French Sunshine Act Equivalent published
The French Government has yesterday (Wednesday 22 May 2013) published the Transparency Decree (n° 2013-414), which details the legal requirements of the French equivalent of the US Sunshine Act deriving from the Bertrand law n° 2011-2012 dated 29 December 2011.
The new article L.1453-1 of the French Public Health Code imposes a general disclosure obligation on any company manufacturing or comercializing health products or services.
Major provisions are:
- The Decree sets out the information that must be disclosed by life sciences companies regarding contracts that they sign with healthcare professionals and students training to become healthcare professionals (HCP). This includes the name and address of the parties, date the contract is signed, purpose of the contract, and if the contract is for hospitality, the agenda for the event.
- Contracts governed by the French Code of commerce, for the purpose of the purchase of goods or services, are expressly excluded from disclosure. This exclusion only applies only to the sale by the company of its goods and services and NOT the provision of services by the HCP to the company.
- Trade or industrial secrets shall not be disclosed.
- Information on signed contracts must be disclosed within 15 days of the date of signature.
- The transparency rules apply to any benefit in cash or in kind, granted directly or indirectly to health care professionals from life sciences companies, even where the professional gives consideration or services in return for that benefit.
- Benefits which are outside the threshold of 10 euros, including VAT, must be disclosed.
- The name, address of the beneficiary and amount of the benefit must be disclosed.
- Information must be disclosed within six months, on the next occurring 1st August or 1st February at the latest.
- Information must be disclosed, in French, (i) through a public website, which requires the publication of an Order from the Ministry of Health, and (ii) to the professional association regulating the recipient of the benefit.
- Before implementation of the National Internet website, information must be disclosed (i) on the website of the professional association regulating the recipient and (ii) on the website of the life sciences company.
- The disclosure obligations apply retrospectively to contracts signed and benefits granted during 2012, an onerous provision for companies.
- This retrospective information must be disclosed no later than 1st June 2013.
- Information is kept in the public domain on the website for a period of at least 5 years.