For those poring over the Sunshine Act's fine print, the latest code of conduct guidelines from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) will seem mellow.
IFPMA says the new revamp draws clear lines between proper and improper ways to woo healthcare providers. The rules require all member companies to train their employees in what constitutes acceptable and unacceptable conduct and bar company-sponsored entertainment at CME events.
For US operators, these rules will seem remedial, yet Mark Grayson, deputy VP of PhRMA, says it's too early to tell if the new regulations will require the US to modify its code of conduct. As for what the changes could mean for global operations, Grayson said “everything is local,” referring to directions in IFPMA's document to comply with local laws.
PhRMA, an IFPMA member, has guidelines that have much in common with its international counterpart. Both require symposia, promotional or scientific events to provide scientific or educational information. Both stipulate that product information be clear and sponsorship explicit and say companies cannot cover guests who accompany healthcare providers to events. And both differentiate between promotional items and gifts and educational items, a distinction IFPMA called out in a statement as a sign of change.
These changes highlight how hard it is to develop codes spanning disparate medical cultures. PhRMA's guidelines say educational items should be of “$100 or less” in value; IFPMA's requirements say that if the item primarily benefits a patient it's OK if companies occasionally give “items of medical utility” such as textbooks and models.
Joanna Groves, chief executive officer of the UK-based patient advocacy group International Alliance of Patients' Organizations said it would be important to monitor member organizations for adherence. She told MM&M that IFPMA has provided a valuable point of reference for industry as well as healthcare and patient organizations.
Grayson told MM&M
his association is still taking stock of the new international code, which goes into effect in September, and will take it from there.