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Uncertainty Remains Pending Modifications to French Sunshine Regulations

29 July 2015
On 24 February 2015 the French Administrative Supreme Court cancelled parts of the French sunshine regulations, and of a related governmental interpretative document. Pursuant to this decision, French sunshine regulations could be construed as requiring the industry to disclose fees paid under agreements with HCPs and with other stakeholders concerned by the regulations. This decision created uncertainty as to how to comply with this new situation, and whether reporting had to be retroactive.   The position of the French Ministry of Health's Direction Générale de la Santé (DGS) in relation to this decision was brought to light in a letter dated 16 July 2015 sent to various industry bodies (including the French Pharmaceutical Industry Association (LEEM) and the French Association of Medical Device manufacturers (SNITEM)).   According to the DGS, the industry must update its sunshine reporting to include fees paid to the stakeholders in all agreements falling under the scope of the sunshine regulations i.e. agreements entered into (or being in effect) as from 1 January 2012.   The DGS' position further maintains the current uncertainty around the regulations, especially in a context where new upcoming French health regulations are supposed to shed light on the manner in which fees are to be reported. These new regulations are expected to be enacted by the end of 2015. In the meantime, French industry associations have responded and challenged the DGS' position.

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