IGES Pharma Iberia

Spain’s Access Landscape: Complex, Decentralized – and Evolving

Spain’s healthcare system provides universal coverage and is characterized by its decentralized structure, with 17 autonomous communities overseeing regional implementation. National-level decision-making remains central for market access, particularly through the Ministry of Health and the Spanish Agency of Medicines and Medical Devices (AEMPS).
Key stakeholders include:

• AEMPS, overseeing regulatory approval,
• Dirección General de Cartera Común de Servicios del SNS y Farmacia, responsible for HTA and reimbursement proposals,
• CIPM (Interministerial Pricing Committee), negotiating the national price,
• Regional HTA bodies, which may impose additional hurdles for access to each of the autonomous communities.

Challenges in the Spanish market include lengthy timelines between regulatory approval and national price publication, limited transparency of pricing decisions, and growing interest in therapeutic positioning reports (IPTs). Additionally, regional heterogeneity can delay real patient access even after national-level approval. However, with new legislative reforms underway—including updates to pricing systems and increased transparency requirements—strategic planning is more critical than ever.

Portugal’s Access Landscape: challenging, administrative delays and shortages

Portugal's Serviço Nacional de Saúde (SNS) provides universal healthcare coverage to all residents. Medicines are accessible through both public and private sectors, with the SNS offering subsidized or free medications for various conditions. Certain groups, such as pensioners, can receive up to a 95% discount on their medications.
Key Stakeholders :

• INFARMED is responsible for evaluating, authorizing, regulating, and controlling human medicines and health products in Portugal. They ensure the quality, safety, and efficacy of medicines and oversee pricing and reimbursement decisions.

Portugal's healthcare system provides broad access to medicines through the SNS, with structured pricing and reimbursement mechanisms. While the system ensures affordability and availability for many, challenges remain in administrative processes and managing shortages. Continuous efforts by INFARMED and other stakeholders aim to enhance access and address existing barriers.

IGES Pharma Iberia – Your Local Partner in a Decentralized System

Led by a senior team with deep expertise in national and regional market access processes, built through extensive experience in both the biotechnology industry and consulting, IGES Pharma Iberia provides tailored strategic support to pharmaceutical, biotech and med tech clients. We translate policy changes into actionable launch strategies, ensuring our clients are prepared for successful reimbursement and patient access across Spain and Portugal.

What We Bring to the Table

Navigating Spain’s and Portugal’s multi-layered access landscape requires local insight, strategic agility, and a deep understanding of evolving stakeholder expectations – and that’s exactly where our expertise begins.
Our services include:

Let’s Make Access Happen
How to Contact Our Team:

pharma@iges.com

Barcelona Office: Via Laietana 26, Entreplanta 08003 Barcelona