Johns Hopkins tightens policies with industry, including CMEs
Johns Hopkins Medicine has adopted a new policy that "significantly limits" interactions with industry while ensuring 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, clarifies several long-standing policies, and adds new restrictions on how Johns Hopkins physicians, scientists, students and staff may interact with industry.
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 said it will no longer accept free pharmaceutical samples. Although, the college said that 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," said Julie Gottlieb, assistant dean and director of the Hopkins' 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:
The entire Johns Hopkins Medicine Policy on Interaction with Industry is available online at: http://www.hopkinsmedicine.org/Research/OPC/JHMindustryinteractionpolicyFINAL.pdf
Called the Johns Hopkins Medicine Policy on Interaction with Industry, the policy, to take effect July 1, clarifies several long-standing policies, and adds new restrictions on how Johns Hopkins physicians, scientists, students and staff may interact with industry.
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 said it will no longer accept free pharmaceutical samples. Although, the college said that 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," said Julie Gottlieb, assistant dean and director of the Hopkins' 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 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, 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.
- 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.
The entire Johns Hopkins Medicine Policy on Interaction with Industry is available online at: http://www.hopkinsmedicine.org/Research/OPC/JHMindustryinteractionpolicyFINAL.pdf