On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) released highly anticipated revisions to its Code on Interactions with Health Care Professionals, effective January 1, 2022.
In order to keep our compliance community updated with these changes, qordata collaborated with Seth Lundy and Brian Bohnenkamp from King & Spalding to bring forth an interactive webinar discussing the updated sections and their implications.
Revisions to Section 7 of the PhRMA Code
The webinar discussed updates to Section 7 of the PhRMA Code which covers guidelines for Speaker Programs. These revisions largely incorporate HHS-OIG’s Special Fraud Alert for Speaker Programs, as issued in November 2020.
The updated code lays down seven principles for Speaker Programs which are as follows:
- The speaker program must have a substantive educational purpose designed to address the attendee’s bona fide educational need.
- Relevant attendees must have a bona fide educational need.
- Incidental meals must be of modest value according to the local standards and subordinate in focus to the educational content.
- No alcohol is paid for or provided by the life sciences company.
- The venue must be suitable and conducive to learning and informational content i.e shouldn’t be the extravagant or main attraction of the speaker program.
- Repeat attendees are not appropriate unless the attendee has bona fide educational needs.
- No guests are allowed unless such individuals also have a bona fide educational need.
Revisions to Section 2
Section 2 around meals other than the Speaker Programs has also been revised, to include the following language:
“Incidental meals can be provided only where there is a reasonable expectation, and reasonable steps are taken to confirm, that each attendee has a substantive interaction or discussion with the company representative. Offering ‘grab-and-go’ meals is not appropriate.”
That means a sales representative providing scientific or educational information regarding a company’s products to health care professionals could provide a modest meal (such as sandwiches or pizza) given that they have a substantive interaction or discussion with the sales rep.
Revisions to Sections 4 and 5:
Since the pandemic shifted many learning and informational events to virtual modality, the PhRMA code also made updates in the language of sections 4 and 5 to clarify the applicability of those sections to virtual events.
“Section 4 applies to in-person CME events and virtual CME events conducted via a digital platform (with audio and/or video conferencing capabilities) with or without an associated in-person event.”
“Section 5 applies to in-person third-party scientific and educational conferences or professional meetings and virtual meetings conducted via a digital platform (with audio and/or video conferencing capabilities) with or without an associated in-person event.”
Revisions to Section 6:
The updated code also includes revisions in Section 6 with regards to the appropriate venue for meeting with consultants. The revised Code adds the following language to Section 6:
“high-end restaurants and entertainment, sporting, or other recreational venues or events are not appropriate.”
Key Differences between PhRMA Code and the Special Fraud Alert
Our speakers also went ahead to compare the key differences between the OIG Special Fraud Alert and this PhRMA code, on the prohibition of alcohol and sales & marketing teams’ input in speaker selection.
The revised Code does not prohibit alcohol from being available for purchase by attendees at a speaker program, whereas the Special Fraud Alert indicates that the mere availability of alcohol—even if not provided by a manufacturer—is “suspect”.
The revised Code also does not prohibit sales and marketing business units from influencing speaker selection, unlike the Special Fraud Alert which considers that “a company’s sales or marketing business units influence the selection of speakers…” is a suspect characteristic.
Although adherence to the PhRMA code is at the discretion of a life sciences company yet in some states, compliance to the PhRMA code is mandatory.
That’s why it’s an important guidance note to be aware of.
The presentation on PhRMA code revisions and their implications by Seth and Brian was followed by a quick Q/A session.
Have a question around PhRMA code for Seth Lundy or Brian Bohnenkamp, or any suggestions/queries about webinars, email us at [email protected]
