Spain is currently reviewing its regulatory framework with the draft Medicines Law. In your opinion, what is the main opportunity and the main risk of this reform?
It is an opportunity to modernize the system and adapt it to a context of rapid biomedical innovation. Well directed, it can improve access to innovative therapies, strengthen sustainability, and provide greater predictability to evaluation and funding processes, key to attracting R&D investment. The risk is that, without a proper balance between sustainability and access, greater uncertainty may be introduced or the incorporation of innovation into the National Health System may be delayed, affecting both patients and the country’s ability to attract research and new investments.
Spain leads the European Union in clinical trials, with 962 approved in 2024, but it still takes more than 350 days to incorporate new medicines into the system. How is this paradox explained?
Spain has built a very competitive clinical research ecosystem, thanks to its professionals, hospital network, and agile regulatory framework. However, this strength does not translate as quickly into clinical practice, due to multiple decision levels and unpredictable criteria. The challenge is to better connect both capabilities: leverage leadership in clinical trials to accelerate decision-making, incorporate more dynamic evaluation models, and move towards earlier and outcome-based access schemes. Only then can we ensure that innovation researched in Spain reaches patients sooner.
Medicines are becoming increasingly sophisticated. How can sustainability and innovation be combined?
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This sophistication is good news. We are facing more targeted therapies, with greater clinical benefit and, in many cases, capable of changing the course of the disease. They provide unquestionable value for patients but require evolving the management of health resources. The key is to make sustainability and innovation compatible with a medium- and long-term vision. Many treatments reduce associated costs, such as hospitalizations or complications. Additionally, artificial intelligence can improve evaluation, anticipate which patients will benefit most, optimize resources, and leverage real-world data for more agile decisions.
“Catalonia has a unique opportunity to establish itself as one of the major biopharmaceutical hubs in Europe”
Is the value of a medicine being measured correctly?
Traditionally, it has been measured very focused on direct cost, and that is the mistake. An innovative therapy is an investment in health and quality of life that also avoids costs in other areas of the system, such as fewer hospitalizations, or fewer or shorter sick leaves.
Catalonia is consolidating itself as a biopharmaceutical hub in southern Europe. How can this position be consolidated in the European context?
Catalonia has built a very solid biopharmaceutical ecosystem, based on collaboration between administrations, research centers, hospitals, and companies. In this sense, the pharmaceutical strategy between the Generalitat and Farmaindustria is very good news because it defines a clear roadmap focused on improving access to innovation, strengthening system sustainability, promoting R&D, and accelerating digitalization in health. This type of alliance allows consolidating its position as one of the major biopharmaceutical hubs in Europe, aligning health and industrial policy with a long-term vision.
