The CEPS (French Health Products Economic Committee) and LEEM (French Pharmaceutical Industry Association) signed on 15 October 2014 a new Charter on information provided for promotional purposes via solicitation or prospection. This charter had been in discussions since 2013. It replaces and broadens the scope of the previous charter applicable to medical representatives’ activities.
The Charter sets out conditions under which employees of pharmaceutical companies, and their service providers, carry out solicitation and prospection activities in the context of the promotion of pharmaceutical products.
The Charter sets out conditions relating to:
- the missions of the persons carrying out the promotional activities, and their supervision;
- the quality of the information provided; and
The conditions applicable to missions of the persons carrying out promotional activities are not fundamentally altered compared to the previous charter. A key innovation is the increased focus on off-label prescriptions. The authorities may require the companies to disseminate information reminding prescribers of the appropriate prescription of products, and this task can be allocated to the persons carrying out the promotional activities. These persons must also report any off-label practices that they have noted, which is consistent with the requirements imposed by French regulations on the industry as regards prevention of off-label prescription.
As regards the quality of the information provided, the Charter sets out a series of requirements which derive from advertising regulations and the French authorities’ recommendations. These relate in particular to the drafting of promotional documentation, use of scientific literature and comparative advertising. Ensuring the quality of the information also requires appropriate training of the persons dedicated to the promotional activities. The Charter provides details on the training requirements, and the manner in which the company must organise and document compliance with such requirements.
Ethics rules include conditions on how visits made to HCPs and to health institutions must be organized and implemented. The Charter also summarises restrictions and disclosure obligations applicable to hospitality, gifts and samples, in line with French anti-benefits and sunshine regulations. In addition to prohibiting the provision of samples of medicines, the Charter provides that samples of cosmetics products, food supplements and medical devices (except medical devices for evaluation purposes) cannot be handed over if the person is also promoting medicines.
The responsible pharmacist, as per the previous charter, has overall responsibility for supervising compliance with the Charter, including with regard to the content of the disseminated information and procedures put in place to ensure effective compliance with the Charter.
The Charter provides for a national observatory for promotional information established by the CEPS and LEEM. Companies will have to carry out an annual study aimed at measuring the quality of their promotional practices for their most promoted product (and up to 2 other products requested by the CEPS). The study data will be used to collate an annual report. The data collected will contribute to the CEPS assessment on limitations on the evolution of promotional activities that it may wish to impose on the industry (for certain pharmacotherapeutic groups or certain products).
The Charter is effective as from 15 October 2014. However, some of its provisions cannot be implemented as such right away: compliance with the Charter requires a certification by the companies with terms of reference set by the French National Authority for Health (HAS). The current terms of reference applicable to the previous charter will need to be updated to take into account the new Charter.