NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A7476
SPONSOR: Gottfried TITLE OF BILL: An act to amend the public health law, in relation to
medical use of marihuana; and repealing certain provisions of such law
relating thereto
PURPOSE OR GENERAL IDEA OF BILL:
To establish a medical model of care which regulates medical marihuana
as a recommended medicine in keeping with recognized medical public
health and safety standards.
SUMMARY OF SPECIFIC PROVISIONS:
Section 1 Legislative findings and intent.
Section 2 amends subdivisions 1,7,8,12 and 15 of Public Health Law §
3360 to remove the prohibition of smokable marihuana as a form of certi-
fied medical use. It adds Alzheimer's disease, traumatic brain injury,
dystonia, wasting syndrome, Crohn's disease, post-traumatic stress
disorder rheumatoid arthritis and lupus to the list of serious condi-
tions. This section adds physician assistant or nurse practitioner to
allow these practitioners to certify patients for use of medical mari-
huana. Individual dose is amended to remove the limitation of no more
than 10 milligrams of tetrahydrocannabinol (THC).
Section 3 amends subdivision 10 of PHL § 3363 to require that the
commissioner of health act by regulation to add any requirements to the
registration identification card.
Section 4 amends subdivisions 4,6 and 13 of PHL § 3364 and adds subdivi-
sion 14 and 15 to allow a registered organization to contract with a
person or entity to provide facilities, equipment or services. All laws
applicable to the registered organization would apply to these
contracts. A registered organization would be able to lawfully, in good
faith, sell, deliver or distribute medical marihuana to a registered
organization.
Section 5 amends subdivisions 1,3,8 and 9 of PHL § 3365 to allow greater
than five registered organizations. During the first two years the
commissioner is limited to registering no more than 20 registered organ-
izations that manufacture medical marihuana. This section eliminates the
requirement for dispensaries to be run by producers by removing the
requirement that dispensaries must be wholly owned and operated by the
manufacturing registered organization.
Section 6 adds a new subdivision 5 to PHL § 3369 to offer legal
protection and reciprocity to patients holding a valid medical marihuana
card from other states as long as the visiting patient's condition is a
serious condition as attested to in writing by a practitioner.
Section 7 amends PHL § 3369-a to require the regulations under this
title be reasonable and consistent with this title, legislative intent,
and verifiable clinical, legal or public safety concerns. An advisory
committee is created to advise the commissioner on regulations and
matters pertaining to the program.
Section 8 amends PHL § 3369-b to remove the requirement that the super-
intendent of state police must certify that the program can be imple-
mented.
Section 9 repeals § 3369-c and § 3369-d of the PHL.
Section 10 is the effective date.
JUSTIFICATION:
Title V-A of the public health law was intended to establish a medical
model of care to regulate medical marihuana in keeping with recognized
medical public health and safety standards. The amendments in this bill
are necessary to make sure the new law meets its purpose.
PRIOR LEGISLATIVE HISTORY:
New bill.
FISCAL IMPLICATIONS:
EFFECTIVE DATE:
Immediately.
STATE OF NEW YORK
________________________________________________________________________
7476
2015-2016 Regular Sessions
IN ASSEMBLY
May 13, 2015
___________
Introduced by M. of A. GOTTFRIED -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to medical use of
marihuana; and repealing certain provisions of such law relating ther-
eto
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Legislative findings and intent. The legislature finds that
2 thousands of New Yorkers have serious medical conditions that can be
3 improved by medically-approved use of marihuana. The law should not
4 stand between them and treatment necessary for life and health. This
5 legislation follows the well-established public policy that a controlled
6 substance can have a legitimate medical use. Many controlled substances
7 that are legal for medical use (such as morphine and steroids) are ille-
8 gal for any other use. The purposes of article 33 of the public health
9 law include allowing legitimate medical use of controlled substances in
10 health care, including palliative care.
11 Title 5-A of article 33 of the public health law, and the amendments
12 to it in this act, establish a medical model of care which regulates
13 medical marihuana as a recommended medicine in keeping with recognized
14 medical public health and safety standards. This policy and this legis-
15 lation do not in any way diminish New York state's strong public policy
16 and laws against illegal drug use, nor should it be deemed in any manner
17 to advocate, authorize, promote, or legally or socially accept the use
18 of marihuana for children or adults, for any non-medical use. This
19 legislation is an appropriate exercise of the state's legislative power
20 to protect the health of its people under article 17 of the state
21 constitution and the tenth amendment of the United States constitution.
22 Furthermore, the legislature finds that New York state has a signif-
23 icant and ongoing economic and non-regulatory interest in the financial
24 viability of organizations that sell marihuana for medical use. The
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD10875-01-5
A. 7476 2
1 legislature finds that the financial viability of such organizations
2 would be greatly diminished and threatened by labor-management conflict,
3 such as a strike at a facility that cultivates marihuana, especially
4 because of the need for enhanced security concerning the products.
5 Replacements during a strike would be difficult to arrange and cause
6 delay far more significant than a strike elsewhere. Accordingly, the
7 legislature finds that the state has a substantial and compelling
8 proprietary interest in this matter, and finds that labor peace is
9 essential for any organization to conduct business relating to the sale
10 of medical marihuana.
11 It is the legislative intent that this act be implemented consistently
12 with these findings and principles, through a reasonable and workable
13 system with appropriate oversight; strong "seed to sale" regulation to
14 prevent diversion, abuse, and other illegal conduct; reasonable access
15 to and appropriate use of medical marihuana by certified patients; eval-
16 uation; and continuing research.
17 § 2. Subdivisions 1, 7, 8, 12 and 15 of section 3360 of the public
18 health law, as added by chapter 90 of the laws of 2014, are amended to
19 read as follows:
20 1. "Certified medical use" means the acquisition, possession, use, or,
21 transportation of medical marihuana by a certified patient, or the
22 acquisition, possession, delivery, transportation or administration of
23 medical marihuana by a designated caregiver, for use as part of the
24 treatment of the patient's serious condition, as authorized in a certif-
25 ication under this title including enabling the patient to tolerate
26 treatment for the serious condition. [A certified medical use does not
27 include smoking.]
28 7. [(a)] "Serious condition" means:
29 (i) having one of the following severe debilitating or life-threaten-
30 ing conditions: cancer, positive status for human immunodeficiency virus
31 or acquired immune deficiency syndrome, amyotrophic lateral sclerosis,
32 Alzheimer's disease, traumatic brain injury, dystonia, Parkinson's
33 disease, multiple sclerosis, damage to the nervous tissue of the spinal
34 cord with objective neurological indication of intractable spasticity,
35 epilepsy, wasting syndrome, Crohn's disease, post traumatic stress
36 disorder, rheumatoid arthritis, lupus, inflammatory bowel disease,
37 neuropathies, Huntington's disease, or as added by the commissioner; and
38 (ii) any of the following conditions where it is clinically associated
39 with, or a complication of, a condition under this paragraph or its
40 treatment: cachexia or wasting syndrome; severe or chronic pain; severe
41 nausea; seizures; severe or persistent muscle spasms; or such conditions
42 as are added by the commissioner.
43 [(b) No later than eighteen months from the effective date of this
44 section, the commissioner shall determine whether to add the following
45 serious conditions: Alzheimer's, muscular dystrophy, dystonia, post-
46 traumatic stress disorder and rheumatoid arthritis.]
47 8. "Medical marihuana" means marihuana as defined in subdivision twen-
48 ty-one of section thirty-three hundred two of this article, intended for
49 a certified medical use[, as determined by the commissioner in his or
50 her sole discretion. Any form of medical marihuana not approved by the
51 commissioner is expressly prohibited].
52 12. "Practitioner" means a practitioner who (i) is a physician, physi-
53 cian assistant or nurse practitioner, licensed or certified by New York
54 state and practicing within the state, acting within his or her lawful
55 scope of practice; (ii) [who] by training or experience is qualified to
56 treat a serious condition as defined in subdivision seven of this
A. 7476 3
1 section; and (iii) has completed a two to four hour course as determined
2 by the commissioner in regulation and registered with the department;
3 provided however, a registration shall not be denied without cause. Such
4 course may count toward board certification requirements. [The commis-
5 sioner shall consider the inclusion of nurse practitioners under this
6 title based upon considerations including access and availability. After
7 such consideration the commissioner is authorized to deem nurse practi-
8 tioners as practitioners under this title.]
9 15. "Individual dose" means a single measure of raw medical marihuana
10 or non-infused concentrates to be determined and clearly identified by a
11 patient's practitioner for the patient's specific certified condition.
12 [For ingestible or sub-lingual medical marihuana products, no individual
13 dose may contain more than ten milligrams of tetrahydrocannabinol.]
14 § 3. Subdivision 10 of section 3363 of the public health law, as added
15 by chapter 90 of the laws of 2014, is amended to read as follows:
16 10. A registry identification card shall:
17 (a) contain the name of the certified patient or the designated care-
18 giver as the case may be;
19 (b) contain the date of issuance and expiration date of the registry
20 identification card;
21 (c) contain a registry identification number for the certified patient
22 or designated caregiver, as the case may be and a registry identifica-
23 tion number;
24 (d) contain a photograph of the individual to whom the registry iden-
25 tification card is being issued, which shall be obtained by the depart-
26 ment in a manner specified by the commissioner in regulations; provided,
27 however, that if the department requires certified patients to submit
28 photographs for this purpose, there shall be a reasonable accommodation
29 of certified patients who are confined to their homes due to their
30 medical conditions and may therefore have difficulty procuring photo-
31 graphs;
32 (e) be a secure document as determined by the department;
33 (f) plainly state any recommendation or limitation by the practitioner
34 as to the form or forms of medical marihuana or dosage for the certified
35 patient; and
36 (g) any other requirements determined by the commissioner in regu-
37 lations.
38 § 4. Subdivisions 4, 6 and 13 of section 3364 of the public health
39 law, as added by chapter 90 of the laws of 2014, are amended and two new
40 subdivisions 14 and 15 are added to read as follows:
41 4. (a) A registered organization may lawfully, in good faith, sell,
42 deliver, distribute or dispense medical marihuana to a certified patient
43 or designated caregiver upon presentation to the registered organization
44 of a valid registry identification card for that certified patient or
45 designated caregiver. When presented with the registry identification
46 card, the registered organization shall provide to the certified patient
47 or designated caregiver a receipt, which shall state: the name, address,
48 and registry identification number of the registered organization; the
49 name and registry identification number of the certified patient and the
50 designated caregiver (if any); the date the marihuana was sold; any
51 recommendation or limitation by the practitioner as to the form or forms
52 of medical marihuana or dosage for the certified patient; and the form
53 and the quantity of medical marihuana sold. The registered organization
54 shall retain a copy of the registry identification card and the receipt
55 for six years.
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1 (b) The [proprietor of a] registered organization shall file or cause
2 to be filed any receipt and certification information with the depart-
3 ment by electronic means on a real time basis as the commissioner shall
4 require by regulation. When filing receipt and certification information
5 electronically pursuant to this paragraph, the proprietor of the regis-
6 tered organization shall dispose of any electronically recorded
7 prescription information in such manner as the commissioner shall by
8 regulation require.
9 6. When a registered organization sells, delivers, distributes or
10 dispenses medical marihuana to a certified patient or designated care-
11 giver, it shall provide to that individual a safety insert, which will
12 be developed and approved by the commissioner and include, but not be
13 limited to, information on:
14 (a) methods for administering medical marihuana in individual doses,
15 (b) any potential dangers stemming from the use of medical marihuana,
16 (c) how to recognize what may be problematic usage of medical marihua-
17 na and obtain appropriate services or treatment for problematic usage,
18 and
19 (d) other information as determined by the commissioner in
20 regulations.
21 13. The commissioner is authorized to make [rules and] regulations
22 restricting the advertising and marketing of medical marihuana, which
23 shall be consistent with the federal regulations governing prescription
24 drug advertising and marketing.
25 14. A registered organization may contract with a person or entity to
26 provide facilities, equipment or services that are part of or incidental
27 to the registered organization's functions or activities under this
28 section. All laws and regulations applicable to the registered organiza-
29 tion shall apply to the contract. The registered organization and other
30 parties to the contract shall each be responsible and accountable for
31 compliance with such laws and regulations under the contract. The
32 commissioner may make regulations consistent with this title relating to
33 contracts and parties to contracts under this subdivision.
34 15. A registered organization may lawfully, in good faith, sell,
35 deliver, or distribute medical marihuana to a registered organization,
36 in accordance with the registration of both registered organizations.
37 § 5. Subdivisions 1, 3, 8 and 9 of section 3365 of the public health
38 law, as added by chapter 90 of the laws of 2014, are amended to read as
39 follows:
40 1. Application for initial registration. (a) An applicant for regis-
41 tration as a registered organization under section thirty-three hundred
42 sixty-four of this title shall include such information prepared in such
43 manner and detail as the commissioner may require, including but not
44 limited to:
45 (i) a description of the activities in which it intends to engage as a
46 registered organization;
47 (ii) that the applicant:
48 (A) is of good moral character;
49 (B) possesses or has the right to use sufficient land, buildings, and
50 other premises (which shall be specified in the application) and equip-
51 ment to properly carry on the activity or activities described in the
52 application, or in the alternative posts a bond of not less than two
53 million dollars;
54 (C) is able to maintain effective security and control to prevent
55 diversion, abuse, and other illegal conduct relating to the marihuana;
A. 7476 5
1 (D) is able to comply with all applicable state laws and regulations
2 relating to the activities in which it intends to engage under the
3 registration;
4 (iii) that the applicant has entered into a labor peace agreement with
5 a bona-fide labor organization that is actively engaged in representing
6 or attempting to represent the applicant's employees. The maintenance of
7 such a labor peace agreement shall be an ongoing material condition of
8 certification.
9 (iv) the applicant's status under subdivision one of section thirty-
10 three hundred sixty-four of this title; and
11 (v) the application shall include the name, residence address and
12 title of each of the officers and directors and the name and residence
13 address of any person or entity that is a member of the applicant. Each
14 such person, if an individual, or lawful representative if a legal enti-
15 ty, shall submit an affidavit with the application setting forth:
16 (A) any position of management or ownership during the preceding ten
17 years of a ten per centum or greater interest in any other business,
18 located in or outside this state, manufacturing or distributing drugs;
19 (B) whether such person or any such business has been convicted of a
20 felony or had a registration or license suspended or revoked in any
21 administrative or judicial proceeding; and
22 (C) such other information as the commissioner may reasonably require.
23 3. Granting of registration. (a) The commissioner shall grant a regis-
24 tration or amendment to a registration under this section if he or she
25 is satisfied that:
26 (i) the applicant will be able to maintain effective control against
27 diversion of marihuana;
28 (ii) the applicant will be able to comply with all applicable state
29 laws;
30 (iii) the applicant and its officers are ready, willing and able to
31 properly carry on the manufacturing or distributing activity for which a
32 registration is sought;
33 (iv) the applicant possesses or has the right to use sufficient land,
34 buildings and equipment to properly carry on the activity or activities
35 described in the application;
36 (v) it is in the public interest that such registration be granted;
37 the commissioner may consider whether the number of registered organiza-
38 tions in an area will be adequate or excessive to reasonably serve the
39 area;
40 (vi) the applicant and its managing officers are of good moral charac-
41 ter;
42 (vii) the applicant has entered into a labor peace agreement with a
43 bona-fide labor organization that is actively engaged in representing or
44 attempting to represent the applicant's employees; and
45 (viii) the applicant satisfies any other conditions as determined by
46 the commissioner.
47 (b) If the commissioner is not satisfied that the applicant should be
48 issued a registration, he or she shall notify the applicant in writing
49 of those factors upon which further evidence is required. Within thirty
50 days of the receipt of such notification, the applicant may submit addi-
51 tional material to the commissioner or demand a hearing, or both.
52 (c) The fee for a registration under this section shall be a reason-
53 able amount determined by the department in regulations; provided,
54 however, if the registration is issued for a period greater than two
55 years the fee shall be increased, pro rata, for each additional month of
56 validity.
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1 (d) Registrations issued under this section shall be effective only
2 for the registered organization and shall specify:
3 (i) the name and address of the registered organization;
4 (ii) which activities of a registered organization are permitted by
5 the registration;
6 (iii) the land, buildings and facilities that may be used for the
7 permitted activities of the registered organization; and
8 (iv) such other information as the commissioner shall reasonably
9 provide to assure compliance with this title.
10 (e) Upon application of a registered organization, a registration may
11 be amended to allow the registered organization to relocate within the
12 state or to add or delete permitted registered organization activities
13 or facilities. The fee for such amendment shall be two hundred fifty
14 dollars.
15 8. The department shall begin issuing registrations for registered
16 organizations as soon as practicable after the [certifications] certif-
17 ication required by section thirty-three hundred sixty-nine-b of this
18 title [are] is given.
19 9. The commissioner shall register [no more than five] registered
20 organizations [that manufacture medical marihuana with no more than four
21 dispensing sites wholly owned and operated by such registered organiza-
22 tion] and facilities to promote reasonable access to medical marihuana
23 in the interest of certified patients and the public. During the first
24 two years after this title takes effect, the commissioner shall register
25 no more than twenty registered organizations that manufacture medical
26 marihuana. The commissioner shall ensure that [such] registered organ-
27 izations and dispensing sites are geographically distributed across the
28 state and shall not require that dispensing sites be owned or operated
29 by the registered organization licensed to manufacture medical
30 marihuana. [The commission may register additional registered organiza-
31 tions.]
32 § 6. Section 3369 of the public health law is amended by adding a new
33 subdivision 5 to read as follows:
34 5. A registry identification card, or its equivalent, that is issued
35 under the laws of another state, district, territory, commonwealth, or
36 possession of the United States that allows the medical use of marihuana
37 has the same force and effect as a registry identification card issued
38 by the department, so long as the visiting patient's condition is a
39 serious condition, as attested to in writing by a practitioner. Where a
40 registered organization dispenses medical marihuana to a patient under
41 this subdivision, a copy of the attestation shall be provided to the
42 registered organization.
43 § 7. Section 3369-a of the public health law, as added by chapter 90
44 of the laws of 2014, is amended to read as follows:
45 § 3369-a. Regulations. 1. The commissioner shall make regulations to
46 implement this title. Regulations under this title shall be reasonable
47 and consistent with this title, the legislative intent, and verifiable
48 clinical, legal or public safety considerations.
49 2. There is hereby established in the department an advisory committee
50 on medical use of marihuana (the "advisory committee") to advise the
51 commissioner on making regulations under this title and on any matters
52 relating to the implementation of this title as the commissioner shall
53 determine. The advisory committee shall consist of fifteen members. The
54 members of the advisory committee shall be appointed as follows: eight
55 to be appointed by the governor, two to be appointed by the governor on
56 the recommendation of the temporary president of the senate, one to be
A. 7476 7
1 appointed by the governor on the recommendation of the minority leader
2 of the senate, two to be appointed by the governor on the recommendation
3 of the speaker of the assembly, one to be appointed by the governor on
4 the recommendation of the minority leader of the assembly, and one to be
5 appointed by the governor on the recommendation of the attorney general
6 of the state of New York. The advisory committee shall include but not
7 be limited to: health care practitioners, patients or representatives of
8 patients with serious conditions, experts in the regulation of
9 controlled substances for medical use, medical marihuana industry
10 professionals and law enforcement. The advisory committee shall be
11 responsible for reviewing the appeal of any patient or caregiver whose
12 registry application has been denied by the department. The advisory
13 committee shall make recommendations regarding any such appeal to the
14 commissioner, who shall make the final determination. The commissioner
15 may also form subcommittees of the advisory committee. The commissioner
16 shall form a subcommittee to assist and advise the commissioner and the
17 advisory committee on clinical matters relating to medical marihuana,
18 including but not limited to expanding or retracting the categories of
19 diseases to be considered serious conditions for purposes of this title,
20 the members of which shall predominantly be clinical professionals in
21 appropriate areas of expertise and shall also include representatives of
22 patients and the general public. Members of a subcommittee need not be
23 members of the advisory committee. Members of the advisory committee
24 shall serve for a term of four years. Members of a subcommittee shall
25 serve at the pleasure of the commissioner. Members of the advisory
26 committee or a subcommittee may receive reimbursement by the department
27 for their reasonable and necessary expenses incurred as members of the
28 advisory committee or a subcommittee. A public employee may be a member
29 of the advisory committee or a subcommittee.
30 § 8. Section 3369-b of the public health law, as added by chapter 90
31 of the laws of 2014, is amended to read as follows:
32 § 3369-b. Effective date. Registry identification cards or registered
33 organization registrations shall be issued or become effective no later
34 than eighteen months from signing or until such time as the commissioner
35 [and the superintendent of state police certify] certifies that this
36 title can be implemented in accordance with public health and safety
37 interests, whichever event comes later.
38 § 9. Sections 3369-c and 3369-d of the public health law are REPEALED
39 and section 3369-e is renumbered section 3369-c.
40 § 10. This act shall take effect immediately; provided that the amend-
41 ments to title 5-a of article 33 of the public health law made by
42 sections two through nine of this act shall not affect the expiration
43 and repeal of such title and shall expire and be deemed repealed there-
44 with.
