Article

Recent revisions to the PhRMA Code on Interactions with Health Care Professionals regarding speaker programs

Authored by Samantha Brabant and Ashley Jones

The Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code) is a voluntary code of ethics that applies to pharmaceutical company interactions with healthcare professionals (HCPs) in the U.S. Three revisions have been made to the PhRMA Code since it was originally published in 2002, including a revision, which is effective Jan. 1, 2022.

The most recent update revises the PhRMA Code’s guidance on speaker programs in response to the Office of Inspector General’s (OIG) Special Fraud Alert on Speaker Programs, which was issued in November 2020.

The PhRMA Code revises three principles of speaker programs sponsored by the pharmaceutical industry:

  • the purpose of speaker programs
  • meals and modest venues
  • speaker program attendance

Purpose of speaker programs

The updated PhRMA Code strengthens the message that the purpose of speaker programs is to present “substantive educational informational designed to help address a bona fide educational need among attendees.” Accordingly:

  • Bona fide educational need should take into account substantive changes to relevant information, such as new medical or scientific information, or a new U.S. Food and Drug Administration (FDA) approved indication for the product
  • Invitations for speaker programs should be limited to individuals who have a bona fide educational need for the information, which is the subject of the speaker program

Meals and modest venues

It’s been PhRMA’s long-standing position that meals provided to speaker program attendees should be modest, as per local standards. In addition, the revision to the PhRMA Code states that pharmaceutical companies should not pay for or provide alcohol in connection with speaker programs and clarifies that “high-end restaurants,” and other such venues, are not appropriate locations for speaker programs.

Speaker program attendance

The recent revision to the PhRMA Code provides additional guidance on HCP attendance at speaker programs. The revised PhRMA Code states the following are generally not permissible in regard to speaker program attendance:

  • Attendance at more than one speaker program on the same or substantially similar topic at which a meal is provided, unless the attendee has a bona fide educational need to receive the information presented;
  • Attendance by speakers as an attendee of a speaker program on the same or substantially similar topic to a speaker program at which the speaker previously presented; and
  • Attendance by the speaker or attendees’ friends, family members, or guests, unless these individuals have an independent, bona fide educational need to receive the information presented.

The revision of the PhRMA Code following the OIG’s issuance of the Special Fraud Alert highlights PhRMA’s continued focus on ensuring interactions between healthcare professionals and pharmaceutical companies follow the highest ethical standards and applicable legal requirements.

For more information about this topic, or to learn how Baker Tilly’s Value Architects™ can help, contact our team.

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