Royal Decree on Health Technology Assessment

After more than 3 years since the process for its approval began, on May 29, 2026, the long-awaited Royal Decree 415/2026, of May 27, was published, which regulates the assessment of health technologies ("HTA") in Spain, which establishes for the first time a complete regulatory framework for the evaluation of medicinal products, medical devices, in vitro diagnostic medical devices, clinical procedures, therapies and digital medical devices, as well as organizational models and measures for the prevention, diagnosis or treatment of diseases (together, these are the health technologies to which the Royal Decree applies, subject to the conditions set out in Article 6).

Although the regulation requires the publication of regulatory instructions and methodological guidelines of a non-regulatory nature, which must take place within one year of the entry into force of the regulation and provides for a transitional application regime after the approval of these instructions, conditional on the favorable report of the AEMPS on the sufficiency of human resources, as well as necessary materials and technologies, there is no doubt that the new regulation begins the path to provide Spain with a solid system for the evaluation of medicines and other health technologies.

The aim of this new Royal Decree is to inform the Administration’s decisions on the incorporation, financing, pricing, reimbursement, modification of conditions of use or divestment of health technologies, so that they are adopted on the basis of the best available scientific evidence, in line with Regulation (EU) 2021/2282 on health technology assessment.

Key Aspects

• Comprehensive evaluation (clinical and non-clinical aspects): The regulation provides that evaluations will include a differentiated report on the comparative clinical evaluation (relative safety, relative clinical efficacy and categorization of added clinical value) and another on non-clinical aspects (cost-effectiveness, budgetary impact and ethical, organizational, social, legal, gender and environmental aspects).
  
  An important fact is that evaluations inform decision-making, but they will not be binding.
  
  The national assessment should be coordinated with the European framework and duplication of joint clinical analyses should be avoided.  

• Established deadlines for evaluations: The Royal Decree introduces strict deadlines in order to provide greater predictability to the process. Although, with respect to the deadlines, the Ministry of Health has referred to the 180 days established in the European framework, the approved regulation introduces the joint period of 140 working days with the following detail:

• For medicinal products, the clinical report must be completed within 70 working days from the start date; where there is a European Joint Clinical Assessment Report, the deadline shall be 15 working days after publication. The report on non-clinical aspects will also have 70 working days from the receipt of the clinical report, and both periods may overlap.
• For other health technologies, the joint term will be 140 working days.
• Re-evaluations will have 50 working days and if the Offices require additional information, the deadlines will be extended by 25 days.

• New institutional architecture: The Royal Decree creates the so-called System for the HTA, structured around three pillars:

• The first is the Governance Council, a strategic oversight body integrated into the Secretary of State for Health, which will approve the methodological guidelines and annual work programmes.
• The second pillar is made up of two independent Evaluation Offices: (i) the Office for the Evaluation of Medicines, configured as a functional unit of the AEMPS; and (ii) the Office for Non-Pharmacological Health Technology Assessment, which assumes the structure of the ETS-Network.
• The third is the Health Technology Adoption Group, a collegiate body attached to the Secretary of State for Health through the Directorate-General for the Common Portfolio of Services of the National Health and Pharmacy System that acts as a bridge between the technical reports of the Offices and the competent decision-making bodies, without substituting, conditioning or questioning them.

• Progressive implementation: As indicated, the effective application of the new evaluation system will not be immediate. The Royal Decree sets a period of one year from its entry into force to approve and publish the first version of the regulatory instructions and methodological guidelines that will guide the entire system and after that period, the Directorate-General for the Common Portfolio of Services of the National Health and Pharmacy System will publish the calendar and deployment phases by resolution in the BOE,  following a favorable report from the AEMPS on the sufficiency of human, material and technological resources.  It will therefore be essential that in the period that opens from the approval of the new regulation, the bodies of the Evaluation System are equipped with sufficient resources.
  
  In the meantime, the previous legal regime will continue to apply.

• Reinforced guarantees for developers: The new regulation recognizes that developers have a full right to submit allegations within a maximum period of ten days on draft reports, which had not been contemplated in previous versions of the regulation and which allows for greater legal certainty.
  
  Likewise, as a novelty, a mechanism for scientific consultations with the Evaluation Offices is also foreseen, at the request of developers, to exchange information on development plans, in a similar way to that established by the European framework for health technology assessment and which, in practice, may mean anticipating an early dialogue with the authorities that may reduce the deadlines for the entry of health technologies into the market.

• Transparency in development and production costs: The new regulation establishes the obligation for developers to provide information on the sources of public funding or non-profit entities received, as well as on the costs of production and development of the product, as this information is considered necessary for economic analysis.

• Conflicts of interest regime. The regulation defines for the first time in detail what constitutes a conflict of interest: "participation in scientific, strategic or technical advisory activities carried out for the industry of development entities directly or indirectly, as well as participation in management, advisory or financing bodies linked to such entities".
  
  All participants in the ETS system will be required to make annual declarations of interests, update them when circumstances change and declare, before each meeting, any interest that may compromise their independence. A specific ministerial order will regulate the declaration documents, their effects and the periods of incompatibility. 

• Patient participation and use of real-life data: Finally, the new standard ensures the systematic participation of patient organizations, carers, consumers and healthcare professionals in all phases of health technology assessment, ensuring, for the first time, patient participation in the health technology assessment phase to ensure that the value for patients,  families and caregivers is taken into account to establish the clinical value of health technologies.
  
  On the other hand, it incorporates the express mention of the National Health Data Space as a secure processing environment and enables the use of real-life clinical data to materialize the secondary use of these health data.

The entry into force of the Royal Decree will take place twenty days after its publication in the Official State Gazette, although as indicated the real operational impact of the new system will be conditioned by the approval of the regulatory instructions and methodological guidelines indicated, which must be approved by the Ministry of Health within one year of the approval of the Royal Decree, and by the subsequent progressive deployment schedule that must be approved following a report from the AEMPS on the existence of sufficient resources. Therefore, over the next few months we will have to keep an eye on this publication.

For more information, please contact our specialists through the Knowledge and Innovation Area.