Constitution and Procedure - Can the Panel's ruling be changed?

  • 7

    Clause 7 - Information, Claims and Comparisons

    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.

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    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.
    • Supplementary information
    • Clause 7.3 Comparisons

    7.4 Any information, claim or comparison must be capable of substantiation.

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    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.

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    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.

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    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.

    Clause 7 General Supplementary Information

    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.

​​​It is sometimes the case that, having been informed of the Code of Practice Panel’s ruling in a case, one or other of the parties will request further information from the Panel as to the reasoning behind its ruling. Occasionally amendments to the Panel ruling might be suggested.

Once the Panel has completed its consideration of a case and informed the parties of the outcome, it has no further role to play in that case. The Panel ruling provides a complete account of the factors in the case that the Panel considered were important in making its ruling. There is no provision in the Constitution and Procedure for the Panel to comment on the reasoning set out in its ruling. Similarly there is no way for the Panel ruling to be changed.

If either party considers that the Panel has made the wrong ruling for whatever reason then their only recourse is to appeal.

See the Constitution and Procedure in the Code of Practice