13/14 March 2024
"Whistle-blowing is the act of telling the authorities or the public that the organization you are working for is doing something immoral or illegal." That is the definition of whistleblowing in the Collins English Dictionary.
In the United States of America, the False Claims Act (FCA, 31 U.S.C. §§ 3729 - 3733) has long encouraged so-called whistleblowing so that evidence of fraud or non-compliance is reported. Whistleblowers are even rewarded for their efforts, for example by receiving money or being protected from retaliation. In the EU, the so-called EU Whistleblowing Directive was then launched in 2019 (Directive (EU) 2019/1937 of 23 October 2019 on the protection of persons who report breaches of Union law). The implementation of this directive aims to protect whistleblowers of wrongdoing from possible retaliation. Whistleblowers should also not be liable under civil, criminal or administrative law (in relation to their employment). To this end, there should be secure internal reporting channels for whistleblowers. The European Medicines Agency (EMA) also has such a reporting channel and procedures for receiving reports of infringements. The Directive also refers to a number of Union acts listed in the Annex, including medicinal products and medical devices. The Directive establishes common minimum standards for the protection of persons reporting infringements that primarily fall under EU law.
As a directive, the document must be transposed into national law. This is proceeding differently in the individual EU Member States. A good overview has now been published by the TMF Group.