10 Key Recommendations for Enhancing Joint Clinical Assessments Under the EU HTA Regulation

Patient Organisations Release 10 Key Recommendations for Enhancing Joint Clinical Assessments Under the EU HTA Regulation

Leading patient organisations across Europe have come together to release a set of ten key recommendations aimed at improving patient involvement in Joint Clinical Assessments (JCAs) under the EU Health Technology Assessment (HTA) Regulation. This collaborative effort highlights the crucial role of patient experiences and insights in shaping effective healthcare assessments and ensuring that the voices of those directly affected by medical innovations are heard and valued. 

The recommendations, developed with input from a wide range of patient groups and based on extensive consultation and practical experience, are designed to foster a more inclusive, transparent, and patient-centered approach to JCAs. The key recommendations are: 

1. Establish a predictable framework for patient involvement in JCAs: A clear, defined structure for patient participation, ensuring timely and effective contributions throughout the assessment process. 
2. Include input from patients, carers, and patient organisations: Integrating unique perspectives and aggregated knowledge of patient organisations and carers to provide robust, evidence-based information on the burden of diseases and the impact of treatments. 
3. Include patient experience data in JCAs: Incorporating comprehensive data on patient experiences to ensure broader representativeness of the impact of health technologies. 
4. Streamline patient involvement throughout the process: Ensuring continuous patient engagement from the preparatory phase through to the final assessment to avoid tokenistic involvement. 
5. Provide plain language summaries of technologies under assessment: Making information accessible to patients and other stakeholders, regardless of their technical expertise. 
6. Broaden the pool of patients and specify selection criteria: Expanding the diversity of patient participants and setting clear, inclusive criteria for their selection. 
7. Support patient participation in JCAs: Providing necessary support and resources to patients to facilitate their meaningful involvement without undue burden. 
8. Make JCA and summary reports available in all EU languages: Ensuring all EU citizens can access and understand the assessment reports in their native language. 
9. Provide feedback to patients on their participation in JCAs: Offering clear and constructive feedback to patients on how their input was used and how they can further contribute. 
10. Adopt a constructive approach to confidentiality and conflict of interest: Balancing confidentiality and transparency to allow effective patient involvement without compromising integrity. 

The recommendations are a call to action for the HTA Coordination Group to integrate these practices into the guidelines they develop to enhance the quality and relevance of JCAs. By doing so, they can ensure that assessments reflect the real-world experiences of patients, ultimately leading to more patient-centered healthcare solutions. 

The full text of the recommendations is available here.