CNMC Report on Draft Royal Decree for Health Technology Assessment in Spain

2024-12-13T12:43:00
Spain
CNMC publishes, at the request of the Ministry of Health, a report assessing the draft Royal Decree regulating the assessment of health technologies
CNMC Report on Draft Royal Decree for Health Technology Assessment in Spain
December 13, 2024
  • Pablo García Vázquez
  • In Spain, the Law on Guarantees and Rational Use of Medicines and Health Products and the Law on Cohesion and Quality of the National Health System provide for the evaluation of new techniques, technologies, and procedures before their inclusion in the National Health System. Now, this draft Royal Decree ("DRD") aims to provide regulatory development in this field.
  • The DRD, in line with European regulations, establishes a systematic, transparent, impartial, rigorous, and evidence-based evaluation process to determine the effectiveness and efficiency of health technologies. The objective of the future regulation is to regulate those evaluation activities specifically aimed at informing decisions of the Public Administration regarding the incorporation, financing, pricing, reimbursement, or divestment in health technologies.
  • The evaluation process includes both clinical aspects (identification of health problems, analysis of technical characteristics, safety, and clinical efficacy) and non-clinical aspects (cost, economic evaluation, ethical, organizational, social, and legal aspects).
  • In its report, the CNMC values the DRD positively, highlighting that the regulatory project analyzed, in addition to aligning the Spanish system with EU requirements, reinforces the assessment of health technologies in several aspects.
  • However, two recommendations are made: (i) to monitor the application, in practice, of the principles of coherence and non-duplication of actions before the Public Administrations, so to ensure that situations of duplication of actions do not occur; and (ii) to reinforce the need to state reasons for those administrative decisions deviating from the scientific assessment, delimiting, at least, the criteria that could be taken into account by public officials to justify a decision that does not follow the aspects included in the scientific assessment.
December 13, 2024