The Path to a Stable Reporting Culture for Life Sciences Companies

Published in Law 360

As the people on the frontlines of medical research, sales promotions, human resources and everything in between, employees of life sciences companies are privy to critical insights that go far beyond a company’s intellectual property. Employees often observe firsthand or hear about potential misconduct and legal violations the C-suite simply cannot see or access.

If employees do not share this information, companies of any size can land in jeopardy, facing the costs of reputational damage, stunted business growth and even legal action. Indeed, in April 2019, the U.S. Department of Justice, widely regarded as the leading enforcement authority in the international compliance space, issued its second version of compliance guidance for life sciences and other companies, which focused on corporate reporting systems and the conduct of internal investigations.

In that document, the DOJ advised:

Another hallmark of a well-designed compliance program is the existence of an efficient and trusted mechanism by which employees can anonymously or confidentially report allegations of a breach of the company’s code of conduct, company policies, or suspected or actual misconduct. Prosecutors should assess whether the company’s complaint-handling process includes pro-active measures to create a workplace atmosphere without fear of retaliation, appropriate processes for the submission of complaints, and processes to protect whistleblowers. Prosecutors should also assess the company’s processes for handling investigations of such complaints, including the routing of complaints to proper personnel, timely completion of thorough investigations, and appropriate follow-up and discipline.

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