For the first time since 2002, Pharmaceutical Research and Manufacturers of America in 2008 updated its voluntary Code on Interactions with Healthcare Professionals, establishing several new guidelines, including a crackdown on gifts to physicians.
The revised code, which went into effect in January 2009, prohibits distribution of noneducational items to healthcare professionals. This even includes small gifts, such as pens, notepads, mugs, and similar “reminder items” with company or product logos on them, even if they are practice-related. Such gifts “may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues,” states the code. Gifts that relate to the education of patients that have no value to the healthcare professional outside of their professional responsibilities are permissible, provided they are valued at less than $100. This would include, for example, an anatomical model for use in the examination room. This marks a change from the previous rules, which allowed small reminder and practice-related gifts.
There are two changes related to CME. The new code specifies that companies should not provide any guidance to the provider about content, faculty, or the program, even if asked. This addition corresponds with new Accreditation Council for CME guidelines. The other change is that companies are not permitted to directly pay for meals at CME events. Previously, companies were allowed to directly underwrite meals in some cases. As in the previous code, financial support of certified continuing medical education is allowed, but companies should separate grant-making functions from sales and marketing functions. Any financial support should be given directly to the conference sponsor and funding for travel, lodging, and personal expenses of non faculty healthcare professionals attending CME is prohibited.
Regarding company-sponsored events, there is a major change: Resorts are deemed inappropriate venues for consultant and speaker-training meetings. Previously, resorts were discouraged, but not prohibited. As in the previous code, modest meals are appropriate, but companies should not provide recreational or entertainment events in conjunction with any type of meeting or interaction with healthcare professionals. Fees paid to speakers and consultants should be fair market value and companies should cap the amount they pay annually to any individual speaker
In another major change, company sales representatives are prohibited from providing restaurant meals to healthcare professionals, but they are allowed to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations.
New provisions also require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations, and industry codes of practice that govern interactions with healthcare professionals. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, as well as contact information for company compliance officers and information about the companies’ annual certifications of compliance.
“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policymakers, healthcare professionals, and others telling us we can do better,” said Billy Tauzin, president and CEO of PhRMA, in a press release. “This updated Code fortifies our companies’ commitment to ensure their medicines are marketed in a manner that benefits patients and enhances the practice of medicine.”
For more on the revisions, go to www.phrma.org.