EU Health Technology Assessment (HTA) – opportunities for patients, carers and clinicians
Patients, carers, and clinical experts play a pivotal role in the EU Health Technology Assessment (HTA). They contribute with their unique perspectives and knowledge to the evaluation of new medicines and medical devices through joint clinical assessments and scientific consultations.
Their input helps ensure that patients' needs and clinical practices are addressed effectively in health technology assessments, thereby shaping the future of medical treatments.
Medicinal products and devices under review
A joint clinical assessment is triggered when the European Medicines Agency receives an application to market:
- any new cancer medicine or advanced therapy medicine
- selected high-risk medical devices.
By 2028, these assessments are to include orphan medicinal products, expanding to all new medicinal products by 2030.
How to get involved
Express your interest by contacting a national or EU-level patient or clinician organisation. They receive requests from the European Commission to nominate individuals as experts. You can also reach out to your national HTA authority or similar body for potential nomination.
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Selection criteria and procedure
Once an organisation nominates you, the HTA Secretariat, based in the European Commission’s Directorate-General for Health & Food Safety, will email you to explain the process.
You will need to submit a Declaration of Interest (DOI) form along with a detailed CV. The secretariat assesses the DOI and based on this assessment, might include you on a list of eligible experts.
That list is submitted to the relevant subgroup (joint clinical assessment or scientific consultation), which will decide whether to select you for a specific procedure based on:
- the relevance of your expertise to the therapeutic area
- geographic diversity criteria
- compliance with conflict-of-interest rules.
If selected, you will be contacted by the Brussels Centre for Collaboration in Health to sign confidentiality agreements and complete paperwork for compensation.
If you are not selected, you will be informed. Not being selected for a specific procedure does not mean that you will not be able to participate in others. The HTA Secretariat will keep your contact details for three years, then delete them.
Please note that all communication with you – as well as the assessments and consultations themselves – will be conducted in English.
Joint clinical assessments – your role
During the assessments, you will:
- review the draft assessment scope that defines the key research questions to examined according to the PICO framework (population, intervention, comparison and outcome)
- provide written input within a 7-day window
- participate in subgroup meetings as needed
- respond to questions as needed
- review the draft joint clinical assessment reports.
- help ensure that patient needs and clinical realities are accurately portrayed in the data-development plans
Joint scientific consultations – your role
During the consultations, you will:
- review the briefing package submitted by the company
- provide feedback via questionnaires or interviews
- join virtual discussion meeting with the company and assessors
- help ensure that patient needs and clinical realities are accurately portrayed in the data-development plans.
Compensation
You will receive compensation based on the Commission's general rules for expert involvement: EUR 450 for a full day and EUR 225 for half a day
Horizontal rules for Commission expert groups (C(2016)3301)
Decision C(2014)2220 – special allowance for participants in Commission expert groups
Support for capacity-building
The EU4Health programme co-funded two capacity-building projects that equip patients and organisations with the necessary knowledge about HTA processes and regulations: HTA4Patients and European Capacity Building for Patients.
Data protection
The Commission secures personal data using advanced technical and organisational safeguards to prevent data loss and ensure privacy, and all processing operations comply with EU data-protection regulations.
Frequently asked questions
In case you are looking for more information about this topic visit our FAQ section.
Contact
For further assistance, the following are available to help throughout your participation in the assessment process:
SANTE-HTA-NETWORK
ec [dot] europa [dot] eu (SANTE-HTA-NETWORK[at]ec[dot]europa[dot]eu) – general enquiries about the involvement of patients, carers and clinicians
SANTE-HTA-IT-SUPPORTec [dot] europa [dot] eu (SANTE-HTA-IT-SUPPORT[at]ec[dot]europa[dot]eu) – IT-related issues
