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SF 2470

3rd Engrossment - 88th Legislature (2013 - 2014) Posted on 10/31/2014 10:30am

KEY: stricken = removed, old language. underscored = added, new language.

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A bill for an act
relating to health; providing for medical cannabis registry program; authorizing
rulemaking; establishing duties of patients, health care practitioners, and
manufacturer of medical cannabis; establishing patient protections; imposing
penalties; establishing fees; requiring impact assessment of medical cannabis
therapeutic research; requiring audits; appropriating money;amending Minnesota
Statutes 2012, sections 13.3806, by adding a subdivision; 256B.0625, subdivision
13d; proposing coding for new law in Minnesota Statutes, chapter 152.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2012, section 13.3806, is amended by adding a
subdivision to read:


Subd. 22.

Medical use of cannabis data.

Data collected under the registry program
authorized under sections 152.22 to 152.37 are governed by sections 152.25, subdivision
1; 152.28, subdivision 2; and 152.37, subdivision 3.

Sec. 2.

[152.22] DEFINITIONS.

Subdivision 1.

Applicability.

For purposes of sections 152.22 to 152.37, the terms
defined in this section have the meanings given them.

Subd. 2.

Commissioner.

"Commissioner" means the commissioner of health.

Subd. 3.

Disqualifying felony offense.

"Disqualifying felony offense" means a
violation of a state or federal controlled substance law that is a felony under Minnesota
law, or would be a felony if committed in Minnesota, regardless of the sentence imposed,
unless the commissioner determines that the person's conviction was for the medical use
of cannabis or assisting with the medical use of cannabis.

Subd. 4.

Health care practitioner.

"Health care practitioner" means a Minnesota
licensed doctor of medicine, a Minnesota licensed physician assistant acting within the
scope of authorized practice, or a Minnesota licensed advanced practice registered nurse
who has the primary responsibility for the care and treatment of the qualifying medical
condition of a person diagnosed with a qualifying medical condition.

Subd. 5.

Health records.

"Health records" means health records as defined in
section 144.291, subdivision 2, paragraph (c).

Subd. 6.

Medical cannabis.

"Medical cannabis" means any species of the genus
cannabis plant, or any mixture or preparation of them, including whole plant extracts
and resins, and is delivered in the form of:

(1) liquid, including, but not limited to, oil;

(2) pill;

(3) vaporized delivery method with use of liquid or oil but which does not require
the use of dried leaves or plant form; or

(4) any other method, excluding smoking, approved by the commissioner.

Subd. 7.

Medical cannabis manufacturer.

"Medical cannabis manufacturer" or
"manufacturer" means an entity registered by the commissioner to cultivate, acquire,
manufacture, possess, prepare, transfer, transport, supply, or dispense medical cannabis,
delivery devices, or related supplies and educational materials.

Subd. 8.

Medical cannabis product.

"Medical cannabis product" means any
delivery device or related supplies and educational materials used in the administration
of medical cannabis for a patient with a qualifying medical condition enrolled in the
registry program.

Subd. 9.

Patient.

"Patient" means a Minnesota resident who has been diagnosed
with a qualifying medical condition by a health care practitioner and who has otherwise
met any other requirements for patients under sections 152.22 to 152.37 to participate in
the registry program under sections 152.22 to 152.37.

Subd. 10.

Patient registry number.

"Patient registry number" means a unique
identification number assigned by the commissioner to a patient enrolled in the registry
program.

Subd. 11.

Registered designated caregiver.

"Registered designated caregiver"
means a person who:

(1) is at least 21 years old;

(2) does not have a conviction for a disqualifying felony offense;

(3) has been approved by the commissioner to assist a patient who has been
identified by a health care practitioner as developmentally or physically disabled and
therefore unable to self-administer medication or acquire medical cannabis from a
distribution facility due to the disability; and

(4) is authorized by the commissioner to assist the patient with the use of medical
cannabis.

Subd. 12.

Registry program.

"Registry program" means the patient registry
established sections 152.22 to 152.37.

Subd. 13.

Registry verification.

"Registry verification" means the verification
provided by the commissioner that a patient is enrolled in the registry program and that
includes the patient's name, registry number, and qualifying medical condition and, if
applicable, the name of the patient's registered designated caregiver or parent or legal
guardian.

Subd. 14.

Qualifying medical condition.

"Qualifying medical condition" means a
diagnosis of any of the following conditions:

(1) cancer, if the underlying condition or treatment produces one or more of the
following:

(i) severe or chronic pain;

(ii) nausea or severe vomiting; or

(iii) cachexia or severe wasting;

(2) glaucoma;

(3) human immunodeficiency virus or acquired immune deficiency syndrome;

(4) Tourette's syndrome;

(5) amyotrophic lateral sclerosis;

(6) seizures, including those characteristic of epilepsy;

(7) severe and persistent muscle spasms, including those characteristic of multiple
sclerosis;

(8) Crohn's disease;

(9) terminal illness, with a probable life expectancy of under one year, if the illness
or its treatment produces one or more of the following:

(i) severe or chronic pain;

(ii) nausea or severe vomiting; or

(iii) cachexia or severe wasting; or

(10) any other medical condition or its treatment approved by the commissioner.

Sec. 3.

[152.23] LIMITATIONS.

(a) Nothing in sections 152.22 to 152.37 permits any person to engage in and does
not prevent the imposition of any civil, criminal, or other penalties for:

(1) undertaking any task under the influence of medical cannabis that would
constitute negligence or professional malpractice;

(2) possessing or engaging in the use of medical cannabis:

(i) on a school bus or van;

(ii) on the grounds of any preschool or primary or secondary school;

(iii) in any correctional facility; or

(iv) on the grounds of any child care facility or home daycare;

(3) vaporizing medical cannabis pursuant to section 152.22, subdivision 6:

(i) on any form of public transportation;

(ii) where the vapor would be inhaled by a nonpatient minor child; or

(iii) in any public place, including any indoor or outdoor area used by or open to the
general public or a place of employment as defined under section 144.413, subdivision
1b; and

(4) operating, navigating, or being in actual physical control of any motor vehicle,
aircraft, train, or motorboat, or working on transportation property, equipment, or facilities
while under the influence of medical cannabis.

(b) Nothing in sections 152.22 to 152.37 require the medical assistance and
MinnesotaCare programs to reimburse an enrollee or a provider for costs associated with
the medical use of cannabis. Medical assistance and MinnesotaCare shall continue to
provide coverage for all services related to treatment of an enrollee's qualifying medical
condition if the service is covered under chapter 256B or 256L.

Sec. 4.

[152.24] FEDERALLY APPROVED CLINICAL TRIALS.

The commissioner may prohibit enrollment of a patient in the registry program if the
patient is simultaneously enrolled in a federally approved clinical trial for the treatment of
a qualifying medical condition with medical cannabis. The commissioner shall provide
information to all patients enrolled in the registry program on the existence of federally
approved clinical trials for the treatment of the patient's qualifying medical condition with
medical cannabis as an alternative to enrollment in the patient registry program.

Sec. 5.

[152.25] COMMISSIONER DUTIES.

Subdivision 1.

Medical cannabis manufacturer registration.

(a) The
commissioner shall register two in-state manufacturers for the production of all medical
cannabis within the state by December 1, 2014, unless the commissioner obtains
an adequate supply of federally sourced medical cannabis by August 1, 2014. The
commissioner shall register new manufacturers or reregister the existing manufacturers by
December 1 of each year, using the factors described in paragraph (c). The commissioner
shall continue to accept applications after December 1, 2014, if two manufacturers that
meet the qualifications set forth in this subdivision do not apply before December 1, 2014.
The commissioner's determination that no manufacturer exists to fulfill the duties under
sections 152.22 to 152.37 is subject to judicial review in Ramsey County District Court.
Data submitted during the application process are private data on individuals or nonpublic
data as defined in section 13.02 until the manufacturer is registered under this section.
Data on a manufacturer that is registered are public data, unless the data are trade secret or
security information under section 13.37.

(b) As a condition for registration, a manufacturer must agree to:

(1) begin supplying medical cannabis to patients by July 1, 2015; and

(2) comply with all requirements under sections 152.22 to 152.37.

(c) The commissioner shall consider the following factors when determining which
manufacturer to register:

(1) the technical expertise of the manufacturer in cultivating medical cannabis and
converting the medical cannabis into an acceptable delivery method under section 152.22,
subdivision 6;

(2) the qualifications of the manufacturer's employees;

(3) the long-term financial stability of the manufacturer;

(4) the ability to provide appropriate security measures on the premises of the
manufacturer;

(5) whether the manufacturer has demonstrated an ability to meet the medical
cannabis production needs required by sections 152.22 to 152.37; and

(6) the manufacturer's projection and ongoing assessment of fees on patients with
a qualifying medical condition.

(d) The commissioner shall require each medical cannabis manufacturer to contract
with an independent laboratory to test medical cannabis produced by the manufacturer.
The commissioner shall approve the laboratory chosen by each manufacturer and require
that the laboratory report testing results to the manufacturer in a manner determined by
the commissioner.

Subd. 2.

Range of compounds and dosages; report.

The commissioner shall
review and publicly report the existing medical and scientific literature regarding the
range of recommended dosages for each qualifying condition and the range of chemical
compositions of any plant of the genus cannabis that will likely be medically beneficial for
each of the qualifying medical conditions. The commissioner shall make this information
available to patients with qualifying medical conditions beginning December 1, 2014, and
update the information annually. The commissioner may consult with the independent
laboratory under contract with the manufacturer or other experts in reporting the range
of recommended dosages for each qualifying medical condition, the range of chemical
compositions that will likely be medically beneficial, and any risks of noncannabis drug
interactions. The commissioner shall consult with each manufacturer on an annual basis
on medical cannabis offered by the manufacturer. The list of medical cannabis offered by
a manufacturer shall be published on the Department of Health Web site.

Subd. 3.

Deadlines.

(a) The commissioner shall adopt rules necessary for the
manufacturer to begin distribution of medical cannabis to patients under the registry
program by July 1, 2015, and have notice of proposed rules published in the State Register
prior to January 1, 2015.

(b) The commissioner shall, by November 1, 2014, advise the public and the cochairs
of the task force on medical cannabis therapeutic research established under section
152.36 if the commissioner is unable to register two manufacturers by the December 1,
2014, deadline. The commissioner shall provide a written statement as to the reason or
reasons the deadline will not be met. Upon request of the commissioner, the task force
shall extend the deadline by six months, but may not extend the deadline more than once.

(c) If notified by a manufacturer that distribution to patients may not begin by
the July 1, 2015, deadline, the commissioner shall advise the public and the cochairs
of the task force on medical cannabis therapeutic research. Upon notification by the
commissioner, the task force shall extend the deadline by six months, but may not extend
the deadline more than once.

Subd. 4.

Reports.

(a) The commissioner shall provide regular updates to the task
force on medical cannabis therapeutic research regarding any changes in federal law or
regulatory restrictions regarding the use of medical cannabis.

(b) The commissioner may submit medical research based on the data collected
under sections 152.22 to 152.37 to any federal agency with regulatory or enforcement
authority over medical cannabis to demonstrate the effectiveness of medical cannabis for
treating a qualifying medical condition.

Sec. 6.

[152.26] RULEMAKING.

The commissioner may adopt rules to implement sections 152.22 to 152.37. Rules
for which notice is published in the State Register before January 1, 2015, may be adopted
using the process in section 14.389.

Sec. 7.

[152.27] PATIENT REGISTRY PROGRAM ESTABLISHED.

Subdivision 1.

Patient registry program; establishment.

(a) The commissioner
shall establish a patient registry program to evaluate data on patient demographics,
effective treatment options, clinical outcomes, and quality-of-life outcomes for the purpose
of reporting on the benefits, risks, and outcomes regarding patients with a qualifying
medical condition engaged in the therapeutic use of medical cannabis.

(b) The establishment of the registry program shall not be construed or interpreted to
condone or promote the illicit recreational use of marijuana.

Subd. 2.

Commissioner duties.

(a) The commissioner shall:

(1) give notice of the program to health care practitioners in the state who are
eligible to serve as health care practitioners and explain the purposes and requirements
of the program;

(2) allow each health care practitioner who meets or agrees to meet the program's
requirements and who requests to participate, to be included in the registry program to
collect data for the patient registry;

(3) provide explanatory information and assistance to each health care practitioner
in understanding the nature of therapeutic use of medical cannabis within program
requirements;

(4) create and provide a certification to be used by a health care practitioner for the
practitioner to certify whether a patient has been diagnosed with a qualifying medical
condition and include in the certification an option for the practitioner to certify whether
the patient, in the health care practitioner's medical opinion, is developmentally or
physically disabled and, as a result of that disability, the patient is unable to self-administer
medication or acquire medical cannabis from a distribution facility;

(5) supervise the participation of the health care practitioner in conducting patient
treatment and health records reporting in a manner that ensures stringent security and
record-keeping requirements and that prevents the unauthorized release of private data on
individuals as defined by section 13.02;

(6) develop safety criteria for patients with a qualifying medical condition as a
requirement of the patient's participation in the program, to prevent the patient from
undertaking any task under the influence of medical cannabis that would constitute
negligence or professional malpractice on the part of the patient; and

(7) conduct research and studies based on data from health records submitted to
the registry program and submit reports on intermediate or final research results to the
legislature and major scientific journals. The commissioner may contract with a third
party to complete the requirements of this clause. Any reports submitted must comply
with section 152.28, subdivision 2.

(b) If the commissioner wishes to add a delivery method under section 152.22,
subdivision 6, or a qualifying medical condition under section 152.22, subdivision 14, the
commissioner must notify the chairs and ranking minority members of the legislative policy
committees having jurisdiction over health and public safety of the addition and the reasons
for its addition, including any written comments received by the commissioner from the
public and any guidance received from the task force on medical cannabis research, by
January 15 of the year in which the commissioner wishes to make the change. The change
shall be effective on August 1 of that year, unless the legislature by law provides otherwise.

Subd. 3.

Patient application.

(a) The commissioner shall develop a patient
application for enrollment into the registry program. The application shall be available to
the patient and given to health care practitioners in the state who are eligible to serve as
health care practitioners. The application must include:

(1) the name, mailing address, and date of birth of the patient;

(2) the name, mailing address, and telephone number of the patient's health care
practitioner;

(3) the name, mailing address, and date of birth of the patient's designated caregiver,
if any, or the patient's parent or legal guardian if the parent or legal guardian will be
acting as a caregiver;

(4) a copy of the certification from the patient's health care practitioner that is dated
within 90 days prior to submitting the application which certifies that the patient has been
diagnosed with a qualifying medical condition and, if applicable, that, in the health care
practitioner's medical opinion, the patient is developmentally or physically disabled and,
as a result of that disability, the patient is unable to self-administer medication or acquire
medical cannabis from a distribution facility; and

(5) all other signed affidavits and enrollment forms required by the commissioner
under sections 152.22 to 152.37, including, but not limited to, the disclosure form required
under paragraph (c).

(b) The commissioner shall require a patient to resubmit a copy of the certification
from the patient's health care practitioner on a yearly basis and shall require that the
recertification be dated within 90 days of submission.

(c) The commissioner shall develop a disclosure form and require, as a condition of
enrollment, all patients to sign a copy of the disclosure. The disclosure must include:

(1) a statement that, notwithstanding any law to the contrary, the commissioner, or
an employee of any state agency, may not be held civilly or criminally liable for any
injury, loss of property, personal injury, or death caused by any act or omission while
acting within the scope of office or employment under sections 152.22 to 152.37; and

(2) the patient's acknowledgement that enrollment in the patient registry program is
conditional on the patient's agreement to meet all of the requirements of sections 152.22
to 152.37.

Subd. 4.

Registered designated caregiver.

(a) The commissioner shall register a
designated caregiver for a patient if the patient's health care practitioner has certified
that the patient, in the health care practitioner's medical opinion, is developmentally or
physically disabled and, as a result of that disability, the patient is unable to self-administer
medication or acquire medical cannabis from a distribution facility and the caregiver has
agreed, in writing, to be the patient's designated caregiver. As a condition of registration
as a designated caregiver, the commissioner shall require the person to:

(1) be at least 21 years of age;

(2) agree to only possess any medical cannabis for purposes of assisting the patient;
and

(3) agree that if the application is approved, the person will not be a registered
designated caregiver for more than one patient, unless the patients reside in the same
residence.

(b) The commissioner shall conduct a criminal background check on the designated
caregiver prior to registration to ensure that the person does not have a conviction for a
disqualifying felony offense. Any cost of the background check shall be paid by the
person seeking registration as a designated caregiver.

Subd. 5.

Parents or legal guardians.

A parent or legal guardian of a patient may
act as the caregiver to the patient without having to register as a designated caregiver. The
parent or legal guardian shall follow all of the requirements of parents and legal guardians
listed in sections 152.22 to 152.37. Nothing in sections 152.22 to 152.37 limits any legal
authority a parent or legal guardian may have for the patient under any other law.

Subd. 6.

Patient enrollment.

(a) After receipt of a patient's application and signed
disclosure, the commissioner shall enroll the patient in the registry program and issue
the patient and patient's registered designated caregiver or parent or legal guardian, if
applicable, a registry verification. A patient's enrollment in the registry program shall only
be denied if the patient:

(1) does not have certification from a health care practitioner that the patient has
been diagnosed with a qualifying medical condition;

(2) has not signed and returned the disclosure form required under subdivision 3,
paragraph (c), to the commissioner;

(3) does not provide the information required;

(4) has previously been removed from the registry program for violations of section
152.30 or 152.33; or

(5) provides false information.

(b) The commissioner shall give written notice to a patient of the reason for denying
enrollment in the registry program.

(c) Denial of enrollment into the registry program is considered a final decision of
the commissioner and is subject to judicial review under the Administrative Procedure
Act pursuant to chapter 14.

(d) A patient's enrollment in the registry program may only be revoked if a patient
violates a requirement under section 152.30 or 152.33.

(e) The commissioner shall develop a registry verification to provide to the patient,
the health care practitioner identified in the patient's application, and to the manufacturer.
The registry verification shall include:

(1) the patient's name and date of birth;

(2) the patient registry number assigned to the patient;

(3) the patient's qualifying medical condition as provided by the patient's health
care practitioner in the certification; and

(4) the name and date of birth of the patient's registered designated caregiver, if any,
or the name of the patient's parent or legal guardian if the parent or legal guardian will
be acting as a caregiver.

Subd. 7.

Notice requirements.

Patients and registered designated caregivers shall
notify the commissioner of any address or name change within 30 days of the change
having occurred. A patient or registered designated caregiver is subject to a $100 fine for
failure to notify the commissioner of the change.

Sec. 8.

[152.28] HEALTH CARE PRACTITIONER DUTIES.

Subdivision 1.

Health care practitioner duties.

(a) Prior to a patient's enrollment
in the registry program, a health care practitioner shall:

(1) determine, in the health care practitioner's medical judgment, whether a patient
suffers from a qualifying medical condition, and, if so determined, provide the patient
with a certification of that diagnosis;

(2) determine whether a patient is developmentally or physically disabled and,
as a result of that disability, the patient is unable to self-administer medication or
acquire medical cannabis from a distribution facility, and, if so determined, include that
determination on the patient's certification of diagnosis;

(3) advise patients, registered designated caregivers, and parents or legal guardians
who are acting as caregivers of the existence of any nonprofit patient support groups or
organizations;

(4) provide explanatory information from the commissioner to patients with
qualifying medical conditions, including disclosure to all patients about the experimental
nature of therapeutic use of medical cannabis; the possible risks, benefits, and side effects
of the proposed treatment; the application and other materials from the commissioner; and
provide patients with the Tennessen warning as required by section 13.04, subdivision
2; and

(5) agree to continue treatment of the patient's qualifying medical condition and
report medical findings to the commissioner.

(b) Upon notification from the commissioner of the patient's enrollment in the
registry program, the health care practitioner shall:

(1) participate in the patient registry reporting system under the guidance and
supervision of the commissioner;

(2) report health records of the patient throughout the ongoing treatment of
the patient to the commissioner in a manner determined by the commissioner and in
accordance with subdivision 2;

(3) determine, on a yearly basis, if the patient continues to suffer from a qualifying
medical condition and, if so, issue the patient a new certification of that diagnosis; and

(4) otherwise comply with all requirements developed by the commissioner.

(c) Nothing in this section requires a health care practitioner to participate in the
registry program.

Subd. 2.

Data.

Data collected on patients by a health care practitioner and
reported to the patient registry are health records under section 144.291, and are private
data on individuals under section 13.02, but may be used or reported in an aggregated,
nonidentifiable form as part of a scientific, peer-reviewed publication of research
conducted under section 152.25 or in the creation of summary data, as defined in section
13.02, subdivision 19.

Sec. 9.

[152.29] MANUFACTURER OF MEDICAL CANNABIS DUTIES.

Subdivision 1.

Manufacturer; requirements.

(a) A manufacturer shall operate four
distribution facilities, which may include the manufacturer's single location for cultivation,
harvesting, manufacturing, packaging, and processing but is not required to include that
location. A manufacturer is required to begin distribution of medical cannabis from at least
one distribution facility by July 1, 2015. All distribution facilities must be operational and
begin distribution of medical cannabis by July 1, 2016. The distribution facilities shall
be located based on geographical need throughout the state to improve patient access. A
manufacturer shall disclose the proposed locations for the distribution facilities to the
commissioner during the registration process. A manufacturer shall operate only one
location where all cultivation, harvesting, manufacturing, packaging, and processing shall
be conducted. Any additional distribution facilities may dispense medical cannabis and
medical cannabis products but may not contain any medical cannabis in a form other than
those forms allowed under section 152.22, subdivision 6, and the manufacturer shall
not conduct any cultivation, harvesting, manufacturing, packaging, or processing at an
additional distribution facility site. Any distribution facility operated by the manufacturer
is subject to all of the requirements applying to the manufacturer under sections 152.22 to
152.37, including, but not limited to, security and distribution requirements.

(b) A medical cannabis manufacturer shall contract with a laboratory, subject to the
commissioner's approval of the laboratory and any additional requirements set by the
commissioner, for purposes of testing medical cannabis manufactured by the medical
cannabis manufacturer as to content, contamination, and consistency to verify the medical
cannabis meets the requirements of section 152.22, subdivision 6. The cost of laboratory
testing shall be paid by the manufacturer.

(c) The operating documents of a manufacturer must include:

(1) procedures for the oversight of the manufacturer and procedures to ensure
accurate record keeping; and

(2) procedures for the implementation of appropriate security measures to deter and
prevent the theft of medical cannabis and unauthorized entrance into areas containing
medical cannabis.

(d) A manufacturer shall implement security requirements, including requirements
for protection of each location by a fully operational security alarm system, facility access
controls, perimeter intrusion detection systems, and a personnel identification system.

(e) A manufacturer shall not share office space with, refer patients to a health care
practitioner, or have any financial relationship with a health care practitioner.

(f) A manufacturer shall not permit any person to consume medical cannabis on
the property of the manufacturer.

(g) A manufacturer is subject to reasonable inspection by the commissioner.

(h) For purposes of sections 152.22 to 152.37, a medical cannabis manufacturer is not
subject to the Board of Pharmacy licensure or regulatory requirements under chapter 151.

(i) A medical cannabis manufacturer may not employ any person who is under 21
years of age or who has been convicted of a disqualifying felony offense. An employee of
a medical cannabis manufacturer must submit a completed criminal history records check
consent form, a full set of classifiable fingerprints, and the required fees for submission
to the Bureau of Criminal Apprehension before an employee may begin working with
the manufacturer. The bureau must conduct a Minnesota criminal history records check
and the superintendent is authorized to exchange the fingerprints with the Federal Bureau
of Investigation to obtain the applicant's national criminal history record information.
The bureau shall return the results of the Minnesota and federal criminal history records
checks to the commissioner.

(j) A manufacturer may not operate in any location, whether for distribution or
cultivation, harvesting, manufacturing, packaging, or processing, within 1,000 feet of a
public or private school existing before the date of the manufacturer's registration with
the commissioner.

(k) A manufacturer shall comply with reasonable restrictions set by the commissioner
relating to signage, marketing, display, and advertising of medical cannabis.

Subd. 2.

Manufacturer; production.

(a) A manufacturer of medical cannabis shall
provide a reliable and ongoing supply of all medical cannabis needed for the registry
program.

(b) All cultivation, harvesting, manufacturing, packaging, and processing of medical
cannabis must take place in an enclosed, locked facility at a physical address provided to
the commissioner during the registration process.

(c) A manufacturer must process and prepare any medical cannabis plant material
into a form allowable under section 152.22, subdivision 6, prior to distribution of any
medical cannabis.

Subd. 3.

Manufacturer; distribution.

(a) A manufacturer shall require that
employees licensed as pharmacists pursuant to chapter 151 be the only employees to
distribute the medical cannabis to a patient.

(b) A manufacturer may dispense medical cannabis products, whether or not the
products have been manufactured by the manufacturer, but is not required to dispense
medical cannabis products.

(c) Prior to distribution of any medical cannabis, the manufacturer shall:

(1) verify that the manufacturer has received the registry verification from the
commissioner for that individual patient;

(2) verify that the person requesting the distribution of medical cannabis is the patient,
the patient's registered designated caregiver, or the patient's parent or legal guardian listed
in the registry verification using the procedures described in section 152.11, subdivision 2d;

(3) assign a tracking number to any medical cannabis distributed from the
manufacturer;

(4) ensure that any employee of the manufacturer licensed as a pharmacist pursuant
to chapter 151 has consulted with the patient to determine the proper dosage for the
individual patient after reviewing the ranges of chemical compositions of the medical
cannabis and the ranges of proper dosages reported by the commissioner;

(5) properly package medical cannabis in compliance with the United States
Poison Prevention Packing Act regarding child resistant packaging and exemptions for
packaging for elderly patients, and label distributed medical cannabis with a list of all
active ingredients and individually identifying information, including:

(i) the patient's name and date of birth;

(ii) the name and date of birth of the patient's registered designated caregiver or,
if listed on the registry verification, the name of the patient's parent or legal guardian,
if applicable;

(iii) the patient's registry identification number;

(iv) the chemical composition of the medical cannabis; and

(v) the dosage; and

(6) ensure that the medical cannabis distributed contains a maximum of a 30-day
supply of the dosage determined for that patient.

(d) A manufacturer shall require any employee of the manufacturer who is
transporting medical cannabis or medical cannabis products to a distribution facility to
carry identification showing that the person is an employee of the manufacturer.

Subd. 4.

Report.

Each manufacturer shall report to the commissioner on a monthly
basis the following information on each individual patient for the month prior to the report:

(1) the amount and dosages of medical cannabis distributed;

(2) the chemical composition of the medical cannabis; and

(3) the tracking number assigned to any medical cannabis distributed.

Sec. 10.

[152.30] PATIENT DUTIES.

(a) A patient shall apply to the commissioner for enrollment in the registry program
by submitting an application as required in section 152.27 and an annual registration
fee as determined under section 152.35.

(b) As a condition of continued enrollment, patients shall agree to:

(1) continue to receive regularly scheduled treatment for their qualifying medical
condition from their health care practitioner; and

(2) report changes in their qualifying medical condition to their health care
practitioner.

(c) A patient shall only receive medical cannabis from a registered manufacturer but
is not required to receive medical cannabis products from only a registered manufacturer.

Sec. 11.

[152.31] DATA PRACTICES.

(a) Government data in patient files maintained by the commissioner and the health
care practitioner, and data submitted to or by a medical cannabis manufacturer, are private
data on individuals, as defined in section 13.02, subdivision 12, or nonpublic data, as
defined in section 13.02, subdivision 9, but may be used for purposes of complying with
chapter 13 and complying with a request from the legislative auditor or the state auditor in
the performance of official duties. The provisions of section 13.05, subdivision 11, apply
to a registration agreement entered between the commissioner and a medical cannabis
manufacturer under section 152.25.

(b) Not public data maintained by the commissioner may not be used for any purpose
not provided for in sections 152.22 to 152.37, and may not be combined or linked in any
manner with any other list, dataset, or database.

Sec. 12.

[152.32] PROTECTIONS FOR REGISTRY PROGRAM
PARTICIPATION.

Subdivision 1.

Presumption.

(a) There is a presumption that a patient enrolled in
the registry program under sections 152.22 to 152.37 is engaged in the authorized use of
medical cannabis.

(b) The presumption may be rebutted by evidence that conduct related to use of
medical cannabis was not for the purpose of treating or alleviating the patient's qualifying
medical condition or symptoms associated with the patient's qualifying medical condition.

Subd. 2.

Criminal and civil protections.

(a) Subject to section 152.23, the
following are not violations under this chapter:

(1) use or possession of medical cannabis or medical cannabis products by a patient
enrolled in the registry program, or possession by a registered designated caregiver
or the parent or legal guardian of a patient if the parent or legal guardian is listed on
the registry verification;

(2) possession, dosage determination, or sale of medical cannabis or medical
cannabis products by a medical cannabis manufacturer, employees of a manufacturer, a
laboratory conducting testing on medical cannabis, or employees of the laboratory; and

(3) possession of medical cannabis or medical cannabis products by any person
while carrying out the duties required under sections 152.22 to 152.37.

(b) Medical cannabis obtained and distributed pursuant to sections 152.22 to 152.37
and associated property is not subject to forfeiture under sections 609.531 to 609.5316.

(c) The commissioner, the commissioner's staff, the commissioner's agents or
contractors and any health care practitioner are not subject to any civil or disciplinary
penalties by the Board of Medical Practice, the Board of Nursing, or by any business,
occupational, or professional licensing board or entity, solely for the participation in the
registry program under sections 152.22 to 152.37. A pharmacist licensed under chapter
151 is not subject to any civil or disciplinary penalties by the Board of Pharmacy when
acting in accordance with the provisions of sections 152.22 to 152.37. Nothing in this
section affects a professional licensing board from taking action in response to violations
of any other section of law.

(d) Notwithstanding any law to the contrary, the commissioner, the governor of
Minnesota, or an employee of any state agency may not be held civilly or criminally liable
for any injury, loss of property, personal injury, or death caused by any act or omission
while acting within the scope of office or employment under sections 152.22 to 152.37.

(e) Federal, state, and local law enforcement authorities are prohibited from
accessing the patient registry under sections 152.22 to 152.37 except when acting pursuant
to a valid search warrant.

(f) Notwithstanding any law to the contrary, neither the commissioner nor a public
employee may release data or information about an individual contained in any report,
document, or registry created under sections 152.22 to 152.37 or any information obtained
about a patient participating in the program, except as provided in sections 152.22 to 152.37.

(g) No information contained in a report, document, registry, or obtained from
a patient under sections 152.22 to 152.37 may be admitted as evidence in a criminal
proceeding unless independently obtained or in connection with a proceeding involving
a violation of sections 152.22 to 152.37.

(h) Notwithstanding section 13.09, any person who violates paragraph (e) or (f) is
guilty of a gross misdemeanor.

(i) An attorney may not be subject to disciplinary action by the Minnesota Supreme
Court or professional responsibility board for providing legal assistance to prospective or
registered manufacturers or others related to activity that is no longer subject to criminal
penalties under state law pursuant to sections 152.22 to 152.37.

(j) Possession of a registry verification or application for enrollment in the program
by a person entitled to possess or apply for enrollment in the registry program does
not constitute probable cause or reasonable suspicion, nor shall it be used to support a
search of the person or property of the person possessing or applying for the registry
verification, or otherwise subject the person or property of the person to inspection by
any governmental agency.

Subd. 3.

Discrimination prohibited.

(a) No school or landlord may refuse to enroll
or lease to and may not otherwise penalize a person solely for the person's status as a
patient enrolled in the registry program under sections 152.22 to 152.37, unless failing to
do so would violate federal law or regulations or cause the school or landlord to lose a
monetary or licensing-related benefit under federal law or regulations.

(b) For the purposes of medical care, including organ transplants, a registry program
enrollee's use of medical cannabis under sections 152.22 to 152.37 is considered the
equivalent of the authorized use of any other medication used at the discretion of a
physician and does not constitute the use of an illicit substance or otherwise disqualify a
patient from needed medical care.

(c) Unless a failure to do so would violate federal law or regulations or cause an
employer to lose a monetary or licensing-related benefit under federal law or regulations,
an employer may not discriminate against a person in hiring, termination, or any term or
condition of employment, or otherwise penalize a person, if the discrimination is based
upon either of the following:

(1) the person's status as a patient enrolled in the registry program under sections
152.22 to 152.37; or

(2) a patient's positive drug test for cannabis components or metabolites, unless the
patient used, possessed, or was impaired by medical cannabis on the premises of the place
of employment or during the hours of employment.

(d) An employee who is required to undergo employer drug testing pursuant to
section 181.953 may present verification of enrollment in the patient registry as part of the
employee's explanation under section 181.953, subdivision 6.

(e) A person shall not be denied custody of a minor child or visitation rights or
parenting time with a minor child solely based on the person's status as a patient enrolled
in the registry program under sections 152.22 to 152.37. There shall be no presumption
of neglect or child endangerment for conduct allowed under sections 152.22 to 152.37,
unless the person's behavior is such that it creates an unreasonable danger to the safety of
the minor as established by clear and convincing evidence.

Sec. 13.

[152.33] VIOLATIONS.

Subdivision 1.

Intentional diversion; criminal penalty.

In addition to any other
applicable penalty in law, a manufacturer or an agent of a manufacturer who intentionally
transfers medical cannabis to a person other than a patient, a registered designated
caregiver or, if listed on the registry verification, a parent or legal guardian of a patient is
guilty of a felony punishable by imprisonment for not more than two years or by payment
of a fine of not more than $3,000, or both. A person convicted under this subdivision
may not continue to be affiliated with the manufacturer and is disqualified from further
participation under sections 152.22 to 152.37.

Subd. 2.

Diversion by patient, registered designated caregiver, or parent;
criminal penalty.

In addition to any other applicable penalty in law, a patient, registered
designated caregiver or, if listed on the registry verification, a parent or legal guardian of a
patient who intentionally sells or otherwise transfers medical cannabis to a person other
than a patient, designated registered caregiver or, if listed on the registry verification, a
parent or legal guardian of a patient is guilty of a felony punishable by imprisonment for
not more than two years or by payment of a fine of not more than $3,000, or both.

Subd. 3.

False statement; criminal penalty.

A person who intentionally makes a
false statement to a law enforcement official about any fact or circumstance relating to
the medical use of cannabis to avoid arrest or prosecution is guilty of a misdemeanor
punishable by imprisonment for not more than 90 days or by payment of a fine of not
more than $1,000, or both. The penalty is in addition to any other penalties that may apply
for making a false statement or for the possession, cultivation, or sale of cannabis not
protected by sections 152.22 to 152.37. If a person convicted of violating this subdivision
is a patient or a registered designated caregiver, the person is disqualified from further
participation under sections 152.22 to 152.37.

Subd. 4.

Submission of false records; criminal penalty.

A person who knowingly
submits false records or documentation required by the commissioner to register as a
manufacturer of medical cannabis under sections 152.22 to 152.37 is guilty of a felony
and may be sentenced to imprisonment for not more than two years or by payment of
a fine of not more than $3,000, or both.

Subd. 5.

Violation by health care practitioner; criminal penalty.

A health care
practitioner who knowingly refers patients to a manufacturer or to a designated caregiver,
who advertises as a manufacturer, or who issues certifications while holding a financial
interest in a manufacturer is guilty of a misdemeanor and may be sentenced to imprisonment
for not more than 90 days or by payment of a fine of not more than $1,000, or both.

Subd. 6.

Other violations; civil penalty.

A manufacturer shall be fined up to
$1,000 for any violation of sections 152.22 to 152.37, or the regulations issued pursuant
to them, where no penalty has been specified. This penalty is in addition to any other
applicable penalties in law.

Sec. 14.

[152.34] NURSING FACILITIES.

Nursing facilities licensed under chapter 144A, boarding care homes licensed under
section 144.50, and assisted living facilities may adopt reasonable restrictions on the use of
medical cannabis by a patient enrolled in the registry program who resides at the facility.
The restrictions may include a provision that the facility will not store or maintain the
patient's supply of medical cannabis, that the facility is not responsible for providing the
medical cannabis for patients, and that medical cannabis be used only in a place specified
by the facility. Nothing contained in this section shall require the facilities to adopt such
restrictions and no facility shall unreasonably limit a patient's access to or use of medical
cannabis to the extent that use is authorized by the patient under sections 152.22 to 152.37.

Sec. 15.

[152.35] FEES; DEPOSIT OF REVENUE.

(a) The commissioner shall collect an enrollment fee of $200 from patients
enrolled under this section. If the patient attests to receiving Social Security disability,
Supplemental Security Insurance payments, or being enrolled in medical assistance or
MinnesotaCare, then the fee shall be $50. The fees shall be payable annually and are due
on the anniversary date of the patient's enrollment. The fee amount shall be deposited in
the state treasury and credited to the state government special revenue fund.

(b) The commissioner shall collect an application fee of $20,000 from each entity
submitting an application for registration as a medical cannabis manufacturer. Revenue
from the fee shall be deposited in the state treasury and credited to the state government
special revenue fund.

(c) The commissioner shall establish and collect an annual fee from a medical
cannabis manufacturer equal to the cost of regulating and inspecting the manufacturer
in that year. Revenue from the fee amount shall be deposited in the state treasury and
credited to the state government special revenue fund.

(d) A medical cannabis manufacturer may charge patients enrolled in the registry
program a reasonable fee for costs associated with the operations of the manufacturer. The
manufacturer may establish a sliding scale of patient fees based upon a patient's household
income and may accept private donations to reduce patient fees.

Sec. 16.

[152.36] IMPACT ASSESSMENT OF MEDICAL CANNABIS
THERAPEUTIC RESEARCH.

Subdivision 1.

Task force on medical cannabis therapeutic research.

(a) A
23-member task force on medical cannabis therapeutic research is created to conduct an
impact assessment of medical cannabis therapeutic research. The task force shall consist
of the following members:

(1) two members of the house of representatives, one selected by the speaker of the
house, the other selected by the minority leader;

(2) two members of the senate, one selected by the majority leader, the other
selected by the minority leader;

(3) four members representing consumers or patients enrolled in the registry
program, including at least two parents of patients under age 18;

(4) four members representing health care providers, including one licensed
pharmacist;

(5) four members representing law enforcement, one from the Minnesota Chiefs of
Police Association, one from the Minnesota Sheriff's Association, one from the Minnesota
Police and Peace Officers Association, and one from the Minnesota County Attorneys
Association;

(6) four members representing substance use disorder treatment providers; and

(7) the commissioners of health, human services, and public safety.

(b) Task force members listed under paragraph (a), clauses (3), (4), (5), and (6), shall
be appointed by the governor under the appointment process in section 15.0597. Members
shall serve on the task force at the pleasure of the appointing authority. All members must
be appointed by July 15, 2014, and the commissioner of health shall convene the first
meeting of the task force by August 1, 2014.

(c) There shall be two cochairs of the task force chosen from the members listed
under paragraph (a). One cochair shall be selected by the speaker of the house and the
other cochair shall be selected by the majority leader of the senate. The authority to
convene meetings shall alternate between the cochairs.

(d) Members of the task force other than those in paragraph (a), clauses (1), (2), and
(7), shall receive expenses as provided in section 15.059, subdivision 6.

Subd. 2.

Impact assessment.

The task force shall hold hearings to conduct
an assessment that evaluates the impact of the use of medical cannabis and evaluates
Minnesota's activities and other states' activities involving medical cannabis, and offer
analysis of:

(1) program design and implementation;

(2) the impact on the health care provider community;

(3) patient experiences;

(4) the impact on the incidence of substance abuse;

(5) access to and quality of medical cannabis and medical cannabis products;

(6) the impact on law enforcement and prosecutions;

(7) public awareness and perception; and

(8) any unintended consequences.

Subd. 3.

Cost assessment.

By January 15 of each year, beginning January 15, 2015,
and ending January 15, 2019, the commissioners of state departments impacted by the
medical cannabis therapeutic research study shall report to the cochairs of the task force
on the costs incurred by each department on implementing sections 152.22 to 152.37. The
reports must compare actual costs to the estimated costs of implementing these sections
and must be submitted to the task force on medical cannabis therapeutic research.

Subd. 4.

Reports to the legislature.

(a) The cochairs of the task force shall submit
the following reports to the chairs and ranking minority members of the legislative
committees and divisions with jurisdiction over health and human services, public safety,
judiciary, and civil law:

(1) by February 1, 2015, a report on the design and implementation of the registry
program; and every two years thereafter, a complete impact assessment report; and

(2) upon receipt of a cost assessment from a commissioner of a state agency, the
completed cost assessment.

(b) The task force may make recommendations to the legislature on whether to add
or remove conditions from the list of qualifying medical conditions.

Subd. 5.

Expiration.

The task force on medical cannabis therapeutic research
does not expire.

Sec. 17.

[152.37] FINANCIAL EXAMINATIONS; PRICING REVIEWS.

Subdivision 1.

Financial records.

A medical cannabis manufacturer shall maintain
detailed financial records in a manner and format approved by the commissioner, and shall
keep all records updated and accessible to the commissioner when requested.

Subd. 2.

Certified annual audit.

A medical cannabis manufacturer shall submit
the results of an annual certified financial audit to the commissioner no later than May
1 of each year. The annual audit shall be conducted by an independent certified public
accountant and the costs of the audit are the responsibility of the medical cannabis
manufacturer. Results of the audit shall be provided to the medical cannabis manufacturer
and the commissioner. The commissioner may also require another audit of the medical
cannabis manufacturer by a certified public accountant chosen by the commissioner with
the costs of the audit paid by the medical cannabis manufacturer.

Subd. 3.

Power to examine.

(a) The commissioner or designee may examine the
business affairs and conditions of any medical cannabis manufacturer, including but not
limited to a review of the financing, budgets, revenues, sales, and pricing.

(b) An examination may cover the medical cannabis manufacturer's business affairs,
practices, and conditions including but not limited to a review of the financing, budgets,
revenues, sales, and pricing. The commissioner shall determine the nature and scope of
each examination and in doing so shall take into account all available relevant factors
concerning the financial and business affairs, practices, and conditions of the examinee.
The costs incurred by the department in conducting an examination shall be paid for by
the medical cannabis manufacturer.

(c) When making an examination under this section, the commissioner may retain
attorneys, appraisers, independent economists, independent certified public accountants,
or other professionals and specialists as designees. A certified public accountant retained
by the commissioner may not be the same certified public accountant providing the
certified annual audit in subdivision 2.

(d) The commissioner shall make a report of an examination conducted under this
section and provide a copy to the medical cannabis manufacturer. The commissioner
shall then post a copy of the report on the department's Web site. All working papers,
recorded information, documents, and copies produced by, obtained by, or disclosed to
the commissioner or any other person in the course of an examination, other than the
information contained in any commissioner official report, made under this section are
private data on individuals or nonpublic data, as defined in section 13.02.

Sec. 18.

Minnesota Statutes 2012, section 256B.0625, subdivision 13d, is amended to
read:


Subd. 13d.

Drug formulary.

(a) The commissioner shall establish a drug
formulary. Its establishment and publication shall not be subject to the requirements of the
Administrative Procedure Act, but the Formulary Committee shall review and comment
on the formulary contents.

(b) The formulary shall not include:

(1) drugs, active pharmaceutical ingredients, or products for which there is no
federal funding;

(2) over-the-counter drugs, except as provided in subdivision 13;

(3) drugs or active pharmaceutical ingredients used for weight loss, except that
medically necessary lipase inhibitors may be covered for a recipient with type II diabetes;

(4) drugs or active pharmaceutical ingredients when used for the treatment of
impotence or erectile dysfunction;

(5) drugs or active pharmaceutical ingredients for which medical value has not
been established; and

(6) drugs from manufacturers who have not signed a rebate agreement with the
Department of Health and Human Services pursuant to section 1927 of title XIX of the
Social Security Act.; and

(7) medical cannabis as defined in section 152.22, subdivision 6.

(c) If a single-source drug used by at least two percent of the fee-for-service
medical assistance recipients is removed from the formulary due to the failure of the
manufacturer to sign a rebate agreement with the Department of Health and Human
Services, the commissioner shall notify prescribing practitioners within 30 days of
receiving notification from the Centers for Medicare and Medicaid Services (CMS) that a
rebate agreement was not signed.

Sec. 19. RULES; ADVERSE INCIDENTS.

(a) The commissioner of health shall adopt rules to establish requirements for
reporting incidents when individuals who are not authorized to possess medical cannabis
under Minnesota Statutes, sections 152.22 to 152.37, are found in possession of medical
cannabis. The rules must identify professionals required to report, the information they
are required to report, and actions the reporter must take to secure the medical cannabis.

(b) The commissioner of health shall adopt rules to establish requirements for
law enforcement officials and health care professionals to report incidents involving an
overdose of medical cannabis to the commissioner of health.

(c) Rules must include the method by which the commissioner will collect and
tabulate reports of unauthorized possession and overdose.

Sec. 20. INTRACTABLE PAIN.

The commissioner of health shall consider the addition of intractable pain, as
defined in Minnesota Statutes, section 152.125, subdivision 1, to the list of qualifying
medical conditions under Minnesota Statutes, section 152.22, subdivision 14, prior to the
consideration of any other new qualifying medical conditions. The commissioner shall
report findings on the need for adding intractable pain to the list of qualifying medical
conditions to the task force established under Minnesota Statutes, section 152.36, no
later than July 1, 2016.

Sec. 21. APPROPRIATIONS; MEDICAL CANNABIS RESEARCH.

Subdivision 1.

Health Department.

$2,795,000 is appropriated in fiscal year
2015 from the general fund to the commissioner of health for the costs of administering
Minnesota Statutes, sections 152.22 to 152.37. The base for this appropriation is $829,000
in fiscal year 2016 and $728,000 in fiscal year 2017.

Subd. 2.

Legislative Coordinating Commission.

$24,000 is appropriated in
fiscal year 2015 from the general fund to the Legislative Coordinating Commission to
administer the task force on medical cannabis therapeutic research under Minnesota
Statutes, section 152.36, and for the task force to conduct the impact assessment on the
use of cannabis for medicinal purposes.

Subd. 3.

Health Department.

$100,000 is appropriated in fiscal year 2015
from the state government special revenue fund to the commissioner of health for the
costs of implementing Minnesota Statutes, sections 152.22 to 152.37. The base for this
appropriation is $834,000 in fiscal year 2016 and $729,000 in fiscal year 2017.

Sec. 22. EFFECTIVE DATE.

Sections 1 to 21 are effective the day following final enactment.

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700 State Office Building, 100 Rev. Dr. Martin Luther King Jr. Blvd., St. Paul, MN 55155 ♦ Phone: (651) 296-2868 ♦ TTY: 1-800-627-3529 ♦ Fax: (651) 296-0569