Bill Text: WV SB231 | 2021 | Regular Session | Comm Sub
Bill Title: Relating generally to medical cannabis
Spectrum: Slight Partisan Bill (Democrat 5-2)
Status: (Engrossed - Dead) 2021-04-01 - To House Health and Human Resources [SB231 Detail]
Download: West_Virginia-2021-SB231-Comm_Sub.html
WEST virginia legislature
2021 regular session
Committee Substitute
for
Senate Bill 231
By Senators Takubo, Stollings, Maroney, Lindsay, Caputo, Romano, and Woelfel
[Originating in the Committee on the Judiciary; reported on March 29, 2021]
A BILL to repeal §16A-4-2 of the Code of West Virginia, 1931, as amended; to repeal §16A-6-4 of said code; to repeal §16A-13-1 of said code; to amend and reenact §16A-2-1 of said code; to amend and reenact §16A-3-1, §16A-3-2, §16A-3-3, and §16A-3-5 of said code; to amend and reenact §16A-4-3 and §16A-4-5 of said code; to amend said code by adding thereto a new section, designated §16A-4-6; to amend and reenact §16A-5-1 of said code; to amend and reenact §16A-6-2, §16A-6-3, §16A-6-6, §16A-6-12, and §16A-6-13 of said code; to amend said code by adding thereto a new section, designated §16A-6-14; to amend and reenact §16A-7-5 of said code; to amend and reenact §16A-8-2 of said code; to amend and reenact §16A-9-1 of said code; to amend and reenact §16A-12-2, §16A-12-7, and §16A-12-8 of said code; to amend and reenact §16A-13-2, §16A-13-3, §16A-13-4, §16A-13-5, §16A-13-6, and §16A-13-8 of said code; to amend and reenact §16A-14-1, §16A-14-2, and §16A-14-3 of said code; and to amend and reenact §16A-15-2 and §16A-15-4 of said code, all relating to medical cannabis generally; defining terms; increasing medical conditions which constitute a serious medical condition; modifying and expanding allowable forms of medical cannabis; authorizing the Commissioner of the Bureau for Public Health to approve additions to the forms of lawful medical cannabis which may be used and the conditions for which medical cannabis use is authorized pursuant to recommendations of the Medical Cannabis Advisory Board; clarifying the duties of practitioners; declaring practitioners immune from civil and criminal liability if acting in compliance with chapter; requiring employees of medical cannabis organizations and establishing a registration fee; authorizing the commissioner to enter into reciprocity agreements with other jurisdictions for terminally ill cancer patients; authorizing the commissioner to promulgate rules relating to 30-day supplies of medical cannabis; removing the residency requirement for medical cannabis organization owners, operators, shareholders, partners, and members; adding certain convictions which preclude participation as or in a medical cannabis organization; clarifying that the Tax Division of the Department of Revenue is charged with monitoring medical cannabis pricing; modifying and clarifying the distance a medical cannabis dispensary must be from certain educational facilities; modifying and clarifying entities engaged in medical cannabis research subject to nondisclosure provisions; removing requirement that certain federal agencies must preapprove medical cannabis research projects; authorizing accredited colleges and medical schools to be eligible to engage in approved medical cannabis research; increasing the number of clinical registrants; clarifying that the governing body of an academic clinical research center must approve the institution’s participation in a medical cannabis research project; clarifying that only those public officials directly involved in the administrations of the medical cannabis program are prohibited from having a monetary interest in a medical cannabis organization; and adding accredited educational institutions engaged in research to the list of persons, entities, and organizations exempt from licensure, discipline for lawful use, possession, or manufacture of medical cannabis.
Be it enacted by the Legislature of West Virginia:
Article 2. definitions.
§16A-2-1. Definitions.
(a) The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise:
(1) “Act” means the West Virginia Medical Cannabis Act and the provisions contained in this chapter.
(2) “Advisory board” means the advisory board established under §16A-11-1 et seq. of this code.
(3) “Bureau” means the Bureau for Public Health within the West Virginia Department of Health and Human Resources.
(4) “Caregiver” means the individual designated by a patient or, if the patient is under 18 years of age, an individual authorized under §16A-5-1 et seq. of this code, to deliver medical cannabis.
(5) “Certified medical use” means the acquisition, possession, use, or transportation of medical cannabis by a patient, or the acquisition, possession, delivery, transportation, or administration of medical cannabis by a caregiver, for use as part of the treatment of the patient’s serious medical condition, as authorized in a certification under this act, including enabling the patient to tolerate treatment for the serious medical condition.
(6) “Change in control” means the acquisition by a person or group of persons acting in concert of a controlling interest in an applicant or permittee either all at one time or over the span of a 12-consecutive-month period.
(7) “Commissioner” means the Commissioner of the Bureau for Public Health.
(8) “Continuing care” means treating a patient, in the course of which the practitioner has completed a full assessment of the patient’s medical history and current medical condition, including an in-person consultation with the patient, and is able to document and make a medical diagnosis based upon the substantive treatment of the patient.
(9) “Compassion certificate” means a temporary certification issued by a practitioner for patients and caregivers to grow, possess, use, or give away cannabis without remuneration for the purpose of obtaining access to medical cannabis as authorized under this article.
(9) 10 “Controlling interest” means:
(A) For a publicly traded entity, voting rights that entitle a person to elect or appoint one or more of the members of the board of directors or other governing board or the ownership or beneficial holding of five percent or more of the securities of the publicly traded entity.
(B) For a privately held entity, the ownership of any security in the entity.
(10) (11) “Dispensary” means a person, including a
natural person, corporation, partnership, association, trust, or other entity,
or any combination thereof, which holds a permit issued by the bureau to
dispense medical cannabis. The term does not include a health care medical
cannabis organization as defined in §16A-13-1 et seq. of this code.
(11) (12) “Family or household member” means the
same as defined in §48-27-204 of this code.
(12) (13) “Financial backer” means an investor, mortgagee,
bondholder, note holder, or other source of equity, capital, or other assets,
other than a financial institution.
(13) (14) “Financial institution” means a bank, a
national banking association, a bank and trust company, a trust company, a
savings and loan association, a building and loan association, a mutual savings
bank, a credit union, or a savings bank.
(14) (15) “Form of medical cannabis” means the
characteristics of the medical cannabis recommended or limited for a particular
patient, including the method of consumption and any particular dosage, strain,
variety and quantity, or percentage of medical cannabis or particular active
ingredient.
(15) (16) “Fund” means the Medical Cannabis Program
Fund established in §16A-9-2 of this code.
(16) (17) “Grower” means a person, including a
natural person, corporation, partnership, association, trust, or other entity,
or any combination thereof, which holds a permit from the bureau under this act
to grow medical cannabis. The term does not include a health care medical
cannabis organization as defined in §16-13-1 et seq. of this code.
(17) (18) “Grower/processor” means either a grower
or a processor.
(18) (19) “Identification card” means a document
issued under §16A-5-1 et seq. of this code that authorizes access to
medical cannabis under this act.
(19) (20) “Individual dose” means a single measure
of medical cannabis.
(20) (21) “Medical cannabis” means cannabis for
certified medical use as set forth in this act.
(21) (22) “Medical cannabis organization” means a
dispensary, grower, or processor. The term does not include a health care
medical cannabis organization as defined in §16A-13-1 et seq. of this
code.
(22) (23) “Patient” means an individual who:
(A) Has a serious medical condition;
(B) Has met the requirements for certification under this act; and
(C) Is a resident of this state.
(23) (24) “Permit” means an authorization issued by
the bureau to a medical cannabis organization to conduct activities under this
act.
(24) (25) “Physician” or “practitioner” means a
doctor of allopathic or osteopathic medicine who is fully licensed pursuant to
the provisions of either §30-3-1 et seq. or §30-14-1 et seq. of
this code to practice medicine and surgery in this state.
(25) (26) “Post-traumatic stress disorder” means a
diagnosis made as part of continuing care of a patient by a medical doctor,
licensed counselor, or psychologist.
(26) (27) “Prescription drug monitoring program”
means the West Virginia Controlled Substances Monitoring Program under
§60A-9-101 et seq. of this code.
(27) (28) “Principal” means an officer, director,
or person who directly owns a beneficial interest in or ownership of the
securities of an applicant or permittee, a person who has a controlling
interest in an applicant or permittee, or who has the ability to elect the
majority of the board of directors of an applicant or permittee, or otherwise
control an applicant or permittee, other than a financial institution.
(28) (29) “Processor” means a person, including a
natural person, corporation, partnership, association, trust, or other entity,
or any combination thereof, which holds a permit from the bureau under this act
to process medical cannabis. The term does not include a health care medical
cannabis organization as defined in §16A-13-1 et seq. of this code.
(29) (30) “Registry” means the registry established
by the bureau for practitioners.
(30) (31) “Serious medical condition” means any of
the following, as has been diagnosed as part of a patient’s continuing care:
(A) Cancer;
(B) Positive status for human immunodeficiency virus
or acquired immune deficiency syndrome;
(C) Amyotrophic lateral sclerosis;
(D) Parkinson’s disease;
(E) Multiple sclerosis;
(F) Damage to the nervous tissue of the spinal cord
with objective neurological indication of intractable spasticity;
(G) Epilepsy;
(H) Neuropathies;
(I) Huntington’s disease;
(J) Crohn’s disease;
(K) Post-traumatic stress disorder;
(L) Intractable seizures;
(M) Sickle cell anemia;
(N) Severe chronic or intractable pain of neuropathic
origin or severe chronic or intractable pain;
(A) Autism;
(B) Agitation of Alzheimer’s disease;
(C) Amyotrophic lateral sclerosis (ALS);
(D) Anorexia nervosa;
(E) Arnold-Chiari malformation;
(F) Cancer;
(G) Cachexia/wasting syndrome;
(H) Causalgia;
(I) Chronic inflammatory demyelinating polyneuropathy;
(J) Chronic pain;
(K) Connective tissue disease;
(L) Crohn’s disease;
(M) CRPS (complex regional pain syndrome Type II);
(N) Dystonia;
(O) Ehlers-Danlos syndrome;
(P) Fibrous Dysplasia;
(Q) Glaucoma;
(R) Hepatitis C;
(S) HIV/AIDS;
(T) Huntington’s Disease;
(U) Hydrocephalus;
(V) Hydromyelia;
(W) Interstitial cystitis;
(X) Irritable bowel syndrome;
(Y) Lupus;
(Z) Migraines;
(AA) Multiple Sclerosis;
(BB) Muscular Dystrophy;
(CC) Myasthenia Gravis;
(DD) Myoclonus;
(EE) Nail-patella syndrome;
(FF) Neuro-Bechet’s autoimmune disease;
(GG) Neurofibromatosis;
(HH) Neuropathy;
(II) Osteoarthritis;
(JJ) Parkinson’s disease;
(KK) Polycystic kidney disease (PKD);
(LL) Post-Concussion Syndrome;
(MM) Post-Traumatic Stress Disorder (PTSD);
(NN) Reflex sympathetic dystrophy;
(OO) Residual limb pain;
(PP) Rheumatoid arthritis;
(QQ) Seizures (including those characteristic of Epilepsy);
(RR) Severe fibromyalgia;
(SS) Sickle Cell Anemia;
(TT) Sjogren’s syndrome;
(UU) Spinal cord disease (including but not limited to arachnoiditis);
(VV) Spinal cord injury is damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity;
(WW) Spinocerebellar ataxia;
(XX) Superior canal dehiscence syndrome;
(YY) Syringomyelia;
(ZZ) Tarlov cysts;
(AAA) Tourette syndrome;
(BBB) Traumatic brain injury;
(CCC) Ulcerative colitis;
(O) (DDD) Terminally ill A terminal
illness; or
(EEE) Any medical condition for which the commissioner approves the use of medical cannabis pursuant to a recommendation to do so by the advisory board.
(31) (32) “Terminally ill “Terminal
illness” means a medical prognosis of life expectancy of approximately one
year or less if the illness runs its normal course.
article 3. medical cannabis program.
§16A-3-1. Establishment of program.
(a) A medical cannabis program for patients suffering from serious medical conditions is established. The program shall be implemented and administered by the bureau. The bureau shall:
(1) Issue permits to medical cannabis organizations to authorize them to grow, process, or dispense medical cannabis and ensure their compliance with this act;
(2) Register practitioners and ensure their compliance with this act;
(3) Have regulatory and enforcement authority over the growing, processing, sale, and use of medical cannabis in this state;
(4) Establish and maintain an electronic database to include activities and information relating to medical cannabis organizations, certifications, and identification cards issued, practitioner registration and electronic tracking of all medical cannabis as required under this act to include:
(A) Ensurance Assurance
that medical cannabis is not diverted or otherwise used for unlawful purposes
by a practitioner or medical cannabis organization;
(B) Ability to establish the authenticity of identification cards;
(C) Recording recommended forms of medical cannabis, if any, provided in a certification filed by the practitioner;
(D) Monitoring all growth, transfer, possession, processing, testing, and dispensing of medical cannabis in this state; and
(E) The tracking system
under §16A-7-1 et seq. of this code must
shall include information under §16A-8-1 of this code and any other
information required by the bureau to be used by the bureau and dispensaries to
enable a dispensary to lawfully provide medical cannabis. The tracking system
and database shall be capable of providing information in real time. The
database shall be capable of receiving information from a dispensary regarding
the disbursement of medical cannabis to patients and caregivers. This information
shall be immediately accessible to the bureau and other dispensaries to inhibit
diversion and ensure compliance with this act.
(5) Maintain a directory of patients and caregivers approved to use or assist in the administration of medical cannabis within the bureau’s database;
(6) Develop a four
one-hour training course for physicians practitioners
regarding the latest scientific research on medical cannabis, including the
risks and benefits of medical cannabis and other information deemed determined
necessary by the bureau; Successful completion of the course shall be
approved as continuing education credits as determined by:
(A) The State Board of
Medicine.
(B) The State Board of
Osteopathic Medicine
(7) Develop a two-hour
an eight-hour course for the principals and employees of a medical
cannabis organization who either have direct contact with patients or
caregivers or who physically handle medical cannabis. Employees must shall
successfully complete the course no later than 90 days after commencing
employment. Principals must shall successfully complete the
course prior to commencing initial operation of the medical cannabis
organization. The subject matter of the course shall include the following:
(A) Methods to recognize and report unauthorized activity, including diversion of medical cannabis for unlawful purposes and falsification of identification cards;
(B) Proper handling of medical cannabis and recordkeeping;
(C) The latest scientific research on medical cannabis, including the risk and benefits of medical cannabis; and
(C) (D) Any other subject required by the bureau;
(8) Develop enforcement procedures, including announced and unannounced inspections of facilities of the grower/processors and dispensaries and all records of the medical cannabis organizations;
(9) Establish a program to authorize the use of medical cannabis to conduct medical research relating to the use of medical cannabis to treat serious medical conditions, including the collection of data and the provision of research grants;
(10) Establish and maintain public outreach programs about the medical cannabis program, including:
(A) A dedicated telephone number for patients, caregivers, and members of the public to obtain basic information about the dispensing of medical cannabis under this act; and
(B) A publicly accessible Internet website with similar information;
(11) Collaborate as necessary with other state agencies or contract with third parties as necessary to carry out the provisions of this act;
(12) Determine the number and type of medical cannabis products to be produced by a grower/processor and dispensed by a dispensary;
(13) Develop recordkeeping requirements for all books, papers, any electronic database or tracking system data, and other information of a medical cannabis organization. Information shall be retained for a minimum period of four years unless otherwise provided by the bureau; and
(14) Restrict the
advertising and marketing of medical cannabis, which shall be consistent with
the federal rules and regulations governing prescription drug
advertising and marketing.
(b) The bureau shall
propose rules for legislative promulgation pursuant to the provisions of
§29A-3-1 et seq. of this code as
may be that are necessary to carry out and implement the provisions
of this act. The bureau shall also have the power to propose and promulgate
emergency rules as may be necessary to carry out and implement the provisions
of this act.
§16A-3-2. Lawful use of medical cannabis.
(a) Notwithstanding any provision of law to the contrary,
the use or possession of medical cannabis as set forth in this act is lawful
within this state, subject to the following conditions:
(1) Medical cannabis may only be dispensed to:
(A) a patient who receives a certification from a practitioner and is in possession of a valid identification card issued by the bureau; and
(B) a caregiver who is in possession of a valid identification card issued by the bureau.
(2) Subject to rules promulgated under this act, medical cannabis may only be dispensed to a patient or caregiver in the following forms:
(A) Pill;
(B) Oil;
(C) Topical forms, including gels, creams, or ointments;
(D) A form medically appropriate for administration by vaporization or nebulization, excluding dry leaf or plant form until dry leaf or plant forms become acceptable under rules adopted by the bureau;
(E) Tincture;
(F) Liquid; or
(G) Dermal patch;
(H) Dry leaf or plant form;
(I) Edible food and beverage; or
(3) Unless otherwise
provided in rules adopted by the bureau under section two, article eleven of
this chapter, medical cannabis may not be dispensed to a patient or a caregiver
in dry leaf or plant form
(J) A form approved by the commissioner upon a recommendation of the advisory board;
(4) (3) An individual may not act as a caregiver
for more than five patients;
(5) (4) A patient may designate up to two
caregivers at any one time;
(6) (5) Medical cannabis that has not been used by
the patient shall be kept in the original package in which it was dispensed;
(7) (6) A patient or caregiver shall possess an
identification card whenever the patient or caregiver is in possession of
medical cannabis; and
(8) (7) Products packaged by a grower/processor
or sold by a dispensary shall may only be identified by the name
of the grower/processor, the name of the dispensary, the form and species of
medical cannabis, and the percentage of tetrahydrocannabinol and cannabinol
contained in the product.
§16A-3-3. Unlawful use of medical cannabis.
(a) Except as provided
in section two of this article, section four of article seven, article thirteen
or article fourteen of this chapter, the use of medical cannabis is unlawful
and shall, in addition to any other penalty provided by law, be deemed a violation
of the Uniform Controlled Substances Act under chapter sixty-a of this code
(b) It shall be
unlawful to:
(1) Smoke medical
cannabis.
(2) Except as provided
under subsection (c), incorporate medical cannabis into edible form or sell in
edible form.
(3) Grow medical
cannabis unless the grower/processor has received a permit from the bureau
under this act.
(4) Grow or dispense
medical cannabis unless authorized as a health care medical cannabis
organization under article thirteen of this chapter.
(5) Dispense medical
cannabis unless the dispensary has received a permit from the bureau under this
act.
(c) Edible medical
cannabis. — Nothing in this act shall be construed to preclude the
incorporation of medical cannabis into edible form by a patient or a caregiver
in order to aid ingestion of the medical cannabis by the patient
Except as provided in this chapter, the provisions of chapter 60A of this code, relating to cannabis remain in full force and effect.
§16A-3-5. Reciprocity for terminally ill cancer patients.
(a) The bureau commissioner may enter into
reciprocity agreements with any states that have state that has
comparable requirements for the use and lawful purchase of medical cannabis in
a manner consistent with the provisions of this article to allow terminally
ill cancer medical cannabis patients to purchase medical cannabis in
another state.
(b) The commissioner may enter into reciprocity agreements with any state that has comparable requirements for medical cannabis patients and caregivers to possess, transport, use, and transfer without renumeration, medical cannabis in this and any other such approved state.
(c) Nothing in this chapter authorizes patients or caregivers to sell cannabis in any form.
article 4. Practitioners.
§16A-4-2. Practitioner restrictions.
[Repealed.]
§16A-4-3. Issuance of certification.
(a) Conditions for issuance. — A certification to use medical cannabis may be issued by a practitioner to a patient if all of the following requirements are met:
(1) The practitioner has been approved by the bureau for inclusion in the registry and has a valid, unexpired, unrevoked, unsuspended license to practice medicine in this state at the time of the issuance of the certification;
(2) The practitioner has determined that the patient has a serious medical condition and has included the condition in the patient’s health care record;
(3) The patient is under the practitioner’s continuing care for the serious medical condition;
(4) In the practitioner’s professional opinion and review of past treatments, the practitioner determines the patient is likely to receive therapeutic or palliative benefit from the use of medical cannabis;
(5) The practitioner has determined that the patient has no past or current medical condition(s) or medication use that would constitute a contraindication for the use of cannabis;
(6) The practitioner has determined that the patient is experiencing serious pathophysiological discomfort, disability, or dysfunction that may be attributable to a serious medical condition and may possibly benefit from cannabis treatment when current medical research exhibits a moderate or higher probability of efficacy; and
(7) The practitioner has educated the patient about cannabis and its safe use.
(b) Compassion certificate. — The bureau shall create a registry of all applicable patients and caregivers granted a compassion certificate by a practitioner pursuant to the provisions of this section. A compassion certificate authorizes a patient or caregiver to lawfully grow no more than 12 mature flowering cannabis plants and up to 12 cannabis seedlings at any one time: Provided, That a caregiver is authorized 12 mature and 12 seedlings per patient. A compassion certificate authorizes each patient to possess no more than four ounces of dry flower or leaf medical cannabis per patient: Provided, however, That compassion certificates and the authority authorized thereby become void upon the bureau declaring that there is sufficient medical cannabis to meet demand through the other means authorized by this article.
(b) (c) Contents. — The certification shall
include:
(1) The patient’s name, date of birth, and address;
(2) The specific serious medical condition of the patient;
(3) A statement by the practitioner that the patient has a serious medical condition and the patient is under the practitioner’s continuing care for the serious medical condition;
(4) The date of issuance;
(5) The name, address, telephone number, and signature of the practitioner;
(6) Any requirement or limitation concerning the appropriate form of medical cannabis and limitation on the duration of use, if applicable, including whether the patient is terminally ill; and
(7) A statement by the
practitioner attesting that he or she has performed the requirements contained
in subsection (a) of this section on a form to be issued by the West
Virginia Department of Health and Human Resources, B bureau for
Public Health.
(c) (d) Consultation. —
(1) A practitioner shall review the prescription drug monitoring program prior to:
(A) Issuing a certification to determine the controlled substance history of a patient; or
(B) Recommending a change of amount or form of medical cannabis.
(2) The practitioner shall consider and give due consideration to other controlled substances the patient may be taking prior to certifying medical cannabis.
(d) (e) Other access by practitioner. — A
practitioner may access the prescription drug monitoring program to do any of
the following:
(1) Determine whether a patient may be under treatment with a controlled substance by another physician or other person;
(2) Allow the practitioner
to review the patient’s controlled substance history as deemed determined
necessary by the practitioner;
(3) Provide to the patient, or caregiver, on behalf of the patient if authorized by the patient, a copy of the patient’s controlled substance history.
(e) (f) Duties of practitioner. — The
practitioner shall:
(1) Provide the certification to the patient;
(2) Provide a copy of the certification to the bureau, which shall place the information in the patient directory within the bureau’s electronic database. The bureau shall permit electronic submission of the certification; and
(3) File a copy of the certification in the patient’s health care record.
(f) (g) Prohibition. — A practitioner may
not issue a certification for the practitioner’s own use or for the use of a
family or household member.
§16A-4-5. Duration.
Receipt and possession
of medical cannabis by a patient or caregiver from a dispensary may not exceed a
30-day supply of individual doses an amount determined by the
commissioner to be appropriate for a 30-day period, by the appropriate measure
of volume, weight or concentration level. During the last seven days of any
30-day period during the term of the identification card, a patient may obtain
and possess a 30-day supply for the subsequent 30-day period. Additional 30-day
supplies may be provided in accordance with this section for the duration of
the authorized period of the identification card unless a shorter period is
indicated on the certification.
§16A-4-6 Immunity for practitioners acting in conformity with chapter.
Notwithstanding any provision of law to the contrary, a practitioner acting in conformity with the provisions of this chapter is immune from civil and criminal liability for issuing or declining to issue certifications.
article 5. patients.
§16A-5-1. Identification cards.
(a) Issuance. — The
bureau may issue an identification card to a patient who has a certification
approved by the bureau and to a caregiver designated by the patient. An
identification card issued to a patient shall authorize authorizes
the patient to obtain and use medical cannabis as authorized by this act. An
identification card issued to a caregiver shall authorize authorizes
the caregiver to obtain medical cannabis on behalf of the patient.
(b) Procedure for issuance. — The bureau shall develop and implement procedures for:
(1) Review and approval of applications for identification cards;
(2) Issuance of identification cards to patients and caregivers; and
(3) Review of the certification submitted by the practitioner and the patient.
(c) Application. — A
patient or a caregiver may apply, in a form and manner prescribed by the
bureau, for issuance or renewal of an identification card. A caregiver must
shall submit a separate application for issuance or renewal. Each
application must shall include:
(1) The name, address, and date of birth of the patient;
(2) The name, address, and date of birth of a caregiver;
(3) The certification issued by the practitioner;
(4) The name, address, and telephone number of the practitioner and documentation from the practitioner that all of the requirements of §16A-4-3 (a) of this code have been met;
(5) A $50 processing fee. The bureau may waive or reduce the fee if the applicant demonstrates financial hardship;
(6) The signature of the applicant and date signed; and
(7) Other information required by the bureau.
(d) Forms. — Application and renewal forms shall be available on the bureau’s publicly accessible Internet website.
(e) Expiration. — An
The identification card of a patient or caregiver shall expire expires
within one year from the date of issuance, upon the death of the patient, or as
otherwise provided in this section.
(f) Separate cards to be issued. — The bureau shall issue separate identification cards for eligible patients and caregivers as soon as reasonably practicable after receiving completed applications, unless it determines that an application is incomplete or factually inaccurate, in which case it shall promptly notify the applicant.
(g) Change in name or address. — A patient or caregiver who has been issued an identification card shall notify the bureau within 10 days of any change of name or address. In addition, the patient shall notify the bureau within 10 days if the patient no longer has the serious medical condition noted on the certification.
(h) Lost or defaced card.
— In the event of a lost, stolen, destroyed, or illegible identification card,
the patient or caregiver shall apply to the bureau within 10 business days of
discovery of the loss or defacement of the card for a replacement card. The
application for a first replacement card shall be on a form furnished by
the bureau and accompanied by a $25 $10 fee. The bureau may
establish higher fees for issuance of second and subsequent replacement identification
cards. The bureau may waive or reduce the fee in cases of demonstrated
financial hardship. The bureau shall issue a replacement identification card as
soon as practicable. A patient or caregiver may not obtain medical cannabis
until the bureau issues the replacement card.
article 6. medical cannabis organizations.
§16A-6-2. Permits.
(a) Application. — An application for a grower, processor, or dispensary permit to grow, process, or dispense medical cannabis shall be in a form and manner prescribed by the bureau and shall include:
(1) Verification of all principals, operators, financial backers, or employees of a medical cannabis grower/processor or dispensary;
(2) A description of responsibilities as a principal, operator, financial backer, or employee;
(3) Any release necessary to obtain information from governmental agencies, employers, and other organizations;
(4) A criminal history
record check. Medical cannabis organizations applying for a permit shall submit
fingerprints of principals, financial backers, operators, and employees to the
West Virginia State Police for the purpose of obtaining criminal history record
checks and the West Virginia State Police or its authorized agent shall submit
the fingerprints to the Federal Bureau of Investigation for the purpose of
verifying the identity of the principals, financial backers, operators, and
employees and obtaining a current record of any criminal arrests and
convictions. Any criminal history record information relating to principals,
financial backers, operators, and employees obtained under this section by the
bureau may be interpreted and used by the bureau only to determine the
principal’s, financial backer’s, operator’s, and employee’s character, fitness,
and suitability to serve as a principal, financial backer, operator, and
employee under this act. This subdivision shall does not apply to
an owner of securities in a publicly traded corporation or an owner of five percent or less in a privately
held business entity if the bureau
determines that the owner of the securities is not substantially involved in
the activities of the medical cannabis organization;
(5) Details relating to a similar license, permit, or other authorization obtained in another jurisdiction, including any suspensions, revocations, or discipline in that jurisdiction;
(6) A description of the business activities in which it intends to engage as a medical cannabis organization;
(7) A statement that the applicant:
(A) Is of good moral
character. For purposes of this subparagraph, an applicant shall include
each financial backer, operator, employee, and principal of the medical
cannabis organization;
(B) Possesses the ability to obtain in an expeditious manner the right to use sufficient land, buildings, and other premises and equipment to properly carry on the activity described in the application and any proposed location for a facility;
(C) Is able to maintain effective security and control to prevent diversion, abuse, and other illegal conduct relating to medical cannabis; and
(D) Is able to comply with all applicable state laws and rules relating to the activities in which it intends to engage under this act.
(8) The name, residential address, and title of each financial backer and principal of the applicant. Each individual, or lawful representative of a legal entity, shall submit an affidavit with the application setting forth:
(A) Any position of management or ownership during the preceding 10 years of a controlling interest in any other business, located inside or outside this state, manufacturing or distributing controlled substances.
(B) Whether the person or business has been convicted of a criminal offense graded higher than a summary offense or has had a permit relating to medical cannabis suspended or revoked in any administrative or judicial proceeding; and
(9) Any other information the bureau may require.
(b) Notice. — An application shall include notice that a false statement made in the application is punishable under the applicable provisions of law.
§16A-6-3. Granting of permit.
(a) The bureau may grant or deny a permit to a grower, processor, or dispensary. In making a decision under this subsection, the bureau shall determine that:
(1) The applicant will maintain effective control of and prevent diversion of medical cannabis;
(2) The applicant will comply with all applicable laws of this state;
(3) The applicant is a
resident of this state as defined in §29-22B-327 of this code or is organized
under the law of this state. If the applicant is a business entity, majority
ownership in the business entity must be held by a state resident or residents
(4) (3) The applicant is ready, willing, and able
to properly carry on the activity for which a permit is sought;
(5) (4) The applicant possesses the ability to
obtain in an expeditious manner sufficient land, buildings, and equipment to
properly grow, process, or dispense medical cannabis;
(6) (5) It is in
the public interest to grant the permit;
(7) (6) The
applicant, including the financial backer or principal, is of good moral
character and has the financial fitness necessary to operate;
(8) (7) The applicant is able to implement and
maintain security, tracking, recordkeeping, and surveillance systems relating
to the acquisition, possession, growth, manufacture, sale, delivery,
transportation, distribution, or the dispensing of medical cannabis as required
by the bureau; and
(9) (8) The applicant satisfies any other
conditions as determined by the bureau.
(b) Nontransferability.
— A permit issued under this chapter shall be is nontransferable.
(c) Privilege. — The
issuance or renewal of a permit shall be is a revocable
privilege.
(d) Dispensary location. — The bureau shall consider the following when issuing a dispensary permit:
(1) Geographic location;
(2) Regional population;
(3) The number of patients suffering from serious medical conditions;
(4) The types of serious medical conditions;
(5) Access to public transportation;
(6) Approval by local health departments;
(7) Whether the county has disallowed the location of a grower, processor, or dispensary; and
(8) Any other factor
the bureau deems considers relevant.
(e) Application
procedure. — The bureau shall establish a procedure for the fair and
objective evaluation of all applications for all medical cannabis organization
permits. Such The evaluations shall score each applicant
numerically according to standards set forth in this chapter.
§16A-6-4. Notice.
[Repealed.]
§16A-6-6. Fees and other requirements.
The following apply:
(1) For a grower or processor:
(A) An initial application fee in the amount of $5,000 shall be paid. The fee is nonrefundable;
(B) A fee for a permit as a grower/processor in the amount of $50,000 shall be paid. The permit shall be valid for one year. Applicants shall submit the permit fee at the time of submission of the application. The fee shall be returned if the permit is not granted;
(C) A renewal fee for the
permit as a grower/processor in the amount of $5,000 shall be paid. and
shall cover renewal for all locations The renewal fee shall be returned if
the renewal is not granted;
(D) An application to renew
a permit must shall be filed with the bureau not more than six
months nor less than four months prior to expiration;
(E) All fees shall be paid by certified check or money order;
(2) For a dispensary:
(A) An initial application fee in the amount of $2,500 shall be paid. The fee is nonrefundable;
(B) A permit fee for a
dispensary shall be is $10,000. for each location The
period of the permit is one year. An applicant shall submit the permit fee at
the time of submission of the application. The fee shall be returned if the
application is not granted;
(C) A renewal fee for the
permit as a dispensary in the amount of $2,500 shall be paid. The fee shall be
returned if the renewal is not granted; and shall cover renewal for all
locations
(D) An application to renew a permit must be filed with the bureau not more than six months nor less than four months prior to expiration; and
(E) All fees shall be paid by certified check or money order;
(3) A fee of $250 shall
be is required when amending the application to indicate relocation
within this state or the addition or deletion of approved activities by the
medical cannabis organization; and
(4) Fees payable under this section shall be deposited into the fund.
§16A-6-12. Convictions prohibited.
(a) The following
individuals may not hold volunteer positions or positions with remuneration in
or be affiliated with a medical cannabis organization, including a clinical registrant
under §16A-14-1 et seq. of this code,
in any way if the individual has been convicted of any felony criminal offense
related to the sale or possession of illegal drugs, narcotics, or controlled
substances, or conspiracy thereof convicted of any provision of
§61-5A-1 et seq. of this code or substantially similar laws of other
states or the federal government, convicted of any misdemeanor or felony
offense involving fraud, deceit, crimes against the government, or crimes of
dishonesty, or conspiracy of any of these offenses, any offense requiring the
individual to register as a sex offender in this state or to register on the
state child abuse registry:
(1) Financial backers;
(2) Principals; and
(3) Employees.
(b) If an individual
seeking to hold a volunteer position or position with remuneration in or be
affiliated with a dispensary is otherwise prohibited under subsection (a) of
this section, such the individual may seek a waiver from the
bureau in order to hold such a the position with a dispensary.
The allowance of the waiver, including any additional restrictions or
conditions as part of the waiver, shall be in is at the
discretion of the bureau: Provided, That under no
circumstances may a person prohibited under subsection (a) of this section from
holding a position or being affiliated with a medical cannabis organization serve
as a principal, financial backer, or manager who oversees conduct of the
dispensary.
§16A-6-13. Limitations on permits.
(a) The following limitations apply to approval of permits for growers, processors, and dispensaries, subject to the limitations in subsection (b) of this section:
(1) The bureau may not issue permits to more than 10 growers: Provided, That each grower may have up to two locations per permit;
(2) The bureau may not issue permits to more than 10 processors;
(3) The bureau may not issue permits to more than 100 dispensaries;
(4) The bureau may not issue more than 10 individual dispensary permits to one person;
(5) The bureau may not issue more than one individual grower permit to one person;
(6) The bureau may not issue more than one individual processor permit to one person;
(7) A dispensary may only obtain medical cannabis from a grower or processor holding a valid permit under this act;
(8) A grower or processor may only provide medical cannabis to a dispensary holding a valid permit under this act; and
(9) A person may hold a grower permit, a processor permit, and a dispensary permit, or any combination thereof, concurrently.
(b) Before a permit may be
issued, the bureau shall obtain the following: (1) A written approval from
the board of health for the county in which the permit is to be located and
operate business.(2) a written statement from the county commission for
the county in which the permit is to be located and conduct business that the
county has not voted, pursuant to §16A-7-6 of this code, to disapprove a
medical cannabis organization to be located or operate within the county.
§16A-6-14. Employee licensure requirements.
(a) Any person employed by a medical cannabis organization involved in the growing, processing, or dispensing of medical cannabis shall be 18 years of age or older, and registered with the bureau.
(b) The bureau shall establish a registry of medical cannabis organization employees and may charge a registration fee not to exceed $25. for each registrant.
article 7. medical cannabis controls.
§16A-7-5. Prices.
The bureau and the Tax
Division of the Department of Revenue shall monitor the price of medical
cannabis sold by growers, processors, and by dispensaries, including a
per-dose price. If the bureau and the Tax Division of the Department of
Revenue determine that the prices are unreasonable or excessive, the bureau may
implement a cap on the price of medical cannabis being sold for a period of six
months. The cap may be amended during the six-month period. If the bureau and
the Tax Division of and the Department of Revenue determine that the
prices become unreasonable or excessive following the expiration of a six-month
cap, additional caps may be imposed for periods not to exceed six months.
article 8. dispensaries.
§16A-8-2. Facility requirements.
(a) General rule. —
(1) A dispensary may only dispense medical cannabis in an indoor, enclosed, secure facility located within this state, as determined by the bureau.
(2) A dispensary may not operate on the same site as a facility used for growing and processing medical cannabis.
(3) A dispensary may not be
located within 1,000 feet of the property line of a public, private, or
parochial school or a daycare center, measured from front door to front
door, along the street or streets.
(4) A dispensary may, pursuant to bureau conditions and limitations, sell medical devices and instruments which are needed to administer medical cannabis under this act.
(b) Adjustment or waiver
of prohibition. — The bureau may amend a prohibition under subsection
(a)(3) subdivision (3), subsection (a) of this section if it is
shown by clear and convincing evidence that the amendment is necessary to
provide adequate access to patients. An amendment may include additional security,
physical plant of a facility, or other conditions necessary to protect
children.
article 9. tax on medical cannabis.
§16A-9-1. Tax on medical cannabis.
(a) Tax imposed. — For the privilege of engaging or continuing within this state in the business of a dispensary of medical cannabis, as defined in §16A-2-1 of this code, there is hereby levied upon and collected from every person exercising the privilege, a privilege tax.
(b) Rate and measure of tax. — The rate of tax imposed by this section shall be 10 percent of the gross receipts the dispensary receives or accrues during the reporting period, depending upon its method of accounting for federal income tax purposes, from the sale of medical cannabis to a patient or to a caregiver: Provided, That beginning on and after July 1, 2021, the rate of tax imposed by this section shall be 20 percent of the gross receipts the dispensary receives or accrues during the reporting period, depending upon its method of accounting for federal income tax purposes, from the sale of medical cannabis to a patient or to a caregiver. The tax imposed by this section shall not be added by the dispensary as a separate charge or line item on any sales slip, invoice, receipt, other statement, or memorandum of the price paid by a patient, or caregiver.
(c) Definitions. — For purposes of this article:
(1) “Gross receipts” means and includes the gross receipts, however denominated, derived from the sale, distribution, or transfer of medical cannabis, without any deduction on account of the cost of property sold; the cost of materials used to grow, process, or sell the medical cannabis; labor costs, taxes, royalties paid in cash or in kind, or otherwise; interest or discount paid; or any other expense, however denominated.
(2) “Person” includes any natural person, corporation, partnership, limited liability company, or other business entity as those terms are defined in §11-1-1 et seq. of this code.
(d) Payment of tax and reports. — Every person
subject to the tax imposed by this section shall make quarterly payments under
this section for each calendar quarter at the rate prescribed in subsection (b)
of this section on the gross receipts received or accrued for the calendar
quarter, depending upon the person’s method of accounting for federal income
tax purposes. The tax shall be due and payable on the 20th day of January,
April, July, and October for the preceding calendar quarter. When the payment
of tax is due, the person shall file a tax return in a form prescribed by the
Tax Commissioner. The Tax Commissioner may require such any forms,
schedules, and returns and impose such any filing and remittance
requirements as may be necessary or convenient for the efficient
administration of taxes imposed by this section.
(e) Electronic filing and payment. ─ The taxes imposed by this section shall be paid to the Tax Commissioner by electronic funds transfer, unless electronic payment is prohibited by state or federal law. Tax returns required by this section shall be filed electronically with the Tax Commissioner.
(f) Liability for reporting and payment of tax. —
If any dispensary does not renew its permit, gives up its permit, loses its
permit to operate a dispensary, or otherwise ceases business then any tax,
additions to tax, penalties, and interest imposed by this article and by
§11-10-1 et seq. of this code, shall become due and payable
immediately and the dispensary shall make a final return or returns and pay any
tax which is due within 30 days after not renewing its permit, giving up its
permit, losing its permit to operate a dispensary, or otherwise ceasing
business. The unpaid amount of any tax is a lien upon the property of the
dispensary and of its owners.
(g) Deposits of proceeds. — All money received from the tax imposed under this section, including any interest and additions to tax paid under §11-10-1 et seq., less the amount of any refunds, shall be deposited into the Medical Cannabis Program Fund.
(h) Exemption. — Sales of medical cannabis shall
are not be subject to the taxes imposed by §11-15-1 et seq.
and §11-15A-1 et seq. of this code, if gross receipts from the sale
thereof are included in the measure of tax under this section and the tax has
been paid as provided in this section. Additionally, sales of medical cannabis shall
not be are not subject to a special district excise tax imposed by a
county or municipality pursuant to this code, or to a county or municipal sales
tax: Provided, That on and after July 1, 2021, sales of medical
cannabis are subject to the taxes imposed by §11-15-1 et seq. and
§11-15A-1 et seq. of this code. Sales of medical cannabis are subject to
any special district excise tax lawfully imposed by a county or municipality
pursuant to this code, and to any lawfully imposed county or municipal sales and
use tax. Notwithstanding any provision of this code to the contrary, any
exemption from the Consumer Sales and Service Tax and use tax on sales of
prescription drugs set forth in §11-15-1, et seq. of this code, or any
other provision of this code, shall not apply to sales of medical cannabis.
(i) Information. —
(1) Persons subject to the tax imposed by this section shall provide to the Tax Commissioner any information the Tax Commissioner may require to administer, collect, and enforce the tax imposed by this section.
(2) Notwithstanding any provision of §11-10-1 et seq. of this code or of this article to the contrary, the Tax Commissioner, the bureau, and the Secretary of Health and Human Resources may enter into written agreements pursuant to which the Tax Commissioner will disclose to designated employees of the bureau and the Secretary of Health and Human Resources, whether a particular grower, processor, or dispensary is in good standing with the Tax Commissioner, and the bureau and the secretary will disclose to designated employees of the Tax Commissioner information a grower, processor, or dispensary provides to the bureau and the secretary pursuant to this code. Tax information disclosed pursuant to a written agreement shall remain confidential in the hands of the receiver and shall not be disclosable under §29B-1-1 et seq. of this code. To the extent feasible, this information should be shared or exchanged electronically.
(j) Rules. — The Tax Commissioner may promulgate,
in accordance with the provisions of §29A-3-1 et seq. of this code, such
are procedural, interpretive, or legislative rules, including emergency
rules, as the Tax Commissioner may deem determine necessary or
convenient for the efficient administration of taxes imposed by this §16A-9-1
of this code.
article 12. offenses related to medical cannabis.
§16A-12-2. Criminal diversion of medical cannabis.
(a) In addition to any
other penalty provided by law Any employee, financial backer, operator, or
principal of any qualifying entities who intentionally and knowingly sells,
dispenses, trades, delivers, or otherwise provides medical cannabis to a person
who is not lawfully permitted to receive medical cannabis, is guilty of a
felony, and upon conviction thereof, shall be imprisoned in a state
correctional facility for not less than one nor more than five years.
(b) For purposes of this
section, “qualifying entity” shall mean means:
(1) A medical cannabis organization;
(2) A health care
medical cannabis organization or college, university, or medical school
participating in a research study under §16A-13-1 et seq. of
this code;
(3) A clinical registrant or academic clinical research center under §16A-14-1 et seq. of this code; and
(4) A laboratory utilized
used to test medical cannabis under §16A-7-4 of this code.
§16A-12-7. Disclosure of information prohibited.
(a) In addition to any
other penalty provided by law, any An employee, financial backer,
operator, or principal who discloses of
a medical cannabis organization, an accredited college, university, or medical
school engaging in approved research may not disclose except to
authorized persons for official governmental law-enforcement purposes, research, or health care purposes, any information related to
the use of medical cannabis: (1) A medical cannabis organization.(2)
A health care medical cannabis organization or university participating in a
research study under article thirteen of this chapter. (3) A clinical
registrant or academic clinical research center under article fourteen of this
chapter.(4) An employee of the bureau identity
of a person holding a medical cannabis certificate.
(b) Exception. —
Subsection (a) of this section shall does not apply where
disclosure is permitted or required by law or by court order.
§16A-12-8. Additional penalties.
(a) Civil penalties. — In addition to any other remedy available to the bureau, the bureau may assess a civil penalty for a violation of this act, a rule promulgated under this act or an order issued under this act or rule, subject to the following:
(1) The bureau may assess a penalty of not more than $10,000 for each violation and an additional penalty of not more than $1,000 for each day of a continuing violation. In determining the amount of each penalty, the bureau shall take the following factors into consideration:
(A) The gravity of the violation;
(B) The potential harm resulting from the violation to patients, caregivers, or the general public;
(C) The willfulness of the violation;
(D) Previous violations, if any, by the person being assessed; and
(E) The economic benefit to the person being assessed for failing to comply with the requirements of this act, a rule promulgated under this act, or an order issued under this act or rule;
(2) If the bureau finds that the violation did not threaten the safety or health of a patient, caregiver, or the general public and the violator took immediate action to remedy the violation upon learning of it, the bureau may issue a written warning in lieu of assessing a civil penalty; and
(3) A person who aids,
abets, counsels, induces, procures, or causes another person to violate this
act, a rule promulgated under this act, or an order issued under this act or
rule shall be is subject to the civil penalties provided under
this subsection.
(b) Sanctions. —
(1) In addition to the
penalties provided in subsection (a) of this section, and any other penalty
authorized by law, the bureau may impose the following sanctions:
(A) Revoke or suspend the permit of a person found to be in violation of this act, a rule promulgated under this act, or an order issued under this act or rule;
(B) Revoke or suspend the permit of a person for conduct or activity or the occurrence of an event that would have disqualified the person from receiving the permit;
(C) Revoke or suspend the registration of a practitioner for a violation of this act or a rule promulgated or an order issued under this act or for conduct or activity which would have disqualified the practitioner from receiving a registration;
(D) Suspend a permit or registration of a person pending the outcome of a hearing in a case in which the permit or registration could be revoked;
(E) Order restitution of
funds or property unlawfully obtained or retained by a permittee; or registrant
(F) Issue a cease and desist order.
(2) A person who aids,
abets, counsels, induces, procures, or causes another person to violate this
act shall be is subject to the sanctions provided under this
subsection.
(c) Costs of action. — The bureau may assess against a person determined to be in violation of this act the costs of investigation of the violation.
(d) Minor violations.
— Nothing in This section shall be construed to does not
require the assessment of a civil penalty or the imposition of a sanction for a
minor violation of this act if the bureau determines that the public interest
will be adequately served under the circumstances by the issuance of a written
warning.
article 13. research program.
§16A-13-1. Definitions.
[Repealed.]
§16A-13-2. Establishment of medical cannabis research program.
(a) Program to be
established. — The bureau shall establish and develop a research program to
study the impact of medical cannabis on the treatment and symptom management of
serious medical conditions. The program shall may not include a clinical
registrant medical cannabis
organization or academic clinical
research center under §16A-14-1 et
seq. of this code.
(b) Bureau duties. — The bureau shall:
(1) Review all serious medical conditions which are cited by a practitioner upon the practitioner’s certification that a patient be granted an identification card;
(2) Create a database of
all serious medical conditions, including comorbidities, which are cited by
practitioners in the certifications of patients; The database shall also
include the form of medical cannabis certified to treat each serious medical
condition.
(3) When the database
contains 25 or more patients with the same serious medical condition petition
the United tates Food and Drug Administration and the United States Drug
Enforcement Administration for approval to study the condition and
the impact of medical cannabis on the condition;
(4) Concurrent with the
request to the United States Food and Drug Administration and United States
Drug Enforcement Administration Publicly announce the formation of a
research study to which a vertically integrated health system and a an accredited college, university, or
medical school within this state may
submit a request to participate;
(5) Upon approval of a
research study by the United States Food and Drug Administration and the United
States Drug Enforcement Administration, select a vertically integrated health
system or systems Select an
accredited college, university, or medical school to conduct the research study; and and
designate the form or forms of medical cannabis which will be used to treat the
serious medical condition
(6) Notify a patient who has been issued an identification card:
(A) That the patient has been selected to participate, at the patient’s option, in a research study to study medical cannabis as a treatment; and
(B) Where the patient may secure medical cannabis through a health care medical cannabis organization at no cost to the patient in accordance with subsection (c) of this section.
(7) If the United
States Food and Drug Administration and the United States Drug Enforcement
Administration reject the proposal for the research study, take all reasonable
steps to collect and collate data on the serious medical condition and the use
of medical cannabis as a treatment for the serious medical condition and consider
submitting an additional request to the United States Food and Drug
Administration and United States Drug Enforcement Administration for a research
study on the same condition
(c) Costs. — The cost of the medical cannabis which is dispensed to patients in accordance with an approved research study shall be paid for by the fund.
(d) Geographic
accessibility. — The bureau shall take into consideration the geographic
location of the health care medical cannabis organization when assigning
a patient to a health care medical cannabis organization for the purposes of research. The bureau shall make an effort to assign a patient
to a health care medical cannabis organization that is located within 50 miles
of the patient’s residence.
(e) Data. — Any
data collected by the health care medical cannabis organization shall be
provided to the university participating in the research study for analysis.
§16A-13-3. Medical cannabis research program administration.
(a) The bureau may
establish a research study for each serious medical condition. The bureau may
engage accredited colleges, universities, and medical schools within this state to participate in the collection,
collation, analysis, and conclusive findings of the research studies. The
bureau shall, by rule, establish the procedure to be used by health care
medical cannabis organizations participating
in research with respect to:
(1) Real time inventory tracking;
(2) Real time tracking of the medical cannabis dispensed; and
(3) Recall of defective medical cannabis.
(b) Request for distributions. — The bureau shall establish a form and procedure for accredited colleges, universities, and medical schools selected to participate in a research study to request distributions from the fund to conduct research on medical cannabis, including administrative costs. These distributions shall also be used to pay for the cost of the medical cannabis so that it is not borne by the patient participating in the research study. The forms shall include, at a minimum, the following:
(1) The form or forms of medical cannabis to be studied; and
(2) The serious medical condition to be studied.
(c) Research reports. —
(1) A vertically integrated health system An accredited college, university, or medical
school engaged in research shall
report to the bureau on the effectiveness of the use of medical cannabis
for the treatment of the serious medical condition studied and all
counterindications and noted side effects. After the accredited college, university, or medical school
engaged in research reports to the
bureau, the bureau shall make the report publicly available within 180 days.
(2) The bureau shall
notify the vertically integrated health system and the university participating
in the research study of the data which is required to meet the United States
Food and Drug Administration’s and the United States Drug Enforcement
Administration’s approval for the research study.
(3) The first report,
including the data required under subdivision (2), shall be submitted to the
bureau, and made publicly available within 180 days of the initiation of a
research study for a specific serious medical condition.
(4) An annual report of
the data required under subdivision (2) shall be submitted to the bureau
beginning one year after the initiation of a research study for a specific
serious medical condition and each year thereafter
§16A-13-4. Approval.
A vertically integrated
health system An accredited college, university, or medical school located in this state may petition the bureau to
participate in a research study to study a serious medical condition. Approval of
the vertically integrated health system as a health care medical cannabis
organization by the bureau shall authorize authorizes access within
a region under subsection (d), section three, article six of this chapter
to medical cannabis for all patients included in an approved research study.
§16A-13-5. Requirements.
(a) Dispensing. — A health
care medical cannabis organization that dispenses medical cannabis shall:
(1) Maintain licensure with the bureau;
(2) Secure the medical
cannabis within the associated pharmacies of the health care medical
cannabis organization in a manner and method prescribed by the bureau;
(3) Keep a daily log of the medical cannabis dispensed and the research study with which the patient and the medical cannabis are associated. Reports shall be delivered to the bureau and the accredited college, university, or medical center participating in the research study on a weekly basis;
(4) Report the utilization rates of those patients participating in the research of medical cannabis and treatment options;
(5) Only dispense medical cannabis received from a grower, processor, or a health care medical cannabis organization that is approved to grow and process medical cannabis; and
(6) Provide all patients or
caregivers with the a safety insert, prepared by the bureau,
which includes potential dangers, recognition and correction of problematic
dosage, and any other information required by the bureau or which the bureau deems
considers relevant for patient safety.
(b) Growing and
processing. — A health care medical cannabis organization that grows
and processes medical cannabis shall:
(1) Maintain licensure with the bureau;
(2) Only make available medical cannabis to health care medical cannabis organizations that dispense medical cannabis; and
(3) Keep a daily log of medical cannabis intended for ultimate use by patients participating in a research study.
§16A-13-6. Restrictions.
A health care
medical cannabis organization may not participate in a research study of any
kind, including the program established under this article, or dispense or grow
and process medical cannabis if it has violated its licensure requirements or
conditions.
§16A-13-8. Nonentitlement.
Nothing in This chapter shall be construed to does not
create an entitlement under law or right of a patient person to receive
medical cannabis or to participate in a research study.
article 14. acAdemic clinical research centers.
§16A-14-1. Definitions.
The following words and
phrases when used in this chapter shall have the meanings given to them
in this section unless the context clearly indicates otherwise:
(1) “Academic clinical research center” means an accredited college, university, or medical school within this state that operates or partners with an acute care hospital licensed within this state.
(2) “Clinical registrant” means an entity that:
(A) Holds a permit as a grower, processor, and a dispensary; and
(B) Is an, or has a contractual relationship with an, academic clinical research center under which the academic clinical research center or its affiliate provides advice to the entity, regarding, among other areas, patient health and safety, medical applications, and dispensing and management of controlled substances.
§16A-14-2. Clinical registrants.
Notwithstanding the
limitations in §16A-6-13 of this code, the bureau may register up to four
eight clinical registrants, and subject to the following:
(1) A clinical registrant must pay the fees and meet all other requirements under this act for obtaining a permit as a grower, processor, and a dispensary; and
(2) The clinical registrant must comply with all other requirements of this act regarding growing, processing, and dispensing medical cannabis.
§16A-14-3. Research study.
Notwithstanding any provision of this act to the contrary, the bureau may, upon application, approve the dispensing of medical cannabis by a clinical registrant to the academic clinical research center for the purpose of conducting a research study. The bureau shall develop the application and standards for approval of such dispensing by the clinical registrant. The following apply to the research study:
(1) The clinical registrant shall disclose the following information to the bureau in its application:
(i) The reason for the research project, including the reason for the trial;
(ii) The strain of medical cannabis to be used and the strength of the medical cannabis to be used in the research study;
(iii) The anticipated duration of the study;
(iv) Evidence of approval
of the trial by an accredited institutional review board, including any
other required regulatory approvals the
governing body of the academic clinical research center; and
(v) Other information required by the bureau, except that the bureau may not require disclosure of any information that would infringe upon the academic clinical research center’s exclusive right to intellectual property or legal obligations for patient confidentiality.
(2) The academic clinical research center shall provide its findings to the bureau within 365 days of the conclusion of the research study or within 365 days of publication of the results of the research study in a peer-reviewed medical journal, whichever is later.
(3) The bureau shall allow the exchange of medical cannabis seed between clinical registrants for the conduct of research.
article 15. miscellaneous provisions.
§16A-15-2. Financial and employment interests.
(a) Financial interests.
— A public official, or an immediate family member thereof, shall whose position involves the direct administration of
this chapter, may not intentionally
or knowingly hold a financial interest in a medical cannabis organization or in
a holding company, affiliate, intermediary, or subsidiary thereof, while the
individual is a public official and for one year following termination of the
individual’s status as a public official.
(b) Employment. —
No A public official or an immediate family member thereof, shall
may not be employed by a medical cannabis organization or by any holding
company, affiliate, intermediary, or subsidiary thereof, while the
individual he or she is a public official and for one year following
termination of the individual’s status as a public official.
(c) For purposes of this
section, “public official” and “immediate family” shall have the same
definitions as those phrases are defined in §6B-1-3 of this code.
§16A-15-4. Protections for patients and caregivers.
(a) Licensure. —
None of the following shall be are subject to arrest,
prosecution, or penalty in any manner, or denied any right or privilege,
including civil penalty or disciplinary action by a state licensing board or
commission, solely for lawful use of medical cannabis or the manufacture
or sale or dispensing of medical cannabis, or for any other action taken in
accordance with this act:
(1) A patient;
(2) A caregiver;
(3) A practitioner;
(4) A medical cannabis organization;
(5) A health care
medical cannabis organization or An
accredited college, university, or medical school
participating in a research study under §16A-13-1 et seq. of
this code;
(6) A clinical registrant or academic clinical research center under §16A-14-1 et seq. of this code;
(7) An employee, principal, or financial backer of a medical cannabis organization;
(8) An employee of a health
care medical cannabis organization or an employee of a an accredited college, university, or medical school
participating in a research study under §16A-13-1 et seq. of
this code; or
(9) An employee of a clinical registrant or an employee of an academic clinical research center under §16A-14-1 et seq. of this code.
(b) Employment. —
(1) No An employer
may not discharge, threaten, refuse to hire, or otherwise discriminate
or retaliate against an employee regarding an employee’s compensation, terms,
conditions, location, or privileges solely on the basis of such the
employee’s status as an individual who is certified to use medical cannabis.
(2) Nothing in This
act shall does not require an employer to make any accommodation
of the use of medical cannabis on the property or premises of any place of
employment. This act shall in no way does not limit an employer’s
ability to discipline an employee for being under the influence of medical
cannabis in the workplace or for working while under the influence of medical
cannabis when the employee’s conduct falls below the standard of care normally
accepted for that position.
(3) Nothing in This
act shall does not require an employer to commit any act that
would put the employer or any person acting on its behalf in violation of
federal law.
