EFA has responded to another proposal for legislation completing the EU Health Technology Assessment Regulation (HTAR) that will determine how individual patients and patients’ organisations are involved in decisions around the access to treatments and technologies in the EU. In our position, we advocate for the inclusion of expert patient voices in shaping healthcare policies as patient participation is essential to advancing patient-centred healthcare across Europe.
In July 2024, EFA responded to the Health Technology Assessment (HTA) stakeholder consultation on the second implementing act of the EU HTA Regulation (HTAR). This process was specifically consulting on a draft to regulate how to assess and manage conflicts of interest of experts involved in HTA, including patients and healthcare professionals. EFA welcomed the opportunity to provide feedback to this important piece of legislation that is set to determine how patient participation, and therefore their needs, will be structured for EU joint HTA procedures and beyond.
The role of patient organisations in HTA Governance
The upcoming act on HTA focused on managing conflicts of interests and can be a turning point on how patient organisations and individual patients participate and inform EU policy decisions.
EFA expressed concern over the de facto restriction on most, if not all, patient organisations to participate in the EU HTA process, based on present, past and even foreseeable income linked to pharmaceutical companies.
In our response, EFA emphasised the blueprint of patients’ organisations like EFA, which function based on governance structures operating under the principles of transparency, independence, accountability and legitimacy, and that closely manage integrity and reputation across their activities. For us, the declaration of potential conflicts of interest and its assessment should serve as a basis to manage potential risk of conflict of interest, rather than apply to a zero risk of conflict criteria that risks to automatic exclusion of patient representatives who are part of patient organisations.
For this purpose, EFA recommended the European Commission to assess the risk of conflicts of interest among patient organisations in a structured and predictable manner. This approach should involve assessing potential risk of conflicts of interest in a more open way, requiring a full declaration of income to present percentages and therefore income dependability, and be accompanied with the internal safeguard procedure adopted by patients’ organisations (such as internal rules, codes of conducts, that are the cornerstone of patient organisations’ governance).
Balanced risk assessment on the involvement of individual experts, including patients
EFA also expressed concerns about the proposed framework under which patient experts who play a leading role in patient organisations that receive funding from companies with products under assessment would be automatically excluded from the EU HTA work. As this criterion significantly restricts the pool of patient experts who can effectively contribute to the EU HTA process, EFA recommended that the assessment of the risk of conflict remains balanced and reflects the reality of patients who are part of patient organisations.
The independence and impartiality of patient experts cannot be questioned solely based on their involvement in the work of patient organisations who are or might have been in relation with single companies.
Deterred patient involvement in the HTA process
The draft regulation also introduces additional criteria for patient involvement, including the expectation that patients refrain from participating in conferences, seminars, and trainings if their expenses exceed 1,000 EUR and are covered by health technology developers. EFA cautioned that such measures can result in patients limiting their participation in discussions affecting their health, and it would be unsustainable for them, often volunteers, to participate in such activities at their own cost, and it should not be expected.
Therefore, EFA recommended to revise the proposal and to follow EMA’s guidance on handling the conflict of interest in such cases, and, at the minimum, consider such payments as not being financial interest that could potentially amount to a conflict of interest in their participation in the HTA procedure.
Looking ahead to a patient centred approach in the HTA regulation
The Commission will adopt the final implementing Regulation on the conflict of interest soon while a the third draft implementing the regulation on the cooperation with the European Medicines Agency (EMA) has been opened for a stakeholder consultation.
Earlier this year, the Commission already adopted the first of its six planned implementing regulations, on the joint clinical assessments (JCA) of medicinal products. EFA contributed to its stakeholder consultation and highlighted the importance of patient involvement. The new HTA Regulation entered into force in January 2022 and applicable as of January 2025,
EFA remains committed to contributing to the implementation of the Health Technology Assessment legislative framework in a patient-centred manner that serves the respiratory patients’ community, as part of the HTA Stakeholder Network and further work in the implementation plan of the HTA Regulation.
You may consult the full EFA response here.