7.1 Upon reasonable request, a company must promptly provide members of the health professions and appropriate administrative staff with accurate and relevant information about the medicines which the company markets.
7.2 Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly. They must not mislead either directly or by implication, by distortion, exaggeration or undue emphasis.
Material must be sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of the medicine.
7.3 A comparison is only permitted in promotional material if:
7.4 Any information, claim or comparison must be capable of substantiation.
7.5 Substantiation for any information, claim or comparison must be provided as soon as possible, and certainly within ten working days, at the request of members of the health professions or appropriate administrative staff.
The validity of indications approved in the marketing authorization can be substantiated by provision of the summary of product characteristics.
7.6 When promotional material refers to published studies, clear references must be given.
7.7 When promotional material refers to data on file, the relevant part of this data must be provided without delay at the request of members of the health professions or appropriate administrative staff.
7.8 All artwork including illustrations, graphs and tables must conform to the letter and spirit of the Code and, when taken from published studies, a reference must be given. Graphs and tables must be presented in such a way as to give a clear, fair, balanced view of the matters with which they deal, and must not be included unless they are relevant to the claims or comparisons being made.
7.9 Information and claims about side-effects must reflect available evidence or be capable of substantiation by clinical experience. It must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency. The word ‘safe’ must not be used without qualification.
7.10 Promotion must encourage the rational use of a medicine by presenting it objectively and without exaggerating its properties. Exaggerated or all-embracing claims must not be made and superlatives must not be used except for those limited circumstances where they relate to a clear fact about a medicine. Claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated.
7.11 The word ‘new’ must not be used to describe any product or presentation which has been generally available, or any therapeutic indication which has been generally promoted, for more than twelve months in the UK.
The application of this clause is not limited to information or claims of a medical or scientific nature. It includes, inter alia, information or claims relating to pricing and market share. Thus, for example, any claim relating to the market share of a
product must be substantiated without delay upon request as required under Clause 7.5.
It should be borne in mind that claims in promotional material must be capable of standing alone as regards accuracy etc. In general claims should not be qualified by the use of footnotes and the like.Back to top
The following are areas where particular care should be taken by companies:
Instances have occurred where claims have been based on published papers in which the arithmetic and/or statistical methodology was incorrect. Accordingly, before statistical information is included in promotional material it must have been subjected to statistical appraisal.
The Code does not preclude the use of other companies’ brand names when making comparisons.
Companies must provide substantiation following a request for it, as set out in Clause 7.5. In addition, when data from clinical trials is used companies must ensure that where necessary that data has been registered in accordance with the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 2008.
Clause 7.6 applies to references to published material, including the use of quotations, tables, graphs and other illustrative matters.
Care must be taken to ensure that artwork does not mislead as to the nature of a medicine or any claim or comparison and that it does not detract from any warnings or contraindications. For example, anatomical drawings used to show
results from a study must not exaggerate those results and depictions of children should not be used in relation to products not authorized for use in children in any way which might encourage such use.
Particular care should be taken with graphs and tables to ensure that they do not mislead, for example by their incompleteness or by the use of suppressed zeros or unusual scales. Differences which do not reach statistical significancemust not be presented in such a way as to mislead.
Graphs and tables must be adequately labelled so that the information presented can be readily understood. When taken from published studies, the source of the artwork must be given (see also Clause 7.6). If a graph, table or suchlike is taken from a published study it must be faithfully reproduced except where modification is needed in order to comply with the Code. In such circumstances it must be clearly stated that the material has been modified. Any such adaptation must not distort or mislead as to the significance of that graph, table etc. Care should be taken not to mislead when expressing data as percentages; patient numbers should be included wherever possible. It should also be noted that if a table, graph etc in a paper is unacceptable in terms of the requirements of the Code, because, for example, it gives a visually misleading impression as to the data shown, then it must not be used or reproduced in promotional material.
The restrictions on the word ‘safe’ apply equally to grammatical derivatives of the word such as ‘safety’. For example, ‘demonstrated safety’ or ‘proven safety’ are prohibited under this clause.
The benefit/risk profile of a medicine must be presented in promotional campaigns in such a way as to comply with the Code. Particular attention should be paid to Clauses 7.2, 7.9 and 7.10.
Superlatives are those grammatical expressions which denote the highest quality or degree, such as best, strongest, widest etc. A claim that a product was ‘the best’ treatment for a particular condition, for example, could not be substantiated as there are too many variables to enable such a sweeping claim to be proven. The use of a superlative is acceptable only if it can be substantiated as a simple statement of fact which can be very clearly demonstrated, such as that a particular medicine is the most widely prescribed in the UK for a certain condition, if this is not presented in a way which misleads as to its significance.
In certain circumstances the use of the word ‘the’ can imply a special merit, quality or property for a medicine which is unacceptable under this clause if it cannot be substantiated. For example, a claim that a product is ‘The analgesic’ implies that it is in effect the best, and might not be acceptable under this clause.
Similarly, great care needs to be taken with the use of the word ‘unique’. Although in some circumstances the word unique may be used to describe some clearly defined special feature of a medicine, in many instances it may simply imply a general superiority. In such instances it is not possible to substantiate the claim as the claim itself is so ill defined.