Author: Roberto Saldaña | Director of Innovation at EUPATI Spain
The new European regulation is encouraging the integration of the patient voice into health technology assessment (HTA) — the process that analyses the effectiveness and safety of therapeutic innovation compared with existing alternatives, while also considering non-clinical aspects such as social, ethical and economic impact. However, one question remains unanswered: how can we capture this patient voice in a systematic, rigorous and decision-useful way?
The EUPATI Spain and Farmaindustria events held this January at the European Commission’s offices in Madrid made this clear: the regulatory framework is moving faster than our ability to generate patient experience data. In particular, we learned what the first impressions have been since the European Regulation came into force on 12 January 2025, that the Spanish Royal Decree is in its final stage, and that the recent EMA Reflection Paper on collecting patient experience data has concluded its public consultation.
The patient perspective will be important both for the JCA (Joint Clinical Assessment) and the JSC (Joint Scientific Consultation prior to the launch of clinical trials for medicine development). Yet the questions around how to gather patient views — and what weight they will carry in each process — remain open. That is why I believe it is especially relevant to share the proposal put forward by patients: qualitative interviews until data saturation, combined with artificial intelligence to categorise, preserve and retrieve them whenever we need to answer questions about what patients are experiencing. This methodology is fully aligned with EMA recommendations. In other words, we are talking about living registries, such as the one we have implemented at EUPATI Spain through IMPACTA HTA, which enable us to visualise the patient journey from the onset of first symptoms, the search for medical support, the assistance received, and the management and impact of the disease — as well as patients’ views on the outcomes achieved.
In practice, these interviews allow us to reconstruct the full patient journey: from the diagnostic experience to the emotional, social, professional and economic impact of the condition, including treatments, hospital admissions, persistent symptoms and future expectations. Each dimension is documented with verbatim testimonies that illustrate the lived reality in the patient’s own words and help any stakeholder understand the relevance of what is being assessed. For patients, there is an added advantage: speaking is more natural than filling in surveys and questionnaires. That is why we ask for it — and above all because it gives us the ability to speed up timelines, anticipate needs, and explore details that until now were unthinkable.
Ultimately, what patients are calling for is rigour in the inclusion of qualitative evidence in an era dominated by reduced datasets that make it impossible to understand the story behind patients’ lives — and that could help us address the challenges they face. That is why patient organisations are calling for joint work to complete the context that experts and decision-makers need in order to debate with greater accuracy. At the same time, we also need a mechanism that allows us to share this evidence at each stage where decisions are made throughout the therapeutic innovation cycle. Only then will we be able to provide better answers to PICO questions (population, intervention, comparator, outcome) and steer medical advances towards solving real-world problems.
We still have time to reflect this, promote its interpretation and publish the findings we begin to uncover. In fact, this knowledge is useful beyond the HTA process itself, because it offers opportunities to design clinical trials with endpoints that are more meaningful to patients, to guide therapeutic adherence programmes, and to support communication around the differential value of each treatment. It can also enrich social value studies: while these quantify the economic and social impact of a disease, qualitative interviews provide the context and narrative that explain how and why that impact occurs. Combining these qualitative analyses with the possibility of quantifying them allows us to understand people’s characteristics and predict how they will identify the therapeutic value of current or future therapies.
The methodology exists. The technology exists. What is missing is for more stakeholders to join in generating this evidence.
References
1. Regulation (EU) 2021/2282 on health technology assessment.
2. European Medicines Agency. Reflection paper on patient experience data (EMA/CHMP/PRAC/148869/2025). Public consultation open until 31 January 2026.
3. EUPATI Spain event, European Commission offices, Madrid, 16 January 2026.
4. Farmaindustria event, European Commission offices, Madrid, 27 January 2026.
