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23 May 2024
CARE, - Healthcare, - Digital Health, - Medicines

In April 2024, EFA responded to the Health Technology Assessment (HTA) stakeholder consultation on the first implementing act of the EU HTA Regulation, the one defining Joint Clinical Assessment (JCA) for Medicinal Products. EFA welcomed the EU proposed framework for Joint Clinical Assessment (JCA) for medicinal products, and emphasised the importance of patient involvement early in the process.

 HTA2As part of the implementation plan of the new HTA Regulation entered into force in January 2022 and applicable as of January 2025, the European Commission published the first implementing act on joint clinical assessments (JCA) of medicinal products. The proposal is crucial for patient involvement in EU HTA procedures which are the ones ultimately guiding healthcare systems national authorisation, pricing and reimbursement policies of medicines and other technologies for health. 

Opportunity to reinforce involvement of patients and patient organisations  

EFA applauded the improved structural involvement of patients and other relevant experts at the different stages in the joint clinical assessment process. However, we emphasised the importance of including patient experts stemming from and supported by European and national patients’ organisations. EFA also recommended the European Commission to include the possibility to engage with carers who represent patients, especially in processes when the medical product assessed is intended for paediatric patients, elderly or people with disabilities.  

Moreover, EFA stressed the importance of compensating experts who dedicate their time and resources to be involved in the joint clinical assessment process, especially patients, patient experts and carers, whose volunteered involvement is very important in the overall assessment process. As such, their work and contribution should be financially compensated in a reasonable and proportionate manner.  

Seek contributions from young patients for better paediatric outcomes  

Children are alarmingly underrepresented in the medicine development cycle, authorisation and HTA procedures. Form EFA community, representing many children patients living with allergy and respiratory disease, their engagement should be encouraged as children and adolescents have a unique perspective. EFA recommends strengthening the involvement of young patients by increasing the effort to engage children in the joint assessment procedure for paediatric products, similarly to the EMA’s principles on the involvement of young patients/consumers within their activities.  

Availability and accessibility of summary reports to patients across Europe 

EFA welcomes the steps taken in the context of the HTA Regulation to make information widely available and accessible to the public about the results of joint clinical assessments. To increase the health literacy of the overall population, and ensure availability and accessibility of the summary reports, it is essential that summary reports are published in all official languages of the EU. Not translating the summary report will continue increasing health inequalities in access to care and health information.  

What are the next steps? 

This is the first draft implementing act out of a total of six expected throughout 2024 as part of the HTA Regulation implementation plan. However, the European Commission opted for not including any EFA asks in the final, adopted, implementing act.

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 to the JCA on Medicinal Products consultation here.