The Bertrand Act - Marketing is never going be the same again
Today, we'll make a short interruption in our MDR series with another regulation that marketers want to take into account when addressing the French market, namely the Bertrand Act.
While it has been out for quite some time now, we have met more and more puzzled clients with lots of questions concerning this bill. Let's try to clarify some basic concepts...
The French Sunshine Act, known as the Loi Bertrand1 entered into force in May 2013 and is part of a long and still in progress legislative process to bring up more transparency between healthcare practitioners and pharmaceutical and medical device manufacturers. It was completed by the Loi Touraine (Loi de modernisation de la santé) enacted on January 26th 2016 and the ordonnance of January 19th, 2017. More recently, an implementation decree has been released on December 2019 and more are awaited in the following months. Over the years, laws and decrees, rules have been tightened, definitions have been refined and the scope of companies and professionals that fall under the Act has been continuously broadened. The central point of the measure is to ban giving or receiving of any gift or financial incentives from pharmaceutical companies to healthcare professionals and this in order to avoid conflicts of interest. The governement ambition to enhance transparency and improve patient’s security has also lead in the new legislation to strengthen the legal frame for advertisement of pharmaceutical products and medical devices. Therefore, If you are marketing your product in France, you fall under the law as the Loi Bertrand is applicable to all companies operating on the French market, regardless of whether the company is based in France or working from outside of France.
If that is your case, all your marketing, brochures, leaflets, posters, website content… should comply with the French regulations on advertising of medical devices.
Article 34 of the Loi Bertrand defines advertisement as : any information that is used to promote prescription or dispension, sell or use of the device. Informing about the use is not considered as advertisement however using this information in order to promote the device falls under the legal frame.
The general rules regarding advertisement of medical device are :
Provide accurate description with objective information, clarity and verifiability
Comply with the list of mandatory information and forbidden statements
The advertisment cannot be misleading nor represent a threat to public health.
It cannot mention recommandations from scientists or healthcare practionners, nor refer to healing cases2
Regarding online advertising, The National Agency for the Safety of Medicines and Health Products (ANSM3), has published in march 2014, a detailed guideline4 for the creation of website contents that comply with the French law.
For certain types of medical devices, the advertising is subject to prior authorisation by the ANSM. The scope of application of the law varies, as showed in the table below, according to the :
type of public : health professionnals and general public/patients.
type of MD : the ones reimbursed by the French Social Security (even partially) and the ones that are not reimbursed.
type of category the device belongs to.
It is the ANSM that is responsible to check the compliance of the advertisement. These checks are performed prior or in hindsight, according to the device’s class category.
Questions regarding compliance of the advertisement can be addressed to the ANSM as they are the recipients of all authorisation applications.
Regardless of your source language applicable regulation and requirements, some adaptation might be needed in order to be compliant under the French law.
At Baguette Translations, we have helped over the years many medical device professionals in delivering marketing documentation adapted to the French market. Contact us to discuss your medical device marketing project in France.
Loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé
The complete text can be found here : https://www.legifrance.gouv.fr/affichCode.do?idArticle=LEGIARTI000025850597&idSectionTA=LEGISCTA000025856846&cidTexte=LEGITEXT000006072665&dateTexte=20170111
Agence Nationale de Sécurité du médicament et des produits de santé
Charte pour la communication et la promotion des produits de santé (médicaments et dispositifs médicaux) sur Internet et le e-media