Originally published as Covington E-Alert on January 20, 2012
Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the “New Law”),creating Articles L. 1453-1 and L. 1454-3 to L. 1454-5 of the French Code of Public Health (“Code de la santé publique” or ‘CSP’)
On December 29, 2011, the French legislature adopted new rules imposing disclosure requirements on a broad section of the life sciences industry, including pharmaceutical, medical devices, and cosmetics companies as well as distributors. The rules also cover providers of related services and more specialised players such as entities marketing organs, tissues and cells, and certain software providers. Contractual arrangements with, or any benefits granted to, a wide range of healthcare actors, including healthcare professionals, hospitals, patient associations, or providers of medical software, must be disclosed; written and spoken press and online publications are also covered. Infringements are subject to criminal sanctions. Additional details will be set forth in an implementing decree (the ‘Decree’) which is not expected before late 2012. The new obligations will only become enforceable after the adoption of the Decree, but they may be retroactively applied to agreements and benefits as from 1 January 2012.
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