The whistleblowing rules in Europe are about to change dramatically. The new Directive on the protection of persons who report breaches of Union law, also referred to as the “Whistleblowing Directive,” will require Member States to create rules that mandate organizations with more than 50 workers to set up whistleblowing hotlines and accept reports about violations of the EU law. Many life sciences organizations will be subject to the new rules under which the whistleblowers will be allowed to report about a broad range of violations of EU law including public health, product safety, protection of privacy and personal data.
The Whistleblowing Directive also provides for minimum standards on how to respond to and handle concerns raised by whistleblowers. These minimum requirements provide sufficient details so that organizations can start reviewing their existing whistleblowing hotlines (if they already have them in place) and adjusting their internal processes to align with the Whistleblowing Directive.
We provide an overview of the main requirements and takeaways in this article.