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French HAS publishes revised certification standard for promotional activities involving healthcare professionals

The High Health Authority (HAS) has published a revised certification standard for information activities aimed at the promotion of medicinal products through canvassing or sales prospecting (référentiel de certification de l'activité d'information par démarchage ou prospection visant a la promotion des médicaments).

Since 2004, the HAS has required that promotional activities of pharmaceutical companies vis-à-vis healthcare professionals – known as "medical visits" (visites médicales) – with respect to reimbursed medicinal products must be certified (in accordance with the HAS certification standard). The principles of the standard correspond with the quality charter regarding medical visits (Charte de qualité de la visite médicale) signed by the pharmaceutical industry association, LEEM, and the French pricing authority, CEPS. The quality charter defines in particular the principles that pharmaceutical companies must respect in relation to information provided to healthcare professionals, the training of sales representatives, and ethics more generally (for example, the prohibition of gifts and benefits).

The update of the HAS standard, which complements an earlier update in 2016, follows the 2014 revision of the quality charter, and extends the certification to all promotional activities:

  • Regardless of their form (for example, including any promotion by telephone or mail) or location.
  • To all healthcare professionals prescribing, using or dispensing medicinal products (no longer limited to physicians, hospital pharmacists and hospital nurses).
  • Irrespective of the person promoting the medicinal product (not only "medical representatives" but also subcontractors or people occasionally promoting medicines).

The standard also reinforces the quality of the organisation of medical visits to healthcare facilities and of the information that must be provided to healthcare professionals, for example, safety data must systematically be provided.

By the end of 2017, the HAS will publish an impact assessment of pharmaceutical companies' promotional activities on prescriptions issued by healthcare professionals.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2017 Issue (Thomson Reuters).

This post was originally co-authored by Patricia Carmona Botana.

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