<a id="pl.1.3"></a><var>1.3</var>requiring clinical trials on the therapeutic use of medical cannabis; setting <br/>
<a id="pl.1.4"></a><var>1.4</var>standards for clinical trials; requiring the commissioner to contract with one <br/>
<a id="pl.1.5"></a><var>1.5</var>manufacturer for medical cannabis products; requiring an impact assessment <br/>
<a id="pl.1.6"></a><var>1.6</var>of medical cannabis therapeutic research; setting fees; requiring reports; <br/>
<a id="pl.1.7"></a><var>1.7</var>appropriating money;amending Minnesota Statutes 2012, section 256B.0625, <br/>
<a id="pl.1.8"></a><var>1.8</var>subdivision 13d; proposing coding for new law in Minnesota Statutes, chapter <br/>
<a id="pl.1.9"></a><var>1.9</var>152.<br/>
<a id="pl.1.10"></a><var>1.10</var>BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:<br/>
<br/>
<a id="bill.0.1.0"></a><a id="pl.1.11"></a><var>1.11</var>    Section 1. <b>[152.22] MEDICAL CANNABIS THERAPEUTIC RESEARCH ACT.</b><br/>
<a id="pl.1.12"></a><var>1.12</var>    Subdivision 1. <b>Findings and purpose.</b> (a) The legislature finds that scientific <br/>
<a id="pl.1.13"></a><var>1.13</var>literature indicates promise for medical cannabis in alleviating certain intractable medical <br/>
<a id="pl.1.14"></a><var>1.14</var>conditions under strictly controlled medical circumstances.<br/>
<a id="pl.1.15"></a><var>1.15</var>(b) The legislature also finds that further research and strictly controlled <br/>
<a id="pl.1.16"></a><var>1.16</var>experimentation regarding the therapeutic use of medical cannabis is necessary and <br/>
<a id="pl.1.17"></a><var>1.17</var>desirable. The intent of this section is to establish clinical trials to investigate and report <br/>
<a id="pl.1.18"></a><var>1.18</var>on the therapeutic effects of medical cannabis. The intent of the legislature is to allow <br/>
<a id="pl.1.19"></a><var>1.19</var>the greatest possible access to patients with a qualifying medical condition residing in <br/>
<a id="pl.1.20"></a><var>1.20</var>Minnesota who meet protocol requirements for these clinical trials. The establishment of <br/>
<a id="pl.1.21"></a><var>1.21</var>this research program is not intended in any manner whatsoever to condone or promote <br/>
<a id="pl.1.22"></a><var>1.22</var>the illicit recreational use of marijuana.<br/>
<a id="pl.1.23"></a><var>1.23</var>    Subd. 2. <b>Definitions.</b> (a) For purposes of this section, the following terms have <br/>
<a id="pl.1.24"></a><var>1.24</var>the meanings given.<br/>
<a id="pl.2.1"></a><var>2.1</var>(b) "Clinical investigators" means a Minnesota licensed doctor of medicine, a <br/>
<a id="pl.2.2"></a><var>2.2</var>Minnesota licensed physician assistant acting within the scope of authorized practice, or <br/>
<a id="pl.2.3"></a><var>2.3</var>a Minnesota licensed advance practice registered nurse.<br/>
<a id="pl.2.4"></a><var>2.4</var>(c) "Commissioner" means the commissioner of health.<br/>
<a id="pl.2.5"></a><var>2.5</var>(d) "Medical cannabis" means the flowers of any species of the genus cannabis <br/>
<a id="pl.2.6"></a><var>2.6</var>plant, or any mixture or preparation of them, including extracts and resins which <br/>
<a id="pl.2.7"></a><var>2.7</var>contain a chemical consistency of cannabidiols and tetrahydrocannabinols determined <br/>
<a id="pl.2.8"></a><var>2.8</var>to be medically beneficial by the principal investigator under subdivision 4 or by the <br/>
<a id="pl.2.9"></a><var>2.9</var>commissioner under subdivision 3, paragraph (d), and that is delivered in the form of:<br/>
<a id="pl.2.10"></a><var>2.10</var>(1) liquid, including, but not limited to, oil;<br/>
<a id="pl.2.11"></a><var>2.11</var>(2) pill; or<br/>
<a id="pl.2.12"></a><var>2.12</var>(3) vaporized delivery method, which does not include smoking, with in-person <br/>
<a id="pl.2.13"></a><var>2.13</var>supervision by a clinical investigator, as specified under subdivision 5.<br/>
<a id="pl.2.14"></a><var>2.14</var>(e) "Medical cannabis manufacturer" means an entity under contract with the <br/>
<a id="pl.2.15"></a><var>2.15</var>commissioner to cultivate, acquire, manufacture, possess, prepare, transfer, transport, <br/>
<a id="pl.2.16"></a><var>2.16</var>supply, or dispense medical cannabis, delivery devices, or related supplies and educational <br/>
<a id="pl.2.17"></a><var>2.17</var>materials to patients with a qualifying medical condition who are participating in a clinical <br/>
<a id="pl.2.18"></a><var>2.18</var>trial.<br/>
<a id="pl.2.19"></a><var>2.19</var>(f) "Medical cannabis product" means medical cannabis as defined in paragraph <br/>
<a id="pl.2.20"></a><var>2.20</var>(d) and any delivery device or related supplies and educational materials used in the <br/>
<a id="pl.2.21"></a><var>2.21</var>administration of a medical cannabis clinical trial for a patient with a qualifying medical <br/>
<a id="pl.2.22"></a><var>2.22</var>condition.<br/>
<a id="pl.2.23"></a><var>2.23</var>(g) "Principal investigator" means an individual or organization with responsibility <br/>
<a id="pl.2.24"></a><var>2.24</var>for the medical and scientific aspects of the research, development of protocol, and <br/>
<a id="pl.2.25"></a><var>2.25</var>contacting and qualifying the clinical investigators in the state, and duties as provided <br/>
<a id="pl.2.26"></a><var>2.26</var>in subdivision 3, paragraph (d).<br/>
<a id="pl.2.27"></a><var>2.27</var>(h) "Program" means the clinical trial research program established pursuant to <br/>
<a id="pl.2.28"></a><var>2.28</var>this section.<br/>
<a id="pl.2.29"></a><var>2.29</var>(i) "Qualifying medical condition" means a diagnosis of the following conditions:<br/>
<a id="pl.2.30"></a><var>2.30</var>(1) cancer;<br/>
<a id="pl.2.31"></a><var>2.31</var>(2) glaucoma;<br/>
<a id="pl.2.32"></a><var>2.32</var>(3) human immunodeficiency virus or acquired immune deficiency syndrome;<br/>
<a id="pl.2.33"></a><var>2.33</var>(4) Tourette's syndrome;<br/>
<a id="pl.2.34"></a><var>2.34</var>(5) amyotrophic lateral sclerosis;<br/>
<a id="pl.2.35"></a><var>2.35</var>(6) seizures, including those characteristic of epilepsy;<br/>
<a id="pl.3.1"></a><var>3.1</var>(7) severe and persistent muscle spasms, including those characteristic of multiple <br/>
<a id="pl.3.2"></a><var>3.2</var>sclerosis;<br/>
<a id="pl.3.3"></a><var>3.3</var>(8) Crohn's disease; or<br/>
<a id="pl.3.4"></a><var>3.4</var>(9) any other medical condition or its treatment approved by the commissioner.<br/>
<a id="pl.3.5"></a><var>3.5</var>    Subd. 3. <b>Clinical trials administration.</b> (a) The commissioner of health shall <br/>
<a id="pl.3.6"></a><var>3.6</var>contract with one or more principal investigators to conduct clinical trials for Minnesota <br/>
<a id="pl.3.7"></a><var>3.7</var>resident patients with a qualifying medical condition regarding the therapeutic use of <br/>
<a id="pl.3.8"></a><var>3.8</var>medical cannabis. As a condition of the contract, the commissioner shall require a <br/>
<a id="pl.3.9"></a><var>3.9</var>principal investigator to:<br/>
<a id="pl.3.10"></a><var>3.10</var>(1) begin the patient testing phase of a clinical trial by July 1, 2015;<br/>
<a id="pl.3.11"></a><var>3.11</var>(2) develop guidelines and protocols necessary to establish empirical bases for <br/>
<a id="pl.3.12"></a><var>3.12</var>the evaluation of medical cannabis as a medically recognized therapeutic substance. <br/>
<a id="pl.3.13"></a><var>3.13</var>The guidelines and protocols shall ensure that stringent security and record-keeping <br/>
<a id="pl.3.14"></a><var>3.14</var>requirements for the clinical trial are met and that participants in the program meet <br/>
<a id="pl.3.15"></a><var>3.15</var>research standards;<br/>
<a id="pl.3.16"></a><var>3.16</var>(3) disclose to all patients the experimental nature of the program and the possible <br/>
<a id="pl.3.17"></a><var>3.17</var>risks and side effects of the proposed treatment and shall provide the program applicants <br/>
<a id="pl.3.18"></a><var>3.18</var>with the Tennessen warning as required by section 13.04, subdivision 2; and<br/>
<a id="pl.3.19"></a><var>3.19</var>(4) comply with the requirements of subdivision 4.<br/>
<a id="pl.3.20"></a><var>3.20</var>(b) The principal investigator may contract with additional qualified entities to assist <br/>
<a id="pl.3.21"></a><var>3.21</var>in fulfilling the requirements of this section.<br/>
<a id="pl.3.22"></a><var>3.22</var>(c) The commissioner shall provide an option to opt out of any placebo trials for <br/>
<a id="pl.3.23"></a><var>3.23</var>patients under age 18 with a qualifying condition. The decision to opt out of placebo trials <br/>
<a id="pl.3.24"></a><var>3.24</var>under this paragraph may only be made by a patient's parent or legal guardian.<br/>
<a id="pl.3.25"></a><var>3.25</var>(d) If a principal investigator is unavailable to evaluate one or more of the qualifying <br/>
<a id="pl.3.26"></a><var>3.26</var>medical conditions, the commissioner shall fulfill the responsibilities of the principal <br/>
<a id="pl.3.27"></a><var>3.27</var>investigator described in this section for that qualifying medical condition.<br/>
<a id="pl.3.28"></a><var>3.28</var>(e) The commissioner may approve the participation of Minnesota residents in a <br/>
<a id="pl.3.29"></a><var>3.29</var>federally approved clinical trial testing the effects of medical cannabis on one or more <br/>
<a id="pl.3.30"></a><var>3.30</var>of the qualifying medical conditions listed in subdivision 2, paragraph (i), subject to the <br/>
<a id="pl.3.31"></a><var>3.31</var>continuance of clinical trials for all other qualifying medical conditions.<br/>
<a id="pl.3.32"></a><var>3.32</var>(f) Nothing in this section requires the medical assistance and MinnesotaCare <br/>
<a id="pl.3.33"></a><var>3.33</var>programs to reimburse an enrollee or a provider for costs associated with the medical use <br/>
<a id="pl.3.34"></a><var>3.34</var>of marijuana.<br/>
<a id="pl.3.35"></a><var>3.35</var>    Subd. 4. <b>Principal investigator duties.</b> A principal investigator shall:<br/>
<a id="pl.4.1"></a><var>4.1</var>(1) give notice of the program to every health care provider in the state who is <br/>
<a id="pl.4.2"></a><var>4.2</var>eligible to serve as a clinical investigator as defined in subdivision 2, paragraph (b), and <br/>
<a id="pl.4.3"></a><var>4.3</var>explain the purposes and requirements of the program;<br/>
<a id="pl.4.4"></a><var>4.4</var>(2) allow each clinical investigator in the state who meets or agrees to meet the <br/>
<a id="pl.4.5"></a><var>4.5</var>principal investigator's requirements, has adequate institutional support, and who requests <br/>
<a id="pl.4.6"></a><var>4.6</var>to participate, to be included in the research program as a clinical investigator to conduct <br/>
<a id="pl.4.7"></a><var>4.7</var>the clinical trials;<br/>
<a id="pl.4.8"></a><var>4.8</var>(3) provide explanatory information and assistance to each clinical investigator <br/>
<a id="pl.4.9"></a><var>4.9</var>in understanding the nature of therapeutic use of medical cannabis within program <br/>
<a id="pl.4.10"></a><var>4.10</var>requirements, including the informed consent document contained in the protocol, and <br/>
<a id="pl.4.11"></a><var>4.11</var>inform and counsel patients involved in the program regarding the appropriate use and the <br/>
<a id="pl.4.12"></a><var>4.12</var>effects of therapeutic use of medical cannabis;<br/>
<a id="pl.4.13"></a><var>4.13</var>(4) supervise the participation of the clinical investigator in conducting the clinical <br/>
<a id="pl.4.14"></a><var>4.14</var>trials;<br/>
<a id="pl.4.15"></a><var>4.15</var>(5) obtain medical cannabis for this clinical trial from the medical cannabis <br/>
<a id="pl.4.16"></a><var>4.16</var>manufacturer which meets the requirements in subdivision 6;<br/>
<a id="pl.4.17"></a><var>4.17</var>(6) determine the chemical consistency of cannabidiols and tetrahydrocannabinols <br/>
<a id="pl.4.18"></a><var>4.18</var>that are medically beneficial for each qualifying medical condition investigated;<br/>
<a id="pl.4.19"></a><var>4.19</var>(7) regulate the proper storage and distribution of medical cannabis products to <br/>
<a id="pl.4.20"></a><var>4.20</var>patients with a qualifying condition, including monitoring the chain of custody;<br/>
<a id="pl.4.21"></a><var>4.21</var>(8) distribute medical cannabis products to clinical investigators for each individual <br/>
<a id="pl.4.22"></a><var>4.22</var>patient after ensuring that the medical cannabis products are properly labeled for each <br/>
<a id="pl.4.23"></a><var>4.23</var>individual patient pursuant to section 151.212 and related rules;<br/>
<a id="pl.4.24"></a><var>4.24</var>(9) develop safety criteria for patients with a qualifying condition as a requirement <br/>
<a id="pl.4.25"></a><var>4.25</var>of the patient's participation in the program, to prevent the patient from undertaking <br/>
<a id="pl.4.26"></a><var>4.26</var>any task under the influence of medical cannabis that would constitute negligence or <br/>
<a id="pl.4.27"></a><var>4.27</var>professional malpractice;<br/>
<a id="pl.4.28"></a><var>4.28</var>(10) submit periodic reports as determined by the commissioner on the numbers of <br/>
<a id="pl.4.29"></a><var>4.29</var>patients involved in the program and the results of the program;<br/>
<a id="pl.4.30"></a><var>4.30</var>(11) submit reports on intermediate or final research results to the commissioner, the <br/>
<a id="pl.4.31"></a><var>4.31</var>legislature, and major scientific journals; and<br/>
<a id="pl.4.32"></a><var>4.32</var>(12) otherwise comply with the provisions of this section.<br/>
<a id="pl.4.33"></a><var>4.33</var>    Subd. 5. <b>Clinical investigator duties.</b> (a) A clinical investigator shall:<br/>
<a id="pl.4.34"></a><var>4.34</var>(1) enroll patients with a qualifying medical condition in the clinical trials;<br/>
<a id="pl.4.35"></a><var>4.35</var>(2) participate in the clinical trials under the guidance and supervision of a principal <br/>
<a id="pl.4.36"></a><var>4.36</var>investigator;<br/>
<a id="pl.5.1"></a><var>5.1</var>(3) provide explanatory information from the principal investigator to patients with <br/>
<a id="pl.5.2"></a><var>5.2</var>qualifying medical conditions;<br/>
<a id="pl.5.3"></a><var>5.3</var>(4) advise patients and parents or legal guardians of patients under age 18 of the <br/>
<a id="pl.5.4"></a><var>5.4</var>existence of any nonprofit patient support groups or organizations;<br/>
<a id="pl.5.5"></a><var>5.5</var>(5) determine, in consultation with the patients, parents or legal guardians of patients <br/>
<a id="pl.5.6"></a><var>5.6</var>under age 18, and the principal investigator, the proper dosage of medical cannabis for <br/>
<a id="pl.5.7"></a><var>5.7</var>each individual patient;<br/>
<a id="pl.5.8"></a><var>5.8</var>(6) obtain from the principal investigator all medical cannabis products needed for <br/>
<a id="pl.5.9"></a><var>5.9</var>each individual patient;<br/>
<a id="pl.5.10"></a><var>5.10</var>(7) ensure that medical cannabis products are properly labeled by the principal <br/>
<a id="pl.5.11"></a><var>5.11</var>investigator for each individual patient prior to distribution to the patient;<br/>
<a id="pl.5.12"></a><var>5.12</var>(8) distribute properly labeled medical cannabis products to patients or provide the <br/>
<a id="pl.5.13"></a><var>5.13</var>patient with information and instructions on obtaining properly labeled medical cannabis <br/>
<a id="pl.5.14"></a><var>5.14</var>from a qualified employee of a principal investigator with responsibility for distributing <br/>
<a id="pl.5.15"></a><var>5.15</var>medical cannabis under subdivision 4, clause (8);<br/>
<a id="pl.5.16"></a><var>5.16</var>(9) provide in-person supervision for the administration of any vaporized delivery <br/>
<a id="pl.5.17"></a><var>5.17</var>method of medical cannabis;<br/>
<a id="pl.5.18"></a><var>5.18</var>(10) report findings from the clinical trial to the principal investigator in a manner <br/>
<a id="pl.5.19"></a><var>5.19</var>determined by the principal investigator; and<br/>
<a id="pl.5.20"></a><var>5.20</var>(11) otherwise comply with all requirements developed by the supervising principal <br/>
<a id="pl.5.21"></a><var>5.21</var>investigator.<br/>
<a id="pl.5.22"></a><var>5.22</var>(b) A patient's enrollment in a clinical trial may not be denied based on the use of <br/>
<a id="pl.5.23"></a><var>5.23</var>medical cannabis in a jurisdiction outside of Minnesota. Enrollment shall only be denied <br/>
<a id="pl.5.24"></a><var>5.24</var>if the patient has not been diagnosed with a qualifying medical condition.<br/>
<a id="pl.5.25"></a><var>5.25</var>    Subd. 6. <b>Manufacturer of medical cannabis.</b> (a) The commissioner shall contract <br/>
<a id="pl.5.26"></a><var>5.26</var>with one manufacturer for the production of all medical cannabis products within the state <br/>
<a id="pl.5.27"></a><var>5.27</var>by December 1, 2014, unless the commissioner obtains an adequate supply of federally <br/>
<a id="pl.5.28"></a><var>5.28</var>sourced medical cannabis products for the clinical trials no later than August 1, 2014. <br/>
<a id="pl.5.29"></a><var>5.29</var>The commissioner shall continue to accept applications after December 1, 2014, if no <br/>
<a id="pl.5.30"></a><var>5.30</var>manufacturer that meets the qualifications set forth in this subdivision applies prior to <br/>
<a id="pl.5.31"></a><var>5.31</var>December 1, 2014. If a federally approved source of medical cannabis becomes available <br/>
<a id="pl.5.32"></a><var>5.32</var>after December 1, 2014, the commissioner may obtain the federally approved medical <br/>
<a id="pl.5.33"></a><var>5.33</var>cannabis in addition to medical cannabis from the contracted manufacturer within the <br/>
<a id="pl.5.34"></a><var>5.34</var>state of Minnesota.<br/>
<a id="pl.5.35"></a><var>5.35</var>(b) The operating documents of the manufacturer must include procedures for the <br/>
<a id="pl.5.36"></a><var>5.36</var>oversight of the manufacturer and procedures to ensure accurate record keeping.<br/>
<a id="pl.6.1"></a><var>6.1</var>(c) The manufacturer shall implement appropriate security measures to deter and <br/>
<a id="pl.6.2"></a><var>6.2</var>prevent the theft of cannabis and unauthorized entrance into areas containing cannabis.<br/>
<a id="pl.6.3"></a><var>6.3</var>(d) All cultivation, harvesting, manufacturing, and packing of cannabis must take <br/>
<a id="pl.6.4"></a><var>6.4</var>place in an enclosed, locked facility at a physical address provided to the commissioner <br/>
<a id="pl.6.5"></a><var>6.5</var>during the contracting process.<br/>
<a id="pl.6.6"></a><var>6.6</var>(e) Prior to distribution of any medical cannabis to the principal investigator, or the <br/>
<a id="pl.6.7"></a><var>6.7</var>commissioner acting as the principal investigator under subdivision 3, paragraph (d), the <br/>
<a id="pl.6.8"></a><var>6.8</var>manufacturer must process and prepare any cannabis plant material into a form allowable <br/>
<a id="pl.6.9"></a><var>6.9</var>under subdivision 2, paragraph (d).<br/>
<a id="pl.6.10"></a><var>6.10</var>(f) The manufacturer shall not share office space with or refer patients to a practitioner.<br/>
<a id="pl.6.11"></a><var>6.11</var>(g) The manufacturer shall not permit any person to consume cannabis on the <br/>
<a id="pl.6.12"></a><var>6.12</var>property of the manufacturer.<br/>
<a id="pl.6.13"></a><var>6.13</var>(h) The manufacturer is subject to reasonable inspection by the commissioner. <br/>
<a id="pl.6.14"></a><var>6.14</var>(i) The manufacturer may not employ or otherwise allow any person who is under <br/>
<a id="pl.6.15"></a><var>6.15</var>21 years of age to be an agent of the manufacturer.<br/>
<a id="pl.6.16"></a><var>6.16</var>(j) All products manufactured must be tested as to content, contamination, and <br/>
<a id="pl.6.17"></a><var>6.17</var>consistency by a certified laboratory to verify such products meet the requirements of <br/>
<a id="pl.6.18"></a><var>6.18</var>subdivision 2, paragraph (d).<br/>
<a id="pl.6.19"></a><var>6.19</var>(k) The medical cannabis manufacturer shall produce medical cannabis with a <br/>
<a id="pl.6.20"></a><var>6.20</var>chemical consistency of cannabidiols and tetrahydrocannabinols as determined by the <br/>
<a id="pl.6.21"></a><var>6.21</var>principal investigator.<br/>
<a id="pl.6.22"></a><var>6.22</var>(l) For the purposes of this section only, the manufacturer of medical cannabis <br/>
<a id="pl.6.23"></a><var>6.23</var>products is not required to be licensed under section 151.252 or 151.47.<br/>
<a id="pl.6.24"></a><var>6.24</var>    Subd. 7. <b>Confidentiality.</b> (a) Data in patient files with both the clinical investigator <br/>
<a id="pl.6.25"></a><var>6.25</var>and the principal investigator, and data submitted to or by the medical cannabis <br/>
<a id="pl.6.26"></a><var>6.26</var>manufacturer are private data on individuals or nonpublic data as defined in section 13.02.<br/>
<a id="pl.6.27"></a><var>6.27</var>(b) Data kept or maintained by the commissioner may not be used for any purpose <br/>
<a id="pl.6.28"></a><var>6.28</var>not provided for in this section and may not be combined or linked in any manner with <br/>
<a id="pl.6.29"></a><var>6.29</var>any other list or database.<br/>
<a id="pl.6.30"></a><var>6.30</var>    Subd. 8. <b>Protections for clinical trial participation; criminal and civil.</b> (a) There <br/>
<a id="pl.6.31"></a><var>6.31</var>is a presumption that a patient enrolled in a clinical trial under this section is engaged in <br/>
<a id="pl.6.32"></a><var>6.32</var>the authorized use of medical cannabis.<br/>
<a id="pl.6.33"></a><var>6.33</var>(b) The presumption may be rebutted by evidence that conduct related to use of <br/>
<a id="pl.6.34"></a><var>6.34</var>medical cannabis was not for the purpose of treating or alleviating the patient's qualifying <br/>
<a id="pl.6.35"></a><var>6.35</var>medical condition or symptoms associated with the patient's qualifying medical condition <br/>
<a id="pl.6.36"></a><var>6.36</var>pursuant to this section.<br/>
<a id="pl.7.1"></a><var>7.1</var>(c) For the purposes of this section only, the following are not violations under <br/>
<a id="pl.7.2"></a><var>7.2</var>this chapter:<br/>
<a id="pl.7.3"></a><var>7.3</var>(1) use or possession of medical cannabis by a patient in the clinical trials program, <br/>
<a id="pl.7.4"></a><var>7.4</var>or possession by the parent or guardian of a patient under age 18;<br/>
<a id="pl.7.5"></a><var>7.5</var>(2) possession of, prescribing the use of, administering, or dispensing of medical <br/>
<a id="pl.7.6"></a><var>7.6</var>cannabis, or any combination of these actions, by the principal investigator or by any <br/>
<a id="pl.7.7"></a><var>7.7</var>clinical investigator;<br/>
<a id="pl.7.8"></a><var>7.8</var>(3) possession or sale of medical cannabis by a pharmacy or the medical cannabis <br/>
<a id="pl.7.9"></a><var>7.9</var>manufacturer which produces or stores medical cannabis on behalf of the principal <br/>
<a id="pl.7.10"></a><var>7.10</var>investigator or a clinical investigator; and<br/>
<a id="pl.7.11"></a><var>7.11</var>(4) possession of medical cannabis products by any person while carrying out the <br/>
<a id="pl.7.12"></a><var>7.12</var>duties required under this section.<br/>
<a id="pl.7.13"></a><var>7.13</var>(d) Medical cannabis obtained and distributed pursuant to this section and associated <br/>
<a id="pl.7.14"></a><var>7.14</var>property is not subject to forfeiture under sections 609.531 to 609.5316.<br/>
<a id="pl.7.15"></a><var>7.15</var>(e) A principal or clinical investigator is not subject to any civil or disciplinary <br/>
<a id="pl.7.16"></a><var>7.16</var>penalties by the Board of Medical Practice or by any business, occupational, or <br/>
<a id="pl.7.17"></a><var>7.17</var>professional licensing board or entity solely for the investigator's participation in a clinical <br/>
<a id="pl.7.18"></a><var>7.18</var>trial under this section. Nothing in this section prohibits a professional licensing board <br/>
<a id="pl.7.19"></a><var>7.19</var>for sanctioning a principal or clinical investigator for an investigator's actions outside of <br/>
<a id="pl.7.20"></a><var>7.20</var>those actions allowed under this section.<br/>
<a id="pl.7.21"></a><var>7.21</var>(f) For the purposes of this section only, medical cannabis is removed from Schedule <br/>
<a id="pl.7.22"></a><var>7.22</var>I contained in section 152.02, subdivision 2, and inserted in Schedule II contained in <br/>
<a id="pl.7.23"></a><var>7.23</var>section 152.02, subdivision 3.<br/>
<a id="pl.7.24"></a><var>7.24</var>    Subd. 9. <b>Discrimination prohibited.</b> (a) No school or landlord may refuse to <br/>
<a id="pl.7.25"></a><var>7.25</var>enroll or lease to and may not otherwise penalize a person solely for the person's status <br/>
<a id="pl.7.26"></a><var>7.26</var>as a patient enrolled in a clinical trial under this section, unless failing to do so would <br/>
<a id="pl.7.27"></a><var>7.27</var>violate federal law or regulations or cause the school or landlord to lose a monetary or <br/>
<a id="pl.7.28"></a><var>7.28</var>licensing-related benefit under federal law or regulations.<br/>
<a id="pl.7.29"></a><var>7.29</var>(b) For the purposes of medical care, including organ transplants, a clinical trial <br/>
<a id="pl.7.30"></a><var>7.30</var>enrollee's use of medical cannabis under this section is considered the equivalent of the <br/>
<a id="pl.7.31"></a><var>7.31</var>authorized use of any other medication used at the discretion of a physician and does <br/>
<a id="pl.7.32"></a><var>7.32</var>not constitute the use of an illicit substance or otherwise disqualify a qualifying patient <br/>
<a id="pl.7.33"></a><var>7.33</var>from needed medical care.<br/>
<a id="pl.7.34"></a><var>7.34</var>(c) Unless a failure to do so would violate federal law or regulations or cause an <br/>
<a id="pl.7.35"></a><var>7.35</var>employer to lose a monetary or licensing-related benefit under federal law or regulations, <br/>
<a id="pl.7.36"></a><var>7.36</var>an employer may not discriminate against a person in hiring, termination, or any term or <br/>
<a id="pl.8.1"></a><var>8.1</var>condition of employment, or otherwise penalize a person, if the discrimination is based <br/>
<a id="pl.8.2"></a><var>8.2</var>upon either of the following:<br/>
<a id="pl.8.3"></a><var>8.3</var>(1) the person's status as a patient enrolled in a program under this section; or<br/>
<a id="pl.8.4"></a><var>8.4</var>(2) a patient's positive drug test for cannabis components or metabolites, unless the <br/>
<a id="pl.8.5"></a><var>8.5</var>patient used, possessed, or was impaired by medical cannabis on the premises of the place <br/>
<a id="pl.8.6"></a><var>8.6</var>of employment or during the hours of employment.<br/>
<a id="pl.8.7"></a><var>8.7</var>(d) A person shall not be denied custody of or visitation rights or parenting time with <br/>
<a id="pl.8.8"></a><var>8.8</var>a minor solely for the person's status as a patient enrolled in a program under this section, <br/>
<a id="pl.8.9"></a><var>8.9</var>and there shall be no presumption of neglect or child endangerment for conduct allowed <br/>
<a id="pl.8.10"></a><var>8.10</var>under this section, unless the person's behavior is such that it creates an unreasonable <br/>
<a id="pl.8.11"></a><var>8.11</var>danger to the safety of the minor as established by clear and convincing evidence.<br/>
<a id="pl.8.12"></a><var>8.12</var>    Subd. 10. <b>Fees.</b> The commissioner may set reasonable application fees and <br/>
<a id="pl.8.13"></a><var>8.13</var>renewal fees to be paid to the commissioner by a patient with a qualifying medical <br/>
<a id="pl.8.14"></a><var>8.14</var>condition that covers the fees incurred in manufacturing medical cannabis by the medical <br/>
<a id="pl.8.15"></a><var>8.15</var>cannabis manufacturer. Fees collected must be deposited in the special revenue fund <br/>
<a id="pl.8.16"></a><var>8.16</var>and are appropriated annually to the commissioner to reimburse costs incurred by the <br/>
<a id="pl.8.17"></a><var>8.17</var>manufacturer of medical cannabis. The commissioner shall establish a sliding scale of <br/>
<a id="pl.8.18"></a><var>8.18</var>patient fees based upon a qualifying patient's household income. The commissioner may <br/>
<a id="pl.8.19"></a><var>8.19</var>accept private donations to reduce patient fees.<br/>
<a id="pl.8.20"></a><var>8.20</var>    Subd. 11. <b>Nursing facilities.</b> Nursing facilities licensed under chapter 144A, or <br/>
<a id="pl.8.21"></a><var>8.21</var>boarding care homes licensed under section 144.50, may adopt reasonable restrictions <br/>
<a id="pl.8.22"></a><var>8.22</var>on the use of medical cannabis by persons receiving inpatient services. The restrictions <br/>
<a id="pl.8.23"></a><var>8.23</var>may include a provision that the facility will not store or maintain the patient's supply of <br/>
<a id="pl.8.24"></a><var>8.24</var>medical cannabis, that the facility is not responsible for providing the medical cannabis for <br/>
<a id="pl.8.25"></a><var>8.25</var>qualifying patients, and that cannabis be consumed only in a place specified by the facility. <br/>
<a id="pl.8.26"></a><var>8.26</var>Nothing contained in this section shall require the facilities to adopt such restrictions, and no <br/>
<a id="pl.8.27"></a><var>8.27</var>facility shall unreasonably limit a qualifying patient's access to or use of medical cannabis.<br/>
<br/>
<a id="bill.0.2.0"></a><a id="pl.8.28"></a><var>8.28</var>    Sec. 2. Minnesota Statutes 2012, section 256B.0625, subdivision 13d, is amended to <br/>
<a id="pl.8.29"></a><var>8.29</var>read:<br/>
<a id="pl.8.30"></a><var>8.30</var>    Subd. 13d. <b>Drug formulary.</b> (a) The commissioner shall establish a drug <br/>
<a id="pl.8.31"></a><var>8.31</var>formulary. Its establishment and publication shall not be subject to the requirements of the <br/>
<a id="pl.8.32"></a><var>8.32</var>Administrative Procedure Act, but the Formulary Committee shall review and comment <br/>
<a id="pl.8.33"></a><var>8.33</var>on the formulary contents.<br/>
<a id="pl.8.34"></a><var>8.34</var>    (b) The formulary shall not include:<br/>
<a id="pl.9.1"></a><var>9.1</var>    (1) drugs, active pharmaceutical ingredients, or products for which there is no <br/>
<a id="pl.9.2"></a><var>9.2</var>federal funding;<br/>
<a id="pl.9.3"></a><var>9.3</var>    (2) over-the-counter drugs, except as provided in subdivision 13;<br/>
<a id="pl.9.4"></a><var>9.4</var>    (3) drugs or active pharmaceutical ingredients used for weight loss, except that <br/>
<a id="pl.9.5"></a><var>9.5</var>medically necessary lipase inhibitors may be covered for a recipient with type II diabetes;<br/>
<a id="pl.9.6"></a><var>9.6</var>    (4) drugs or active pharmaceutical ingredients when used for the treatment of <br/>
<a id="pl.9.7"></a><var>9.7</var>impotence or erectile dysfunction;<br/>
<a id="pl.9.8"></a><var>9.8</var>    (5) drugs or active pharmaceutical ingredients for which medical value has not <br/>
<a id="pl.9.9"></a><var>9.9</var>been established; and<br/>
<a id="pl.9.10"></a><var>9.10</var>    (6) drugs from manufacturers who have not signed a rebate agreement with the <br/>
<a id="pl.9.11"></a><var>9.11</var>Department of Health and Human Services pursuant to section 1927 of title XIX of the <br/>
<a id="pl.9.12"></a><var>9.12</var>Social Security Act; and<br/>
<a id="pl.9.13"></a><var>9.13</var>    (7) medical cannabis as defined under section 152.22.<br/>
<a id="pl.9.14"></a><var>9.14</var>    (c) If a single-source drug used by at least two percent of the fee-for-service <br/>
<a id="pl.9.15"></a><var>9.15</var>medical assistance recipients is removed from the formulary due to the failure of the <br/>
<a id="pl.9.16"></a><var>9.16</var>manufacturer to sign a rebate agreement with the Department of Health and Human <br/>
<a id="pl.9.17"></a><var>9.17</var>Services, the commissioner shall notify prescribing practitioners within 30 days of <br/>
<a id="pl.9.18"></a><var>9.18</var>receiving notification from the Centers for Medicare and Medicaid Services (CMS) that a <br/>
<a id="pl.9.19"></a><var>9.19</var>rebate agreement was not signed.<br/>
<br/>
<a id="bill.0.3.0"></a><a id="pl.9.20"></a><var>9.20</var>    Sec. 3. <b>IMPACT ASSESSMENT OF MEDICAL CANNABIS THERAPEUTIC </b><br/>
<a id="pl.9.21"></a><var>9.21</var><b>RESEARCH.</b><br/>
<a id="pl.9.22"></a><var>9.22</var>    Subdivision 1. <b>Task force on medical cannabis therapeutic research.</b> (a) A <br/>
<a id="pl.9.23"></a><var>9.23</var>23-member task force on medical cannabis therapeutic research is created to conduct an <br/>
<a id="pl.9.24"></a><var>9.24</var>impact assessment of medical cannabis therapeutic research. The task force shall consist <br/>
<a id="pl.9.25"></a><var>9.25</var>of the following members:<br/>
<a id="pl.9.26"></a><var>9.26</var>(1) two members of the house of representatives of the state of Minnesota, one <br/>
<a id="pl.9.27"></a><var>9.27</var>selected by the speaker of the house, the other selected by the minority leader;<br/>
<a id="pl.9.28"></a><var>9.28</var>(2) two members of the senate of the state of Minnesota, one selected by the majority <br/>
<a id="pl.9.29"></a><var>9.29</var>leader, the other selected by the minority leader;<br/>
<a id="pl.9.30"></a><var>9.30</var>(3) four members representing consumers or patients, including at least two parents <br/>
<a id="pl.9.31"></a><var>9.31</var>of patients under age 18;<br/>
<a id="pl.9.32"></a><var>9.32</var>(4) four members representing health care providers;<br/>
<a id="pl.9.33"></a><var>9.33</var>(5) four members representing law enforcement, one from the Minnesota Chiefs of <br/>
<a id="pl.9.34"></a><var>9.34</var>Police Association, one from the Minnesota Sheriff's Association, one from the Minnesota <br/>
<a id="pl.10.1"></a><var>10.1</var>Police and Peace Officers Association, and one from the Minnesota County Attorneys <br/>
<a id="pl.10.2"></a><var>10.2</var>Association;<br/>
<a id="pl.10.3"></a><var>10.3</var>(6) four members representing substance use disorder treatment providers; and<br/>
<a id="pl.10.4"></a><var>10.4</var>(7) the commissioners of health, human services, and public safety.<br/>
<a id="pl.10.5"></a><var>10.5</var>(b) Task force members listed under paragraph (a), clauses (3), (4), (5), and (6), shall <br/>
<a id="pl.10.6"></a><var>10.6</var>be appointed by the governor. Members shall serve on the task force at the pleasure of <br/>
<a id="pl.10.7"></a><var>10.7</var>the appointing authority.<br/>
<a id="pl.10.8"></a><var>10.8</var>(c) There shall be two cochairs of the task force chosen from the members listed <br/>
<a id="pl.10.9"></a><var>10.9</var>under paragraph (a). One cochair shall be selected by the speaker of the house and <br/>
<a id="pl.10.10"></a><var>10.10</var>the other cochair shall be selected by the majority leader of the senate. The expense <br/>
<a id="pl.10.11"></a><var>10.11</var>reimbursement for members of the task force is governed by section 15.059.<br/>
<a id="pl.10.12"></a><var>10.12</var>    Subd. 2. <b>Impact assessment.</b> The task force shall hold hearings to conduct the <br/>
<a id="pl.10.13"></a><var>10.13</var>impact assessment on medical cannabis therapeutic research that must evaluate Minnesota <br/>
<a id="pl.10.14"></a><var>10.14</var>activities and other states' activities involving medical cannabis and offer analysis of:<br/>
<a id="pl.10.15"></a><var>10.15</var>(1) program design and implementation;<br/>
<a id="pl.10.16"></a><var>10.16</var>(2) the impact on the health care provider community;<br/>
<a id="pl.10.17"></a><var>10.17</var>(3) patient experiences;<br/>
<a id="pl.10.18"></a><var>10.18</var>(4) the impact on the incidence of substance abuse;<br/>
<a id="pl.10.19"></a><var>10.19</var>(5) access to and quality of medical products;<br/>
<a id="pl.10.20"></a><var>10.20</var>(6) the impact on law enforcement and prosecutions;<br/>
<a id="pl.10.21"></a><var>10.21</var>(7) public awareness and perception; and<br/>
<a id="pl.10.22"></a><var>10.22</var>(8) any unintended consequences.<br/>
<a id="pl.10.23"></a><var>10.23</var>    Subd. 3. <b>Reports to the legislature.</b> (a) The cochairs shall submit the following <br/>
<a id="pl.10.24"></a><var>10.24</var>reports to the chairs and ranking minority members of the legislative committees and <br/>
<a id="pl.10.25"></a><var>10.25</var>divisions with jurisdiction over health and human services, judiciary, and civil law:<br/>
<a id="pl.10.26"></a><var>10.26</var>(1) by February 1, 2015, a report on the design and implementation of the clinical <br/>
<a id="pl.10.27"></a><var>10.27</var>trial program;<br/>
<a id="pl.10.28"></a><var>10.28</var>(2) by February 1, 2016, a final report on the impact assessment; and<br/>
<a id="pl.10.29"></a><var>10.29</var>(3) by June 30, 2019, a review and assessment of the clinical trial results.<br/>
<a id="pl.10.30"></a><var>10.30</var>(b) The task force may make recommendations to the legislature on whether to add <br/>
<a id="pl.10.31"></a><var>10.31</var>or remove conditions from the list of qualifying medical conditions.<br/>
<a id="pl.10.32"></a><var>10.32</var>    Subd. 4. <b>Expiration.</b> The task force on medical cannabis therapeutic research <br/>
<a id="pl.10.33"></a><var>10.33</var>expires on June 30, 2019, or upon the conclusion of the clinical trial, whichever is later.<br/>
<br/>
<a id="bill.0.4.0"></a><a id="pl.10.34"></a><var>10.34</var>    Sec. 4. <b>APPROPRIATIONS; MEDICAL CANNABIS THERAPEUTIC </b><br/>
<a id="pl.10.35"></a><var>10.35</var><b>RESEARCH ACT.</b><br/>
<a id="pl.11.1"></a><var>11.1</var>(a) $1,100,000 in fiscal year 2016 and $1,100,000 in fiscal year 2017 are appropriated <br/>
<a id="pl.11.2"></a><var>11.2</var>from the general fund to the commissioner of health for grants to the principal investigators <br/>
<a id="pl.11.3"></a><var>11.3</var>for purposes of conducting the clinical trials under Minnesota Statutes, section 152.22.<br/>
<a id="pl.11.4"></a><var>11.4</var>(b) $450,000 in fiscal year 2015 is appropriated from the general fund to the <br/>
<a id="pl.11.5"></a><var>11.5</var>commissioner of health for the costs of administering Minnesota Statutes, section 152.22. <br/>
<a id="pl.11.6"></a><var>11.6</var>Funds are available until June 30, 2019.<br/>
<a id="pl.11.7"></a><var>11.7</var>(c) $50,000 in fiscal year 2015 is appropriated from the general fund to the <br/>
<a id="pl.11.8"></a><var>11.8</var>Legislative Coordinating Commission to administer the task force on medical cannabis <br/>
<a id="pl.11.9"></a><var>11.9</var>therapeutic research and for the task force to conduct the impact assessment on the use of <br/>
<a id="pl.11.10"></a><var>11.10</var>cannabis for medicinal purposes. These funds are available until the expiration of the task <br/>
<a id="pl.11.11"></a><var>11.11</var>force on medical cannabis therapeutic research.<br/>
<br/>
<a id="bill.0.5.0"></a><a id="pl.11.12"></a><var>11.12</var>    Sec. 5. <b>EFFECTIVE DATE.</b><br/>
<a id="pl.11.13"></a><var>11.13</var>Sections 1 and 3 are effective July 1, 2014.<br/>