Nine months after the Office of Inspector General’s (OIG) November 2020 Special Fraud Alert: Speaker Programs was published, on August 6, 2021, PhRMA issued a statement addressing an update to the PhRMA Code on Interactions with Health Care Professionals. Effective January 1, 2022, PhRMA updated its principles relating to company-sponsored speaker programs and clarified other provisions of the PhRMA Code.
PhRMA followed OIG’s lead by supporting several of the provisions that its signatory companies, which include both PhRMA members and non-members submit annual certifications fostering internal compliance with the PhRMA Code. Originally published in 2002, the PhRMA Code was updated in 2009 and 2019 as part of its focus on ensuring that pharmaceutical company interactions comply with the highest ethical standards. In this latest guidance, PhRMA communicated:
- Education: The updated PhRMA Code reiterates that the purpose of a speaker program should be to present substantive educational information designed to help address a bona fide educational need among attendees, taking into account recent substantive changes in relevant information or the importance of the availability of such educational programming. Invitations to speaker programs should be limited to those who have a bona fide educational need for the information being presented.
- Meals: In addition to reiterating that meals should be an incidental business courtesy to attendees of company-sponsored speaker programs and modest as judged by local standards, the updated PhRMA Code states that pharmaceutical companies should not pay for or provide alcohol in connection with speaker programs. The update also clarifies that high-end restaurants and other such venues are not appropriate locations for speaker programs.
- Attendance: The PhRMA Code states that repeat attendance at speaker programs that are substantially the same is generally not appropriate, attendance by speakers as participants at programs after speaking on the same or substantially the same topic is generally not appropriate, spouses or other guests should not attend company-sponsored informational presentations unless these individuals are health care professionals for whom the informational presentation is appropriate, and that attendance by non-HCP guests of a speaker or invited attendee is not appropriate.
Contrasting OIG’s 2020 Guidance with PhRMA’s 2021 Updated Code:
This guidance around speaker programs began in 2003 when the OIG of the Department of Health and Human Services continued its efforts to promote voluntary compliance. Biopharma companies then developed and implemented internal controls and procedures. The industry changed the way it was delivering speaker programs as entertainment had long been gone, and to me, so many of the changes were a breath of fresh air because they curtailed egregious activities. Then in November 2020, the OIG delivered, “Special Fraud Alert: Speaker Programs,” prompting regulatory professionals and compliance officers to ask themselves, “how can we continue to educate healthcare professionals utilizing the effective educational aspects of peer-to-peer programs?”
Do you have questions about how to support this new guidance? If you’d like to ensure you’re working with an agency dedicated to the highest ethical standards in speaker programs, speaker training, and speaker bureau management, give a shout to Vision2Voice Healthcare Communications; the only Medical Communications Agency to have been awarded BBB’s Integrity Award for its dedication to ethics and integrity.
Want to learn more about the OIG’s Special Fraud Alert or hear what the experts are saying? Check out our OIG resource page for more information.
