Advisory Boards

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.

•  Cases 
• Guidance
• Supplementary information Clause 22.1 Meetings and Hospitality

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

• What are the relevant requirements for meetings when UK health professionals/other relevant decision makers attend a company organised meeting outside the UK as delegates?

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

• Supplementary information Clause 22.2 Maximum Cost of a Meal

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.

• Supplementary information Clause 22.3 Payment of Room Rental

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.

• Supplementary information Clause 22.4 Sponsorship and Reports of Meetings

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

• Supplementary information   Sponsorship of attendance

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.

• Supplementary information
• Clause 23.2 Disclosure
• Clause 23.2 Research and Development Transfers of Value

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).

• Supplementary information 
• Advice 
• Clause 23.3 Disclosure 
• Should pharmaceutical companies disclose Transfers of Value made for 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.

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.

• Guidance

• Supplementary information Clause 24.1 Transfers of Value

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.

• Clause 24.1 Consent to Disclosure
• Clause 24.1 Mode of Disclosure
• Clause 24.1 Date of Implementation
• What should pharmaceutical companies do if a health professional/HCO donates their transfer of value to a third party, eg a charity, charitable trust or other institution?

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.

• Supplementary information Clause 24.9 Disclosure of Transfers of Value to Individuals

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.

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.

• Clause 3 Conditional Marketing Authorizations
• Clause 3 Early Access to Medicines Scheme
• Clause 3 Compassionate Use
• Clause 3 Promotion at International Meetings
• Can companies engage in pre-licence activity?
• Guidance

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.

• Supplementary information
• Cases