5/26/2018 House DFL - SF.2470.Med.marijuana.brief

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SF 2470 (Melin)Medical Cannabis

Therapeutic Research Study

House

DFL

Caucus

DESCRIPTION: The compromise medical marijuana legislation would implement anobservational research study (rather than the previous clinical trial model) for medicalmarijuana. This scaled-back medical marijuana proposal would allow limited participation onlyby children who are suffering and adults with severe illnesses. Patients who are participating inthe study will get their medical cannabis through a single manufacturer, approved and regulatedby the Minnesota Department of Health (MDH). Patients must pay a fee to participate in theregistry and receive their medical cannabis. The patient registry program enables ongoing studyand 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 impactof $2.9 million in FY 14-15 and a total of $4.9 million over the next three years (There is a $2million 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 Departmentof Health for the purpose of making clinically significant findings on the therapeutic use ofmedical cannabis. The registry program is the structure through which:

1. Approved patients receive medical cannabis;

2. Health practitioners1treat 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. Alicensed health practitioner must provide written certification to MDH that the patient has beendiagnosed 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 developmentaldisability, they may designate one caregiver to assist them.

MDH must also develop a registry verification system that allows the health care practitioneridentified in the patientsapplication to verify patient enrollment in the patient registry program.

Who can participate?A person must be diagnosed with a specified qualifying medicalcondition in order to participate in the patient registry program. This includes people diagnosedwith the following conditions:

Cancer Glaucoma HIV/AIDS Tourettes syndrome Amyotrophic lateral sclerosis

1Defined as licensed physicians, physician assistants or advanced practice registered nurses (APRNs).

2Intermediate and final research results are then submitted to the legislature and major scientific journals.

http://www.mmb.state.mn.us/bis/bbs/bis_reports/bisfnts/S2470_2A.pdfhttp://www.mmb.state.mn.us/bis/bbs/bis_reports/bisfnts/S2470_2A.pdfhttp://www.mmb.state.mn.us/bis/bbs/bis_reports/bisfnts/S2470_2A.pdf

5/26/2018 House DFL - SF.2470.Med.marijuana.brief

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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 inobservational research study. Estimates of the number of participating patients are based on theincidence of conditions that qualify for participation and participation rates for medical marijuanaprograms 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 inliquid 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 noticeis provided to the Legislature and the Legislature opts not to pass legislation preventing therequested change.

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

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