Hot take – I disagree with the notion that the goal of a life science compliance program should be to build a “speak up culture.”

A compliance program that is effective doesn’t have a “speak-up” culture – “-” . Here’s why:

The phrase “speak-up” conveys that obvious bad conduct could take place and the issue is that employees will ignore it. But this isn’t how most serious compliance issues arise in the life science industry.

Most compliance issues that turn into government investigations and eventually settlements typically involve one of two “gray area” scenarios:

The first is standard business conduct that is being abused, like speaker programs, consultant payments, grants, patient assistance or HCP services. We’ve seen numerous cases like this over the years involving alleged abuses of speaker and consultant payments.

The second scenario is when companies think they’ve found a “loophole” to a legal or compliance rule. Many of the recent DOJ settlements involving patient assistance grants involved what I would call “loophole” conduct. But anti-kickback laws are not the tax code.

The conduct under these most common scenarios is not obviously a problem. It’s gray area conduct that needs probing to understand whether it is appropriate and complies with the intent of legal and compliance rules.

That is why effective compliance programs have a “speak with” culture.

What this looks like:

  • Compliance is integrated into the business and seen as a business partner to solve problems in an appropriate manner
  • Compliance has built a trust relationship with field teams
  • The field team knows who to contact with compliance questions and field managers know to consult compliance when questions are raised to them
  • Employees feel comfortable that management will support them when they ask questions to compliance or ask compliance type questions
  • There is a dialogue about key risks, why they are problematic, what to avoid, and proper purposes
  • Employees feel concerns will be investigated and treated seriously

If you are a legal or compliance professional, how are you encouraging a speak-with culture? How are you testing or assessing your speak-with culture?

#effectivecompliance#healthcarecompliance

Dan Curto

For more than 20 years Dan Curto has been focused on helping life sciences companies solve legal, compliance and regulatory challenges. Dan was a member of the international law firm of McDermott, Will & Emery from 1998 to 2012. As a partner at…

For more than 20 years Dan Curto has been focused on helping life sciences companies solve legal, compliance and regulatory challenges. Dan was a member of the international law firm of McDermott, Will & Emery from 1998 to 2012. As a partner at McDermott, his practice focused on guiding life sciences companies through government investigations, litigation, and compliance remediation. Since 2012, Dan has held various leadership positions at Sanofi, Biogen and BeiGene, including lead global commercial roles, heading a global investigation function that oversaw all internal and external compliance and government investigations and serving as head of global litigation and enterprise risk management. Dan opened Curto Pharma Law and Compliance in 2021 to provide counsel and compliance on demand support to Life Sciences companies.