EMA's Rasi Moves to Streamline Conflict of Interest Policies at EMA

The European Medicines Agency (EMA) has released an updated procedure governing how the agency's employees are investigated for any potential conflicts of interest (COI) relative to their duties reviewing medicinal products.

The standard operating procedure (SOP), Conducting checks for conflicts of interest of Agency employees assigned duties relating to medicinal products for human or veterinary use, was approved by EMA Executive Director Guido Rasi on 23 March 2012 and released on EMA's website 14 May 2012.

The scope of the SOP increases dramatically under the newest revision. EMA notes the guidance previously did not cover-but now includes-managers, product/project team members for a range of procedures, scientific advice administrators, orphan and pediatric coordinators, legal and regulatory affairs advisers, press and media officers, web editors and other scientific administrators.

Secretarial-, administrative- and assistant-level staff are not required to be checked for COIs, while all other staff must be checked by their respective Directorate.

Compliance with such checks will be the responsibility of each Head of Unit, Head of Sector, Head of Section and the Executive Director of EMA.

As part of the SOP, EMA has released a process map of the revised COI procedure. Employees will be assessed in accordance to one of three risk levels.

• A level one risk level implies there are no conflicts, allowing the employee to proceed with his or her duties unimpeded. This allows for an expedited review process.
• A level two risk level notes there are minor, likely indirect conflicts which may preclude the employee from full participations. EMA will determine how this conflict of interest might affect the employee's participations, if restrictions are applicable and if it is permissible for a waiver to be granted.
• A level three risk level is reserved for employees with direct conflicts of interest, and is dealt with in the same manner as employees with a level two risk factor.

The SOP is effective 15 May 2012, and is scheduled to be reviewed on 15 May 2015.

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