Spain has introduced its first national legal framework for health technology assessment (HTA) through Royal Decree 415/2026. It is a significant step forward, but the system is still being built.
Background
In March 2023, an OHE blog on Spain’s health technology assessment (HTA) system asked whether the country was “there yet”. Three years later, after the annulment of REvalMed and the adoption of Royal Decree 415/2026, the answer is probably: closer than ever, but not quite yet. Spain now has its first comprehensive legal framework for HTA, while two further reforms – a draft Royal Decree on medicines pricing and reimbursement and a new Medicines and Medical Devices Bill – are still moving through the policy pipeline. Together, these texts could reshape how medicines and other health technologies are assessed, priced and funded in the Spanish National Health System (SNS). But the new model remains, for now, more a legal architecture than a functioning HTA system.
First steps
It’s been a long journey to get here. The story begins with Therapeutic Positioning Reports (Informes de Posicionamiento Terapéutico, IPTs), introduced in 2013 to provide a common therapeutic assessment of new medicines for the SNS. In 2020, the Ministry of Health sought to strengthen this model through the Plan for the Consolidation of IPTs. Approved on 3 February 2020 and updated on 8 July 2020, the plan aimed to make IPTs the reference instrument not only for therapeutic positioning, but also for cost-effectiveness assessment and economic evidence to inform pricing and reimbursement decisions. It also created REvalMed, a medicines evaluation network involving the Spanish Agency for Medicines and Medical Devices (AEMPS), the Ministry and the autonomous communities.
Conceptually, this was a major step towards a more integrated medicines HTA process (it was a ‘now or never’ issue). It also responded to a long-standing weakness of the Spanish system: the limited and uneven use of economic evaluation in national reimbursement decisions. However, the reform had a fragile legal foundation. In June 2023, Spain’s National Court annulled the 2020 IPT consolidation plan. The Court considered that the plan had regulatory content but had not followed the legally required procedure for adopting such a norm, and that it conflicted with the legal hierarchy then governing IPTs. The consequence was a legal and institutional reset. REvalMed was effectively dismantled. AEMPS continued producing IPTs, but without the previous regional network and without the pharmacoeconomic layer that the 2020 plan had intended to consolidate.
Where we are now
Royal Decree 415/2026, published on 29 May 2026 and in force since 18 June 2026, is the government’s answer to that legal vacuum. It creates a national Sistema para la Evaluación de Tecnologías Sanitarias (Health Technology Assessment system), explicitly aligned with the EU HTA Regulation. The new system covers medicines, medical devices, in vitro diagnostics, digital health technologies, clinical procedures, organisational models and other preventive, diagnostic or therapeutic measures. Its institutional design has three main pillars: an HTA Governance Council; two HTA Offices (one located within AEMPS to assess medicines; and one based on RedETS to assess non-pharmaceutical technologies); and an Adoption Group (intended to connect scientific assessment with the bodies responsible for pricing, reimbursement, inclusion in the benefits basket or disinvestment).
The Royal Decree also makes a clear distinction between clinical and non-clinical domains. The clinical domains broadly mirror the European HTA framework: the health problem and current technology, the technical characteristics of the technology, relative safety and relative clinical effectiveness. The non-clinical domains are where the Spanish reform becomes especially relevant: costs, resource use, efficiency and budget impact, as well as ethical, organisational, social, legal and environmental-related aspects. Economic evaluation is therefore back on the table, but now through a formal legal instrument rather than through the annulled IPT consolidation plan.
Fragile: handle with care!
The main achievement of the recent reform is that Spain now has a legally grounded, state-wide HTA framework that separates assessment from decision-making and places economic and broader social dimensions alongside clinical evidence. For an international HTA audience, this should be seen as a significant step forward.
And yet, the decree is mostly an organisational statute. It defines the container, not yet the content. The real substance of the system – methodological guidelines, dossier templates, procedural instructions, conflict-of-interest rules, standards for patient and expert involvement, and the precise way economic evidence will be produced and assessed – remains to be developed. The Royal Decree gives the authorities one year from entry into force to publish the first version of the normative instructions and methodological guidance. Moreover, after that period, implementation will be progressive and conditional on a favourable AEMPS report on the adequacy of the human, material and technological resources required for each phase.
This point should not be underestimated. Spain has often had good HTA intentions but insufficient institutional capacity. The new timelines are demanding, especially if high-quality economic evaluations and budget impact analyses are to be appraised rigorously. The crucial question is therefore not only whether the law allows economic evaluation, but whether the system will have enough qualified people to do it well. In our view, a credible Spanish HTA model will require structured collaboration with independent health economics experts from universities, public research centres and non-profit institutions. Without that external scientific capacity, there is a risk that economic evaluation becomes a formal requirement rather than a robust decision-support tool.
The second uncertainty concerns the draft Royal Decree on pricing and reimbursement of medicines, submitted to public consultation in June 2026. This text seeks to regulate the administrative procedure for public funding and price setting, including the role of the Interministerial Commission on Medicine Prices. It requires companies to submit clinical, therapeutic, economic, comparative and budget-impact information, and it explicitly presents itself as part of a broader modernisation package together with Royal Decree 415/2026. However, the interface between the two decrees is still not fully clear. Key questions remain: how exactly will HTA reports feed into price negotiations? Will cost-effectiveness results be used explicitly or only implicitly? How will uncertainty, managed entry agreements and reassessment be linked to the HTA process? And how will national assessment interact with regional implementation in a decentralised SNS?
Finally, the broader Medicines and Medical Devices Bill may provide a more stable legislative basis for the new system, but its parliamentary approval is uncertain. In a fragmented Spanish Parliament, passing a comprehensive medicines law may be politically difficult. This matters because Spain’s recent HTA history, most notably the collapse of REvalMed, shows that legal robustness is not a technical detail; it is a precondition for institutional continuity.
Conclusion
So, is Spain there yet? Not quite. But the country has moved from an improvised, legally vulnerable pharmacoeconomic reform to a formal HTA framework with the potential to integrate clinical value, cost-effectiveness, budget impact and social value. The next 12 months will be decisive.
Spain will only be “there” if the forthcoming methodological guidance is rigorous and coherently aligned with the existing economic evaluation guideline issued by the Advisory Committee on Pharmaceutical Financing (Comité Asesor para la Financiación de la Prestación Farmacéutica, CAPF); if sufficient independent expertise is mobilised; if the link between HTA and pricing is clarified; and if the new architecture survives the political and administrative pressures that have historically shaped medicines evaluation in the SNS.
