October 20, 2020

Volume X, Number 294

October 19, 2020

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HCP Conflicts of Interest: Virtual Informational Sessions – With Lunch - Supported by PhRMA During Declared Emergencies

On June 30, 2020, PhRMA released a Statement on Application of PhRMA Code Section 2 During Emergency Periods, which recognizes the difficulty in complying with the Code’s requirement that informative presentations given to health care providers (“HCPs”), which may include a meal, are delivered in person by field sales representatives or their immediate managers. The Statement will enable such presentations to occur remotely (over video or audio conferencing) with by-delivery of a modest meal, as is discussed in greater detail below.

By way of background, Section 2 of the PhRMA Code (the “Code”) states:

In order to provide important scientific information and to respect health care professionals’ abilities to manage their schedules and provide patient care, company representatives may present scientific and clinical information about medicines during health care professionals’ working day, including at mealtimes.  In connection with such presentations or discussions, it is appropriate for occasional meals to be offered as a business courtesy to the health care professionals as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals are: (a) modest as judged by local standards; (b) not part of an entertainment or recreational event; and (c) provided in a manner conducive to informational communication.

The Code also states that any such meals offered in connection with informational presentations made by field sales representatives or their immediate managers should be limited to in-office or in-hospital settings, and that offering “take-out” meals or meals to be eaten without a company representative present (e.g., “dine & dash”) is not appropriate.

Acknowledging that during the COVID-19 emergency period and potentially during future emergency periods, healthcare facilities and offices may have differing standards with respect to physical access for patients, families, visitors, and company representatives, PhRMA offered the following guidance regarding Section 2 of the Code:

  • Offering informational presentations remotely over video or audio conferencing accompanied by delivery of a modest meal to HCPs and members of their staff is appropriate under Section 2 of the Code, provided:

    • The representative should remain virtually “present” over video or audio conference throughout the event.

    • Meals should only be provided where there is a reasonable expectation that healthcare professionals will remain present throughout the event. “Take-out” meals and “dine & dash” programs are not appropriate.

    • Any meal offered should otherwise comply with the provisions of Section 2 of the Code, including that the meal should be modest as judged by local standards, provided in a manner that is conducive to informational communication, limited to an in-office or in-hospital setting, and a healthcare professional’s spouse or other guest should not be included.

    • Meals should not be provided where prohibited by the policies of the HCP office or healthcare facility. Companies should consider health care facility policies regarding utilization of contactless delivery, food handling, and limitations on meal sharing.

  • During emergency periods, meals provided to HCPs by company representatives should continue to be limited to sessions occurring “in-office or in-hospital” settings.

    • Note, however, that informational presentations alone, without a meal provided by the representative, may be offered outside of a hospital or office setting, so long as the location of the presentation is conducive to informational communication. The Code does not restrict whether such presentations occur in-person or virtually over video or audio conference.

PhRMA’s statement is applicable during any national public health emergency period or any state or local declaration of an emergency that impacts access to an HCP’s office. Importantly, PhRMA’s statement is not intended to replace or supersede applicable federal or state laws, which may also apply.

© 2020 Foley & Lardner LLPNational Law Review, Volume X, Number 197


About this Author

Kyle Faget, Foley Lardner, Government policy lawyer
Special Counsel

Kyle Faget is a special counsel and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to...