The Draft Royal Decree on Health Technology Assessment

The Spanish Ministry of Health has taken a significant step towards improving the Spanish healthcare system with the publication of the first draft of the Royal Decree for the regulation of health technology assessment (the "HTA Royal Decree"). The HTA Royal Decree aims to regulate health technology assessment (HTA) activities.

For the purposes of the HTA Royal Decree, health technologies include medicines, medical devices, in vitro diagnostic tests, medical and surgical procedures, digital health products and therapies, organizational models, and measures for the prevention, diagnosis, or treatment of diseases.

In Spain and Europe, the evaluation of medicines and medical devices has followed different paths due to the specific characteristics and regulations of each type of technology. To adapt to these differences, a common evaluation structure has been established with separate configurations for medicines and medical devices, and other technologies.

Currently, HTA is regulated by Regulation (EU) 2021/2282 of the European Parliament and of the Council, of December 15, 2021, on health technology assessment and amending Directive 2011/24/EU (the "HTA Regulation"), which will apply from January 12, 2025. The HTA Regulation establishes a joint evaluation model at the European level for four (4) clinical domains for the evaluation of medicines and medical devices:

1. Identification of the health problem and existing health technology.
2. Analysis of the technical characteristics of the new technology.
3. Its relative safety.
4. Its relative clinical efficacy.

The HTA Regulation leaves the door open for Member States to include additional or complementary clinical and non-clinical domains. In this case, the HTA Royal Decree includes five (5) additional non-clinical domains: 

1. Cost and economic evaluation of the health technology.
2. Ethical aspects.
3. Organizational aspects.
4. Social aspects.
5. Legal aspects.

Therefore, HTA in Spain will cover a total of nine (9) domains, four (4) clinical and five (5) non-clinical.

Additionally, the HTA Royal Decree introduces a new system for evaluating the efficiency of health technologies, composed of:

• Governance Council: Oversees and ensures alignment with the policies of the Ministry of Health.
• Office for the Evaluation of the Efficiency of Health Technologies: Operates within the Spanish Agency of Medicines and Medical Devices for medicines, and within the Spanish Network of Health Technology Assessment Agencies and Benefits of the National Health System (RedETS) for other products.
• Health Technology Positioning Group: Divided into subgroups for medicines and other technologies.

HTA will include, separately, a report on the comparative clinical evaluation, which may be replaced by the joint clinical evaluation carried out in accordance with the HTA Regulation, and another on the evaluation of non-clinical aspects. The HTA Royal Decree includes an obligation for the Ministry of Health to publish guidelines and methodological guides, as well as a mandatory dossier model for health technology developers.

As a result of the alignment of the HTA Royal Decree and the HTA Regulation and to avoid duplications, HTA reports conducted at the national or regional level must take into account the joint clinical assessment reports prepared at the European level under the HTA Regulation.

The clinical evaluation report has some general aspects and others specific (applicable only to medicines or, where appropriate, to health technologies). To carry out the clinical evaluation report, its scope will be defined taking into account the following aspects:

• The patient population.
• The intervention or interventions.
• The comparator or comparators.
• The health outcomes.

The evaluation of non-clinical aspects will include the economic evaluation and other non-clinical aspects, based on the information provided by developers according to the models published by the Spanish Ministry of Health.

The HTA Royal Decree underwent a hearing and public information process, during which organizations and citizens were able to provide their input. The deadline for submitting contributions was September 20, 2024. Currently, the HTA Royal Decree is awaiting final approval and publication.