French Sunshine Obligations Clarified and Extended
The long-awaited decree that clarifies the French "Sunshine" obligations was recently published in the French Official Gazette, and it brings about some important changes to the existing transparency requirements that apply in the life sciences sector in France.
Indeed, pursuant to French Decree no. 2016-1939 of December 28, 2016 ("Sunshine Regulations"), health care companies ("HCCs") manufacturing or marketing health care products in France (including, in particular, drugs, medical devices, and cosmetics) will have to report detailed information on contracts as well as remunerations or fees granted to health care professionals ("HCPs"). This much-awaited decree finally clarifies the French Sunshine regime, in force since 2012, which had been partially overruled by the Conseil d'Etat (French Administrative Supreme Court) in 2015 and modified by the Touraine Law of January 26, 2016.
Under the 2012 French Sunshine regime, HCCs are obligated to report all benefits of €10 or more granted directly or indirectly to HCPs, such as hospitality in the context of a conference, travel costs, or meals. However, the provisions of the 2012 French Sunshine regime were interpreted as excluding remunerations or fees, even though, as noted by patients' associations, a large consulting fee is more likely to create a conflict of interest than "coffee and doughnuts." HCCs also currently report the existence of contracts with HCPs, but until now they did not have to disclose the precise subject matter of the contract.
The information disclosed in the framework of the French Sunshine regime is made public on an official Transparence website established by the French authorities. However, at this stage, the interface of the website does not allow for the provision of detailed information about a contract and does not include remunerations or fees.
However, under the recently published Sunshine Regulation, all remunerations and fees of €10 or more granted by an HCC to an HCP must also be reported. With respect to contracts, it will be necessary to report the precise subject matter, the date of signature, and the date it enters into force, together with the total amount paid or otherwise granted to the HCP. In addition, the name, titles, and professional address of the HCP must be disclosed. HCCs must also include all information necessary to identify the indirect beneficiaries of a contract. For instance, in the context of a research contract with a hospital, "indirect beneficiaries" would include the specific department or individuals involved. As regards the reporting of remunerations and fees, the identification of the HCP must be included, as well as the remunerations or fees paid during the previous six-month period in the case of ongoing arrangements.
It should be noted that the scope of the Sunshine Regulations is wide. In addition to traditional HCPs such as doctors, pharmacists, and nurses, medical scholar societies and even medical media or prescription assistance software companies also are covered. The definition of "HCP" includes students of medical professions as well as medical education establishments and continuing medical education programs.
The new reporting requirements under the Sunshine Regulations will apply as of the publication of the ministerial order detailing the items to be reported and modifying the Transparence website, but no later than July 1 2017, as stated by Decree no. 2016-1939. This means that even if the ministerial orders mandated by this decree are not published by July 1, 2017, HCCs have an obligation to report the information on contracts, remunerations, and fees called for by the decree, either on the current Transparence website (notwithstanding that such website has not been redesigned) or possibly on corporate websites or through professional boards, as previously done in 2012–2013, when the first Sunshine obligations under the 2012 French Sunshine regime became enforceable prior to the launch of the Transparence website.
In any case, the Sunshine Regulations apply in tandem with stringent antibribery provisions that forbid HCPs from accepting (or HCCs from offering) gifts—except in a few specific circumstances detailed by the French Public Health Code—as well as with codes of ethics or conduct and policies applicable to a specific profession or company.
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Françoise S. Labrousse
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