SF 1771

as introduced - 89th Legislature (2015 - 2016) Posted on 03/23/2015 10:33am

A bill for an act
relating to health; changing provisions in the medical cannabis program;
amending Minnesota Statutes 2014, sections 144.99, subdivision 1; 152.22,
subdivision 4; 152.25, subdivision 1; 152.26; 152.27, subdivisions 2, 6; 152.29,
subdivisions 1, 2, 3; 152.32, subdivision 2; Laws 2014, chapter 311, section 20;
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 2014, section 144.99, subdivision 1, is amended to read:

Subdivision 1.

Remedies available.

The provisions of chapters 103I and 157 and
sections 115.71 to 115.77; 144.12, subdivision 1, paragraphs (1), (2), (5), (6), (10), (12),
(13), (14), and (15); 144.1201 to 144.1204; 144.121; 144.1222; 144.35; 144.381 to
144.385; 144.411 to 144.417; 144.495; 144.71 to 144.74; 144.9501 to 144.9512; 144.97 to
144.98; 144.992; new text begin 152.22 to 152.37; new text end 326.70 to 326.785; 327.10 to 327.131; and 327.14 to
327.28 and all rules, orders, stipulation agreements, settlements, compliance agreements,
licenses, registrations, certificates, and permits adopted or issued by the department or
under any other law now in force or later enacted for the preservation of public health
may, in addition to provisions in other statutes, be enforced under this section.

Sec. 2.

Minnesota Statutes 2014, section 152.22, subdivision 4, is amended to read:

Subd. 4.

Health care practitioner.

"Health care practitioner" means a new text begin person
who has the primary responsibility for the care and treatment of the qualifying medical
condition of a person diagnosed with a qualifying medical condition and who is a new text end
Minnesota licensed deleted text begin 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. deleted text end new text begin :
new text end

new text begin (1) doctor of medicine;
new text end

new text begin (2) physician assistant acting within the scope of authorized practice; or
new text end

new text begin (3) advanced practice registered nurse.
new text end

Sec. 3.

Minnesota Statutes 2014, section 152.25, subdivision 1, is amended to read:

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 deleted text begin of each year deleted text end new text begin every three years new text end , 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 new text begin approved by the commissioner new text end to test medical cannabis
produced by the manufacturer. The commissioner shall deleted text begin approve the laboratory chosen by
each manufacturer and deleted text end require that the laboratory report testing results to the manufacturer
in a manner determined by the commissioner.

Sec. 4.

Minnesota Statutes 2014, section 152.26, is amended to read:

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. new text begin Rules for implementing additional qualifying medical
conditions may be adopted using the process in section 14.389.
new text end

Sec. 5.

Minnesota Statutes 2014, section 152.27, subdivision 2, is amended to read:

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.

new text begin (c) If the commissioner authorizes additional distribution facilities or additional
distribution options for patients to improve patient access to medical cannabis pursuant
to section 152.29, subdivision 1, the commissioner shall provide notice by publishing
notice of the change in the State Register and must notify the chairs and ranking minority
members of the legislative policy committees having jurisdiction over health and public
safety of the addition, including any written comments received by the commissioner from
the public and any guidance received from the task force on medical cannabis research.
The change shall become effective upon publication in the State Register.
new text end

Sec. 6.

Minnesota Statutes 2014, section 152.27, subdivision 6, is amended to read:

Subd. 6.

Patient enrollment.

(a) After receipt of a patient's application new text begin , application
fees, new text end 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. new text begin The commissioner shall approve or
deny a patient's application for participation in the registry program within 30 days after
the commissioner receives the patient's application and application fee. The commissioner
may approve applications up to 60 days after the receipt of a patient's application and
application fees until January 1, 2016. new text end 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 new text begin upon the
death of the patient or new text end 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.

Sec. 7.

Minnesota Statutes 2014, section 152.29, subdivision 1, is amended to read:

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. new text begin The commissioner may
authorize additional distribution facilities and additional distribution options for patients
in order to improve patient access if the commissioner determines existing distribution
facility locations do not adequately serve patient need. new text end 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 new text begin approved
by the commissioner new text end , subject to deleted text begin the commissioner's approval of the laboratory and deleted text end 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.

Sec. 8.

Minnesota Statutes 2014, section 152.29, subdivision 2, is amended to read:

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.

new text begin (d) A manufacturer may transfer cannabis plants prior to the plant having been
processed into an allowable form, as defined under section 152.22, subdivision 6, to
another manufacturer registered under section 152.25, subdivision 1, after receiving
approval from the commissioner.
new text end

Sec. 9.

Minnesota Statutes 2014, section 152.29, subdivision 3, is amended to read:

Subd. 3.

Manufacturer; distribution.

(a) A manufacturer shall require that
employees licensed as pharmacists pursuant to chapter 151 deleted text begin be the only employees to
distribute the deleted text end new text begin consult with the patient prior to the initial distribution of new text end medical cannabis to
a deleted text begin patient deleted text end new text begin person listed on the patient's registry verification and prior to distribution at any
time the dosage or range of chemical compositions changes for the individual patient new text end .

new text begin (b) A manufacturer may distribute medical cannabis manufactured by any medical
cannabis manufacturer registered under section 152.25, subdivision 1.
new text end

deleted text begin (b) deleted text end new text begin (c) new text end 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.

deleted text begin (c) deleted text end new text begin (d) new text end 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 deleted text begin , 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 deleted text end new text begin or is a person listed on the patient's registry verification new text end ;

(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.

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

Sec. 10.

Minnesota Statutes 2014, section 152.32, subdivision 2, is amended to read:

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; deleted text begin and
deleted text end

new text begin (3) possession of cannabis prior to the cannabis having been processed into an
allowable form as defined under section 152.22, subdivision 6, while engaged in
employment duties, by a manufacturer, employee of a manufacturer, a laboratory
conducting testing, or an employee of the laboratory; and
new text end

deleted text begin (3) deleted text end new text begin (4) new text end 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, or 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.

Sec. 11.

new text begin [152.38] TITLE.
new text end

new text begin Sections 152.21 to 152.38 may be cited as the "Medical Cannabis Therapeutic
Research Act."
new text end

Sec. 12.

Laws 2014, chapter 311, section 20, is amended to read:

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 deleted text begin July deleted text end new text begin January new text end 1, 2016.