EU HTA: framework for management of conflict of interests

2nd Implementing Act on the way

Thu, 2024 / 05 / 30
The European Commission published the draft Implementing Act (IA) on the management of conflicts of interest in Health Technology Assessments on May, 29th. The feedback period is open until 26 June 2024.

After the 1st IA on JCA has been endorsed last week this 2nd piece of the puzzle now aims to provide rules for managing conflicts of interest of participants / stakeholders such as the representatives in the Member State Coordination Group, (co-)assessors, patients, and clinical experts.

Primarily, the demanded declaration of interests (DOI) asks about interactions with the industry sector in the last 3-5 years, depending on the section. Interestingly, Annex II gives clear guidance:

  • As an example, clinical experts having advised the manufacturer in the last three years are considered ineligible for the joint HTA Work due to a conflict of interest.
  • Considering the small number of experts, especially in orphan situations, this will be extremely challenging. Unfortunately, it appears that the specialties of rare diseases are not sufficiently considered in most of the EU HTA framework as of today.

It is still a draft, but potential for debate is obvious, especially since the industry is supposed to interact with clinical experts and patients to understand the needs. We as SKC and concurrently with our partners and associations will now analyze in detail and submit our statement.

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About the author

Ihr Ansprechpartner Dr. rer. nat. Ingo Hantke
Dr. rer. nat. Ingo Hantke
M. Sc. Life Science
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18

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