Businesses in the Life Science sector have already seen that there can be major consequences where an employee blows the whistle on wrongdoing at work. Previous well-publicised instances of regulatory action were taken after reports of alleged kickbacks and off-label marketing as well as significant sums awarded by the courts in false claims suits.
So far, many of these proceedings have taken place in the USA. But the implementation of the EU Whistleblower Protection Directive means there could soon be an increase in whistleblowing activity on this side of the Atlantic.
This update provides an overview of key features of the Directive and looks at some related issues that could affect businesses in the Life Sciences sector.
KEY PROVISIONS OF THE WHISTLEBLOWING DIRECTIVE
The Directive provides protection from retaliation for people who obtain information about a breach of certain EU laws in a work-related context and then report the breach internally, externally or publicly. Laws setting quality and safety standards for medicinal products and medical devices are covered along with other laws concerning, for example, public health, consumer protection and product safety and compliance. The Directive also requires employers of 50 or more workers to set up internal channels to receive and manage reports of breaches.
The deadline for transposition of the Directive was 17 December 2021, but few Member States met this. At the start of 2023, only 13 of the 27 EU countries had...
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