Connecticut Seal

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House of Representatives

File No. 700

General Assembly

 

February Session, 2016

(Reprint of File No. 486)

Substitute House Bill No. 5450

 

As Amended by House Amendment

Schedule "A"

Approved by the Legislative Commissioner

April 21, 2016

AN ACT CONCERNING THE PALLIATIVE USE OF MARIJUANA.

Be it enacted by the Senate and House of Representatives in General Assembly convened:

Section 1. Section 21a-408 of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

As used in [sections 21a-408] this section, sections 21a-408a to 21a-408o, inclusive, as amended by this act, and sections 10 to 14, inclusive, of this act, unless the context otherwise requires:

(1) "Cultivation" includes planting, propagating, cultivating, growing and harvesting;

(2) "Debilitating medical condition" means (A) cancer, glaucoma, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, Parkinson's disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy or uncontrolled intractable seizure disorder, cachexia, wasting syndrome, Crohn's disease, posttraumatic stress disorder, irreversible spinal cord injury with objective neurological indication of intractable spasticity, cerebral palsy, cystic fibrosis or terminal illness requiring end-of-life care, except, if the qualifying patient is under eighteen years of age, "debilitating medical condition" means terminal illness requiring end-of-life care, irreversible spinal cord injury with objective neurological indication of intractable spasticity, cerebral palsy, cystic fibrosis, severe epilepsy or uncontrolled intractable seizure disorder, or (B) any medical condition, medical treatment or disease approved for qualifying patients by the Department of Consumer Protection pursuant to regulations adopted under section 21a-408m;

(3) "Institutional animal care and use committee" means a committee that oversees an organization's animal program, facilities and procedures to ensure compliance with federal policies, guidelines and principles related to the care and use of animals in research;

(4) "Institutional review board" means a specifically constituted review body established or designated by an organization to protect the rights and welfare of persons recruited to participate in biomedical, behavioral or social science research;

(5) "Laboratory" means a laboratory located in the state that is licensed to provide analysis of controlled substances pursuant to section 21a-246 and section 10 of this act;

(6) "Laboratory employee" means a person who is (A) licensed as a laboratory employee pursuant to section 10 of this act, or (B) holds a temporary certificate of registration issued pursuant to section 10 of this act;

[(3)] (7) "Licensed dispensary" or "dispensary" means a person who is licensed as a dispensary pursuant to section 21a-408h, as amended by this act;

[(4)] (8) "Licensed producer" or "producer" means a person who is licensed as a producer pursuant to section 21a-408i;

[(5)] (9) "Marijuana" means marijuana, as defined in section 21a-240;

(10) "Nurse" means a person who is licensed as a nurse under chapter 378;

[(6)] (11) "Palliative use" means the acquisition, distribution, transfer, possession, use or transportation of marijuana or paraphernalia relating to marijuana, including the transfer of marijuana and paraphernalia relating to marijuana from the patient's primary caregiver to the qualifying patient, to alleviate a qualifying patient's symptoms of a debilitating medical condition or the effects of such symptoms, but does not include any such use of marijuana by any person other than the qualifying patient;

[(7)] (12) "Paraphernalia" means drug paraphernalia, as defined in section 21a-240;

[(8)] (13) "Physician" means a person who is licensed as a physician under chapter 370, but does not include a physician assistant, as defined in section 20-12a;

[(9)] (14) "Primary caregiver" means a person, other than the qualifying patient and the qualifying patient's physician, who is eighteen years of age or older and has agreed to undertake responsibility for managing the well-being of the qualifying patient with respect to the palliative use of marijuana, provided (A) in the case of a qualifying patient (i) under eighteen years of age and not an emancipated minor, or (ii) otherwise lacking legal capacity, such person shall be a parent, guardian or person having legal custody of such qualifying patient, and (B) in the case of a qualifying patient eighteen years of age or older or an emancipated minor, the need for such person shall be evaluated by the qualifying patient's physician and such need shall be documented in the written certification;

[(10)] (15) "Qualifying patient" means a person who: [is eighteen years of age or older, is] (A) Is a resident of Connecticut, [and] (B) has been diagnosed by a physician as having a debilitating medical condition, and (C) (i) is eighteen years of age or older, (ii) is an emancipated minor, or (iii) has written consent from a custodial parent, guardian or other person having legal custody of such person that indicates that such person has permission from such parent, guardian or other person for the palliative use of marijuana for a debilitating medical condition and that such parent, guardian or other person will (I) serve as a primary caregiver for the qualifying patient, and (II) control the acquisition and possession of marijuana and any related paraphernalia for palliative use on behalf of such person. "Qualifying patient" does not include an inmate confined in a correctional institution or facility under the supervision of the Department of Correction;

(16) "Research program" means a study approved by the Department of Consumer Protection in accordance with this chapter and undertaken to increase information or knowledge regarding the growth, processing, medical attributes, dosage forms, administration or use of marijuana to treat or alleviate symptoms of any medical conditions or the effects of such symptoms;

(17) "Research program employee" means a person who (A) is licensed as a research program employee under section 12 of this act, or (B) holds a temporary certificate of registration issued pursuant to section 12 of this act;

(18) "Research program subject" means a person registered as a research program subject pursuant to section 14 of this act;

[(11)] (19) "Usable marijuana" means the dried leaves and flowers of the marijuana plant, and any mixtures or preparations of such leaves and flowers, that are appropriate for the palliative use of marijuana, but does not include the seeds, stalks and roots of the marijuana plant; and

[(12)] (20) "Written certification" means a written certification issued by a physician pursuant to section 21a-408c, as amended by this act.

Sec. 2. Subsection (b) of section 21a-408a of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

(b) The provisions of subsection (a) of this section do not apply to:

(1) Any palliative use of marijuana that endangers the health or well-being of a person other than the qualifying patient or the primary caregiver; or

(2) The ingestion of marijuana (A) in a motor bus or a school bus or in any other moving vehicle, (B) in the workplace, (C) on any school grounds or any public or private school, dormitory, college or university property, unless such college or university is participating in a research program and such use is pursuant to the terms of the research program, (D) in any public place, or (E) in the presence of a person under the age of eighteen, unless such person is a qualifying patient or research program subject. For the purposes of this subdivision, (i) "presence" means within the direct line of sight of the palliative use of marijuana or exposure to second-hand marijuana smoke, or both; (ii) "public place" means any area that is used or held out for use by the public whether owned or operated by public or private interests; (iii) "vehicle" means a vehicle, as defined in section 14-1; (iv) "motor bus" means a motor bus, as defined in section 14-1; and (v) "school bus" means a school bus, as defined in section 14-1.

Sec. 3. Section 21a-408b of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

(a) No person may serve as a primary caregiver for a qualifying patient (1) unless such qualifying patient has a valid registration certificate from the Department of Consumer Protection pursuant to subsection (a) of section 21a-408d, as amended by this act, and (2) if such person has been convicted of a violation of any law pertaining to the illegal manufacture, sale or distribution of a controlled substance. A primary caregiver may not be responsible for the care of more than one qualifying patient at any time, except that a primary caregiver may be responsible for the care of more than one qualifying patient if the primary caregiver and each qualifying patient have a parental, guardianship, conservatorship or sibling relationship.

(b) A primary caregiver who has a valid registration certificate from the Department of Consumer Protection pursuant to subsection (a) of section 21a-408d, as amended by this act, and complies with the requirements of sections 21a-408 to 21a-408n, inclusive, as amended by this act, shall not be subject to arrest or prosecution, penalized in any manner, including, but not limited to, being subject to any civil penalty, or denied any right or privilege, including, but not limited to, being subject to any disciplinary action by a professional licensing board, for the acquisition, distribution, possession or transportation of marijuana or paraphernalia related to marijuana on behalf of such primary caregiver's qualifying patient, provided (1) the amount of any marijuana so acquired, distributed, possessed or transported, together with the combined amount of usable marijuana possessed by the qualifying patient and the primary caregiver, does not exceed an amount reasonably necessary to ensure uninterrupted availability for a period of one month, as determined by the Department of Consumer Protection pursuant to regulations adopted under section 21a-408m, and (2) such amount is obtained solely within this state from a licensed dispensary. Any person with a valid registration certificate who is found to be in possession of marijuana that did not originate from the selected dispensary may be subject to a hearing before the commissioner for possible enforcement action concerning the registration certificate issued by the department. For the purposes of this subsection, "distribution" or "distributed" means the transfer of marijuana and paraphernalia related to marijuana from the primary caregiver to the qualifying patient.

(c) A dispensary shall not dispense any marijuana product in a smokable, inhalable or vaporizable form to a primary caregiver for a qualifying patient who is under eighteen years of age.

Sec. 4. Section 21a-408c of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

(a) A physician may issue a written certification to a qualifying patient that authorizes the palliative use of marijuana by the qualifying patient. Such written certification shall be in the form prescribed by the Department of Consumer Protection and shall include a statement signed and dated by the qualifying patient's physician stating that, in such physician's professional opinion, the qualifying patient has a debilitating medical condition and the potential benefits of the palliative use of marijuana would likely outweigh the health risks of such use to the qualifying patient.

(b) Any written certification for the palliative use of marijuana issued by a physician under subsection (a) of this section shall be valid for a period not to exceed one year from the date such written certification is signed and dated by the physician. Not later than ten calendar days after the expiration of such period, or at any time before the expiration of such period should the qualifying patient no longer wish to possess marijuana for palliative use, the qualifying patient or the primary caregiver shall destroy all usable marijuana possessed by the qualifying patient and the primary caregiver for palliative use.

(c) A physician shall not be subject to arrest or prosecution, penalized in any manner, including, but not limited to, being subject to any civil penalty, or denied any right or privilege, including, but not limited to, being subject to any disciplinary action by the Connecticut Medical Examining Board or other professional licensing board, for providing a written certification for the palliative use of marijuana under subdivision (1) of subsection (a) of section 21a-408a if:

(1) The physician has diagnosed the qualifying patient as having a debilitating medical condition;

(2) The physician has explained the potential risks and benefits of the palliative use of marijuana to the qualifying patient and, if the qualifying patient lacks legal capacity, to a parent, guardian or person having legal custody of the qualifying patient;

(3) The written certification issued by the physician is based upon the physician's professional opinion after having completed a medically reasonable assessment of the qualifying patient's medical history and current medical condition made in the course of a bona fide physician-patient relationship; and

(4) The physician has no financial interest in a dispensary licensed under section 21a-408h, as amended by this act, or a producer licensed under section 21a-408i.

(d) A nurse shall not be subject to arrest or prosecution, penalized in any manner, including, but not limited to, being subject to any civil penalty, or denied any right or privilege, including, but not limited to, being subject to any disciplinary action by the Board of Examiners for Nursing, or other professional licensing board, for administering marijuana to a qualifying patient or research program subject in a hospital or health care facility licensed by the Department of Public Health.

Sec. 5. Section 21a-408d of the 2016 supplement to the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

(a) Each qualifying patient who is issued a written certification for the palliative use of marijuana under subdivision (1) of subsection (a) of section 21a-408a, and the primary caregiver of such qualifying patient, shall register with the Department of Consumer Protection. Such registration shall be effective from the date the Department of Consumer Protection issues a certificate of registration until the expiration of the written certification issued by the physician. The qualifying patient and the primary caregiver shall provide sufficient identifying information, as determined by the department, to establish the personal identity of the qualifying patient and the primary caregiver. If the qualifying patient is under eighteen years of age and not an emancipated minor, the custodial parent, guardian or other person having legal custody of the qualifying patient shall also provide a letter from both the qualifying patient's primary care provider and a physician who is board certified in an area of medicine involved in the treatment of the debilitating condition for which the qualifying patient was certified that confirms that the palliative use of marijuana is in the best interest of the qualifying patient. A physician may issue a written certification for the palliative use of marijuana by a qualifying patient who is under eighteen years of age, provided such written certification shall not be for marijuana in a dosage form that requires that the marijuana be smoked, inhaled or vaporized. The qualifying patient or the primary caregiver shall report any change in [such] the identifying information to the department not later than five business days after such change. The department shall issue a registration certificate to the qualifying patient and to the primary caregiver and may charge a reasonable fee, not to exceed twenty-five dollars, for each registration certificate issued under this subsection. Any registration fees collected by the department under this subsection shall be paid to the State Treasurer and credited to the General Fund.

(b) The qualifying patient, or, if the qualifying patient is under eighteen years of age and not an emancipated minor, the custodial parent, guardian or other person having legal custody of the qualifying patient, shall select a licensed, in-state dispensary to obtain the palliative marijuana products at the time of registration. Upon the issuance of the certificate of registration by the department, the qualifying patient, or the qualifying patient's custodial parent, guardian or other person having legal custody of the qualifying patient, shall purchase such palliative marijuana products from such dispensary, except that the qualifying patient, or the qualifying patient's custodial parent, guardian or other person having legal custody of the qualifying patient, may change such dispensary in accordance with regulations adopted by the department. Any person with a valid registration certificate who is found to be in possession of marijuana that did not originate from the selected dispensary may be subject to hearing before the commissioner for possible enforcement action concerning the registration certificate issued by the department.

(c) A dispensary shall not dispense any marijuana products in a smokable, inhalable or vaporizable form to a qualifying patient who is under eighteen years of age.

[(b)] (d) Information obtained under this section shall be confidential and shall not be subject to disclosure under the Freedom of Information Act, as defined in section 1-200, except that reasonable access to registry information obtained under this section and temporary registration information obtained under section 21a-408n, as amended by this act, shall be provided to: (1) State agencies, federal agencies and local law enforcement agencies for the purpose of investigating or prosecuting a violation of law; (2) physicians and pharmacists for the purpose of providing patient care and drug therapy management and monitoring controlled substances obtained by the qualifying patient; (3) public or private entities for research or educational purposes, provided no individually identifiable health information may be disclosed; (4) a licensed dispensary for the purpose of complying with sections 21a-408 to 21a-408n, inclusive, as amended by this act; (5) a qualifying patient, but only with respect to information related to such qualifying patient or such qualifying patient's primary caregiver; or (6) a primary caregiver, but only with respect to information related to such primary caregiver's qualifying patient.

Sec. 6. Section 21a-408h of the 2016 supplement to the general statutes is amended by adding subsection (d) as follows (Effective October 1, 2016):

(NEW) (d) On or before January 1, 2017, and annually thereafter, each licensed dispensary shall report data to the Department of Consumer Protection relating to the types, mixtures and dosages of palliative marijuana dispensed by such dispensary. A report prepared pursuant to this subsection shall be in such form as may be prescribed by the Commissioner of Consumer Protection.

Sec. 7. Subsection (a) of section 21a-408j of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

(a) No licensed dispensary or employee of the dispensary may: (1) Acquire marijuana from a person other than a licensed producer; (2) distribute or dispense marijuana to a person who is not (A) a qualifying patient registered under section 21a-408d, as amended by this act, or 21a-408n, as amended by this act; [, or] (B) a primary caregiver of such qualifying patient; (C) a hospice or other inpatient care facility licensed by the Department of Public Health pursuant to chapter 368v that has protocol for the handling and distribution of marijuana that has been approved by the Department of Consumer Protection; (D) a laboratory; and (E) an organization engaged in a research program; or (3) obtain or transport marijuana outside of this state in violation of state or federal law.

Sec. 8. Subsection (a) of section 21a-408k of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

(a) No licensed producer or employee of the producer may: (1) Sell, deliver, transport or distribute marijuana to a person who is not (A) a licensed dispensary, (B) a laboratory, or (C) an organization engaged in a research program, or (2) obtain or transport marijuana outside of this state in violation of state or federal law.

Sec. 9. Section 21a-408l of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

(a) The Commissioner of Consumer Protection shall establish a Board of Physicians consisting of eight physicians or surgeons who are knowledgeable about the palliative use of marijuana and certified by the appropriate American board [in one of the following specialties: Neurology, pain medicine, pain management, medical oncology, psychiatry, infectious disease, family medicine or gynecology] in the medical specialty in which they practice, at least one of whom shall be a board certified pediatrician appointed in consultation with the Connecticut Chapter of the American Academy of Pediatrics. Four of the members of the board first appointed shall serve for a term of three years and four of the members of the board first appointed shall serve for a term of four years. Thereafter, members of the board shall serve for a term of four years and shall be eligible for reappointment. Any member of the board may serve until a successor is appointed. The Commissioner of Consumer Protection shall serve as an ex-officio member of the board, and shall select a chairperson from among the members of the board.

(b) A quorum of the Board of Physicians shall consist of [three] four members.

(c) The Board of Physicians shall:

(1) Review and recommend to the Department of Consumer Protection for approval the debilitating medical conditions, medical treatments or diseases to be added to the list of debilitating medical conditions that qualify for the palliative use of marijuana for qualifying patients eighteen years of age or older;

(2) Review and recommend to the Department of Consumer Protection for approval any illnesses that are severely debilitating, as defined in 21 CFR 312.81(b), to be added to the list of debilitating medical conditions that qualify for the palliative use of marijuana for qualifying patients under eighteen years of age, taking into account, among other things, the effect of the palliative use of marijuana on the brain development of such patients;

[(2)] (3) Accept and review petitions to add medical conditions, medical treatments or diseases to the list of debilitating medical conditions that qualify for the palliative use of marijuana;

[(3)] (4) Convene at least twice per year to conduct public hearings and to evaluate petitions, which shall be maintained as confidential pursuant to subsection [(d)] (e) of this section, for the purpose of adding medical conditions, medical treatments or diseases to the list of debilitating medical conditions that qualify for the palliative use of marijuana;

[(4)] (5) Review and recommend to the Department of Consumer Protection protocols for determining the amounts of marijuana that may be reasonably necessary to ensure uninterrupted availability for a period of one month for qualifying patients, including amounts for topical treatments; and

[(5)] (6) Perform other duties related to the palliative use of marijuana upon the request of the Commissioner of Consumer Protection.

(d) The Board of Physicians may review the list of debilitating medical conditions that qualify for the palliative use of marijuana and make recommendations to the joint standing committees of the General Assembly having cognizance of matters relating to general law and public health for the removal of a debilitating medical condition, medical treatment or disease from such list.

[(d)] (e) Any individually identifiable health information contained in a petition received under this section shall be confidential and shall not be subject to disclosure under the Freedom of Information Act, as defined in section 1-200.

Sec. 10. (NEW) (Effective October 1, 2016) (a) Except as provided in subsection (b) of this section, no person may act as a laboratory employee or represent that such person is a licensed laboratory employee unless such person has obtained a license from the Commissioner of Consumer Protection pursuant to this section.

(b) Prior to the effective date of regulations adopted under this section, the Commissioner of Consumer Protection may issue a temporary certificate of registration to a laboratory employee. The commissioner shall prescribe the standards, procedures and fees for obtaining a temporary certificate of registration as a laboratory employee.

(c) The Commissioner of Consumer Protection shall adopt regulations, in accordance with chapter 54 of the general statutes, to (1) provide for the licensure of laboratories and laboratory employees, (2) establish standards and procedures for the revocation, suspension, summary suspension and nonrenewal of laboratory and laboratory employee licenses, provided such standards and procedures are consistent with the provisions of subsection (c) of section 4-182 of the general statutes, (3) establish a license and renewal fee for each licensed laboratory and licensed laboratory employee, provided the aggregate amount of such license and renewal fees shall not be less than the amount necessary to cover the direct and indirect cost of licensing and regulating laboratories and laboratory employees in accordance with the provisions of chapter 420f of the general statutes, and (4) establish other licensing, renewal and operational standards deemed necessary by the commissioner.

(d) Any fees collected by the Department of Consumer Protection under this section shall be paid to the State Treasurer and credited to the General Fund.

Sec. 11. (NEW) (Effective October 1, 2016) (a) No laboratory employee may (1) acquire marijuana from a person other than a licensed producer, licensed dispensary or organization engaged in a research program, (2) deliver, transport or distribute marijuana to (A) a person who is not a licensed dispensary, (B) a person who is not a licensed producer, or (C) an organization not engaged in a research program, or (3) obtain or transport marijuana outside of this state in violation of state or federal law.

(b) (1) No laboratory employee acting within the scope of his or her employment shall be subject to arrest or prosecution, penalized in any manner, including, but not limited to, being subject to any civil penalty, or denied any right or privilege, including, but not limited to, being subject to any disciplinary action by a professional licensing board, for acquiring, possessing, delivering, transporting or distributing marijuana to a licensed dispensary, a licensed producer or an organization engaged in an approved research program under the provisions of chapter 420f of the general statutes.

(2) No laboratory shall be subject to prosecution, penalized in any manner, including, but not limited to, being subject to any civil penalty or denied any right or privilege, for acquiring, possessing, delivering, transporting or distributing marijuana to a licensed dispensary, a licensed producer or an organization engaged in an approved research program under the provisions of chapter 420f of the general statutes.

Sec. 12. (NEW) (Effective October 1, 2016) (a) The Commissioner of Consumer Protection may approve a research program if such research program will (1) be administered or overseen by (A) a hospital or health care facility licensed by the Connecticut Department of Public Health pursuant to chapter 368v of the general statutes, (B) an institution of higher education, as defined in section 10a-55 of the general statutes, (C) a licensed producer, or (D) a licensed dispensary, and (2) have institutional review board oversight and, if the research program involves the use of animals, have an institutional animal care and use committee.

(b) Except as provided in subsection (c) of this section, no person may act as a research program employee or represent that such person is a licensed research program employee unless such person has obtained a license from the Commissioner of Consumer Protection pursuant to this section.

(c) Prior to the effective date of regulations adopted under this section, the Commissioner of Consumer Protection may issue a temporary certificate of registration to a research program employee. The commissioner shall prescribe the standards, procedures and fees for obtaining a temporary certificate of registration as a research program employee.

(d) The Commissioner of Consumer Protection shall adopt regulations, in accordance with chapter 54 of the general statutes, to (1) provide for the approval of research programs and licensure of research program employees, (2) establish standards and procedures for the termination or suspension of a research program, (3) establish standards and procedures for the revocation, suspension, summary suspension and nonrenewal of a research program employee license, provided such standards and procedures are consistent with the provisions of subsection (c) of section 4-182 of the general statutes, (4) establish a (A) fee for research program review and approval, and (B) license and renewal fee for each research program employee, provided the aggregate amount of such fees shall not be less than the amount necessary to cover the direct and indirect cost of approving research programs and licensing and regulating research program employees pursuant to the provisions of chapter 420f of the general statutes, and (5) establish other licensing, renewal and operational standards deemed necessary by the commissioner.

(e) Any fees collected by the Department of Consumer Protection under this section shall be paid to the State Treasurer and credited to the General Fund.

Sec. 13. (NEW) (Effective October 1, 2016) (a) No research program or research program employee may (1) acquire marijuana from a person other than a licensed producer, licensed dispensary or laboratory, (2) deliver, transport or distribute marijuana to a person who is not (A) a licensed dispensary, (B) a licensed producer, or (C) a research program subject, (3) distribute or administer marijuana to an animal unless such animal is an animal research subject, or (4) obtain or transport marijuana outside of this state in violation of state or federal law.

(b) No research program employee acting within the scope of his or her employment shall be subject to arrest or prosecution, penalized in any manner, including, but not limited to, being subject to any civil penalty, or denied any right or privilege, including, but not limited to, being subject to any disciplinary action by a professional licensing board, for acquiring, possessing, delivering, transporting or distributing marijuana to a licensed dispensary, a licensed producer or a research program subject or distributing or administering marijuana to an animal research subject under the provisions of chapter 420f of the general statutes.

Sec. 14. (NEW) (Effective October 1, 2016) (a) Any person seeking to participate as a research program subject shall register with the Department of Consumer Protection prior to participating in an approved research program. The Commissioner of Consumer Protection shall prescribe the standards and procedures for obtaining a certificate of registration as a research program subject.

(b) A research program subject who has a valid registration certificate from the Department of Consumer Protection and is acting within the scope of his or her involvement in an approved research program shall not be subject to arrest or prosecution, penalized in any manner, including, but not limited to, being subject to any civil penalty or denied any right or privilege, including, but not limited to, being subject to any disciplinary action by a professional licensing board, for the use of marijuana.

(c) The provisions of subsection (b) of this section do not apply to:

(1) Any use of marijuana that endangers the health or well-being of a person other than the research program subject or a research program employee; or

(2) The ingestion of marijuana (A) in a motor bus or a school bus or in any other moving vehicle, (B) in the workplace, (C) on any school grounds or any public or private school, dormitory, college or university property unless such college or university is participating in a research program and such use is pursuant to the terms of the research program, (D) in any public place, or (E) in the presence of a person under eighteen years of age unless such person is a qualifying patient or research program subject. For purposes of this subdivision, (i) "presence" means within the direct line of sight of the palliative use of marijuana or exposure to second-hand marijuana smoke, or both; (ii) "public place" means any area that is used or held out for use by the public, whether owned or operated by public or private interests; (iii) "vehicle" means a vehicle, as defined in section 14-1 of the general statutes; (iv) "motor bus" means a motor bus, as defined in section 14-1 of the general statutes; and (v) "school bus" means a school bus, as defined in section 14-1 of the general statutes.

(d) Information obtained under this section shall be confidential and shall not be subject to disclosure under the Freedom of Information Act, as defined in section 1-200 of the general statutes, except that reasonable access to registry information obtained under this section shall be provided to (1) state agencies, federal agencies and local law enforcement agencies for the purpose of investigating or prosecuting a violation of law, (2) physicians and pharmacists for the purpose of providing patient care and drug therapy management and monitoring controlled substances obtained by the research program subject, (3) public or private entities for research or educational purposes, provided no individually identifiable health information may be disclosed, (4) a licensed dispensary for the purpose of complying with sections 21a-408 to 21a-408n, inclusive, of the general statutes, as amended by this act, or (5) a research program subject, but only with respect to information related to such research program subject.

Sec. 15. Subsection (a) of section 21a-408n of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2016):

(a) During the period beginning on October 1, 2012, and ending thirty calendar days after the effective date of regulations adopted pursuant to section 21a-408m, a qualifying patient who would be determined to be eligible for a registration certificate pursuant to subsection (a) of section 21a-408d, as amended by this act, except for the lack of effective regulations concerning licensed dispensaries, licensed producers, distribution systems and amounts of marijuana, may obtain a written certification from a physician and upon presenting the written certification to the Department of Consumer Protection, the department shall issue a temporary registration certificate for the palliative use of marijuana. The department shall indicate on such temporary registration certificate the amount of usable marijuana that constitutes a one month supply which may be possessed pursuant to such temporary registration certificate. The department shall maintain a list of all temporary registration certificates issued pursuant to this section and the information on such list shall be confidential and shall not be subject to disclosure under the Freedom of Information Act, as defined in section 1-200, except that such information may be disclosed in the manner set forth in subsection [(b)] (d) of section 21a-408d, as amended by this act.

This act shall take effect as follows and shall amend the following sections:

Section 1

October 1, 2016

21a-408

Sec. 2

October 1, 2016

21a-408a(b)

Sec. 3

October 1, 2016

21a-408b

Sec. 4

October 1, 2016

21a-408c

Sec. 5

October 1, 2016

21a-408d

Sec. 6

October 1, 2016

21a-408h

Sec. 7

October 1, 2016

21a-408j(a)

Sec. 8

October 1, 2016

21a-408k(a)

Sec. 9

October 1, 2016

21a-408l

Sec. 10

October 1, 2016

New section

Sec. 11

October 1, 2016

New section

Sec. 12

October 1, 2016

New section

Sec. 13

October 1, 2016

New section

Sec. 14

October 1, 2016

New section

Sec. 15

October 1, 2016

21a-408n(a)

The following Fiscal Impact Statement and Bill Analysis are prepared for the benefit of the members of the General Assembly, solely for purposes of information, summarization and explanation and do not represent the intent of the General Assembly or either chamber thereof for any purpose. In general, fiscal impacts are based upon a variety of informational sources, including the analyst's professional knowledge. Whenever applicable, agency data is consulted as part of the analysis, however final products do not necessarily reflect an assessment from any specific department.

OFA Fiscal Note

State Impact:

Agency Affected

Fund-Effect

FY 17 $

FY 18 $

Resources of the General Fund

GF - Revenue Gain

Less than 10,000

Less than 10,000

Note: GF=General Fund

Municipal Impact: None

Explanation

The bill results in a revenue gain of less than $10,000 in FY 17 and FY 18 by allowing minors to be qualifying patients for the palliative marijuana program. It is estimated that fewer than 100 minors would participate in the program.

House “A” (LCO 4338) is technical and results in no fiscal impact.

The Out Years

The annualized ongoing fiscal impact identified above would continue into the future subject to the number of minors participating in the program.

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:

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:

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 — DEBILITATING CONDITIONS FOR ADULTS

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

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:

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:

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:

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:

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

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:

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)

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