KOL Engagement and Enforcement in Canada, Relative to the United States

December 16, 2010 · 2 comments

In the Field with Neil: Observations from Neil Mellor, Business Development Consultant

“When the US sneezes,” as they say, “Canada catches a cold.” This cliché could not be more apt for the Canada pharmaceutical executive when it comes to managing relationships with key opinion leaders (KOLs). Canada is still a long way off from having similar regulatory activity to the US, with regard to governing interaction with healthcare professionals, but Canadians should pay attention to what is happening south of the border.

The Office of the Inspector General (OIG) is a well-known entity to any US pharmaceutical sales representative, product manager, sales or marketing executive. The OIG is a division of the US Department of Health and Human Services and has strict powers governing how the US pharmaceutical industry engages with KOLs and promotes pharmaceutical products. According to The OIG’s website (http://oig.hhs.gov/), “The OIG’s duties are carried out through a nationwide network of audits, investigations, inspections and other mission-related functions performed by OIG components.” The OIG has sweeping powers to investigate, prosecute and fine, if necessary, or even invoke jail terms. Since 2000, over $11.7 billion in legal settlements have been collected by the OIG from pharma companies promoting off-label usage of their products or violating the agency’s expectations of how the industry should interact with KOLs.

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