GalxoSmithKline recently came to a whopping $3Billion settlement with the US Government for off-label marketing (in other words promoting products for purposes other than what was approved). That’s a lot of money! The US has a tough regulatory framework for pharmaceutical companies and companies that come under the scanner of the US Government for violations of compliance law come under the CIA. CIA refers to the Corporate Integrity Agreement. By signing this agreement, pharmaceutical companies are allowed to function and participate in federal health programs, Medicare, Medicaid in exchange for adhering to strict guidelines that are constantly monitored.
Glaxo is not the only company to come under the CIA, other major pharmaceutical companies have also settled with the Government under this agreement. Clearly, compliance training is serious business and pharmaceutical companies are scrambling to ensure that they are fully compliant with the local laws and regulations.
The scope of this challenge is literally on a global scale. Pharma companies are invariably large and are geographically distributed (you cannot possibly fund drug development without large revenues and access to talent pool). Hence, compliance training has to be delivered to all employees in every corner of the globe. This presents a whole lot of complications as local laws and business practices are very different. In addition, the infrastructure needed to deliver and track training content, language versions, reporting, and periodic updates are some logistical issues to contend with.
The other major challenge in ensuring compliance is the way sales teams are compensated and motivated. Here is what the Department of Justice had to say in a press release – “Our five-year integrity agreement with GlaxoSmithKline requires individual accountability of its board and executives,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services. “For example, company executives may have to forfeit annual bonuses if they or their subordinates engage in significant misconduct, and sales agents are now being paid based on quality of service rather than sales targets.”
And finally, the biggest challenge in delivering compliance training is not just to follow the rules, but to change the way every employee does business. This goes beyond compliance and has everything to do with ethics. One of the experts in the pharmaceutical compliance business that I spoke to recently summed up by saying, “don’t do anything that you will not do in front of your grandmother.” Now that’s easy.
And here is a video on CIA 🙂