Lobbying Activity
Response to Health technology assessment - Joint clinical assessments of medicinal products
31 Mar 2024
HELLENIC LEAGUE AGAINST RHEUMATISM/ELEANA welcomes the roles patients and other experts might have in defining the assessment scope, in providing input during the assessment, and in reviewing the JCA reports. HELLENIC LEAGUE AGAINST RHEUMATISM/ELEANA would like to highlight conditions of success regarding these joint assessments: 1. The assessment scope (the PICOs) should reflect state-of-the-art medical knowledge. The numbers of PICO should be realistic, as timelines are short, and the analysis should focus on latest evidence and state-of-the-art medical knowledge. There are differences between Member States on standards of care, that can drive the choice of comparators, however only scientifically sounded questions should be asked to developers. 2. Developers need to be given adequate time to conduct all the analysis requested by the JCA subgroup. The timelines are very tight, for the HTD to submit all the requested data, exposing the Joint Clinical Assessments to the risk of being poor quality, and to the detriment of the European Cooperation on HTA itself. 3. Joint Clinical Assessment reports and their summaries should provide information that demonstrates the utility of the HTA Cooperation After reading the JCA report and/or its summary, no one should be left with the impression nothing can be concluded from the work done. 4. Patients and healthcare professionals should be involved in joint clinical assessments for their active contribution to scoping, assessment, and report review, as per the Regulation and the implementing Act. In addition, their roles as witnesses of the procedures should be acknowledged: civil society in general, and patients in particular, should have the right to verify assessments are based on science and medical evidence. The contributions of patients and/or their organisations in the JCA reports should be prominent. One last general comment on Working days: the Implementing Act does not define whether the working days are defined according to the calendar of working days of the HTA secretariat, or the working days of the HTD (depending on where the HTD is located, bank holidays might apply, and this can create differences between the expected dates for the HTA secretariat and for the HTD)
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