Q&As

Are there any rules that dictate a strict separation of the medical and commercial roles in a pharmaceutical company, particularly with a view to avoiding the risk of such company being accused of 'off-label' promotion?

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Published on LexisPSL on 17/10/2017

The following Life Sciences Q&A provides comprehensive and up to date legal information covering:

  • Are there any rules that dictate a strict separation of the medical and commercial roles in a pharmaceutical company, particularly with a view to avoiding the risk of such company being accused of 'off-label' promotion?
  • Notion of ‘promotion’ and prohibition of off-label promotion
  • The distinction between ‘promotion’ and ‘scientific information’
  • Importance of independence of medical and commercial staff
  • Obligations of medical sales representatives

A clear separation should be maintained between medical and commercial teams. No sales personnel should ever be involved in the delivery of scientific information that could be interpreted as off-label promotion. Medical personnel should, however, be involved in the training of commercial staff and in the review of commercial messaging to ensure its medical accuracy and completeness.

Notion of ‘promotion’ and prohibition of off-label promotion

'Advertising' (ie, promotion) of pharmaceutical products is defined in Article 86(1) of Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code as: ‘any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products’. Article 87 of Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code requires that all parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics (the SMPC). Consequently, any advertising that is not in line with the SMPC (ie, 'off-label') is prohibited. This principle is reinforced in industry self-regulatory codes of conduct, namely the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code on the Promotion of Prescription-only Medicine to and Interactions with, Healthcare Professionals (EFPIA Code) and the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry (ABPI Code).

The distinction between ‘promotion’ and ‘scientific information’

It is accepted in the EU that not all messages delivered by

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