The European and Spanish pharmaceutical frameworks are undergoing simultaneous transformations, posing the challenge of balancing innovation, strategic autonomy, sustainability, access to medications, and legal security. This was the focus of the inaugural session of the 5th Pharmaceutical Law Congress of the Madrid Bar Association, which featured interventions from Javier Padilla, Secretary of State for Health, and Pilar Jimeno, Director General of Health Inspection and Planning for the Madrid Community.
The congress aims to analyze the main reforms redefining the sector, including European pharmaceutical regulation, biotechnology, financing, and access to medications, as well as digital health and new pharmaceutical service models. Padilla situated this process in a context that exceeds traditional health policy limits, noting that the reform of European pharmaceutical legislation and proposals like the Critical Medicines Act and the Biotech Act also aim to strengthen Europe’s industrial and productive capabilities, reduce dependencies, and align innovation incentives with the needs of health systems and patients.
A Strategic Regulation for a Key Sector
Padilla placed the Medicines and Health Products Bill at the center of a broader reform process in Spain, alongside the new system for evaluating health technologies and changes in financing and pricing for medications and health products. He considered the pharmaceutical sector strategic not only from an economic and industrial perspective but also from a social one, emphasizing that “the pharmaceutical sector is a strategic sector, not only from an economic or industrial point of view, but also from a social point of view.”
The Secretary of State for Health defended the need for regulations that are “very open to dialogue” and the institutionalization of multilateral spaces where administrations, industry, professionals, and patients can participate in defining pharmaceutical policies. He cited the Pharmaceutical Industry Strategy 2024-2028 and its follow-up bodies as examples of stable interlocution between the different actors involved.
Javier Mata, a member of the Madrid Bar Association’s Governing Board, emphasized the importance of the specialized legal profession in this context, noting that lawyers can no longer limit themselves to interpreting norms after they have been approved. Instead, they must intervene earlier in decision-making processes to anticipate risks and provide solutions, especially in areas like the pharmaceutical sector where technology advances faster than regulation.
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This intervention highlights the need for legal security that serves to investigate, invest, and make decisions while preserving patient guarantees. Mata defended the necessity of ordering the different interests at play through predictable rules, avoiding simplistic confrontations between innovation, sustainability, and access.
Balance Between Innovation, Security, and Sustainability
Pilar Jimeno discussed the reforms currently underway in Europe and Spain and their direct impact on research, drug development, sector competitiveness, and patient access to new therapies.
From the perspective of community pharmacy, Manuel Martínez del Peral, President of the Official College of Pharmacists of Madrid, emphasized the role of pharmacies in the health system.
Martínez del Peral concluded, “Good regulation is not measured only by how well it orders the system, but above all by the trust it generates and by what it allows those who are daily by the patients’ side to do better.”
Nuria Amarilla, president of the Pharmaceutical Law Section of the Madrid Bar Association, explained that the Congress aims to provide an update on the latest developments in pharmaceutical law, both for professionals already working in the field and for those just starting to approach it. She highlighted the value of specialized legal advice in a highly regulated and complex area.
