This is the fourth post in a series written by guest blogger Jeremy Petitprez, a student at the Paris Bar School. Jeremy holds a master’s degree in pharmaceutical law from the Paris Law Faculty (Faculté de droit de Paris).
A new French law wants to strengthen the safety of drugs and medical products. Article 34 establishes new provisions concerning the advertisement of medical devices and in vitro diagnostic medical devices that pertain to any entity that makes, distributes, or imports medical devices. It redefines the rules for advertising content and for authorizing advertising for medical devices.
Two decrees outline the rules for the application of the article. They enter into effect January 1, 2013.
The first (Décret n° 2012-743 du 9 mai 2012 relatif à la publicité pour les dispositifs médicaux ) concerns medical devices.
- Article R.5213-1details rules for advertisements to the public. It stipulates that the advertising must be clear, the product must be identified clearly as a medical device, and notice of all advertising must contain mandatory minimal mentions. This excludes statements that are covered by public insurance and some other information.
- Article R.5213-2 details rules for advertisements to health care professionals. They must contain mandatory minimal mentions.
- Article R.5213-3 states that information must be exact, up to date, and sufficient for the public to understand intended use and for professionals to understand performance.
- Article R.5213-4 states that if an advertisement does not comply, the French agency for the security of health products (l’agence nationale de sécurité du médicament et des produits de santé [ANSM]) shall notify the manufacturer of the device to comply with the contents of the legislation. If the manufacturer does not respond to the request, the ad may be prohibited.
- Article R.5213-5 states that for a medical device posing high risk to human health and listed by the health minister, a request must be made to the ANSM for details regarding what kind of information its advertisement must contain.
- Article R. 5213-6 to-11 details the power of the head office of the ANSM on this authorization.
The second (Décret n° 2012-744 du 9 mai 2012 relatif à la publicité pour les dispositifs médicaux de diagnostic in vitro ) contains the same provisions but for in vitro medical devices (article R. 5223-1 to -11 Code de la santé publique).