What needs to be certified or examined with respect to arrangements for health professionals etc who are delivering services under an agreement?

  • 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

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    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.

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    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.

     

  • 22.1

    ​​22.1 Companies must not provide hospitality to members of the health professions and other relevant decision makers except in association with scientific meetings, promotional meetings, scientific congresses and other such meetings, and training. Meetings must be held in appropriate venues conducive to the main purpose of the event. Hospitality must be strictly limited to the main purpose of the event and must be secondary to the purpose of the meeting ie subsistence only. The level of subsistence offered must be appropriate and not out of proportion to the occasion. The costs involved must not exceed that level which the recipients would normally adopt when paying for themselves. It must not extend beyond members of the health professions or other relevant decision makers.

  • 23

    Clause 23 - The Use of Consultants

    ​23.1 Health professionals and other relevant decision makers may be used as consultants and advisors, whether in groups or individually, for services such as speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration and/or travel. The arrangements which cover these genuine consultancy or other services must, to the extent relevant to the particular arrangement, fulfil all the following criteria:

    • a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services
    • a legitimate need for the services must be clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants
    • the criteria for selecting consultants must be directly related to the identified need and the persons responsible for selecting the consultants must have the expertise necessary to evaluate whether the particular consultants meet those criteria
    • the number of consultants retained must not be greater than the number reasonably necessary to achieve the identified need
    • the contracting company must maintain records concerning, and make appropriate use of, the services provided by consultants
    • the hiring of the consultant to provide the relevant service must not be an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
    • the compensation for the services must be reasonable and reflect the fair market value of the services provided. In this regard, token consultancy arrangements must not be used to justify compensating health professionals and other relevant decision makers
    • in their written contracts or agreements with consultants, companies must include provisions regarding the obligation of the consultant to declare that he/she is a consultant to the company whenever he/she writes or speaks in public about a matter that is the subject of the agreement or any other issue relating to that company. Similarly, companies that employ, on a part-time basis, health professionals that are still practising their profession must ensure that such persons are obliged to declare their employment arrangement with the company whenever they write or speak in public about a matter that is the subject of the employment or any other issue relating to that company.
    • Clause 23.1 The Use of Consultants Supplementary information
    • Guidance
    • 23 Use of Consultants

    The term ‘consultant’ in Clause 23 covers any health professional or other relevant decision maker consulted for the purposes described in Clause 23 regardless of their normal roles.

    Other relevant decision makers covered by Clause 23 are those who could influence in any way the prescription, supply, administration, recommendation, purchase or sale of any medicine.

    • Clause 23 Patient Organisations

    23.2 Pharmaceutical companies must publicly disclose details of the fees paid to consultants in the UK, or to their employers on their behalf, for certain services rendered by them such as chairing and speaking at meetings, assistance with training and participation in advisory boards etc. It includes payments to consultants in relation to research and development work, including the conduct of clinical trials.

    23.3 In addition to the information required to be made public by Clause 23.2, companies must publicly disclose details of payments made to consultants in relation to market research (unless the company concerned is not aware of the identities of those participating in the market research).

    23.4 Fees, expenses and the like due to consultants in relation to Clauses 23.2 and 23.3 must be disclosed whether paid directly to them or to their employers or to healthcare organisations or to companies or charities etc.

     

The arrangements in this regard (Clauses 14 and 23) include: the venue, the agenda, the hospitality and accommodation. What needs to be certified/examined or checked with respect to the arrangements for health professionals who are delivering services under an agreement will first and foremost depend on where the meeting takes place. If the meeting is in the UK companies should ensure there is adequate oversight of the meeting arrangements, through examination as set out in the supplementary information to Clause 22.1. Meetings which involve travel outside the UK must be certified as set out in Clause 14.2