AdvaMed issues pandemic compliance guidance for med-tech

Among the topics addressed in the AdvaMed compliance guidance include ongoing contractual/legal obligations during a declared state of emergency; charitable donations that include products, equipment, services, and/or financial support; volunteer activity by company personnel; and virtual educational events.

AdvaMed’s global compliance steering committee oversaw development of the guidance and received active input from over a dozen member-company compliance officers. “The guidance complements AdvaMed’s existing Code of Ethics and addresses shared compliance concerns, experiences, and best practices developed by our member companies as they respond to the COVID-19 pandemic,” said Christopher White, AdvaMed COVID action team leader, chief operating officer, and general counsel.

Regarding charitable donations, for example, the guidance states that donations of products, equipment, services, and financial support do not violate AdvaMed’s Code of Ethics, “as long as the decision to provide the support is made without undue commercial influence and free from any intent to inappropriately induce or reward purchase of products or services now or in the future; and is adequately documented to allow for appropriate recordkeeping and applicable transparency reporting.”

The same applies to volunteer personnel. AdvaMed said it supports medically qualified employees—such as field service, clinical specialists, and qualified sales personnel—who volunteer their expertise to help healthcare providers fight the pandemic.

In such cases, however, AdvaMed recommends that companies:

• Create a process to approve and document any staff that seek to volunteer to support the COVID-19 response, including specifying the temporary nature of the service and the direct need related to the COVID-19 crisis;
• Involve legal, compliance, and HR departments in this process and consider the health and safety of company staff both during and after the volunteer service;
• Require that all staff be properly qualified for the services; and
• Support nonprofit organizations where possible and avoid actual, or the perception of, favoritism.

Company processes

The guidance also addresses internal company process. Here, AdvaMed recommends that member companies “explore all possibilities to expedite appropriate humanitarian efforts.” This might include, among other things:

• A centralized resource or site for submitting requests and tracking approvals;
• A simplified review and approval process;
• New and simplified forms; and
• A single approval committee with representatives from different divisions.

“In all cases, compliance personnel should be involved in whatever approval processes are chosen for the emergency support requests related to COVID-19,” the guidance states. “All provisions of support should be properly documented.” In urgent situations where proper approval can’t be given in advance, AdvaMed recommends completing the required report “as soon as possible after the support is provided.”