In March 2022, the Quality Charter for Professional Practices was published to provide a framework for the presentation, information and promotion of medical devices for individual use, health products other than medicinal products and any associated services. The publication of the Quality Charter for Professional Practices marks a turning point in the supervision of commercial and promotional practices, with the aim of guaranteeing transparent information that complies with quality requirements in the field of medical devices and associated services.
A strengthened regulatory framework
This charter, published by decree in the Official Journal on 8 March 2022, is part of an initiative to regulate promotional practices for healthcare products. It was drawn up in consultation with the “Comité économique des produits de santé” (CEPS) and the sector’s professional organisations. Its main objective is to provide a better framework for interactions between healthcare professionals and companies marketing or distributing medical devices or associated services included on the list of reimbursable products and services (LPP).
The charter applies to all products and services listed on the LPP, used in towns and in healthcare and medico-social establishments, under both brand names and generic descriptions.
The charter imposes several essential rules to guarantee reliable and ethical information:
– Control of promotional visits: A threshold is proposed for the frequency of visits to healthcare professionals in order to avoid excessive commercial pressure.
– Transparency of information: obligation to provide exhaustive data on the proper use of products.
– Certification of practices: commitment by manufacturers, operators and distributors to respect the principles of the charter and to join a certification process.
On the basis of this text, the French National Authority for Health (HAS) is drawing up a set of guidelines with a view to the implementation, by accredited bodies, of a certification audit procedure for the practices of economic operators.
But with all this:
What can companies give doctors, and what should companies give them? And above all, how should medical sales representatives be trained? How often? How do you declare a conference with a speaker?
ATESSIA can help you decipher these regulations, prepare for your internal audits, audits of your subcontractors, certification audits, draw up procedures or train your teams in the field.
Sandrine DE SOUSA, Senior Advisor Compliance and Quality of External Communications