INFARMED Leadership Appointments: A New Era in Health Regulation and Expertise
INFARMED Leadership Appointments: Renewed Expertise for Medicines Oversight
The Portuguese Council of Ministers has issued Resolution No. 207/2025, designating the new members of the Board of Directors for INFARMED – the National Authority for Medicines and Health Products, I.P., effective January 1, 2026. These INFARMED leadership appointments address the expiration of the previous board’s term on July 13, 2025, naming Rui dos Santos Ivo as President, Raquel Maria Sousa e Silva Ascenção as Vice-President, and Eduardo Polena Pacheco Araújo Costa as a Board Member. Proposed by the Minister of State for Finance and the Minister of Health, the selections received favorable opinions from the Commission for Recruitment and Selection for Public Administration, highlighting appointees’ proven expertise in pharmaceutical regulation, health economics, and clinical pharmacology to maintain robust governance in Portugal’s medicines authority.
Profiles Powering Regulatory Advances
At the core of this resolution lies the selection of board members whose professional backgrounds align closely with the demands of regulating medicines and health products in a dynamic European context. Rui dos Santos Ivo, the newly designated President, brings extensive experience as the current President of the European Medicines Agency (EMA) Board since March 2025 and prior leadership roles, including multiple terms at INFARMED and as chair of the Heads of Health Technology Assessment (HTA) Agencies Group from 2021 to 2025; his academic credentials, including a degree in Pharmaceutical Sciences from the University of Lisbon and postgraduate training in health law and regulation, position him to advance evidence-based decision-making in drug approval and market surveillance.
Complementing this, Vice-President Raquel Maria Sousa e Silva Ascenção, a specialist in clinical pharmacology and general medicine, offers practical insights from her roles as a hospital coordinator in clinical pharmacology at the Lisbon Central University Hospital Center and as a former member of INFARMED’s Health Technology Assessment Commission from 2016 to 2018, with her ongoing doctoral work in medicine enhancing her contributions to pharmacovigilance and ethical health practices. Board Member Eduardo Polena Pacheco Araújo Costa adds a strong economic dimension, holding a PhD in Economics from Nova School of Business and Economics and serving as an expert on INFARMED’s Health Technology Assessment Commission since 2022, with research focused on pharmaceutical market regulation and public health expenditure sustainability, evidenced by over 40 publications and prior presidency of the Portuguese Health Economics Association from 2023 to 2025. These profiles collectively signal a board equipped to tackle complex challenges in health technology evaluation and policy integration.
Shaping Health Economics and Market Strategies
This board renewal at INFARMED seeks to integrate regulatory, clinical, and economic perspectives, particularly in evaluating the cost-effectiveness of novel therapies amid rising public health expenditures. With President Ivo’s EMA leadership experience, the board is poised to align Portuguese policies with EU-wide HTA initiatives, potentially streamlining reimbursement decisions for innovative medicines and enhancing cross-border data sharing on real-world outcomes, which could reduce delays in patient access to high-cost treatments.
Vice-President Ascenção’s clinical pharmacology expertise may drive advancements in pharmacovigilance and good clinical practices, informing HEOR models that incorporate safety and efficacy data to support value-based pricing, while Board Member Costa’s focus on pharmaceutical market competition and fiscal sustainability could refine methodologies for assessing budget impacts, drawing from his research on public spending in health systems.
In the context of broader industry trends, such as the EU’s push for joint clinical assessments, these INFARMED leadership appointments may bolster Portugal’s position in collaborative frameworks, ultimately promoting equitable market access and optimized reimbursement policies that balance innovation incentives with resource allocation in national health services. As Director at Syenza, I extend my congratulations to the new board on their appointments and wish them success in their upcoming term, anticipating their contributions to advancing evidence-informed health policy.
