Spain’s New HTA Law Gives Patient Involvement in HTA a Legal Footing

Spain has spent two years turning patient involvement in HTA from a good intention into a legal requirement, and patient groups say the shift is real. The trigger is Real Decreto 415/2026, approved on 27 May 2026, which creates a national framework for health technology assessment and writes patient and carer participation into every stage of the process. At a recent webinar run by the HTAi Patients and Citizens Involvement Interest Group, speakers from Spain’s patient platform, Cancer Patients Europe, Bristol Myers Squibb and NICE laid out what the law does, and how a plain-language summary of information for patients (SIP) could keep that involvement from becoming symbolic.

Patient involvement in HTA gets a legal footing in Spain

Pedro Carrascal Rueda, director general of the Plataforma de Organizaciones de Pacientes (POP), and his colleague Lucía, a research and communication project officer at the POP, explained what changed. The POP is an umbrella body for 50 federations of chronic disease patients, spanning autism, oncology, neurology and rare diseases, backed by a network of about 2,000 patient associations.

The backdrop is the EU Health Technology Assessment Regulation, adopted in December 2021 and applied from January 2025, starting with oncology and advanced therapy medicines. Spain’s own framework is meant to complement the European system rather than duplicate it. Under the law, the Spanish Agency of Medicines and Medical Devices (AEMPS) evaluates medicines through therapeutic positioning reports (IPTs), while the Spanish Network of HTA Agencies (RedETS) handles medical devices.

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The POP fought for four things during the decree’s drafting, Carrascal said: participation that is not symbolic, clear criteria for which organisations can take part, an official and transparent registry, and training plus resources so patients can participate on equal terms. All four made it into the final text. The decree sets up a governance council with patient organisation seats, specific participation guarantees in Article 25, and adoption groups with patient representatives for medicines and non-pharmacological technologies. A separate law to regulate patient associations has begun its passage through the Spanish Congress.

For Carrascal, the headline is simple. He put it this way:

“La voz del paciente ya está dentro del sistema, hemos conseguido que ocurra, pero ahora hay que convertirlo en soluciones reales para los pacientes y que esto realmente tenga impacto.”

The hard part, he said, is what comes next. A ministerial order still has to define the methodology, phases, deadlines and how much weight patient contributions carry, along with how the system coordinates across Spain’s regions and how it tracks the difference patient input made.

Why plain-language summaries matter

José Díaz, from Bristol Myers Squibb’s global team, made the case that a SIP is the mechanism that turns patient involvement in HTA from a box-ticking exercise into something substantive. BMS is co-leading the HTAi project with Antonella Cardone, chief executive of Cancer Patients Europe, a pan-European, all-cancer-type patient organisation.

Díaz was blunt about the stakes:

“La voz del paciente aporta una evidencia única que ningún ensayo clínico puede ofrecer.”

He said a plain-language summary puts patients and carers on the same footing as doctors, technicians and scientists, because it lets them understand what is being assessed and then explain the real impact the disease has on their lives, not just on their physical health but on their mental health, their carers and their ability to wor.

The concept came from the Scottish Medicines Consortium (SMC), and it is already in use at NICE in England and Wales and at the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, with pilots being explored in Taiwan, Singapore, several Latin American countries and Belgium. The template has four sections: a summary of the new medicine and the company behind it, the current situation including disease burden, diagnosis and available treatments, the new medicine itself (how it works, efficacy, safety and dosing), and annexes with a glossary and reference.

In practice, Díaz explained, the pharmaceutical company drafts the SIP alongside its submission dossier. The HTA body reviews it, sends it back for changes if needed, and then shares it with the relevant patient group so patients can comment with a full understanding of what is being assesse.

Costs, decisions and the gaps that remain

The question-and-answer session surfaced two gaps. A participant named Juan asked what decision-making power patients ultimately hold, and whether the hidden costs patients and carers carry, such as travel to an infusion centre and the time a carer gives up, are captured by HTA. In Spain’s national health system the doctor makes the final call, but in systems where patients pay part of the cost, patient choice may carry more weight, he note.

Díaz said many HTA bodies do not capture those indirect costs or the productivity impact of a medicine; they focus on the health system’s perspective. Spain’s Royal Decree, he added, does say additional value elements should be captured, which leaves room for these costs to count. He also pointed to a parallel project, led by Cancer Patients Europe and the European Patients Forum, on how the patient voice is built into the EU Joint Clinical Assessment, and to EUPATI, the European Patients’ Academy, whose training resources are available in Spanish.

Cardone closed the session by underlining what the webinar was really about. She said the SIP is a tool, not the goal:

“I really like to stress meaningful involvement of patient and patient organisations in the HTA process, not just a theoretical or academic exercise.”

Spain is the natural next test case, the speakers agreed. With a new decree, new processes and the EU Joint Clinical Assessment being embedded into the national system, there is an opening to pilot the SIP early, while the process is still being defined, rather than trying to bolt on patient involvement later.

Source: HTAi Patient and Citizen Involvement Interest Group webinar, 2026.