152.21 THC Therapeutic Research Act.

Subdivision 1. Findings and purpose. The legislature finds that
scientific literature indicates promise for
delta-9-tetrahydro-cannabinol (THC), the active component of
marijuana, in alleviating certain side effects of cancer chemotherapy
under strictly controlled medical circumstances.

The legislature also finds that further research and strictly
controlled experimentation regarding the therapeutic use of THC is
necessary and desirable. The intent of this section is to establish an
extensive research program to investigate and report on the
therapeutic effects of THC under strictly controlled circumstances in
compliance with all federal laws and regulations promulgated by the
federal Food and Drug Administration, the National Institute on Drug
Abuse and the Drug Enforcement Administration. The intent of the
legislature is to allow this research program the greatest possible
access to qualified cancer patients residing in Minnesota who meet
protocol requirements. The establishment of this research program is
not intended in any manner whatsoever to condone or promote the
illicit recreational use of marijuana.

Subd. 2. Definitions. For purposes of this section, the following
terms shall have the meanings given.

(a) “Commissioner” means the commissioner of health.

(b) “Marijuana” means marijuana as defined in section 152.01,
subdivision 9, and delta-9-tetrahydro-cannabinol (THC),
tetrahydrocannabinols or a chemical derivative of
tetrahydrocannabinols, and all species of the genus Cannabis.

(c) “Principal investigator” means the individual responsible for the
medical and scientific aspects of the research, development of
protocol, and contacting and qualifying the clinical investigators in
the state.

(d) “Clinical investigators” means those individuals who conduct the
clinical trials.

(e) “Sponsor” means that individual or organization who, acting on
behalf of the state, has the total responsibility for the state
program.

Subd. 3. Research grant. The commissioner of health shall grant funds
to the principal investigator selected by the commissioner pursuant to
subdivision 4 for the purpose of conducting a research program under a
protocol approved by the FDA regarding the therapeutic use of oral THC
and other dosage forms, if available, according to the guidelines and
requirements of the federal Food and Drug Administration, the Drug
Enforcement Administration and the National Institute on Drug Abuse.
The commissioner shall ensure that the research principal investigator
complies with the requirements of subdivision 5. The commissioner may
designate the principal investigator as the sponsor.

Subd. 4. Principal investigator. Within three months of April 25,
1980, the commissioner shall, in consultation with a representative
chosen by the state Board of Pharmacy and a representative chosen by
the state Board of Medical Examiners, select a person or research
organization to be the principal investigator of the research program.

Subd. 5. Duties. The principal investigator shall:

(1) Apply to the Food and Drug Administration for a notice of “Claimed
Investigational Exemption for a New Drug (IND)” pursuant to the
Federal Food, Drug and Cosmetic Act, United States Code, title 21,
section 301, et seq., and shall comply with all applicable laws and
regulations of the federal Food and Drug Administration, the Drug
Enforcement Administration, and the National Institute on Drug Abuse
in establishing the program;

(2) Notify every oncologist in the state of the program, explain the
purposes and requirements of the program to them, provide on request
each of them with a copy of the approved protocol which shall include
summaries of current papers in medical journals reporting on research
concerning the safety, efficacy and appropriate use of THC in
alleviating the nausea and emetic effects of cancer chemotherapy, and
provide on request each of them with a bibliography of other articles
published in medical journals;

(3) Allow each oncologist (clinical investigator) in the state who
meets or agrees to meet all applicable federal requirements for
investigational new drug research and who so requests to be included
in the research program as a clinical investigator to conduct the
clinical trials;

(4) Provide explanatory information and assistance to each clinical
investigator in understanding the nature of therapeutic use of THC
within program requirements, including the informed consent document
contained in the protocol, informing and counseling patients involved
in the program regarding the appropriate use and the effects of
therapeutic use of THC;

(5) Apply to contract with the National Institute on Drug Abuse for
receipt of dosage forms of THC, fully characterized as to contents and
delivery to the human system, pursuant to regulations promulgated by
the National Institute on Drug Abuse, and the federal Food and Drug
Administration. The principal investigator shall ensure delivery of
the THC dosages to clinical investigators as needed for participation
in the program;

(6) Conduct the research program in compliance with federal laws and
regulations promulgated by the federal Food and Drug Administration,
the Drug Enforcement Administration, the National Institute on Drug
Abuse, and the purposes and provisions of this section;

(7) Submit periodic reports as determined by the commissioner on the
numbers of oncologists and patients involved in the program and the
results of the program;

(8) Submit reports on intermediate or final research results, as
appropriate, to the major scientific journals in the United States;
and

(9) Otherwise comply with the provisions of this section.

Subd. 6. Exemption from criminal sanctions. For the purposes of this
section, the following are not violations under this chapter:

(1) use or possession of THC, or both, by a patient in the research program;

(2) possession, prescribing use of, administering, or dispensing THC,
or any combination of these actions, by the principal investigator or
by any clinical investigator; and

(3) possession or distribution of THC, or both, by a pharmacy
registered to handle schedule I substances which stores THC on behalf
of the principal investigator or a clinical investigator.

THC obtained and distributed pursuant to this section is not subject
to forfeiture under sections 609.531 to 609.5316.

For the purposes of this section, THC is removed from schedule I
contained in section 152.02, subdivision 2, and inserted in schedule
II contained in section 152.02, subdivision 3.

Subd. 7. Citation. This section may be cited as the “THC Therapeutic
Research Act.”

HIST: 1980 c 614 s 93; 1988 c 665 s 2; 1989 c 290 art 3 s 23; 1997 c 7
art 2 s 22

Copyright 2005 by the Office of Revisor of Statutes, State of Minnesota.