In August 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced an updated and enhanced PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code).1 The revisions apply to the PhRMA Code’s principles applicable to company-sponsored speaker programs. The changes will go into effect on January 1, 2022.
Background
PhRMA is an association consisting of leading research-based pharmaceutical and biotechnology companies. The PhRMA Code, originally published in 2002, is a voluntary code that provides the principles and guardrails upon which ethical relationships with healthcare professionals may be established. The PhRMA Code was updated in 2009 and again in 2019, and “is based on the principle that a healthcare professional’s care of patients should be based, and should be perceived as being based, solely on each patient’s medical needs and the healthcare professional’s medical knowledge and experience.” The current version of the PhRMA Code addresses company-sponsored speaker programs, recognizing that such programs provide important educational information about pharmaceutical or certain disease states.
Updates to the PhRMA Code
- The updated PhRMA Code reiterates that speaker programs should be intended “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 (e.g., new medical or scientific information or a new FDA-approved indication for the product) 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 presented at the program.”
- The PhRMA Code reiterates its long-held principle that incidental meals furnished to attendees of a speaker program must be “modest as judged by local standards, as well as subordinate in focus to the educational presentation.”
- Under the revised PhRMA Code, pharmaceutical companies should not pay for or provide alcohol in connection with speaker programs.
- The venue selected to host the program should not be extravagant or the main attraction of the event or perceived as such. The PhRMA Code clarifies that high-end restaurants and other such venues are not appropriate locations for speaker programs.
- The PhRMA Code states that repeat attendance at a speaker program on the same or substantially the same topic where a meal is provided to the attendee is generally not appropriate, unless the attendee has a bona fide educational need to receive the information presented.
- The PhRMA Code also clarifies that it is generally not appropriate for a speaker to attend a program after speaking on the same or substantially the same topic.
- The PhRMA Code has long held that spouses or other guests should not attend the speaker program, unless these individuals are healthcare professionals themselves and the presentation is appropriate.
- The updated PhRMA Code clarifies this point by elaborating that attendance by friends, significant others, family members and other guests of a speaker or invited attendee is not appropriate, unless these individuals have an independent, bona fide educational need to receive the information presented.
AGG Observations
- The updated PhRMA Code follows the November 2020 Office of Inspector General (“OIG”) Special Fraud Alert addressing the fraud and abuse risks of speaker programs. The changes likely reflect the increased government scrutiny and enforcement action related to company-sponsored speaker programs.
- While the PhRMA Code is a voluntary code, it is widely recognized as the industry standard for pharmaceutical company interactions with healthcare professionals. There are also a handful of states that require pharmaceutical companies or pharmaceutical detailers to adopt or comply with the PhRMA code or a code that substantially comports with its requirements.
- We recommend reviewing applicable speaker program policies, SOPs, and contracts to make any necessary revisions prior to the January 2022 effective date.
- Companies should also remember to review applicable federal or state laws to ensure speaker programs comply.
[1] A copy of the updated PhRMA Code is available at: https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-Code—Final—July-2021.pdf.
