On July 10, the Pharmaceutical Research and Manufacturers Association (PhRMA) released an updated version of its Code for Interaction with Healthcare Professionals, commonly known in the industry as the “PhRMA Code.” Originally released in 2002, the voluntary Code is part of PhRMA’s ongoing outreach to promote ethical pharmaceutical marketing.
Major changes to the Code include:
Non-educational promotional items are prohibited. The revised code is explicit in prohibiting practice-related items of minimal value, including pens, mugs or other “reminder” items. Educational items for physicians, such as journal subscriptions, copies of clinical practice guidelines and textbooks, and materials designed to educate patients about their disease or treatment options are also permitted.
Sales personnel may not provide off-site meals for healthcare professionals or their staffs. While sales representatives may continue to provide in-office meals in conjunction with informational sessions, they are no longer permitted to provide restaurant meals. Non-sales personnel are permitted to provide off-site or restaurant meals.
Recreational and entertainment items are no longer allowed. Regardless of a healthcare provider’s connection to the company (e.g., speaker or consultant), manufacturers are no longer permitted to provide such items as theater or sporting event tickets, trips or sporting equipment.
Each manufacturer should implement processes to ensure compliance and state their intention to abide by the code. Companies should state their intent to abide by the code, and implement compliance programs. Compliance should be reviewed annually to ensure proper adherence to the Code. PhRMA is encouraging companies to seek external verification of compliance.
Company representatives must be well versed in codes of practice (including the PhRMA Code), regulations and applicable laws governing the healthcare industry. Additionally, companies should regularly assess representatives’ compliance and, if necessary, provide additional training.
In addition to these revisions, more detailed standards are included regarding continuing medical education (CME) and guidance for speaking and consulting arrangements.
Compensation for speakers and consultants must be based on fair market value. This is largely unchanged from the original Code, although recreational or entertainment events are prohibited (see above).
CME support must be unbiased. The code directs companies to develop objective criteria for making CME grant decisions. Support should not be intended to influence the decision to prescribe a particular medicine or treatment. CME grant-making functions should be separate from the sales and marketing departments. Moreover, companies should not directly provide food or beverage at CME events, although a CME provider may choose to apply funds for participant meals.
The revised Code will go into effect in January 1, 2009. The full Code is available on line at the PhRMA web site.
Wendy Waldsachs Isett, Communications Manager, AUA