OBJECTIVES: Joint Clinical Assessments (JCA) aim to accelerate patient access to new innovative medicines by conducting single submission of data to address issues of relative effectiveness and relative safety. The JCA released their draft Implementing Act and opened the feedback period between 05-03-2024 and 02-04-2024.

METHODS: Feedback was provided by non-governmental organisations, pharmaceutical and medical device companies, research institutions, trade unions, European citizens, and other organisations. The statements were summarised and analysed by organisation type.

RESULTS: A total of 129 feedback statements were received in the aforementioned period. The overarching feedback was consistent across the organisations focusing on Articles 2, 11, 12, 14, and 20. Firstly, reviewers highlighted the need for early involvement of key stakeholders in the scoping assessment. Patient and clinician organisations highlighted that the involvement of patients and clinicians is crucial from the early steps of the process, and the same participants should be further involved in key process steps to ensure continuity and consistency. Furthermore, a scope explanation meeting should be made mandatory, and opportunity should be given to the stakeholders to provide input. Secondly, in addition to extension of timelines for the development of the JCA dossier and report, alignment of the timelines to the European Medicines Agency regulation process was noted, to avoid potential changes in the scope after the label is issued and it does not match the original submission. Lastly, companies and business associations all recommended revisions of the rules and regulations for protection of confidential data.

CONCLUSIONS: Overall, feedback received on the draft Implementing Act of the JCA was consistent, highlighting the three key areas where revisions might be needed. Those include the stakeholder engagement, timelines of the submission, and management of commercially sensitive data. Revisions need to be implemented by the JCA to ensure a smooth process, which enables faster access to innovative treatments.