Lost in translation? International drug marketing guidelines are vague, toothlessFor those poring over the fine print of the Sunshine Act, the latest code of conduct guidelines from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) will seem refreshingly mellow.
IFPMA says the latest revamp draws clear lines between proper and improper ways to woo healthcare providers by distinguishing between items such as gifts (not permitted) and items of medical utility, such as an anatomical figure to use when discussing conditions with patients (permitted). The rules also require all member companies to train their employees in what constitutes acceptable and unacceptable conduct and bar company-sponsored entertainment at CME events.
As for enforcement? Well, IFPMA's code says members are obligated to comply with all applicable local and national codes but should default to its rules in the absence of such codes. And if they are found to be in violation of the code? They have ten days to furnish a compliance statement of how they'll put things right. In really serious cases, they may be named and shamed on the IFPMA's website!
For US operators, these rules will seem pretty remedial, yet Mark Greyson, deputy VP of PhRMA, cautions that it's too early to tell if these new regulations will require the US to modify its current code of conduct. As for what these changes could mean for global operations, Greyson said “everything is local,” referring to directions that run throughout IFPMA's document to comply with local laws.
PhRMA, which is an IFPMA member, has guidelines that have much in common with its international counterpart. For example, both require symposia, promotional or scientific events to provide scientific or educational information. Both require that product information be clear and sponsorship explicit and say companies cannot cover any guests—spouses or other companions who accompany healthcare providers to events. And both differentiate between promotional items and gifts versus educational items, a distinction IFPMA called out in an association statement as a sign of change.
Change it may be, but it highlights the difficulty of developing international codes spanning disparate medical cultures. PhRMA's guidelines specify that educational items are OK as long as “such items ... not be of substantial value, i.e. they should be $100 or less.” IFPMA's requirements are more open-ended, instructing that if the item primarily benefits a patient then it's OK as long as companies occasionally give “items of medical utility” such as textbooks and models.
These sorts of differences also apply to meals, which PhRMA OKs so long as they are “modest, occasional meals,” whereas IFPMA defines appropriate as meals that are “moderate and reasonable as judged by local standards.”
Joanna Groves of the UK-based patient advocacy group International Alliance of Patients' Organizations said it would be important to monitor member organizations for adherence. The association's chief executive officer told MM&M the new code is “a positive in that it is broader in scope and also sort of clarifies and covers more interactions than the previous code” and that IFPMA has provided a valuable point of reference for industry as well as healthcare and patient organizations.
“To start to clarify about what expectations there are around appropriate procedures and appropriate interactions is a step in the right direction,” she added.
Greyson told MM&M his association is still taking stock of the new international code and will take it from there. The new code goes into effect in September.