EPF’s feedback on the draft Implementing Act for Assessing and Managing Conflict of Interest

The European Patients' Forum (EPF) welcomes the publication of the draft Implementing Act for assessing and managing conflicts of interest (CoI). This crucial document will determine which patients and clinical experts participate in Health Technology Assessment (HTA) cooperation at the EU level.

The experiences and perspectives of patients provide essential evidence and guidance for evaluating the clinical effectiveness and safety of health technologies, ensuring that HTA is conducted in the best interests of those directly impacted.

When it comes to HTA, it is essential to maintain the high integrity of the assessment process to secure trust and acceptance from national HTA bodies and involved stakeholders. Integrity implies accountability of those taking part, and transparency and reliability of sources informing the decision-making process. In other words, it is in the interest of all parties to generate soundly based decisions. 

However, elevating the risk of CoI to an exclusion criterion for patient involvement in HTA risks producing the unwanted effect of missing valuable input generated through interactions with other stakeholders.

What are we calling for? Four recommendations to ensure optimal patient involvement in EU HTA processes: 

  1. Establish a scoring system to assess risk of Conflict of Interest among experts;
  2. Allow the “expert witness” status for experts in HTA process;
  3. Develop guidelines to mitigate CoI among patients;
  4. Offer accessible and patient-friendly onboarding support for EU HTA processes

You can find out more on why EPF is asking for this and what generates a conflict of interest, as well as the role played by patient organisations and other stakeholders in managing conflict of interest by reading our full statement.