During the COVID-19 pandemic, manufacturers of medical devices are providing support to healthcare professionals (HCPs), healthcare organisations (HCOs), healthcare systems and governments. However, codes of conduct for the industry, such as MedTech Europe’s Code of Ethical Business Practice (the MedTech Code) and the Association of British HealthTech Industries’ Code of Ethical Business Practice (the ABHI Code, together the Codes), continue to apply. These Codes set out strict requirements regulating the industry’s relationship with HCPs and HCOs to ensure that all interactions are ethical and professional. Owing to the seriousness of the COVID-19 crisis, it is likely that some actions taken by manufacturers in response to the crisis may contravene some of the requirements of the Codes.
For that reason, on March 27, MedTech Europe released Code Committee Guidance titled “COVID-19 Internal Compliance Guidance on Emergency Support” (the Guidance). This Guidance aims to support medical device manufacturers’ legal and/or compliance teams “when considering emergency processes to fast-track requests related to the COVID-19 crisis to the benefit to society as a whole while attempting to limit the inherent compliance risks.” Essentially, the Guidance puts in place new rules allowing for the taking of urgent actions that may otherwise breach the MedTech Code. Elements of the Guidance that contradict parts of the MedTech Code will take precedence in relation to (and only in relation to) requests for relief as a result of the COVID-19 crisis, “for the duration of the crisis” and until the crisis passes. The ABHI has responded to the Guidance and has stated that it fully supports MedTech Europe’s proposals. The ABHI has therefore adopted the Guidance alongside the ABHI Code.
The Guidance will supersede the Code only where a response to a COVID-19 request is free from any intention to improperly induce purchase; fully documented to allow for detailed transparency; made in consideration of the perception and image of the industry; and, where grants or donations are made, those decisions are made independent of the sales departments. In brief summary, the Guidance provides the following:
- Processes and Documentation: Ad hoc, fast-track processing may take place, as long as legal/compliance departments supervise, and support is properly documented. If acts occur prior to processes being completed, this must be reconciled as soon as possible after the event.
- Donations and “free of charge loans”: Whereas the MedTech Code does not ordinarily allow for donations to hospitals that are not under financial hardship, the Guidance makes allowances for donations or free of charge loans that address an immediate need related to COVID-19. Such loans must not be to individual HCPs and should generally be provided to not-for-profit organisations or competent authorities wherever possible. If equipment is being donated, the Guidance recommends the use of loan arrangements, properly documented and including clear retrieval criteria.
- Staff-related support: Requests for the provision of medical device manufacturers’ staff may be carried out in accordance with the law, as long as such programmes are approved and documented by the compliance/legal departments and as long as the provision is only temporary, addressing a direct need related to COVID-19. Companies should coordinate with their HR departments, and the Guidance recommends limiting the support to volunteers only. Whenever possible, support should be given to nongovernmental organisations to avoid the perception of favouritism.
- Payment waivers: Medical device manufacturers may (where legal, and only as a last resort) exceptionally decide to consider payment waivers for HCOs that have demonstrated a critical financial situation. The relevant contracts should be amended beforehand, and each request documented, with a special emphasis on the underlying reasons.
- Employer notification and virtual educational events: In an addendum, the Guidance states that owing to the crisis, face-to-face educational events for HCPs are very difficult. To encourage medical education, the Guidance states that invitations to HCPs to participate in Company Organised Virtual Educational Events do not require Employer Notification.
