We analyzed the draft of the new Royal Decree and sent a document to the Ministry of Health in which we call for a greater role for civil society, for the assessment of these technologies to be linked to decision-making on their prices, and for more depth on everything related to transparency in the R&D costs of pharmaceutical companies.
At Salud por Derecho, we have submitted proposals to the Draft Royal Decree on Health Technology Assessments (HTA), whose public consultation period ended last Friday. This decree regulates the assessment of new medicines, medical procedures, and other technologies, analyzing their efficacy, safety, and cost-effectiveness—information that supports decision-making on their inclusion in the National Health System.
Its importance lies in the fact that it not only influences which treatments will be available to the public, but also how their price is set and how the sustainability of the health system is managed. After reviewing the Ministry’s proposal, Salud por Derecho highlights three key issues that should be considered to ensure effective and transparent regulations:
More transparency in research and development (R&D) costs
The text drafted by the Ministry of Health states that “the developer of a technology under evaluation is obliged to provide reliable costs of production, research, and development, as well as the sources of financing for these costs, whether public or private.” However, we consider this approach insufficient, as it is too broad and leaves room for ambiguous interpretations that may limit its usefulness.
For this reason, we propose a more exhaustive development of the articles, where pharmaceutical companies clearly and specifically detail the tax incentives received, public subsidies, and any other type of financial support, whether direct or indirect, from national or international sources. Additionally, we emphasize the importance of including the role of philanthropic entities, due to their significant contribution to the funding of R&D projects. We also highlight the need to break down the costs of each development phase, from basic research to preclinical, clinical, and post-marketing studies. This breakdown would help identify in which phases the public sector played a crucial role, as it often takes on the riskiest stages, highlighting the contribution of public funds to the development of these products.
Furthermore, we demand that HTA reports include information on the duration of market exclusivity periods (such as patents or data protection), as these also directly influence prices.
Many of these requests are already included in the text adopted by the European Parliament regarding the reform of the European pharmaceutical legislation, while others go further, seeking to reaffirm Spain’s commitment to transparency in this sector.
Linking the HTA to decision-making on prices and reimbursements
We also demand that HTA reports be directly linked to the processes of price-setting and reimbursement decisions.
The proposal aims to ensure that these reports not only provide a technical assessment of the added value of the technologies but also include clear recommendations to guide decision-making related to price-setting and National Health System coverage. This would ensure coherence between evaluation and economic decisions, preventing HTA from being isolated and having no impact on health policy.
Inclusion of civil society in decision-making processes
We also highlight the importance of civil society, through non-profit organizations, participating in HTA, as they defend human rights and underrepresented populations. This participation is key to ensuring fair and transparent governance, in line with the Treaty on the Functioning of the European Union.
Last Friday, we sent the document to the Ministry of Health and hope that these recommendations will be incorporated into the final text of the royal decree, as they would contribute to a fairer, more effective, and transparent HTA, with direct benefits for the public health system and citizens as a whole.
