OLR Bill Analysis

sHB 5450 (as amended by House "A")*

AN ACT CONCERNING THE PALLIATIVE USE OF MARIJUANA.

SUMMARY:

This bill makes various changes to the state's medical marijuana program, which the Department of Consumer Protection (DCP) administers. Among other things, the bill:

1. allows minors to be qualifying patients, subject to certain additional requirements and limitations beyond those that apply for adults;

2. adds to the list of qualifying debilitating conditions for adults;

3. requires patients to select a dispensary from which they will purchase marijuana, and subjects patients to a possible enforcement hearing if they possess marijuana obtained from another source;

4. allows dispensaries to distribute marijuana to hospices and other inpatient care facilities that have protocols for handling and distributing marijuana;

5. specifically allows nurses to administer marijuana in licensed health care facilities;

6. allows the DCP commissioner to approve medical marijuana research programs, requires him to adopt regulations on licensing research program employees and related matters, and requires research program subjects to register with the department;

7. requires the DCP commissioner to adopt regulations on licensing marijuana laboratories and laboratory employees;

8. makes changes to qualifications of and other matters concerning the medical marijuana board, including allowing the board to recommend that a medical condition, treatment, or disease be removed from the list of qualifying debilitating conditions; and

9. requires dispensaries to report annually to DCP.

The bill also makes technical and conforming changes.

*House Amendment “A” adds provisions (1) allowing the medical marijuana board to recommend that conditions be removed from the qualifying list, (2) specifying that certain requirements for minors apply only to unemancipated minors, and (3) making clarifying and conforming changes.

EFFECTIVE DATE: October 1, 2016

1-3 & 5 — MINORS AS QUALIFYING PATIENTS

Under current law, only state residents age 18 or older may be qualifying medical marijuana patients. The bill extends the program to state residents under age 18. As under current law, inmates are ineligible. (While the law refers to “palliative” rather than “medical” marijuana use, the program is generally referred to as the medical marijuana program.)

As is the case for adult patients under existing law, before using marijuana for medical purposes, minors must have a written certification by a physician who determined, among other things, that the patient has a qualifying debilitating medical condition (see below). Patients, and their primary caregivers, must register with DCP and pay certain fees.

The bill creates additional requirements that must be met for unemancipated minors to qualify (see below).

Current law prohibits the use of medical marijuana in the presence of minors. The bill creates an exception if the minor is a qualifying patient or research program subject.

Written Consent by Parent or Person with Legal Custody and Agreement to Serve as Primary Caregiver

Under the bill, to qualify for medical marijuana use, an unemancipated minor must have written consent from a custodial parent, guardian, or other person with legal custody, indicating that the person has given permission for the minor to use marijuana for a debilitating condition.

The written consent must also state that the person will (1) serve as the minor's primary caregiver and (2) control the acquisition and possession of marijuana and any related paraphernalia on the minor's behalf.

By law, a medical marijuana patient's primary caregiver is someone at least age 18, other than the patient or the patient's physician, who agrees to take responsibility for managing the patient's well-being with respect to palliative marijuana use. Someone convicted of illegally making, selling, or distributing controlled substances cannot serve as a primary caregiver (CGS 21a-408b).

Under current law, an adult medical marijuana patient's physician must evaluate the patient's need for a primary caregiver and document the need in the certification of palliative use. The bill also requires this for patients who are emancipated minors. (As noted above, for unemancipated minors, the bill requires a parent or other person with legal custody to serve as the primary caregiver.)

Letter from Two Physicians

Under the bill, if the qualifying patient is an unemancipated minor, the person with legal custody must provide DCP with a letter from the minor's primary care provider and a physician board certified in an area involved in the treatment of the minor's debilitating condition. The letter must confirm that the palliative use of marijuana is in the patient's best interest.

Qualifying Debilitating Conditions and Form of Marijuana

The bill allows a minor to use marijuana for:

1. a terminal illness requiring end-of-life care;

2. an irreversible spinal cord injury with objective neurological indication of intractable spasticity;

3. cerebral palsy;

4. cystic fibrosis;

5. severe epilepsy or uncontrolled intractable seizure disorder; or

6. any other medical condition, treatment, or disease that DCP approves through regulations.

The bill prohibits a dispensary from dispensing any marijuana product in a smokable, inhalable, or vaporizable form to a (1) patient who is a minor or (2) primary caregiver of such a patient. It similarly prohibits a physician from issuing a written certification for a minor's marijuana use in a dosage form requiring that the marijuana be smoked, inhaled, or vaporized.

Other Existing Provisions

Otherwise, the bill applies the same program requirements and prohibitions when minors are patients as for adults under existing law and the bill. For example:

1. patients who comply with the law may not be arrested, prosecuted, or otherwise penalized, including being subject to civil penalties, or denied any right or privilege, including being disciplined by a professional licensing board, for the medical use of marijuana;

2. these protections do not apply if the patient ingests marijuana in certain settings, such as at work, at school, or in public;

3. schools, landlords, and employers are prohibited from taking certain actions against a medical marijuana patient or caregiver if solely based on the person's status as such, unless the actions are required by federal law or to obtain federal funding; and

4. health insurers are not required to cover medical marijuana use.

1 — DEBILITATING CONDITIONS FOR ADULTS

The bill adds the following to the list of qualifying debilitating conditions for adult medical marijuana patients:

1. uncontrolled intractable seizure disorder (epilepsy is already a qualifying condition),

2. irreversible spinal cord injury with objective neurological indication of intractable spasticity,

3. cerebral palsy,

4. cystic fibrosis, and

5. terminal illness requiring end-of-life care.

3 & 5 — SOURCE OF MARIJUANA

Under the bill, when a qualifying medical marijuana patient registers with DCP, he or she must select a licensed, in-state dispensary from which to obtain his or her marijuana. If the patient is an unemancipated minor, the requirement instead applies to the custodial parent, guardian, or other person with legal custody.

After registering, patients (or the person with legal custody of the patient) may purchase marijuana only from the selected dispensary, unless they change their selection in accordance with DCP regulations.

If a registered medical marijuana patient or person with legal custody is found to possess marijuana that did not originate from the selected dispensary, he or she may be subject to a hearing before the DCP commissioner, on possible enforcement action against the person's registration certificate.

4 & 7 — MARIJUANA USE AT LICENSED HEALTH CARE FACILITIES

The bill allows licensed marijuana dispensaries or their employees to distribute or dispense marijuana to a hospice or other inpatient care facility licensed by the Department of Public Health (DPH). This applies only if the facility has a DCP-approved protocol for handling and distributing marijuana.

The bill extends legal protections to nurses who administer marijuana to qualifying patients or research program subjects in hospitals or health care facilities licensed by DPH. The protections are similar to those under existing law for physicians who issue written certifications for marijuana use as allowed by law.

Thus, under the bill, these nurses cannot be arrested, prosecuted, or otherwise penalized, including being subject to civil penalties, or denied any right or privilege, including being disciplined by the Board of Examiners for Nursing or another professional licensing board, for administering marijuana as set forth above.

1, 2, 7, 8 & 12-14 — RESEARCH PROGRAMS

Under specified conditions, the bill allows the DCP commissioner to approve medical marijuana research programs (i.e., studies intended to increase knowledge of the growth, processing, medical attributes, dosage forms, administration, or use of marijuana to treat or alleviate symptoms of any medical condition or the symptoms' effects). As described below, it requires research program employees to be licensed by, and research program subjects to register with, DCP.

Program Approval

The bill allows the DCP commissioner to approve a marijuana research program if it will:

1. be administered or overseen by a DPH-licensed hospital or health care facility, a higher education institution, or a licensed producer or dispensary and

2. have institutional review board oversight.

Under the bill, an institutional review board is a specifically constituted review body established or designated by an organization to protect the rights and welfare of people recruited to participate in biomedical, behavioral, or social science research.

If the research will involve animals, the program also must have an institutional animal care and use committee. This is a committee overseeing an organization's animal program, facilities, and procedures to ensure compliance with federal policies, guidelines, and principles on animal research.

Research Programs, Employees, and Related Regulations

The bill requires the DCP commissioner to adopt regulations to:

1. provide for the approval of research programs and licensure of research program employees;

2. set standards and procedures for terminating or suspending research programs;

3. set standards and procedures for employee license revocation, suspension, summary suspension, and nonrenewal, consistent with Uniform Administrative Procedure Act provisions requiring agencies to give notice and an opportunity to show compliance before revoking or suspending a license, except for summary suspensions when emergency action is needed;

4. set fees for research program review and approval and employee licenses and license renewal, with the aggregate amount of fees at least covering the costs of program approval and the licensing and regulating of research employees under the medical marijuana law; and

5. establish other licensing, renewal, and operational standards the commissioner deems necessary.

Before the regulations take effect, the commissioner may issue temporary registration certificates to research program employees, and he must prescribe the standards, procedures, and fees for obtaining them. After the regulations take effect, no unlicensed person may act as a research program employee or represent that he or she is licensed as such.

The bill requires any such program approval, employee licensing, or temporary certificate fees to be paid to the state treasurer for deposit in the General Fund.

It allows licensed dispensaries or their employees to distribute or dispense marijuana to organizations engaged in approved research programs. It allows licensed producers or their employees to sell or otherwise distribute marijuana to these organizations. It also allows laboratory employees to deliver or distribute marijuana to these organizations.

Current law does not allow qualifying patients to ingest marijuana on college or university property. The bill creates an exception if the institution is participating in an approved research program and the marijuana is used under the terms of that program.

Prohibited Acts and Legal Protections for Research Programs and Employees

The bill prohibits research programs, or their licensed or temporarily certified employees, from:

1. acquiring marijuana from anyone other than a licensed dispensary, producer, or laboratory;

2. delivering, transporting, or distributing marijuana to anyone other than licensed dispensaries or producers or research program subjects;

3. distributing or administering marijuana to animals who are not research subjects; and

4. obtaining or transporting marijuana outside of the state in violation of state or federal law.

The bill extends legal protections to licensed or temporarily certified research program employees who, when acting within the scope of their employment, (1) acquire, possess, deliver, transport, or distribute marijuana to a licensed dispensary or producer or research program subject or (2) distribute or administer marijuana to an animal research subject, under the medical marijuana law. They may not be arrested, prosecuted, or otherwise penalized, including being subject to civil penalties, or denied any right or privilege, including being disciplined by a professional licensing board, for these actions.

Research Program Subjects

The bill requires anyone seeking to participate as a research program subject to first register with DCP. The commissioner must prescribe registration standards and procedures.

The bill generally extends the legal protections noted above to a research program subject with a valid registration certificate, for the use of marijuana while acting within the scope of an approved research program.

However, these protections do not apply to marijuana use in certain settings, similar to the restrictions on other medical marijuana users under existing law and the bill. Thus, the protections for research subjects do not apply if the person's marijuana use endangers the health or well-being of someone else, other than a research program employee. The protections also do not apply if the person ingests marijuana:

1. in a motor bus, school bus, or other moving vehicle;

2. at work;

3. on school grounds or any public or private school, dormitory, college, or university property, unless the college or university is participating in a research program and the marijuana use is part of that program;

4. in any public place; or

5. in the presence of a person under age 18 who is not a qualifying patient or research program subject.

Similar to existing law for qualifying patients, the bill provides that:

1. information on research program subject registration is generally confidential and not subject to disclosure under the Freedom of Information Act, but

2. DCP must give reasonable access to this information to certain people for specified purposes (e.g., local, state, and federal agencies for law enforcement purposes or physicians and pharmacists for treatment and monitoring purposes).

1, 7, 8, 10 & 11 — LABORATORIES AND LABORATORY EMPLOYEES

Existing law generally requires anyone operating a laboratory providing analysis of controlled substances to be licensed by DCP (CGS 21a-246). The bill requires the DCP commissioner to adopt regulations providing for the licensure of marijuana laboratories and laboratory employees.

The regulations must cover similar topics as those noted above for research programs and employees, such as (1) standards and procedures for disciplinary actions against licensees and (2) licensure and renewal fees that cover the cost of licensing and regulating laboratories and employees.

Under the bill, as with research programs and employees:

1. after the regulations take effect, no unlicensed person may act as a laboratory employee or represent that he or she is licensed as such;

2. before then, the commissioner may issue temporary registration certificates to laboratory employees, and must prescribe related standards, procedures, and fees; and

3. any fees for laboratory or laboratory employee licensing or renewal and temporary certificates must be paid to the state treasurer and be deposited in the General Fund.

The bill allows licensed marijuana dispensaries or their employees to distribute or dispense marijuana to these laboratories. It also allows licensed marijuana producers or their employees to sell or otherwise distribute marijuana to these laboratories.

Prohibited Acts and Legal Protections

The bill prohibits licensed or temporarily certified laboratory employees from acquiring marijuana from, or delivering, transporting, or distributing marijuana to, anyone other than licensed producers or dispensaries or organizations engaged in approved research programs. They also must not obtain or transport marijuana outside of the state in violation of state or federal law.

The bill extends the legal protections noted above for research program employees to licensed or temporarily certified laboratory employees acting within the scope of their employment, when acquiring, possessing, delivering, transporting, or distributing marijuana to licensed dispensaries or producers or organizations engaged in an approved research program. It extends similar protections to licensed laboratories as applicable.

9 — BOARD OF PHYSICIANS

By law, the DCP commissioner must establish a board of eight physicians knowledgeable about palliative marijuana use. The bill eliminates the requirement that physicians on the board be certified in one of certain listed specialties. It instead requires that (1) at least one member be a board certified pediatrician, appointed in consultation with the state chapter of the American Academy of Pediatrics, and (2) the other members be board certified in the medical specialty in which they practice.

The bill allows the board to review the list of qualifying debilitating medical conditions and make recommendations to the General Law and Public Health Committees for removing conditions, treatments, or diseases from the list.

One of the board's existing duties is to review and recommend to DCP additions to the list of debilitating conditions that qualify for medical marijuana use for adults. The bill additionally requires the board to review and recommend to DCP for approval any illnesses defined as severely debilitating in specified federal regulations, to be added to the list of qualifying debilitating conditions for minors. When doing so, the board must consider the effect of medical marijuana use on the brain development of patients who are minors. Under the federal regulation, a disease or condition is “severely debilitating” if it causes major irreversible morbidity (21 C.F.R. 312.81(b)).

The bill also increases the members needed for a quorum, from three to four.

6 — DISPENSARY ANNUAL REPORTING

The bill requires licensed dispensaries to annually report to DCP on the types, mixtures, and dosages of palliative marijuana they dispense. The first report is due by January 1, 2017. The DCP commissioner may prescribe the form for the reporting.

BACKGROUND

Related Bill

sSB 67 (File 391), reported favorably by the Public Health Committee, extends to advanced practice registered nurses the same authority as physicians to certify patients for medical marijuana use, except for glaucoma.

COMMITTEE ACTION

Public Health Committee

Joint Favorable Substitute

Yea

22

Nay

6

(03/21/2016)

General Law Committee

Joint Favorable

Yea

10

Nay

3

(04/15/2016)