Assembly Actions -
Lowercase Senate Actions - UPPERCASE |
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---|---|
Mar 10, 2020 |
reported and committed to finance |
Feb 19, 2020 |
print number 5657b |
Feb 19, 2020 |
amend and recommit to health |
Jan 08, 2020 |
referred to health |
May 22, 2019 |
print number 5657a |
May 22, 2019 |
amend and recommit to health |
May 10, 2019 |
referred to health |
Senate Bill S5657B
2019-2020 Legislative Session
Relates to medical marihuana
download bill text pdfSponsored By
(D, IP) Senate District
Archive: Last Bill Status - In Senate Committee Finance Committee
- Introduced
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- In Committee Assembly
- In Committee Senate
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- On Floor Calendar Assembly
- On Floor Calendar Senate
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- Passed Assembly
- Passed Senate
- Delivered to Governor
- Signed By Governor
Actions
Votes
Bill Amendments
2019-S5657 - Details
- Current Committee:
- Senate Finance
- Law Section:
- Public Health Law
- Laws Affected:
- Amd Pub Health L, generally
2019-S5657 - Summary
Provides that medical marihuana may be used as part of the treatment of a patient's condition and removes the "serious" designation of such condition; provides that a practitioner be authorized to prescribe controlled substances in the state and removes the requirement that a physician prescribe such medical marihuana; increases the supply amount of marihuana from thirty to sixty days; allows a designated caregiver facility or designated caregiver facility employee to possess, acquire, deliver, transfer, transport or administer medical marihuana
2019-S5657 - Sponsor Memo
BILL NUMBER: S5657 SPONSOR: SAVINO TITLE OF BILL: An act to amend the public health law, in relation to medical marihuana PURPOSE OR GENERAL IDEA OF BILL: This bill addresses several problems with the medical marijuana program. This bill consolidates several proposals from other bills, as well as changes to the medical program proposed in the 2019 Executive Budget's Cannabis Regulation and Taxation Act (CRTA). SUMMARY OF SPECIFIC PROVISIONS: Section 1: Amends PHL § 3360 to: *Expand eligible conditions to include any condition certified by the practitioner; *Allow any practitioner otherwise authorized to prescribe controlled substances to certify patients for medical marijuana;
*Remove prohibitions on the smoking of medical marijuana; and *Create the categories of "designated caregiver facility," "designated caregiver facility employee," and "medical marihuana research program." Section 2: Amends PHI § 3361 to make conforming changes. Section 3: Amends PHL § 3362 to: *Change possession limits from a 30 day to a 60 day supply; *Authorize possession, acquisition, delivery, transfer, and adminis- tration of medical marijuana by designated caregiver facilities and their employees subject to certain requirements; and *Prohibit smoking of medical marijuana in any place where tobacco may not be smoked under the Clean Indoor Air Act. Section 4: Amends PHL § 3363 to: *Remove the $50 patient application fee for registry ID cards; *Remove patient-per-caregiver limits when the caregiver is a designated caregiver facility; and *Make conforming changes Section 5: Amends PHL § 3364 to: *Authorize registered organizations (ROs) to contract out ancillary functions such as shipping, construction, and security; and *Make conforming changes Section 6: Creates a new PHL § 3364-a, "medical marihuana research licenses," to: *Establish a medical marijuana research license for purposes of testing, clinical investigations, and safety and efficacy or genomic or agricul- tural research relating to medical marijuana; and *Details application, licensing, and oversight process. Section 7: Creates a new PHL § 3364-b, "registration of designated care- giver facilities," to: *Establishes registration process for "designated caregiver facilities" among provider types defined in section 1 of the bill; and *Details application, registration, and oversight process. Section 8: Creates a new PHL § 3364-c, "laboratory permits," to: *Detail application, permitting, and oversight process. Section 9: Amends PHI § 3365 to: *Increase dispensaries per RO from 4 to 8; and *Direct the Commissioner to register additional ROs reflecting the demo- graphics of the state. Section 10: Amends PHL § 3365-a to make conforming changes. Section 11: Amends PHL § 3369 to make conforming changes. Section 12: Amends PHL § 3369-d to remove prior approval of medical marijuana prices; maintain requirement for ROs to document price chang- es; and maintain the commissioner's power to modify prices if necessary to maintain access. Section 13: Effective date. JUSTIFICATION: Open conditions list: There is no pharmaceutical other than medical marijuana for which the State restricts its use to a limited list of conditions. Setting a conditions list in statute takes medical decisions out of the hands of the practitioners who know their patients best and whose judgment the law respects for much more dangerous drugs. Practi- tioners also lack clarity about which conditions are actually covered. For example, the Public Health Law definition of "severe or chronic pain" is inconsistent with regulatory language for "severe debilitating pain that degrades health and functional capability." This bill would maintain the naming of several conditions in statute for illustrative purposes, including some added in the Governor's 2019 Cannabis Regulation and Taxation Act (CRTA), but also allows "any other condition certified by the practitioner." While the drafting is differ- ent, the effect is the same as A.1125-A of 2019. Expanded practitioner list: Today, physicians, physician assistants, and nurse practitioners can certify patients. However, there are other cate- gories of practitioner outside these who are authorized to prescribe much more dangerous substances and often treat conditions for which a patient may be eligible (such as podiatrists and dentists whose treat- ments involve pain medication.) This bill expands the practitioner cate- gories to cover these groups, similar to A.1149 of 2019. Strike patient registry fees; increase supply from 30 to 60 days: Current law requires a $50 application fee for registry identification cards and limits patients to a 30 day supply. While the application fee is often waived, it presents a barrier to access that does not exist for patients with any other pharmaceutical product. Current law also limits patients to acquiring 30 day supplies at once. For patients with limited mobility, or who may have to travel long distances, this limits access. The 2019 Executive budget proposed Cannabis Regulation and Taxation Act (CRTA) included both of these changes. Allow smoking: For some patients, smoking is the most affordable deliv- ery method and enable them to effectively limit dosage. Out of over 30 states that now have medical marijuana programs, only 4 disallow smoking as New York does. While smoking can involve respiratory or other issues, the quantities involved in medical marijuana use are very limited, and should be a matter between patient and practitioner. This legislation would protect the public by making medical marihuana smoking subject to the Clean Indoor Air Act restrictions, similar to A.1032 of 2019. Facility caregivers: Current law allows patients to designate up to two people as caregivers under the program. Caregivers are capped at five patients each. These caps have caused problems administering medical marijuana in residential facilities or hospitals where there may be more than five patients using medical marijuana for a given caregiver, or where a patient may see more than two potential caregiver personnel (e.g., nurses) on a regular basis. This bill authorizes, but does not mandate, certain facilities to become "designated caregiver facilities," exempting them from such restrictions, similar to A.1131 of 2019 and language in the CRTA. Research licenses: While there is significant research being done over- seas, medical marijuana research in the United States is limited. This bill would facilitate medical marijuana research in New York based on departmental regulations. Both A.1131 of 2019 and the CRTA also author- ize research licenses. Expanded lab testing: Today, the State's Wadsworth Laboratory is the only lab authorized to test medical marijuana. As the program expands, more lab capacity is needed. Commercial labs with Drug Enforcement Agen- cy (DEA) licenses may be reluctant to test medical marijuana out of fear of endangering these DEA licenses. This bill removes the requirement that a lab which tests medical marijuana hold a DEA license and details State permitting of labs for medical marijuana testing, similar to both A.1131 of 2019 and the CRTA. RO contracting: Registered organizations (R0s) are currently not allowed to contract out any part of the production and distribution processes. This is contrary to standard business practice, is inefficient and rais- es costs. This bill allows ROs to contract out ancillary functions, such as security or transportation, while ensuring that laws applicable to the RO for the purpose of those services would apply to the contractors as well. This is similar to both A.1131 of 2019 and the CRTA. Increased dispensaries and ROs: Current law authorizes up to four dispensaries for each of the 10 ROs that engages in manufacturing. This places New York far below every other state medical marijuana programs for dispensary access per population. For comparison, New York has approximately 500,000 people per dispensary versus 233,000 to 1 in Illi- nois; 192,000 in Michigan, and 70,000 in Florida. This bill would double the number from 4 to 8 per RO. The bill also directs the commissioner to register additional ROs "reflecting the demographics of the state." While current law does authorize the registration of additional ROs, this explicit direction signals the importance of greater minority and women-owned participation in the medical marijuana program. The dispen- sary expansion is also found in A.1131 of 2019. Modifying price controls: Current law authorizes price setting by the commissioner and prohibits any sale not in accordance with such prices. In practice, ROs submit prices and price changes to the department for approval. Since enactment, not one price setting or proposed change has ever been rejected. But it takes weeks or even months for ROs to get approvals, during which time they either cannot roll out new products or cannot sell existing products at their new, typically lower prices (nearly all price changes are downward.) This bill repeals the require- ment for prior approval of price changes; maintains reporting of all price changes to the department; and maintains the commissioner's authority to reject or modify prices if necessary to maintain access. PRIOR LEGISLATIVE HISTORY: New bill FISCAL IMPLICATIONS: Minimal. Minor reduction in patient registration fees ($50 each); likely revenue increase from licensing of additional ROs and fees associated with new license categories. EFFECTIVE DATE: Immediate.
2019-S5657 - Bill Text download pdf
S T A T E O F N E W Y O R K ________________________________________________________________________ 5657 2019-2020 Regular Sessions I N S E N A T E May 10, 2019 ___________ Introduced by Sen. SAVINO -- read twice and ordered printed, and when printed to be committed to the Committee on Health AN ACT to amend the public health law, in relation to medical marihuana THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. Subdivisions 1, 5, 7 and 12 of section 3360 of the public health law, subdivisions 1, 5, 7 and 12 as added by chapter 90 of the laws of 2014, paragraph (a) of subdivision 7 as amended by chapter 273 of the laws of 2018, are amended and three new subdivisions 5-a, 5-b and 19 are added to read as follows: 1. "Certified medical use" means the acquisition, possession, use, or, transportation of medical marihuana by a certified patient, or the acquisition, possession, delivery, transportation or administration of medical marihuana by a designated caregiver, for use as part of the treatment of the patient's [serious] condition, as authorized in a certification under this title including enabling the patient to toler- ate treatment for the [serious] condition. [A certified medical use does not include smoking.] 5. "Designated caregiver" means the individual OR CAREGIVER FACILITY designated by a certified patient in a registry application. A certified patient may designate up to two designated caregivers, NOT COUNTING A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE. 5-A. "DESIGNATED CAREGIVER FACILITY" MEANS AN ENTITY THAT REGISTERS WITH THE COMMISSIONER TO ASSIST ONE OR MORE CERTIFIED PATIENTS WITH THE ACQUISITION, POSSESSION, DELIVERY, TRANSPORTATION OR ADMINISTRATION OF MEDICAL MARIHUANA AND IS: A GENERAL HOSPITAL OR RESIDENTIAL HEALTH CARE FACILITY OPERATING UNDER ARTICLE TWENTY-EIGHT OF THIS CHAPTER; AN ADULT CARE FACILITY OPERATING UNDER TITLE TWO OF ARTICLE SEVEN OF THE SOCIAL SERVICES LAW; A COMMUNITY MENTAL HEALTH RESIDENCE ESTABLISHED UNDER SECTION 41.44 OF THE MENTAL HYGIENE LAW; A HOSPITAL OPERATING UNDER SECTION 7.17 OF THE MENTAL HYGIENE LAW; A MENTAL HYGIENE FACILITY OPER- EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted.
LBD11129-03-9 S. 5657 2 ATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW; AN INPATIENT OR RESIDENTIAL TREATMENT PROGRAM CERTIFIED UNDER ARTICLE THIRTY-TWO OF THE MENTAL HYGIENE LAW; A RESIDENTIAL FACILITY FOR THE CARE AND TREAT- MENT OF PERSONS WITH DEVELOPMENTAL DISABILITIES OPERATING UNDER ARTICLE SIXTEEN OF THE MENTAL HYGIENE LAW; A RESIDENTIAL TREATMENT FACILITY FOR CHILDREN AND YOUTH OPERATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW; A PUBLIC SCHOOL OR PRIVATE SCHOOL OPERATING UNDER THE EDUCATION LAW; A RESEARCH INSTITUTION WITH AN INTERNAL REVIEW BOARD; A MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-A OF THIS TITLE; OR ANY OTHER FACILITY AS DETERMINED BY THE COMMISSIONER IN REGULATION. 5-B. "DESIGNATED CAREGIVER FACILITY EMPLOYEE" MEANS AN EMPLOYEE OF A DESIGNATED CAREGIVER FACILITY. 7. (a) ["Serious condition"] "CONDITION" means: (i) having one of the following [severe debilitating or life-threaten- ing] conditions: cancer, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, amyotrophic lateral scler- osis, Parkinson's disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, inflammatory bowel disease, neuropa- thies, Huntington's disease, post-traumatic stress disorder, pain that degrades health and functional capability where the use of medical mari- huana is an alternative to opioid use, substance use disorder, ALZHEIMER'S, MUSCULAR DYSTROPHY, DYSTONIA, RHEUMATOID ARTHRITIS, AUTISM, or [as added by the commissioner; and (ii) any of the following conditions where it is clinically associated with, or a complication of, a condition under this paragraph or its treatment: cachexia or wasting syndrome; severe or chronic pain; severe nausea; seizures; severe or persistent muscle spasms; or such conditions as are added by the commissioner. (b) No later than eighteen months from the effective date of this section, the commissioner shall determine whether to add the following serious conditions: Alzheimer's, muscular dystrophy, dystonia, post- traumatic stress disorder and rheumatoid arthritis] ANY OTHER CONDITION CERTIFIED BY THE PRACTITIONER. 12. "Practitioner" means a practitioner who (i) [is a physician licensed by New York state and practicing within the state,] IS AUTHOR- IZED TO PRESCRIBE CONTROLLED SUBSTANCES WITHIN THE STATE; (ii) [who] by training or experience is qualified to treat a [serious] condition as defined in subdivision seven of this section; and (iii) [has completed a two to four hour course as determined by the commissioner in regulation and registered with the department; provided however, a registration shall not be denied without cause. Such course may count toward board certification requirements. The commissioner shall consider the inclu- sion of nurse practitioners under this title based upon considerations including access and availability. After such consideration the commis- sioner is authorized to deem nurse practitioners as practitioners under this title] COMPLETES, AT A MINIMUM, A TWO HOUR COURSE AS DETERMINED BY THE COMMISSIONER. A PERSON'S STATUS AS A PRACTITIONER UNDER THIS TITLE IS DEEMED TO BE A "LICENSE" FOR PURPOSES OF SECTION THIRTY-THREE HUNDRED NINETY OF THIS ARTICLE. 19. "MEDICAL MARIHUANA RESEARCH PROGRAM" MEANS A MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-A OF THIS TITLE. § 2. Subdivisions 1, 2, and 9 of section 3361 of the public health law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and S. 5657 3 subdivision 9 as added by chapter 416 of the laws of 2015, are amended to read as follows: 1. A patient certification may only be issued if: (a) a practitioner has been registered with the department to issue a certification as determined by the commissioner; (b) the patient has a [serious] condi- tion, which shall be specified in the patient's health care record; (c) the practitioner by training or experience is qualified to treat the [serious] condition; (d) the patient is under the practitioner's contin- uing care for the [serious] condition; and (e) in the practitioner's professional opinion and review of past treatments, the patient is like- ly to receive therapeutic or palliative benefit from the primary or adjunctive treatment with medical use of marihuana for the [serious] condition. 2. The certification shall include (a) the name, date of birth and address of the patient; (b) a statement that the patient has a [serious] condition and the patient is under the practitioner's care for the [serious] condition; (c) a statement attesting that all requirements of subdivision one of this section have been satisfied; (d) the date; and (e) the name, address, federal registration number, telephone number, and the handwritten signature of the certifying practitioner. The commissioner may require by regulation that the certification shall be on a form provided by the department. The practitioner may state in the certification that, in the practitioner's professional opinion, the patient would benefit from medical marihuana only until a specified date. The practitioner may state in the certification that, in the prac- titioner's professional opinion, the patient is terminally ill and that the certification shall not expire until the patient dies. 9.(a) A certification may be a special certification if, in addition to the other requirements for a certification, the practitioner certi- fies in the certification that the patient's [serious] condition is progressive and degenerative or that delay in the patient's certified medical use of marihuana poses a serious risk to the patient's life or health. (b) The department shall create the form to be used for a special certification and shall make that form available to be downloaded from the department's website. § 3. Subdivisions 1 and 2 of section 3362 of the public health law, as added by chapter 90 of the laws of 2014, are amended and a new subdivi- sion 3 is added to read as follows: 1. The possession, acquisition, use, delivery, transfer, transporta- tion, or administration of medical marihuana by a certified patient or designated caregiver possessing a valid registry identification card, for certified medical use, shall be lawful under this title; provided that: (a) the marihuana that may be possessed by a certified patient shall not exceed a [thirty] SIXTY day supply of the dosage as determined by the practitioner, consistent with any guidance and regulations issued by the commissioner, provided that during the last seven days of any [thir- ty] SIXTY day period, the certified patient may also possess up to such amount for the next [thirty] SIXTY day period; (b) the marihuana that may be possessed by designated caregivers does not exceed the quantities referred to in paragraph (a) of this subdivi- sion for each certified patient for whom the caregiver possesses a valid registry identification card, up to five certified patients; (C) THE MARIHUANA THAT MAY BE POSSESSED BY DESIGNATED CAREGIVER FACIL- ITIES DOES NOT EXCEED THE QUANTITIES REFERRED TO IN PARAGRAPH (A) OF S. 5657 4 THIS SUBDIVISION FOR EACH CERTIFIED PATIENT UNDER CARE OR TREATMENT OF THE FACILITY; [(c)] (D) the form or forms of medical marihuana that may be possessed by the certified patient [or], designated caregiver, OR DESIGNATED CARE- GIVER FACILITY pursuant to a certification shall be in compliance with any recommendation or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient in the certification; and [(d)] (E) the medical marihuana shall be kept in the original package in which it was dispensed under subdivision twelve of section thirty- three hundred sixty-four of this title, except for the portion removed for immediate consumption for certified medical use by the certified patient. 2. Notwithstanding subdivision one of this section: (a) possession of medical marihuana shall not be lawful under this title if it is smoked, consumed, vaporized, or grown in a public place, regardless of the form of medical marihuana stated in the patient's certification. (b) a [person] CERTIFIED PATIENT OR DESIGNATED CAREGIVER possessing medical marihuana under this title shall possess his or her registry identification card at all times when in immediate possession of medical marihuana. (C) MEDICAL MARIHUANA MAY NOT BE SMOKED IN ANY PLACE WHERE TOBACCO MAY NOT BE SMOKED UNDER ARTICLE THIRTEEN-E OF THIS CHAPTER, REGARDLESS OF THE FORM OF MEDICAL MARIHUANA STATED IN THE PATIENT'S CERTIFICATION. 3. THE POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR ADMINISTRATION OF MEDICAL MARIHUANA BY A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE LAWFUL UNDER THIS TITLE PROVIDED THAT: (A) THE DESIGNATED CAREGIVER FACILITY REGISTERS WITH THE DEPARTMENT ON A FORM PROVIDED BY THE COMMISSIONER; (B) SUCH POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR ADMINISTRATION IS ON BEHALF OF A CERTIFIED PATIENT POSSESSING A REGISTRY IDENTIFICATION CARD; (C) THE DESIGNATED CAREGIVER FACILITY MAINTAINS A COPY OF THE REGISTRY IDENTIFICATION CARD OF EACH CERTIFIED PATIENT FOR WHICH IT POSSESSES, ACQUIRES, DELIVERS, TRANSFERS, TRANSPORTS, OR ADMINISTERS MEDICAL MARI- HUANA; AND (D) A DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE IDENTIFIED AS AN EMPLOYEE WHEN NECESSARY, AS PROVIDED BY THE COMMISSIONER. § 4. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health law, as added by chapter 90 of the laws of 2014, are amended to read as follows: 2. To obtain, amend or renew a registry identification card, a certi- fied patient or designated caregiver shall file a registry application with the department. The registry application or renewal application shall include: (a) in the case of a certified patient: (i) the patient's certification (a new written certification shall be provided with a renewal application); (ii) the name, address, and date of birth of the patient; (iii) the date of the certification; (iv) if the patient has a registry identification card based on a current valid certification, the registry identification number and expiration date of that registry identification card; S. 5657 5 (v) the specified date until which the patient would benefit from medical marihuana, if the certification states such a date; (vi) the name, address, federal registration number, and telephone number of the certifying practitioner; (vii) any recommendation or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient; and (viii) other individual identifying information required by the department; (b) (I) in the case of a certified patient, if the patient designates a designated caregiver, the name, address, and date of birth of the designated caregiver, and other individual identifying information required by the department; (II) IF THE DESIGNATED CAREGIVER IS A MEDICAL MARIHUANA RESEARCH PROGRAM, THE NAME OF THE ORGANIZATION CONDUCTING THE RESEARCH; THE ADDRESS, PHONE NUMBER, AND NAME OF THE INDIVIDUAL LEADING THE RESEARCH OR APPROPRIATE DESIGNEE; AND OTHER IDENTIFYING INFORMATION REQUIRED BY THE DEPARTMENT; (c) in the case of a designated caregiver: (i) the name, address, and date of birth of the designated caregiver; (ii) if the designated caregiver has a registry identification card, the registry identification number and expiration date of that registry identification card; and (iii) other individual identifying information required by the depart- ment; (d) a statement that a false statement made in the application is punishable under section 210.45 of the penal law; (e) the date of the application and the signature of the certified patient or designated caregiver, as the case may be; AND (f) [a fifty dollar application fee, provided, that the department may waive or reduce the fee in cases of financial hardship; and (g)] any other requirements determined by the commissioner. 3. Where a certified patient is under the age of eighteen: (a) The application for a registry identification card shall be made by an appropriate person over twenty-one years of age. The application shall state facts demonstrating that the person is appropriate. (b) The designated caregiver shall be (i) a parent or legal guardian of the certified patient, (ii) a person designated by a parent or legal guardian, [or] (iii) IN THE CASE OF SUCH A CERTIFIED PATIENT BEING CARED FOR BY A DESIGNATED CAREGIVER FACILITY, THE DESIGNATED CAREGIVER FACILI- TY DESIGNATED BY THE PARENT OR LEGAL GUARDIAN; OR (IV) an appropriate person approved by the department upon a sufficient showing that no parent or legal guardian is appropriate or available. 5. No person may be a designated caregiver for more than five certi- fied patients at one time; PROVIDED HOWEVER THAT THIS LIMITATION SHALL NOT APPLY TO A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE. 11. A certified patient or designated caregiver who has been issued a registry identification card shall notify the department of any change in his or her name or address or, with respect to the patient, if he or she ceases to have the [serious] condition noted on the certification within ten days of such change. The certified patient's or designated caregiver's registry identification card shall be deemed invalid and shall be returned promptly to the department. S. 5657 6 § 5. Subdivisions 3 and 5 of section 3364 of the public health law, as added by chapter 90 of the laws of 2014, are amended and a new subdivi- sion 14 is added to read as follows: 3. Each registered organization shall contract with an independent laboratory PERMITTED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-C OF THIS CHAPTER to test the medical marihuana produced by the registered organization. The commissioner shall approve the laboratory and require that the laboratory report testing results in a manner determined by the commissioner. The commissioner is authorized to issue regulation requir- ing the laboratory to perform certain tests and services. 5. (a) No registered organization may sell, deliver, distribute or dispense to any certified patient or designated caregiver a quantity of medical marihuana larger than that individual would be allowed to possess under this title. (b) When dispensing medical marihuana to a certified patient or desig- nated caregiver, the registered organization (i) shall not dispense an amount greater than a [thirty] SIXTY day supply to a certified patient until the certified patient has exhausted all but a seven day supply provided pursuant to a previously issued certification, and (ii) shall verify the information in subparagraph (i) of this paragraph by consult- ing the prescription monitoring program registry under section thirty- three hundred forty-three-a of this article. (c) Medical marihuana dispensed to a certified patient or designated caregiver by a registered organization shall conform to any recommenda- tion or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient. 14. A REGISTERED ORGANIZATION MAY CONTRACT WITH A PERSON OR ENTITY TO PROVIDE FACILITIES, EQUIPMENT OR SERVICES THAT ARE ANCILLARY TO THE REGISTERED ORGANIZATION'S FUNCTIONS OR ACTIVITIES UNDER THIS SECTION (INCLUDING, BUT NOT LIMITED TO, SHIPPING, MAINTENANCE, CONSTRUCTION, REPAIR, AND SECURITY). ALL LAWS AND REGULATIONS APPLICABLE TO SUCH FACILITIES, EQUIPMENT, OR SERVICES SHALL APPLY TO THE CONTRACT. THE REGISTERED ORGANIZATION AND OTHER PARTIES TO THE CONTRACT SHALL EACH BE RESPONSIBLE FOR COMPLIANCE WITH SUCH LAWS AND REGULATIONS UNDER THE CONTRACT. THE COMMISSIONER MAY MAKE REGULATIONS CONSISTENT WITH THIS TITLE RELATING TO CONTRACTS AND PARTIES TO CONTRACTS UNDER THIS SUBDIVI- SION. § 6. The public health law is amended by adding a new section 3364-a to read as follows: § 3364-A. MEDICAL MARIHUANA RESEARCH LICENSES. 1. THE COMMISSIONER SHALL ESTABLISH A MEDICAL MARIHUANA RESEARCH LICENSE THAT PERMITS A LICENSEE TO PRODUCE, PROCESS, PURCHASE, POSSESS, TRANSFER, AND SELL MARIHUANA, SUBJECT TO THIS SECTION, FOR THE FOLLOWING LIMITED RESEARCH PURPOSES: (A) TO TEST CHEMICAL POTENCY AND COMPOSITION LEVELS; (B) TO CONDUCT CLINICAL INVESTIGATIONS OF MARIHUANA-DERIVED PRODUCTS; (C) TO CONDUCT RESEARCH ON THE EFFICACY AND SAFETY OF ADMINISTERING MARIHUANA AS PART OF MEDICAL TREATMENT; OR (D) TO CONDUCT GENOMIC OR AGRICULTURAL RESEARCH RELATING TO MEDICAL MARIHUANA. 2. AS PART OF THE APPLICATION PROCESS FOR A MEDICAL MARIHUANA RESEARCH LICENSE, AN APPLICANT MUST SUBMIT TO THE COMMISSIONER A DESCRIPTION OF THE RESEARCH THAT IS INTENDED TO BE CONDUCTED AS WELL AS THE AMOUNT OF MARIHUANA TO BE GROWN OR PURCHASED. THE COMMISSIONER SHALL REVIEW AN APPLICANT'S RESEARCH PROJECT AND DETERMINE WHETHER IT MEETS THE REQUIRE- S. 5657 7 MENTS OF SUBDIVISION ONE OF THIS SECTION. IN ADDITION, THE COMMISSIONER SHALL ASSESS THE APPLICATION BASED ON THE FOLLOWING CRITERIA: (A) PROJECT QUALITY, STUDY DESIGN, VALUE, AND IMPACT; (B) WHETHER THE APPLICANT HAS THE APPROPRIATE PERSONNEL, EXPERTISE, FACILITIES AND INFRASTRUCTURE, FUNDING, AND (TO THE EXTENT LEGALLY AVAILABLE) APPROVALS RELATING TO HUMAN OR ANIMAL RESEARCH, IN PLACE TO SUCCESSFULLY CONDUCT THE PROJECT; AND (C) WHETHER THE AMOUNT OF MARIHUANA TO BE GROWN OR PURCHASED BY THE APPLICANT IS CONSISTENT WITH THE PROJECT'S SCOPE AND GOALS. 3. IF THE COMMISSIONER DETERMINES THAT THE RESEARCH PROJECT MEETS THE REQUIREMENTS OF SUBDIVISION ONE OF THIS SECTION, THE COMMISSIONER MAY APPROVE THE APPLICATION. IF NOT, THE APPLICATION SHALL BE DENIED. 4. A MEDICAL MARIHUANA RESEARCH LICENSEE MAY ONLY SELL OR TRANSFER MARIHUANA GROWN OR PRODUCED WITHIN ITS OPERATION TO OTHER MEDICAL MARI- HUANA RESEARCH LICENSEES, OR OTHERWISE FOR PURPOSES OF THE LICENSEE'S RESEARCH. 5. IN ESTABLISHING A MEDICAL MARIHUANA RESEARCH LICENSE, THE COMMIS- SIONER MAY MAKE REGULATIONS ON THE FOLLOWING: (A) APPLICATION REQUIREMENTS; (B) LICENSE RENEWAL REQUIREMENTS, INCLUDING WHETHER ADDITIONAL RESEARCH PROJECTS MAY BE ADDED OR CONSIDERED; (C) CONDITIONS FOR LICENSE REVOCATION; (D) SECURITY MEASURES TO ENSURE MARIHUANA IS NOT DIVERTED TO PURPOSES OTHER THAN RESEARCH; (E) AMOUNT OF PLANTS, USEABLE MARIHUANA, MARIHUANA CONCENTRATES, OR MARIHUANA-INFUSED PRODUCTS A LICENSEE MAY HAVE ON ITS PREMISES; (F) LICENSEE REPORTING REQUIREMENTS; (G) CONDITIONS UNDER WHICH MARIHUANA GROWN BY LICENSED MEDICAL MARI- HUANA PRODUCERS AND OTHER PRODUCT TYPES FROM LICENSED MEDICAL MARIHUANA PROCESSORS MAY BE DONATED TO MEDICAL MARIHUANA RESEARCH LICENSEES; AND (H) ANY ADDITIONAL REQUIREMENTS DEEMED NECESSARY BY THE COMMISSIONER. 6. A MARIHUANA RESEARCH LICENSE ISSUED UNDER THIS SECTION SHALL BE ISSUED IN THE NAME OF THE APPLICANT OR APPLICANTS, SPECIFY THE LOCATION AT WHICH THE MARIHUANA RESEARCHER INTENDS TO OPERATE, WHICH SHALL BE WITHIN THE STATE, AND SHALL NOT ALLOW ANY OTHER PERSON TO USE THE LICENSE EXCEPT AS UNDER SUBDIVISION FOUR OF THIS SECTION. 7. PARTICIPATION BY CERTIFIED PATIENTS IN ANY MEDICAL MARIHUANA RESEARCH PROGRAM SHALL BE VOLUNTARY. 8. THE APPLICATION FEE FOR A MEDICAL MARIHUANA RESEARCH LICENSE SHALL BE DETERMINED BY THE COMMISSIONER ON AN ANNUAL BASIS. 9. EACH MEDICAL MARIHUANA RESEARCH LICENSEE SHALL ISSUE AN ANNUAL REPORT TO THE COMMISSIONER. THE COMMISSIONER SHALL REVIEW SUCH REPORT AND MAKE A DETERMINATION AS TO WHETHER THE RESEARCH PROJECT CONTINUES TO MEET THE RESEARCH QUALIFICATIONS UNDER THIS SECTION. § 7. The public health law is amended by adding a new section 3364-b to read as follows: § 3364-B. REGISTRATION OF DESIGNATED CAREGIVER FACILITIES. 1. TO OBTAIN, AMEND OR RENEW A REGISTRATION AS A DESIGNATED CAREGIVER FACILI- TY, THE FACILITY SHALL FILE AN APPLICATION WITH THE COMMISSIONER. THE APPLICATION SHALL INCLUDE: (A) THE FACILITY'S FULL NAME AND ADDRESS; (B) OPERATING CERTIFICATE OR LICENSE NUMBER WHERE APPROPRIATE; (C) NAME, TITLE, AND SIGNATURE OF AN AUTHORIZED FACILITY REPRESEN- TATIVE; (D) A STATEMENT THAT THE FACILITY AGREES TO SECURE AND ENSURE PROPER HANDLING OF ALL MEDICAL MARIHUANA PRODUCTS; S. 5657 8 (E) AN ACKNOWLEDGEMENT THAT A FALSE STATEMENT IN THE APPLICATION IS PUNISHABLE UNDER SECTION 210.45 OF THE PENAL LAW; AND (F) ANY OTHER INFORMATION THAT MAY BE REQUIRED BY THE COMMISSIONER. 2. PRIOR TO ISSUING OR RENEWING A DESIGNATED CAREGIVER FACILITY REGIS- TRATION, THE COMMISSIONER MAY VERIFY THE INFORMATION SUBMITTED BY THE APPLICANT. THE APPLICANT SHALL PROVIDE, AT THE COMMISSIONER'S REQUEST, SUCH INFORMATION AND DOCUMENTATION, INCLUDING ANY CONSENTS OR AUTHORI- ZATIONS, THAT MAY BE NECESSARY FOR THE COMMISSIONER TO VERIFY THE INFOR- MATION. 3. THE APPLICATION SHALL BE APPROVED, DENIED OR DETERMINED INCOMPLETE OR INACCURATE BY THE COMMISSIONER WITHIN THIRTY DAYS OF RECEIPT OF THE APPLICATION. IF THE APPLICATION IS APPROVED, THE COMMISSIONER SHALL ISSUE A REGISTRATION AS SOON AS IS REASONABLY PRACTICABLE. 4. REGISTRATIONS UNDER THIS SECTION SHALL REMAIN VALID FOR TWO YEARS FROM THE DATE OF ISSUANCE. § 8. The public health law is amended by adding a new section 3364-c to read as follows: § 3364-C. LABORATORY PERMITS. 1. THE COMMISSIONER SHALL APPROVE AND PERMIT ONE OR MORE INDEPENDENT LABORATORIES TO TEST MEDICAL MARIHUANA. TO BE PERMITTED AS AN INDEPENDENT LABORATORY UNDER THIS SECTION, A LABO- RATORY MUST APPLY TO THE DEPARTMENT IN A FORM AND MANNER PRESCRIBED BY THE COMMISSIONER AND MUST DEMONSTRATE THE FOLLOWING TO THE SATISFACTION OF THE COMMISSIONER: (A) THE OWNERS AND DIRECTORS OF THE LABORATORY ARE OF GOOD MORAL CHAR- ACTER; (B) THE LABORATORY AND ITS STAFF HAVE THE SKILLS, RESOURCES, AND EXPERTISE NEEDED TO ACCURATELY AND CONSISTENTLY PERFORM ALL TESTING REQUIRED; (C) THE LABORATORY HAS IN PLACE AND WILL MAINTAIN ADEQUATE POLICIES, PROCEDURES, AND FACILITY SECURITY TO ENSURE PROPER COLLECTION, LABELING, ACCESSIONING, PREPARATION, ANALYSIS, RESULT REPORTING, DISPOSAL, AND STORAGE OF MEDICAL MARIHUANA; (D) THE LABORATORY IS PHYSICALLY LOCATED IN NEW YORK STATE; (E) THE LABORATORY HAS A CERTIFICATE OF APPROVAL AS AN ENVIRONMENTAL LABORATORY ISSUED BY THE COMMISSIONER UNDER TITLE ONE OF ARTICLE FIVE OF THIS CHAPTER; AND (F) THE LABORATORY MEETS ALL REQUIREMENTS PRESCRIBED BY THIS CHAPTER AND THE COMMISSIONER IN REGULATION. 2. THE OWNER OF AN INDEPENDENT LABORATORY PERMITTED UNDER THIS SECTION SHALL NOT HOLD A REGISTRATION AS A REGISTERED ORGANIZATION AND SHALL NOT HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH REGISTERED ORGAN- IZATION. NO BOARD MEMBER, MANAGER, OWNER, PARTNER, PRINCIPAL STAKEHOLD- ER, OR MEMBER OF A REGISTERED ORGANIZATION, OR SUCH PERSON'S IMMEDIATE FAMILY, SHALL HAVE AN INTEREST OR VOTING RIGHTS IN ANY INDEPENDENT LABO- RATORY PERMITTEE. NO REGISTERED ORGANIZATION SHALL HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH LABORATORY. 3. AN INDEPENDENT LABORATORY SHALL NOT BE REQUIRED TO BE LICENSED BY THE FEDERAL DRUG ENFORCEMENT ADMINISTRATION. § 9. Subdivision 9 of section 3365 of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: 9. [The commissioner shall register no more than five] A registered [organizations] ORGANIZATION that [manufacture] MANUFACTURES medical marihuana [with] MAY HAVE no more than [four] EIGHT dispensing sites wholly owned and operated by [such] THE registered organization. The commissioner shall ensure that such [registered organizations and] dispensing sites are geographically distributed across the state. The S. 5657 9 commission [may] SHALL register additional registered organizations REFLECTING THE DEMOGRAPHICS OF THE STATE. § 10. Subdivision 1 of section 3365-a of the public health law, as added by chapter 416 of the laws of 2015, is amended to read as follows: 1. There is hereby established in the department an emergency medical marihuana access program (referred to in this section as the "program") under this section. The purpose of the program is to expedite the avail- ability of medical marihuana to avoid suffering and loss of life, during the period before full implementation of and production under this title, especially in the case of patients whose [serious] condition is progressive and degenerative or is such that delay in the patient's medical use of marihuana poses a serious risk to the patient's life or health. The commissioner shall implement the program as expeditiously as practicable, including by emergency regulation. § 11. Subdivision 1 of section 3369 of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: 1. Certified patients, designated caregivers, DESIGNATED CAREGIVER FACILITIES, DESIGNATED CAREGIVER FACILITY EMPLOYEES, MEDICAL MARIHUANA RESEARCH PROGRAM EMPLOYEES, practitioners, registered organizations and the employees of registered organizations shall not be subject to arrest, prosecution, or penalty in any manner, or denied any right or privilege, including but not limited to civil penalty or disciplinary action by a business or occupational or professional licensing board or bureau, solely for the certified medical use or manufacture of marihua- na, or for any other action or conduct in accordance with this title. § 12. Section 3369-d of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the price determined by the commissioner. Every charge made or demanded for medical marihuana not in accordance with the price determined by the commissioner, is prohibited. 2. The commissioner is hereby authorized to set the per dose price of each form of medical marihuana sold by any registered organization. In setting the per dose price of each form of medical marihuana, the commissioner shall consider the fixed and variable costs of producing the form of marihuana and any other factor the commissioner, in his or her discretion, deems relevant to determining the per dose price of each form of medical marihuana.] REGISTERED ORGANIZATIONS SHALL SUBMIT DOCUMENTATION OF ANY PRICE AND CHANGE IN PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PRODUCT TO THE COMMISSIONER WITHIN FIFTEEN DAYS OF SETTING OR CHANGING THE PRICE. PRIOR APPROVAL BY THE COMMISSIONER SHALL NOT BE REQUIRED FOR ANY PRICE OR CHANGE OF PRICE. HOWEVER, THE COMMISSIONER IS AUTHORIZED TO MODIFY THE PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PROD- UCT IF NECESSARY TO MAINTAIN PUBLIC ACCESS TO APPROPRIATE MEDICATION. § 13. This act shall take effect immediately; provided, however, that the amendments to title 5-A of article 33 of the public health law made by sections one, two, three, four, five, six, seven, eight, nine, ten, eleven and twelve of this act shall not affect the repeal of such title and shall be deemed repealed therewith. Effective immediately, the addi- tion, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized to be made and completed on or before such effective date.
2019-S5657A - Details
- Current Committee:
- Senate Finance
- Law Section:
- Public Health Law
- Laws Affected:
- Amd Pub Health L, generally
2019-S5657A - Summary
Provides that medical marihuana may be used as part of the treatment of a patient's condition and removes the "serious" designation of such condition; provides that a practitioner be authorized to prescribe controlled substances in the state and removes the requirement that a physician prescribe such medical marihuana; increases the supply amount of marihuana from thirty to sixty days; allows a designated caregiver facility or designated caregiver facility employee to possess, acquire, deliver, transfer, transport or administer medical marihuana
2019-S5657A - Sponsor Memo
BILL NUMBER: S5657A SPONSOR: SAVINO TITLE OF BILL: An act to amend the public health law, in relation to medical marihuana PURPOSE OR GENERAL IDEA OF BILL: THIS BILL ADDRESSES SEVERAL PROBLEMS WITH THE MEDICAL MARIJUANA PROGRAM. THIS BILL CONSOLIDATES SEVERAL PROPOSALS FROM OTHER BILLS, AS WELL AS CHANGES TO THE MEDICAL PROGRAM PROPOSED IN THE 2019 EXECUTIVE BUDGET'S CANNABIS REGULATION AND TAXATION ACT (CRTA). SUMMARY OF SPECIFIC PROVISIONS: Section 1: Amends PHL § 3360 to: * Expand eligible conditions to include any condition certified by the practitioner;
* Allow any practitioner otherwise authorized to prescribe controlled substances to certify patients for medical marijuana; * Remove prohibitions on the smoking of medical marijuana; and * Create the categories of "designated caregiver facility," "designated caregiver facility employee," and "medical marihuana research program." Section 2: Amends PHI § 3361 to make conforming changes. Section 3: Amends PHL § 3362 to: * Change possession limits from a 30 day to a 60 day supply; * Authorize possession, acquisition, delivery, transfer, and adminis- tration of medical marijuana by designated caregiver facilities and their employees subject to certain requirements; and * Prohibit smoking of medical marijuana in any place where tobacco may not be smoked under the Clean Indoor Air Act. Section 4: Amends PHL § 3363 to: * Remove the $50 patient application fee for registry ID cards; * Remove patient-per-caregiver limits when the caregiver is a designated caregiver facility; and * Make conforming changes Section 5: Amends PHL . 3364 to: * Authorize registered organizations (ROs) to contract out ancillary functions such as shipping, construction, and security; and * Make conforming changes Section 6: Creates a new PHL § 3364-a, "medical marihuana research licenses," to: * Establish a medical marijuana research license for purposes of test- ing, clinical investigations, and safety and efficacy or genomic or agricultural research relating to medical marijuana; and *Details appli- cation, licensing, and oversight process. Section 7: Creates a new PHL § 3364-b, "registration of designated care- giver facilities," to: * Establishes registration process for "designated caregiver facilities" among provider types defined in section 1 of the bill; and * Details application, registration, and oversight process. Section 8: Creates a new PHL § 3364-c, "laboratory permits," to: * Detail application, permitting, and oversight process. Section 9: Amends PHL § 3365 to: * Increase dispensaries per RO from 4 to 8; and * Direct the Commissioner to register additional ROs reflecting the demographics of the state. Section 10: Amends PHL § 3365-a to make conforming changes. Section 11: Amends PHL § 3369 to make conforming changes. Section 12: Amends PHL § 3369-d to remove prior approval of medical marijuana prices; maintain requirement for ROs to document price chang- es; and maintain the commissioner's power to modify prices if necessary to maintain access. Section 13: Effective date. JUSTIFICATION: Open conditions list: There is no pharmaceutical other than medical marijuana for which the State restricts its use to a limited list of conditions. Setting a conditions list in statute takes medical decisions out of the hands of the practitioners who know their patients best and whose judgment the law respects for much more dangerous drugs. Practi- tioners also lack clarity about which conditions are actually covered. For example, the Public Health Law definition of "severe or chronic pain" is inconsistent with regulatory language for "severe debilitating pain that degrades health and functional capability." This bill would maintain the naming of several conditions in statute for illustrative purposes, including some added in the Governor's 2019 Cannabis Regulation and Taxation Act (CRTA), but also allows "any other condition certified by the practitioner." While the d rafting is differ- ent, the effect is the same as S2058 of 2019. Expanded practitioner list: Today, physicians, physician assistants, and nurse practitioners can certify patients. However, there are other cate- gories of practitioner outside these who are authorized to prescribe much more dangerous substances and often treat conditions for which a patient may be eligible (such as podiatrists and dentists whose treat- ments involve pain medication.) This bill expands the practitioner cate- gories to cover these groups, similar to S2056 of 2019. Strike patient registry fees; increase supply from 30 to 60 days: Current law requires a $50 application fee for registry identification cards and limits patients to a 30-day supply. While the application fee is often waived, it presents a barrier to access that does not exist for patients with any other pharmaceutical product. Current law also limits patients to acquiring 30-day supplies at once distances, this limits access. The 2019 Executive budget proposed Cannabis Regulation and Taxa- tion Act (CRTA) included both of these changes. Allow smoking: For some patients, smoking is the most affordable deliv- ery method and enable them to effectively limit dosage. Out of over 30 states that now have medical marijuana programs, only 4 disallow smoking as New York does. While smoking can involve respiratory or other issues, the quantities involved in medical marijuana use are very limited, and should be a matter between patient and practitioner. This legislation would protect the public by making medical marihuana smoking subject to the Clean Indoor Air Act restrictions, similar to S490 of 2019. Facility caregivers: Current law allows patients to designate up to two people as caregivers under the program. Caregivers are capped at five patients each. These caps have caused problems administering medical marijuana in residential facilities or hospitals where there may be more than five patients using medical marijuana for a given caregiver, or where a patient may see more than two potential caregiver personnel (e.g., nurses) on a regular basis. This bill authorizes, but does not mandate, certain facilities to become "designated care giver facili- ties," exempting them from such restrictions, similar to 52059 of 2019 and language in the CRTA. Research licenses: While there is significant research, being done over- seas, medical marijuana research in the United States is limited. This bill would facilitate medical marijuana research in New York based on departmental regulations. Both S2059 of 2019 and the CRTA also authorize research licenses. Expanded lab testing: Today, the State's Wadsworth Laboratory is the only lab authorized to test medical marijuana. As the program expands, more lab capacity is needed. Commercial labs with Drug Enforcement Agen- cy (DEA) licenses may be reluctant to test medical marijuana out of fear of endangering these DEA licenses. This bill removes the requirement that a lab which tests medical marijuana hold a DEA license and details State permitting of labs for medical marijuana testing, similar to both S2059 of 2019 and the CRTA. RO contracting: Registered organizations (R0s) are currently not allowed to contract out any part of the production and distribution processes. This is contrary to standard business practice, is inefficient and rais- es costs. This bill allows ROs to contract out ancillary functions, such as security or transportation, while ensuring that laws applicable to the RO for the purpose of those services would apply to the contractors as well and excluding certain service s directly related to the manufac- turing process (such as trimming). This is similar to both 52059 of 2019 and the CRTA. Increased dispensaries and ROs: Current law authorizes up to four dispensaries for each of the 10 ROs that engages in manufacturing. This places New York far below every other state medical marijuana programs for dispensary access per population. For comparison, New York has approximately 500,000 people per dispensary versus 233,000 to 1 in Illi- nois; 192,000 in Michigan, and 70,000 in Florida. This bill would double the number from 4 to 8 per RO. The bill also directs the commissioner to register additional ROs "reflecting the demographics of the state." While current law does authorize the registration of additional ROs, this explicit direction signals the importance of greater minority and women-owned participation in the medical marijuana program. The dispen- sary expansion is also found in S2059 of 2019. Modifying price controls: Current law authorizes price setting by the commissioner and prohibits any sale not in accordance with such prices. In practice, ROs submit prices and price changes to the department for approval. Since enactment, not one price setting or proposed change has ever been rejected. But it takes weeks or even months for ROs to get approvals, during which time they either cannot roll out new products or cannot sell existing products at their new, typically lower prices (nearly all price changes are downward changes; maintains reporting of all price changes to the department; and maintains the commissioner's authority to reject or modify prices if necessary to maintain access. PRIOR LEGISLATIVE HISTORY: New bill FISCAL IMPLICATIONS: Minimal. Minor reduction in patient registration fees ($50 each); likely revenue increase from licensing of additional ROs and fees associated with new license categories. EFFECTIVE DATE: Immediate.
2019-S5657A - Bill Text download pdf
S T A T E O F N E W Y O R K ________________________________________________________________________ 5657--A 2019-2020 Regular Sessions I N S E N A T E May 10, 2019 ___________ Introduced by Sen. SAVINO -- read twice and ordered printed, and when printed to be committed to the Committee on Health -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee AN ACT to amend the public health law, in relation to medical marihuana THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. Subdivisions 1, 5, 7 and 12 of section 3360 of the public health law, subdivisions 1, 5, 7 and 12 as added by chapter 90 of the laws of 2014, paragraph (a) of subdivision 7 as amended by chapter 273 of the laws of 2018, are amended and three new subdivisions 5-a, 5-b and 19 are added to read as follows: 1. "Certified medical use" means the acquisition, possession, use, or, transportation of medical marihuana by a certified patient, or the acquisition, possession, delivery, transportation or administration of medical marihuana by a designated caregiver, for use as part of the treatment of the patient's [serious] condition, as authorized in a certification under this title including enabling the patient to toler- ate treatment for the [serious] condition. [A certified medical use does not include smoking.] 5. "Designated caregiver" means the individual OR CAREGIVER FACILITY designated by a certified patient in a registry application. A certified patient may designate up to two designated caregivers, NOT COUNTING A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE. 5-A. "DESIGNATED CAREGIVER FACILITY" MEANS AN ENTITY THAT REGISTERS WITH THE COMMISSIONER TO ASSIST ONE OR MORE CERTIFIED PATIENTS WITH THE ACQUISITION, POSSESSION, DELIVERY, TRANSPORTATION OR ADMINISTRATION OF MEDICAL MARIHUANA AND IS: A GENERAL HOSPITAL OR RESIDENTIAL HEALTH CARE FACILITY OPERATING UNDER ARTICLE TWENTY-EIGHT OF THIS CHAPTER; AN ADULT CARE FACILITY OPERATING UNDER TITLE TWO OF ARTICLE SEVEN OF THE SOCIAL SERVICES LAW; A COMMUNITY MENTAL HEALTH RESIDENCE ESTABLISHED UNDER SECTION 41.44 OF THE MENTAL HYGIENE LAW; A HOSPITAL OPERATING UNDER SECTION 7.17 OF THE MENTAL HYGIENE LAW; A MENTAL HYGIENE FACILITY OPER- ATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW; AN INPATIENT
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD11129-05-9 S. 5657--A 2 OR RESIDENTIAL TREATMENT PROGRAM CERTIFIED UNDER ARTICLE THIRTY-TWO OF THE MENTAL HYGIENE LAW; A RESIDENTIAL FACILITY FOR THE CARE AND TREAT- MENT OF PERSONS WITH DEVELOPMENTAL DISABILITIES OPERATING UNDER ARTICLE SIXTEEN OF THE MENTAL HYGIENE LAW; A RESIDENTIAL TREATMENT FACILITY FOR CHILDREN AND YOUTH OPERATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW; A PUBLIC SCHOOL OR PRIVATE SCHOOL OPERATING UNDER THE EDUCATION LAW; A RESEARCH INSTITUTION WITH AN INTERNAL REVIEW BOARD; A MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-A OF THIS TITLE; OR ANY OTHER FACILITY AS DETERMINED BY THE COMMISSIONER IN REGULATION. 5-B. "DESIGNATED CAREGIVER FACILITY EMPLOYEE" MEANS AN EMPLOYEE OF A DESIGNATED CAREGIVER FACILITY. 7. (a) ["Serious condition"] "CONDITION" means: (i) having one of the following [severe debilitating or life-threaten- ing] conditions: cancer, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, amyotrophic lateral scler- osis, Parkinson's disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, inflammatory bowel disease, neuropa- thies, Huntington's disease, post-traumatic stress disorder, pain that degrades health and functional capability where the use of medical mari- huana is an alternative to opioid use, substance use disorder, ALZHEIMER'S, MUSCULAR DYSTROPHY, DYSTONIA, RHEUMATOID ARTHRITIS, AUTISM, or [as added by the commissioner; and (ii) any of the following conditions where it is clinically associated with, or a complication of, a condition under this paragraph or its treatment: cachexia or wasting syndrome; severe or chronic pain; severe nausea; seizures; severe or persistent muscle spasms; or such conditions as are added by the commissioner. (b) No later than eighteen months from the effective date of this section, the commissioner shall determine whether to add the following serious conditions: Alzheimer's, muscular dystrophy, dystonia, post- traumatic stress disorder and rheumatoid arthritis] ANY OTHER CONDITION CERTIFIED BY THE PRACTITIONER. 12. "Practitioner" means a practitioner who (i) [is a physician licensed by New York state and practicing within the state,] IS AUTHOR- IZED TO PRESCRIBE CONTROLLED SUBSTANCES WITHIN THE STATE; (ii) [who] by training or experience is qualified to treat a [serious] condition as defined in subdivision seven of this section; and (iii) [has completed a two to four hour course as determined by the commissioner in regulation and registered with the department; provided however, a registration shall not be denied without cause. Such course may count toward board certification requirements. The commissioner shall consider the inclu- sion of nurse practitioners under this title based upon considerations including access and availability. After such consideration the commis- sioner is authorized to deem nurse practitioners as practitioners under this title] COMPLETES, AT A MINIMUM, A TWO HOUR COURSE AS DETERMINED BY THE COMMISSIONER. A PERSON'S STATUS AS A PRACTITIONER UNDER THIS TITLE IS DEEMED TO BE A "LICENSE" FOR PURPOSES OF SECTION THIRTY-THREE HUNDRED NINETY OF THIS ARTICLE. 19. "MEDICAL MARIHUANA RESEARCH PROGRAM" MEANS A MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-A OF THIS TITLE. § 2. Subdivisions 1, 2, and 9 of section 3361 of the public health law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and S. 5657--A 3 subdivision 9 as added by chapter 416 of the laws of 2015, are amended to read as follows: 1. A patient certification may only be issued if: (a) a practitioner has been registered with the department to issue a certification as determined by the commissioner; (b) the patient has a [serious] condi- tion, which shall be specified in the patient's health care record; (c) the practitioner by training or experience is qualified to treat the [serious] condition; (d) the patient is under the practitioner's contin- uing care for the [serious] condition; and (e) in the practitioner's professional opinion and review of past treatments, the patient is like- ly to receive therapeutic or palliative benefit from the primary or adjunctive treatment with medical use of marihuana for the [serious] condition. 2. The certification shall include (a) the name, date of birth and address of the patient; (b) a statement that the patient has a [serious] condition and the patient is under the practitioner's care for the [serious] condition; (c) a statement attesting that all requirements of subdivision one of this section have been satisfied; (d) the date; and (e) the name, address, federal registration number, telephone number, and the handwritten signature of the certifying practitioner. The commissioner may require by regulation that the certification shall be on a form provided by the department. The practitioner may state in the certification that, in the practitioner's professional opinion, the patient would benefit from medical marihuana only until a specified date. The practitioner may state in the certification that, in the prac- titioner's professional opinion, the patient is terminally ill and that the certification shall not expire until the patient dies. 9.(a) A certification may be a special certification if, in addition to the other requirements for a certification, the practitioner certi- fies in the certification that the patient's [serious] condition is progressive and degenerative or that delay in the patient's certified medical use of marihuana poses a serious risk to the patient's life or health. (b) The department shall create the form to be used for a special certification and shall make that form available to be downloaded from the department's website. § 3. Subdivisions 1 and 2 of section 3362 of the public health law, as added by chapter 90 of the laws of 2014, are amended and a new subdivi- sion 3 is added to read as follows: 1. The possession, acquisition, use, delivery, transfer, transporta- tion, or administration of medical marihuana by a certified patient or designated caregiver possessing a valid registry identification card, for certified medical use, shall be lawful under this title; provided that: (a) the marihuana that may be possessed by a certified patient shall not exceed a [thirty] SIXTY day supply of the dosage as determined by the practitioner, consistent with any guidance and regulations issued by the commissioner, provided that during the last seven days of any [thir- ty] SIXTY day period, the certified patient may also possess up to such amount for the next [thirty] SIXTY day period; (b) the marihuana that may be possessed by designated caregivers does not exceed the quantities referred to in paragraph (a) of this subdivi- sion for each certified patient for whom the caregiver possesses a valid registry identification card, up to five certified patients; (c) THE MARIHUANA THAT MAY BE POSSESSED BY DESIGNATED CAREGIVER FACIL- ITIES DOES NOT EXCEED THE QUANTITIES REFERRED TO IN PARAGRAPH (A) OF S. 5657--A 4 THIS SUBDIVISION FOR EACH CERTIFIED PATIENT UNDER CARE OR TREATMENT OF THE FACILITY; (D) the form or forms of medical marihuana that may be possessed by the certified patient [or], designated caregiver, OR DESIGNATED CAREGIV- ER FACILITY pursuant to a certification shall be in compliance with any recommendation or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient in the certif- ication; and [(d)] (E) the medical marihuana shall be kept in the original package in which it was dispensed under subdivision twelve of section thirty- three hundred sixty-four of this title, except for the portion removed for immediate consumption for certified medical use by the certified patient. 2. Notwithstanding subdivision one of this section: (a) possession of medical marihuana shall not be lawful under this title if it is smoked, consumed, vaporized, or grown in a public place, regardless of the form of medical marihuana stated in the patient's certification. (b) a [person] CERTIFIED PATIENT OR DESIGNATED CAREGIVER possessing medical marihuana under this title shall possess his or her registry identification card at all times when in immediate possession of medical marihuana. (C) MEDICAL MARIHUANA MAY NOT BE SMOKED IN ANY PLACE WHERE TOBACCO MAY NOT BE SMOKED UNDER ARTICLE THIRTEEN-E OF THIS CHAPTER, REGARDLESS OF THE FORM OF MEDICAL MARIHUANA STATED IN THE PATIENT'S CERTIFICATION. 3. THE POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR ADMINISTRATION OF MEDICAL MARIHUANA BY A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE LAWFUL UNDER THIS TITLE PROVIDED THAT: (A) THE DESIGNATED CAREGIVER FACILITY REGISTERS WITH THE DEPARTMENT ON A FORM PROVIDED BY THE COMMISSIONER; (B) SUCH POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR ADMINISTRATION IS ON BEHALF OF A CERTIFIED PATIENT POSSESSING A REGISTRY IDENTIFICATION CARD; (C) THE DESIGNATED CAREGIVER FACILITY MAINTAINS A COPY OF THE REGISTRY IDENTIFICATION CARD OF EACH CERTIFIED PATIENT FOR WHICH IT POSSESSES, ACQUIRES, DELIVERS, TRANSFERS, TRANSPORTS, OR ADMINISTERS MEDICAL MARI- HUANA; AND (D) A DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE IDENTIFIED AS AN EMPLOYEE WHEN NECESSARY, AS PROVIDED BY THE COMMISSIONER. § 4. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health law, as added by chapter 90 of the laws of 2014, are amended to read as follows: 2. To obtain, amend or renew a registry identification card, a certi- fied patient or designated caregiver shall file a registry application with the department. The registry application or renewal application shall include: (a) in the case of a certified patient: (i) the patient's certification (a new written certification shall be provided with a renewal application); (ii) the name, address, and date of birth of the patient; (iii) the date of the certification; (iv) if the patient has a registry identification card based on a current valid certification, the registry identification number and expiration date of that registry identification card; S. 5657--A 5 (v) the specified date until which the patient would benefit from medical marihuana, if the certification states such a date; (vi) the name, address, federal registration number, and telephone number of the certifying practitioner; (vii) any recommendation or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient; and (viii) other individual identifying information required by the department; (b) (I) in the case of a certified patient, if the patient designates a designated caregiver, the name, address, and date of birth of the designated caregiver, and other individual identifying information required by the department; (II) IF THE DESIGNATED CAREGIVER IS A MEDICAL MARIHUANA RESEARCH PROGRAM, THE NAME OF THE ORGANIZATION CONDUCTING THE RESEARCH; THE ADDRESS, PHONE NUMBER, AND NAME OF THE INDIVIDUAL LEADING THE RESEARCH OR APPROPRIATE DESIGNEE; AND OTHER IDENTIFYING INFORMATION REQUIRED BY THE DEPARTMENT; (c) in the case of a designated caregiver: (i) the name, address, and date of birth of the designated caregiver; (ii) if the designated caregiver has a registry identification card, the registry identification number and expiration date of that registry identification card; and (iii) other individual identifying information required by the depart- ment; (d) a statement that a false statement made in the application is punishable under section 210.45 of the penal law; (e) the date of the application and the signature of the certified patient or designated caregiver, as the case may be; AND (f) [a fifty dollar application fee, provided, that the department may waive or reduce the fee in cases of financial hardship; and (g)] any other requirements determined by the commissioner. 3. Where a certified patient is under the age of eighteen: (a) The application for a registry identification card shall be made by an appropriate person over twenty-one years of age. The application shall state facts demonstrating that the person is appropriate. (b) The designated caregiver shall be (i) a parent or legal guardian of the certified patient, (ii) a person designated by a parent or legal guardian, [or] (iii) IN THE CASE OF SUCH A CERTIFIED PATIENT BEING CARED FOR BY A DESIGNATED CAREGIVER FACILITY, THE DESIGNATED CAREGIVER FACILI- TY DESIGNATED BY THE PARENT OR LEGAL GUARDIAN; OR (IV) an appropriate person approved by the department upon a sufficient showing that no parent or legal guardian is appropriate or available. 5. No person may be a designated caregiver for more than five certi- fied patients at one time; PROVIDED HOWEVER THAT THIS LIMITATION SHALL NOT APPLY TO A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE. 11. A certified patient or designated caregiver who has been issued a registry identification card shall notify the department of any change in his or her name or address or, with respect to the patient, if he or she ceases to have the [serious] condition noted on the certification within ten days of such change. The certified patient's or designated caregiver's registry identification card shall be deemed invalid and shall be returned promptly to the department. S. 5657--A 6 § 5. Subdivisions 3 and 5 of section 3364 of the public health law, as added by chapter 90 of the laws of 2014, are amended and a new subdivi- sion 14 is added to read as follows: 3. Each registered organization shall contract with an independent laboratory PERMITTED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-C OF THIS TITLE to test the medical marihuana produced by the registered organization. The commissioner shall approve the laboratory and require that the laboratory report testing results in a manner determined by the commissioner. The commissioner is authorized to issue regulation requir- ing the laboratory to perform certain tests and services. 5. (a) No registered organization may sell, deliver, distribute or dispense to any certified patient or designated caregiver a quantity of medical marihuana larger than that individual would be allowed to possess under this title. (b) When dispensing medical marihuana to a certified patient or desig- nated caregiver, the registered organization (i) shall not dispense an amount greater than a [thirty] SIXTY day supply to a certified patient until the certified patient has exhausted all but a seven day supply provided pursuant to a previously issued certification, and (ii) shall verify the information in subparagraph (i) of this paragraph by consult- ing the prescription monitoring program registry under section thirty- three hundred forty-three-a of this article. (c) Medical marihuana dispensed to a certified patient or designated caregiver by a registered organization shall conform to any recommenda- tion or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient. 14. A REGISTERED ORGANIZATION MAY CONTRACT WITH A PERSON OR ENTITY TO PROVIDE FACILITIES, EQUIPMENT OR SERVICES THAT ARE ANCILLARY TO THE REGISTERED ORGANIZATION'S FUNCTIONS OR ACTIVITIES UNDER THIS SECTION (INCLUDING, BUT NOT LIMITED TO, SHIPPING, MAINTENANCE, CONSTRUCTION, REPAIR, AND SECURITY), BUT NOT INCLUDING ANY FUNCTION OR ACTIVITY DIRECTLY INVOLVING THE PLANTING, GROWING, TENDING, HARVESTING, PROCESS- ING, OR PACKAGING OF PLANTS; OR ANY OTHER FUNCTION DIRECTLY INVOLVING MANUFACTURING OR RETAILING OF MEDICAL MARIHUANA. ALL LAWS AND REGU- LATIONS APPLICABLE TO SUCH FACILITIES, EQUIPMENT, OR SERVICES SHALL APPLY TO THE CONTRACT. THE REGISTERED ORGANIZATION AND OTHER PARTIES TO THE CONTRACT SHALL EACH BE RESPONSIBLE FOR COMPLIANCE WITH SUCH LAWS AND REGULATIONS UNDER THE CONTRACT. THE COMMISSIONER MAY MAKE REGULATIONS CONSISTENT WITH THIS TITLE RELATING TO CONTRACTS AND PARTIES TO CONTRACTS UNDER THIS SUBDIVISION. § 6. The public health law is amended by adding a new section 3364-a to read as follows: § 3364-A. MEDICAL MARIHUANA RESEARCH LICENSES. 1. THE COMMISSIONER SHALL ESTABLISH A MEDICAL MARIHUANA RESEARCH LICENSE THAT PERMITS A LICENSEE TO PRODUCE, PROCESS, PURCHASE, POSSESS, TRANSFER, AND SELL MARIHUANA, SUBJECT TO THIS SECTION, FOR THE FOLLOWING LIMITED RESEARCH PURPOSES: (A) TO TEST CHEMICAL POTENCY AND COMPOSITION LEVELS; (B) TO CONDUCT CLINICAL INVESTIGATIONS OF MARIHUANA-DERIVED PRODUCTS; (C) TO CONDUCT RESEARCH ON THE EFFICACY AND SAFETY OF ADMINISTERING MARIHUANA AS PART OF MEDICAL TREATMENT; OR (D) TO CONDUCT GENOMIC OR AGRICULTURAL RESEARCH RELATING TO MEDICAL MARIHUANA. 2. AS PART OF THE APPLICATION PROCESS FOR A MEDICAL MARIHUANA RESEARCH LICENSE, AN APPLICANT MUST SUBMIT TO THE COMMISSIONER A DESCRIPTION OF THE RESEARCH THAT IS INTENDED TO BE CONDUCTED AS WELL AS THE AMOUNT OF S. 5657--A 7 MARIHUANA TO BE GROWN OR PURCHASED. THE COMMISSIONER SHALL REVIEW AN APPLICANT'S RESEARCH PROJECT AND DETERMINE WHETHER IT MEETS THE REQUIRE- MENTS OF SUBDIVISION ONE OF THIS SECTION. IN ADDITION, THE COMMISSIONER SHALL ASSESS THE APPLICATION BASED ON THE FOLLOWING CRITERIA: (A) PROJECT QUALITY, STUDY DESIGN, VALUE, AND IMPACT; (B) WHETHER THE APPLICANT HAS THE APPROPRIATE PERSONNEL, EXPERTISE, FACILITIES AND INFRASTRUCTURE, FUNDING, AND (TO THE EXTENT LEGALLY AVAILABLE) APPROVALS RELATING TO HUMAN OR ANIMAL RESEARCH, IN PLACE TO SUCCESSFULLY CONDUCT THE PROJECT; AND (C) WHETHER THE AMOUNT OF MARIHUANA TO BE GROWN OR PURCHASED BY THE APPLICANT IS CONSISTENT WITH THE PROJECT'S SCOPE AND GOALS. 3. IF THE COMMISSIONER DETERMINES THAT THE RESEARCH PROJECT MEETS THE REQUIREMENTS OF SUBDIVISION ONE OF THIS SECTION, THE COMMISSIONER MAY APPROVE THE APPLICATION. IF NOT, THE APPLICATION SHALL BE DENIED. 4. A MEDICAL MARIHUANA RESEARCH LICENSEE MAY ONLY SELL OR TRANSFER MARIHUANA GROWN OR PRODUCED WITHIN ITS OPERATION TO OTHER MEDICAL MARI- HUANA RESEARCH LICENSEES, OR OTHERWISE FOR PURPOSES OF THE LICENSEE'S RESEARCH. 5. IN ESTABLISHING A MEDICAL MARIHUANA RESEARCH LICENSE, THE COMMIS- SIONER MAY MAKE REGULATIONS ON THE FOLLOWING: (A) APPLICATION REQUIREMENTS; (B) LICENSE RENEWAL REQUIREMENTS, INCLUDING WHETHER ADDITIONAL RESEARCH PROJECTS MAY BE ADDED OR CONSIDERED; (C) CONDITIONS FOR LICENSE REVOCATION; (D) SECURITY MEASURES TO ENSURE MARIHUANA IS NOT DIVERTED TO PURPOSES OTHER THAN RESEARCH; (E) AMOUNT OF PLANTS, USEABLE MARIHUANA, MARIHUANA CONCENTRATES, OR MARIHUANA-INFUSED PRODUCTS A LICENSEE MAY HAVE ON ITS PREMISES; (F) LICENSEE REPORTING REQUIREMENTS; (G) CONDITIONS UNDER WHICH MARIHUANA GROWN BY LICENSED MEDICAL MARI- HUANA PRODUCERS AND OTHER PRODUCT TYPES FROM LICENSED MEDICAL MARIHUANA PROCESSORS MAY BE DONATED TO MEDICAL MARIHUANA RESEARCH LICENSEES; AND (H) ANY ADDITIONAL REQUIREMENTS DEEMED NECESSARY BY THE COMMISSIONER. 6. A MARIHUANA RESEARCH LICENSE ISSUED UNDER THIS SECTION SHALL BE ISSUED IN THE NAME OF THE APPLICANT OR APPLICANTS, SPECIFY THE LOCATION AT WHICH THE MARIHUANA RESEARCHER INTENDS TO OPERATE, WHICH SHALL BE WITHIN THE STATE, AND SHALL NOT ALLOW ANY OTHER PERSON TO USE THE LICENSE EXCEPT AS UNDER SUBDIVISION FOUR OF THIS SECTION. 7. PARTICIPATION BY CERTIFIED PATIENTS IN ANY MEDICAL MARIHUANA RESEARCH PROGRAM SHALL BE VOLUNTARY. 8. THE APPLICATION FEE FOR A MEDICAL MARIHUANA RESEARCH LICENSE SHALL BE DETERMINED BY THE COMMISSIONER ON AN ANNUAL BASIS. 9. EACH MEDICAL MARIHUANA RESEARCH LICENSEE SHALL ISSUE AN ANNUAL REPORT TO THE COMMISSIONER. THE COMMISSIONER SHALL REVIEW SUCH REPORT AND MAKE A DETERMINATION AS TO WHETHER THE RESEARCH PROJECT CONTINUES TO MEET THE RESEARCH QUALIFICATIONS UNDER THIS SECTION. § 7. The public health law is amended by adding a new section 3364-b to read as follows: § 3364-B. REGISTRATION OF DESIGNATED CAREGIVER FACILITIES. 1. TO OBTAIN, AMEND OR RENEW A REGISTRATION AS A DESIGNATED CAREGIVER FACILI- TY, THE FACILITY SHALL FILE AN APPLICATION WITH THE COMMISSIONER. THE APPLICATION SHALL INCLUDE: (A) THE FACILITY'S FULL NAME AND ADDRESS; (B) OPERATING CERTIFICATE OR LICENSE NUMBER WHERE APPROPRIATE; (C) NAME, TITLE, AND SIGNATURE OF AN AUTHORIZED FACILITY REPRESEN- TATIVE; S. 5657--A 8 (D) A STATEMENT THAT THE FACILITY AGREES TO SECURE AND ENSURE PROPER HANDLING OF ALL MEDICAL MARIHUANA PRODUCTS; (E) AN ACKNOWLEDGEMENT THAT A FALSE STATEMENT IN THE APPLICATION IS PUNISHABLE UNDER SECTION 210.45 OF THE PENAL LAW; AND (F) ANY OTHER INFORMATION THAT MAY BE REQUIRED BY THE COMMISSIONER. 2. PRIOR TO ISSUING OR RENEWING A DESIGNATED CAREGIVER FACILITY REGIS- TRATION, THE COMMISSIONER MAY VERIFY THE INFORMATION SUBMITTED BY THE APPLICANT. THE APPLICANT SHALL PROVIDE, AT THE COMMISSIONER'S REQUEST, SUCH INFORMATION AND DOCUMENTATION, INCLUDING ANY CONSENTS OR AUTHORI- ZATIONS, THAT MAY BE NECESSARY FOR THE COMMISSIONER TO VERIFY THE INFOR- MATION. 3. THE APPLICATION SHALL BE APPROVED, DENIED OR DETERMINED INCOMPLETE OR INACCURATE BY THE COMMISSIONER WITHIN THIRTY DAYS OF RECEIPT OF THE APPLICATION. IF THE APPLICATION IS APPROVED, THE COMMISSIONER SHALL ISSUE A REGISTRATION AS SOON AS IS REASONABLY PRACTICABLE. 4. REGISTRATIONS UNDER THIS SECTION SHALL REMAIN VALID FOR TWO YEARS FROM THE DATE OF ISSUANCE. § 8. The public health law is amended by adding a new section 3364-c to read as follows: § 3364-C. LABORATORY PERMITS. 1. THE COMMISSIONER SHALL APPROVE AND PERMIT ONE OR MORE INDEPENDENT LABORATORIES TO TEST MEDICAL MARIHUANA. TO BE PERMITTED AS AN INDEPENDENT LABORATORY UNDER THIS SECTION, A LABO- RATORY MUST APPLY TO THE DEPARTMENT IN A FORM AND MANNER PRESCRIBED BY THE COMMISSIONER AND MUST DEMONSTRATE THE FOLLOWING TO THE SATISFACTION OF THE COMMISSIONER: (A) THE OWNERS AND DIRECTORS OF THE LABORATORY ARE OF GOOD MORAL CHAR- ACTER; (B) THE LABORATORY AND ITS STAFF HAVE THE SKILLS, RESOURCES, AND EXPERTISE NEEDED TO ACCURATELY AND CONSISTENTLY PERFORM ALL TESTING REQUIRED; (C) THE LABORATORY HAS IN PLACE AND WILL MAINTAIN ADEQUATE POLICIES, PROCEDURES, AND FACILITY SECURITY TO ENSURE PROPER COLLECTION, LABELING, ACCESSIONING, PREPARATION, ANALYSIS, RESULT REPORTING, DISPOSAL, AND STORAGE OF MEDICAL MARIHUANA; (D) THE LABORATORY IS PHYSICALLY LOCATED IN NEW YORK STATE; (E) THE LABORATORY HAS A CERTIFICATE OF APPROVAL AS AN ENVIRONMENTAL LABORATORY ISSUED BY THE COMMISSIONER UNDER TITLE ONE OF ARTICLE FIVE OF THIS CHAPTER; AND (F) THE LABORATORY MEETS ALL REQUIREMENTS PRESCRIBED BY THIS CHAPTER AND THE COMMISSIONER IN REGULATION. 2. THE OWNER OF AN INDEPENDENT LABORATORY PERMITTED UNDER THIS SECTION SHALL NOT HOLD A REGISTRATION AS A REGISTERED ORGANIZATION AND SHALL NOT HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH REGISTERED ORGAN- IZATION. NO BOARD MEMBER, MANAGER, OWNER, PARTNER, PRINCIPAL STAKEHOLD- ER, OR MEMBER OF A REGISTERED ORGANIZATION, OR SUCH PERSON'S IMMEDIATE FAMILY, SHALL HAVE AN INTEREST OR VOTING RIGHTS IN ANY INDEPENDENT LABO- RATORY PERMITTEE. NO REGISTERED ORGANIZATION SHALL HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH LABORATORY. 3. AN INDEPENDENT LABORATORY SHALL NOT BE REQUIRED TO BE LICENSED BY THE FEDERAL DRUG ENFORCEMENT ADMINISTRATION. § 9. Subdivision 9 of section 3365 of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: 9. [The commissioner shall register no more than five] A registered [organizations] ORGANIZATION that [manufacture] MANUFACTURES medical marihuana [with] MAY HAVE no more than [four] EIGHT dispensing sites wholly owned and operated by [such] THE registered organization. The S. 5657--A 9 commissioner shall ensure that such [registered organizations and] dispensing sites are geographically distributed across the state. The commission [may] SHALL register additional registered organizations REFLECTING THE DEMOGRAPHICS OF THE STATE. § 10. Subdivision 1 of section 3365-a of the public health law, as added by chapter 416 of the laws of 2015, is amended to read as follows: 1. There is hereby established in the department an emergency medical marihuana access program (referred to in this section as the "program") under this section. The purpose of the program is to expedite the avail- ability of medical marihuana to avoid suffering and loss of life, during the period before full implementation of and production under this title, especially in the case of patients whose [serious] condition is progressive and degenerative or is such that delay in the patient's medical use of marihuana poses a serious risk to the patient's life or health. The commissioner shall implement the program as expeditiously as practicable, including by emergency regulation. § 11. Subdivision 1 of section 3369 of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: 1. Certified patients, designated caregivers, DESIGNATED CAREGIVER FACILITIES, DESIGNATED CAREGIVER FACILITY EMPLOYEES, MEDICAL MARIHUANA RESEARCH PROGRAM EMPLOYEES, practitioners, registered organizations and the employees of registered organizations shall not be subject to arrest, prosecution, or penalty in any manner, or denied any right or privilege, including but not limited to civil penalty or disciplinary action by a business or occupational or professional licensing board or bureau, solely for the certified medical use or manufacture of marihua- na, or for any other action or conduct in accordance with this title. § 12. Section 3369-d of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the price determined by the commissioner. Every charge made or demanded for medical marihuana not in accordance with the price determined by the commissioner, is prohibited. 2. The commissioner is hereby authorized to set the per dose price of each form of medical marihuana sold by any registered organization. In setting the per dose price of each form of medical marihuana, the commissioner shall consider the fixed and variable costs of producing the form of marihuana and any other factor the commissioner, in his or her discretion, deems relevant to determining the per dose price of each form of medical marihuana.] REGISTERED ORGANIZATIONS SHALL SUBMIT DOCUMENTATION OF ANY PRICE AND CHANGE IN PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PRODUCT TO THE COMMISSIONER WITHIN FIFTEEN DAYS OF SETTING OR CHANGING THE PRICE. PRIOR APPROVAL BY THE COMMISSIONER SHALL NOT BE REQUIRED FOR ANY PRICE OR CHANGE OF PRICE. HOWEVER, THE COMMISSIONER IS AUTHORIZED TO MODIFY THE PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PROD- UCT IF NECESSARY TO MAINTAIN PUBLIC ACCESS TO APPROPRIATE MEDICATION. § 13. This act shall take effect immediately; provided, however, that the amendments to title 5-A of article 33 of the public health law made by sections one, two, three, four, five, six, seven, eight, nine, ten, eleven and twelve of this act shall not affect the repeal of such title and shall be deemed repealed therewith. Effective immediately, the addi- tion, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized to be made and completed on or before such effective date.
2019-S5657B (ACTIVE) - Details
- Current Committee:
- Senate Finance
- Law Section:
- Public Health Law
- Laws Affected:
- Amd Pub Health L, generally
2019-S5657B (ACTIVE) - Summary
Provides that medical marihuana may be used as part of the treatment of a patient's condition and removes the "serious" designation of such condition; provides that a practitioner be authorized to prescribe controlled substances in the state and removes the requirement that a physician prescribe such medical marihuana; increases the supply amount of marihuana from thirty to sixty days; allows a designated caregiver facility or designated caregiver facility employee to possess, acquire, deliver, transfer, transport or administer medical marihuana
2019-S5657B (ACTIVE) - Sponsor Memo
BILL NUMBER: S5657B SPONSOR: SAVINO TITLE OF BILL: An act to amend the public health law, in relation to medical marihuana PURPOSE OR GENERAL IDEA OF BILL: THIS BILL ADDRESSES SEVERAL PROBLEMS WITH THE MEDICAL MARIJUANA PROGRAM. THIS BILL CONSOLIDATES SEVERAL PROPOSALS FROM OTHER BILLS, AS WELL AS CHANGES TO THE MEDICAL PROGRAM PROPOSED IN THE 2019 EXECUTIVE BUDGET'S CANNABIS REGULATION AND TAXATION ACT (CRTA). SUMMARY OF SPECIFIC PROVISIONS: Section 1: Legislative Intent Section 2: Amends PHL § 3360 to: *Expand eligible conditions to include any condition certified by the
practitioner; *Allow any practitioner otherwise authorized to prescribe controlled substances to certify patients for medical marijuana; *Remove prohibitions on the smoking of medical marijuana; and *Create the categories of "designated caregiver facility," "designated caregiver facility employee," and "medical marihuana research program." Section 3: Amends PHL § 3361 to make conforming changes. Section 4: Amends PHL § 3362 to: *Change possession limits from a 30 day to a 60 day supply; *Authorize possession, acquisition, delivery, transfer, and adminis- tration of medical marijuana by designated caregiver facilities and their employees subject to certain requirements; and *Prohibit smoking of medical marijuana in any place where tobacco may not be smoked under the Clean Indoor Air Act. Section 5: Amends PHL § 3363 to: *Remove the $50 patient application fee for registry ID cards; *Remove patient-per-caregiver limits when the caregiver is a designated caregiver facility; and *Make conforming changes Section 6: Amends PHL § 3364 to: *Authorize registered organizations (ROs) to contract out ancillary functions such as shipping, construction, and security; and *Make conforming changes Section 7: Creates a new PHL § 3364-a, "medical marihuana research licenses," to: *Establish a medical marijuana research license for purposes of testing, clinical investigations, and safety and efficacy or genomic or agricul- tural research relating to medical marijuana; and *Details application, licensing, and oversight process. Section 8: Creates a new PHL § 3364-b, "registration of designated care- giver facilities," to: *Establishes registration process for "designated caregiver facilities" among provider types defined in section 1 of the bill; and *Details application, registration, and oversight process. Section 9: Creates a new PHL § 3364-c, "laboratory permits," to: *Detail application, permitting, and oversight process. Section 10: Amends PHL § 3365 to: *Increase dispensaries per RO from 4 to 8; and *Direct the Commissioner to register additional ROs reflecting the demo- graphics of the state. Section 11: Amends PHL § 3365-a to make conform- ing changes. Section 12: Amends PHL § 3369 to make conforming changes. Section 13: Amends PHL § 3369-d to remove prior approval of medical marijuana prices; maintain requirement for ROs to document price chang- es; and maintain the commissioner's power to modify prices if necessary to maintain access. Section 14: Immediate effective date. Amendments - New Section 1- Legislative Intent - with focus on expanding the program for patients and business opportunities for social equity applicants. Rest of bill is renumbered New Section 9 - adds requirement that registered organiza- tions establishes a subsidy program to provide assistance and increase access to patients. New Section 10 - adds outlines the social and economic equity plan JUSTIFICATION: Open conditions list: There is no pharmaceutical other than medical marijuana for which the State restricts its use to a limited list of conditions. Setting a conditions list in statute takes medical decisions out of the hands of the practitioners who know their patients best and whose judgment the law respects for much more dangerous drugs. Practi- tioners also lack clarity about which conditions are actually covered. For example, the Public Health Law definition of "severe or chronic pain" is inconsistent with regulatory language for "severe debilitating pain that degrades health and functional capability." This bill would maintain the naming of several conditions in statute for illustrative purposes, including some added in the Governor' s 2019 Cannabis Regulation and Taxation Act (CRTA), but also allows "any other condition certified by the practitioner." While the drafting is differ- ent, the effect is the same as 52058 of 2019. Expanded practitioner list: Today, physicians, physician assistants, and nurse practitioners can certify patients. However, there are other cate- gories of practitioner outside these who are authorized to prescribe much more dangerous substances and often treat conditions for which a patient may be eligible (such as podiatrists and dentists whose treat- ments involve pain medication.) This bill expands the practitioner cate- gories to cover these groups, similar to S2056 of 2019. Strike patient registry fees; increase supply from 30 to 60 days: Current law requires a $50 application fee for registry identification cards and limits patients to a 30-day supply. While the application fee is often waived, it presents a barrier to access that does not exist for patients with any other pharmaceutical product. Current law also limits patients to acquiring 30-day supplies at once distances, this limits access. The 2019 Executive budget proposed Cannabis Regulation and Taxa- tion Act (CRTA) included both of these changes. Allow smoking: For some patients, smoking is the most affordable deliv- ery method and enable them to effectively limit dosage. Out of over 30 states that now have medical marijuana programs, only 4 disallow smoking as New York does. While smoking can involve respiratory or other issues, the quantities involved in medical marijuana use are very limited, and should be a matter between patient and practitioner. This legislation would protect the public by making medical marihuana smoking subject to the Clean Indoor Air Act restrictions, similar to S490 of 2019. Facility caregivers: Current law allows patients to designate up to two people as caregivers under the program. Caregivers are capped at five patients each. These caps have caused problems administering medical marijuana in residential facilities or hospitals where there may be more than five patients using medical marijuana for a given caregiver, or where a patient may see more than two potential caregiver personnel (e.g., nurses) on a regular basis. This bill authorizes, but does not mandate, certain facilities to become "designated care giver facili- ties," exempting them from such restrictions, similar to S2059 of 2019 and language in the CRTA. Research licenses: While there is significant research, being done over- seas, medical marijuana research in the United States is limited. This bill would facilitate medical marijuana research in New York based on departmental regulations. Both S2059 of 2019 and the CRTA also authorize research licenses. Expanded lab testing: Today, the State's Wadsworth Laboratory is the only lab authorized to test medical marijuana. As the program expands, more lab capacity is needed. Commercial labs with Drug Enforcement Agen- cy (DEA) licenses may be reluctant to test medical marijuana out of fear of endangering these DEA licenses. This bill removes the requirement that a lab which tests medical marijuana hold a DEA license and details State permitting of labs for medical marijuana testing, similar to both S2059 of 2019 and the CRTA. RO contracting: Registered organizations (R0s) are currently not allowed to contract out any part of the production and distribution processes. This is contrary to standard business practice, is inefficient and rais- es costs. This bill allows ROs to contract out ancillary functions, such as security or transportation, while ensuring that laws applicable to the RO for the purpose of those services would apply to the contractors as well and excluding certain services directly related to the manufac- turing process (such as trimming). This is similar to both S2059 of 2019 and the CRTA. Increased dispensaries and ROs: Current law authorizes up to four dispensaries for each of the 10 ROs that engages in manufacturing. This places New York far below every other state medical marijuana programs for dispensary access per population. For comparison, New York has approximately 500,000 people per dispensary versus 233,000 to 1 in Illi- nois; 192,000 in Michigan, and 70,000 in Florida. This bill would double the number from 4 to 8 per RO. The bill also directs the commissioner to register additional ROs "reflecting the demographics of the state." While current law does authorize the registration of additional ROs, this explicit direction signals the importance of greater minority and women-owned participation in the medical marijuana program. The dispen- sary expansion is also found in S2059 of 2019. Modifying price controls: Current law authorizes price setting by the commissioner and prohibits any sale not in accordance with such prices. In practice, ROs submit prices and price changes to the department for approval. Since enactment, not one price setting or proposed change has ever been rejected. But it takes weeks or even months for ROs to get approvals, during which time they either cannot roll out new products or cannot sell existing products at their new, typically lower prices (nearly all price changes are downward changes; maintains reporting of all price changes to the department; and maintains the commissioner's authority to reject or modify prices if necessary to maintain access. PRIOR LEGISLATIVE HISTORY: New bill FISCAL IMPLICATIONS: Minimal. Minor reduction in patient registration fees ($50 each); likely revenue increase from licensing of additional ROs and fees associated with new license categories. EFFECTIVE DATE: Immediate.
2019-S5657B (ACTIVE) - Bill Text download pdf
S T A T E O F N E W Y O R K ________________________________________________________________________ 5657--B 2019-2020 Regular Sessions I N S E N A T E May 10, 2019 ___________ Introduced by Sen. SAVINO -- read twice and ordered printed, and when printed to be committed to the Committee on Health -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee -- recommitted to the Committee on Health in accord- ance with Senate Rule 6, sec. 8 -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee AN ACT to amend the public health law, in relation to medical marihuana THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. Legislative intent. The compassionate care act provides patients with necessary access to medical marihuana. While the program has provided relief to numerous patients, several improvements are necessary. Specifically, the program has suffered from overly restric- tive requirements regarding market participation and product regulation. Currently, the program restricts access by only permitting one dispen- sary for every 500,000 New Yorkers - leaving both urban and rural commu- nities drastically underserved. This act will improve the existing program by providing opportunities for social equity applicants to participate in the marketplace in a manner that more accurately repres- ents the demographics of the state. Social equity applicants will include applicants from communities disproportionately impacted by cannabis law enforcement. This act will also provide necessary flexi- bility for market participants to offer products that are more accessi- ble and affordable to some of New York's most vulnerable citizens. Specifically, current restrictions on the sale of whole flower result in medical products that are cost-prohibitive to many. Moreover, this act will provide greater access to individuals who are unable to enroll in the program including those with Alzheimer's disease and who have been diagnosed with autism spectrum disorder. Much like the addition of chronic pain as a qualifying condition, this will allow medical practi- EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD11129-08-0
S. 5657--B 2 tioners to recommend an alternative to addictive opiates. These changes will give New Yorkers access to quality care they deserve. § 2. Subdivisions 1, 5, 7 and 12 of section 3360 of the public health law, subdivisions 1, 5, 7 and 12 as added by chapter 90 of the laws of 2014, paragraph (a) of subdivision 7 as amended by chapter 273 of the laws of 2018, are amended and three new subdivisions 5-a, 5-b and 19 are added to read as follows: 1. "Certified medical use" means the acquisition, possession, use, or, transportation of medical marihuana by a certified patient, or the acquisition, possession, delivery, transportation or administration of medical marihuana by a designated caregiver, for use as part of the treatment of the patient's [serious] condition, as authorized in a certification under this title including enabling the patient to toler- ate treatment for the [serious] condition. [A certified medical use does not include smoking.] 5. "Designated caregiver" means the individual OR CAREGIVER FACILITY designated by a certified patient in a registry application. A certified patient may designate up to two designated caregivers, NOT COUNTING A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE. 5-A. "DESIGNATED CAREGIVER FACILITY" MEANS AN ENTITY THAT REGISTERS WITH THE COMMISSIONER TO ASSIST ONE OR MORE CERTIFIED PATIENTS WITH THE ACQUISITION, POSSESSION, DELIVERY, TRANSPORTATION OR ADMINISTRATION OF MEDICAL MARIHUANA AND IS: A GENERAL HOSPITAL OR RESIDENTIAL HEALTH CARE FACILITY OPERATING UNDER ARTICLE TWENTY-EIGHT OF THIS CHAPTER; AN ADULT CARE FACILITY OPERATING UNDER TITLE TWO OF ARTICLE SEVEN OF THE SOCIAL SERVICES LAW; A COMMUNITY MENTAL HEALTH RESIDENCE ESTABLISHED UNDER SECTION 41.44 OF THE MENTAL HYGIENE LAW; A HOSPITAL OPERATING UNDER SECTION 7.17 OF THE MENTAL HYGIENE LAW; A MENTAL HYGIENE FACILITY OPER- ATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW; AN INPATIENT OR RESIDENTIAL TREATMENT PROGRAM CERTIFIED UNDER ARTICLE THIRTY-TWO OF THE MENTAL HYGIENE LAW; A RESIDENTIAL FACILITY FOR THE CARE AND TREAT- MENT OF PERSONS WITH DEVELOPMENTAL DISABILITIES OPERATING UNDER ARTICLE SIXTEEN OF THE MENTAL HYGIENE LAW; A RESIDENTIAL TREATMENT FACILITY FOR CHILDREN AND YOUTH OPERATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW; A PUBLIC SCHOOL OR PRIVATE SCHOOL OPERATING UNDER THE EDUCATION LAW; A RESEARCH INSTITUTION WITH AN INTERNAL REVIEW BOARD; A MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-A OF THIS TITLE; OR ANY OTHER FACILITY AS DETERMINED BY THE COMMISSIONER IN REGULATION. 5-B. "DESIGNATED CAREGIVER FACILITY EMPLOYEE" MEANS AN EMPLOYEE OF A DESIGNATED CAREGIVER FACILITY. 7. (a) ["Serious condition"] "CONDITION" means: (i) having one of the following [severe debilitating or life-threaten- ing] conditions: cancer, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, amyotrophic lateral scler- osis, Parkinson's disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, inflammatory bowel disease, neuropa- thies, Huntington's disease, post-traumatic stress disorder, pain that degrades health and functional capability where the use of medical mari- huana is an alternative to opioid use, substance use disorder, ALZHEIMER'S, MUSCULAR DYSTROPHY, DYSTONIA, RHEUMATOID ARTHRITIS, AUTISM, or [as added by the commissioner; and (ii) any of the following conditions where it is clinically associated with, or a complication of, a condition under this paragraph or its treatment: cachexia or wasting syndrome; severe or chronic pain; severe S. 5657--B 3 nausea; seizures; severe or persistent muscle spasms; or such conditions as are added by the commissioner. (b) No later than eighteen months from the effective date of this section, the commissioner shall determine whether to add the following serious conditions: Alzheimer's, muscular dystrophy, dystonia, post- traumatic stress disorder and rheumatoid arthritis] ANY OTHER CONDITION CERTIFIED BY THE PRACTITIONER. 12. "Practitioner" means a practitioner who (i) [is a physician licensed by New York state and practicing within the state,] IS AUTHOR- IZED TO PRESCRIBE CONTROLLED SUBSTANCES WITHIN THE STATE; (ii) [who] by training or experience is qualified to treat a [serious] condition as defined in subdivision seven of this section; and (iii) [has completed a two to four hour course as determined by the commissioner in regulation and registered with the department; provided however, a registration shall not be denied without cause. Such course may count toward board certification requirements. The commissioner shall consider the inclu- sion of nurse practitioners under this title based upon considerations including access and availability. After such consideration the commis- sioner is authorized to deem nurse practitioners as practitioners under this title] COMPLETES, AT A MINIMUM, A TWO HOUR COURSE AS DETERMINED BY THE COMMISSIONER. A PERSON'S STATUS AS A PRACTITIONER UNDER THIS TITLE IS DEEMED TO BE A "LICENSE" FOR PURPOSES OF SECTION THIRTY-THREE HUNDRED NINETY OF THIS ARTICLE. 19. "MEDICAL MARIHUANA RESEARCH PROGRAM" MEANS A MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-A OF THIS TITLE. § 3. Subdivisions 1, 2, and 9 of section 3361 of the public health law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and subdivision 9 as added by chapter 416 of the laws of 2015, are amended to read as follows: 1. A patient certification may only be issued if: (a) a practitioner has been registered with the department to issue a certification as determined by the commissioner; (b) the patient has a [serious] condi- tion, which shall be specified in the patient's health care record; (c) the practitioner by training or experience is qualified to treat the [serious] condition; (d) the patient is under the practitioner's contin- uing care for the [serious] condition; and (e) in the practitioner's professional opinion and review of past treatments, the patient is like- ly to receive therapeutic or palliative benefit from the primary or adjunctive treatment with medical use of marihuana for the [serious] condition. 2. The certification shall include (a) the name, date of birth and address of the patient; (b) a statement that the patient has a [serious] condition and the patient is under the practitioner's care for the [serious] condition; (c) a statement attesting that all requirements of subdivision one of this section have been satisfied; (d) the date; and (e) the name, address, federal registration number, telephone number, and the handwritten signature of the certifying practitioner. The commissioner may require by regulation that the certification shall be on a form provided by the department. The practitioner may state in the certification that, in the practitioner's professional opinion, the patient would benefit from medical marihuana only until a specified date. The practitioner may state in the certification that, in the prac- titioner's professional opinion, the patient is terminally ill and that the certification shall not expire until the patient dies. S. 5657--B 4 9.(a) A certification may be a special certification if, in addition to the other requirements for a certification, the practitioner certi- fies in the certification that the patient's [serious] condition is progressive and degenerative or that delay in the patient's certified medical use of marihuana poses a serious risk to the patient's life or health. (b) The department shall create the form to be used for a special certification and shall make that form available to be downloaded from the department's website. § 4. Subdivisions 1 and 2 of section 3362 of the public health law, as added by chapter 90 of the laws of 2014, are amended and a new subdivi- sion 3 is added to read as follows: 1. The possession, acquisition, use, delivery, transfer, transporta- tion, or administration of medical marihuana by a certified patient or designated caregiver possessing a valid registry identification card, for certified medical use, shall be lawful under this title; provided that: (a) the marihuana that may be possessed by a certified patient shall not exceed a [thirty] SIXTY day supply of the dosage as determined by the practitioner, consistent with any guidance and regulations issued by the commissioner, provided that during the last seven days of any [thir- ty] SIXTY day period, the certified patient may also possess up to such amount for the next [thirty] SIXTY day period; (b) the marihuana that may be possessed by designated caregivers does not exceed the quantities referred to in paragraph (a) of this subdivi- sion for each certified patient for whom the caregiver possesses a valid registry identification card, up to five certified patients; (c) THE MARIHUANA THAT MAY BE POSSESSED BY DESIGNATED CAREGIVER FACIL- ITIES DOES NOT EXCEED THE QUANTITIES REFERRED TO IN PARAGRAPH (A) OF THIS SUBDIVISION FOR EACH CERTIFIED PATIENT UNDER CARE OR TREATMENT OF THE FACILITY; (D) the form or forms of medical marihuana that may be possessed by the certified patient [or], designated caregiver, OR DESIGNATED CAREGIV- ER FACILITY pursuant to a certification shall be in compliance with any recommendation or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient in the certif- ication; and [(d)] (E) the medical marihuana shall be kept in the original package in which it was dispensed under subdivision twelve of section thirty- three hundred sixty-four of this title, except for the portion removed for immediate consumption for certified medical use by the certified patient. 2. Notwithstanding subdivision one of this section: (a) possession of medical marihuana shall not be lawful under this title if it is smoked, consumed, vaporized, or grown in a public place, regardless of the form of medical marihuana stated in the patient's certification. (b) a [person] CERTIFIED PATIENT OR DESIGNATED CAREGIVER possessing medical marihuana under this title shall possess his or her registry identification card at all times when in immediate possession of medical marihuana. (C) MEDICAL MARIHUANA MAY NOT BE SMOKED IN ANY PLACE WHERE TOBACCO MAY NOT BE SMOKED UNDER ARTICLE THIRTEEN-E OF THIS CHAPTER, REGARDLESS OF THE FORM OF MEDICAL MARIHUANA STATED IN THE PATIENT'S CERTIFICATION. 3. THE POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR ADMINISTRATION OF MEDICAL MARIHUANA BY A DESIGNATED CAREGIVER FACILITY S. 5657--B 5 OR DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE LAWFUL UNDER THIS TITLE PROVIDED THAT: (A) THE DESIGNATED CAREGIVER FACILITY REGISTERS WITH THE DEPARTMENT ON A FORM PROVIDED BY THE COMMISSIONER; (B) SUCH POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR ADMINISTRATION IS ON BEHALF OF A CERTIFIED PATIENT POSSESSING A REGISTRY IDENTIFICATION CARD; (C) THE DESIGNATED CAREGIVER FACILITY MAINTAINS A COPY OF THE REGISTRY IDENTIFICATION CARD OF EACH CERTIFIED PATIENT FOR WHICH IT POSSESSES, ACQUIRES, DELIVERS, TRANSFERS, TRANSPORTS, OR ADMINISTERS MEDICAL MARI- HUANA; AND (D) A DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE IDENTIFIED AS AN EMPLOYEE WHEN NECESSARY, AS PROVIDED BY THE COMMISSIONER. § 5. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health law, as added by chapter 90 of the laws of 2014, are amended to read as follows: 2. To obtain, amend or renew a registry identification card, a certi- fied patient or designated caregiver shall file a registry application with the department. The registry application or renewal application shall include: (a) in the case of a certified patient: (i) the patient's certification (a new written certification shall be provided with a renewal application); (ii) the name, address, and date of birth of the patient; (iii) the date of the certification; (iv) if the patient has a registry identification card based on a current valid certification, the registry identification number and expiration date of that registry identification card; (v) the specified date until which the patient would benefit from medical marihuana, if the certification states such a date; (vi) the name, address, federal registration number, and telephone number of the certifying practitioner; (vii) any recommendation or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient; and (viii) other individual identifying information required by the department; (b) (I) in the case of a certified patient, if the patient designates a designated caregiver, the name, address, and date of birth of the designated caregiver, and other individual identifying information required by the department; (II) IF THE DESIGNATED CAREGIVER IS A MEDICAL MARIHUANA RESEARCH PROGRAM, THE NAME OF THE ORGANIZATION CONDUCTING THE RESEARCH; THE ADDRESS, PHONE NUMBER, AND NAME OF THE INDIVIDUAL LEADING THE RESEARCH OR APPROPRIATE DESIGNEE; AND OTHER IDENTIFYING INFORMATION REQUIRED BY THE DEPARTMENT; (c) in the case of a designated caregiver: (i) the name, address, and date of birth of the designated caregiver; (ii) if the designated caregiver has a registry identification card, the registry identification number and expiration date of that registry identification card; and (iii) other individual identifying information required by the depart- ment; (d) a statement that a false statement made in the application is punishable under section 210.45 of the penal law; S. 5657--B 6 (e) the date of the application and the signature of the certified patient or designated caregiver, as the case may be; AND (f) [a fifty dollar application fee, provided, that the department may waive or reduce the fee in cases of financial hardship; and (g)] any other requirements determined by the commissioner. 3. Where a certified patient is under the age of eighteen: (a) The application for a registry identification card shall be made by an appropriate person over twenty-one years of age. The application shall state facts demonstrating that the person is appropriate. (b) The designated caregiver shall be (i) a parent or legal guardian of the certified patient, (ii) a person designated by a parent or legal guardian, [or] (iii) IN THE CASE OF SUCH A CERTIFIED PATIENT BEING CARED FOR BY A DESIGNATED CAREGIVER FACILITY, THE DESIGNATED CAREGIVER FACILI- TY DESIGNATED BY THE PARENT OR LEGAL GUARDIAN; OR (IV) an appropriate person approved by the department upon a sufficient showing that no parent or legal guardian is appropriate or available. 5. No person may be a designated caregiver for more than five certi- fied patients at one time; PROVIDED HOWEVER THAT THIS LIMITATION SHALL NOT APPLY TO A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE. 11. A certified patient or designated caregiver who has been issued a registry identification card shall notify the department of any change in his or her name or address or, with respect to the patient, if he or she ceases to have the [serious] condition noted on the certification within ten days of such change. The certified patient's or designated caregiver's registry identification card shall be deemed invalid and shall be returned promptly to the department. § 6. Subdivisions 3 and 5 of section 3364 of the public health law, as added by chapter 90 of the laws of 2014, are amended and a new subdivi- sion 14 is added to read as follows: 3. Each registered organization shall contract with an independent laboratory PERMITTED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-C OF THIS TITLE to test the medical marihuana produced by the registered organization. The commissioner shall approve the laboratory and require that the laboratory report testing results in a manner determined by the commissioner. The commissioner is authorized to issue regulation requir- ing the laboratory to perform certain tests and services. 5. (a) No registered organization may sell, deliver, distribute or dispense to any certified patient or designated caregiver a quantity of medical marihuana larger than that individual would be allowed to possess under this title. (b) When dispensing medical marihuana to a certified patient or desig- nated caregiver, the registered organization (i) shall not dispense an amount greater than a [thirty] SIXTY day supply to a certified patient until the certified patient has exhausted all but a seven day supply provided pursuant to a previously issued certification, and (ii) shall verify the information in subparagraph (i) of this paragraph by consult- ing the prescription monitoring program registry under section thirty- three hundred forty-three-a of this article. (c) Medical marihuana dispensed to a certified patient or designated caregiver by a registered organization shall conform to any recommenda- tion or limitation by the practitioner as to the form or forms of medical marihuana or dosage for the certified patient. 14. A REGISTERED ORGANIZATION MAY CONTRACT WITH A PERSON OR ENTITY TO PROVIDE FACILITIES, EQUIPMENT OR SERVICES THAT ARE ANCILLARY TO THE REGISTERED ORGANIZATION'S FUNCTIONS OR ACTIVITIES UNDER THIS SECTION S. 5657--B 7 (INCLUDING, BUT NOT LIMITED TO, SHIPPING, MAINTENANCE, CONSTRUCTION, REPAIR, AND SECURITY), BUT NOT INCLUDING ANY FUNCTION OR ACTIVITY DIRECTLY INVOLVING THE PLANTING, GROWING, TENDING, HARVESTING, PROCESS- ING, OR PACKAGING OF PLANTS; OR ANY OTHER FUNCTION DIRECTLY INVOLVING MANUFACTURING OR RETAILING OF MEDICAL MARIHUANA. ALL LAWS AND REGU- LATIONS APPLICABLE TO SUCH FACILITIES, EQUIPMENT, OR SERVICES SHALL APPLY TO THE CONTRACT. THE REGISTERED ORGANIZATION AND OTHER PARTIES TO THE CONTRACT SHALL EACH BE RESPONSIBLE FOR COMPLIANCE WITH SUCH LAWS AND REGULATIONS UNDER THE CONTRACT. THE COMMISSIONER MAY MAKE REGULATIONS CONSISTENT WITH THIS TITLE RELATING TO CONTRACTS AND PARTIES TO CONTRACTS UNDER THIS SUBDIVISION. § 7. The public health law is amended by adding a new section 3364-a to read as follows: § 3364-A. MEDICAL MARIHUANA RESEARCH LICENSES. 1. THE COMMISSIONER SHALL ESTABLISH A MEDICAL MARIHUANA RESEARCH LICENSE THAT PERMITS A LICENSEE TO PRODUCE, PROCESS, PURCHASE, POSSESS, TRANSFER, AND SELL MARIHUANA, SUBJECT TO THIS SECTION, FOR THE FOLLOWING LIMITED RESEARCH PURPOSES: (A) TO TEST CHEMICAL POTENCY AND COMPOSITION LEVELS; (B) TO CONDUCT CLINICAL INVESTIGATIONS OF MARIHUANA-DERIVED PRODUCTS; (C) TO CONDUCT RESEARCH ON THE EFFICACY AND SAFETY OF ADMINISTERING MARIHUANA AS PART OF MEDICAL TREATMENT; OR (D) TO CONDUCT GENOMIC OR AGRICULTURAL RESEARCH RELATING TO MEDICAL MARIHUANA. 2. AS PART OF THE APPLICATION PROCESS FOR A MEDICAL MARIHUANA RESEARCH LICENSE, AN APPLICANT MUST SUBMIT TO THE COMMISSIONER A DESCRIPTION OF THE RESEARCH THAT IS INTENDED TO BE CONDUCTED AS WELL AS THE AMOUNT OF MARIHUANA TO BE GROWN OR PURCHASED. THE COMMISSIONER SHALL REVIEW AN APPLICANT'S RESEARCH PROJECT AND DETERMINE WHETHER IT MEETS THE REQUIRE- MENTS OF SUBDIVISION ONE OF THIS SECTION. IN ADDITION, THE COMMISSIONER SHALL ASSESS THE APPLICATION BASED ON THE FOLLOWING CRITERIA: (A) PROJECT QUALITY, STUDY DESIGN, VALUE, AND IMPACT; (B) WHETHER THE APPLICANT HAS THE APPROPRIATE PERSONNEL, EXPERTISE, FACILITIES AND INFRASTRUCTURE, FUNDING, AND (TO THE EXTENT LEGALLY AVAILABLE) APPROVALS RELATING TO HUMAN OR ANIMAL RESEARCH, IN PLACE TO SUCCESSFULLY CONDUCT THE PROJECT; AND (C) WHETHER THE AMOUNT OF MARIHUANA TO BE GROWN OR PURCHASED BY THE APPLICANT IS CONSISTENT WITH THE PROJECT'S SCOPE AND GOALS. 3. IF THE COMMISSIONER DETERMINES THAT THE RESEARCH PROJECT MEETS THE REQUIREMENTS OF SUBDIVISION ONE OF THIS SECTION, THE COMMISSIONER MAY APPROVE THE APPLICATION. IF NOT, THE APPLICATION SHALL BE DENIED. 4. A MEDICAL MARIHUANA RESEARCH LICENSEE MAY ONLY SELL OR TRANSFER MARIHUANA GROWN OR PRODUCED WITHIN ITS OPERATION TO OTHER MEDICAL MARI- HUANA RESEARCH LICENSEES, OR OTHERWISE FOR PURPOSES OF THE LICENSEE'S RESEARCH. 5. IN ESTABLISHING A MEDICAL MARIHUANA RESEARCH LICENSE, THE COMMIS- SIONER MAY MAKE REGULATIONS ON THE FOLLOWING: (A) APPLICATION REQUIREMENTS; (B) LICENSE RENEWAL REQUIREMENTS, INCLUDING WHETHER ADDITIONAL RESEARCH PROJECTS MAY BE ADDED OR CONSIDERED; (C) CONDITIONS FOR LICENSE REVOCATION; (D) SECURITY MEASURES TO ENSURE MARIHUANA IS NOT DIVERTED TO PURPOSES OTHER THAN RESEARCH; (E) AMOUNT OF PLANTS, USEABLE MARIHUANA, MARIHUANA CONCENTRATES, OR MARIHUANA-INFUSED PRODUCTS A LICENSEE MAY HAVE ON ITS PREMISES; (F) LICENSEE REPORTING REQUIREMENTS; S. 5657--B 8 (G) CONDITIONS UNDER WHICH MARIHUANA GROWN BY LICENSED MEDICAL MARI- HUANA PRODUCERS AND OTHER PRODUCT TYPES FROM LICENSED MEDICAL MARIHUANA PROCESSORS MAY BE DONATED TO MEDICAL MARIHUANA RESEARCH LICENSEES; AND (H) ANY ADDITIONAL REQUIREMENTS DEEMED NECESSARY BY THE COMMISSIONER. 6. A MARIHUANA RESEARCH LICENSE ISSUED UNDER THIS SECTION SHALL BE ISSUED IN THE NAME OF THE APPLICANT OR APPLICANTS, SPECIFY THE LOCATION AT WHICH THE MARIHUANA RESEARCHER INTENDS TO OPERATE, WHICH SHALL BE WITHIN THE STATE, AND SHALL NOT ALLOW ANY OTHER PERSON TO USE THE LICENSE EXCEPT AS UNDER SUBDIVISION FOUR OF THIS SECTION. 7. PARTICIPATION BY CERTIFIED PATIENTS IN ANY MEDICAL MARIHUANA RESEARCH PROGRAM SHALL BE VOLUNTARY. 8. THE APPLICATION FEE FOR A MEDICAL MARIHUANA RESEARCH LICENSE SHALL BE DETERMINED BY THE COMMISSIONER ON AN ANNUAL BASIS. 9. EACH MEDICAL MARIHUANA RESEARCH LICENSEE SHALL ISSUE AN ANNUAL REPORT TO THE COMMISSIONER. THE COMMISSIONER SHALL REVIEW SUCH REPORT AND MAKE A DETERMINATION AS TO WHETHER THE RESEARCH PROJECT CONTINUES TO MEET THE RESEARCH QUALIFICATIONS UNDER THIS SECTION. § 8. The public health law is amended by adding a new section 3364-b to read as follows: § 3364-B. REGISTRATION OF DESIGNATED CAREGIVER FACILITIES. 1. TO OBTAIN, AMEND OR RENEW A REGISTRATION AS A DESIGNATED CAREGIVER FACILI- TY, THE FACILITY SHALL FILE AN APPLICATION WITH THE COMMISSIONER. THE APPLICATION SHALL INCLUDE: (A) THE FACILITY'S FULL NAME AND ADDRESS; (B) OPERATING CERTIFICATE OR LICENSE NUMBER WHERE APPROPRIATE; (C) NAME, TITLE, AND SIGNATURE OF AN AUTHORIZED FACILITY REPRESEN- TATIVE; (D) A STATEMENT THAT THE FACILITY AGREES TO SECURE AND ENSURE PROPER HANDLING OF ALL MEDICAL MARIHUANA PRODUCTS; (E) AN ACKNOWLEDGEMENT THAT A FALSE STATEMENT IN THE APPLICATION IS PUNISHABLE UNDER SECTION 210.45 OF THE PENAL LAW; AND (F) ANY OTHER INFORMATION THAT MAY BE REQUIRED BY THE COMMISSIONER. 2. PRIOR TO ISSUING OR RENEWING A DESIGNATED CAREGIVER FACILITY REGIS- TRATION, THE COMMISSIONER MAY VERIFY THE INFORMATION SUBMITTED BY THE APPLICANT. THE APPLICANT SHALL PROVIDE, AT THE COMMISSIONER'S REQUEST, SUCH INFORMATION AND DOCUMENTATION, INCLUDING ANY CONSENTS OR AUTHORI- ZATIONS, THAT MAY BE NECESSARY FOR THE COMMISSIONER TO VERIFY THE INFOR- MATION. 3. THE APPLICATION SHALL BE APPROVED, DENIED OR DETERMINED INCOMPLETE OR INACCURATE BY THE COMMISSIONER WITHIN THIRTY DAYS OF RECEIPT OF THE APPLICATION. IF THE APPLICATION IS APPROVED, THE COMMISSIONER SHALL ISSUE A REGISTRATION AS SOON AS IS REASONABLY PRACTICABLE. 4. REGISTRATIONS UNDER THIS SECTION SHALL REMAIN VALID FOR TWO YEARS FROM THE DATE OF ISSUANCE. § 9. The public health law is amended by adding a new section 3364-c to read as follows: § 3364-C. LABORATORY PERMITS. 1. THE COMMISSIONER SHALL APPROVE AND PERMIT ONE OR MORE INDEPENDENT LABORATORIES TO TEST MEDICAL MARIHUANA. TO BE PERMITTED AS AN INDEPENDENT LABORATORY UNDER THIS SECTION, A LABO- RATORY MUST APPLY TO THE DEPARTMENT IN A FORM AND MANNER PRESCRIBED BY THE COMMISSIONER AND MUST DEMONSTRATE THE FOLLOWING TO THE SATISFACTION OF THE COMMISSIONER: (A) THE OWNERS AND DIRECTORS OF THE LABORATORY ARE OF GOOD MORAL CHAR- ACTER; S. 5657--B 9 (B) THE LABORATORY AND ITS STAFF HAVE THE SKILLS, RESOURCES, AND EXPERTISE NEEDED TO ACCURATELY AND CONSISTENTLY PERFORM ALL TESTING REQUIRED; (C) THE LABORATORY HAS IN PLACE AND WILL MAINTAIN ADEQUATE POLICIES, PROCEDURES, AND FACILITY SECURITY TO ENSURE PROPER COLLECTION, LABELING, ACCESSIONING, PREPARATION, ANALYSIS, RESULT REPORTING, DISPOSAL, AND STORAGE OF MEDICAL MARIHUANA; (D) THE LABORATORY IS PHYSICALLY LOCATED IN NEW YORK STATE; (E) THE LABORATORY HAS A CERTIFICATE OF APPROVAL AS AN ENVIRONMENTAL LABORATORY ISSUED BY THE COMMISSIONER UNDER TITLE ONE OF ARTICLE FIVE OF THIS CHAPTER; AND (F) THE LABORATORY MEETS ALL REQUIREMENTS PRESCRIBED BY THIS CHAPTER AND THE COMMISSIONER IN REGULATION. 2. THE OWNER OF AN INDEPENDENT LABORATORY PERMITTED UNDER THIS SECTION SHALL NOT HOLD A REGISTRATION AS A REGISTERED ORGANIZATION AND SHALL NOT HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH REGISTERED ORGAN- IZATION. NO BOARD MEMBER, MANAGER, OWNER, PARTNER, PRINCIPAL STAKEHOLD- ER, OR MEMBER OF A REGISTERED ORGANIZATION, OR SUCH PERSON'S IMMEDIATE FAMILY, SHALL HAVE AN INTEREST OR VOTING RIGHTS IN ANY INDEPENDENT LABO- RATORY PERMITTEE. NO REGISTERED ORGANIZATION SHALL HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH LABORATORY. 3. AN INDEPENDENT LABORATORY SHALL NOT BE REQUIRED TO BE LICENSED BY THE FEDERAL DRUG ENFORCEMENT ADMINISTRATION. § 10. Subdivision 9 of section 3365 of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: 9. [The commissioner shall register no more than five] A registered [organizations] ORGANIZATION that [manufacture] MANUFACTURES medical marihuana [with] MAY HAVE no more than [four] EIGHT dispensing sites wholly owned and operated by [such] THE registered organization. PROVIDED, HOWEVER, THAT ANY DISPENSING SITE OPENED PURSUANT TO THIS SECTION BY A REGISTERED ORGANIZATION LICENSED PRIOR TO THE EFFECTIVE DATE OF THE CHAPTER OF THE LAWS OF TWO THOUSAND TWENTY THAT AMENDED THIS SUBDIVISION SHALL NOT BE APPROVED BY THE DEPARTMENT UNTIL SUCH REGIS- TERED ORGANIZATIONS ESTABLISHES A SUBSIDY PROGRAM TO PROVIDE ASSISTANCE AND INCREASE ACCESS TO PATIENTS. The commissioner shall ensure that such [registered organizations and] dispensing sites are geographically distributed across the state. The commission [may] SHALL register addi- tional registered organizations REFLECTING THE DEMOGRAPHICS OF THE STATE. (A) THE DEPARTMENT SHALL IMPLEMENT A SOCIAL AND ECONOMIC EQUITY PLAN AND ACTIVELY PROMOTE APPLICATIONS FROM COMMUNITIES DISPROPORTIONATELY IMPACTED BY CANNABIS PRODUCTION, AND PROMOTE RACIAL, ETHNIC, AND GENDER DIVERSITY WHEN ISSUING THE ADDITIONAL FOUR REGISTERED ORGANIZATIONS LICENSES, INCLUDING BY PRIORITIZING CONSIDERATION OF APPLICATIONS BY APPLICANTS WHO ARE FROM COMMUNITIES DISPROPORTIONATELY IMPACTED BY THE ENFORCEMENT OF CANNABIS PROHIBITION OR WHO QUALIFY AS A MINORITY OR A WOMEN-OWNED BUSINESS. SUCH QUALIFICATIONS SHALL BE DETERMINED BY THE DEPARTMENT IN REGULATION. (B) THE DEPARTMENT SHALL ISSUE FOUR ADDITIONAL REGISTERED ORGANIZATION LICENSES AND CREATE A SOCIAL AND ECONOMIC EQUITY PLAN TO PROMOTE DIVER- SITY IN OWNERSHIP AND EMPLOYMENT IN THE MEDICAL MARIHUANA INDUSTRY AND ENSURE INCLUSION OF: (I) INDIVIDUALS FROM COMMUNITIES DISPROPORTIONATELY IMPACTED BY THE ENFORCEMENT OF CANNABIS PROHIBITION; (II) MINORITY-OWNED BUSINESSES; (III) WOMEN-OWNED BUSINESSES; S. 5657--B 10 (IV) MINORITY AND WOMEN-OWNED BUSINESSES, AS DEFINED IN PARAGRAPH (D) OF THIS SUBDIVISION; AND (C) THE SOCIAL AND ECONOMIC EQUITY PLAN SHALL REQUIRE AN ANALYSIS OF HOW TO PRIORITIZE OPPORTUNITIES FOR APPLICANTS THAT ARE: (I) A MEMBER OF A COMMUNITY GROUP THAT HAS BEEN DISPROPORTIONATELY IMPACTED BY THE ENFORCEMENT OF CANNABIS PROHIBITION; (II) WAS CONVICTED OF A CANNABIS-RELATED OFFENSE PRIOR TO THE EFFEC- TIVE DATE OF THE CHAPTER OF THE LAWS OF TWO THOUSAND TWENTY THAT AMENDED THIS SUBDIVISION, OR HAD A PARENT, GUARDIAN, CHILD, SPOUSE, OR DEPEND- ENT, OR WAS A DEPENDENT OF AN INDIVIDUAL WHO, PRIOR TO THE EFFECTIVE DATE OF THE CHAPTER OF THE LAWS OF TWO THOUSAND TWENTY THAT AMENDED THIS SUBDIVISION, WAS CONVICTED OF A CANNABIS-RELATED OFFENSE. (D) FOR THE PURPOSES OF THIS SECTION, THE FOLLOWING DEFINITIONS SHALL APPLY: (I) "MINORITY-OWNED BUSINESS" SHALL MEAN A BUSINESS ENTERPRISE, INCLUDING A SOLE PROPRIETORSHIP, PARTNERSHIP, LIMITED LIABILITY COMPANY OR CORPORATION THAT IS: (1) AT LEAST FIFTY-ONE PERCENT OWNED BY ONE OR MORE MINORITY GROUP MEMBERS; (2) AN ENTERPRISE IN WHICH SUCH MINORITY OWNERSHIP IS REAL, SUBSTAN- TIAL AND CONTINUING; (3) AN ENTERPRISE IN WHICH SUCH MINORITY OWNERSHIP HAS AND EXERCISES THE AUTHORITY TO CONTROL INDEPENDENTLY THE DAY-TO-DAY BUSINESS DECISIONS OF THE ENTERPRISE; (4) AN ENTERPRISE AUTHORIZED TO DO BUSINESS IN THIS STATE AND INDE- PENDENTLY OWNED AND OPERATED; AND (5) AN ENTERPRISE THAT IS A SMALL BUSINESS. (II) "MINORITY GROUP MEMBER" SHALL MEAN A UNITED STATES CITIZEN OR PERMANENT RESIDENT ALIEN WHO IS AND CAN DEMONSTRATE MEMBERSHIP IN ONE OF THE FOLLOWING GROUPS: (1) BLACK PERSONS HAVING ORIGINS IN ANY OF THE BLACK AFRICAN RACIAL GROUPS; (2) HISPANIC PERSONS OF MEXICAN, PUERTO RICAN, DOMINICAN, CUBAN, CENTRAL OR SOUTH AMERICAN OF EITHER INDIAN OR HISPANIC ORIGIN, REGARD- LESS OF RACE; (3) NATIVE AMERICAN OR ALASKAN NATIVE PERSONS HAVING ORIGINS IN ANY OF THE ORIGINAL PEOPLES OF NORTH AMERICA; OR (4) ASIAN AND PACIFIC ISLANDER PERSONS HAVING ORIGINS IN ANY OF THE FAR EAST COUNTRIES, SOUTH EAST ASIA, THE INDIAN SUBCONTINENT OR THE PACIFIC ISLANDS. (III) "WOMEN-OWNED BUSINESS" SHALL MEAN A BUSINESS ENTERPRISE, INCLUD- ING A SOLE PROPRIETORSHIP, PARTNERSHIP, LIMITED LIABILITY COMPANY OR CORPORATION THAT IS: (1) AT LEAST FIFTY-ONE PERCENT OWNED BY ONE OR MORE UNITED STATES CITIZENS OR PERMANENT RESIDENT ALIENS WHO ARE WOMEN; (2) AN ENTERPRISE IN WHICH THE OWNERSHIP INTEREST OF SUCH WOMEN IS REAL, SUBSTANTIAL AND CONTINUING; (3) AN ENTERPRISE IN WHICH SUCH WOMEN OWNERSHIP HAS AND EXERCISES THE AUTHORITY TO CONTROL INDEPENDENTLY THE DAY-TO-DAY BUSINESS DECISIONS OF THE ENTERPRISE; (4) AN ENTERPRISE AUTHORIZED TO DO BUSINESS IN THIS STATE AND INDE- PENDENTLY OWNED AND OPERATED; AND (5) AN ENTERPRISE THAT IS A SMALL BUSINESS. (IV) "A FIRM OWNED BY A MINORITY GROUP MEMBER WHO IS ALSO A WOMAN" MAY INCLUDE A MINORITY-OWNED BUSINESS, A WOMEN-OWNED BUSINESS, OR BOTH. S. 5657--B 11 (V) "COMMUNITIES DISPROPORTIONATELY IMPACTED" SHALL MEAN, BUT NOT BE LIMITED TO, A HISTORY OF ARRESTS, CONVICTIONS, AND OTHER LAW ENFORCEMENT PRACTICES IN A CERTAIN GEOGRAPHIC AREA, SUCH AS, BUT NOT LIMITED TO PRECINCTS, ZIP CODES, NEIGHBORHOODS, AND POLITICAL SUBDIVISIONS, REFLECTING A DISPARATE ENFORCEMENT OF CANNABIS PROHIBITION DURING A CERTAIN TIME PERIOD, WHEN COMPARED TO THE REST OF THE STATE. THE DEPARTMENT SHALL ISSUE GUIDELINES TO DETERMINE HOW TO ASSESS WHICH COMMUNITIES HAVE BEEN DISPROPORTIONATELY IMPACTED AND HOW TO ASSESS IF SOMEONE IS A MEMBER OF A COMMUNITY DISPROPORTIONATELY IMPACTED. (E) THE DEPARTMENT SHALL ACTIVELY PROMOTE APPLICANTS THAT FOSTER RACIAL, ETHNIC, AND GENDER DIVERSITY IN THEIR WORKFORCE. § 11. Subdivision 1 of section 3365-a of the public health law, as added by chapter 416 of the laws of 2015, is amended to read as follows: 1. There is hereby established in the department an emergency medical marihuana access program (referred to in this section as the "program") under this section. The purpose of the program is to expedite the avail- ability of medical marihuana to avoid suffering and loss of life, during the period before full implementation of and production under this title, especially in the case of patients whose [serious] condition is progressive and degenerative or is such that delay in the patient's medical use of marihuana poses a serious risk to the patient's life or health. The commissioner shall implement the program as expeditiously as practicable, including by emergency regulation. § 12. Subdivision 1 of section 3369 of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: 1. Certified patients, designated caregivers, DESIGNATED CAREGIVER FACILITIES, DESIGNATED CAREGIVER FACILITY EMPLOYEES, MEDICAL MARIHUANA RESEARCH PROGRAM EMPLOYEES, practitioners, registered organizations and the employees of registered organizations shall not be subject to arrest, prosecution, or penalty in any manner, or denied any right or privilege, including but not limited to civil penalty or disciplinary action by a business or occupational or professional licensing board or bureau, solely for the certified medical use or manufacture of marihua- na, or for any other action or conduct in accordance with this title. § 13. Section 3369-d of the public health law, as added by chapter 90 of the laws of 2014, is amended to read as follows: § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the price determined by the commissioner. Every charge made or demanded for medical marihuana not in accordance with the price determined by the commissioner, is prohibited. 2. The commissioner is hereby authorized to set the per dose price of each form of medical marihuana sold by any registered organization. In setting the per dose price of each form of medical marihuana, the commissioner shall consider the fixed and variable costs of producing the form of marihuana and any other factor the commissioner, in his or her discretion, deems relevant to determining the per dose price of each form of medical marihuana.] REGISTERED ORGANIZATIONS SHALL SUBMIT DOCUMENTATION OF ANY PRICE AND CHANGE IN PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PRODUCT TO THE COMMISSIONER WITHIN FIFTEEN DAYS OF SETTING OR CHANGING THE PRICE. PRIOR APPROVAL BY THE COMMISSIONER SHALL NOT BE REQUIRED FOR ANY PRICE OR CHANGE OF PRICE. HOWEVER, THE COMMISSIONER IS AUTHORIZED TO MODIFY THE PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PROD- UCT IF NECESSARY TO MAINTAIN PUBLIC ACCESS TO APPROPRIATE MEDICATION. § 14. This act shall take effect immediately; provided, however, that the amendments to title 5-A of article 33 of the public health law made by sections two, three, four, five, six, seven, eight, nine, ten, elev- S. 5657--B 12 en, twelve and thirteen of this act shall not affect the repeal of such title and shall be deemed repealed therewith. Effective immediately, the addition, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized to be made and completed on or before such effective date.
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