The Council of Ministers has given its approval this Tuesday to the Royal Decree ordering the evaluation of health technologies (ETS). According to the Ministry of Health, this regulation will establish for the first time in Spain a "complete, transparent, and coordinated" regulatory framework for the analysis of medicines, health products, and other technologies used in the National Health System (SNS).
The purpose of the decree is to specify how health technologies will be evaluated when these reports—which are mandatory, although not binding—are used to support public decisions on financing, pricing, inclusion in the service portfolio, changes in conditions of use, or withdrawal of said technologies.
At the same time, the new regulation aligns the Spanish model with European Union regulations. This coordination, Health points out, guarantees the efficiency of the system by expressly prohibiting the repetition of clinical evaluations already carried out at the community level—focused on efficacy and safety—allowing national efforts to be concentrated on determining added value and studying non-clinical aspects, such as economic, organizational, social, ethical, and environmental impact in the Spanish context.
Among the technologies subject to evaluation are medicines and health products; diagnostic tests (PCR, rapid tests, genetic tests, or artificial intelligence tools capable of detecting tumors in X-rays); clinical procedures (surgical techniques, minimally invasive interventions, or new rehabilitation methods); digital therapies (mobile applications for diabetes management), as well as new ways of organizing healthcare (remote patient monitoring programs or home care systems).
A system structured in three main pillars
The System for the Evaluation of Health Technologies is structured into three pillars designed to separate scientific evaluation from political decision-making. The first is the Governance Council (ETS Council), the highest governing body of the system, which will be attached to the Secretary of State for Health. Its task will be to set the evaluation strategy, monitor the proper functioning of the model as a whole, and approve technical guidelines that ensure evaluations are consistent with health and pharmacy policies.
The second pillar consists of the Offices for the Assessment of Health Technologies. Two independent offices with functional autonomy are created to carry out the assessments: the Office for the Assessment of Medicines, which is configured as a functional unit within the Spanish Agency of Medicines and Medical Devices (AEMPS), and the Office for the Assessment of Non-Pharmacological Health Technologies, which adopts the structure of the Spanish Network of Health Technology Assessment Agencies (RedETS).
The third element is the Group for the Adoption of Health Technologies (Adoption Group), which will act as a link between scientific assessment and decision-making bodies (such as the Interministerial Commission for the Pricing of Medicines). This group will issue the final assessment on the relative position of each technology within the therapeutic scheme.
Maximum deadlines of 180 days and support for innovation
The Royal Decree also aims to transform the assessment system into a lever to promote biomedical innovation and strengthen Spain's strategic capacity in the healthcare field. Health emphasizes that a "more stable, transparent, and with defined deadlines" environment is being established, so that companies, research centers, and developers have greater clarity on the requirements to be met and the duration of the assessment procedures.
Within this framework, a maximum period of 90 calendar days is set for drafting reports relating to clinical aspects and another 90 calendar days for non-clinical aspects in the case of medicines. For non-pharmacological health technologies, a maximum overall period of 180 days is established. These times may be extended when re-assessments need to be carried out.
Regarding medicines, when there is a joint clinical assessment carried out by the European Commission, the national report on clinical aspects must be issued within a maximum of 15 days from its publication.
The text also incorporates the option of carrying out voluntary scientific consultations between the Administration and the developing companies before a technology reaches the market. These meetings will serve to guide research from early stages towards the real needs of the National Health System and facilitate the presentation of new products with the necessary evidence so that their evaluation can be completed more quickly.
Social participation and maximum ethical guarantees
On the social level, the regulations ensure the systematic participation of civil society in all phases of the evaluation. According to the Ministry, the system ceases to be an analysis reserved for experts to grant a "leading role" to patient and disability organizations.
This openness aims for the evaluation not to be limited to measuring clinical results, but to explicitly incorporate the real effect on the quality of life of those affected, taking into account factors such as the usability of technologies, ease of use, and the elimination of accessibility barriers that may condition the success of treatments.
The Royal Decree also aims to impose the "strictest guarantees" of transparency and ethics. All participants, from the system's technical staff to external clinical experts who collaborate occasionally, will be required by law to act with independence and impartiality.
To this end, public and annual declarations of interest are required, which must be updated in the event of any change and reiterated before each working meeting. The rule prohibits evaluators from having economic or professional interests in the developing companies (such as pharmaceutical or technology manufacturers) that could call their objectivity into question.
If any conflict is detected, strict participation limitations will be applied, thus ensuring that the scientific process is fully autonomous and remains outside commercial pressures. As an additional reinforcement of social control, both the list of participants, the minutes of the meetings, and the final reports will be available to all citizens.
With this Royal Decree, Health aims to place Spain among European countries with a more advanced health technology assessment model, "reinforcing the capacity of the SNS to incorporate useful, safe, and evidence-based innovation," concludes the Ministry.