SPAIN Trends and Developments Contributed by: Lluís Alcover, Joan Carles Bailach and Claudia Gonzalo, Faus Moliner
In this context, the Draft Law introduces three main changes: • expanding the scope of the provision to all areas of sales of NHS-reimbursed medicinal products (including hospital use products and hospital-dis- pensed products); • revising the contribution percentages; and • redefining the allocation of the funds collected under this modification. To calculate the contribution that pharmaceutical companies must pay, the Draft Law requires them to report, on a quarterly basis, the sales of medicines at acquisition price by hospital centres. Based on this information, the MOH will determine the amounts to be paid. The Draft Law also provides that, if compa- nies fail to report their quarterly sales, or if significant errors are detected, the contribution calculations will be performed at the PVL (ie, without considering any discounts that may have been applied by the com- panies). Following the contributions received during the public hearing, the MOH will produce a final draft for parlia- mentary processing. Given the technical complexity of the regulation and the current political landscape, final approval is not expected before the end of 2026. Other Regulations Under Development or Already Approved In addition to the Draft Law, during 2025 the MOH has been working on other regulations. Law on Digital Health The legislative journey of the future Spanish Digital Health Act (SDHA) began in September 2025, when the MOH opened the prior public consultation phase for its preliminary draft, seeking opinions following a set of questions to determine the exact content the future SDHA shall cover. The future legislation will be articulated around two strategic pillars: implementing the European Health Data Space (EHDS) and the introduction of autono- mous national measures to accelerate the digital transformation of the healthcare system.
Firstly, the SDHA aims to adapt Spanish legislation to the EHDS framework, ensuring a harmonised sys- tem for the primary and secondary use of health data across the EU. This involves establishing high stand- ards for data interoperability and portability, allowing patients to share their health information securely with providers in any member state while fostering a robust environment for scientific research and innova- tion. Additionally, the text addresses the consolida- tion of a unified electronic health record system and the enhancement of cybersecurity protocols across regional health services. Regarding secondary use of health data, one of the most debated open issues is how practical measures will be established to ensure that data holders can effectively protect information containing intellectual property or trade secrets while complying with data sharing requirements. The future act is also set to include additional domes- tic measures specifically designed to modernise the NHS. A notable highlight is the creation of a formal regulatory pathway for the financing of digital medical devices (digital therapies, etc). The prior public consultation closed on October 2025, and a draft act is expected to be made public during 2026. Health technology assessment The MOH published the draft of the new Royal Decree on Health Technology Assessment in August 2024. This new Royal Decree was the response to the judg- ment of the Spanish National High Court that declared void the “Plan for the Consolidation of the Therapeutic Position Reports”, and also reflects the need to regu- late the national phase of the assessment process initiated under the EU HTA Regulation. The MOH proposal is to create a HTA system separate from the price and reimbursement system. Therefore, the evaluation will be separated from the decision- making process. A health technology evaluation includes an evaluation of clinical aspects and another of non-clinical aspects. The latter will assess economic, environmental, ethical
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