The European Commission recently held an online public consultation on the first draft implementing act supporting the EU health technology assessment (HTA) regulation. The EU HTA regulation will be implemented from 2025 and aims to increase the collaboration on health technology assessment across EU member states. Implementing acts set out the legislative detail of different elements of a regulation. The first of six implementing acts, the draft outlines the process for conducting joint clinical assessments (JCA) of new medicines and how patient experts will be involved.

MPE provided detailed feedback on the proposed implementing act. Specifically, MPE called for:

• Stronger wording on patient involvement.
• Clearer timelines on patient expert involvement, on how they will be supported and the method of involvement at each stage.
• Clarity on the involvement of patient organisations.
• Better alignment between patient expert involvement in the European Medicines Agency (EMA – the European medicines regulator) and JCA processes.
• Provision of lay summaries to patient experts to ensure they have the information needed to comment effectively.
• Ensuring the conflict-of-interest policy allows for the appropriate declaration of any conflict, whilst also ensuring the contribution of the best and most appropriate patient and clinical experts.

For details, please see the full MPE response.

Next steps

This is the first of six expected implementing acts on the EU HTA regulation. The next act for consultation will be on conflict of interest, which is expected in the coming months. As well as following developments, MPE will be participating in a range of stakeholder activities and running a series of educational programmes for our members and other advocacy groups. Keep an eye out on our website for further information on:

• A planned webinar, in collaboration with the Acute Leukemia Advocates Network (ALAN), on the basics of EU HTA regulation for patient representatives on 22 May 2024 with Béla Dajka, Health Policy Officer, European Commission.
• An online multi-stakeholder panel discussion taking place on 26 June 2024 on patient involvement and conflict of interest.
• Collaboration with other patient organisations to ensure the effective involvement of patient representatives and timely access to medicines.
• Attending and co-facilitating a breakout session on conflict of interest at the European Access Academy.
• Holding a session for MPE members on the EU HTA regulation during the MPE Masterclass in Madrid.
• Attending the next meeting of the EU HTA stakeholder network, which MPE is part of, in Brussels in June.

In the meantime, if you have any comments or questions, please email info@mpeurope.org