EMA Board releases a policy on handling of information on alleged improprieties concerning EMA activities

In March 2017, the board of the EMA adopted a policy (POLICY/0072) on how it handles information received from external sources on “alleged improprieties” that concern activities related to the evaluation and supervision of products by the EMA. Allegations of impropriety relating to the competence of the EMA can be made when there is a potential impact on the authorisation, supervision or maintenance of products due to alleged departures from current good practice standards.

The policy covers several principles in how allegations of improprieties are handled by the EMA, including issues around confidentiality, both of the reporter and any individuals who may be the subject of the report; how the information is treated, including restricted access considerations and privacy statements; transmission of the information to relevant other parties such as the European Anti-Fraud Office (OLAF) or relevant competent authorities; and the procedures for communication with the external source including timelines for this correspondence.

The EMA may not be the appropriate or competent authority to investigate the report, and in this instance the EMA will delegate the investigation to either the relevant national competent authority (for national products) or to OLAF or another international partner.  Such areas include nationally authorised products, clinical trials or products not manufactured and authorised in an EU Member State.

The policy applies to both human and veterinary medicines, and interacts with or complements both the EMA whistleblowing procedure and the breach of trust procedure. It is designed to create an atmosphere of trust, so that reporters can make their concerns known safe in the knowledge that their report will be handled in an appropriate way and dealt with according to a published procedure.

The policy can be found at the here.

Reports can be made to the following dedicated email inbox: reporting@ema.europa.eu or by sending a letter to the EMA.