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?

In determining whether any event/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.

Events/meetings range from small lunchtime audiovisual presentations in a group practice; hospital meetings and events/meetings at postgraduate education centres; advisory board meetings; visits to research and manufacturing facilities; planning, training and investigator meetings for clinical trials and non-interventional studies; launch events/meetings for new products; management training courses; patient support group meetings; and satellite symposia through to large international events/meetings organised by independent bodies with sponsorship from pharmaceutical companies.

The hospitality costs involved in events/meetings must not exceed that level which the recipients would normally adopt when paying for themselves.

Companies should only offer or provide economy air travel to delegates attending events/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.

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

A useful criterion in determining whether the arrangements for any event/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 event/meeting must always be kept in mind.

Events/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 the event/meeting 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 event/meeting outside the UK or, given the location of the relevant resource or expertise that is the object or subject matter of the event/meeting, it makes greater logistical sense to hold the event/meeting outside the UK. Consideration should be given to the use of technology to avoid travel outside the UK, eg webinars, virtual meetings.

Companies should remind their affiliates outside the UK that the ABPI Code must be complied with if UK health professionals attend events/meetings which they organise, regardless of whether such events/meetings occur in the UK or abroad.

Pharmaceutical companies must ensure that all events/meetings which are planned are examined to see that they comply with the Code. Companies must have a written document that sets out their policies on events/meetings and hospitality and the associated allowable expenditure. In addition, events/meetings which involve travel outside the UK must be certified as set out in Clause 8.2.

The General Medical Council (GMC) is the regulatory body for doctors and is responsible for giving guidance on standards of professional conduct and on medical ethics. In its guidance, the GMC advises that ‘You must not allow any interests you may have to affect the way you prescribe for, treat, refer or commission services for patients’ and ‘You must not ask for or accept from patients, colleagues or others any inducement, gift or hospitality that may affect or be seen to affect the way you prescribe for, treat or refer patients or commission services for patients. You must not offer these inducements’.

The General Pharmaceutical Council is the regulatory body for pharmacists and pharmacy technicians. The Council’s Standards for pharmacy professionals includes that they must use their professional judgement and must behave in a professional manner. They are expected to ‘declare any personal or professional interests and manage these professionally’.

The Code of the Nursing & Midwifery Council, Professional standards of practice and behaviour for nurses and midwives, states ‘You must act with honesty and integrity in any financial dealings you have with everyone you have a professional relationship with, including people in your care’.

In a joint statement, the chief executives of statutory regulators of health and care professionals (which refers to individuals regulated by one of nine regulators overseen by the Professional Standards Authority, including those referred to above) expect health and social care professionals to ‘Ensure their professional judgement is not compromised by personal, financial or commercial interests, incentives, targets or similar measures’ and to ‘Refuse all but the most trivial gifts, favours or hospitality, if accepting them could be interpreted as an attempt to gain preferential treatment or would contravene your professional code of practice’.

The provisions of this and all other relevant clauses in the Code apply equally to meetings and courses organised or sponsored by pharmaceutical companies which are CPD approved. The fact that a meeting or course has CPD approval does not mean that the arrangements are automatically acceptable under the Code. The relevant provisions of the Code and, in particular, those relating to hospitality, must be observed.

Pens/pencils and notepads are the only items that can be provided to health professionals and other relevant decision makers for them to keep and then only at bona fide meetings. They cannot be provided, for example, by representatives when calling upon health professionals.

The maximum of £75 plus VAT and gratuities is appropriate only in very exceptional circumstances, such as a dinner at a residential meeting for senior consultants or a dinner at a learned society conference with substantial educational content. The cost of subsistence (food and drink) should normally be well below this figure. The requirements relating to hospitality in Clause 10.1 and its supplementary information still apply.

The maximum of £75 plus VAT and gratuities (or local equivalent) does not apply when an event/meeting is held outside the UK in a European country where the national association is a member of EFPIA and thus covered by the EFPIA Code. In such circumstances, the limits in the host country code would apply. Information can be found at www.efpia.eu.

This provision does not preclude the payment of room rental to postgraduate medical centres and the like.

Payment of room rental to doctors or groups of doctors or to other prescribers is not permissible even if such payment is made to equipment funds or patients’ comforts funds and the like or to charities or companies.

Attention is drawn to Clause 5.5 which requires that all material relating to medicines and their uses, whether promotional or not, which is sponsored by a pharmaceutical company must clearly indicate that it has been sponsored by the company.

Where companies are involved in the sponsorship and/or distribution of reports on events/meetings or symposia, etc these reports may constitute promotional material and thus be fully subject to the requirements of the Code.

Disclosure of this information must be carried out in accordance with Clause 28.

The information required by Clause 10.10 must be publicly disclosed annually in respect of support for attendance at events/meetings whether paid directly, indirectly or via another party. Support in this context includes registration fees and the costs of accommodation and travel, both inside and outside the UK.

The information which must be disclosed comprises registration fees and the costs of accommodation and travel, both inside and outside the UK. The name of each recipient and the associated transfer of value for that recipient must be given.

Where a transfer of value is made to a health professional or other relevant decision maker indirectly via a healthcare organisation, institution or other party, such a transfer should be disclosed once only, preferably as being a transfer to the health professional or other relevant decision maker.

Disclosure of this information must be carried out in accordance with Clause 28.

Sponsorship in this context includes registration fees and the costs of accommodation and travel, both inside and outside the UK, whether paid directly or indirectly. If, when providing sponsorship to a healthcare organisation, institution or other organisation in relation to their own event, a company contributes towards the overall cost of subsistence (food and drink), then this must be included in the disclosure of the cost of the sponsorship to the healthcare organisation, institution or other organisation.

An acceptable way to comply with Clause 8.1 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 8.6.

All promotional material must be certified in this way, including audio and audiovisual 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.

Companies should be aware that if they use a non-promotional item for a promotional purpose, it would need to be certified.

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 the item has been examined and signed in its final form to ensure it accurately reflects the content and presentation certified electronically. In such circumstances, the material will have a certificate and a declaration approving the final form and both must be preserved as they form the certification of the item. The examination of the printed form can be carried out by a signatory, an appropriately qualified person signatory (AQP signatory) or an appropriately qualified person (AQP).

In certifying audio and audiovisual material and promotional material on databases, interactive systems and the internet, companies must ensure that a written transcript of the material is available, 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.

See also the supplementary information to Clause 11 regarding the certification of promotional material to be used at international conferences.

When certifying dynamic content such as websites etc care must be taken to ensure the dynamic content meets the requirements of the Code as a standalone item. As the final form is not static, consideration needs to be given to the context in which it appears but each possible combination does not need to be certified.

In deciding whether a person can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outside the industry, length of service and seniority. In addition, signatories must have an up-to-date, detailed knowledge of the Code. The registered medical practitioner should be capable of being registered in the UK without the need for additional tests of medical/clinical knowledge.

In a joint venture in which a third party provides a service on behalf of a number of pharmaceutical companies, the pharmaceutical companies involved are responsible for any activity carried out by that third party on their behalf.

It follows, therefore, that the pharmaceutical companies involved should be aware of all aspects of the service carried out on their behalf and take this into account when certifying the material or activity involved. Similarly, if two or more pharmaceutical companies organise a joint event/meeting, each company should ensure that the arrangements for the event/meeting are acceptable.

Under co-promotion arrangements or other arrangements where companies work together, such as collaborative working projects, the companies concerned can agree to have only one final signatory to certify on behalf of all the companies. This must all be agreed beforehand and the MHRA and the PMCPA must be informed in advance who the signatory will be. In the event of a complaint about material certified in this way, each company involved in the project/activity would be responsible under the Code.

It is possible for a company to have different individuals who would act as an AQP for examination depending on their skill sets and the material and activities etc being examined. For example, an individual with proof reading skills could examine and sign the final form of printed material which has been certified electronically as set out in the supplementary information to Clause 8.1. It is unlikely that this AQP would also have the necessary skills to examine market research material to ensure it does not contravene the Code as set out under the supplementary information to Clause 8.3.

UK companies have responsibilities under the Code for events/meetings which they organise and when UK delegates are supported and/or UK speakers are contracted to go to events/meetings outside the UK. Clauses 24, 28, 29, 30 and 31 in relation to disclosure of transfers of value will also need to be followed.

When certifying arrangements for events/meetings which involve travel outside the UK, all the relevant documents and arrangements must be considered, including the programme, the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitality and the like.

If the company’s only involvement is to support a speaker to present at the event/meeting and there is no pharmaceutical company involvement with the event/meeting at all, for example, a learned society event/meeting, then neither certification nor examination is required.

When a pharmaceutical company based outside the UK arranges via a UK company for a UK speaker to present at an event/meeting to be held outside the UK, then that speaker’s presentation materials do not need to be certified or examined by the UK, provided there are no UK delegates and the UK company has no role whatsoever in relation to the event/meeting or the presentation. In such circumstances, the event/meeting arrangements, in as much as they apply to the UK speaker, will not have to be certified or examined.

In deciding whether someone other than a registered medical practitioner or a pharmacist registered in the UK is appropriately qualified to certify events/meetings involving travel outside the UK (AQP signatory), account should be taken of relevant experience both within and outside the industry, length of service and seniority. In addition, such a person must have an up-to-date and detailed knowledge of the Code.

It is possible for a company to have different individuals who would act as an AQP for examination depending on their skill sets and the material and activities etc being examined. For example, an individual with proof reading skills could examine and sign the final form of printed material which has been certified electronically as set out in the supplementary information to Clause 8.1. It is unlikely that this AQP would also have the necessary skills to examine market research material to ensure it does not contravene the Code as set out under the supplementary information to Clause 8.3.

Material issued by companies which is not required to be certified under the Code should be examined by a signatory or an AQP, who needs not be a signatory, to ensure that it does not contravene the Code or the relevant statutory requirements. Such material might include corporate advertising, press releases, market research material, financial information to inform shareholders, the Stock Exchange and the like, and written responses from medical information departments or similar to unsolicited enquiries from the public etc.

The names and qualifications of signatories and changes to them should be notified to the MHRA by email to signatories.advertising@mhra.gov.uk. The PMCPA can be notified by completing the nominated signatory form which can be found at www.pmcpa.org.uk. The names and qualifications to be sent to the MHRA and PMCPA are those of the registered medical practitioner or the pharmacist registered in the UK or, if the product is for dental use only, a UK registered dentist as set out in Clause 8.1 and the AQP signatory as set out in Clause 8.2.

The MHRA is entitled to request details of an advertisement, including particulars as to the content and form of the advertisement, the method of dissemination and the date of first dissemination, and such a request is not subject to any time limit. This does not apply to the certificates themselves in respect of which the three year limit in Clause 8.6 is applicable. There is further information in the MHRA Blue Guide.

Companies must ensure that they have appropriate arrangements in place to lawfully disclose information about transfers of value and that recipients are aware of the process for disclosure.

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

There is a central platform for disclosure in the UK which companies must use. The template to be used is available from the PMCPA website www.pmcpa.org.uk.

The clauses of the Code noted in Clause 28.2 should be consulted for further information about the requirements. In addition, the requirements of Clauses 10.1 and 10.10 should be borne in mind in relation to meetings.

If when providing sponsorship to a healthcare organisation, institution, other organisation etc in relation to their own event, a company contributes towards the overall cost of subsistence (food and drink), then this must be included in the disclosure of the cost of the sponsorship to the healthcare organisation, institution, other organisation etc. Where a company supports individual health professionals or other relevant decision makers (directly or indirectly) to attend events/meetings, there is no requirement to disclose subsistence (food and drink) as in Clause 10.1.

If an individual health professional or other relevant decision maker receives a number of transfers of value from a company and decides not to agree to disclosure of one or more of those transfers of value, then that company can disclose all of that individual’s transfers of value in its aggregate amount.

The information required by Clause 30 must be publicly disclosed annually in respect of transfers of value made in 2022 and each calendar year thereafter.