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PUBLIC LAWS OF MAINE
First Regular Session of the 121st

CHAPTER 430
H.P. 209 - L.D. 254

An Act To Require Full Disclosure of Prescription Drug Marketing Costs

Be it enacted by the People of the State of Maine as follows:

     Sec. 1. 22 MRSA §2699 is enacted to read:

§2699. Marketing costs

     A manufacturer or labeler of prescription drugs dispensed in this State that employs, directs or utilizes marketing representatives in this State shall report marketing costs for prescription drugs in this State as provided in this section.

     1. Purposes. Marketing costs for prescription drugs in this State must be reported to the department for the purposes of assisting this State in its role as a purchaser of prescription drugs and an administrator of prescription drug programs, enabling this State to determine the scope of prescription drug marketing costs and their effect on the cost, utilization and delivery of health care services and furthering the role of this State as guardian of the public interest.

     2. Definitions. As used in this section, unless the context otherwise indicates, the following terms have the following meanings.

     3. Manner of reporting. 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 as it pertains to marketing activities conducted within this State in a form that provides the value, nature, purpose and recipient of the expense:

     5. Exceptions. The following marketing expenses are not subject to the requirements of this section:

     6. Department reports. 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, 2005 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.

     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. 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.

     8. Penalty. This section may be enforced in a civil action brought by the Attorney General. A manufacturer or labeler that fails to provide a report as required by this section commits a civil violation for which a fine of $1,000 plus costs and attorney's fees may be adjudged.

     9. Rulemaking. The department shall adopt rules to implement this section. Rules adopted pursuant to this section are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A.

     Sec. 2. Report. The Department of Human Services shall report to the joint standing committee of the Legislature having jurisdiction over health and human services matters on or before January 1, 2005 and on or before July 1, 2005 on the assessment of fees on manufacturers and labelers of prescription drugs pursuant to the Maine Revised Statutes, Title 22, section 2699 and the use of those fees to support the work of the department with regard to the provisions of Title 22, section 2699.

     Sec. 3. Effective date. This Act takes effect July 1, 2004.

Effective July 1, 2004.

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