Code Compliance Resource Aids Firms on Global Scale

NEWS TRENDS

Companies that do business on a global level are faced with a variety of regional and national laws, which can cause a great deal of conflict. Complying with codes of conduct, especially when handling financial relationships between firms and healthcare professionals, is a high-risk area in which enforcement has increased in the past couple of years alone.

“It's apparent to us that pharma has been under the gun for some time from the OIG in the United States and from other authorities overseas,” says Scott Willoughby, managing director at Huron Consulting Group (Washington, DC). “The medical device [industry] seems to be the one next in line for all the attention.”

Huron, along with Compliance-Alliance LLC (Arlington, VA) and King & Spalding LLP (Washington, DC), addressed this complicated issue by compiling a reference book to help device companies implement compliance programs on a global scale. The International Medical Device Compliance Code Compendium contains national and regional codes of conduct, along with supporting analysis of each region's code.

The authors detailed a number of topics under various countries. These topics include regional information about gifts and arrangements with consultants, grants and donations, sales and promotional meetings, and supporting third-party educational conferences. An observations column notes enforcement actions taken in the various countries.

Part of the catalyst behind the code compendium was that companies had been expressing increased interest in regional codes and what enforcement actions had been taken in various countries. The problem was that many companies didn't know where to turn to get this information. “The challenge is that [information about the codes] is not easy to come by in countries,” says Paul Silver, a managing director at Huron's Atlanta office.

Willoughby says this will be useful to international device companies building their own compliance programs. “The most helpful thing is that [manufacturers] actually have a resource that might not be the end-all be-all to which codes are in place, but it'll certainly be a good place to start to understand the regulations being implemented,” says Willoughby.

As device companies put together global compliance programs, they need to consider constructing a global overarching policy that is broad enough to take into account the differences between countries, according to Rosemary Weghorst, manager at Huron's Chicago branch. They should also take into account how national and regional levels of operating procedures tie back into to their corporate policy.

Despite the differences in country codes, Silver and Willoughby say there aren't specific countries that pose more significant risks for U.S. manufacturers than others. Silver suggests that the countries in which there's a higher amount of business conduct might see more of a focus on the codes versus smaller countries where it's harder to find information about guidances.

Depending on the number of changes made to various country codes, the authors anticipate updating the reference book every one to two years. At press time, more information, including an online link to the compendium, was scheduled to be available on Huron's Web site.

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