Sunshine Act Compliance: An Elusive, Confusing Task in the United States and France

“Sunshine compliance is a mess,” said Michelle Axelrod, opening the recent AdvaMed 2012 The Medtech Conference panel “Sunshine Act Compliance—Best Practices for Medical Device Companies.” Her Power Point slide of different states across the United States and their respective histories of sunshine legislation made it clear that transparency and accountability is not easy to regulate and generates much disagreement. No two states have the same laws on the subject, and many have none.

“Sunshine” laws detail legislation that mandates the provision of data to interested and affected parties. In the medical device community, sunshine laws can require companies to disclose money spent on sales events, dinners with potential customers such as doctors or hospital administrators, and other such expenditures that potentially could be likened to bribes. The intention of Sunshine laws is to “shine” a metaphorical light on business practices to maintain accountability and transparency.

The panel was moderated by Axelrod, an attorney and vice president at Porzio, Bromberg, and Newman P.C., a Morristown, N.J.-based law firm with offices in New York City, Princeton, N.J., and Westborough, Mass. On the panel were Edward Evantash, M.D., medical director and vice president of medical affairs at Hologic Inc.; Tracy Berns, chief regulatory counsel for Covidien plc; and Laure Le Calvé, a French attorney with expertise in medical device and life science compliance law.

Le Calvé took the lead on the panel with a discussion of France’s sunshine laws for medical devices. As in the United States, French lawmakers are having difficulty finalizing the draft law. French lawmakers passed the French Sunshine Act (FSA) in December 2011 as a provision of the Bertrand Act, but it will not be implemented until a final draft of the law is published, and that has not yet happened. Le Calvé said she is not sure when the law will be published (it already has been delayed several times).

Despite the similarities between sunshine laws paths both in the United States and France, Le Calvé noted that the laws actually are very different. “Companies operating in the United States with French affiliates might think they know what the French Sunshine Act is,” she warned, “but it’s different in France.”

According to the FSA, medtech companies must disclose “agreements and advantages” procured to health professionals and students; professional, student and patient associations; healthcare institutes, foundations and societies; press and media companies; and service providers working in healthcare. One of the most challenging aspects of the new law,Le Calvé said, is the lack of definition of “advantages.” In addition, the term “service providers working in the healthcare industry” is very broad. It could mean any number of workers or vendors, including contract research organizations. Since she works closely with the industry, Le Calvé joked that people often ask her whether she, too, could be included in that group.

In the United States, sunshine act compliance is in a similar state of disarray.

“Sunshine act is leading us to state of confusion,” said Evantash, the token physician on the panel of lawyers. “We don’t know what to anticipate. We understand there’s a need for transparency, but how it’s going to impact relationships is unclear—will doctors be anxious and pull back? We don’t want to fracture relationships.”

“We’re concerned that sunshine act and disclosure of payments will be seen as a negative, that doctors are [seen as] tainted somehow,” Berns agreed. “We just want to make sure there’s a proper relationship between industry and doctors. We want to provide that information to the public so they know it’s an appropriate relationship.”

Berns’ advice to companies dealing with sunshine compliance for the first time was to identify community leaders, and to work with them so they understand the value of what your company is doing. Direct communication with doctors also is key.

The panel stressed the importance of having a well-defined corporate team in charge of aggregate spending, or “ag-spend” (the total amount of money spent by healthcare manufacturers on gifts, payments, travel, etc.) A quick poll of the session’s attendees confirmed Axelrod’s suspicion that few companies have a team of people—let alone a single person—responsible for ag-spend.

“A lot of companies are not taking ownership of this issue,” said Axelrod. “No one in the company feels prepared. So many resources are needed. Ag-spend is not a one-person or even a one-department job. Companies need teams that span departments to take it on.”