Spain, with a population of approximately 46.9 million people, represents a significant Market Access priority for pharma, biotech, and medtech firms. The country’s well-established Spanish National Health System (Sistema Nacional de Salud or SNS) ensures universal coverage and equitable access to healthcare services. Spain’s healthcare expenditure, amounting to around 10.7% of its GDP, reflects its substantial investment in the sector. Our agency Justin Stindt Consultants is specialized in Market Access Spain and can help you navigate Spanish Market Access.
Market Access Spain – Essential to access this large EU market for pharma, biotech, and medtech firms
Spain operates under a unique healthcare system, with 19 autonomous regions and a single payer National Health Service (NHS). Understanding the intricacies of pricing and reimbursement in Spain is crucial for successful market access.
Understanding the Reimbursement Process in Spain: National and Regional Levels of Medicines Evaluation and Pricing
The reimbursement process in Spain undergoes multiple iterations, with decisions made at both national and regional levels. At the national level, the Spanish Agency of Medicines and Medical Devices (AEMPS) evaluates medicines to determine commercialization eligibility and initiates the elaboration of the therapeutic positioning report (IPT), which is instrumental in the pricing and reimbursement (P&R) process. Once the AEMPS grants the national code to the medicine, the General Direction of Common Health Services and Pharmacy (DGCYF) initiates the P&R assessment, requesting further information (e.g. P&R dossier, pricing information included in the ‘escandallos’, etc.).
Spain’s P&R Negotiations: The Role of DGCYF and CIPM in Determining Drug Pricing and Reimbursement
With that information, P&R negotiations between evaluators of the DGCYF and the companies begin. The evaluators review the information available (including the IPT and the economic offers) to generate a technical evaluation that is then shared with the Interministerial Medicinal Products Pricing Commission (CIPM). At this point, the CIPM determines the maximum ex-factory price and the DGCYF determines whether the drug is reimbursed. Regions also have an important role at a national level as they are represented in the CIPM and hold 3 of the 11 votes.
For more information about the Pricing & Reimbursement dossier and submission in Spain, see our page on this topic.
Spain’s Hospital Market Dynamics: Operating Without DRG System and Awaiting New Regulations for Health Product Reimbursement
In the hospital market, unlike other EU countries, Spain does not utilize a Diagnosis-Related Group (DRG) system but still operates hospital budgets.
Currently, the inclusion of health products (other than medicines) in the reimbursed list of the NHS is on hold waiting for the publication of a new regulation.
Please contact us for the most recent updates on this situation. Alternative pathways also enable access to drugs in special situations. For more information about the Pricing & Reimbursement pathways in Spain, see our page on this topic.
Regional Market Access in Spain
There are 19 Spanish regions, which are responsible for the administration of care, operate independently, and take responsibility for the healthcare services’ planning and budgets. Some regions conduct their own HTA appraisals such as Catalunya, where the ‘Consell Assessor de la Medicació hospitalària’ (CAMH) is responsible for the assessment of new medicines and submitting recommendations to the CFT-SISCAT, which then issues access guidelines and requests approval to CATSALUT (regional health authority). Other regions operate in a decentralized manner and access is decided on a hospital level (e.g. Madrid).
A deep understanding of the tendering processes is also crucial as the approach to tenders is also managed differently by the regions. On the one hand, while some regions use centralized tendering procedures (e.g. Madrid), others conduct tenders at a local level. On the other hand, some centralized regions leverage the ‘Registro Oficial de Licitadores y Empresas Clasificadas del Estado’ (ROLECE) platform to publish tenders, while some others have their own systems.
The ‘Grupo de Evaluación de Novedades, EStandarización e Investigación en Selección de Medicamentos’ (GENESIS group) de Evaluación de Medicamentos’ de la ‘Sociedad Española de Farmacia Hospitalaria’ (SEFH) also develops assessment reports that are often referenced by the regional and local pharmacy commissions.
The ‘Guía para la valoración de Inclusión de Nuevos Fármacos’ (GINF) Guide is a form used by hospital physicians to request the incorporation of a new drug in the hospital formulary.
Justin Stindt Consultants is your agency to support you with Market Access in Spain
Justin Stindt Consultants is your consulting agency with experts who have extensive experience in Market Access Spain.
Our agency has helped many clients by developing Spanish P&R dossiers.
As a service provider, our consultants also support price negotiations. For medical devices and digital health apps, our agency supports dossiers and negotiations. Many of our consulting firm’s clients have found Spain as an attractive country for Market Access in Europe and decided to enlist our agency as partner of choice given our footprint and experience in the Spanish market.
Contact our experts today to learn how our agency can tailor our services to meet your unique needs to enable Market Access in Spain.
Dirección General de Cartera Común de Servicios del Sistema Nacional de Salud y Farmacia
- Comisión Interministerial de Precios de Medicamentos y Productos Sanitarios (CIPM)
Market Access services for Pharma and Biotech in Spain
Case studies for Spanish market
- Support entire Spanish Market Access process
- ATU Feasibility Assessment
- HAS early dialogue meeting
