The European Union has adopted its Regulation on Health Technology Assessment (HTA) which will come into force by next January 2025 for oncology products and advanced therapy medicinal products (ATMPs).
Ahead of January, the European Commission is publishing 6 Implementing Acts aiming to clarify how the HTA will be led. A first implementing Act was published in April to clarify the procedure for the Joint Clinical Assessments (JCAs) and a second implementing Act on the management of conflicts of interest was published in June.
A third Implementing Act titled “Cooperation with the European Medicines Agency”, setting out the rules on exchanging information for EU-level assessments of new health technologies, is now under consultation until next Wednesday 24th July at midnight.
This consultation is open to everyone; including but not limited to patient organisations.
At CPE, we welcome this third Implementing Act (IA) relating to the cooperation by exchange of information with the European Medicines Agency (EMA) and pursuant to Regulation (EU) 2021/2282, as it clarifies the rules for cooperation with the EMA such as the identification of experts, including patients, to be involved in HTA. However, additional clarifications are necessary to ensure the sustainable engagement of patients in HTA.
To ensure the sustainable engagement of patients in the HTA, we propose:
• To include a clear indication of how the EMA recommendations for experts, including patients, will be taken into account
• The HTA Secretariat should use and adapt the EMA procedures for the identification of experts, including patients, to provide expertise in its activities.
• Declaration of Interest statements provided by patients to the EMA should be accepted within the EU-HTA framework whether the specific patient has no new activities to declare.
• Patient information should only be shared if absolutely necessary and with the prior written consent of the patient.
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