Life Sciences Strategy: Europe’s commitment to remain a global leader in health

On July 2, the European Commission presented to the Parliament, the Council, the Economic and Social Committee, and the Committee of the Regions the document Choose Europe for life sciences: A strategy to position the EU as the world’s most attractive place for life sciences by 2030.

This strategy, designed and developed by the Commission, aims to establish the foundations of a highly integrated approach that will allow Europe to remain competitive and attractive for investment in health, not only against established markets such as the U.S., but also emerging ones such as China.

The document followed a consultation phase in which biotechnology and health stakeholders had the opportunity to provide diverse perspectives to enrich the text.

What do we mean by Life Sciences?

Life sciences are those that study living systems—humans, animals, plants, microorganisms, and ecosystems, as well as their interconnections—through various often interrelated disciplines. In this context, biotechnology emerges as the essential harmonizing tool, capable of driving progress and innovation across all these areas.

The biotech sector is one of the leading drivers of innovation in the EU, with a 5.3% growth rate. Its productivity is 2.85 times higher than the European average and it generates six times more employment than other sectors.

Similarly, in Spain, the biotech sector grew by 4.1% in 2023, reaching 1,000 companies, with human health representing the largest share. In addition, its productivity is three times higher than the Spanish economy average.

Challenges ahead

The Commission points out that there is no real European integration in research, but rather fragmented R&D ecosystems with various entry and exit barriers that affect the European value chain as a whole.

The rigidity of approval procedures for drug and therapy development guarantees the reliability and good practices of the EU. However, emerging markets with looser quality standards gain competitive advantages in terms of research agility. The challenge lies in reducing delays without compromising quality in approval processes.

Optimizing European research and development

Although the EU highly values the biotech sector’s economic performance compared with global competitors, it acknowledges that in order to keep pace with giants like the U.S. and China, gross investment must increase.

Some of the main measures include:

• The creation of a network of European Centers of Excellence in Advanced Therapy Medicinal Products to coordinate member states’ joint development.
• The launch of a phased financing pilot project for collaborative research within the Horizon Europe 2026–2027 work program.
• A pilot project to identify and leverage collaboration opportunities among EU biotech clusters, with special focus on scaling startups and strengthening their global position in industrial innovation. This action will build on existing initiatives such as the European Cluster Collaboration Platform.

During the consultation phase, AseBio proposed strengthening public–private collaboration and enhancing synergies between academia and industry, recommendations that are closely aligned with this European Commission communication.

The pilot project for leveraging biotech clusters is a step in the same direction.

A holistic vision of life sciences: the One Health approach

The One Health approach emphasizes the connections between human, animal, and environmental health, recognizing that tackling all these dimensions together is the optimal way to address health challenges arising from realities such as climate change.

The Commission will promote One Health within programs like Horizon Europe, allocating an additional €100 million. It also announced a new strategic agenda to mitigate climate change, in which public–private collaboration between industry and member states will play a key role.

Unlocking the potential of AI and Big Data in health

The EU has an AI action plan focused on promoting equitable development of computational models and data factories.

In healthcare, the European Health Data Space (EHDS) provides the roadmap for integrating predictive models into research, diagnosis, and treatment. At AseBio, we encourage the Commission to ensure its rapid and effective implementation.

In addition, the Commission announced the creation of the European R&I Data Assembly in Life Sciences, which will bring together various EU and member state authorities working with data, along with major EU R&D bodies. Its mission will be to support consistent interpretation and harmonization of relevant data frameworks and reinforce inter-regulatory coordination and collaboration.

European sustainability

Several European initiatives—such as reducing dependency on scarce sustainable biomass or the European water resilience strategy—find significant opportunities in life sciences to advance a circular bioeconomy, aiming for no waste to be discarded without a new useful life. The objectives include:

• Improving efficiency in bioproduction and bioremediation within Horizon Europe.
• Driving innovation through public–private collaborations, fostering the growth of biotech startups and SMEs.
• Supporting academia in introducing New Alternative Methodologies (NAMs), with the goal of progressively replacing or reducing evidence based on animal testing.

Towards more efficient market access

The safety offered by the EU’s drug and medical product control network sometimes leads to slower and more complex approval processes.

The Commission’s key initiative to address this challenge is the Biotech Act, designed to adapt the regulatory system to the innovation pace of the sector.

In addition, the Commission will create an interactive AI tool specialized in regulatory matters to help researchers and innovators better understand the regulatory framework.

At AseBio, we advocate for a comprehensive modernization of the regulatory framework to simplify processes and avoid overlaps—especially in highly innovative fields such as Advanced Therapy Medicinal Products and digital health solutions.

We welcome the introduction of AI-based tools to facilitate access to the European market.

Governance mechanisms in life sciences

The Commission plans to establish a Life Sciences Coordination Group under its umbrella to ensure policies, funding, and activities favorable to innovation.

Its main functions will be to foster a dynamic R&D ecosystem in life sciences, promote high-level debate, and support the creation of an interactive AI tool to help navigate the regulatory landscape.

Strengthening SMEs and biotech training: other AseBio proposals

We believe SMEs are key players in both Spanish and European biotech ecosystems, facing very specific challenges. Reinforcing public investment and connections with private investors is essential to continue generating European biotech innovation.

It is also crucial to adapt Europe’s biotech workforce to the rapid advances in life sciences, the integration of digital technologies, and AI. For this reason, training biotech professionals across multiple disciplines is fundamental. We recommend Dual Vocational Training, which combines professional training with paid practical experience.

The immediate future of the European Health Union

This strategy aims to prepare the biotech sector for the legislative drive of the EU4Health program, designed to strengthen European healthcare systems and improve their interconnection.

The EU’s legislative health landscape is currently very active, with high-impact legislative projects such as the Critical Medicines Act and the European Biotech Act. The former has already completed the consultation phase, while the latter is still open. Both documents are expected to be approved by 2026.

At AseBio, we will continue working to ensure that this new legislation reflects the reality of the biotech sector, bringing the needs of our companies and institutions to European decision-makers. Our goal is to secure a regulatory framework that fosters innovation, strengthens competitiveness, and facilitates market access for biotech solutions, with special attention to SMEs and startups that form the backbone of the ecosystem.