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Biocat has led at the European Parliament the event “Regions for Health Innovation: Personalised Medicine and ATMPs driving Europe’s Future,” within the framework of the PRECISEU project, with the support of the Government of Catalonia and hosted by MEP Nicolás González Casares (S&D). The meeting has placed personalized medicine and advanced therapies (ATMPs) at the center of the European agenda as engines of competitiveness and cohesion in the EU, and has served to reinforce the role of Catalonia as one of the European benchmarks in these fields.

The event brought together more than 80 professionals from authorities of the European Commission, MEPs, representatives of Catalonia and other regional governments, patients, industry and research centers, who participated in debate on personalized medicine and other topics such as the European Health Data Space (EHDS), the pharmaceutical reform, the biotechnology law, or territorial competitiveness.

The session opened with speeches by the Delegate of the Government of the Generalitat to the EU, Ms. Ester Borràs; MEP Nikos Papandreou; and Robert Fabregat, CEO of Biocat, who stated: “The European Union is at a decisive moment. Personalized medicine and advanced therapies redefine prevention, diagnosis and treatment; these advances must go hand in hand with equity, sustainable reimbursement and regulatory frameworks, and robust supply chains. Catalonia is determined to play a proactive role in this European strategy.” For her part, Ester Borràs emphasized “the value of interregional alliances to move from pilots to shared, scalable operational models within the EU.”

Legislation and data to accelerate patients’ access to innovation


The first panel, moderated by Montserrat Daban (Biocat) with participation from EFPIA, Asphalion and the Platform of Patients’ Organisations, addressed how the European Health Data Space and the Pharmaceutical Package can reduce access times and reinforce safety and traceability without losing patient focus. The debate pointed to the need to harmonize regulatory frameworks and to promote incentives for innovation among states and regions, while deploying data governance that facilitates research and secondary use, including clinical and real‑world data.

It was also highlighted that the complexity and breadth of current legislation can hinder investment in a sector like health, which is why there have been calls to simplify authorization and market access processes and to reduce bureaucracy.

The speakers insisted on strengthening collaboration among academia, industry and regulators to accelerate adoption of new technologies and update training for key profiles. In parallel, the need for agile regulatory frameworks that facilitate clinical trials and cross‑border participation by patients and researchers was emphasized.
 

Sharing successful models: the importance of advanced therapies hubs in Europe

With David Morrow (EATRIS) as chair and Kathleen d’Hont (Government of Flanders), Antoni Plasència (Government of Catalonia) and Jim Lund (CCRM Nordic) as speakers, the second panel shared different models from three leading ATMP hubs in Europe, along with their driving policies and strengths. They agreed on the need to advance a European mapping of GMP capacities, which would allow mechanisms for procurement and shared use of infrastructures, as well as defining common standards for traceability and pharmacovigilance from trials through post‑marketing follow‑up.

In this context, it was underlined that the creation of regional collaborative networks and ecosystems drives the innovation race and scientific development, and that strengthening cooperation between companies around a sustainability and competitiveness approach is key. The panel advocated establishing cross‑border patient pathways in prioritized indications, with shared funding and criteria, and deploying European itinerant training programs for critical profiles, such as GMP, quality and data stewardship, to circulate talent between hubs.

The debate allowed highlighting Catalonia’s positioning as a leading European hub in ATMP and health data, with initiatives such as ATMP Catalonia and the coordination of PRECISEU to connect regional capacities and place equitable access at the center.

Regions and competitiveness: cohesion with impact

The third block, moderated by Ewa Chomicz (ERRIN) with representatives of the Directorate‑General for Research & Innovation of the European Commission, the Government of Catalonia and the Government of Navarra, focused on how regional innovation ecosystems drive European competitiveness, with emphasis on Regional Innovation Valleys, the 2028–2034 cohesion policy reform, and the future European Competitiveness Fund. In the conversation, emphasis was placed on interregional projects across the full value chain, from research to industrialization and patient access, on specific financial instruments for scaling and manufacturing ATMPs within the Union, and on coordinated incentives between states and regions.

To measure impact, prioritization of common indicators such as time to patient, territorial equity and time‑to‑scale for companies and solutions was highlighted. Likewise, the improvement of interaction and collaboration between the scientific, clinical and technological sectors was emphasized as a condition for turning knowledge into value. In this context, Catalonia emphasized its participation in advanced R + D projects, which have reinforced its role as a platform for translation and industrialization of health technologies at European scale.

The event also included an in‑depth view of the future European biotechnology law (Biotech Act), presented by Claire Skentelbery (EuropaBio), and the current debate in the European Parliament on impactful legislation in the sector, presented by MEP Nicolás González Casares.

González Casares made an urgent call to defend the role of science in society in the face of growing anti‑European, anti‑scientific and commercial threats. In this regard, he underscored the need to strengthen the public research sector and to build bridges with industry to accelerate commercialization of scientific advances, with a clear mission to improve European competitiveness and reinforce the Union’s scientific capacities. The MEP also referred to the latest threads of the general pharmaceutical legislation under negotiation and stressed that hospital exemption policies are another example of good practices being seen in Catalonia. Finally, in the framework of the European Health Data Space, the MEP referred to the need to define a clear purpose for the use of patients’ genetic data, and appealed to ethics as a common framework for defining patient secondary data use. “We have the opportunity to strengthen all the capacities we have in Europe, the talent, and also to attract innovation, an innovation that reaches the regions and that is key to improve our competitiveness,” González Casares concluded.

The closing was delivered by MEP Laura Ballarin and by Francesc Trillas, Secretary of Economic Affairs and European Funds of the Government of Catalonia.

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