Johns Hopkins Medicine has adopted a new policy that significantly limits interactions with industry while ensuring effective, principled and appropriate partnerships with drug and medical device makers.
Called the Johns Hopkins Medicine Policy on Interaction with Industry, the policy, to take effect July 1, strengthens and clarifies several long-standing policies while adding new restrictions on how Johns Hopkins physicians, scientists, students and staff may interact with industry.
"This policy will help us promote a culture in which Hopkins faculty and other personnel can exercise independent, unbiased judgment in all their activities while interacting with industry in appropriate ways that support our missions of delivering excellent care to patients, and integrity in teaching and research," said Edward D. Miller, dean of the medical faculty and CEO of Johns Hopkins Medicine.
Chief among the new rules are those that prohibit the acceptance of gifts or entertainment - including food - regardless of value, from pharmaceutical and medical device companies. Consulting arrangements that carry personal compensation but no real duties also are prohibited, and - beginning in 2010 - Hopkins will no longer accept free pharmaceutical samples, although in some limited cases, de-identified samples (those without the brand name or manufacturer's name) may be used for patient education.
The new policy restricts access by pharmaceutical representatives to non-patient care areas only, and then, only on the invitation of the physician or other Hopkins staff members. Similar restrictions are levied on medical device industry representatives. Unrestricted gifts to the institution from industry may be accepted under certain carefully spelled out circumstances.
"Industry plays a crucial role in advancing medical research and treatments, and the intent is not to discourage principled partnerships," says Julie Gottlieb, assistant dean and director of the JHM Office of Policy Coordination. "The major reason for developing this policy is to limit the impact of industry marketing influence on faculty and physicians' decision making and by so doing protect patients."
Other areas covered by the new policy include:
- Continuing Medical Education (CME): The Hopkins Office of CME (OCME) will continue to be the sole provider of programs offering CME credit under the Johns Hopkins name, and all industry-supported CME courses must be managed by the OCME. There will be central review of all non-credit educational events supported by industry to ensure that the programs are consistent with Accreditation Council for Continuing Medical Education (ACCME) standards. Other provisions of the policy require disclosure of the industry sponsor whenever a company supports non-credit educational courses, and an outright ban on industry funding for Hopkins' department meetings, retreats or social events.
- Participation in industry-sponsored programs: Hopkins employees may not speak at or on behalf of industry-sponsored programs (for example, "speakers bureaus") if the arrangement gives a company the right to dictate the content of a presentation, gives a company final approval over the content, or has a Hopkins faculty member or other employee acting as a company spokesperson. In making presentations for which there is industry payment or support, full disclosure must be made of the support. Employees may consult with industry to provide scientific advice provided payment for the service is at fair market value, the arrangement is detailed in a written agreement and complies with the Johns Hopkins University School of Medicine's policy on conflict of commitment, and the arrangement is reported as required by the relevant Hopkins administrative unit.
- Acceptable professional practices: Funds for professional travel, industry sponsorship of scholarships and other educational support for trainees will be required to be made at the institutional, not individual, level. The policy reiterates an existing ban on ghost-writing.
- Purchasing of products and services: Strict conflict of interest rules and disclosures will govern the purchase of equipment, products and services.
"Interactions between academic medical centers and industry are complex and important," say Gottlieb. "We continually review and revise our policies to address the challenging issues of industry influence and conflicts of interest. Our goal is to foster a culture at Johns Hopkins in which professionals exercise independent judgment when making clinical decisions."
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