Creating a compliance plan and minimizing risk is top of mind for many, if not all, life science companies. Sometimes, gathering your thoughts and brainstorming with others facing similar dilemmas can help you formulate an effective strategy.
Learning Best Practices
The MediSpend team participated in the19th Annual Pharmaceutical and Medical Device Compliance Congress from Nov. 7 to 9 in Washington, D.C. During the conference, we had the opportunity to network, share product demonstrations, and hear from industry leaders about a variety of pressing pharmaceutical and medical device compliance topics.
One of the sessions, “The FCPA Enforcement Update,” was a discussion focused on trends in enforcement and healthcare compliance. It yielded important information for those contemplating compliance in the life sciences. Among the speakers were:
- Leslie Backschies, MA
Supervisor Special Agent and Unit Chief, International Corruption Unit, Federal Bureau of Investigation (FBI), Los Angeles
- Jacob Elberg, JD
Assistant U.S. Attorney, U.S. Attorney’s Office, District of New Jersey, U.S. Department of Justice, Newark, N.J.
- Tarek Helou, JD
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, U.S. Department of Justice, Washington, D.C.
- Cheryl J. Scarboro, JD
Partner, Simpson Thacher & Bartlett; Former Chief, Foreign Corrupt Practices Act Unit, Enforcement Division, U.S. Securities and Exchange Commission, Washington, D.C.
- Gary F. Giampetruzzi, JD
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, N.Y., United States (Moderator)
Some Takeaways for Your Compliance Plan
1. More Countries, More Potential Problems
You might see it as obvious, but the risk of committing violations related to the Foreign Corrupt Practices Act (FCPA) increases with the number of countries in which you do business. This is, of course, especially true if you are working with countries that are notorious for corruption. Being aware of the increased risk is the first step to protecting your company.
Once you recognize that conducting business in certain countries can be a challenge, you can begin to train your employees better about what’s inappropriate and how to navigate the landscape in a particular place. It helps those in compliance to truly understand the laws and the challenges people may face when conducting business abroad.
2. Create a Culture of Compliance
Around here, we’re constantly talking about making transparency your brand. Having a culture in which compliance and ethics are baked in is a necessity. Questions companies should ask themselves are, for example:
- Is the company actively promoting compliance?
- Are the sales people vetted and monitored?
- How is the bonus structure? Is there an incentive to bribe?
Another thing mentioned by the speakers was that they partner with international prosecutors. Prosecutors in other countries are helping, for example, to collect evidence.
3. Lead from the Top
Furthermore, the group offered practical, actionable advice to make compliance more tangible. For starters, top management must provide the right message and set the tone for everyone else. They have to make sure compliance officers and salespeople and others in the business realm work together.
In addition, they should create the opportunity for whistleblowers to come forward. Certainly, the whole company should be behind opportunities to ask the right questions and dig deeply into business practices by auditing the system and regularly monitoring activities.
Self-disclosure is recommended and often leads to less severe punishments. Therefore, self-disclosure is recommendable and worth looking into when discovering that there is a potential violation. The bottom line is life sciences organizations must find out what is really happening on the ground when it comes to conducting business and how employees are behaving. Then, they should document their findings and use the information to shape their compliance program.