Advanced therapies represent a paradigm shift in medicine, but they require a regulatory framework capable of ensuring equitable and sustainable access for all patients.
This was the key message shared today at the Senate during the event on advanced therapies organised by the consultancies Lasker and PORIB, with the endorsement of the Spanish Patients’ Organisations Platform (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
During the first panel, entitled Sustainability and Innovation: Regulatory Framework, Value Assessment and Access to Advanced Therapies, Pedro Carrascal, Director General of the Spanish Patients’ Organisations Platform, moderated an insightful discussion in which the speakers — Daniel de Vicente, member of the board of FEDER; Valentín García Gutiérrez, Second Vice-President of 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 outcomes-based model for assessment and access, one that structurally incorporates the patient voice and guarantees equity across the whole country.
“The issue with advanced therapies is that they are a new product, an expensive product; there is no balance between supply and demand, and therefore there is no access. We all want access to be possible, and for that we need to build trust,” said Manuel García Goñi, Professor of Applied Economics at the Faculty of Economics and Business Studies 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 is driving the debate
The second panel, moderated by Manuel Delgado, Managing Partner at Lasker, featured contributions from Paschalia Koufokotsiou, Policy Officer at the European Commission’s DG SANTE; 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 speakers offered a range of key perspectives on European harmonisation and its implementation in Spain, highlighting the need to accelerate the transposition of European regulations in order to keep pace with global innovation, while maintaining a people-centred approach.
A comprehensive view of the positioning and access to advanced therapies from the 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 speakers — Nekane Murga, Coordinator for Personalised and Precision Medicine and Advanced Therapies at Osakidetza; Gonzalo Balbontín, Managing Director of the Progreso y Salud Foundation of the Regional Government of Andalusia; Enrique Ruiz Escudero, PP spokesperson on the Senate Health Committee; and Concepción Andreu, Second Vice-President of the Senate and PSOE member of the Senate Health Committee — emphasised the key role of the Autonomous Communities in the arrival of advanced therapies in Spain and their important management responsibilities.
They noted that each Autonomous Community has its own specific characteristics, but that all must act as guarantors of equity in patient treatment, through collaboration rather than competition.
POP Vice-President Manuel Arellano closed the conference by describing advanced therapies as “an unprecedented opportunity to improve patients’ lives” and called for “their development, assessment and access to be built through dialogue among all stakeholders in the system, always placing affected individuals at the centre.”
The event was supported by Bristol Myers Squibb, Johnson & Johnson and Vertex Pharmaceuticals, three companies firmly committed to advancing these therapies in order to improve patients’ lives.