Each time the state of Minnesota has tried to clarify treatment of respondent incentives for the participation of health care practitioners in marketing research sponsored by pharmaceutical manufacturers, companies still end up confused. What do the law, regulations and guidance tell us?
Minnesota law restricts “gifts” from pharmaceutical manufacturers and wholesalers to “practitioners” and requires reporting of payments to practitioners (if not otherwise prohibited).
A practitioner is anyone licensed by the state who can write prescriptions for drugs.
The Insights Association helped the Minnesota Board of Pharmacy to clarify the gift ban in 2010, in a revised FAQ guidance document, explaining that marketing/sales under the guise of research with practitioners (sugging) was prohibited, but that respondent incentives for “bona fide market research (i.e. a “genuine research project”)” were allowed.
As the FAQs explain at the bottom of page 1: "Q. Under Minnesota law, is it appropriate to make cash payments to practitioners for participation in so-called “surveys” that are intended by pharmaceutical manufacturers to promote, market or sell a drug directly to those practitioners? A. No. Such practices would be considered commercial marketing activities, rather than bona fide market research (i.e. a “genuine research project”) conducted by independent survey research organizations. Participation in marketing activities is not a “substantial service,” nor does it involve a “genuine research project” as intended by the legislature. Therefore, cash payments to practitioners who participate in marketing activities are prohibited under the gifts to practitioners statute."
Modest meals constitute prohibited gifts if over $50, unless "the practitioner is providing to the manufacturer ‘substantial professional and consulting services’ as part of a genuine research project" (e.g., bona fide marketing research).
Per M.S. § 151.461, manufacturers "may legally" pay "compensation for the substantial professional or consulting services of a practitioner in connection with a genuine research project" – which, as noted above, the Board of Pharmacy has clarified to include respondent incentives for marketing research.
Per M.S. § 151.152, manufacturers must “file an annual report” regarding such payments: “The report shall identify the nature and value of any payments totaling $100 or more to a particular practitioner during the year, and shall identify the practitioner. Reports filed under this subdivision are public data.”
However, the reporting requirement is partially offset by the federal Physician Payments Sunshine Act, which preempted state payment reporting schemes for payments to physicians. As explained on the Minnesota Board of Pharmacy website, "States can no longer collect data on payments made to physicians (and the federal act broadly defines physicians to also include dentists, optometrists, and podiatrists)." According to a July 9, 2014 memorandum from the Board of Pharmacy, “The intent was to have the Board continue to collect data on payments made to other practitioners (physician assistants, nurse practitioners, veterinarians and dental therapists)."
- respondent incentives for practitioners participating in bona fide marketing research sponsored by pharmaceutical manufacturers are legal in Minnesota;
- modest meals for practitioners participating in such bona fide studies are also legal in Minnesota; and
- those respondent incentives, if provided to physician assistants, nurse practitioners, veterinarians or dental therapists in Minnesota, and totaling $100 or more annually, must be reported publicly.
As a result, marketing research and data analytics companies and departments should presume that pharmaceutical manufacturers’ compliance departments will avoid research studies with Minnesota’s physician assistants, veterinarians, and dental therapists.
Any company or department getting pushback on MR/A projects from pharma compliance departments (particularly on research with physicians, dentists, optometrists, and podiatrists in Minnesota, which should be fine) should contact me at howard dot fienberg at insightsassociation dot org.
NOT AN INSIGHTS ASSOCIATION MEMBER? JOIN TODAY FOR COMPLIANCE INFORMATION, INSIGHTS INDUSTRY ADVOCACY, AND MORE.
As the leading voice, resource and network of the marketing research and data analytics community, the Insights Association helps its members create competitive advantage. All our revenue is invested in quality standards, legal and business advocacy, education, certification and direct support to enable our members to thrive in an evolving industry and drive business impact.
This information is not intended and should not be construed as or substituted for legal advice. It is provided for informational purposes only. It is advisable to consult with private counsel on the precise scope and interpretation of any laws/regulation/legislation and their impact on your particular business.