SF 2470 (Melin) Medical Cannabis

Therapeutic Research Study

House
DFL
Caucus


DESCRIPTION: The compromise medical marijuana legislation would implement an
observational research study (rather than the previous clinical trial model) for medical
marijuana. This scaled-back medical marijuana proposal would allow limited participation only
by children who are suffering and adults with severe illnesses. Patients who are participating in
the study will get their medical cannabis through a single manufacturer, approved and regulated
by the Minnesota Department of Health (MDH). Patients must pay a fee to participate in the
registry and receive their medical cannabis. The patient registry program enables ongoing study
and research of the therapeutic benefits of medical cannabis. The MS Society supports this bill.
Law enforcement remains unopposed to this bill.

FISCAL IMPACT: The Medical Cannabis Therapeutic Research Study will have a fiscal impact
of $2.9 million in FY 14-15 and a total of $4.9 million over the next three years (There is a $2
million fiscal impact for FY-16-17). The fiscal note on this bill is available here:
http://www.mmb.state.mn.us/bis/bbs/bis_reports/bisfnts/S2470_2A.pdf

Observational Research Study: This bill creates a program under the Minnesota Department
of Health for the purpose of making clinically significant findings on the therapeutic use of
medical cannabis. The registry program is the structure through which:

1. Approved patients receive medical cannabis;
2. Health practitioners
1
treat patients, record treatment plans and outcomes and submit
data to the patient registry program;
3. MDH, or a contracted third party, can research and study the health record data
submitted by the participating health practitioners.
2


Patients must apply to MDH and be approved to participate in the patient registry program. A
licensed health practitioner must provide written certification to MDH that the patient has been
diagnosed with one of the qualifying medical conditions (see below for list of conditions).

If a patient is unable to self-administer the medical cannabis due to a physical or developmental
disability, they may designate one caregiver to assist them.

MDH must also develop a registry verification system that allows the health care practitioner
identified in the patients application to verify patient enrollment in the patient registry program.

Who can participate? A person must be diagnosed with a specified qualifying medical
condition in order to participate in the patient registry program. This includes people diagnosed
with the following conditions:
Cancer
Glaucoma
HIV/AIDS
Tourettes syndrome
Amyotrophic lateral sclerosis

1
Defined as licensed physicians, physician assistants or advanced practice registered nurses (APRNs).
2
Intermediate and final research results are then submitted to the legislature and major scientific journals.
SF 2470 (Melin) Medical Cannabis
Therapeutic Research Study

House
DFL
Caucus

Seizures, including epilepsy
Severe and persistent muscle spasms, including multiple sclerosis,
Crohns disease

Only Minnesota residents can participate.

How many Minnesotans will participate?
The Minnesota Department of Health estimates that 5,045 Minnesotans will enroll in
observational research study. Estimates of the number of participating patients are based on the
incidence of conditions that qualify for participation and participation rates for medical marijuana
programs in other states.

What forms of marijuana are allowed? Medical cannabis is allowed in liquid and pill form only.
Smoking marijuana is prohibited. Vaporizing is allowed but only by using cannabis that comes in
liquid or pill form. Vaporized delivery of the plant/leaf is also prohibited.

The Commissioner may add a delivery form or a qualifying medical condition, as long as notice
is provided to the Legislature and the Legislature opts not to pass legislation preventing the
requested change.

Single Minnesota manufacturer: There will be one medical cannabis manufacturer, approved
by MDH, responsible for supplying all approved patients with medical cannabis. This is in
contrast to the bill in the Minnesota Senate, which would permit more than 54 dispensaries
throughout the state.

Criteria MDH must used to choose the single manufacturer include:
The technical expertise of the manufacturer in cultivating medical cannabis and
converting it into the acceptable delivery methods;
The qualification of the manufacturers employees;
Ability to provide appropriate security measures;
Whether they can meet the required production needs;
Their projection and ongoing assessment of patient fee levels.

The approved manufacturer is required to:
Provide a reliable, ongoing supply of all medical cannabis and cannabis products to
patients by July 1, 2015;
Cultivate, harvest, manufacture and pack cannabis in an enclosed, locked facility at a
physical address known to the Commissioner, according to the chemical compositions
determined by the Commissioner;
Contract with an MDH-approved laboratory to test all medical cannabis to verify content,
contamination, consistency and chemical composition.
Properly label all medical cannabis products.