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Bundesarbeitsgemeinschaft Selbsthilfe von Menschen mit Behinderung, chronischer Erkrankung und ihren Angehörigen e.V.

BAG SELBSTHILFE

Die Bundesarbeitsgemeinschaft Selbsthilfe von Menschen mit Behinderung, chronischer Erkrankung und ihren Angehörigen (BAG SELBSTHILFE e.V.)

Lobbying Activity

Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

19 Jun 2024

Position Paper on the Implementing Act on Conflict of Interest On Wednesday 29 May, the European Commission published its draft Implementing Act for assessing and managing Conflict of Interest for representatives in the Coordination Group and individual experts, including patients. This set of implementing rules is the second one out of six being released, and is part of the process of implementing the EU Regulation on Health Technology Assessment (HTA). Process of assessing conflict of interest According to the Implementing Act Patients should fill in a Declaration of Interest (DOI) accompanied by a curriculum vitae (CV) based on the Europass template. If no further information is required, the Commission will assess the declared interests within 15 working days. Otherwise, the expert has 10 days to provide any additional information requested by the Commission. The DOI should be valid as long as the patient is involved in the joint work and renewed every year. The DOI and CV of all individual experts should be published on a publicly accessible website, except those of patients.
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Response to Health technology assessment - Joint clinical assessments of medicinal products

27 Mar 2024

We comment the Implementing Act pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in the preparation and update of joint clini-cal assessments of medicinal products for human use at Union level as follows: a) We fully agree with the coordination group that the JCA Subgroup should give the opportunity to patient organizations to provide their input on joint clinical assessments. (15)
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