Clause 3 - Marketing Authorization

The promotion of medicines at international meetings held in the UK may on occasion pose certain problems with regard to medicines or indications for medicines which do not have a marketing authorization in the UK although they are so authorized in another major industrialised country.

The display and provision of promotional material for such medicines is permitted at international meetings in the UK provided that the following conditions are met:

• the meeting must be a truly international meeting of high scientific standing with a significant proportion of the attendees from countries outside the UK in which the product is licensed
• the medicine or indication must be relevant and proportional to the purpose of the meeting
• promotional material for a medicine or indication that does not have a UK marketing authorization must be clearly and prominently labelled to that effect
• in relation to an unlicensed indication, UK approved prescribing information must be readily available for a medicine authorized in the UK even though it will not refer to the unlicensed indication
• the names must be given of countries in which the medicine or indication is authorized which must include at least one major developed country and it must be stated that registration conditions differ from country to country
• the material is certified in accordance with Clause 14, except that the signatories need certify only that in their belief the material is a fair and truthful presentation of the facts about the medicine.

NHS organisations and others involved in the purchase of medicines need to estimate their likely budgets two to three years in advance in order to meet Treasury requirements and there is a need for them to receive advance information about the introduction of new medicines, or changes to existing medicines, which may significantly affect their level of expenditure during future years.

At the time this information is required, the medicines concerned (or the changes to them) will not be the subject of marketing authorizations (though applications will often have been made) and it would thus be contrary to the Code for them to be promoted. Information may, however, be provided on the following basis:

i) the information must relate to:
(a) a product which contains a new active substance, or
(b) a product which contains an active substance prepared in a new way, such as by the use of biotechnology, or
(c) a product which is to have a significant addition to the existing range of authorized indications, or
(d) a product which has a novel and innovative means of administration

ii) information should be directed to those responsible for making policy decisions on budgets rather than those expected to prescribe

iii) whether or not a new medicine or a change to an existing medicine is the subject of a marketing authorization in the UK must be made clear in advance information

iv) the likely cost and budgetary implications must be indicated and must be such that they will make significant differences to the likely expenditure of NHS organisations and others

v) only factual information must be provided which should be limited to that sufficient to provide an adequate but succinct account of the product’s properties; other products should only be mentioned to put the new product into context in the therapeutic area concerned

vi) the information may be attractively presented and printed but should not be in the style of promotional material – product specific logos should be avoided but company logos may be used; the brand name of the product may be included in moderation but it should not be stylised or used to excess

vii) the information provided should not include mock up drafts of either summaries of product characteristics or package leaflets

viii) if requested, further information may be supplied or a presentation made.

The promotion of indications not covered by the marketing authorization for a medicine is prohibited by this clause.