Pharmaceutical Research and Manufacturers of America (PhRMA) announced that it has revised its Code on Interactions with Healthcare Professionals. PhRMA, which is comprised of top executives of America’s pharmaceutical research and biotechnology companies, said that the Code was revised to reflect PhRMA’s continuing commitment to the needs of patients and the healthcare community by “ensuring that pharmaceutical marketing practices comply with the highest ethical standards.” The new rules are an update to the previous version, last published in 2002, and are set to take effect on January 1, 2009.
The 2009 version prohibits distribution of non-educational items with company or product logos or other branding. As with the prior version, pharmaceutical company sales personnel cannot provide to healthcare professionals recreation or entertainment activities of any kind, and can no longer furnish restaurant meals, other than in-office meals provided during informational presentations. The new guidelines also contain strengthened training requirements for sales personnel.
New code provisions also include more detailed standards regarding the independence of continuing medical education; principles on the responsible use of non-patient identified prescriber data; and additional guidance for speaking and consulting arrangements with healthcare professionals, including disclosure requirements for healthcare providers who are members of committees that set formularies or develop clinical practice guidelines and who also serve as speakers or consultants for a pharmaceutical company.
According to PhRMA, “interactions between company representatives and healthcare professionals should be focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education.”
Similar to Sarbanes-Oxley compliance mechanisms, each member company of PhRMA must state its intentions to abide by the code through annual certifications of CEOs and Compliance Officers. Johnson & Johnson, Merck & Co., Amgen Inc., Eli Lilly & Co. and AstraZeneca PLC have reportedly already done so as of today.