Advanced therapies represent a paradigm shift in medicine, but they require a regulatory framework that guarantees equitable and sustainable access for all patients.
This was the central theme of today's discussion in the Senate during an event on advanced therapies, organized by the consulting firms Lasker and PORIB, with the support of the Platform of Patient Organizations (POP).
The conference, entitled Opportunities and Challenges in the Regulation, Assessment and Access to Advanced Therapies, brought together national and regional authorities, healthcare experts and patient associations to examine the major paradigm shift posed by these new therapies within the context of the new Medicines and Medical Devices Act.
In his opening remarks, the President of the Senate, Pedro Rollán, stressed that “Spain has one of the best healthcare systems in Europe and in the world. As public institutions, we must ensure that innovation reaches all citizens without creating inequalities and while safeguarding the sustainability of our healthcare system.”
“Although a medicine may have received a positive opinion from the European Medicines Agency, this does not necessarily mean that it is available in all European Union countries,” confirmed Sol Ruiz, Head of the Biological Medicines, Biotechnology and Advanced Therapies Division at the Spanish Agency of Medicines and Medical Devices (AEMPS), during her presentation entitled Clinical and Comprehensive Definition of Advanced Therapies.
César Hernández, Director General for the Common Portfolio of NHS Services and Pharmacy at the Ministry of Health, stated that “the challenge for the healthcare system is to make the extraordinary become commonplace. The industry strategy reflects the Ministry’s vision for the future development of advanced therapies in Spain.”
Sustainability and innovation: regulatory framework, value assessment and access to advanced therapies.
In the first panel, entitled 'Sustainability and innovation: regulatory framework, value assessment and access to advanced therapies', Pedro Carrascal, general director of the Platform of Patient Organizations, moderated an enriching conversation in which the speakers – Daniel de Vicente, member of the board of directors of FEDER; Valentín García Gutiérrez, 2nd vice president of the SEHH; Isabel Pineros, director of the access department at Farmaindustria; and Miguel Ángel Calleja, Hospital Pharmacist – agreed on the need to promote a more dynamic, coordinated and results-oriented evaluation and access model, which structurally incorporates the patient's voice and guarantees equity throughout the territory.
“The problem with advanced therapies is that they are a new product, an expensive product, we don't have a balance between supply and demand, and therefore we don't have access. We all want access, and for that we have to build trust,” declared Manuel García Goñi, Professor of Applied Economics at the Faculty of Economics and Business Administration of the Complutense University of Madrid, during his presentation on 'Financing Models and Public Procurement'.
Building the Regulatory Framework for Advanced Therapies: The Pace of Innovation Fuels the Debate.
The second panel, moderated by Manuel Delgado, managing partner of Lasker, featured presentations by Paschalia Koufokotsiou, Policy Officer, DG SANTE of the European Commission; Alba Soldevilla, PSOE representative on the Health Committee of the Congress of Deputies; and Rafael Belmonte, second secretary of the Health Committee of the Congress of Deputies.
The participants offered key perspectives on European harmonization and its application in Spain, emphasizing the need to accelerate the transposition of European regulations to keep pace with global innovation, with a people-centered approach.
A comprehensive view of the positioning and access to advanced therapies, from a regional perspective.
The third and final panel was moderated by Miguel Ángel Casado, director of Pharmacoeconomics & Outcomes Research Iberia and president of the PORIB Foundation.
The panelists—Nekane Murga, coordinator of Personalized and Precision Medicine and Advanced Therapies at Osakidetza (the Basque Health Service); Gonzalo Balbontín, managing director of the Progress and Health Foundation of the Andalusian Regional Government; Enrique Ruiz Escudero, spokesperson for the People's Party (PP) on the Senate Health Committee; and Concepción Andreu, second vice-president of the Senate and member of the Socialist Party (PSOE) on the Health Committee—highlighted the key role of the Autonomous Communities in the arrival of advanced therapies in Spain and their important management role.
They shared that each Autonomous Community has its own particularities, but we must guarantee equity in patient treatment, through collaboration, never competition.
The Vice President of the POP, Manuel Arellano, concluded the day by describing advanced therapies as “an unprecedented opportunity to improve patients' lives” and with a call for “their development, evaluation, and access to be built through dialogue among all stakeholders in the system, always placing the affected individuals at the center.”
The event was made possible through the collaboration of Bristol Myers Squibb, Johnson & Johnson, and Vertex Pharmaceuticals, three companies with a strong commitment to advancing these therapies to improve patients' lives.