Clause 7 - Information, Claims and Comparisons

​7.1 Upon reasonable request, a company must promptly provide members of the health professions and other relevant decision makers 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:

• it is not misleading
• medicines or services for the same needs or intended for the same purpose are compared
• one or more material, relevant, substantiable and representative features are compared
• no confusion is created between the medicine advertised and that of a competitor or between the advertiser’s trade marks, trade names, other distinguishing marks and those of a competitor
• the trade marks, trade names, other distinguishing marks, medicines, services, activities or circumstances of a competitor are not discredited or denigrated
• no unfair advantage is taken of the reputation of a trade mark, trade name or other distinguishing marks of a competitor
• medicines or services are not presented as imitations or replicas of goods or services bearing a competitor’s trade mark or trade name.

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 other relevant decision makers.

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 other relevant decision makers.

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 adverse reactions must reflect available evidence or be capable of substantiation by clinical experience. It must not be stated that a product has no adverse reactions, 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 promoted, for more than twelve months in the UK.

​Clause 7 Supplementary Information

Clause 7 General

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.

Clause 7.2 Misleading Information, Claims and Comparisons

The following are areas where particular care should be taken by companies:

• claims for superior potency in relation to weight are generally meaningless and best avoided unless they can be linked with some practical advantage, for example, reduction in adverse reactions or cost of effective dosage
• the use of data derived from in-vitro studies, studies in healthy volunteers and in animals. Care must be taken with the use of such data so as not to mislead as to its significance. The extrapolation of such data to the clinical situation should only be made where there is data to show that it is of direct relevance and significance
• reference to absolute risk and relative risk. Referring only to relative risk, especially with regard to risk reduction, can make a medicine appear more effective than it actually is. In order to assess the clinical impact of an outcome, the reader also needs to know the absolute risk involved. In that regard relative risk should never be referred to without also referring to the absolute risk. Absolute risk can be referred to in isolation
• economic evaluation of medicines. Care must be taken that any claim involving the economic evaluation of a medicine is borne out by the data available and does not exaggerate its significance
  To be acceptable as the basis of promotional claims, the assumptions made in an economic evaluation must be clinically appropriate and consistent with the marketing authorization
• emerging clinical or scientific opinion. Where a clinical or scientific issue exists which has not been resolved in favour of one generally accepted viewpoint, particular care must be taken to ensure that the issue is treated in a balanced manner in promotional material
• hanging comparisons whereby a medicine is described as being better or stronger or suchlike without stating that with which the medicine is compared must not be made
• price comparisons. Price comparisons, as with any comparison, must be accurate, fair and must not mislead. Valid comparisons can only be made where like is compared with like. It follows therefore that a price comparison should be made on the basis of the equivalent dosage requirement for the same indications. For example, to compare the cost per ml for topical preparations is likely to mislead unless it can be shown that their usage rates are similar or, where this is not possible, for the comparison to be qualified in such a way as to indicate that usage rates may vary
  
• statistical information. Care must be taken to ensure that there is a sound statistical basis for all information, claims and comparisons in promotional material. Differences which do not reach statistical significance must not be presented in such a way as to mislead
  
  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.
  

Clause 7.3 Comparisons

The Code does not preclude the use of other companies’ brand names when making comparisons.

Clause 7.5 Data from Clinical Trials

Companies must provide substantiation following a request for it, as set out in Clause 7.5. In addition, when data from a clinical trial is used companies must ensure that where necessary that trial has been registered and the results disclosed in accordance with Clause 13.1.

Clause 7.6 References

Clause 7.6 applies to references to published material, including the use of quotations, tables, graphs and artwork.

Clause 7.8 Artwork, Illustrations, Graphs and Tables

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 contra- indications. 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 significance must 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.

Clause 7.9 Use of the Word ‘Safe’

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.

Clause 7.10 Benefit/Risk Profile

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.

Clause 7.10 Superlatives

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.

Clause 7.10 Use of the Words ‘The’ and ‘Unique’

In certain circumstances ‘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.

Similarly, care needs to be taken with the use of ‘unique’. Although ‘unique’ may sometimes be used to describe some clearly defined special feature of a medicine, often 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.