Orchestrating Compliance - Pharmaceutical Executive


Orchestrating Compliance
Product managers are not always happy to see their compliance officers. That may be changing.

Pharmaceutical Executive

In addition, foreign governments are in the process of developing guidelines similar to OIG, and are enforcing laws similar to the Anti-Kickback and False Claims Acts abroad. As global awareness of compliance increases, there will be pressure to synchronize compliance efforts on an international level. To prepare, US compliance officers can begin this process by consulting with their international counterparts to gain understanding of the relevant issues.

Words Into Action

With an agenda in hand, the remaining question for compliance officers is: How can they take action? They should start by defining roles and responsibilities. To ensure that compliance activities are effectively orchestrated, compliance officers should ask:

  • What is legal's role in policy setting?
  • What is the role of marketing or sales in enforcement?
  • Who is involved in auditing?

Compliance officers should convene meetings with leadership personnel across these various functions to define who plays which role. For example, a determination that corporate legal is responsible for setting healthcare law-related policy will avoid confusion and redundant efforts. After roles have been set, the next step is making sure that all parties work together toward their common goal of company-wide compliance. This involves ongoing oversight and guidance of those involved in day-to-day activities. By working closely with all involved functions, the compliance officer can ensure that everyone is on tempo and in tune.

Ultimately, for compliance to become an enduring part of an organization, it must become ingrained as a core value, not just a reactive fire drill. Consequently, a compliance officer's clearest test of success is the ability to make compliance part of company culture. This can be achieved by communicating the view that compliance benefits the organization, and does not just add an additional cost or impediment to business activities. These benefits include reduced risk of regulatory scrutiny, and improved public perception and corporate ethics. By focusing on training and collaborating closely with the business, compliance officers have an opportunity to create a new corporate value.

Andy Bender (
) is president, Noah Shannon (
) is director, and Judith Braun-Davis (
) is a compliance specialist for Polaris Management Partners.


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