|SAME AS||No Same As|
|COSPNSR||Lupardo, Brindisi, Bronson, McDonald, Skoufis, Seawright|
|Amd SS3360, 3363, 3364, 3365, 3369, 3369-a & 3369-b, rpld SS3369-c & 3369-d, ren S3369-e to be S3369-c, Pub Health L|
|Makes various amendments to statute authorizing the use of medical marihuana.|
|05/13/2015||referred to health|
|01/06/2016||referred to health|
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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.
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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. LBD10875-01-5A. 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 not27 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 this44 section, the commissioner shall determine whether to add the following45 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 or50 her sole discretion. Any form of medical marihuana not approved by the51 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 thisA. 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 this6 title based upon considerations including access and availability. After7 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 individual13 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.A. 7476 4 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.A. 7476 6 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 four21 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 beA. 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.