When it comes to mandating transparency in the relationships between life sciences companies and health care professionals, it appears that Europe will not be outdone by the United States. Although compliance professionals at global pharmaceutical and medical device companies lately have been fixated on the recently released final regulations implementing the Sunshine Act provisions of the Patient Protection and Affordable Care Act, a U.S.-centric approach will fail to address the growing demands of European transparency regulations.
The trend toward greater transparency imposed by governments has accelerated over the past nine months, with France, Portugal, Denmark and Slovakia leading the way in Europe.
On May 21, 2013, the French government issued its long-awaited decree to implement its Sunshine Act, which was passed on Dec. 29, 2011. The French decree requires pharmaceutical and medical device companies to report agreements they have with health care professionals, as well as benefits they provide to them. Several aspects of the decree are controversial, especially in terms of the low thresholds for reporting and the onerous burdens that the reporting requirements impose on life sciences companies.
The final decree imposes two main types of disclosure requirements on pharmaceutical and medical device companies: all agreements, except for commercial sales agreements of goods and services, that they have with certain categories of individuals and entities and certain benefits given to those individuals and entities.
Specifically, companies must disclose the existence of agreements with and benefits provided to the following -
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