If a representative gained agreement to deliver approved risk minimisation materials to a health professional and then used this as an opportunity to promote medicines to the health professional would this be acceptable?

  • 1.2

    1.2 The term promotion means any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines. It includes:

    • journal and direct mail advertising
    • the activities of representatives including any electronic or printed material used by them
    • the supply of samples
    • the provision of inducements to prescribe, supply, administer, recommend, buy or sell medicines by the gift, offer or promise of any benefit or bonus, whether in money or in kind
    • the provision of hospitality for promotional purposes
    • the sponsorship of promotional meetings
    • the sponsorship of scientific meetings including payment of travelling and accommodation expenses in connection therewith
    • all other sales promotion in whatever form.

    It does not include:

    • replies made in response to individual enquiries from members of the health professions or other relevant decision makers or in response to specific communications from them whether of enquiry or comment, including letters published in professional journals, but only if they relate solely to the subject matter of the letter or enquiry, are accurate and do not mislead and are not promotional in nature
    • factual, accurate, informative announcements and reference material concerning licensed medicines and relating, for example, to pack changes, adverse reaction warnings, trade catalogues and price lists, provided they include no product claims
    • price lists relating to unlicensed medicines, provided they include no product claims and they make clear that the products are unlicensed
    • information supplied by pharmaceutical companies to national public organisations, such as the National Institute for Health and Care Excellence (NICE), the All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC) is exempt from the Code provided the information is factual, accurate and not misleading
    • measures or trade practices relating to prices, margins or discounts which were in regular use by a significant proportion of the pharmaceutical industry on 1 January 1993
    • summaries of product characteristics
    • European public assessment reports
    • Risk minimisation material
    • UK public assessment reports
    • the labelling on medicines and accompanying package leaflets insofar as they are not promotional for the medicines concerned; the contents of labels and package leaflets are covered by regulations
    • information relating to human health or diseases provided there is no reference, either direct or indirect, to specific medicines.
  • 12.1

    12.1 Promotional material and activities must not be disguised.

Risk minimisation materials might be required as part of a medicines marketing authorisation and a company might be required to provide certain risk minimisation materials to health professionals. If a representative were to deliver such material to a health professional and also use this as an opportunity to promote the medicine or any other medicine it would be likely that the company had not met the requirements of Clause 12.1 which states: 'Promotional material and activities must not be disguised'.