What are the expectations with regard to using data on file?

  • 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.

    MOST RECENT CASES See all  Applicable Code year

    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.

    MOST RECENT CASES See all Applicable Code year

    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.

    MOST RECENT CASES  See all  Applicable Code year

    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.

    MOST RECENT CASES See all Applicable Code year

    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.

  • 7.4

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

  • 14

    Clause 14 - Certification and Examination

    14.1 Promotional material must not be issued unless its final form, to which no subsequent amendments will be made, has been certified by one person on behalf of the company in the manner provided for by this clause, subject to the provisions of the supplementary information to this clause where relevant. This person must be a registered medical practitioner or a pharmacist registered in the UK or alternatively, in the case of a product for dental use only, a UK registered dentist.

    The person certifying on behalf of the company must not be the person responsible for developing or drawing up the material.

    An acceptable way to comply with Clause 14.1 is for the final proof to be certified but this is not obligatory provided that that which is certified is in its final form to which no subsequent amendments will be made. Companies may use validated electronic signatures for certifying material. Paper or electronic copies of certificates and the final form of material etc must be preserved in order to comply with Clause 14.6.

    When certifying material where the final form is to be printed companies can certify the final electronic version of the item to which no subsequent amendments will be made. When such material is printed the company must ensure that the printed material cannot be used until an appropriately qualified person has checked and signed the item in its final form. In such circumstances the material will have two certificates and both must be preserved.

    All promotional material must be certified in this way including audio and audio-visual material, promotional material on databases, interactive data systems and the Internet and relevant representatives’ briefing materials. Promotional aids must also be certified. Although not strictly promotional material they are used for a promotional purpose.

    Account should be taken of the fact that a non-promotional item can be used for a promotional purpose and therefore come within the scope of the Code.

    In certifying audio and audio-visual material and promotional material on databases, interactive systems and the Internet, companies must ensure that a written transcript of the material is certified including reproductions of any graphs, tables and the like that appear in it. In the event of a complaint, a copy of the written material will be requested. Alternatively, companies may certify material on interactive systems by means of producing an electronic copy, for example on a CD Rom or data stick, if the electronic copy is write protected and unable to be changed.

    The guidelines on company procedures relating to the Code (on page 54 of the printed Code) give further information on certification.

    See also the supplementary information to Clause 3 on promotion at international conferences regarding the certification of such material.

    • Clause 14.1 Certifying Digital Material
    • Clause 14.1 Suitable Qualifications for Signatories
    • Clause 14.1 Joint Ventures and Co-Promotion

    MOST RECENT CASES  See all  Applicable Code year

    14.2 All meetings involving travel outside the UK, unless the company’s only involvement is to support a speaker to present at the meeting, must be certified in advance by an appropriately qualified person. That person does not need to be either a registered medical practitioner or a UK registered pharmacist.

    14.3 The following must be certified in advance in a manner similar to that provided for by Clause 14.1:

    • educational material for the public or patients issued by companies which relates to diseases or medicines but is not intended as promotion for those medicines
    • material relating to working with patient organisations as described in Clause 27 and its supplementary information
    • material relating to joint working between the NHS and the pharmaceutical industry as described in Clause 20 and its supplementary information
    • material relating to patient support programmes involving the provision to health professionals of items to be passed on to patients as described in Clause 18.2 and its supplementary information
    • non-promotional material for patients or health professionals relating to the provision of medical and educational goods and services, including relevant internal company instructions, as described in Clause 1 and paragraph 8 of its supplementary information.
    • Supplementary information
    • Clause 14.3 Examination of Other Material
    • Clause 14.3 Non-Interventional Studies

    14.4 The names of those nominated as signatories as set out in Clauses 14.1 and 14.2, together with their qualifications, shall be notified in advance to
    the Advertising Standards Unit, Vigilance and Risk Management of Medicines of the Medicines and Healthcare products Regulatory Agency and to the  Prescription Medicines Code of Practice Authority. The names and qualifications of designated alternative signatories must also be given. Changes in the names of nominees must be promptly notified.

    14.5 The certificate for promotional material must certify that the signatories have examined the final form of the material and that in their belief it is in accordance with the requirements of the relevant regulations relating to advertising and this Code, is not inconsistent with the marketing authorization and the summary of product characteristics and is a fair and truthful presentation of the facts about the medicine.

    The certificates for material covered by Clause 14.3 above must certify that the signatories have examined the final form of the material and that in their belief it complies with the Code.

    Material which is still in use must be recertified at intervals of no more than two years to ensure that it continues to conform with the relevant regulations relating to advertising and the Code.

    The certificate for meetings involving travel outside the UK must certify that the signatories have examined all the proposed arrangements for the meeting and that in their belief the arrangements are in accordance with the relevant regulations relating to advertising and the Code.

    MOST RECENT CASES See all Applicable Code year

    14.6 Companies shall preserve all certificates. In relation to certificates for promotional material, the material in the form certified and information indicating the persons to whom it was addressed, the method of dissemination and the date of first dissemination must also be preserved. In relation to certificates for meetings involving travel outside the UK, details of the programme, the venue, the reasons for using the venue, the audience, the anticipated and actual costs and the nature of the hospitality and the like must also be preserved.

    Companies shall preserve certificates and the relevant accompanying information for not less than three years after the final use of the promotional material or the date of the meeting and produce them on request from the Medicines and Healthcare Products Regulatory Agency or the Prescription Medicines Code of Practice Authority.

    The certificates for material covered by Clause 14.3 above shall be preserved for not less that three years after the final use of the material and companies shall produce them on request from the Medicines and Healthcare Products Regulatory Agency or the Prescription Medicines Code of Practice Authority.

     

Claims, comparisons etc must be capable of substantiation as required by Clause 7.4.

When reviewing data on file companies should be confident it is consistent with the summary of product characteristics.

There is an expectation that the results are not dissimilar to those in the registration trials. Care needs to be taken to ensure the data on file meets all other requirements of the Code including Clause 7.

Guidance
2021 Q&As by Topic OR Clause