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Regulatory background

 

Until the 1st of January, 2012, the French regulatory system for the certification of promotional materials defined 2 types of promotional control:

  • Promotional material for general public required a visa from AFSSAPS before use
  • Promotional material for health professionals required an auto-certification by the company before use

 

On the 29th of December 2012, among a lot of new provisions the law for reinforcement of health security for medicines and health products harmonized these 2 systems by creating a single visa for all type of promotional materials.

New provisions

The legislation concerning the strengthening of the safety for drug and health products introduced three new provisions to control advertising.

The main provision concerns the introduction of a new article L.5122-9 of the Code de la Santé Publique (CSp, Code of Public Health), which provides that “advertising for a drug to a health professional authorized to prescribe or dispense medicines or to use them in the exercise of his art is subject to prior authorization of the national Security Agency of Medicines and health Products, called advertising visa.

Thus, as well as advertising to the general public, advertising to health professionals will be subject to obtaining a visa in advance. It will be issued for a period not exceeding the duration of the marketing authorization.

On the same model as the visa for advertising to the General Public (GP visa), these visa applications are submitted to the National Agency according to a schedule determined by the director of the Agency (Article L.5122-9-1 CSp).

The current Article L.5122-3 of the Code of Public Health stipulating that only drugs with marketing authorization may be advertised is also subject to change. Thus, it is now stated that “advertising is not permitted for a drug when the drug is subject to a reassessment of the benefits/risks ratio as a result of a pharmacovigilance report“. In addition, health professionals should be informed by the commercial life science company of the revaluation carried out in this framework.

 

 

The new visa process

On the 9th of May 2012, a decree gave details about the new process to get a visa from ANSM[1], the French competent Authority.

The applicant must fill in 2 forms:

  • One describing the context of use for the promotional material
  • One listing the bibliographic references used in this material

These forms (including a sample of the promotional material, a copy of the bibliographic references and the fees) are submitted during fixed submission periods all over the year (about 4 or 5 per year).

If ANSM do not send a refusal letter to the applicant past a 2 months period, the visa is considered as granted.

The visa number has to be printed on the material. This visa will stay valid for 2 years.

In case of health emergency, the pharmaceutical company can circulate a promotional material without a visa. However, this document will have to be submitted to ANSM for the next submission period.

 

Which practical impacts?

A new imperative, the planning of documents to validate

In practice, the implementation of prior control for advertising to health professionals will require a review of the validation process for these promotional materials, bearing in mind two goals:

  • Organize and plan the provision to sales forces of these documents in relation to the timing of future meetings of the committee in charge of assigning these visas
  • Ensure compliance with deadlines for validation of these documents to ensure that visa applications will be filed in a timely manner

Indeed, any delay in the validation of these documents will expose the laboratory to the risk of not being able to use its document having failed to obtain a visa in time. Thus, the compliance with deadlines and planning will become critical elements of the process of promotional validation.

In addition, this new system of prior control will likely lead to reconsider the terms of advertising to health professionals and, in particular, to reduce the number of promotional materials used. This will require optimization of promotional materials available both in qualitative and quantitative terms.

 

An even closer link to the monitoring of pharmacovigilance reports

According to this law, laboratories can no longer advertise for a drug which risk-benefit ratio is being reassessed.

As a result regulatory services in charge of promotional control shall be informed, in a timely manner, of any reassessment of the benefit-risk ratio underway for a drug, in order to:

  • be able to identify very quickly:
    • Promotional materials currently being validated and that are impacted
    • Promotional materials already distributed, with a view to stop them or even to recall them
  • To take a decision (stop, withdrawal, recall)

 



[1] ANSM : Agence Nationale de Sécurité du Médicament et des produits de santé is the new name of AFSSAPS since 2012.

 

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