Advisory Boards

  • 22

    Clause 22 - Meetings, Hospitality and Sponsorship

    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.

    The provision of hospitality is limited to refreshments/subsistence (meals and drinks), accommodation, genuine registration fees and the payment of reasonable travel costs which a company may provide to sponsor a delegate to attend a meeting. The payment of travel expenses and the like for persons accompanying the delegate is not permitted. Funding must not be offered or provided to compensate merely for the time spent by health professionals in attending meetings. The payment of reasonable honoraria and reimbursement of out of pocket expenses, including travel, for speakers, advisory board members and the providers of other professional services, is permissible. The arrangements for meetings must comply with Clause 22.1 with regard to hospitality and venues.

    Companies should only offer or provide economy air travel to delegates sponsored to attend meetings. Delegates may organise and pay at their own expense the genuine cost of an upgrade. For flights that are scheduled to take longer than six hours companies may pay for an upgrade from economy to premium economy or similar.

    Pharmaceutical companies may appropriately hold or sponsor a wide range of meetings. These range from small lunchtime audio-visual presentations in a group practice, hospital meetings and meetings at postgraduate education centres, advisory board meetings, visits to research and manufacturing facilites, planning, training and investigator meetings for clinical trials and non-interventional studies, launch meetings for new products, management training courses, patient support group meetings and satellite symposia through to large international meetings organised by independent bodies with sponsorship from pharmaceutical companies.

    With any meeting, certain basic principles apply:

    • the meeting must have a clear educational content
    • the venue must be appropriate and conducive to the main purpose of the meeting; lavish, extravagant or deluxe venues must not be used, companies must not sponsor or organise entertainment (such as sporting or leisure events) and companies should avoid using venues that are renowned for their entertainment facilities
    • the subsistence associated with the meeting must be secondary to the nature of the meeting, must be appropriate and not out of proportion to the occasion
    • any hospitality provided must not extend to a spouse or other such person unless that person is a health professional or other relevant decision maker and qualifies as a proper delegate or participant at the meeting in their own right
    • spouses and other accompanying persons, unless qualified as above, may not attend the actual meeting and may not receive any associated hospitality at the company’s expense; the entire costs which their presence involves are the responsibility of those they accompany.

    Administrative staff may be invited to meetings where appropriate. For example, receptionists might be invited to a meeting in a general practice when the subject matter related to practice administration.

    A useful criterion in determining whether the arrangements for any meeting are acceptable is to apply the question ‘would you and your company be willing to have these arrangements generally known?’ The impression that is created by the arrangements for any meeting must always be kept in mind.

    Meetings organised for groups of doctors, other health professionals and/or for other relevant decsion makers etc. which are wholly or mainly of a social or sporting nature are unacceptable.

    Meetings organised by pharmaceutical companies which involve UK health professionals at venues outside the UK are not necessarily unacceptable. There have, however, to be valid and cogent reasons for holding meetings at such venues. These are that most of the invitees are from outside the UK and, given their countries of origin, it makes greater logistical sense to hold the meeting outside the UK or, given the location of the relevant resource or expertise that is the object or subject matter of the meeting, it makes greater logistical sense to hold the meeting outside the UK. As with meetings held in the UK, in determining whether such a meeting is acceptable or not, consideration must also be given to the educational programme, overall cost, facilities offered by the venue, nature of the audience, subsistence provided and the like. As with any meeting it should be the programme that attracts delegates and not the associated hospitality or venue.

    Promotional material which is displayed or provided at international meetings held outside the UK may, unless prohibited or otherwise regulated by local laws and regulations, refer to medicines or their indications which are not registered in the country where the event takes place, or which are registered under different conditions, so long as any such material is accompanied by a suitable statement indicating countries where the product is registered and making clear that the product is not registered locally. Any such promotional material which refers to the prescribing information authorized in a country or countries where the medicine is registered must be accompanied by an explanatory statement indicating that registration conditions differ internationally.

    The requirements relating to international meetings held in the UK are set out in the supplementary information to Clause 3.

    The requirements of the Code do not apply to the provision of hospitality other than to that referred to in Clauses 22.1 and 27.2 and the supplementary information to Clauses 23 and 26.2.

    • Clause 22.1 Meetings Organised by Affiliates Outside the UK
    • Clause 22.1 Certification of Meetings
    • Clause 22.1 Health Professionals’ Codes of Conduct
    • Clause 22.1 Continuing Professional Development (CPD) Meetings and Courses

    MOST RECENT CASES  See all  Applicable Code year

    22.2 The cost of a meal (including drinks) provided by way of subsistence must not exceed £75 per person, excluding VAT and gratuities.

    22.3 Payments may not be made to doctors or groups of doctors or to other prescribers, either directly or indirectly, for rental for rooms to be used for meetings.

    22.4 When meetings are sponsored by pharmaceutical companies, that fact must be disclosed in all of the papers relating to the meetings and in any published proceedings. The declaration of sponsorship must be sufficiently prominent to ensure that readers are aware of it at the outset.

    22.5 Pharmaceutical companies must publicly disclose financial details of sponsorship of UK health professionals and other relevant decision makers in relation to attendance at meetings. Sponsorship in this context includes registration fees and the costs of accommodation and travel, both inside and outside the UK

  • 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.

     

  • 24

    Clause 24 - Transfers of Value to Health Professionals and Healthcare Organisations

    24.1 Companies must document and publicly disclose certain transfers of value made directly or indirectly to health professionals and healthcare organisations located in Europe.

    The term ‘transfer of value’ is defined in Clause 1.10. The term ‘Europe’ comprises those countries that are within the EU and other countries with a trade association that is a member of EFPIA. 

    The term ‘health professional’ in relation to disclosure of transfers of value also includes any employee of a pharmaceutical company whose primary occupation is that of a practising health professional as defined in Clause 1.4.

    Disclosure is required even if the payments etc are made by overseas affiliates, head offices in the UK or overseas and UK based offices.

    24.2 The transfers of value covered by Clause 24.1 are

    • joint working in accordance with Clause 20
    • donations, grants and benefits in kind provided to institutions, organisations and associations in accordance with Clauses 19.1 and 19.2
    • contracts between companies and institutions, organisations and associations in accordance with Clause 21
    • sponsorship of attendance by health professionals and other relevant decision makers at meetings in accordance with Clause 22.5
    • fees and expenses paid to health professionals and other relevant decision makers, or to their employers on their behalf, in accordance with Clauses 23.2, 23.3 and 23.4
    • contributions towards the costs of meetings paid to healthcare organisations or to third parties managing events on their behalf, which may include sponsorship of health professionals by way of registration fees and accommodation and travel.

    Supplementary information Clause 24.2 Further Information

    24.3  Clause 24.1 does not apply to transfers of value to patient organisations. These transfers of value are covered by Clauses 27.7 and 27.8.

    24.4 Disclosures must be made annually in respect of each calendar year. Disclosure must be in the first six months after the end of the calendar year in which the transfers of value were made.

    24.5 The information disclosed must remain in the public domain for at least three years from the time of disclosure.

    24.6 Companies must document all disclosures and retain the records for at least five years after the end of the calendar year to which they relate.

    24.7 Different categories of transfers of value to individual health professionals can be aggregated on a category by category basis, provided that itemised disclosure would be made available upon request to the relevant recipient or the relevant authorities.

    Payments to healthcare organisations are required to be disclosed on a per activity basis.

    24.8 Where a transfer of value is made to a health professional indirectly via a healthcare organisation such a transfer should be disclosed once only, preferably as being a transfer to the health professional.

    24.9 Where recipients of transfers of value cannot be identified for legal reasons, the amount attributable to such transfers must be disclosed on an aggregate basis. The number of recipients involved must be stated together with the percentage of all recipients that they represent and the aggregate amount attributable to transfers of value to such recipients.

    24.10 Each company providing transfers of value must publish a note summarising the methodologies used by it in preparing the disclosures and identifying each category of transfer of value. The note, including a general summary and/or country specific considerations, must describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues relating to the timing and amount of transfers of value for the purposes of this Code.

     

  • 3

    Clause 3 - Marketing Authorization

    The legitimate exchange of medical and scientific information during the development of a medicine is not prohibited provided that any such information or activity does not constitute promotion which is prohibited under this or any other clause.

    3.1 A medicine must not be promoted prior to the grant of the marketing authorization which permits its sale or supply.

    • Supplementary information
    • Clause 3.1 Advance Notification of New Products or Product Changes which May Significantly Affect Expenditure

    3.2 The promotion of a medicine must be in accordance with the terms of its marketing authorization and must not be inconsistent with the particulars listed in its summary of product characteristics.

     

ADVISORY BOARDS AND THE LIKE 
The PMCPA cannot approve any materials or activities, it can only give informal advice based on its interpretation of the ABPI Code.  In the event of a complaint being received about a matter upon which advice was sought, it would be considered in the usual way; the ABPI Code of Practice Appeal Board would make the final decision if a case went to appeal.

The arrangements for advisory board meetings and the like are often the subject of enquiries to the PMCPA for informal advice and there have been complaints about them.  The Medicines and Healthcare products Regulatory Agency (MHRA) has regularly raised concerns about advisory boards including examples of advisory board meeting proposals which appear to be promotional. It is acceptable for companies to arrange advisory board meetings and the like and to pay health professionals and others for advice on subjects relevant to their products.  Advisory boards should only be held to enable companies to answer legitimate business questions to which they do not know or have the expertise in-house to answer.  The arrangements for such meetings must comply with the ABPI Code.

Advisory board meetings need to meet the requirements for meetings as set out in Clause 22 of the ABPI Code including the requirements that the meeting is held in an appropriate venue conducive to the business purpose of the meeting and that hospitality is secondary to that purpose and not out of proportion to that occasion.

To be considered a legitimate advisory board the choice and number of participants should stand up to independent scrutiny; each should be chosen according to their expertise such that they will be able to contribute meaningfully to the purpose and expected outcomes of the meeting.  The number of participants should be limited so as to allow active participation by all and should not be driven by the invitees’ willingness to attend.  The agenda should allow adequate time for discussion.  The number of meetings and the number of participants at each should be dictated by need ie both should be strictly limited to no more than the number required to achieve the stated objective.  Multiple advisory boards on the same topic should be avoided unless a clear need can be demonstrated.  Companies should determine if and when advisory board meetings are required; advisory boards should never be held in response to participants’ willingness to discuss issues.  Invitations to participate in an advisory board meeting should state the purpose of the meeting, the expected advisory role and the amount of work to be undertaken.

The content of advisory board meetings should relate solely to the matter in hand.  Discussion of clinical data about a particular medicine should only take place at an advisory board if such discussion is essential to meet the stated objective.  To do otherwise might risk the meeting being viewed as disguised promotion for that medicine or promotion of an unlicensed medicine or indication.

If an honorarium is offered it should be made clear that it is a payment for such work and advice.  Honoraria must be commensurate with the time and effort involved and the professional status of the recipients.  The payment of advisory board members must be declared in accordance with Clauses 23 and 24.

PRACTICAL GUIDANCE – POINTS TO CONSIDER

The PMCPA has developed the following points to consider which are to help companies and others ensure that advisory boards and the like meet the requirements of the ABPI Code and that the relevant information is available when assessing proposals.  The points to consider reflect what information might be required in the event that a company has to respond to a complaint under the ABPI Code. 

The answers to the following questions should be ‘yes’:

  • Does the company have a legitimate unanswered business question?
  • Is an advisory board the most appropriate way of obtaining the information?
  • Does every participant have the relevant expertise to contribute meaningfully to the purpose and expected output of the meeting?
  • Is the number of participants limited so as to allow active participation by all?
  • Does the agenda allow adequate time for discussion?
  • Is a significant majority of the time spent on feedback from the participants?
  • Has the company wholly and solely determined its need for the advisory board, with no input from expected attendees
  • Is the number of delegates/meetings strictly limited to that required to answer the question?
  • Does the invitation to participate clearly state the purpose of the meeting, the expected advisory role and the amount of work to be undertaken?
  • Are the participants being paid no more than ‘fair market value’?
  • Are intended presentations to participants relevant to their role in answering the business question?

If the answers to any of the following questions is ‘no’ then there may be a compliance issue to be addressed:

  • Is this the only advisory board to address the business question at issue?
  • Are the participants expected to do any preparatory work?
  • If the product/indication is unlicensed, has the PMCPA Guidance on Marketing Authorization (Clause 3) been taken into account?
  • Are all those involved with the meeting (staff, third parties, participants) clear on the need for and expected output from the meeting?

Companies should ensure that the following questions are considered:

  • Are the arrangements (eg venue, subsistence, travel, contract) appropriate?
  • How were the participants selected?
  • Who from, or on behalf of, the company is attending and why?
  • Do all company attendees (including those attending on behalf of the company) have a defined role and is the ratio of company employees/others to participants reasonable?
  • Will there be a conclusions/recommendations report?
  • What use will be made of conclusions/recommendations report?
  • Have any advisory boards for the same medicine/therapy area already taken place/been planned within eg a 12 month period? If so, what is the justification for another one?
  • What follow-up, if any, is to be undertaken with participants? If so, is this appropriate given the non promotional nature of advisory boards?
  • Is this advisory board held in conjunction with any other meeting such as a learned society congress?

last updated November 2019