CHAPTER 286
S.P. 534 - L.D. 1539
An Act Pertaining to Reporting of Prescription Drug Advertising Costs
Be it enacted by the People of the State of Maine as follows:
Sec. 1. 22 MRSA §2698-A, sub-§§3, 4 and 6, as amended by PL 2003, c. 688, Pt. C, §8, are further amended to read:
3. Manner of reporting. Beginning in 2006 2007, by July 1st each year, a manufacturer or labeler of prescription drugs that directly or indirectly distributes prescription drugs for dispensation to residents of this State shall file a report with the department in the form and manner provided by the department. The report must be accompanied by payment of a fee, as set by the department in rule, to support the work of the department under this section.
4. Content of annual report by manufacturer or labeler. The annual report filed under subsection 3 must include the following information for each calendar year, beginning with calendar year 2005 2006, as it pertains to marketing activities conducted within this State in a form that provides the value, nature, purpose and recipient of the expense:
A. All expenses associated with advertising, marketing and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail and telephone communications as they pertain to residents of this State, except for expenses associated with advertising purchased for a regional or national market that includes advertising within the State;
B. With regard to all persons and entities licensed to provide health care in this State, including health care professionals and persons employed by them in this State, carriers licensed under Title 24 or Title 24-A, health plans and benefits managers, pharmacies, hospitals, nursing facilities, clinics and other entities licensed to provide health care under this Title, the following information:
(1) All expenses associated with educational or informational programs, materials and seminars and remuneration for promoting or participating in educational or informational sessions, regardless of whether the manufacturer or labeler provides the educational or informational sessions or materials;
(2) All expenses associated with food, entertainment, gifts valued at more than $25 and anything provided to a health care professional for less than market value;
(3) All expenses associated with trips and travel; and
(4) All expenses associated with product samples, except for samples that will be distributed free of charge to patients; and
C. The aggregate cost of all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed in paragraphs A and B, including all forms of payment to those employees. The cost reported under this paragraph must reflect only that portion of payment to employees or contractors that pertains to activities within this State or to recipients of the advertising or promotional activities who are residents of or are employed in this State.
6. Department reports. Beginning in 2006 2007, by November 30th each year, the department shall provide an annual report, providing information in aggregate form, on prescription drug marketing expenses to the Legislature and the Attorney General. By January 1, 2007 2008 and every 2 years after that date, the department shall provide a report to the Legislature and the Attorney General, providing information in aggregate form, containing an analysis of the data submitted to the department, including the scope of prescription drug marketing activities and expenses and their effect on the cost, utilization and delivery of health care services and any recommendations with regard to marketing activities of prescription drug manufacturers and labelers.
Sec. 2. 22 MRSA §2698-A, sub-§7, as reallocated by RR 2003, c. 1, §17 and affected by §18, is amended to read:
7. Confidentiality; public information. Notwithstanding any provision of law to the contrary, information submitted to the department pursuant to this section is confidential and is not a public record as defined in Title 1, section 402, subsection 3. Disclosure may be made by the department to a contractor providing services to the department under this section; however, that disclosure does not change the confidential status of the information. Data compiled in aggregate form by the department for the purposes of reporting required by this section is a public record as defined in Title 1, section 402, subsection 3, as long as it does not reveal trade information that is protected by state or federal law.
Effective September 17, 2005.
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