Industry Relations

New PhRMA Code on Interaction with Healthcare Professionals: Summary highlighting key elements of the guidelines

By Allison Shuren and Courtney Yohe, Arnold & Porter

Starting in January, pharmaceutical manufacturers will have many more restrictions on their interactions with health care professionals if they choose to adopt the new guidelines issued by the Pharmaceutical Research and Manufacturers of America (PhRMA). Although practitioners may still have regular visits from “drug reps,” they might notice a change in how “pharmaceutical detailers” deliver their respective messages. PhRMA is not the only trade group strengthening its provider protocols. AdvaMed, representing the medical device manufacturers along with other, international bodies are also examining their practices in the face of federal legislation and regulation that may ask companies to disclose their payments and gifts to health care professionals.

Among its changes, the revised PhRMA Code:

• Prohibits distribution of non-educational items (such as pens, mugs and other “reminder” objects typically adorned with a company or product logo) to healthcare providers and their staff. Gifts deemed to be educational items may not exceed $100 in value.
• Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.
• Companies may continue to sponsor Continuing Medical Education (CME) if the following guidelines are met:
  • Any financial support should be given to the CME provider, which, in turn, can use the money to reduce the overall CME registration fee for all participants.
  • The CME provider should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME.
  • The company should not provide any advice or guidance to the CME provider
  • The company may not offer direct or indirect financial support to cover the costs of travel, lodging, or other personal expenses of non-faculty healthcare professionals attending CME
  • Financial assistant for scholarships or other educational funds to permit medical students, residents, fellows, and other healthcare professionals in training to attend carefully selected educational conferences may be offered so long as the selection of individuals who will receive the funds is made by the academic or training institution.
• Companies may continue to obtain the services of professional consultants who provide advisory services if certain criteria for a bona fide consulting arrangement are met. Bona fide consultants may receive compensation as well as reimbursement for reasonable expenses associated with their services, however, speaking arrangements may not be used as inducements or rewards for prescribing behavior.
• Companies should require any healthcare professional who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the existence and nature of his or her relationship with the company. This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement.
• Companies that choose to use non-patient identified prescriber data to facilitate communications with healthcare professionals should use the data responsibly.

For more information on the new PhRMA Code on Interactions with Healthcare Professionals, please visit, http://www.phrma.org/code_on_interactions_with_healthcare_professionals/.

To view an outline of the updates to the Pharma Guidelines, click here.

This guidance is intended to establish general advice and recommendations for NAPNAP members regarding their interactions with pharmaceutical, medical device, and medical supply companies, and should not be considered to articulate specific legal standards. Further, the recommendations are neither definitive nor binding. Questions about specific activities or arrangements should be directed to a competent health care attorney.