Yesterday (8th July 2020), EFPIA published an ethical guide for national trade associations and member companies in light of COVID-19. Contained within it, was joint guidance developed by IFPMA, EFPIA, and PhRMA on the support of third-party international congresses that are now being held virtually. Whilst independent medical associations and societies look at innovative ways for their events to proceed, companies are being invited to remain involved through the provision of virtual promotional and non-promotional exhibition stands, satellite symposia, and presentation of data at poster sessions.
In many ways, company diligence concerning events run virtually remains the same, but operationally the controls will be different. Incorporating the guidance provided, Pharma Integrity has provided these considerations:
OBJECTIVE: Company support must continue to be based on the event's educational value & medical / scientific programme.
INTENDED AUDIENCE: Companies must have full oversight over the intended audience of the event, specifically whether there will be HCP delegates and non-HCP delegates. Companies must work with congress organisers to categorise participants such that their exposure to information is appropriate, i.e. European non-HCPs are not exposed to promotional information about prescription-only medicines. Particular care should be taken to determine how visitors gain access to virtual exhibitions. It would be reasonable to assume that the principles governing the provision of other content online would apply here, such that self-disclosure by visitors as a "HCP" or "non-HCP" (providing sufficient non-HCP content is available), should be sufficient. Considering the likelihood that some delegates will be accessing content away from their place of work, additional warnings that the content should only be viewed by the registered user and not others, e.g. non-HCP family members, are likely to be relevant reminders. If companies are expected to have more specific regard on restricting access, it would certainly be helpful for IPHA and the ABPI/PMCPA to promptly advise companies in Ireland and the UK accordingly.
COST: Consideration must continue to be made as to the overall cost of company support, and the appropriateness thereof. Companies should question whether the cost for medical associations of running congresses virtually is equitable to that when they are held in physical conference venues. If significant innovative technology is being made available, then this will likely have come at a high cost, but companies should carefully consider the appropriateness of the level of their funding on a case-by-case basis.
HOSPITALITY: Companies may NOT provide hospitality to individual HCPs participating as a delegate in a virtual meeting, however, companies MAY provide hospitality to groups of HCPs participating in virtual meetings in line with hospitality limits that would apply had the meeting been held face-to-face. This means companies can't arrange for delivery of a coffee and a sandwich to an individual HCP participating in a meeting on their own, but they could provide subsistence to a department who are collectively participating. Care must be taken to ensure hospitality is only provided in association with participation in the meeting however, and companies may find it challenging to manage this if they don't have a member of staff in attendance. Consider what safeguards can be applied here.
SECURITY: Due to the virtual nature of the event, companies must pay particular regard towards cybersecurity and privacy arrangements. It is highly advisable to gain early input from cross-functional experts on these topics. Companies should also be reminded that competitor companies are highly likely to have full access to material and activities that they host.
CONSENT: Delegates will need to agree to terms and conditions that address their access to different parts of the virtual meeting according to their status (e.g. HCP / non-HCP access to lectures, commercial exhibitions, social engagement sites, etc.), and what personal information will be stored and shared with conference sponsors. As potential data controllers / processors, companies must ensure consent is fully informed, and the requirements of GDPR legislation are adhered to.
SIGN OFF: Whereas usually a "host country" is identified based on the country where the congress physically takes place, and all material and activities are assessed against the local national requirements, this isn't so clear in the virtual setting. It would, however, be impossible to gain approval from every country from which a delegate is expected to participate. The guidance that has been provided is to consider the Code from the region from which the majority of delegates would be expected to come based on past experience. Local companies that are members of the ABPI in the UK or IPHA in Ireland should be reminded that (as with physical meetings), if they are the legal entity within their company that is leading the company's activities at the virtual event, they must apply the requirements of the ABPI or IPHA Code of Practice as applicable. Their membership with the respective association means that they must observe the relevant local Code in all that they do and that which they are responsible for. When activities are targeted towards delegates from a specific country, the local national Code (and legislation) of the target audience must be applied.
PRODUCT LICENCE: Companies should consider options to tailor content accordingly, however, it is likely that HCPs will be able to access material developed for use in countries other than their own. In doing so, it has been accepted that promotional material may be developed based on a regional licence, e.g. US / European label, but companies must clearly state the relevant label, to avoid confusion. The supporting prescribing information must indicate the countries in which the medicinal product is registered, and an explanatory statement that licensing may differ internationally must be provided. A prominent (e.g. pop-up box) notification must direct delegates to refer to local prescribing information. Examples of appropriate statements provided in the guidance document are:
“You are viewing an International Virtual Congress run by [society name] and provided to international HCPs from around the world. Please note that prescribing information provided here may vary depending on local approval in each country. For purposes of [congress name], best efforts were undertaken by [society name] and congress sponsors to ensure compliance with [relevant code], however, you should review your local prescribing information and consult directly the local affiliate of the relevant Company to address any questions.”
“The materials for [PRODUCT(S)] contained in this virtual exhibition are approved for use only in [COUNTRY]. Prescribing information may vary depending on local approval in each country. Therefore, before prescribing any product, always refer to local materials such as the prescribing information and/or the Summary of Product Characteristics (SPC).”
IMPRESSION: As with all events, appropriate due diligence includes assessing the overall impression / perception of the event and companies’ involvement.
The full guidance is available here, and it shall remain in effect until 31st December 2020. A commitment has been made to amend and update it in response to experience over the coming weeks and months. Companies should share their experiences in these new situations with national trade associations and EFPIA to drive broad understanding and appropriate updates.
Note: National trade associations are expected to provide specific guidance on the support of national congresses where the focus is on HCPs from that country. Pharma Integrity will share information released from IPHA and the ABPI/PMCPA as it becomes available. Company-organised meetings are deemed to be out of scope of the joint IFPMA/EFPIA/PhRMA guidance.