With an aim to encourage whistleblowers and others to feel safe coming forward with possible details of improprieties, the European Medicines Agency’s (EMA) Management Board on Monday adopted a new policy detailing how the agency handles such allegations, including those that could have an impact on the evaluation and supervision of medicines.
Since 2013, EMA says it has received a total of 43 of such reports detailing a variety of issues and allegations, from the manufacturing of medicines to the conduct of clinical trials.
"Although no formal policy has existed until now, all reports were dealt with in line with the principles included in the new policy," EMA says, noting that this new policy will help EMA assess any reports and co-ordinate any further investigation in a structured way, while protecting the confidentiality of the reporter.
Any external entity who becomes aware of any facts pointing at an impropriety with a potential impact on the authorization, supervision and maintenance of human and veterinary medicinal products may, in the public interest, report them to EMA at: firstname.lastname@example.org.
EMA says it will ensure the confidentiality of information from external sources and the sources’ identities, as well as the protection of personal data, whether this data leads to further examination by EMA or by the European Anti-Fraud Office (OLAF) or not.
"Examples of allegations that may be made include that the integrity of the data in the studies used to support market authorisation cannot be relied upon. This data integrity is fundamental to trust and confidence in the authorised medicinal products. Such problems could arise due to poor training, inadequate implementation of procedures and controls or even falsification of data," the policy says.
"If there are any concerns that the improprieties may affect the balance of benefits and risks of the medicine, EMA’s scientific committees may consider regulatory action," the agency said in a statement. And if the allegations concern a nationally authorized medicine, EMA may, on a case-by-case basis, refer the matter to that member state’s national medicines agency.
The policy, which came into effect on 17 March 2017 and was prepared in consultation with the European Commission and OLAF, will be reviewed in three years.
Policy on how EMA handles allegations of improprieties received from external parties