SF 2470

1st Unofficial Engrossment - 88th Legislature (2013 - 2014) Posted on 05/07/2014 11:13am

1.1A bill for an act

1.2relating to health; adopting the Medical Cannabis Therapeutic Research Act;
1.3requiring clinical trials on the therapeutic use of medical cannabis; setting
1.4standards for clinical trials; requiring the commissioner to contract with one
1.5manufacturer for medical cannabis products; requiring an impact assessment
1.6of medical cannabis therapeutic research; setting fees; requiring reports;
1.7appropriating money;amending Minnesota Statutes 2012, section 256B.0625,
1.8subdivision 13d; proposing coding for new law in Minnesota Statutes, chapter
1.9152.
1.10BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.11    Section 1. [152.22] MEDICAL CANNABIS THERAPEUTIC RESEARCH ACT.
1.12    Subdivision 1. Findings and purpose. (a) The legislature finds that scientific
1.13literature indicates promise for medical cannabis in alleviating certain intractable medical
1.14conditions under strictly controlled medical circumstances.
1.15(b) The legislature also finds that further research and strictly controlled
1.16experimentation regarding the therapeutic use of medical cannabis is necessary and
1.17desirable. The intent of this section is to establish clinical trials to investigate and report
1.18on the therapeutic effects of medical cannabis. The intent of the legislature is to allow
1.19the greatest possible access to patients with a qualifying medical condition residing in
1.20Minnesota who meet protocol requirements for these clinical trials. The establishment of
1.21this research program is not intended in any manner whatsoever to condone or promote
1.22the illicit recreational use of marijuana.
1.23    Subd. 2. Definitions. (a) For purposes of this section, the following terms have
1.24the meanings given.
2.1(b) "Clinical investigators" means a Minnesota licensed doctor of medicine, a
2.2Minnesota licensed physician assistant acting within the scope of authorized practice, or
2.3a Minnesota licensed advance practice registered nurse.
2.4(c) "Commissioner" means the commissioner of health.
2.5(d) "Medical cannabis" means the flowers of any species of the genus cannabis
2.6plant, or any mixture or preparation of them, including extracts and resins which
2.7contain a chemical consistency of cannabidiols and tetrahydrocannabinols determined
2.8to be medically beneficial by the principal investigator under subdivision 4 or by the
2.9commissioner under subdivision 3, paragraph (d), and that is delivered in the form of:
2.10(1) liquid, including, but not limited to, oil;
2.11(2) pill; or
2.12(3) vaporized delivery method, which does not include smoking, with in-person
2.13supervision by a clinical investigator, as specified under subdivision 5.
2.14(e) "Medical cannabis manufacturer" means an entity under contract with the
2.15commissioner to cultivate, acquire, manufacture, possess, prepare, transfer, transport,
2.16supply, or dispense medical cannabis, delivery devices, or related supplies and educational
2.17materials to patients with a qualifying medical condition who are participating in a clinical
2.18trial.
2.19(f) "Medical cannabis product" means medical cannabis as defined in paragraph
2.20(d) and any delivery device or related supplies and educational materials used in the
2.21administration of a medical cannabis clinical trial for a patient with a qualifying medical
2.22condition.
2.23(g) "Principal investigator" means an individual or organization with responsibility
2.24for the medical and scientific aspects of the research, development of protocol, and
2.25contacting and qualifying the clinical investigators in the state, and duties as provided
2.26in subdivision 3, paragraph (d).
2.27(h) "Program" means the clinical trial research program established pursuant to
2.28this section.
2.29(i) "Qualifying medical condition" means a diagnosis of the following conditions:
2.30(1) cancer;
2.31(2) glaucoma;
2.32(3) human immunodeficiency virus or acquired immune deficiency syndrome;
2.33(4) Tourette's syndrome;
2.34(5) amyotrophic lateral sclerosis;
2.35(6) seizures, including those characteristic of epilepsy;
3.1(7) severe and persistent muscle spasms, including those characteristic of multiple
3.2sclerosis;
3.3(8) Crohn's disease; or
3.4(9) any other medical condition or its treatment approved by the commissioner.
3.5    Subd. 3. Clinical trials administration. (a) The commissioner of health shall
3.6contract with one or more principal investigators to conduct clinical trials for Minnesota
3.7resident patients with a qualifying medical condition regarding the therapeutic use of
3.8medical cannabis. As a condition of the contract, the commissioner shall require a
3.9principal investigator to:
3.10(1) begin the patient testing phase of a clinical trial by July 1, 2015;
3.11(2) develop guidelines and protocols necessary to establish empirical bases for
3.12the evaluation of medical cannabis as a medically recognized therapeutic substance.
3.13The guidelines and protocols shall ensure that stringent security and record-keeping
3.14requirements for the clinical trial are met and that participants in the program meet
3.15research standards;
3.16(3) disclose to all patients the experimental nature of the program and the possible
3.17risks and side effects of the proposed treatment and shall provide the program applicants
3.18with the Tennessen warning as required by section 13.04, subdivision 2; and
3.19(4) comply with the requirements of subdivision 4.
3.20(b) The principal investigator may contract with additional qualified entities to assist
3.21in fulfilling the requirements of this section.
3.22(c) The commissioner shall provide an option to opt out of any placebo trials for
3.23patients under age 18 with a qualifying condition. The decision to opt out of placebo trials
3.24under this paragraph may only be made by a patient's parent or legal guardian.
3.25(d) If a principal investigator is unavailable to evaluate one or more of the qualifying
3.26medical conditions, the commissioner shall fulfill the responsibilities of the principal
3.27investigator described in this section for that qualifying medical condition.
3.28(e) The commissioner may approve the participation of Minnesota residents in a
3.29federally approved clinical trial testing the effects of medical cannabis on one or more
3.30of the qualifying medical conditions listed in subdivision 2, paragraph (i), subject to the
3.31continuance of clinical trials for all other qualifying medical conditions.
3.32(f) Nothing in this section requires the medical assistance and MinnesotaCare
3.33programs to reimburse an enrollee or a provider for costs associated with the medical use
3.34of marijuana.
3.35    Subd. 4. Principal investigator duties. A principal investigator shall:
4.1(1) give notice of the program to every health care provider in the state who is
4.2eligible to serve as a clinical investigator as defined in subdivision 2, paragraph (b), and
4.3explain the purposes and requirements of the program;
4.4(2) allow each clinical investigator in the state who meets or agrees to meet the
4.5principal investigator's requirements, has adequate institutional support, and who requests
4.6to participate, to be included in the research program as a clinical investigator to conduct
4.7the clinical trials;
4.8(3) provide explanatory information and assistance to each clinical investigator
4.9in understanding the nature of therapeutic use of medical cannabis within program
4.10requirements, including the informed consent document contained in the protocol, and
4.11inform and counsel patients involved in the program regarding the appropriate use and the
4.12effects of therapeutic use of medical cannabis;
4.13(4) supervise the participation of the clinical investigator in conducting the clinical
4.14trials;
4.15(5) obtain medical cannabis for this clinical trial from the medical cannabis
4.16manufacturer which meets the requirements in subdivision 6;
4.17(6) determine the chemical consistency of cannabidiols and tetrahydrocannabinols
4.18that are medically beneficial for each qualifying medical condition investigated;
4.19(7) regulate the proper storage and distribution of medical cannabis products to
4.20patients with a qualifying condition, including monitoring the chain of custody;
4.21(8) distribute medical cannabis products to clinical investigators for each individual
4.22patient after ensuring that the medical cannabis products are properly labeled for each
4.23individual patient pursuant to section 151.212 and related rules;
4.24(9) develop safety criteria for patients with a qualifying condition as a requirement
4.25of the patient's participation in the program, to prevent the patient from undertaking
4.26any task under the influence of medical cannabis that would constitute negligence or
4.27professional malpractice;
4.28(10) submit periodic reports as determined by the commissioner on the numbers of
4.29patients involved in the program and the results of the program;
4.30(11) submit reports on intermediate or final research results to the commissioner, the
4.31legislature, and major scientific journals; and
4.32(12) otherwise comply with the provisions of this section.
4.33    Subd. 5. Clinical investigator duties. (a) A clinical investigator shall:
4.34(1) enroll patients with a qualifying medical condition in the clinical trials;
4.35(2) participate in the clinical trials under the guidance and supervision of a principal
4.36investigator;
5.1(3) provide explanatory information from the principal investigator to patients with
5.2qualifying medical conditions;
5.3(4) advise patients and parents or legal guardians of patients under age 18 of the
5.4existence of any nonprofit patient support groups or organizations;
5.5(5) determine, in consultation with the patients, parents or legal guardians of patients
5.6under age 18, and the principal investigator, the proper dosage of medical cannabis for
5.7each individual patient;
5.8(6) obtain from the principal investigator all medical cannabis products needed for
5.9each individual patient;
5.10(7) ensure that medical cannabis products are properly labeled by the principal
5.11investigator for each individual patient prior to distribution to the patient;
5.12(8) distribute properly labeled medical cannabis products to patients or provide the
5.13patient with information and instructions on obtaining properly labeled medical cannabis
5.14from a qualified employee of a principal investigator with responsibility for distributing
5.15medical cannabis under subdivision 4, clause (8);
5.16(9) provide in-person supervision for the administration of any vaporized delivery
5.17method of medical cannabis;
5.18(10) report findings from the clinical trial to the principal investigator in a manner
5.19determined by the principal investigator; and
5.20(11) otherwise comply with all requirements developed by the supervising principal
5.21investigator.
5.22(b) A patient's enrollment in a clinical trial may not be denied based on the use of
5.23medical cannabis in a jurisdiction outside of Minnesota. Enrollment shall only be denied
5.24if the patient has not been diagnosed with a qualifying medical condition.
5.25    Subd. 6. Manufacturer of medical cannabis. (a) The commissioner shall contract
5.26with one manufacturer for the production of all medical cannabis products within the state
5.27by December 1, 2014, unless the commissioner obtains an adequate supply of federally
5.28sourced medical cannabis products for the clinical trials no later than August 1, 2014.
5.29The commissioner shall continue to accept applications after December 1, 2014, if no
5.30manufacturer that meets the qualifications set forth in this subdivision applies prior to
5.31December 1, 2014. If a federally approved source of medical cannabis becomes available
5.32after December 1, 2014, the commissioner may obtain the federally approved medical
5.33cannabis in addition to medical cannabis from the contracted manufacturer within the
5.34state of Minnesota.
5.35(b) The operating documents of the manufacturer must include procedures for the
5.36oversight of the manufacturer and procedures to ensure accurate record keeping.
6.1(c) The manufacturer shall implement appropriate security measures to deter and
6.2prevent the theft of cannabis and unauthorized entrance into areas containing cannabis.
6.3(d) All cultivation, harvesting, manufacturing, and packing of cannabis must take
6.4place in an enclosed, locked facility at a physical address provided to the commissioner
6.5during the contracting process.
6.6(e) Prior to distribution of any medical cannabis to the principal investigator, or the
6.7commissioner acting as the principal investigator under subdivision 3, paragraph (d), the
6.8manufacturer must process and prepare any cannabis plant material into a form allowable
6.9under subdivision 2, paragraph (d).
6.10(f) The manufacturer shall not share office space with or refer patients to a practitioner.
6.11(g) The manufacturer shall not permit any person to consume cannabis on the
6.12property of the manufacturer.
6.13(h) The manufacturer is subject to reasonable inspection by the commissioner.
6.14(i) The manufacturer may not employ or otherwise allow any person who is under
6.1521 years of age to be an agent of the manufacturer.
6.16(j) All products manufactured must be tested as to content, contamination, and
6.17consistency by a certified laboratory to verify such products meet the requirements of
6.18subdivision 2, paragraph (d).
6.19(k) The medical cannabis manufacturer shall produce medical cannabis with a
6.20chemical consistency of cannabidiols and tetrahydrocannabinols as determined by the
6.21principal investigator.
6.22(l) For the purposes of this section only, the manufacturer of medical cannabis
6.23products is not required to be licensed under section 151.252 or 151.47.
6.24    Subd. 7. Confidentiality. (a) Data in patient files with both the clinical investigator
6.25and the principal investigator, and data submitted to or by the medical cannabis
6.26manufacturer are private data on individuals or nonpublic data as defined in section 13.02.
6.27(b) Data kept or maintained by the commissioner may not be used for any purpose
6.28not provided for in this section and may not be combined or linked in any manner with
6.29any other list or database.
6.30    Subd. 8. Protections for clinical trial participation; criminal and civil. (a) There
6.31is a presumption that a patient enrolled in a clinical trial under this section is engaged in
6.32the authorized use of medical cannabis.
6.33(b) The presumption may be rebutted by evidence that conduct related to use of
6.34medical cannabis was not for the purpose of treating or alleviating the patient's qualifying
6.35medical condition or symptoms associated with the patient's qualifying medical condition
6.36pursuant to this section.
7.1(c) For the purposes of this section only, the following are not violations under
7.2this chapter:
7.3(1) use or possession of medical cannabis by a patient in the clinical trials program,
7.4or possession by the parent or guardian of a patient under age 18;
7.5(2) possession of, prescribing the use of, administering, or dispensing of medical
7.6cannabis, or any combination of these actions, by the principal investigator or by any
7.7clinical investigator;
7.8(3) possession or sale of medical cannabis by a pharmacy or the medical cannabis
7.9manufacturer which produces or stores medical cannabis on behalf of the principal
7.10investigator or a clinical investigator; and
7.11(4) possession of medical cannabis products by any person while carrying out the
7.12duties required under this section.
7.13(d) Medical cannabis obtained and distributed pursuant to this section and associated
7.14property is not subject to forfeiture under sections 609.531 to 609.5316.
7.15(e) A principal or clinical investigator is not subject to any civil or disciplinary
7.16penalties by the Board of Medical Practice or by any business, occupational, or
7.17professional licensing board or entity solely for the investigator's participation in a clinical
7.18trial under this section. Nothing in this section prohibits a professional licensing board
7.19for sanctioning a principal or clinical investigator for an investigator's actions outside of
7.20those actions allowed under this section.
7.21(f) For the purposes of this section only, medical cannabis is removed from Schedule
7.22I contained in section 152.02, subdivision 2, and inserted in Schedule II contained in
7.23section 152.02, subdivision 3.
7.24    Subd. 9. Discrimination prohibited. (a) No school or landlord may refuse to
7.25enroll or lease to and may not otherwise penalize a person solely for the person's status
7.26as a patient enrolled in a clinical trial under this section, unless failing to do so would
7.27violate federal law or regulations or cause the school or landlord to lose a monetary or
7.28licensing-related benefit under federal law or regulations.
7.29(b) For the purposes of medical care, including organ transplants, a clinical trial
7.30enrollee's use of medical cannabis under this section is considered the equivalent of the
7.31authorized use of any other medication used at the discretion of a physician and does
7.32not constitute the use of an illicit substance or otherwise disqualify a qualifying patient
7.33from needed medical care.
7.34(c) Unless a failure to do so would violate federal law or regulations or cause an
7.35employer to lose a monetary or licensing-related benefit under federal law or regulations,
7.36an employer may not discriminate against a person in hiring, termination, or any term or
8.1condition of employment, or otherwise penalize a person, if the discrimination is based
8.2upon either of the following:
8.3(1) the person's status as a patient enrolled in a program under this section; or
8.4(2) a patient's positive drug test for cannabis components or metabolites, unless the
8.5patient used, possessed, or was impaired by medical cannabis on the premises of the place
8.6of employment or during the hours of employment.
8.7(d) A person shall not be denied custody of or visitation rights or parenting time with
8.8a minor solely for the person's status as a patient enrolled in a program under this section,
8.9and there shall be no presumption of neglect or child endangerment for conduct allowed
8.10under this section, unless the person's behavior is such that it creates an unreasonable
8.11danger to the safety of the minor as established by clear and convincing evidence.
8.12    Subd. 10. Fees. The commissioner may set reasonable application fees and
8.13renewal fees to be paid to the commissioner by a patient with a qualifying medical
8.14condition that covers the fees incurred in manufacturing medical cannabis by the medical
8.15cannabis manufacturer. Fees collected must be deposited in the special revenue fund
8.16and are appropriated annually to the commissioner to reimburse costs incurred by the
8.17manufacturer of medical cannabis. The commissioner shall establish a sliding scale of
8.18patient fees based upon a qualifying patient's household income. The commissioner may
8.19accept private donations to reduce patient fees.
8.20    Subd. 11. Nursing facilities. Nursing facilities licensed under chapter 144A, or
8.21boarding care homes licensed under section 144.50, may adopt reasonable restrictions
8.22on the use of medical cannabis by persons receiving inpatient services. The restrictions
8.23may include a provision that the facility will not store or maintain the patient's supply of
8.24medical cannabis, that the facility is not responsible for providing the medical cannabis for
8.25qualifying patients, and that cannabis be consumed only in a place specified by the facility.
8.26Nothing contained in this section shall require the facilities to adopt such restrictions, and no
8.27facility shall unreasonably limit a qualifying patient's access to or use of medical cannabis.

8.28    Sec. 2. Minnesota Statutes 2012, section 256B.0625, subdivision 13d, is amended to
8.29read:
8.30    Subd. 13d. Drug formulary. (a) The commissioner shall establish a drug
8.31formulary. Its establishment and publication shall not be subject to the requirements of the
8.32Administrative Procedure Act, but the Formulary Committee shall review and comment
8.33on the formulary contents.
8.34    (b) The formulary shall not include:
9.1    (1) drugs, active pharmaceutical ingredients, or products for which there is no
9.2federal funding;
9.3    (2) over-the-counter drugs, except as provided in subdivision 13;
9.4    (3) drugs or active pharmaceutical ingredients used for weight loss, except that
9.5medically necessary lipase inhibitors may be covered for a recipient with type II diabetes;
9.6    (4) drugs or active pharmaceutical ingredients when used for the treatment of
9.7impotence or erectile dysfunction;
9.8    (5) drugs or active pharmaceutical ingredients for which medical value has not
9.9been established; and
9.10    (6) drugs from manufacturers who have not signed a rebate agreement with the
9.11Department of Health and Human Services pursuant to section 1927 of title XIX of the
9.12Social Security Act; and
9.13    (7) medical cannabis as defined under section 152.22.
9.14    (c) If a single-source drug used by at least two percent of the fee-for-service
9.15medical assistance recipients is removed from the formulary due to the failure of the
9.16manufacturer to sign a rebate agreement with the Department of Health and Human
9.17Services, the commissioner shall notify prescribing practitioners within 30 days of
9.18receiving notification from the Centers for Medicare and Medicaid Services (CMS) that a
9.19rebate agreement was not signed.

9.20    Sec. 3. IMPACT ASSESSMENT OF MEDICAL CANNABIS THERAPEUTIC
9.21RESEARCH.
9.22    Subdivision 1. Task force on medical cannabis therapeutic research. (a) A
9.2323-member task force on medical cannabis therapeutic research is created to conduct an
9.24impact assessment of medical cannabis therapeutic research. The task force shall consist
9.25of the following members:
9.26(1) two members of the house of representatives of the state of Minnesota, one
9.27selected by the speaker of the house, the other selected by the minority leader;
9.28(2) two members of the senate of the state of Minnesota, one selected by the majority
9.29leader, the other selected by the minority leader;
9.30(3) four members representing consumers or patients, including at least two parents
9.31of patients under age 18;
9.32(4) four members representing health care providers;
9.33(5) four members representing law enforcement, one from the Minnesota Chiefs of
9.34Police Association, one from the Minnesota Sheriff's Association, one from the Minnesota
10.1Police and Peace Officers Association, and one from the Minnesota County Attorneys
10.2Association;
10.3(6) four members representing substance use disorder treatment providers; and
10.4(7) the commissioners of health, human services, and public safety.
10.5(b) Task force members listed under paragraph (a), clauses (3), (4), (5), and (6), shall
10.6be appointed by the governor. Members shall serve on the task force at the pleasure of
10.7the appointing authority.
10.8(c) There shall be two cochairs of the task force chosen from the members listed
10.9under paragraph (a). One cochair shall be selected by the speaker of the house and
10.10the other cochair shall be selected by the majority leader of the senate. The expense
10.11reimbursement for members of the task force is governed by section 15.059.
10.12    Subd. 2. Impact assessment. The task force shall hold hearings to conduct the
10.13impact assessment on medical cannabis therapeutic research that must evaluate Minnesota
10.14activities and other states' activities involving medical cannabis and offer analysis of:
10.15(1) program design and implementation;
10.16(2) the impact on the health care provider community;
10.17(3) patient experiences;
10.18(4) the impact on the incidence of substance abuse;
10.19(5) access to and quality of medical products;
10.20(6) the impact on law enforcement and prosecutions;
10.21(7) public awareness and perception; and
10.22(8) any unintended consequences.
10.23    Subd. 3. Reports to the legislature. (a) The cochairs shall submit the following
10.24reports to the chairs and ranking minority members of the legislative committees and
10.25divisions with jurisdiction over health and human services, judiciary, and civil law:
10.26(1) by February 1, 2015, a report on the design and implementation of the clinical
10.27trial program;
10.28(2) by February 1, 2016, a final report on the impact assessment; and
10.29(3) by June 30, 2019, a review and assessment of the clinical trial results.
10.30(b) The task force may make recommendations to the legislature on whether to add
10.31or remove conditions from the list of qualifying medical conditions.
10.32    Subd. 4. Expiration. The task force on medical cannabis therapeutic research
10.33expires on June 30, 2019, or upon the conclusion of the clinical trial, whichever is later.

10.34    Sec. 4. APPROPRIATIONS; MEDICAL CANNABIS THERAPEUTIC
10.35RESEARCH ACT.
11.1(a) $1,100,000 in fiscal year 2016 and $1,100,000 in fiscal year 2017 are appropriated
11.2from the general fund to the commissioner of health for grants to the principal investigators
11.3for purposes of conducting the clinical trials under Minnesota Statutes, section 152.22.
11.4(b) $450,000 in fiscal year 2015 is appropriated from the general fund to the
11.5commissioner of health for the costs of administering Minnesota Statutes, section 152.22.
11.6Funds are available until June 30, 2019.
11.7(c) $50,000 in fiscal year 2015 is appropriated from the general fund to the
11.8Legislative Coordinating Commission to administer the task force on medical cannabis
11.9therapeutic research and for the task force to conduct the impact assessment on the use of
11.10cannabis for medicinal purposes. These funds are available until the expiration of the task
11.11force on medical cannabis therapeutic research.

11.12    Sec. 5. EFFECTIVE DATE.
11.13Sections 1 and 3 are effective July 1, 2014.