Sec. 1. 34-B MRSA §3011 is enacted to read:

§3011.__Clinical trials

Beginning January 1, 2006, a manufacturer of pharmaceutical drugs or a research organization or other health organization that sponsors a clinical trial of a pharmaceutical drug, treatment option or medical device and that enrolls as a participant in the trial a person who is receiving mental health treatment at a state mental health institute, as described in section 3201, at a community or specialty hospital if that treatment is fully or partially reimbursed with state funds, or at a juvenile or adult correctional facility shall notify the Executive Director of Dirigo Health established under Title 24-A, chapter 87 prior to beginning the clinical trial.__The Executive Director of Dirigo Health shall report by February 1st each year to the joint standing committee of the Legislature having jurisdiction over health and human services matters regarding the notifications received for the prior calendar year under this section.

SUMMARY

Beginning January 1, 2006, this bill requires a manufacturer of pharmaceutical drugs or a research organization or other health organization that sponsors a clinical trial of a pharmaceutical drug, treatment option or medical device and that enrolls as a participant in the trial a person who is receiving mental health treatment at a state mental health institute, as defined in the Maine Revised Statutes, Title 34-B, section 3201, at a community or specialty hospital if that treatment is fully or partially reimbursed with state funds, or at a juvenile or adult correctional facility to notify the Executive Director of Dirigo Health prior to beginning the clinical trial. The bill requires annual reports from the executive director regarding notifications of clinical trials.