29 July 2022

Status of implementation of the “Whistleblower” Directive

The definition of whistleblowing as per the Collins English dictionary is the act of telling the authorities or the public that the organization you are working for is doing something immoral or illegal.”

In the United States of America, the False Claims Act 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 deadline for implementing Directive passed on 17th of December 2021. The intention of the legislation is to set a harmonised minimum standard of protection for those who report breaches of EU law, and all member states must transpose the new EU regulations into national law.

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 been published by the TMF Group.