The Council of Ministers has approved the new Royal Decree on Health Technology Assessment (HTA), a regulation that will govern how medicines, medical devices, and other technologies are evaluated before their incorporation, funding, or reimbursement within the National Health System. The decree adapts the Spanish framework to the European HTA Regulation and establishes a common methodology to inform public decisions on pricing and reimbursement.
At Salud por Derecho, we welcome the fact that the final text of the Royal Decree maintains, as announced, the obligation for developers to provide information on sources of funding, as well as on production and development costs necessary for economic analyses. We value the inclusion of this clause, as it was a demand we defended during the drafting process and we consider it essential in order to obtain a realistic picture of the context in which pricing and reimbursement decisions are made.
Pending publication of the final text, we nevertheless consider the approach insufficient, as we have warned since the beginning of the drafting process. We therefore reiterate our call for a comprehensive implementing framework requiring clear and verifiable disclosure of tax incentives received, national and international public subsidies, and a breakdown of costs for each stage of development, from basic research to post-marketing studies.
The reality of public investment in R&D in Europe shows that indirect financial support, particularly tax incentives and exclusivity periods, constitutes one of the main policy tools to promote investment in R&D.
According to OECD data, the proportion of tax incentives in relation to total public budget allocations for R&D across all sectors can exceed 30% in some EU countries. Furthermore, this information must be broken down by development stage in order to understand current innovation chains and their dynamics, where different phases involve different costs and risks, and where the public sector is more heavily involved in the highest-risk stages.
Finally, we call for HTA reports to include information on market exclusivity periods, such as patents or data protection, since these directly influence price setting. Knowing the effective monopoly period (defined as the total duration of all intellectual property protection granted under both the current patent system and supplementary protection certificates, plus all regulatory protection periods related to data or market exclusivity) is necessary in order to assess the economic impact and its projected effects over the coming years.
“It is a step in the right direction, but it is insufficient. Without information on indirect financing, including tax benefits, as well as the effective duration of monopoly periods, the transparency promised by the decree remains incomplete, and we will continue negotiating without data that are essential,” said Jaime Manzano, Policy Advocacy Officer at Salud por Derecho.
