The ABPI Code states that:
“The requirements of Clause 22, which covers meetings for health professionals and other relevant decision makers, also apply to pharmaceutical companies supporting patient organisation meetings.”
Clause 22 provides detail on what is considered appropriate. There are some clear principles set out in the supplementary information, extracted below:
✔ 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 meeting must have a clear educational content.
✔ 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.
Note that the supplementary information to Clause 27 makes it clear that companies can pay for carers’ expenses under certain conditions:
“…in the case of clear health needs such as disability, companies can pay for subsistence, accommodation, genuine registration fees and reasonable travel costs for an accompanying carer.”
At some events there may be a mixed audience consisting of both health professionals and lay people. Many pharmaceutical companies – and indeed patient organisations – worry about what can be shared when patients are in the room.
The principle on sharing information with the general public still stands: promotion of prescription-only medicines is not permitted. That means that promotional presentations or other material suitable for health professionals would not be appropriate for patients to see. Clause 26.2 of the ABPI Code, and associated supplementary information, provides detail on information that can be shared with the public.
But people can find it irritating to have to leave a platform just when the debate is getting interesting; it can seem very strange to have to walk past posters or other material that is covered up because it is not for them.
When planning ahead, think carefully about room layout and access, structure of the agenda, timing of Q&As or closing remarks, and how to signpost clearly in advance which sessions are suitable for which audiences; with webinars or other online events, descriptive language and passwords will help to make this distinction. If it’s an independent congress, provide feedback on the format ahead of time.
It is useful to explain to a patient participant the reasons why certain aspects are not suitable for patients, rather than just saying no.
As for any activity, the purpose of patient or patient organisation involvement at an event should be articulated well before it happens, and agreement sought on the respective roles and responsibilities of companies and patient organisations. Aim for a shared, joint solution that respects the interests of all parties as well as the need for good compliance.
This also means considering inclusion requirements in terms of venue, as far as reasonably possible, and providing a named person for patients or members of the public to liaise with before and during the event, especially if they have additional needs. You can find further information on NIHR INVOLVE’s diversity and inclusion pages, including guidance on working with children and young people.
There have to be valid reasons for using a venue outside the UK for a meeting, which are set out in the supplementary information to Clause 22:
As with any meeting, consider carefully the principles of Clause 22, set out above.
The same rules apply for overseas events as for UK events, in terms of what can be paid to individuals and how this is disclosed.
Companies can arrange advisory board meetings and pay health professionals and others – for example patients or representatives of patient organisations – for advice on subjects relevant to their products.
Advisory boards are not used to promote a company’s medicines and must not be an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products. They should only be held to enable companies to answer legitimate business questions to which they do not already know the answer.
If you plan to invite patients or patient organisations to an advisory board, check that the answer to all the following questions is “yes”: If the answer to any of the questions is “no”, you should stop and think carefully in case there is a compliance issue.
✔ 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?
✔ Is this the only advisory board to address the business question at issue?
✔ Are the participants expected to do any preparatory work?
✔ Are all those involved with the meeting (staff, third parties, participants) clear on the need for and expected output from the meeting?