Life Science Compliance Update

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May 28, 2014

French Sunshine Act: Public Database Published

As we've said a lot this year, transparency is a global phenomenon. The Loi Bertrand, or the French Sunshine Act, is similar in many ways to the US Physician Payments Sunshine Act, but even more expansive. These differences pose significant hurdles for companies attempting to build uniform programs to comply with these laws. Furthermore, the French Sunshine Act's disclosure obligations are retroactive to transactions occurring in 2012. The first French reports were due August 2013, and the payment information is now up on a public website. 

Click here for the health products company list. So far, the company information isn't very reader-friendly.

 Click here for a searchable database by healthcare provider name.

The French law requires that health products companies make available on a public website:

  • The existence of any Agreement with health care providers (HCPs) and certain entities of the health sector within 15 days after execution (a continuing obligation) and
  • Any Benefit in cash or in kind granted to the latter exceeding €10 (about $13.70 US dollars), which must be disclosed within 6 months—the first of August, or first of February of the following year at the latest.

The only exception to the broad scope of the disclosure obligation are commercial sales agreements of goods and services concluded between companies and HCPs.

Furthermore, whereas U.S. Sunshine requires disclosures of direct and indirect transfers of value to physicians and teaching hospitals, the French law covers benefits provided to those recipients as well as other health care professionals (including pharmacists and nurses), students, and organizations (such as societies and associations of health care professionals). The law applies to manufacturers of virtually all regulated health and cosmetic products, regardless of whether the products are reimbursed under the French social security regime. 

The following information must be made publicly available concerning payment or "advantages" granted by companies to HCPs:

  • The qualifications and medical specialties of the parties, including the qualification and registration number for HCPs, school and registration number for students and any information related to the legal person
  • Signature date
  • Subject matter of the agreement: this must be referred to in general terms (clinical trial, congress speech, advice in scientific board, promotional event, etc).
  • For scientific events, the detailed agenda. For example, look at Boehringer Ingelheim programs they reported

Companies that fail to fulfill the disclosure obligation are subject to penalties, including a fine of up to €45,000 and additional sanctions.

For a very helpful table comparing the requirements of the US Sunshine Act with the French Sunshine Act check out Potomac River Partners coverage of the French law: "Let The Sun Shine In France."

We searched for media coverage so far and haven't found many stories related to this data. We will fill you in with news that could foreshadow the US Sunshine data due later this year.

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