e4ethics

APPEALS

A major change in the scope of the decisions rendered by e4ethics is their binding nature. This means that a member would be in infringement of the EFPIA Code of Practice if they provided support to a Third Party Educational Event assessed as not compliant.

Therefore, it is possible for the Third Party Educational Event Organiser or an EFPIA member, to file an appeal on a final decision rendered by the Ethical MedTech Compliance Officers provided that the following requirements are respected:

  • Appeals to the Compliance Panel cannot be filed during the correction notice period, but only after a final decision was rendered by the Compliance Officers.
  • Appeals must be filed within a deadline of 10 working days for Pre-Clearance and Regular Submissions only after the Compliance Officers’ assessment decision has been rendered.
  • The formal appeal with supporting documentation must be addressed to the Chair of the Compliance Panel, and sent by email to both Compliance Officers clarisse.aillet@ethicalmedtech.eu and myriam.invidia@ethicalmedtech.eu.

The Compliance Panel acts as a last decision-making instance an any appealed assessment and endeavours to respond to appeals within 5 working days of receipt. Their role is defined in the MedTech Europe Code’s Procedural Framework and Internal Procedure document.

In the framework of the integration of e4ethics and harmonisation with the CVS procedures, EFPIA Member Associations will not have a formal role anymore in the appeal process. However,  the Compliance Panel may, at their discretion, consult the relevant member association for additional information during an appeal review process.

It is important to note that the Compliance Panel does not provide guidance and interpretation on the EFPIA Code of Practice.