EU HTA: framework for management of conflict of interests

After the 1^st IA on JCA has been endorsed last week this 2^nd 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.

Source: 

• EC: Health technology assessment: Procedural rules for assessing and managing conflicts of interest