The scope and more specifically the format of the information to be disclosed may be found in an Order dated 3 December 2013 regarding the operating conditions of the single public website mentioned in Article R. 1453-4 of the Public Health Code (in French “Arrêté du 3 décembre 2013 relatif aux conditions de fonctionnement du site internet public unique mentionné à l’article R. 1453-4 du code de la santé publique”).In essence it is necessary to disclose:
- any contract or agreement with a recipient: this includes contracts of any nature, in particular R&D contracts (clinical trials, observational studies…), as well as other consultancy agreements (speaker, proctoring, advisory boards…), and this also includes the so-called “hospitality conventions” (invitations to individuals HCPs at scientific or medical events for which covered companies pay the related costs, such as registration fees, travel costs, meals and accommodation expenses)- except agreements entered into in the context of commercial relationships (Articles L. 441-3 and L. 441-7 of the Code of Commerce)
- any benefit in cash or in kind granted to a covered recipient beyond a certain threshold i.e beyond 10 Euros: this includes for example any item offered to a covered recipient, any lunch offered to a HCP by a medical sales representative after a medical visit, but also the honoraria/fee received under the agreements per the terms of a decision of French Highest Admistrative Court (“Conseil d’Etat”) decision (1ère / 6ème SSR, 24/02/2015, 369074).
- The contracts falling in this disclosure obligation are the contracts which (i) are effective as of the 1st of January 2012 or which (ii) become effective after the 1st of January 2012. Any benefit in cash or in kind granted to a covered recipient as from the 1st of January 2012 also falls in this scope.
The term ‘agreement’ is a translation of the term ‘convention’.
The FSA does not provide a clear definition of what is an “agreement”.
Article L. 1453-1 of the French Public Health Code simply requires disclosure of the existence of all agreements entered into between companies and operators in the health field without defining what may constitute an agreement.
Some agreements, however, are excluded from the disclosure obligation. In fact, the legislator did not intend to include agreements entered into in the context of commercial relationships (Articles L. 441-3 and L. 441-7 of the Code of Commerce). This means that agreements relating to the purchase of goods or services from the companies covered by this measure are exempted from the transparency measure. In addition, these purchases are subject to invoicing in accordance with Article L. 441-3 of the Code of Commerce.
It is nevertheless to be noted that various amendments relating to agreements are currently being legislated upon and therefore some changes are to be expected in 2016-2017 when the relevant Decree is eventually published.