AseBio presents its proposals to the European Commission for the future Biotech Act

AseBio has submitted its proposals for the future Biotech Act, the new legislative initiative promoted by the European Commission to strengthen biotechnology development in Europe. This legislation aims to establish a comprehensive regulatory framework that boosts investment, innovation, and competitiveness in the European biotech sector, at a key moment for the EU's strategic autonomy.

Currently, the Biotech Act is in a preliminary phase within the public consultation process known as the Call for Evidence. Through this process, the European Commission is gathering input from key players in the biotech ecosystem such as AseBio in order to design ambitious legislation aligned with the sector’s challenges and opportunities.

At AseBio, we enthusiastically welcome the European Commission’s initiative to develop a comprehensive Biotechnology Act, convinced that a solid legislative framework is essential to unlock the full potential of biotechnology for the benefit of the economy, health, the environment, and Europe’s strategic autonomy.

Based on this belief, our contribution directly addresses the sector’s main challenges and opportunities, organizing our recommendations around three key pillars: faster and more accessible funding to drive innovation; regulatory simplification and agility to accelerate development processes; and a stronger, more cohesive European Union to enhance global competitiveness. These proposals align with the consensus of the European biotech industry and reflect our firm commitment to building a resilient and world-leading biotech ecosystem.

Faster and More Accessible Funding to Drive Innovation

One of the main obstacles faced by the European biotech sector is the difficulty in accessing appropriate funding. Innovation in biotechnology involves high risk and requires substantial and sustained investments over time. However, capital market fragmentation and risk aversion hinder this access within the EU, pushing many companies to seek financial support outside the continent.

To address this challenge, we propose a set of measures aimed at creating a more stable, predictable, and competitive investment environment in Europe. Among these, we emphasize the need to develop innovation ecosystems that ensure legal certainty, stable regulatory frameworks, and favorable tax regimes. Additionally, we highlight the importance of attracting specialized venture capital that not only provides funding but also offers sector-specific expertise and strategic support.

In this regard, we strongly support the completion of the Capital Markets Union and the creation of dedicated funds for SMEs and industrial scale-up projects, as well as integrating markets like BME Growth into a pan-European network with more proportionate requirements. We also propose creating a European Biotech Index (similar to NASDAQ), which would increase visibility for companies in the sector and facilitate access to capital within the EU.

We suggest exploring tax incentives and measures such as temporary VAT reductions to improve the competitiveness of biotech SMEs, along with incentives for private investors backing strategic technologies. In parallel, we propose the establishment of co-investment mechanisms to attract foreign investment (particularly from the U.S. and China), provided that funded companies maintain their operations within European territory.

Finally, we consider it urgent to reform the EU grant system, reducing administrative burdens and adapting programs such as the EIC Accelerator so they can also benefit early-stage startups, which are currently excluded due to technical requirements difficult to meet at such stages.

Regulatory Simplification and Agility to Accelerate Innovation

The European biotech ecosystem faces a complex, fragmented, and often outdated regulatory environment that does not adequately reflect the sector’s specific characteristics. This situation hinders development and delays market access for new innovative solutions. Therefore, we prioritize reducing authorization and development timelines through simpler, more coherent, and predictable regulatory frameworks—without ever compromising safety.

To this end, we propose the launch of a “Biotech Omnibus Package” to comprehensively review all relevant legislation, aiming to establish more innovation-friendly regulatory pathways. This review should incorporate key principles such as technological neutrality—evaluating products based on their characteristics and risks, not their production method—, updating the Clinical Trials Regulation to make Europe more attractive for research, and promoting early collaboration frameworks, especially useful in areas like rare diseases and disruptive therapies. Through EuropaBio, we are already working on a proposal for this legislative omnibus package.

Moreover, we believe it would be beneficial to accelerate the implementation of the Unitary Patent, which would allow European startups to compete on equal terms with the U.S. or China by reducing costs and administrative burdens. We also believe that ethical and risk-benefit evaluations—essential in biotechnology—should be integrated swiftly and efficiently into new regulatory processes, avoiding bottlenecks.

Another key area is the promotion of effective, fair, and transparent Public-Private Partnerships (PPPs) from the early stages of product development. In this regard, we propose creating public-private scale-up funds through an initiative such as “Biotech for Europe”, inspired by the Chips Act or TechEU, using tools like the European Investment Bank (EIB) and the European Investment Fund (EIF) to reduce private capital risk.

We round off our proposals in this area with improvements in coordination among key European agencies such as EMA, EFSA, and ECHA, to advance toward greater regulatory and operational coherence—essential for a more agile and efficient environment that fosters biotech innovation.

A Stronger and More United EU for Global Competitiveness

If Europe aspires to lead the biotech revolution, it must decisively confront its current “industrial emergency” and reverse the declining share of industry in the EU’s GDP, in contrast to trends in countries like the United States. We believe biotechnology is a key tool to reindustrialize Europe, strengthen its strategic autonomy, and ensure global competitiveness.

One of the priorities should be to strengthen industrial scalability. Currently, many startups receiving public funding are required to request multiple quotes when subcontracting services, a practice that almost automatically favors non-EU providers—such as those in India or China—based solely on cost criteria. To reverse this trend, we propose increasing public funding for startups that hire providers with their main activity within the European Union. We also advocate for the modernization of public procurement rules to prioritize innovation’s added value beyond price, introducing “Innovative Purchasing” principles into public funding calls.

At the same time, it is vital to boost human capital. While training programs exist, they do not replace practical experience in business management. Therefore, we believe small companies must be allowed to incorporate executive talent with proven biotech experience, ensuring that public aid—especially for R&D—is flexible enough to cover these strategic salaries. It is also important to foster a genuine entrepreneurial culture that values the role of the entrepreneur and reduces fear of failure through effective support networks.

Another key element of competitiveness is digitalization. In this context, we propose integrating artificial intelligence tools to enhance process efficiency and sector productivity, as well as promoting the development of European digital platforms under a clear, stable, and legally secure regulatory framework.

Finally, we emphasize the need for better governance of the European biotech ecosystem. In this sense, we propose the creation of a Biotechnology and Life Sciences Office within the European Commission, led by a Chief Biotech Officer (CBO), supported by a European Biotechnology Council with participation from key industry stakeholders and coordinated with national offices in Member States. Additionally, to ensure a coherent political approach, greater coordination is needed between different European Parliament committees—such as ITRE and SANT—to strengthen the common message and strategy toward the Commission.