PA 12-55—HB 5389

Judiciary Committee

Finance, Revenue and Bonding Committee

Public Health Committee

AN ACT CONCERNING THE PALLIATIVE USE OF MARIJUANA

SUMMARY: This act allows a licensed physician to certify an adult patient's use of marijuana after determining that the patient has a debilitating medical condition and could potentially benefit from the palliative use of marijuana, among other requirements. The act lists certain conditions that qualify as debilitating (e. g. , cancer, AIDS or HIV, and Parkinson's disease) and also allows the Department of Consumer Protection (DCP) commissioner to approve additional conditions.

Among other requirements, patients seeking to use marijuana for palliative purposes must have a written certification by a physician and register with DCP. The act allows qualifying patients and their primary caregivers to possess a combined one-month marijuana supply.

The act sets conditions on who can be primary caregivers and requires them to register with DCP. The act authorizes DCP to impose a $25 registration fee on patients and caregivers and requires the commissioner to establish additional fees for patients to offset the costs of administering the palliative use of marijuana.

The act also creates licensing requirements for pharmacists (termed “dispensaries”) to supply the marijuana and for producers to grow it. DCP must limit the number of dispensaries and producers (the number of producers must be at least three but no more than 10), set dispensary and producer fees, and set financial requirements for producers that may include maintaining a $2 million escrow account.

The act prohibits patients, their caregivers or doctors, dispensaries, or producers from being subject to criminal or civil penalties, or being denied any right or privilege, for specified actions relating to palliative marijuana use. Caregivers are only protected from such punishments if, among other things, they obtain marijuana from a licensed dispensary. The same restriction does not apply to patients.

The act prohibits schools, landlords, or employers from taking certain actions against a patient or caregiver if the actions are solely based on the person's status as a palliative marijuana patient or caregiver, unless the actions are required by federal law or to obtain federal funding.

The act prohibits patients from ingesting marijuana in certain settings, including at work or school, in public places, in moving vehicles, or in front of children.

The act requires the DCP commissioner to establish a board of physicians who are knowledgeable about palliative marijuana use. Among other things, the board must (1) recommend to DCP additions to the list of debilitating conditions and (2) convene public hearings to evaluate petitions by those seeking to add conditions to the list. It requires the DCP commissioner to submit regulations reclassifying marijuana from a Schedule I to a Schedule II controlled substance.

Among other things, the act (1) specifies that it does not require health insurers to cover the palliative use of marijuana and (2) requires that all fees DCP collects under the act be deposited in a separate, nonlapsing palliative marijuana administration account the act establishes.

EFFECTIVE DATE: October 1, 2012, except for the provisions (1) defining various terms ( 1), (2) providing for dispensary and producer licensing ( 9-10), (3) creating a Board of Physicians ( 13), (4) requiring or allowing certain regulations ( 14), and (5) establishing the palliative marijuana administration account ( 19), which are effective upon passage.

1 & 3 — USE OF MARIJUANA FOR PALLIATIVE PURPOSES

Under the act, “palliative use” means the acquisition, distribution, transfer, possession, use, or transportation of marijuana or related paraphernalia to alleviate a qualifying patient's symptoms of a debilitating condition or their effects. It includes the transfer of marijuana and related paraphernalia to the patient from his or her primary caregiver but does not include use by someone other than a qualifying patient.

Under the act, a qualifying patient is a state resident who is at least age 18 and has been diagnosed by a physician as having a debilitating medical condition. The term does not include inmates confined in a correctional institution or facility under the supervision of the Department of Correction.

Subject to various requirements and conditions, the act allows the palliative use of marijuana by qualifying patients to treat cancer; glaucoma; HIV; AIDS; Parkinson's disease; multiple sclerosis; certain spinal cord injuries (specifically, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity); epilepsy; cachexia (emaciation often caused by cancer or cardiac diseases); wasting syndrome; Crohn's disease; posttraumatic stress disorder; and other medical conditions, treatments, or diseases that DCP approves through regulations, as explained below.

Primary Caregivers

Under the act, a patient's primary caregiver is someone at least age 18, other than the patient or the patient's doctor, who agrees to take responsibility for managing the patient's well-being with respect to his or her palliative use of marijuana.

The qualifying patient's physician must evaluate the patient's need for a primary caregiver and document the need in the certification of palliative use. If the patient lacks legal capacity, the caregiver must be the patient's parent, guardian, or legal custodian. Someone convicted of illegally making, selling, or distributing controlled substances cannot serve as a primary caregiver. The act limits caregivers to only one patient at a time, unless the caregiver and each patient have a parental, guardianship, conservatorship, or sibling relationship.

4 — CERTIFICATION OF MARIJUANA USE

Under the act, a physician may certify a qualifying patient's use of marijuana only after determining, in the physician's professional opinion, that the patient has a debilitating condition and the potential benefits of the palliative use of marijuana would likely outweigh its health risks. The certification must include a statement to this effect and be (1) in writing, (2) signed and dated by the physician, and (3) in DCP-prescribed form. The act specifies that it does not allow physician assistants to issue certifications for palliative marijuana use.

The act makes the certification valid for up to one year from the date it is signed. It requires the patient or the primary caregiver to destroy all usable marijuana that the patient and caregiver possess for palliative use (1) within 10 days after the certification expires or (2) at any time before then if the patient no longer wishes to possess marijuana for palliative use. The act defines “usable marijuana” as the dried leaves and flowers of the marijuana plant, and any mixtures or preparations of the leaves and flowers, that are appropriate for the palliative use of marijuana, but not including the plant's seeds, stalks, and roots.

5 & 15 — PATIENT AND CAREGIVER REGISTRATION

Registration Requirement

The act requires certified, qualifying patients and their primary caregivers to register with DCP. DCP must issue the patient and the primary caregiver a registration certificate that, once issued, is valid for the same period as the written certification from the physician, up to one year. When registering, the patient and caregiver must give DCP information (as DCP determines) that sufficiently and personally identifies them. They must report any change in the information within five business days after it occurs.

DCP may charge a reasonable fee of up to $25 for each registration certificate. It must turn over any registration fees it collects to the state treasurer for deposit in the palliative marijuana administration account the act creates.

Disclosure of Registration Information

Under the act, registration information obtained by DCP is generally confidential and not subject to disclosure under the Freedom of Information Act (FOIA). But the act requires DCP to give the following people or entities reasonable access to this information:

1. state and federal agencies and local law enforcement agencies to investigate or prosecute a violation of law;

2. physicians and pharmacists to provide patient care and drug therapy management and monitor controlled substances the qualifying patient obtains;

3. public or private entities for research or educational purposes, as long as no individually identifiable health information is disclosed;

4. licensed dispensaries, for the purpose of complying with the act;

5. qualifying patients, but only with respect to information related to themselves or their primary caregivers; and

6. primary caregivers, but only with respect to information related to their qualifying patients.

Temporary Registration

The act allows qualifying patients to apply to DCP for temporary registration if they would otherwise be eligible for a registration certificate, except that regulations on licensed dispensaries and producers, distribution systems, and specific amounts of marijuana have not yet taken effect (see below). They may do so from October 1, 2012 until 30 days after the regulations take effect. To apply, they must present a physician's written certification to DCP, which must grant the temporary certificate to patients who qualify. The act requires DCP to indicate on a temporary registration certificate how much usable marijuana constitutes a one-month supply, which is the amount that the patient may possess.

DCP must maintain a list of temporary registration certificates it issues. Information on the list is subject to the same confidentiality and disclosure provisions as other registration information as specified above.

9 — DISPENSARY LICENSING

The act establishes licensing requirements for pharmacists seeking to dispense marijuana for palliative use. It prohibits anyone who is not licensed by DCP as a dispensary from acting as one or representing that he or she is a licensed dispensary.

Under the act, the DCP commissioner must determine how many dispensaries are appropriate to meet the needs of the state's qualifying patients. He must adopt regulations limiting the number of dispensaries and providing for their licensure and standards (see below). Once the regulations take effect, the commissioner can issue dispensary licenses to licensed pharmacists who (1) apply for a dispensary license in accordance with those regulations and (2) the commissioner deems qualified to acquire, possess, distribute, and dispense marijuana pursuant to the act. The number of dispensary licenses issued cannot exceed the maximum number appropriate to meet qualifying patients' needs.

The dispensary regulations must at least:

1. set the maximum number of dispensary licenses;

2. provide that only a licensed pharmacist may apply for and receive a dispensary license;

3. provide that no marijuana may be dispensed from, obtained from, or transferred out-of-state;

4. set licensing and renewal fees that at least cover the direct and indirect cost of licensing and regulating dispensaries under the act;

5. require license renewal at least every two years; and

6. describe areas in the state where licensed dispensaries may not locate, after considering the law's criteria for the location of retail liquor permit premises.

The regulations must also establish:

1. health, safety, and security requirements for licensed dispensaries, which may include maintaining (a) adequate control against the diversion, theft, and loss of marijuana acquired or possessed by the dispensary and (b) knowledge, judgment, procedures, security controls, and ethics to ensure optimal safety and accuracy in the distributing, dispensing, and use of palliative marijuana;

2. standards and procedures for license revocation, suspension, summary suspension, and nonrenewal that comply with the Uniform Administrative Procedure Act's (UAPA) requirements for taking such actions; and

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

Under the act, DCP must give the state treasurer any fees it collects related to dispensary licensing. The fees must be credited to the palliative marijuana administration account the act creates.

10 — PRODUCER LICENSING

The act requires DCP to license palliative marijuana producers and prohibits anyone who is not licensed by DCP as a producer from acting as one or representing that he or she is a licensed producer.

To qualify for a producer license, the person must be organized to cultivate (plant, propagate, cultivate, grow, and harvest) marijuana for palliative use in the state. The commissioner must also find that the applicant (1) has appropriate agricultural expertise and (2) is qualified to cultivate marijuana and sell, deliver, transport, or distribute it solely within the state pursuant to the act.

The act's provisions for producers are in many ways similar to its provisions for dispensaries, although there are some notable differences. The DCP commissioner must determine how many producers are appropriate to meet the needs of the state's qualifying patients. He must adopt regulations (1) providing for producer licensure, standards, and locations and (2) specifying the maximum number of licenses, which must be at least three but no more than 10. After the regulations are effective, the commissioner can issue producer licenses to qualifying applicants who apply in accordance with the regulations.

The required producer regulations also must at least:

1. provide that a producer may not sell, deliver, transport, or distribute marijuana from or to an out-of-state location;

2. establish a nonrefundable license application fee of at least $25,000;

3. establish licensing and renewal fees that in the aggregate cover the direct and indirect cost of licensing and regulating producers under the act;

4. require license renewal every five years;

5. designate permissible locations for licensed producers and prohibit them from cultivating marijuana for palliative use outside the state;

6. establish financial requirements for producers, under which (a) applicants must demonstrate the financial capacity to build and operate a marijuana production facility and (b) licensees may be required to maintain a $2 million escrow account at an in-state financial institution;

7. establish health, safety, and security requirements which require an applicant or licensed producer to demonstrate the ability to (a) maintain adequate control against the diversion, theft, and loss of marijuana the producer cultivates and (b) cultivate pharmaceutical grade marijuana for palliative use in a secure indoor facility;

8. define “pharmaceutical grade marijuana for palliative use”;

9. establish standards and procedures for license revocation, suspension, summary suspension, and nonrenewal, that comply with the UAPA's standards for such actions; and

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

The act requires DCP to give the state treasurer any producer licensing fees that it collects. The fees must be credited to the palliative marijuana administration account.

2-4, 6, 11-12, & 15 — PROTECTIONS FROM PUNISHMENT RELATED TO PALLIATIVE MARIJUANA USE; EXCEPTIONS

The act prohibits qualifying patients, their caregivers or doctors, or licensed dispensaries or producers from being 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 taking specified actions related to the palliative use of marijuana. The particular requirements for each group are explained below.

The act also prohibits anyone from being arrested or prosecuted solely for being present during, or in the vicinity of, the palliative use of marijuana permitted by the act.

2 & 15 — Qualifying Patients

Under the act, qualifying patients cannot be subjected to the actions or penalties specified above for palliative marijuana use if the:

1. patient has a valid registration certificate from DCP;

2. patient's physician has issued a written certification for the patient's palliative use of marijuana after (a) prescribing prescription drugs to address the symptoms or effects the marijuana is supposed to treat or (b) determining it is not in the patient's best interest to prescribe them;

3. combined amount of marijuana possessed by the patient and his or her primary caregiver for palliative use does not exceed a usable amount reasonably necessary to ensure a one-month supply, as set by DCP in regulation;

4. patient does not have more than one primary caregiver at a time; and

5. patient otherwise complies with the act.

The protection against such punishment or disciplinary action does not apply if a patient's palliative use of marijuana endangers the health or well-being of someone else, other than the primary caregiver. The protection also does not apply if the patient ingests marijuana:

1. on 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;

4. in any public place (i. e. , any area that is used or held out for use by the public whether owned or operated for public or private interests);

5. within the direct line of sight of anyone under age 18; or

6. in a way that exposes someone under age 18 to second-hand marijuana smoke.

If a patient has a temporary registration certificate from DCP, he or she cannot be penalized for possessing marijuana if the usable amount possessed by the patient and primary caregiver does not exceed the amount allowed by the temporary registration.

4 & 15 — Physicians

The act prohibits a physician from being subject to such actions or penalties for writing a certification for palliative marijuana use as long as he or she:

1. diagnoses a qualifying patient with a debilitating condition;

2. explains the potential risks and benefits of using marijuana for palliative purposes to the patient and the parent, guardian, or legal custodian of a patient who lacks legal capacity;

3. bases the written certification on his or her professional opinion after completing a medically reasonable assessment of the patient's medical history and current medical condition in the course of a bona fide physician-patient relationship; and

4. has no financial interest in a licensed dispensary or producer.

The act also provides that physicians are not subject to such actions or penalties for writing a certification that a patient uses for a temporary registration.

3 & 15 — Primary Caregivers

Subject to the following conditions, if a primary caregiver has a valid registration certificate from DCP and complies with the act, he or she is protected from the punishments or penalties specified above for acquiring, distributing, possessing, or transporting marijuana or related paraphernalia for the qualifying patient. For this protection to apply, the amount of marijuana, along with the combined usable amount the patient and caregiver possess, cannot exceed a reasonably necessary one-month supply in accordance with DCP regulations adopted under the act. Additionally, the marijuana must be obtained from a state-licensed dispensary. The protection against punishment for distribution applies only when the drug or paraphernalia is transferred from the caregiver to the patient.

If a patient has a temporary registration certificate from DCP, the primary caregiver cannot be penalized for possessing marijuana as long as the usable amount possessed by the patient and caregiver does not exceed the amount allowed by that registration.

11 — Dispensaries

The act protects licensed dispensaries, or their employees acting within the scope of their employment, from the actions or penalties specified above for acquiring, possessing, distributing, or dispensing marijuana pursuant to the act. But it prohibits licensed dispensaries or their employees from:

1. acquiring marijuana from someone other than a licensed producer;

2. distributing or dispensing marijuana to someone who is not a qualifying patient registered with DCP or primary caregiver of such a patient; or

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

12 – Producers

The act protects licensed producers, or their employees acting within the scope of their employment, from the actions or penalties specified above for cultivating marijuana or selling, delivering, transporting, or distributing it to licensed dispensaries. It prohibits licensed producers or their employees from (1) selling, delivering, transporting, or distributing marijuana to someone who is not a licensed dispensary or (2) obtaining or transporting marijuana outside of the state in violation of state or federal law.

7 — RETURN OF SEIZED PROPERTY

The act requires law enforcement agencies to return marijuana, related paraphernalia, or other property seized from qualifying patients or primary caregivers who comply with its provisions, immediately after a court determines that they are entitled to it. Under the act, such an entitlement can be shown by a prosecutor's decision not to prosecute, the dismissal of the charges, or the patient's or caregiver's acquittal.

8 — FRAUDULENT REPRESENTATION TO LAW ENFORCEMENT

The act makes it a class C misdemeanor (see Table on Penalties) to lie to a law enforcement official about the palliative use of marijuana for the purpose of avoiding arrest or prosecution for any crime. It makes it a class A misdemeanor (see Table on Penalties) to lie to a law enforcement official about the issuance, contents, or validity of a (1) written certification for palliative marijuana use or (2) document purporting to be a written certification.

13 — PHYSICIAN BOARD

Membership and Appointment

The act requires the DCP commissioner to establish a Board of Physicians, consisting of eight physicians or surgeons who are (1) knowledgeable about the palliative use of marijuana and (2) certified by the appropriate American board in neurology, pain medicine, pain management, medical oncology, psychiatry, infectious disease, family medicine, or gynecology. It appears that the commissioner selects the board members. The commissioner also serves as an ex-officio board member. He must select a chairperson from among the members.

Under the act, half of the initial appointees serve three-year terms and the other half serve four-year terms. All members are subsequently appointed for four-year terms. Members can be reappointed, and each member may serve until a successor is appointed. Three board members constitute a quorum.

Board Duties

The act requires the board of physicians to:

1. review and recommend to DCP for approval any debilitating medical conditions, treatments, or diseases to be added to the list of conditions that qualify for the palliative use of marijuana;

2. accept and review petitions for additions to the list of debilitating conditions (any individually identifiable health information contained in such a petition the board receives is confidential and not subject to disclosure under FOIA);

3. meet at least twice a year to conduct public hearings and to evaluate such petitions;

4. review and recommend to DCP protocols for determining how much marijuana may be reasonably necessary to ensure uninterrupted availability for one month for qualifying patients, including amounts for topical treatments; and

5. perform other duties related to the palliative use of marijuana at the DCP commissioner's request.

14 — IMPLEMENTING REGULATIONS

In addition to the other required regulations specified above, the act requires the DCP commissioner to adopt implementing regulations on various matters. The regulations must at least:

1. govern how DCP considers applications for issuing and renewing qualifying patients' and their caregivers' registration certificates and establish any additional information to be contained in the certificates;

2. define protocols for determining how much usable marijuana constitutes an adequate supply to ensure uninterrupted availability for one month, including amounts for topical treatments;

3. set criteria for adding medical conditions, treatments, or diseases to the list of debilitating conditions that qualify for the palliative use of marijuana;

4. establish a process for members of the public to submit petitions, in the manner and form prescribed in the regulations, regarding the addition of medical conditions, treatments, or diseases to the list of debilitating conditions;

5. establish a process for public comment and public hearings before the physician board regarding the addition of medical conditions, treatments, or diseases to the list of debilitating conditions;

6. govern adding medical conditions, treatments, or diseases to the list of debilitating conditions, as the physician board recommends; and

7. develop a system for distributing marijuana for palliative use that provides for (a) marijuana production facilities housed on secured grounds in the state and operated by licensed producers and (b) distribution to qualifying patients or their primary caregivers by licensed dispensaries.

The commissioner must also adopt regulations establishing a reasonable fee to charge qualifying certified patients to offset the direct and indirect costs of administering the palliative use of marijuana. This fee is in addition to any registration fee. The commissioner must collect this fee when qualifying patients register with DCP and must remit the fees to the state treasurer, to be credited to the account established by the act.

The commissioner must submit these regulations to the General Assembly's Regulation Review Committee by July 1, 2013.

The act also permits, but does not require, the commissioner to adopt regulations, after consultation with the board of physicians, establishing (1) a standard form for physicians' written certifications for the palliative use of marijuana and (2) procedures for registration with DCP by patients and caregivers.

While the act does not require DCP to adopt regulations establishing a standard form for written certifications, it requires such certifications to be in DCP-prescribed form.

17 — PROHIBITION ON DISCRIMINATION OR DISCIPLINARY ACTIONS BY SCHOOLS, LANDLORDS, OR EMPLOYERS

Unless required by federal law or required to obtain federal funding, the act prohibits the following actions if they are based solely on a person's status as a qualifying patient or primary caregiver under the act:

1. a K-12 school or higher education institution, whether public or private, (a) refusing to enroll someone or (b) discriminating against a student;

2. a landlord (a) refusing to rent a dwelling unit to someone or (b) taking action against a tenant (such as actions for possession or recoupment) and

3. an employer with at least one employee, including the state or its political subdivisions, (a) refusing to hire someone or (b) firing, penalizing, or threatening an employee; but this provision does not restrict an employer's ability to prohibit the use of intoxicating substances during work hours or to discipline an employee for being under the influence of such substances during work hours.

The act specifies that these provisions must not be construed to permit the palliative use of marijuana in a way that violates other provisions prohibiting palliative marijuana use in certain settings (e. g. , ingesting marijuana at work, school, or other specified settings, or using it in a way that endangers the health of others).

18 — RECLASSIFICATION OF MARIJUANA AS SCHEDULE II CONTROLLED SUBSTANCE

The act requires the DCP commissioner to submit to the Regulation Review Committee amendments to DCP regulations, reclassifying marijuana from a Schedule I to a Schedule II controlled substance. He must do so by January 1, 2013. This requirement applies despite the general procedures giving the commissioner discretion over a controlled substance's schedule classification.

Under existing law, if there is an inconsistency between the state controlled substance schedule and the federal schedule, the federal schedule prevails, unless Connecticut places the substance in a higher schedule (Schedule I is the highest, V the lowest). The act creates an exception for the reclassification of marijuana, which is a Schedule I controlled substance under federal law (see BACKGROUND).

19 — PALLIATIVE MARIJUANA ADMINISTRATION ACCOUNT

The act establishes a separate, nonlapsing palliative marijuana administration account in the General Fund. The account consists of the various fees DCP collects under the act, as specified above (e. g. , registration and licensing fees); investment earnings; and any other money the law requires to be deposited in it. The account can only be used to provide funds to DCP for palliative marijuana administration. Any money remaining in the account at the end of a fiscal year must be carried forward to the next fiscal year.

BACKGROUND

Controlled Substance Classification

Federal law classifies marijuana as a Schedule I controlled substance. The law generally prohibits anyone from knowingly or intentionally manufacturing, distributing, dispensing, or possessing with intent to manufacture, distribute, or dispense Schedule I drugs. Licensed practitioners, including pharmacies, can use Schedule I substances in government-approved research projects. The penalty for violations varies depending on the amount of drugs involved.

To be placed in either Schedule I or Schedule II, the drug must have a high potential for abuse. Placement in Schedule I requires the drug to have no currently accepted medical use in the U. S. By contrast, placement in Schedule II requires the drug to have a currently accepted medical use or such a use with severe restrictions (21 U. S. C. 812, 823, and 841(a)(1)).

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