European Patients’ Academy on Therapeutic Innovation (EUPATI)
EUPATI Fellow, EUPATI Czechia
EUPATI Fellow, EUPATI Italy
fter four years of preparation and consultations from key stakeholders, the EU Health Technology Assessment Regulation has been in force since January 2025 and the first two Joint Clinical Assessments (JCA) are in progress, being led by two separate member state HTA bodies/authorities (assessors and co-assessors) including the National Centre for Pharmacoeconomics, Ireland, and the Institute for Quality and Efficiency in Health Care, Germany, on a treatment for pediatric low-grade glioma; and the National Authority for Health, France, and the Agency for Health Technology Assessment and Tariff System, Poland, on an advanced therapy for treatment of melanoma. This regulation aims to simultaneously achieve a high level of protection of health for patients and users and to establish a framework to support Member State cooperation and the measures needed for clinical assessment of health technologies.
For the first time, those who will benefit the most from new health technologies—patients—are key stakeholders throughout this process and have several opportunities to be involved and contribute to the joint work.
It is critical that patients are provided with training opportunities on the EU HTA process so that they can be actively involved and provide informed input.
The degree to which patients are involved in HTA has varied across the EU. The HTAR has introduced a clear harmonized mandate approach for the EU HTA process where European patients can provide input via the appropriate national mechanisms and/or the European mechanism for the joint work that will be conducted (Joint Scientific Consultations [JSCs] and JCAs). For example, they will be involved in the scoping questions (more commonly known as PICOs [Population, Intervention, Comparison, and Outcome]) and the review stage of the draft JCA report via the appropriate European and national mechanisms.
The European Patients’ Academy on Therapeutic Innovation (EUPATI) is committed to providing information and training on health innovation to patients and patient representatives. In 2023, EUPATI launched an EU-funded project, HTA4Patients, focusing on building knowledge among patient communities around the HTAR. The HTA4Patients and European Capacity Building for Patients (EUCAPA) projects have the shared aim of providing training opportunities and building capacity on the EU HTAR for the patient community. Both initiatives have been co-funded by the European Union and have produced complementary educational resources.
Through the HTA4Patients Project, EUPATI and its partners have co-created a free e-learning course, EU Health Technology Assessment Regulation (HTAR), and are organizing online training sessions on the HTAR for different patient groups. EUPATI will also be translating the training materials into eight different languages (Portuguese, Greek, Czech, Dutch, French, Spanish, German, and Italian) (already up to five and counting) and exploring ways to continue running training sessions on a regular basis.
Through this project, EUPATI has seen growing interest in HTA and HTAR in the patient community: Viewership of the new HTAR course has already passed the 3000 mark, and more than 100 individuals are expected to complete the course by November 2025. EUPATI also envisions that further uptake of the course will explode after the translated versions are made available.
When interacting with these groups within the framework of this EUPATI project, patients have expressed difficulty in accessing such a complex topic as HTA: how it works and relates to their personal treatments and patient journey, why it matters, and the technical jargon associated with this topic.
At this early stage of HTAR, EUPATI reached out to two patients involved in the project in two different EU countries to capture their experience of how the HTAR is shaping patient involvement in HTA so far:
EUPATI: What does the HTAR mean for you and the patients with whom you engage?
“The new EU Health Technology Assessment (HTA) Regulation provides a major opportunity for meaningful and systematic patient involvement at the European and national level. For the first time, patients are formally included in JSCs and JCAs,” Petra explained. “This allows patients to contribute directly to shaping the scope of assessments and ensuring that outcomes reflect what truly matters to those living with the conditions.”
Paola foresaw “the contribution of patients both to the JSC and the JCA and the inclusion of European-level patient organizations in the stakeholder network. In the JSC and JCA, single patient representatives are expected to provide the patient perspective on the technology under assessment.”
The Czech HTA agency served as a guarantor of the EUPATI training module on HTA. Speakers from guarantors, including the HTA agency, contribute their time without remuneration; their costs are covered by their respective employers. “Within HTAR, we are now preparing official cooperation in the form of a contract with patient organizations whose representatives have completed the Czech version of the EUPATI training,” said Petra. This illustrates demand for this training within the patient community, as well as the HTA body’s willingness to represent the patient perspective in the joint work.
How can patients prepare for the opportunity to contribute to the EU HTA process?
Both highlight the need for continued training. “Patient representatives and organizations should keep training on the HTAR, and organizations in particular should identify members that have the right profile for possible involvement in the JSC and JCA to be prepared when a request arrives, as typically response time will be very tight,” Paola proposed.
“Patient organizations should also keep collecting evidence from the patient community on the technologies under examination, in order to have relevant data to submit when asked to participate in the JSC and JCA.
“At the national level, relevant HTA bodies are expected to establish a stakeholder network and involve patients in the societal impact of the technology and the value for patients.
“The JCA is expected to speed up the whole process of pricing and reimbursement at the national level by providing solid evidence that does not need to be collected again. However, if this outcome is going to be achieved or not will depend greatly on how the national HTA systems adapt to this new process. Patient representatives and organizations can closely monitor this aspect and collaborate with relevant institutions,” she concluded.
“In order to fully realize the potential for patient involvement in HTA regulation that we now see in the Czech Republic, patient organizations must now prepare and support their communities to actively participate. This includes further training of patient experts on HTA processes within the Czech EUPATI national platform. Our platform and localized EUPATI training have received the patronage of the Minister of Health, and through our activities, EUPATI training is being promoted as a prerequisite for patient (Patient Expert or Patient Advocate) involvement in administrative processes and other activities of all stakeholders in the health sector,” Petra suggested.
“Patient organizations should now follow all processes at the European level and establish cooperation with national HTA bodies, because only by working together can we refine the possibilities for patient involvement. It is equally important to be involved in the definition of national PICOs so that the subsequent HTA assessment at the national level is carried out quickly and without unnecessary delays so that the new technology reaches patients across Europe as soon as possible,” Petra concluded.
EUPATI has observed a clear gap in the knowledge about and capacity for the EU HTA process and the subject of HTA more generally. For patients to be fully informed, they need training on the EU HTA landscape, what is changing in it, and how they can prepare for this new reality. To learn more about HTA and the HTAR, visit EUPATI’s Open Classroom.