19/20 October 2021
On 17 March 2017 the European Medicines Agency (EMA) released a new policy on the handling of information which has been received from external sources about serious concerns, e.g. related to GMP deviations or Data Integrity issues. The EMA stated in its press release that "since 2013 EMA has received a total of 43 reports that relate for example, to the manufacturing of medicine or the conduct of clinical trials."
So far there has been no formal procedure in place to handle these cases. This gap has now been closed with the publication of the EMA Policy/0072 entitled: "EMA's handling of information from external sources disclosing alleged improprieties concerning EMA activities related to the authorisation, supervision and maintenance of human and veterinary medicinal products". In this document the EMA describes how reports will be handled and which actions will be taken. In the US a procedure for so called "whistleblowers" is well known in public. However, in Europe very few countries have procedures for individuals to report improprieties to an authority.
The document published by the EMA intends to help especially individuals to report their observations if they notice illegal procedures within companies. This might be the case if, for example, raw data has been deleted or adulterated. Such cases of fraud might cause serious risks for patient safety e.g. if a QC test confirms that a product is out of specification and the corresponding data has been deleted or if manufacturing steps have not been performed according to the documentation in the company. In the past years more and more cases have become public about Data Integrity. The policy for external individuals will support them to ensure that the information provided will be treated in a structured manner and that the personal data of the individuals will be treated confidentially.