Spain should signal support for innovation as it takes EU Presidency

Earlier this month, Spain assumed the Presidency of the Council of the EU. The six-month term, rotated between each of the 27 EU Member States, sets the Council’s political direction, ensuring continuity and cooperation in handling ongoing negotiations around relevant EU legislative files.

Among these are proposals for three regulations – European Health Data Space (EHDS), Substances of Human Origin (SoHO) and a revision to the fees system operated by the European Medicines Agency (EMA). BMS has perspectives on each.

European Health Data Space

The EHDS would help the EU to radically improve how healthcare is delivered in Europe. If properly implemented and funded, it would give people more control over their health data. The EHDS can help to place Europe at the forefront of the global data economy. It could allow researchers and innovators to accelerate and improve diagnostics, treatments and vaccines. Our understanding of diseases and development of new treatments would be faster and safer.

Substances of Human Origin

SoHO aims to ensure that Europeans can count on the highest standards of quality and safety for substances of human origin intended for human application, including blood products. We urge EU decision-makers to adopt a holistic approach to the measures needed to boost the sustainability of the blood sector, including patient blood management and optimal blood use. Both can contribute to helping to reduce healthcare costs and support the sustainability and resilience of European healthcare systems. There should be coherence between the SoHO Regulation and the proposed revision to the EU General Pharmaceutical Legislation (GPL). The EU GPL’s measures should retain primacy in the case of borderline products such as advanced therapeutic medicinal products.

EMA Fees

We fully support a targeted approach to ensuring sustainable funding for the EMA and the regulatory network, and streamlined processes and structures. These changes are part of the revision to the EMA’s fees system. Regulatory bodies across the EU should be better resourced so that they can efficiently assess the industry’s surging medicines pipeline. Regulatory pathways should aim to keep pace with fast-moving science.

Among the list of political priorities highlighted by the Spanish Presidency, we welcome the focus on preventative health, health system resilience and health strategies for major diseases, including cancer. EU Member States’ commitment is needed to raise healthcare standards through innovation. In that, Spain is leading by example.

Spain has a vibrant life sciences industry. Some 44,000 people work in its biopharmaceutical industry. Just over half of them are women. In 2021, 37% of jobs in the industry were filled by people aged under 30¹. Strong regional scientific ecosystems, especially in Catalonia, the Basque country and around Madrid, make Spain a leading location for research and development. A BioCluster in Catalonia and the Basque Health Cluster bring together industry, academic and clinical leaders to advance healthcare innovation.

Spain ranks 29th among 132 economies measured by the Global Innovation Index which is published by the World Intellectual Property Organization, a specialized agency of the United Nations². The country has a strong concentration of skilled talent, research institutions and knowledge-based industries, alongside supportive government policies for innovation and an extensive network of public and private hospitals.

As a global innovator with a strong commitment to Europe, BMS contributes to Spain’s scientific ecosystem, with a well-established research and development footprint. BMS scientists at our Center for Innovation and Translational Research Europe (CITRE) in Seville are working to narrow the gap between basic and clinical research and, in turn, accelerate breakthroughs in the design and development of transformational therapies.

CITRE houses computational, clinical and biology research teams, alongside dedicated computational research infrastructure and laboratory facilities. Real-world patient datasets, advanced clinical trial solutions and robust predictive science approaches like artificial intelligence and machine learning are revolutionizing medicines development. As part of our global network of research and development centers, CITRE is at the heart of BMS’ efforts to translate science into treatments for patients all over the world.

Evolving Innovation Landscape

Spain’s government is working on a strategic plan for the biopharmaceutical industry. It will be an important roadmap for the development of the country’s scientific ecosystem, as well improving research capabilities and access to innovation for patients. The ambition will require concrete actions, including developing a predictable access process, advancing public-private financing mechanisms for preclinical and translational research, and strengthening incentives for innovation and production of strategic medicines.

The new plan comes as the European Parliament and the Council of the EU begin discussions on the proposed revision to the EU GPL. The European Commission’s proposals would make regulatory pathways more efficient, with faster decision-making, less bureaucracy and more digitalization. But moves to reduce the Regulatory Data Protection (RDP) baseline period from eight years to six years – with the chance to ‘earn back’ the baseline period conditional on unviable requirements - would reduce certainty and predictability for innovators.

Overall, the proposed revision to the EU GPL measures would harm innovation in Europe. It would accelerate several negative trends, including a 25% relative decline in European research and development and a drop in Europe’s global share of clinical trials from 25% to 19%. Between 2018 and 2022, research and development spending growth in China was more than three times higher than in Europe³.

European Innovation

The challenge for the coming decades is not whether innovation in medicines will happen but rather where it will happen. Innovation is fast-moving. The EU’s policy environment should enable the translation of science into treatments and deliver them fast to patients. By updating the existing legislative framework for medicines, policymakers can signal that the EU wants to be at the heart of global health innovation.

Innovation-intensive EU Member States like Spain should back the strengthening of Europe’s scientific ecosystem. Through the Presidency of the Council of the EU, Spain has a chance to signal that innovation is important nationally and for the EU.

A shared vision for European science is possible. From it would emerge jobs, investments and higher healthcare standards for this generation of Europeans and the ones to come.

References:
1. Farmaindustria, the biopharmaceutical industry’s representative organisation in Spain
2. GII 2022 Report
3. EFPIA