Massachusetts Marketing Code of Conduct and the Effects on Drug and Device Marketing Research

By: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com

On March 11, 2009 the Massachusetts Public Health Council released the new Marketing Code of Conduct to regulate the interactions between healthcare practitioners and pharmaceutical and medical device manufacturing companies. The regulations require mandatory reporting of the “value, nature, purpose and the recipient of any fee, payment, subsidy, or economic gift” with a value of $50 or more, that is provided through the company or by company agents for sales and marketing activities. The new regulations also apply to payments to healthcare practitioners participating in marketing surveys. [1]

The Marketing Research Association (MRA) has stated that the regulations will severely impact research with practitioners. [2] Pharmaceutical and medical device manufacturers are required to publicly disclose the name of the participant, which will make practitioners less likely to participate in important and beneficial marketing research. The MRA states that reduced participation will lead to less research being performed, which can have a number of adverse implications down the line, including loss of jobs and a significant decrease in income for the state of Massachusetts (medical conventions held in Boston generate millions of dollars in visitor spending per year, but some groups have already canceled their convention, and others have stated that they are avoiding Boston because of the uncertainty with the law). [3]

The intent of the regulations is to prevent undue influence in the relationship between manufacturers and healthcare practitioners. However, the MRA has issued a statement advocating that marketing research incentives be exempt from the reporting requirements. The MRA states that the “regulation will severely hinder survey and opinion research with healthcare professionals, whose participation is often tied to sizeable research incentives, because of the high demands on and cost of their time” and that the “regulation will damage the quality of research by injecting bias [because] in most research the participants – and often the interviewers – are unaware of who sponsored the study.” They also point out that publicly disclosing personally identifiable information undermines the ethical code of survey and opinion research to maintain confidentiality of participants. [4]

The statement also highlights the value that marketing research brings to the public and patients, including patient compliance, prevention of medical errors, and simulations that ensure patient safety.

While there is a need for transparency in the relationship between healthcare practitioners and drug and device manufacturers, the MRA has made a valid argument for marketing research incentives to be exempt from the reporting requirements.

To read more about the MRA and their position on the Massachusetts Marketing Code of Conduct, visit their website: http://www.mra-net.org/.

Sources:
[1] http://www.cmor.org/ga/gaArticle04_09.cfm
[2] http://www.policymed.com/2009/04/marketing-research-association-to-massachusetts-slow-down.html
[3] http://meetingsnet.com/medicalmeetings/news/massachusetts_law_medical_conventions_0109/
[4] http://www.cmor.org/pdf/mra_issue_paper-mass_healthcare_reg.pdf
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