2013 was a year of unprecedented scrutiny of financial relationships between manufacturers and health care professionals, such as physicians. Both the United States and France imposed sweeping new reporting and disclosure requirements in an effort to provide transparency and, theoretically, to enable the public – including patients – to make informed treatment decisions and assess possible conflicts of interest. Both sets of requirements carry potentially large financial penalties for failure to report and for incorrect reporting. For manufacturers operating globally, compliance with these provisions will be an ongoing challenge.
At the same time, a review of the highlights of the two Sunshine Acts demonstrates that transparency is not necessarily the same on one side of the Atlantic as the other.
Under the new law, U.S. manufacturers will primarily be reporting payments and transfers of value to physicians and teaching hospitals, along with physician ownership information. In contrast, manufacturers operating in France have reporting obligations on a much broader list of HCPs than in the United States, and they must also identify the nature of the agreements they sign with such HCPs in order to know what data they need to disclose. Further, they must report to several authorities, comply with data protection regulations, and ensure compliance regarding cosmetics products.
Therefore, a summary chart may be helpful as a first step to identify the scope of the transparency requirements in both systems. The chart compares and contrasts the primary requirements of the two sets of Sunshine reporting requirements. Please note that the law and regulations in both countries are highly complex, with detailed and sometimes confusing definitions and regulatory interpretations; this overview is designed primarily to offer an “at a glance” comparison.
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