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Client Alert - French Sunshine Act

Client Alert - French Sunshine Act

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Published by Stradling
On May 21, 2013 France issued a decree implementing French Law No. 2011-2012 on the Strengthening of Health Protection for Medicinal and Health Products, known as the Loi Bertrand or the French Sunshine Act (“the Decree”). The Decree imposes a general disclosure obligation on any company manufacturing or marketing pharmaceuticals, medical devices, and cosmetics in France.
On May 21, 2013 France issued a decree implementing French Law No. 2011-2012 on the Strengthening of Health Protection for Medicinal and Health Products, known as the Loi Bertrand or the French Sunshine Act (“the Decree”). The Decree imposes a general disclosure obligation on any company manufacturing or marketing pharmaceuticals, medical devices, and cosmetics in France.

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Categories:Types, Business/Law
Published by: Stradling on Jun 05, 2013
Copyright:Attribution Non-commercial

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07/20/2013

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COPYRIGHT©2013 STRADLING YOCCA CARLSON & RAUTH, P.C.
 
 Authors
:
Kathleen MarcusChair, Compliance Practice
(949) 725-4080kmarcus@sycr.com
Jason de Bretteville
(949) 725-4095 jdebretteville@sycr.com
Susan Tran
(949) 725-4083stran@sycr.com
May 29, 2013 sycr.com
 
French Sunshine Act Requires Immediate Action
BRIEF SUMMARY
 
On May 21, 2013 France issued a decree implementing French Law No. 2011-2012 on theStrengthening of Health Protection for Medicinal and Health Products, known as the LoiBertrand or the French Sunshine Act (“the Decree”). The Decree imposes a generaldisclosure obligation on any company manufacturing or marketing pharmaceuticals,medical devices, and cosmetics in France.The Decree includes
 retroactive
disclosure obligations that apply to all benefits granted and agreements signed since
January 1, 2012
. Companies must transmit the information for 2012 to the National Council of the relevant health profession, such as the National MedicalAssociation, before
June 1, 2013
. The information must be published on companywebsites before
October 1, 2013
. The Decree includes the imposition of severe penaltiesfor failing to timely disclose the relevant data.
TO WHOM DO THE REPORTING REQUIREMENTS APPLY?
The Decree affects a broad range of health care companies, including any companymanufacturing or distributing any of the categories of products listed in Article L 5311-1 of the French Code of Public Health
1
(“Covered Companies”). These include companiesmanufacturing or distributing medicines, medical devices, cosmetic products, contact lensesand tattoo products. A Covered Company is subject to the Decree even if its products arenot eligible for social security reimbursement.Covered Companies must report and publish both benefits granted and agreement details, inFrench, with covered recipients. The Decree covers a broad range of recipients, includinghealthcare professionals (“HCPs”), associations of HCPs, medical students, patientassociations, hospitals, nonprofit associations, providers of medical software, consultingcompanies which advise on health products, companies running a press, radio, television or online public communication service or legal entities providing or participating in thetraining of healthcare professionals (“Covered Recipients”).
1
Article L 5311-1 covers: Drugs including insecticides, acaricides, pest control human products,compound, hospital and pharmaceutical preparations, narcotic substances, psychotropic or  poisonous substances, essential oils, medicinal plants, raw materials
Contraceptive or contragestive products
Biomaterials and medical devices
In vitro diagnostics medical devices
 
Labile blood products
Human or animal organ tissue or cell
Therapeutic cells products
 
Breast milk 
Contacts lenses products
Products for disinfecting sanitary rooms and vehicles
 
Ancillary therapeutic products
 
 Non-corrective contact lenses
Cosmetic products
Micro-organism and toxin products
Tattoo products
Software
Devices that are not medicallynecessary but are used in medical biology laboratories to perform medical biology tests.
 
 
COPYRIGHT©2013 STRADLING YOCCA CARLSON & RAUTH, P.C.
 
WHAT MUST BE REPORTED?
Benefits Granted by Companies to Covered Recipients
The Decree mandates disclosures of any benefit in cash or kind valued at over 10 euros,including VAT (value added tax), given to a Covered Recipient. Under French PublicHealth Law, the term “benefits” encompasses any form of payment or hospitality, including payment of a contractual fee. Benefits must be reported whether they are granted directlyor indirectly to a Covered Recipient from a Covered Company, even where the Covered Recipient gives consideration or services in return for that benefit.The Covered Company must report: (1) the name and address of the Covered Recipient; (ii)the amount of the benefit; and (iii) the date and nature of the benefit.
Agreements Signed Between Companies and Covered Recipients
The Decree sets out the information that must be disclosed by Covered Companiesregarding agreements with Covered Recipients. This includes: (1) the name and address of the parties; (ii) the date the contract is signed; (iii) the purpose of the contract; and (iv) theagenda for the event, if the contract is for hospitality related to a scientific or promotionalevent.
Exemptions
Agreements governed by the French Code of Commerce for the purchase of goods areexpressly excluded from disclosure. This exclusion only applies to a sale by the Covered Company of its goods and not the provision of services by the Covered Recipient to theCovered Company.In reporting the purpose of the contract, trade or industrial secrets shall not be disclosed.Companies manufacturing or marketing cosmetic products, contact lenses and tattoo products need only publish the key elements of clinical trial agreements or agreementsrelated to safety evaluations. For example, those companies do not need to discloseagreements not related to hospitality or advisory boards.
WHEN DOES DATA COLLECTION BEGIN?
Transitional Period
Importantly, the Decree applies retroactively and requires that companies disclose all benefits and agreement details from the
2012 calendar year
by
June 1, 2013
.As previously noted, to comply with the Decree, Covered Companies must: (1) submit thedata to the National Council of the relevant health profession and (2) post the disclosures onthe Covered Company’s website, a website shared with other companies or via the websiteof the relevant industry association. Until the adoption of the national website, which will publish all the transparency data, the Decree also requires the National Council of therelevant health profession and Covered Companies to publish the information on their websites by
October 1, 2013
.

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