How does the ABPI Code apply to congresses? Mitigating the risks of breaching the Code.
The ABPI Code of Practice provides guidance for pharmaceutical industry meetings and third-party meetings that the industry supports, covering meeting content and arrangements. Congresses, by their very nature, tend to include a variety of different activities that fall under the scope of the Code and activities continue to bring about complaints to the PMCPA (eight complaints relating to this area were published in the past two years).
Given all planned meetings must be checked to ensure they comply with the Code, from the outset there must be a clear and unambiguous Meetings Standard Operating Procedure (SOP) covering the various ways in which congresses can be supported. These are highlighted below with typical examples of issues observed (in our dealings and noted in PMCPA case reports).
Occasionally, employees attend congresses as delegates in their own right. Both the type and number of employees attending must be considered: e.g. “If several medical science liaisons were attending a congress symposia about the company’s own medicine, were they there to solicit enquiries on that medicine?”
Conduct of company employees
Given that staff are on professional duty 24/7 at congresses, risks associated with their conduct tend to occur during ‘downtime’. These range from staff acting inappropriately (Case AUTH 2174/10/08 Anonymous v Merck Serono) and even getting thrown out of bars (Case AUTH 2509/6/12 Anonymous v Roche).
Companies may provide subsistence, accommodation, registration fees and travel to delegates they sponsor to attend a congress. Delegates should be suitably qualified or in an appropriate role to gain benefit from the congress, and this leads to potential risk: e.g. “Were delegates chosen solely for promotional purposes? Can attendees that are not part of the sponsored delegation be provided with any subsistence?”
As with all meetings, there must be clear educational content, in a venue that is not lavish, with reasonable subsistence, secondary to the nature of the meeting. Although the programme, audience and hospitality pose risks, other risks can be associated with content and company-paid speakers: e.g. “Why was the speaker allowed to keep slides that mention product? Why did the speaker mention the product in a medical education presentation?” (Case AUTH 2598/4/13 Consultant rheumatologist v Roche)
Hosting a promotional exhibition stand
These must be separate to non-promotion as all material, staff and discussions will be promotional. There are risks associated with applicable Codes at international congresses as well as social media: e.g. “Is the company liable if the stand production company posts a picture of a promotional stand panel on social media in the interests of business development?” (Case AUTH 3010/1/18 Bristol Myers Squibb and Pfizer v Daiichi Sankyo)
Hosting a non-promotional exhibition stand
Whilst medical education, medical information, clinical research and corporate stands are acceptable, increasingly, the cumulative impression of all company activities at congresses can pose risks: e.g. “If the company symposium is about an unlicensed medicine, will their medical education stand be deemed to solicit questions on this medicine?” (Case AUTH 2868/8/16 Janssen-Cilag v Sanofi Genzyme)
Supporting scientific sessions
Pharmaceutical companies’ support of congress activities range from speaker payment, to room hire or providing lunch. Declaration of involvement must be made clear on all meeting materials. e.g. “Will the company be held liable if the agenda contains an untrue declaration?” (Case AUTH 3133/12/18 Anonymous v Novo Nordisk).
Research and development activities generally fall outside the scope of the Code.
Key actions to mitigate risks
There are several key actions that can help mitigate risks of breaching the Code at congresses.
- Assemble a steering group with oversight of the whole congress to ensure all activities (stands, symposia, affiliate meetings, dinners etc.) are known in advance, documented and in line with business strategy. This allows for the overall cumulative impression to be considered.
- Communicate well with affiliates to allow good planning of activities and materials in line with applicable Codes.
- Mobilise and engage stakeholders through clear and concise SOPs and checklists to aid efficient approval.
- Centralised teams to efficiently assess all plans and materials to allow clear categorisation of each type of activity and determine the applicable Codes vs company involvement, e.g. Company symposia flyers in congress delegate bags vs open invites from stands.
- Once each activity is well understood, associated materials can be approved vs a compliance checklist.
Tried and tested top tips
- Sometimes the company strategy is poorly understood which can manifest as compliance issues. Diligence defines liability in situations where company support of third-party congresses is varied. This diligence must be well-documented. E.g. If the only support a company has provided is a stand, they will not be held liable for other aspects (according to strict conditions). (Case AUTH/2561/11/12 Anonymous group of NHS health professionals v Recordati). If the company provides a stand and lunch, was the strategy still focused on promotional interactions at the stand? Unfortunately, liability now depends on diligence (What was the lunch? What was the cost per head? Did it comply with all applicable codes? Was it in proportion to the education on the agenda? Is education good quality and relevant to clinical or medical aspects?) – and this is far more difficult to check and approve.
- Agencies used to support congresses (from stand production to social media and events management) must be kept well-informed about Code requirements and relevant PMCPA cases. This should ensure that risks due to company liability are reduced.
- Evening meal provision does not always require there to be associated education at that time. More companies are benefitting from providing evening subsistence to attendees that have attended the congress (and therefore received education) but have not been taken as delegates by that company.
- Medical symposia under the scope of the Code must be further categorised so their compliance can be checked. It is not acceptable for such symposia to bypass relevant requirements because they are ‘medical’ or ‘scientific’ etc.
- If a medical area is needed on promotional stands solely to address questions, consider booking a separate room for medical staff to deal with enquiries so that conversations can’t be overheard, requests can be well-documented and the juxtaposition of the promotional vs medical stands cannot be accused of soliciting enquiries.
- Lastly, staff briefings about expected behaviour prior to congresses are key to ensuring no complaints (and therefore no breaches). These should ideally contain a list of dos and don’ts with examples and cross-reference to relevant case rulings.
It is possible for all activities and materials at international and national congresses to be well-planned, approved in a timely manner and executed well in line with all applicable codes. However, this is not an easy task so should not be entered into lightly.
Dr Rina Newton is Managing Director of CompliMed. Go to www.complimed.co.uk
Read more on ABPI and mitigating risk from Rina Newton here >