The Biotech Act drives the debate on the future of European biomedical innovation

The MGS auditorium in Barcelona hosted this Thursday the XIX Annual Conference of the Biomedical Research Technology Platforms under the claim “Scientific and industrial excellence: towards the consolidation of an innovation hub”.

Organized by the Biotech Platform, the Spanish Innovation Platform in Health Technology, the Innovative Medicines Technology Platform, the Spanish Animal Health Technology Platform, and the Spanish Nanomedicine Platform, the event focused on the need to strengthen collaboration between academia and industry to accelerate knowledge transfer, strengthen biomedical innovation, and improve European competitiveness and strategic autonomy in health.

In this context, from the Spanish Bioindustry Association (AseBio), as coordinators of the Biotech Platform, we organized the panel “European Biotechnology Act: an opportunity to consolidate Spain as a hub for biotechnological innovation”. The session analyzed how the future Biotech Act can boost European competitiveness, strengthen the sector’s industrial and innovation capacity, and position Spain as a strategic player in areas such as clinical trials, advanced therapies, and biomanufacturing.

Biotechnology as a strategic priority for Europe

Growing global competition and the need to strengthen Europe’s strategic autonomy have positioned biotechnology as one of the priority sectors for the continent’s industrial and healthcare future. The reports by Enrico Letta and Mario Draghi warn about Europe’s loss of competitiveness in key technological sectors and highlight the need to move towards more agile and innovation-friendly frameworks.

In this context, the future European Biotechnology Act represents an opportunity to accelerate sector development, reduce regulatory barriers, and transform European scientific knowledge into innovation, investment, and industrial capacity.

“The XIX Annual Conference of the Biomedical Research Technology Platforms comes at a key moment for the future of biotechnology and competitiveness in Europe. The proposed EU Biotech Act represents a strategic opportunity to strengthen Europe’s technological and industrial autonomy, accelerate the transfer of scientific knowledge to the market, and consolidate biomanufacturing and biotechnological development capacities within Europe,” said Carlota Gómez de la Hoz, Executive Director of Corporate Affairs and Sustainability at HIPRA.

“At HIPRA, we believe that Spain has unique strengths — scientific talent, leadership in clinical trials, and real industrial capabilities — to consolidate itself as one of Europe’s major biotechnology hubs. Dialogue spaces such as this Conference are essential to move towards a shared vision among institutions, science, and industry that transforms research excellence into innovation, investment, and long-term industrial capacity.”

From scientific knowledge to industrial application

Europe has a world-class scientific and academic base in biotechnology and life sciences. However, difficulties persist in transferring this knowledge to the market, scaling business projects, and consolidating industrial capacities.

Many high-potential innovations continue to face regulatory barriers, administrative fragmentation, financing difficulties, and long authorization timelines. The Biotech Act seeks to address some of these challenges through measures aimed at streamlining processes, promoting strategic projects, strengthening biomanufacturing capacities, and fostering more efficient and coordinated regulatory environments.

In this context, Sol Ruiz, Head of the Biotechnology and Biological Products Division at the Spanish Agency of Medicines and Medical Devices (AEMPS), stated that “the biotechnology sector in the European Union (EU) has experienced remarkable growth in recent years, with a significant contribution from healthcare biotechnology. Even so, the EU appears to have lost competitiveness at a global level.”

She therefore emphasized that the European Biotechnology Act “is presented as a legislative framework designed to revitalize the region’s biotechnology and biomanufacturing sectors. It reinforces the role of the European Medicines Agency (EMA) in streamlining medicine approvals and reducing the regulatory burden for companies in the sector in Europe, as well as simplifying clinical trial authorizations, measures that can significantly increase the impact of the European biotechnology sector.”

Attracting investment to become more competitive

Beyond generating knowledge or creating startups, one of the main challenges remains consolidating companies capable of growing and competing internationally.

Access to advanced-stage financing, the mobilization of private capital, and the creation of attractive investment environments will be key elements in strengthening Europe’s competitiveness in biotechnology.

Although the proposed European Biotechnology Act includes measures to attract investment and support sector development, different ecosystem stakeholders agree on the need to move towards a more ambitious approach, especially regarding incentives, financial instruments, and specialized infrastructure.

“Europe has built a solid scientific and entrepreneurial base. The challenge now is clear: accelerate the transformation of that base into global companies and generate success stories that establish Europe as a global biotechnology benchmark,” argued Laura Rodríguez, partner at Invivo Partners, a firm specialized in strategic advisory and financing for innovative biotechnology and life sciences companies.

How Spain can leverage the momentum of the Biotech Act

Spain is in a particularly favorable position to benefit from the momentum generated by the future European Biotechnology Act. In recent years, it has consolidated itself as one of Europe’s leading countries in biomedical research and clinical development, leading clinical trials and strengthening an increasingly dynamic and specialized biotech ecosystem.

The revision of the European clinical trials framework and the planned measures to simplify procedures and reduce administrative timelines respond to a longstanding sector demand: to have more agile, coordinated, and innovation-adapted regulatory environments.

In this regard, Julio Font, CEO of Histocell, a biotechnology company specialized in regenerative medicine, advanced therapies, and the development of innovative solutions based on cell therapy, stated that “the Biotech Act is a legislative opportunity to truly address the problems facing the European biotechnology sector. It can be genuinely useful in advancing areas such as biomanufacturing, but the challenge ahead is how to implement it quickly and flexibly without losing the impact promised by the proposal’s text.”

The Biotech Act therefore represents an opportunity not only to strengthen European competitiveness, but also to consolidate Spain as one of the leading biotechnology hubs on the continent.