Ladies and Gentlemen,

As we informed you beforehand this year the EU is implementing a system of Health-Technology-Assessment (HTA) for new medicinal products, in-vitro-diagnostics and medical devices.
With selected products the system will be launched in January 2025.

As a stakeholder Prof. Dr. Thomas Deitmer, Secretary General of the Germans Society of ORL-HNS, has participated in several meetings on this topic as a representative of the CEORL.

With few words the procedure is, that the EU will guide Joint Clinical Assessments on safety and efficacy of medicines and devices and will need experts for this task. The European scientific societies (e.g. the CEORL) will probably be asked to propose experts for those assessments, who are best informed about the topic but have at best no conflicts of interest to declare. This might raise a problem, as real experts often have scientific cooperations with manufacturers

We presume, that the first contact in the field of ENT-HNS might be a new type or model of cochlea implants and we cannot be sure when a call for experts will come up.

The CEORL proposes to prepare for such a call and therefore asks the national member societies to look for experts who are open to cooperate in such assessments and are willing to give a declaration of conflicts of interest to be eligible.

To give you deeper insights into the entire procedure you can visit the web-platform of the EU-HTA-Assessment
https://health.ec.europa.eu/health-technology-assessment_en

The rules for managing conflicts of interest were recently implemented and the documents are published on the EU-website and are available in many languages.
https://ec.europa.eu/newsroom/sante/newsletter-archives/56926
https://eur-lex.europa.eu/eli/reg_impl/2024/2745/oj