Despite the passage of the Physician Payments Sunshine Act as part of Obamacare in 2010, whose regulations on transparency in payments from pharmaceutical and medical device companies to physicians exclude blind marketing research with health care professionals, state legislators continue to offer legislation that would potentially restrict pharmaceutical and medical device marketing research studies. Meanwhile, across the pond, research associations in France are getting new help in combatting a Sunshine Act equivalent that failed to exclude pharmaceutical marketing research incentives for doctors.
S.B. 3270A would require the pharmaceutical manufacturers or labelers of each prescription drug to file annual reports on the the marketing costs of each drug with the Department of Health. It also would eliminate the tax deductivility for pharmaceutical advertising. S.B. 3428A would require a cost/benefit analysis of pharmaceutical advertising and promotional expenses.
Niether one, on their face, would appear problematic for survey, opinion and marketing research. However, we have ample experience from Maine that demonstrates the danger in such legislation when it does not explicitly exclude marketing research. Maine's law similarly required annual reporting on marketing expenditures, but the regulator specifically added a provision in the rules to require the reporting of marketing research expenses as well. That led to pharmaceutical companies shutting down nearly all such research in Maine, until MRA helped convince the state to repeal its law in 2011. A similar situation continues to exist in West Virginia.
That is why MRA remains opposed to Senator Krueger's bills, absent any explicit carve out for marketing research -- although it is not a marketing activity, legislators and regulators often don't realize that, or just plain don't care.
A French law that came into effect in May 2013, the Loi Bertrand, appears to require public reporting of incentive payments to physicians who participate in pharmaceutical marketing research -- the exact outcome we fought so hard to prevent here in the U.S. According to our European counterparts, ESOMAR, "meetings with French authorities organised by local French associations have led to the responsible ministry confirming that the application of the law would also cover incentives paid out by research agencies when conducting surveys."
However, ESOMAR reported in February that ESOMAR, EphMRA, and French associations SYNTEC and UDA convinced Françiose Castex, a French Member of European Parliament (MEP), to take up the marketing research profession's cause. Castex has sought to get the European Commission to accept that the Loi Bertrand's reporting requirements for marketing research incentives may violate the European Union Data Directive, and thus to at least carve out marketing research from the Loi Bertrand.
More to come
MRA continues to keep watch on state-level legislation that could negatively impact pharmaceutical and medical device marketing research with doctors and to help our partners around the world to combat similar mistakes in their nations.
For researchers looking to conduct such research in the U.S., we encourage review of our industry 1-pager on the Sunshine Act, our compliance FAQs, a joint FAQ developed with CASRO and PMRG, and a model form for a physician's acknowledgement of participation in marketing research.
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.