According to Maame Ewusi-Mensah Frimpong, the deputy assistant attorney general at the US Department of Justice (DOJ), compliance has become more about understanding people and their motivations, and statement changes the perception of compliance professionals as they take a deep dive into the world of compliance and how DOJ views compliance.
She added at the CBI’s 10th Annual Pharmaceutical Compliance Congress (PCC) that non-compliance boils down to the failure of individuals and gave five questions that Chief Compliance Officers should ask themselves about their colleagues (which we will get to in the end).
In addition to evaluating and monitoring compliance processes, operations, manufacturing facilities, internal policies, and ethical conduct, DOJ, in the name of “protecting consumers where they are most vulnerable,” also focuses on people since processes and policies (at least publicly-circulated processes and policies) don’t typically break the law, people do, said Frimpong.
Dynamic shifts and realizations in Life Sciences compliance mount pressure on companies and compliance teams. However, there are ways to reduce the complexity and challenges involved in meeting compliance obligations, and one of the ways to reduce the aspects mentioned above is by leveraging data-driven compliance solutions.
Moreover, traditional practices are no longer the key to success in today’s highly regulated compliance environment. But a slight change of mindset, from viewing compliance as an obligation or something to be mitigated or avoided to considering it as a risk that can also be a creator of value and, when approached effectively, can provide actionable insights that can be used to strengthen decision making is critical to achieving success in this domain.
By the end, Frimpong recommended that the attendees of the PCC ask themselves the following five questions to identify potential compliance risks before the government does a thorough investigation:
1. Do we have the right people? Are they experts in their domain?
Frimpong said, “People are not fungible.” Considering the complexity involved in the manufacturing processes, it is imperative to hire the right person to do the right job.
2. Are people using the right incentives (compliance tools) to identify, report, and fix problems?
Frimpong said, “Strong communications are key to facilitating diligent compliance programs.”
3. Are people satisfied and engaged with the company and their jobs?
Frimpong said that “the departure of key people can sometimes lead to a gap in compliance. She cited SB Pharmaco, a GSK subsidiary, and the manufacturing deficiencies at the company’s closed plant in Puerto Rico.
4. Are people and policies working in harmony?
Frimpong said, “Companies should set realistic goals and refrain from crafting compliance programs and procedures that cannot be met.” She further added, “Unrealistic standards are doomed to fail.”
5. Do we, as Chief Compliance Officers (CCOs), know what our people are doing?
In multinational and massive Life Sciences and Pharmaceutical companies, leadership should make a substantial effort to communicate with associates to assess the performance of specific individuals. This would enable them to identify performance gaps while uncovering risky behaviors, reducing non-compliance probability.
In the end, Frimpong gave examples of companies that put patients in harm’s way. She said, “When companies put profits over patients, everyone loses.”
