HOUSE BILL No. 5390

 

October 31, 2007, Introduced by Reps. Donigan, Brown, Byrum, Simpson, McDowell, Bieda, Vagnozzi, Valentine, Corriveau, Polidori, Leland, Hopgood, Dean, Miller, Alma Smith, Lemmons, Wojno, Kathleen Law, Constan, Accavitti and Hammel and referred to the Committee on Health Policy.

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

(MCL 333.1101 to 333.25211) by adding part 96A.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

PART 96A. CLINICAL TRIALS – HUMAN SUBJECT RESEARCH

 

     Sec. 9651. As used in this part:

 

     (a) "Clinical trial" means a clinical investigation approved

 

by the federal food and drug administration that involves any

 

experiment to test the safety or efficacy of a drug or biological

 

product and 1 or more human subjects and is intended to be

 

submitted to, or held for inspection by, the federal food and drug

 

administration as part of an application for a research or

 

marketing permit.


 

     (b) "Department" means the department of community health.

 

     (c) "Human subject" means a living individual about whom an

 

investigator conducting research obtains data through intervention

 

or interaction with the individual or obtains identifiable private

 

information.

 

     (d) "Institutional review board" means any board, committee,

 

or other group formally designated by a person to review, to

 

approve the initiation of, and to conduct periodic review of,

 

biomedical research involving human subjects.

 

     (e) "Manufacturer" means a person who prepares, produces,

 

derives, propagates, compounds, processes, packages, or repackages

 

a drug or device salable on prescription only, or otherwise changes

 

the container or the labeling of a drug or device salable on

 

prescription only, and who supplies, distributes, sells, offers for

 

sale, barters, or otherwise disposes of that drug or device and any

 

other drug or device salable on prescription only, to another

 

person for resale, compounding, or dispensing.

 

     (f) "Person" means an individual, partnership, corporation,

 

association, governmental entity, or other legal entity, public or

 

private.

 

     (g) "Research" means a systematic investigation, including

 

research development, testing, and evaluation, designed to develop

 

or contribute to general knowledge.

 

     Sec. 9653. (1) The department shall adopt rules to incorporate

 

by reference federal statutes and regulations on clinical trials

 

and the protection of human subjects. The department may adopt

 

amendments to those statutes and regulations that are not


 

inconsistent with those statutes and regulations. A manufacturer or

 

other person that does business in this state shall not conduct a

 

clinical trial unless that research is conducted in compliance with

 

this part and rules promulgated pursuant to this part.

 

     (2) A manufacturer or other person who does business in this

 

state shall report to the department as prescribed under section

 

9655 any clinical trial that it conducts or sponsors and shall make

 

the results of the clinical trial available to the department and

 

the public.

 

     Enacting section 1. This amendatory act does not take effect

 

unless all of the following bills of the 94th Legislature are

 

enacted into law:

 

     (a) Senate Bill No.____ or House Bill No. 5395(request no.

 

02308'07).

 

     (b) Senate Bill No.____ or House Bill No. 5392(request no.

 

02311'07).

 

     (c) Senate Bill No.____ or House Bill No. 5393(request no.

 

02312'07).

 

     (d) Senate Bill No.____ or House Bill No. 5391(request no.

 

02313'07).

 

     (e) Senate Bill No.____ or House Bill No. 5394(request no.

 

02314'07).