Medical promotion : how is it regulated?

 

According to article L. 5122-1 of the French Public Health Code, medical promotion is defined as any form of information, including canvassing, or inducement, which is intended to promote the prescription, delivery, sale or consumption of these drugs. The advertising of medicines is closely supervised. It is subject to control by the French National Agency for the Safety of Medicines and Health Products (ANSM). In France, it is forbidden to advertise drugs reimbursed by the Social Security and/or drugs on a list of poisonous substances to health professionals without following certain rules (1). Pharmaceutical companies inform healthcare professionals about their treatments mainly through medical sales calls, which are governed by the Medical Sales Call Charter. Other communication channels are used, such as the medical press and the new media.

How is medical promotion regulated? We tell you everything...

 

Advertising of medicines to healthcare professionals is subject to prior approval by the ANSM

For all medicines, whether or not they are subject to medical prescription, all promotional documents intended for health professionals are subject to a priori control by the ANSM, i.e. before any distribution. Applications for approval are evaluated within a period of 2 months, starting from the day following the end of the submission period. The absence of a response from the ANSM at the end of this period is equivalent to tacit agreement and results in a PM visa, which is valid for 2 years (2).

 

Advertising of medicinal products to the general public is also subject to prior authorization by the ANSM

As with advertising of medicinal products to healthcare professionals, advertising of medicinal products to the general public is also subject to prior control by the ANSM before any distribution. The request for prior authorization results in the issuance of a GP visa valid for 2 years. It should be noted that advertising to the general public is only authorized for certain health products. These are medicines not subject to compulsory medical prescription and not reimbursed by Social Security, vaccines and smoking cessation products (2).

 

The objective of the a priori control by the ANSM is to secure the promotional message

The aim of the a priori control is to secure the promotional message which, on the one hand, must be objective and, on the other hand, must encourage the proper use of medicines so as not to induce bad prescribing or use habits (3). A list of types of promotional material exists and can be consulted on the ANSM website (4). These are mainly visit aids, press advertisements, offprints, brochures, light information documents, fact sheets, slide shows, films, posters and prescription pads (non-exhaustive list).

 

Pharmaceutical companies must have an advertising department

Pharmaceutical companies are required to have an advertising department. This department is under the control of the pharmacist in charge, who ensures compliance with the provisions of the Public Health Code governing drug advertising, and in particular the scientific validity of the information disseminated in these promotional documents (5).

Drug advertising is highly regulated by the ANSM. Promotional documents intended for healthcare professionals and the general public are subject to an a priori approval, without which these documents cannot be distributed. Within the operating pharmaceutical establishment, it is the Responsible Pharmacist who ensures the scientific validity of the information and the regulatory compliance of the documents with regard to the rules governing pharmaceutical advertising.

 

Bibliographical references :

  1. https://www.leem.org/publicite-pour-les-medicaments-les-regles
  2. https://ansm.sante.fr/vos-demarches/industriel/modalites-encadrant-les-demandes-de-visa-de-publicite-pour-les-medicaments-gp-pm
  3. https://ansm.sante.fr/page/le-controle-de-la-publicite-des-medicaments
  4. https://ansm.sante.fr/documents/reference/quels-supports-peuvent-etre-utilises-en-publicite
  5. https://www.has-sante.fr/upload/docs/application/pdf/2013-04/description_de_la_regulation_de_la_promotion_des_produits_de_sante_-_2013.pdf