On Wednesday April 20, 2022, our 3rd Lunchwork of the year took place. On the occasion of this lunchtime event, accessible free of charge to our ATESSIA INTELLIGENCE subscribers and having gathered more than 70 participants from many pharmaceutical companies and DM manufacturers, we had the pleasure to welcome the LEXCASE for a presentation dedicated to the new French Quality Charter of professional practices for reimbursable products and services.
Diane BANDON-TOURRET, Associate Lawyer, Victoire STORKSEN, Lawyer, and Lucie CLOUIN-MOTHE, Director of Operations of ATESSIA, gave an update on the new obligations, the stakes and what has still to be precised, in the management of this major turning point for the practices applied to the marketing of reimbursable products and services in France, especially medical devices.
After a review of the origins of the system, the history of the difficult negotiations between the various stakeholders, and the establishment of the legal framework, the speakers discussed the current status of the work of drafting the certification guide and the timeframe for implementation.
While stressing that all the texts are not yet available and that many things remain unclear, the speakers detailed the scope, the operators and products concerned and excluded, the semantic analysis and the definition of terms and of the different roles according to the new Charter, as well as the possible financial penalties.
Although it is possible to draw parallels with the Charter applicable to medicines in France, the two systems are clearly different in many respects. This observation can be made in many areas, such as the rules for organizing visits, the for ethics and for distributing samples. In this context, the simultaneous management of two Charters, with sometimes contradictory injunctions or additional restrictive terms, is likely to become a challenge for the companies that will be subject to both systems, beyond possible inequities between competitors who, due to their product portfolios, would not be subject to the equivalent requirements.
While waiting for more details, one thing to remember is that the Charter already applies, and even if many actions can only be undertaken once the entire system has been clarified and the certification guide is not yet available, there are already applicable measures! ATESSIA can assist you in setting up and adapting your processes to comply with these new standards.
Article written by Raphaël DAUVERGNE, Regulatory and Pharmaceutical Affairs Advisor