Medical device salespeople will no longer be able to drop in on physicians or make unsolicited calls to doctors in the Partners Healthcare system without a written invitation.
The Boston Globe first reported the stricter regulations, which are slated to go into effect October 1.
Partners Healthcare’s system includes Brigham and Women’s hospital, Massachusetts General Hospital, the Spaulding Rehabilitation Hospital Network and several other hospitals and clinics across the state.
The new rules bar Partners network physicians from accepting paid speaking engagements and from receiving gifts, entertainment or food from medical device and drug companies.
The move comes on the heels of a larger, statewide gift ban enacted by the Massachusetts legislature and an even more stringent ban by Johns Hopkins University and Stanford University School of Medicine.
The regulations came out of a Partners watchdog group called the Commission on Interactions With Industry. The committee was created in the fall of 2007 by Partners president and CEO
Dr. James Mongan and is comprised of physician’s from across Partner’s vast healthcare system.
The requirements include:
– A written invitation “defining the purpose and terms of visit” before access to Partners and Partners staff is granted.
– A prohibition on all gifts, including meals and funding for meals, to Partners staff.
– A hospital-run distribution system for drug samples, routed through hospital pharmacies rather than directly to physicians.
– The establishment of a “president’s fund” to manage all fellowships and endowments from industry for educational purposes.
– The creation of a committee to examine “research-related conflict of interest” and a general conflicts of interest.
– Stricter oversight of outside activities, including bans on faculty speaking engagements, accepting “ghost writing” credits on articles written by others and the development of an internal review process for “certain outside activities.”
The rules are likely to raise concerns within the medical device community, particularly the invitation-only limitations on the contact industry can have with physicians. Unlike pharmaceutical companies, which advertise directly to the consumer, medical device firms rely on direct interaction with doctors to inform potential customers of new products and innovations.
Thomas Sommer, president of the Massachusetts Medical Device Industry Council (MassMEDIC), said the rules present a significant barrier to medical device marketing efforts.
“It just raises another obstacle for medical device companies interacting with physicians,” Sommer said, adding that the council’s members will do their best to comply with the new rules.
See below for a PDF version of the regulations.