Call for proposals to support the implementation of the Regulation on health technology assessment – training of patient and clinical experts contributing to joint health technology assessment activities

Background and policy context

As laid down in the Regulation on health technology assessment (‘the HTA Regulation’) patient and clinical experts will play an important role in implementing the new framework. In order to ensure that joint work is of the highest scientific quality and reflects the state of the art, the HTA Regulation establishes that external experts with relevant in-depth specialised expertise should provide input on joint clinical assessments and joint scientific consultations. Such experts should include clinical experts in the therapeutic area concerned, patients affected by the disease, and other relevant experts on, for example, the type of technology concerned or issues related to the relevant clinical study design. In addition, patient organisations and learned societies will have the opportunity to provide input through the Stakeholder Network.

The EUnetHTA joint actions took the first steps to engage external experts in their activities, however currently there is still further need to engage patients and clinical experts as experts contributing to joint scientific consultations and joint clinical assessments. There is therefore a need to put in place appropriate training programmes for both patient and clinical experts. Such training should be based on the work carried out by EUnetHTA joint actions and the subsequent adaptation to fulfil the needs set out in the HTA Regulation. This action should ensure the appropriate and timely contribution to the joint activities that should start at the implementation date. Transparency on funding as well as representativeness and independence of the experts and organisations involved are key in the appropriate implementation of the action.

This action supports the implementation of the HTA Regulation and implements the EU4Health Programme’s general objective of strengthening health systems (Article 3, point (d)) through the specific objectives defined in Article 4, points (h) and (i), of Regulation (EU) 2021/522.

Objectives pursued

The action will support a timely implementation of the new legislation through capacity building activities. It is divided in two subtopics: subtopic a) on patient experts, subtopic b) on clinical experts.

Description of the activities to be funded under this topic

a) Increasing the capacity of patient organisations and learned societies to provide robust and meaningful input to HTA activities carried out by the Coordination Group and its sub-groups, including dissemination of the output produced;

b) Increasing the knowledge of patients and clinical experts on the new Union HTA legal framework, clarifying their role when invited to contribute to joint HTA activities for their subject matter expertise and acting in individual capacity (rather than representing any particular organisation, institution, or Member State);

c) Ensuring the appropriate implementation of the rules to ensure the independence and impartiality of patients and clinical experts involved in joint HTA work.

Expected results and impact

The action is expected to:

a) develop training programmes for patients and clinical experts participating in their individual capacity to joint scientific consultations and joint clinical assessments;

b) contribute to the appropriate implementation of the rules to ensure the independence and impartiality of patients and clinical experts involved in joint HTA work;

c) raise awareness among patient and clinical experts on the new Union legal framework on HTA and stimulate their engagement with HTA bodies at national and Union level, including dissemination of produced output.

Specific mandatory deliverables and/or milestones

For subtopic a)

• Training programme targeted to patients experts. Training programmes should be developed in English and made available, also online, in as many EU official languages as possible.
• Training sessions. Training sessions could be carried out face to face or online or in combination. If only face to face, the minimum number of training sessions should be 6, if only online, the minimum number of these training sessions should be 10.
• List of national and EU-wide patient organisations per disease area (as a minimum on cancer, including rare cancers) who could support the joint work of Coordination Group in the framework set out by the HTA Regulation.
• List of candidate patient experts trained by the national and/or EU-wide patient organisations who could provide input to joint clinical assessments and joint scientific consultations as set out by the Regulation on HTA (as a minimum in the area of cancer, including rare cancers).
• Dissemination tools (e.g. website, newsletter, leaflet) to increase awareness about the Regulation on HTA among patient organisations.

For subtopic b)

• Training programme targeted to clinical experts. Training programmes should be developed in English and made available, also online, in as many EU official languages as possible.
• Training sessions. Training sessions could be carried out face to face or online or in combination. If only face to face, the minimum number of training sessions should be 6 , if only online, the minimum number of these training sessions should be 10.
• List of national and EU-wide organisations such as healthcare professionals, clinical and learned societies per disease area (as a minimum for cancer, including rare cancers) who could support the joint work of Coordination Group as set out in the HTA Regulation.
• List of candidate clinical experts who could provide high-level scientific input to joint HTA work, as set out by the Regulation on HTA, following the training programme (as a minimum in the area of cancer, including rare cancers).
• Dissemination tools (e.g. website, newsletter, leaflet) to increase awareness about the Regulation on HTA among organisations such as healthcare professionals, clinical and learned societies respectively

Specific action-level indicators for reporting purposes

Applicants must be prepared to include data on the following specific action-level indicators in their regular reporting activities in case of award:

For subtopic a)

• Number of training sessions developed for patients experts
• Number of participants per training session and programme
• Number of national and EU-wide patient organisations participating to the training programmes developed by this action
• Number of national and EU-wide patient organisations identified per disease area (as a minimum for cancer, including rare cancers)
• Number of candidate patient experts identified and trained per disease area (as a minimum for cancer, including rare cancers)
• Number of dissemination documents (e.g. newsletter, leaflet) produced to increase the awareness of patients about the Regulation on HTA.

For subtopic b)

• Number of training sessions developed for clinical experts
• Number of participants per training session and programme
• Number of national and EU-wide healthcare professionals’ organisations and learned societies participating to the training programmes developed by this action
• Number of national and EU-wide healthcare professionals’ organisations and learned societies identified per disease area (as a minimum for cancer, including rare cancers)
• Number of candidate clinical experts per disease area (as a minimum for cancer, including rare cancers)
• Number of dissemination documents (e.g. newsletter, leaflet) produced to increase the awareness of clinical experts about the Regulation on HTA.

The applicants are required to include in their proposals additional specific action-level indicators which will be agreed with the Commission during the grant agreement preparation.

The Commission may require the awardees to collect data for additional specific action-level indicators, where needed to complement the above indicators.