On October 1, 2013, pursuant to the French Public Health Code, LOI n 2011-2012 Du 29 Décembre 2011 Relative Au Renforcement De La Sécurité Sanitaire Du Médicament Et Des Produits De Santé (“French Sunshine Act”), seven (7) French National Councils publicly made available on their websites statements and reports regarding agreements and benefits related to healthcare professionals in France. The French National Councils govern doctors, midwives, pharmacists, dentists, physiotherapists, podologists and nurses (“HCPs”) in France.
The French Sunshine Act, and its implementing decree, No. 2013-414 On The Transparency Of Benefits Provided By The Companies Producing Or Marketing Products For Sanitary And Cosmetic Purposes For Human Use (“2013 Decree”), which was issued on May 21, 2013, require the tracking and reporting of these benefits and agreements.
In essence, the French Sunshine Act and the 2013 Decree require broad disclosure by pharmaceutical and medical device companies of agreements with HCPs and benefits provided to HCPs and various entities.
The final decree imposes two main types of disclosure requirements on pharmaceutical and medical device companies: 1) all agreements, except for commercial sales agreements of goods and services, which they have with specified individuals and entities; and 2) certain benefits given to those individuals and entities. Specifically, companies must disclose the existence of agreements with and benefits provided to the following:
- Healthcare professionals (e.g., physicians, nurses, but the disclosure requirements do not apply to the reporting company’s employees);
- Associations of healthcare professionals and associations of students of relevant occupations;
- Students of relevant occupations;
- User associations of the health system (public or private);
- Health facilities;
- Foundations, learned societies, and consulting companies or organisations in the health sector;
- Publishing companies: press, radio, television, and on-line media;
- Editors of prescription and dispensing software; and
- Legal entities contributing to the initial training of healthcare professionals.
As to benefits, companies must disclose all benefits that they provide, whether direct or indirect, in kind or in cash, to the aforementioned recipients if the benefits are equal to or exceed ten Euros, inclusive of value added tax. Benefits worth less than ten Euros do not have to be disclosed.
Links to the reports published by the seven (7) French National Councils are provided below: