EU Regulation 2021/2282, applicable as of January 12, 2025

Since January 12, 2025, Regulation (EU) 2021/2282, of December 15, 2021, on the assessment of health technologies (the "HTAR"), has been applicable, marking a significant milestone in the legislation and assessment of health technologies in the European Union ("EU"). This regulation establishes a framework for the assessment of health technologies, with the aim of improving the availability and access to innovative and effective technologies for patients across the EU.

The term “health technology” is defined in Article 3, letter l), of Directive 2011/24 as: “a medicinal product, a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare”.

One of the most notable aspects of the HTAR is its focus on cooperation and coordination among EU Member States. The HTAR introduces a model of collaborative evaluation at a European level through the joint clinical assessments (JCA).

The JCA process is based on the collection and analysis of comparative clinical data on a health technology compared to other existing technologies. The resulting reports from these assessments will not contain value judgments or conclusions about the overall added clinical value of the assessed technology, but will be limited to describing the scientific analysis of the relative effects of the health technology on the health outcomes and the degree of certainty about these effects. This approach allows Member States to draw their own conclusions about the added clinical value of a health technology in the context of their specific healthcare system 

The JCA procedures will be applied gradually as follows:

• From January 12, 2025, they will be applicable to oncology medicinal products with new active substances and advanced therapy medicinal products.
• From January 13, 2028, their application will be extended to orphan medicinal products.
• From January 13, 2030, it will be applicable to all new medicinal products subject to JCA, under Article 7.1 of the HTAR.

Additionally, from 2026, certain high-risk medical devices will be assessed with the JCA, according to the European Commission's Questions and Answers document.

The regulation also establishes a Coordination Group on health technology assessment, composed of representatives from Member States, which will oversee the conduct of JCA and other joint work. This group will be responsible for ensuring that assessments are conducted independently, impartially, and transparently, following international standards of evidence-based medicine.

Despite the significant advances that the HTAR introduces, it is important to note that the conclusions of the Coordination Group are not binding for Member States. This means that Member States can conduct complementary clinical analyses and are responsible for the non-clinical aspects of the assessment, such as the cost and economic evaluation of the technology. This flexibility allows Member States to adapt the assessments to their specific national healthcare contexts, thus ensuring more informed and timely decision-making on the pricing and reimbursement of health technologies.

The legislation also introduces the possibility of conducting Joint Scientific Consultations, which allow health technology developers to exchange information with Member States about their development plans. These consultations aim to generate evidence that meets the requirements of a subsequent JCA, thus facilitating faster and broader access to innovative and effective products for patients.

The HTAR also establishes a support framework for voluntary cooperation among Member States in the assessment of health technologies. This cooperation may include non-clinical assessments, collaborative assessments on medical devices and in vitro diagnostic medical devices, and the provision of additional evidence necessary to support health technology assessments. The voluntary cooperation will be included in the annual work programs of the Coordination Group, and the results of this cooperation will be published on the information technology platform created by the European Commission.

Application of the HTAR in Spain

Last September, the Ministry of Health published the first draft of a Royal Decree Project regulating the assessment of health technologies. Its approval is expected in the following months.

The Royal Decree Project introduces some variations in the health technologies assessment procedure compared to the HTAR as detailed earlier in this entry. Mainly, regarding the assessment of non-clinical aspects (economic evaluation, budget impact, etc.), the creation of a governance council, and an office for the assessment of the efficiency of health technologies, among others.

The HTAR and the Spanish regulation will coexist. However, it should be noted that according to the HTAR, Member States must consider the JCA reports when developing their own health technology assessment reports, both at national and regional levels. In other words, in Spanish reports, the clinical assessment may be replaced by the JCA conducted in accordance with the HTAR and complemented by the non-clinical assessment carried out at the national level.

Pending the approval of the Royal Decree, the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios) must consider different scenarios for the evaluation of health technologies. These scenarios will depend on whether the medicinal product or medical device is subject to joint clinical evaluations and whether the Royal Decree has already been approved.