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New circular clarifies revised French transparency requirements

The French General Directorate of Health (DGS) recently published a new circular relating to the transparency of relationships between life sciences companies and healthcare actors. The circular replaces its 2013 predecessor, and provides further guidance with respect to the revised transparency provisions introduced by the December 2016 Decree and March 2017 Order, now requiring life sciences companies to disclose the value/amount of agreements entered into with a wide range of healthcare actors.

(See also previous updates: Revised French transparency regime enters into force, Agreements between life sciences companies and healthcare actors subject to stricter transparency requirements).

The new circular provides further guidance on:

  • The new notion of final beneficiary (for benefits granted in the framework of agreements). In cases where there is further subcontracting, the contractual beneficiary is required to inform the life sciences company of the final beneficiary, and the parties to the contract must arrange for disclosure to be made only once.
  • The new notion of indirect beneficiary (for benefits granted outside of agreements). The direct beneficiary must inform the life sciences company of possible indirect beneficiaries, for example, relatives, or groups of which the direct beneficiary is a member.
  • The disclosure of the amount of the agreement.  This relates to the financial information included in an agreement, and the amount foreseen at the moment of its signature. If the agreement is amended, a revised declaration (and disclosure) is necessary.
  • The disclosure of remunerations. This relates to remunerations that are paid/disbursed to the relevant healthcare actor, which can be the net/gross remuneration, including or excluding taxes.

The circular further confirms (in clearer terms than the previous circular) that the transparency obligations apply to life sciences companies when the agreement or benefit concerns a healthcare actor based in France, regardless of whether they are headquartered in France or manufacture or distribute products in France.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, June 2017 Issue (Thomson Reuters).