Section 1" 152.22 CBD THERAPEUTIC RESEARCH ACT.

Subdivision

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and purpose.

The legislature finds that scientific literature indicates promise for cannabidiol (CBD) in

alleviating certain intractable epilepsy under strictly controlled medical circumstances. The
le9islature also finds that further research and strictly controlleil experimentation regarding the therapeutic use of CBD is necessary and desirable. The intent of this section is to establish a randomized clinical trial to investigate and report on the therapeutic effects of CBD. The intent

of the legislature is to allow the greatest possible access to qualified epileps], patients residing in
Minnesota who meet protocol requirements to these clinical trials. 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 meanines given. (a) "Commissionetmeans the commissioner of health.
(b,\

"Cannabidiol" (CBD) 'means any extract derived from an], plant of the genus carulabis

and which contain cannabinols and cannabidiols which has a purit), of at least 5 percent or

higher cannabidiol iq combination with 2 percent or less of tetrah]rdrocannabinols. that is

delivered to the patient in the form of a liquid. piII. or other delivery method approved bv

the Commissioner but which does not include smoking..

(c) "Intractable epilepsy'' means epilepsy that. as determined by a neurologist. meets both of the

'

following criteria:

a.

failure of 4 or more appropriate anti-epileptic therapies at maximum tolerated doses for

lack ofefhcacy

b.

i.

a seizure frequency

of at least four generalized seizure (including anv combination of

tonic clonic. tonic. clonic" atonic (leading to falls) or focal dyscosnitive seizures) every 4
weeks. and no history of nonepileptic behavioral events. or

ii. iii.

recurrent epileptic spasms with clusters at least every two days. or

a genetically proven diagnosis of Dravet syndrome

with prolonged seizures

requiring rescue therapy at least every four weeks or recurrent daily nonconvuisive seizures documented by video-EEG" or

iv.

intractable generalized epilepsy with recurrent daily nonconvulsive seizures documented by video-EEG

(d) "Principal investigator" means the individual responsible.for the medical and scientific
aspects of the research" development of protocol. and contacting and qualifuing the clinical
,

(e) "Clinical investigators" mean those individuals who conduct the clinical trials. Subd. 3.Research erant.

(a) Within the limits of appropriations made available for this purpose. the commissioner of
health shall grant funds to the Mayo Clinic to serve as the principal investigator for a randomized clinical trial in children aged 12 months to 18 years regarding the therapeutic use of CBD for intractable epilepsy.

(b) As a cond.ition of the grant. the commissioner shall require the Mayo Clinic to

i.

develop guidelines and protocols necessary to establish empirical bases for the evaluation of CBD as a medically recognized therapeutic substance. The guideiines

and Protocols shall ensure that stringent security and record-keeping requirements

for

the clinical trial are met and that participants in the program meet research standards.

ii.

(c) With approval of the commissioner. the Mayo Clinic ma), use grant funds to contract
with Qualified entities to assist in fulfilling the duties of principal investigator. Subd.4.Duties.
The.principal investigator shall:
(1) Notitv every pediatrician in the state of the program and explain the purposes and requirements of the program to them: (2) Allow each oediatric epileptologist (board certified in pediatric neurolog], wiflr
subsPecialtY training in qpilepsyXclinical investigator) in the state who meets or agrees to meet the PrinciPal investigator's requirements and has adequate institutional sunrort. exPerience in clinical trials" who so requests to be included in the research

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investigator to conduct the clinical trials: (3) Provide exPlanatory information and assistance to each clinical investigator in understandin9 the nature of therapeutic use of CBD within prograrn requiremerrtr. in"lrdirrU th.

informed consent document cofltained in the protocol. informing and counseling patients involved in the Pro9ram regarding the appropriate use and the

ects of therao",rti"

ur. of CBD,

(4) Obtain CBD for this clinical trial from a compan), experienced with the

,r.drrtir, .f CBD

that is located within a state where CBD products are tested as to content. cor-rturrirrutior,
consistencY bY a certified laboratory provided that the CBD products are thus "

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manufacturer of CBD.

(5) Submitpgriodic reports as determined by the Commissioner on the numbers of patients involved in the program and the results of the program: (6) Submit reports on intermediate or final research results. as directed by the
Commissioner. to the Commissioner" the legislature and major scientific journals in the United
States: and

(7) Otherwise comply with the provisions of this section. Subd. 6. Exemption from criminal sanctions.
For the purposes of this section only. the following are not violations under this chapter:

(1) use or possession of CBD. or both. by (2) possession. preScribine use o

patient in the research proeram:

these actions. bv the principal investigator or by any,clinical investigator: and

(3) possession or distribution of CBD. or both. by of the principal investigator or a clinical investigator.

pharmacy which stores CBD on behalf

CBD obtained and distributed pursuant to this section is not subject to forfeiture under
sections 609.53 1 to 609.53 1 6. For the purposes of this section only. CBD 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. Exemption from wholesaler and manufacturer licensing requirements. For the purposes of this section only. a distributor or manufacturer of CBD is not required

to be licensed under sections 151.252 or 751.47.

Section 2 . HEALTH IMPACT ASSESSMENT OF CANNABIS Sub' 1. The conunissioner of health. in consultation with the comrnissioners of public safbtr, human services shall provide a report to the legisiature on the likely health impactr
use of carmabis for medical purposes in

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Minnesota. That report shall address issues and

concerns identifled by cornrnunity representatives and the experience of other states wiflh current

medical cannabis programs with particular emphasis on:

(a) program design and implementationl (b) impact on the health care provider community:

(c) patient experiencesl

(d) impact on substance abuse:

(e)

access to and quality

ofproduct:

(g) public awareness and perception: and (h) Any unintended consequences. Subd. 2 Advisorv Committee

(a)

In performing this assessment. the commissioner of health shall establish a 2l-member

advisorv committee. The committee shall consist of the f-o[owing members:

(1)

2 members of the house of representatives of the state of Minnesota. one selected by the

speaker of the House" the other selected by the Minority Leader:

(2)

2 members of the senate of the state of Minnesota. one selected b), the Majoritv Leader" the

other selected by the Minority Leader:

(4) (5)

4 members representing health providers. selected by the Minnesota Medical Association:

4 members representing law enforcement. one from the Minnesota Chief of Police

and one from the Minnesota Count)'Attorneys Association and:

commissioner of the Deparbnent of Human Services.

(b) The chair of the advisor], committee shall be selected by the members of the committee.
advisory committee is governed by section 15.059.

The

Subd. 3 The commissioner shall submit an interim report on the progress of the assessment to the

jurisdiction over health and human services. judiciary. and civil lawby Februar.v 1. 2015. The
commissioner shall issue a final report to the chairs and ranking minority members of the

legislative committees and divisions with jurisdiction over health and human services. judiciarv.
and

civil law by February 1. 2016.

Subd. 3 The commissioner shall submit an interim report on the progress of the assessment to the

chairs and ranking minority members of the legislative committees and divisions with

jurisdiction over health and human services. judiciar.v. and civil law by February
commissioner shall issue a final report to the chairs and ranking

1" 2015. The

minorit members of the

legislative committees and divisions with jurisdiction over health and human services" iudiciary.
anrl

civil law bv Februarv 1.2016.

Section 3. APPROPRIATIONS.

(a) $2.200.000 is appropriated from the general fund in fiscal ),ear 2015 to the commisrior". of health for a research grant under section 1. subdivision 3 of this chapter. No more than five
Percent maY be retained by the commissioner for the costs of administering the grant. This is a

one-time appropriation. Funds are available until June 30.2019.

(b) $390.000.is appropriated from the general fund in fiscal ]rear 2015 to the co*rrrirriorr", of
health to conduct a health impact assessment on the use of cannabis for medicinhl purposes under section 2 of this chapter. This is a one-time appropriation. Funds are availubl"

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30.2016.
Section 4. EFFECTIYE DATE.

Sections

are eflective Julv 1. 2014.