On 12th August 2024, the Spanish Ministry of Health released the highly anticipated Draft Royal Decree aimed at regulating Health Technology Assessments (HTAs) in Spain. This decree sets the stage for a new framework that will govern future HTAs across the country. The public consultation period has now commenced, with stakeholders invited to submit their contributions by the deadline of 20th September 2024.
Key highlights
The Draft Royal Decree introduces a comprehensive governance structure designed to oversee the HTA process in Spain. Central to this structure is a Governance Council, comprised of 21 members, including six representatives from the autonomous communities. This council will oversee two specialised offices dedicated to evaluating the efficacy of health technologies—one focusing on medicines and the other on other health technologies. Notably, the Office for the Evaluation of the Efficiency of Medicines will operate as a functional unit under the Spanish Agency of Medicines and Medical Devices (AEMPS).
The Health Technologies Positioning Group will play a crucial role in finalising assessments, drawing on evaluation reports from these offices, as well as additional inputs from experts, professionals, and patients as needed. This group will ensure that the HTA process is thorough, transparent, and inclusive.
The decree also aligns Spain’s HTA process with the European Union Network for Health Technology Assessment (EUnetHTA) by incorporating its nine assessment domains, which include both clinical and non-clinical areas. The clinical domains address the identification of health problems, analysis of new health technology characteristics, and the assessment of safety and clinical efficacy. The non-clinical domains cover cost, economic evaluations, and the ethical, organisational, social, and legal aspects of the technology.
The HTA reports will consist of two distinct sections: one focused on comparative clinical effectiveness and the other on non-clinical aspects, including an economic evaluation. The clinical evaluation will feature a classification of clinical added value, following the methodology approved by the Governance Council.
Moreover, the decree encourages the use of real-world data to enhance the evaluation and monitoring of health technologies. It also formalises the involvement of patients and health professionals in the assessment process, ensuring that diverse perspectives are considered.
Implications for the industry
This Draft Royal Decree represents a significant shift in the HTA landscape in Spain, with far-reaching implications for manufacturers and the broader healthcare industry. As Spain prepares to integrate its HTA process with the upcoming EU-HTA framework in 2025, this decree will serve as the foundation for future assessments.
Manufacturers aiming to launch products in Spain should closely monitor the developments surrounding this decree, as it will shape the regulatory environment in which they operate.
Action steps
Market access managers and industry stakeholders should take proactive steps to understand the implications of this decree and prepare for its eventual implementation. Engaging with the public consultation process, staying informed about updates, and seeking guidance from experts will be essential in navigating the new HTA landscape in Spain.
For further assistance in understanding the impact of this Draft Royal Decree and how it may affect your market access strategies, please reach out to us.
This is a pivotal moment for the industry, and staying ahead of the curve will be key to ensuring successful product launches in Spain’s evolving healthcare market.
Explore our EU HTA resources here.
Sources:
1. Ministry of Health. News: The Ministry of Health publishes the draft of the draft royal decree regulating the assessment of health technologies. Accessed 13/08/2024, https://www.sanidad.gob.es/gabinete/notasPrensa.do?id=6493
2. Ministry of Health. Hearing and Public Information. Accessed 13/08/2024, https://www.sanidad.gob.es/normativa/audiencia/home.htm
3. Arganda C. An office attached to the Aemps will carry out the economic evaluations of medicines. Accessed 13/08/2024, https://diariofarma.com/2024/08/12/una-oficina-adscrita-a-la-aemps-hara-las-evaluaciones-economicas-de-medicamentos
4. Ministry of Health. Royal Decree XXXXXXX/ 2024, of X of XXXXXX, which regulates the evaluation of health technologies. Accessed 13/08/2024, https://www.sanidad.gob.es/normativa/audiencia/docs/DG_54_24_Solicitud_informacion_publica_RD_EVALUACION_TECNOLOGIAS_SANITARIAS.pdf