A Message from Partners President and CEO James J. Mongan, MDon new policies regarding interactions with industry (September 30, 2009)
I am writing to let you know that as of October 1, 2009, Partners HealthCare will begin implementing the recommendations announced last April of an internal, physician-led commission that examined our policies and practices for interacting with pharmaceutical and medical device companies.
This examination was undertaken because Partners considers interactions with industry to be essential for translating scientific advances into improvements in patient care – but we also recognize that these relationships must be managed carefully to assure patients and the public that they do not introduce bias, either real or perceived, into decisions about optimal patient care, the conduct of research, or the content of medical education and training.
As I indicated last April, I asked MGH President Peter Slavin, MD to lead a Commission Implementation Task Force, and thanks to the commitment and leadership of this group, which includes clinicians and senior leaders from across Partners, tremendous progress has been made, and we are ready to move forward on the first group of policy changes.
You will recall that key elements of the commission recommendations were to tighten current conflict of interest policies, introduce several new policies, and strengthen internal education, oversight and enforcement. This message contains a brief overview of changes occurring October 1, a description of the new oversight and compliance committees now in place, and a summary of what remains to be accomplished over the coming months.
Key new policies are:
Gifts.A comprehensive ban on gifts to all Partners faculty and staff from pharmaceutical companies, medical device companies, and all other vendors. This includes any items for the personal use of staff members, as well as meals and funding of meals for individual staff members.
Speakers Bureaus. A ban on participation in speakers bureaus. (Existing contractual and other financial commitments may be honored through December 31, 2009.)
Ghostwriting. An explicit ban on ghost writing.
Royalties. A new requirement to ensure that a Partners entity does not benefit from royalties on sales of products made to that entity.
Purchasing Transactions. Stronger oversight processes for significant purchasing transactions, to ensure that any relevant conflicts created by personal relationships of Partners individuals with the company involved are appropriately vetted and managed.
Industry Support of Educational Programs. At Brigham and Women’s Hospital, Massachusetts GeneralHospital, and McLeanHospital, establishment of a “President’s Fund for Medical Education” as a mechanism to allow companies to contribute to the support of institutionally determined priorities in medical education. Similar Funds will be established at other Partners hospitals. Existing approved contractual and financial commitments are not affected by this phase of policy implementation. Additional policies relating to industry support of educational programs, as recommended in the Commission Report, will be developed in the course of the next phases of policy implementation.
Outside Activities of Senior Officials.New restrictions on the outside activities of senior institutional officials, which include limits on the amount and type of compensation they can receive for serving on boards of directors of biomedical companies or other companies that may do significant business with any Partners entity. (The compensation limits will be in effect as of January 1, 2010.)
Creation of an implementation and compliance structure.As recommended by the
commission, three new organizational structures have been created to manage the new policies.
They are:
Conflicts of Interest Committee (COI Committee). Responsible for handling day-to-day matters including the more rigorous conflict review processes that may raise conflict of interest issues. Barbara Bierer, MD, Senior Vice President for Research at Brigham and Women’s Hospital, and Richard Bringhurst, MD, Senior Vice President for Research at Massachusetts GeneralHospital, will serve as co-chairs. Full committee membership will be announced later this fall.
Education Review Board. (ERB) Responsible for overseeing industry support of Partners educational activities. Discussions are underway about the chair for the ERB, and full committee membership will be announced later this fall.
Office for Interactions with Industry. Responsible for oversight of industry interactions, this new office (which will report to the General Counsel) will consolidate a number of activities currently handled by different offices throughout Partners, and it will also have responsibility for new activities. In collaboration with Partners hospitals and other entities, this new office will oversee and implement all policies relating to interactions with industry, and outside activities, including oversight and integration of all COI disclosure processes. It will staff and manage the COI Committee and ERB responsibilities, and it will develop and maintain educational/training programs and an audit/compliance and sanction system. Christopher Clark, who for over twenty years has been deeply involved in institutional policies regarding interactions with industry, has agreed to serve as director of this new office. He will do this while retaining his position as a senior attorney in the Office of the General Counsel, and his OGC portfolio will be revised to accommodate this new, additional leadership responsibility.
While significant progress has been made, a great deal of work remains. We have begun to build the administrative infrastructure to oversee and sustain these new policies, but until the offices are fully staffed and operational, some of the commission recommendations cannot be fully implemented. We expect that the remaining commission recommendations in regard to research conflicts and industry support of educational activities and fellowships will be implemented in phases over the upcoming year and beyond.
I recognize that these new rules will lead to many questions. The entity compliance officers should continue to be viewed as the primary source of information on the new policies. When the Office for Interactions with Industry is staffed up early next year, that office, and the website it will maintain, will become an additional resource for “one-stop shopping” regarding issues, questions and activities related to interactions with industry.
I am especially grateful to Dr. Peter Slavin for his effective leadership of this most important effort, and for the ongoing diligent work that he and his colleagues on the Implementation Task Force and its subcommittees are doing that will enable us to achieve full implementation of the commission’s recommendations in the months ahead.
James J. Mongan, MD
President and CEO