff working document analyzing the effects of the Biotech Act. While the proposed legislation also addresses European food and animal healthcare, most of it aims to improve the regulation and economic drivers of human biotechnology products.
"The Biotech Act aims to strengthen Europe’s biotechnology and biomanufacturing sectors, notably in the field of health, and to accelerate the development, production and market uptake of biotechnology-based innovations, products and services across the EU," said the Commission. "The initiative sets out a range of measures to support the health biotechnology sector, alongside targeted actions relevant to other biotechnology applications, including food and feed, industrial biotechnology and agricultural biotechnology.
"Published in the form of a Staff Working Document, the analysis outlines the expected impacts of the proposed measures, drawing on supporting studies, stakeholder contributions and available evidence," it added. "It highlights the potential of the Biotech Act to contribute to regulatory simplification, reduce administrative burden and strengthen Europe’s competitiveness, while maintaining high standards of safety and public health protection."
Biotechnology challenges
The Commission said biotechnology and biomanufacturing, with the support of artificial intelligence (AI) and digital tools, have the potential to modernize the region's economy and boost competitiveness and innovation. However, despite hosting a world-class scientific base, it noted that the EU is trailing competitors translating that science into development, market deployment, and manufacturing.
"Fragmented ecosystems, financing constraints, complex regulatory pathways, and a lag in adapting regulatory frameworks to technological advances, hinder EU biotechnology companies’ potential to innovate, bring innovation to market, produce and grow in the EU," said the Commission. "As a result, the EU’s biotechnology sector does not meet its full potential to tackle major societal challenges and faces a widening global competitiveness gap."
The Commission notes that there are three major problem drivers for the biotech industry in Europe, including regulatory and administrative hurdles that delay products coming to market, the fragmented nature of the biotechnology ecosystem that fails to fully tap into the region's research infrastructure and access to capital, and advances in biotech that result in slow and obsolete governing frameworks. It said that ultimately, the Biotechnology Act is intended to address the shortcomings and make the region more attractive for biomedical manufacturers and increase access to novel treatments for European patients.
The Commission noted that the act aims to improve the functioning of the EU internal market by creating a framework that strengthens the region's biotechnology competitiveness from research to production, facilitates the timely market entry of products, and ensures public safety.
Biotechnology interventions
The Commission listed 17 interventions intended in the proposed legislation to address shortcomings in the current biotechnology ecosystem. They include providing regulatory assistance by the EU Health Biotechnology Support Network to product developers.
"This targeted, early-stage support will be particularly valuable for [small- and medium-sized enterprises (SME)], which often lack extensive in-house regulatory expertise," said the Commission. "The support will consist of facilitating information on, and access to, applicable legislative frameworks, including procedures for seeking guidance on regulatory status, rules applicable to products combining different technologies or regulatory frameworks, and access to regulatory sandboxes."
Furthermore, it proposes establishing a publicly available repository of regulatory status decisions, opinions, and scientific recommendations for products under development in the region, to ensure transparency and regulatory consistency.
"In addition, the proposal establishes a foresight panel for emerging health innovation comprising scientific and regulatory experts from the SoHO Coordination Board (SCB), the Medical Devices Coordination Group (MDCG), the Coordination group on Health Technology Assessment, the EMA, and the competent authorities of the Member States," said the Commission. "The panel would provide early recommendations to the Commission, relevant EU agencies, and Member State competent authorities.
"Moreover, a cross-framework coordination for regulatory sandboxes in the health area aims to allow for dialogue and information exchange among authorities operating regulatory sandboxes for health biotechnology products across different Union legislative frameworks (MDR, IVDR, SoHO Regulation, Pharmaceutical Regulation)," it added. "Member State and Union-level authorities operating sandboxes under different frameworks would have to consult with each other and with the foresight panel regarding sandbox design and implementation, ensuring the potential integration of cross-framework aspects, which is needed given the increasing cross-cutting nature of health product innovations."
The Commission also noted that the proposed legislation includes other interventions such as targeted regulatory reform of the Advanced Therapy Medicinal Products (ATMPs) framework to make the region more attractive for high-risk biotech investments; reforming the Clinical Trials Regulation (CTR) to shorten trial authorizations and strengthen collaboration between member states; reforming the regulatory directive on human organ transplantation; and more.
In addition to the regulatory reforms, the Commission noted that the Biotech Act is intended to provide interventions for industry, including strategic, high-impact projects and healthcare ecosystem support for product developers and manufacturers.
"Together, these measures aim to boost the EU’s competitiveness and resilience in health biotechnology, by strengthening biomanufacturing capacity, value chains, research and technology infrastructures in the sector, accelerating innovation and technology deployment and addressing ecosystem fragmentation through coordinated support mechanisms," said the Commission.
