PA 16-23—sHB 5450
Public Health Committee
General Law Committee
AN ACT CONCERNING THE PALLIATIVE USE OF MARIJUANA
SUMMARY: This act makes various changes to the state's medical marijuana program, which the Department of Consumer Protection (DCP) administers. Among other things, the act does the following:
1. allows minors to be qualifying patients but subjects them to certain additional requirements and limitations beyond those that apply to adults;
2. expands 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 removal of a medical condition from the list of qualifying debilitating conditions; and
9. requires dispensaries to report annually to DCP.
The act also makes technical and conforming changes.
EFFECTIVE DATE: October 1, 2016
§§ 1-3 & 5 — MINORS AS QUALIFYING PATIENTS
The act extends eligibility for the state's medical marijuana program to state residents under age 18. Under prior law, only state residents age 18 or older could be qualifying medical marijuana patients. As under existing 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 issued by a physician who determined, among other things, that the patient has a qualifying debilitating medical condition (see below). By law, qualifying patients and their primary caregivers must register with DCP, and the department may charge a reasonable registration fee.
The act creates additional requirements that must be met for unemancipated minors to qualify (see below).
Prior law prohibited the use of medical marijuana in the presence of minors. The act creates an exception if the minor is a qualifying patient or research program subject (§ 2).
Written Consent by Parent or Person with Legal Custody and Agreement to Serve as Primary Caregiver (§ 1)
Under the act, 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 existing 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 act also requires this for patients who are emancipated minors. (As noted above, for unemancipated minors, the act requires a parent or other person with legal custody to serve as the primary caregiver. )
Letter from Primary Care Provider and Physician (§ 5)
Under the act, 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 (§ 1)
The act allows a minor to use marijuana for the following conditions:
1. a terminal illness requiring end-of-life care;
2. 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.
(Changes to the list of qualifying debilitating conditions for adults are discussed below. )
Form of Marijuana (§§ 3 & 5)
The act 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 Requirements and Prohibitions
In addition to the new requirements above, the act applies the same existing program requirements and prohibitions for minors who are patients as for adults under existing law and the act. 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 (CGS § 21a-408a(a));
2. these protections do not apply if the patient ingests marijuana in certain settings, such as at work, at school, or in public (CGS § 21a-408a(b), as amended by section 2);
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 (CGS § 21a-408p); and
4. health insurers are not required to cover medical marijuana use (CGS § 21a-408o).
§ 1 — DEBILITATING CONDITIONS FOR ADULTS
The act adds the following to the list of qualifying debilitating conditions for adult medical marijuana patients:
1. uncontrolled intractable seizure disorder (epilepsy was 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 — MARIJUANA SOURCE
Under the act, when a qualifying medical marijuana patient registers with DCP, he or she must select a licensed, in-state dispensary from which to obtain marijuana. If the patient is an unemancipated minor, the requirement applies instead to the custodial parent, guardian, or other person with legal custody.
After registering, a patient or his or her legal custodian 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 primary caregiver 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 act allows licensed marijuana dispensaries and 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 act extends legal protections to nurses in hospitals or health care facilities licensed by DPH who administer marijuana to qualifying patients or research program subjects. The protections are similar to those under existing law for physicians who issue written certifications for marijuana use.
Thus, a nurse who administers marijuana as set forth above 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 any other professional licensing board, for this action.
§§ 1, 2, 7, 8 & 11-14 — RESEARCH PROGRAMS
Under specified conditions, the act 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).
Program Approval (§ 12)
The act allows the DCP commissioner to approve a marijuana research program that meets the following criteria:
1. is administered or overseen by a DPH-licensed hospital or health care facility, a higher education institution, or a licensed producer or dispensary and
2. has institutional review board oversight.
Under the act, 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 the care and use of research animals.
Research Programs, Employees, and Related Regulations
The act 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 direct and indirect costs of program approval and the licensing and regulating of research program employees; and
5. establish other licensing, renewal, and operational standards the commissioner deems necessary.
The act generally prohibits unlicensed individuals from acting as research program employees or representing that they are licensed as such. 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 such certificates.
The act requires that any research program approval, employee licensing, or temporary certificate fees be paid to the state treasurer for deposit in the General Fund.
The act also allows the following:
1. licensed dispensaries and their employees to distribute or dispense marijuana to organizations engaged in approved research programs (§ 7);
2. licensed producers and their employees to sell, deliver, transport, or distribute marijuana to these organizations (§ 8); and
3. laboratory employees to deliver, transport, or distribute marijuana to these organizations (§ 11).
Under prior law, qualifying patients were not allowed to ingest marijuana on college or university property. The act creates an exception if the institution is participating in an approved research program and the marijuana is used under the terms of that program (§ 2).
Prohibited Acts and Legal Protections for Research Programs and Employees (§ 13)
The act prohibits research programs, or their licensed or temporarily certified employees, from doing the following:
1. acquiring marijuana from anyone other than a licensed dispensary, producer, or laboratory;
2. delivering, transporting, or distributing marijuana to anyone other than (a) licensed dispensaries or producers or (b) research program subjects;
3. distributing or administering marijuana to animals that are not research subjects; and
4. obtaining or transporting marijuana outside of the state in violation of state or federal law.
The act 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. These employees 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 such actions.
Research Program Subjects (§ 14)
The act requires anyone seeking to participate as a research program subject to first register with DCP. The commissioner must prescribe registration standards and procedures.
The act generally extends the legal protections noted above for a research program employee to a research program subject who has 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 act. 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 under any of the following circumstances:
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 act provides that information on research program subject registration is generally confidential and not subject to disclosure under the Freedom of Information Act; however, DCP must give reasonable access to registry 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 act 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, including (1) standards and procedures for disciplinary actions against licensees; (2) licensure and renewal fees that cover the cost of licensing and regulating laboratories and employees; and (3) other licensing, renewal, and operational standards the commissioner deems necessary.
Under the act, as with research employees, unlicensed persons may not act as laboratory employees or represent that they are licensed, except the DCP commissioner may issue temporary registration certificates before regulations take effect. He must prescribe standards, procedures, and fees for the temporary certificates. Licensing fees are deposited in the General Fund.
The act allows licensed marijuana dispensaries and their employees to distribute or dispense marijuana to these laboratories (§ 7). It also allows licensed marijuana producers and their employees to sell or otherwise distribute marijuana to these laboratories (§ 8).
Prohibited Acts and Legal Protections (§ 11)
The act prohibits licensed or temporarily certified laboratory employees from acquiring marijuana from, or delivering, transporting, or distributing marijuana to, anyone other than (1) licensed producers or dispensaries or (2) organizations engaged in approved research programs. These employees also must not obtain or transport marijuana outside of the state in violation of state or federal law.
The act extends the legal protections noted above for research program employees and subjects 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 act eliminates the requirement that physicians on the board be certified in one of several listed specialties. It instead requires that the members be board certified in the medical specialty in which they practice, including at least one board-certified pediatrician appointed in consultation with the state chapter of the American Academy of Pediatrics.
The act 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 act additionally requires the board to review and recommend to DCP 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 act also increases the members needed for a quorum of the board from three to four.
§ 6 — DISPENSARY ANNUAL REPORTING
The act requires licensed dispensaries, starting January 1, 2017, to annually report to DCP on the types, mixtures, and dosages of palliative marijuana they dispense. The DCP commissioner may prescribe the form for the reporting.
PA 16-39, §§ 47-51, extends to advanced practice registered nurses the same authority as physicians to certify patients for medical marijuana use except for the treatment of glaucoma.
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