In a move to meet demands of regulators and legislators, PhRMA has released their new guidelines for interaction with healthcare professionals (press release). The Code on Interaction with Healthcare Professionals, which takes effect in January 2009, is an update from their 2002 guidelines. It makes several important changes:
A) No gifts outside of educational materials for the benefit of patients and professionals (no more pens, notepads, stethoscopes, DVD players …).
B) No compensation to participation in promotional education programs.
C) Eliminate the use of resorts for any purposes (consultant meetings, speaker trainings …).
D) Prohibit out-of-office meals from sales representatives.
E) Enhance the independence of Continuing Medical Education funded by companies.
F) Set guidelines on the use of prescriber data, supporting appropriate use of the data, allowing for physician opt-out, and providing a contact for physicians.
G) Require training and monitoring of sales representatives to maintain the highest ethical standards.
H) Require company CEOs and Compliance Officers to certify annually that they have policies and procedures in place to foster compliance with the Code (patterned after the Sarbanes-Oxley standard).
I) Provide a venue on the PhRMA website for patients and providers to learn where to voice concerns and view a list of companies that have signed onto the Code.
J) Create a more transparent speaker and consultant relationship by requiring disclosure of relationships with industry and requiring each company to cap the amount of annual compensation and number of talks on individual physician speaker.
K) Education of Employees for compliance to the code and other regulations.
L) Education of speakers to comply with FDA guidelines and the code.
M) Speakers agree to disclose for up to two years involvement in speaker programs if they serve on a formulary or guidelines committee.
N) Re-enforces prohibition of entertainment and recreation.
For CME:
They follow along with the current ACCME standards for commercial support.
– Companies should separate CME Grant making functions from their sales and marketing departments.
– Support given to the CME provider to use at their discretion.
– The company should respect the independent judgment of the CME provider and follow standards for commercial support established by the ACCME or other entity that may accredit the CME.
– Control over selecting content, faculty, educational methods, materials and venue belong to the organizers of the conferences and meetings in accordance with their guidelines.
– Companies should not provide any advice or guidance to the CME provider even when asked by the provider, regarding the content or faculty for a particular CME program funded by the company.
– No support should be provided for attendees personal expense travel or lodging. (This is already covered by the ACCME rules but just re-enforces them.)
Overall this is an important step in meeting the expectations of the public, and policy makers. This is a very clear and concise document that provides a roadmap for ethical interactions with healthcare professionals. These guidelines go along way to showing legislators that the pharmaceutical industry is serious about making sure they meet high ethical guidelines.
There is a reasonable amount of time given to companies to comply, and this will serve as a light post for other similar organizations.