STATUS: S5040 LEIBELL Public Health Law TITLE....Provides for medical use of cannabis 04/18/05 REFERRED TO HEALTH SUMMARY: LEIBELL Add Art 33 Title V-A SS3360 - 3367, Pub Health L Legalizes the possession, manufacture, sale, administration, delivery, dispensing and distribution of marihuana in connection with medical use thereof for certified patients; prescribes procedures for such possession, manufacture, sale, etc. including certification of patients by their physician, for a specified period, not to exceed one year (to the effect that the patient has a serious condition, and that the patient is under the practitioner's care for such condition, and that, in the physician's medical judgment, the condition can and should be treated with the medical use of marijuana); permits registered organizations to sell, administer, deliver, etc. marijuana to certified patients or the caregiver of a certified patient for certified medical use, and permits caregivers of a certified patient to sell, administer, deliver, etc. marijuana to a certified patient for a medical use, and also permits any federal, state or local law enforcement agency to sell, deliver, distribute, etc. marijuana to a registered organization; provides that possession or manufacture of marijuana shall not be lawful under these provisions if it is consumed or displayed in a public place or if the aggregate weight of the preparation, compound, etc exceeds 8 ounces, excluding the weight of any food; directs the department of health to monitor such use and promulgate rules and regulations; provides for reports by physicians and evaluation and reporting by the department. BILL TEXT: STATE OF NEW YORK ________________________________________________________________________ 5040 2005-2006 Regular Sessions IN SENATE April 18, 2005 ___________ Introduced by Sen. LEIBELL -- 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 use of cannabis; and providing for the repeal of such provisions upon expira- tion thereof The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Legislative findings and intent. The legislature finds that 2 thousands of New Yorkers have serious medical conditions that can be 3 improved by medically-approved use of cannabis. The law should not stand 4 between them and life and health-sustaining treatment under a physi- 5 cian's supervision. Many controlled substances that are legal for 6 medical use (such as morphine and steroids) are otherwise illegal. This 7 legislation follows the well-established public policy that a controlled 8 substance can have a legitimate medical use. The purposes of article 33 9 of the public health law are to allow legitimate use of controlled 10 substances in health care, including palliative care; veterinary care; 11 research and other uses authorized by this article or other law; under 12 appropriate regulation. This policy and this legislation do not in any 13 way diminish New York state's strong public policy and laws against 14 illegal drug use. 15 It is the legislative intent that this act be implemented consistently 16 with these findings and principles, through a reasonable and workable 17 system with appropriate oversight, evaluation and continuing research. 18 § 2. Article 33 of the public health law is amended by adding a new 19 title V-A to read as follows: 20 TITLE V-A 21 MEDICAL USE OF CANNABIS 22 Section 3360. Definitions. 23 3361. Certification of patients. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD11292-01-5 S. 5040 2 1 3362. Possession and sale of medical cannabis. 2 3363. Registered organizations. 3 3364. Registering of registered organizations. 4 3365. Reports by physicians. 5 3366. Evaluation; research programs; report by department. 6 3367. Applicability of other provisions of this article. 7 § 3360. Definitions. As used in this title, the following terms shall 8 have the following meanings, unless the context clearly requires other- 9 wise: 10 1. "Physician" means a physician of a certified patient. 11 2. "Certified medical use" means the medical use of cannabis by a 12 certified patient for the serious condition specified in a certification 13 under section thirty-three hundred sixty-one of this title. 14 3. "Certified patient" means a patient certified under section thir- 15 ty-three hundred sixty-one of this title. 16 4. "Medical use" means use as part of the treatment of a serious 17 condition, including enabling a patient to tolerate treatment for a 18 serious condition. 19 5. "Public place" means a public place as defined in section 240.00 of 20 the penal law, a motor vehicle as defined in section one hundred twen- 21 ty-five of the vehicle and traffic law, an aircraft as defined in 22 section two hundred forty of the general business law and/or a vessel as 23 defined in section two of the navigation law. 24 6. "Registered organization" means a registered organization under 25 section thirty-three hundred sixty-three of this title. 26 7. "Serious condition" means a life-threatening, degenerative or 27 permanently disabling condition, or a condition associated with or a 28 complication of such a condition. 29 8. "Certified caregiver of a certified patient" means a person who 30 provides medical or domestic services to a certified patient and who has 31 registered as a caregiver to such certified patient with the county 32 department of health of the county in which the certified patient 33 resides as well as with the office of the district attorney of the coun- 34 ty in which the certified patient resides. 35 9. "Cannabis" means the controlled substance commonly known as "Mari- 36 huana" as defined in subdivision twenty-one of section thirty-three 37 hundred two of this article, or "concentrated cannabis" as defined in 38 subdivision four of section thirty-three hundred two of this article. 39 § 3361. Certification of patients. 1. A physician may make a certif- 40 ication that a patient is eligible to receive a prescription for the 41 medical use of cannabis under the following conditions: (a) the patient 42 has a serious condition as defined in subdivision seven of section thir- 43 ty-three hundred sixty of this title, which shall be specified in the 44 certification; (b) the patient is under the physician's care for the 45 serious condition; and (c) in the physician's professional judgment, the 46 serious condition can and should be treated with the medical use of 47 cannabis, and that other drugs or treatments would not be as effective. 48 2. The certification shall be in writing and include in addition to 49 the requirements of subdivision one of this section: (a) the date; (b) 50 the name, address, federal registration number, telephone number, and 51 the handwritten signature of the certifying physician; (c) the specific 52 directions for use of the medical cannabis, including but not limited 53 to, the dosage and frequency of dosage and the maximum daily dosage of 54 the same; (d) the number of renewals authorized by the physician, 55 provided that no such authorization shall be effective for a period S. 5040 3 1 greater than six months from the date the certification is signed; and 2 (e) the name and address of the certified patient. 3 3. In addition to the requirements established in subdivisions one 4 and two of this section, the commissioner may also require by regulation 5 that the certification shall be on a form provided by the department. 6 4. Any certification produced under this section shall be given to 7 the certified patient, and a copy shall be sent to the department 8 together with a copy to the department of health of the county in which 9 the certified patient resides, and a copy shall be placed in the 10 patient's health care record. 11 5. No certification under this section shall be made for a quantity of 12 cannabis that would exceed a fourteen day supply if it were used in 13 accordance with the directions for use specified on the certification. 14 6. No physician shall issue a certification under this section for 15 himself or herself. 16 § 3362. Possession and sale of medical cannabis. 1. Possession. (a) 17 Possession or manufacture of medical cannabis shall be lawful under the 18 express limitations of this article where it is by a registered organ- 19 ization, for the purpose of lawful possession, sale, administering, 20 delivering, dispensing or distributing under this title. 21 (b) Possession of medical cannabis shall be lawful under the express 22 limitations of this article where it is by a certified patient, for 23 their personal prescribed medical use under this title. 24 (c) Notwithstanding paragraphs (a) and (b) of this subdivision, 25 possession or manufacture of medical cannabis shall not be lawful under 26 this title if it is consumed or displayed in a public place as defined 27 in subdivision five of section thirty-three hundred sixty of this title. 28 2. Sale. It shall be lawful under this article to sell, administer, 29 deliver, dispense, or distribute medical cannabis where it is: 30 (a) by a registered organization, to a certified patient, pursuant to 31 a physician's prescription, for a certified medical use; 32 (b) by any federal, state or local law enforcement agency, to a regis- 33 tered organization; or 34 (c) by a certified caregiver of a certified patient, to the certified 35 patient, pursuant to a physician's prescription for a certified medical 36 use. 37 § 3363. Registered organizations. 1. A registered organization shall 38 be: 39 (a) a not-for-profit corporation organized for the purpose of lawfully 40 selling, administering, delivering, dispensing or distributing medical 41 cannabis; 42 (b) a pharmacy, including an employee of a pharmacy licensed to 43 dispense prescription medication from such pharmacy; 44 (c) the department; or 45 (d) a local health department. 46 2. A registered organization shall not possess, sell, administer, 47 deliver, dispense or distribute medical cannabis under this title, 48 except under a registration under section thirty-three hundred sixty- 49 four of this title or a renewal thereof. 50 3. A registered organization may, in good faith, sell and dispense to 51 a certified patient, or a certified caregiver of a certified patient, 52 medical cannabis pursuant to a physician's prescription, upon delivery 53 to the registered organization of a written certification, dated within 54 thirty days of the date the certification was signed by a physician, 55 together with a prescription by a physician prescribing medical cannabis 56 for the certified patient of an authorized medical use. No registered S. 5040 4 1 organization may sell or dispense greater than a fourteen day supply of 2 medical cannabis to a certified patient, or to a certified caregiver of 3 a certified patient, unless and until the patient has exhausted all but 4 a seven day supply of medical cannabis provided pursuant to any previ- 5 ously issued written certification and prescription. 6 4. A certification may be renewed not more than the number of times 7 specifically authorized by the physician upon the certification, 8 provided, however, that no authorization shall be effective for a period 9 greater than six months from the date the certification is signed. 10 Unless an earlier renewing is authorized by the physician, no certif- 11 ication or prescription may be renewed earlier than seven days prior to 12 the date the previously dispensed supply would be exhausted if used in 13 conformity with the directions for use. 14 5. Medical cannabis may be dispensed only if enclosed in a suitable 15 container, and: 16 (a) Affixed to such container is a label upon which is indelibly 17 typed, printed, or otherwise legibly written the following: 18 (i) the name and address of the certified patient for whom the medical 19 cannabis is intended; 20 (ii) the name, address, and telephone number of the registered organ- 21 ization from which such medical cannabis is dispensed; 22 (iii) specific directions for use as stated on the certification; 23 (iv) the name of the physician; 24 (v) the legend, prominently marked or printed in either boldface or 25 upper case lettering: "CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS 26 DIRECTED"; 27 (b) The container shall be identified as medical cannabis by either: 28 (i) an orange label; 29 (ii) a label of another color over which is superimposed an orange 30 transparent adhesive tape; or 31 (iii) an auxiliary orange label affixed to the front of the container 32 and bearing the legend, prominently marked or printed "Controlled 33 Substance, Dangerous Unless Used As Directed"; 34 (c) Any label, transparency, or auxiliary label shall be applied in a 35 manner which would inhibit its removal. 36 6. The department may suspend or terminate the registration of a 37 registered organization, on grounds and using procedures under this 38 article relating to a license, to the extent consistent with this title. 39 7. A county department of health for the county in which a certified 40 patient resides may also suspend or terminate the registration of a 41 registered organization within such county, on the grounds that such 42 organization is not in compliance with the terms of this title. 43 § 3364. Registering of registered organizations. 1. Application for 44 initial registration. (a) An applicant for registration as a registered 45 organization under section thirty-three hundred sixty-three of this 46 title shall furnish to the department any information it shall reason- 47 ably require and evidence that the applicant: 48 (i) and its managing officers are of good moral character; 49 (ii) possesses sufficient land, buildings and equipment to properly 50 carry on the activity described in the application; 51 (iii) is able to maintain effective control against diversion of the 52 medical cannabis; and 53 (iv) is able to comply with all applicable state laws and regulations 54 relating to the manufacture or distribution of medical cannabis. S. 5040 5 1 (b) The application shall establish the applicant's status under 2 subdivision one of section thirty-three hundred sixty-three of this 3 title. 4 (c) The application shall include the name, residence address and 5 title of each of the officers and directors and the name and residence 6 address of any person or entity that is a member of the applicant. Each 7 such person, if an individual, or lawful representative if a legal enti- 8 ty, shall submit an affidavit with the application setting forth: 9 (i) any position of management or ownership during the preceding ten 10 years of a ten per centum or greater interest in any other business, 11 located in or outside this state, manufacturing or distributing drugs; 12 (ii) whether such person or any such business has been convicted, 13 fined, censured or had a registration suspended or revoked in any admin- 14 istrative or judicial proceeding relating to or arising out of the manu- 15 facture or distribution of drugs; and 16 (iii) such other information as the commissioner may reasonably 17 require. 18 (d) The applicant shall be under a continuing duty to report to the 19 department any change in facts or circumstances reflected in the appli- 20 cation or any newly discovered or occurring fact or circumstance which 21 is required to be included in the application. 22 2. Granting of registration. (a) The commissioner shall grant a regis- 23 tration or amendment to a registration under this section if he or she 24 is satisfied that: 25 (i) the applicant will be able to maintain effective control against 26 diversion of medical cannabis; 27 (ii) the applicant will be able to comply with all applicable state 28 laws; 29 (iii) the applicant and its officers are ready, willing and able to 30 properly carry on the manufacturing or distributing activity for which a 31 registration is sought; 32 (iv) the applicant possesses sufficient land, buildings and equipment 33 to properly carry on the activity described in the application; 34 (v) it is in the public interest that such registration be granted; 35 and 36 (vi) the applicant and its managing officers are of good moral charac- 37 ter. 38 (b) If the commissioner is not satisfied that the applicant should be 39 issued a registration, he or she shall notify the applicant in writing 40 of those factors upon which further evidence is required. Within thirty 41 days of the receipt of such notification, the applicant may submit addi- 42 tional material to the commissioner or demand a hearing or both. 43 3. Applications for renewal of registrations. (a) An application for 44 the renewal of any registration issued under this title shall be filed 45 with the department not more than six months nor less than four months 46 prior to the expiration thereof. 47 (b) The application for renewal shall include such information 48 prepared in the manner and detail as the commissioner may require, 49 including but not limited to: 50 (i) any material change in the circumstances or factors listed in 51 subdivision one of this section; and 52 (ii) every known charge or investigation, pending or concluded during 53 the period of the registration, by any governmental agency with respect 54 to: S. 5040 6 1 (1) each incident or alleged incident involving the theft, loss, or 2 possible diversion of medical cannabis manufactured or distributed by 3 the applicant; and 4 (2) compliance by the applicant with the laws of the state with 5 respect to any substance listed in section thirty-three hundred six of 6 this article. 7 (c) An applicant for renewal shall be under a continuing duty to 8 report to the department any change in facts or circumstances reflected 9 in the application or any newly discovered or occurring fact or circum- 10 stance which is required to be included in the application. 11 (d) If the commissioner is not satisfied that the applicant is enti- 12 tled to a renewal of the registration, he or she shall within forty-five 13 days after the filing of the application serve upon the applicant or his 14 or her attorney of record in person or by registered or certified mail 15 an order directing the applicant to show cause why his or her applica- 16 tion for renewal should not be denied. The order shall specify in detail 17 the respects in which the applicant has not satisfied the commissioner 18 that the registration should be renewed. 19 (e) Within thirty days of service of such order, the applicant may 20 either submit additional material to the commissioner or demand a hear- 21 ing or both. If a hearing is demanded, the commissioner shall fix a date 22 for a hearing not sooner than fifteen days nor later than thirty days 23 after receipt of the demand, unless such time limitation is waived by 24 the applicant. 25 4. Granting of renewal of registrations. (a) The commissioner shall 26 renew a registration unless he or she determines and finds that the 27 applicant: 28 (i) is unlikely to maintain or be able to maintain effective control 29 against diversion; or 30 (ii) is unlikely to comply with all state laws applicable to the manu- 31 facture or distribution of medical cannabis. 32 (b) For purposes of this section, proof that a registered organiza- 33 tion, during the period of its registration, has failed to maintain 34 effective control against diversion or has knowingly or negligently 35 failed to comply with applicable state laws relating to the manufacture 36 or distribution of medical cannabis, shall constitute substantial 37 evidence that the applicant will be unlikely to maintain effective 38 control against diversion or will be unlikely to comply with the appli- 39 cable state statutes during the period of proposed renewal. 40 § 3365. Reports by physicians. The department shall, by regulation, 41 require each physician who makes a certification under this title to 42 file reports of each certification, on forms provided by the department, 43 including an initial report and periodic follow-up reports not more 44 frequently than every ninety days, covering the effective period of the 45 certification. Each report shall include the date, effective period, and 46 specified condition of the certification, the name and address of the 47 certifying physician, and the name and address of the patient. Each 48 follow-up report shall include a brief statement of the level and 49 pattern of medical cannabis use by the certified patient and the effec- 50 tiveness of the medical use of medical cannabis for the certified 51 patient. 52 § 3366. Evaluation; research programs; report by department. 1. The 53 department may provide for the analysis and evaluation of reports filed 54 by physicians and registered organizations under this title. 55 2. The department may develop, seek any necessary federal approval 56 for, and carry out research programs relating to medical use of medical S. 5040 7 1 cannabis. Participation in any such research program shall be voluntary 2 on the part of physicians, certified patients, and registered organiza- 3 tions. 4 3. The department shall report every two years, beginning one year 5 after this title takes effect, to the governor and the legislature on 6 the medical use of medical cannabis under this title and make appropri- 7 ate recommendations. 8 § 3367. Applicability of other provisions of this article. The 9 provisions of this article shall apply to this title, except that where 10 a provision of this title conflicts with another provision of this arti- 11 cle, this title shall apply. 12 § 3. The commissioner of health shall enter into agreements with one 13 or more persons, not-for-profit corporations or other organizations, 14 other than a state employee, official or agency, for the performance of 15 an evaluation of the implementation and effectiveness of the provisions 16 of this act. Such evaluation shall include, but not be limited to, an 17 analysis of the practical operation of this act, the clinical value of 18 medical use of medical cannabis under this act, and the effect (if any) 19 on illegal use of controlled substances. 20 § 4. This act shall take effect immediately; provided that the depart- 21 ment of health shall promulgate rules and regulations necessary for the 22 implementation of the provisions of this act and shall issue any forms 23 provided for in this act within 180 days after this act shall have 24 become a law; and provided, further, that the provisions of this act 25 shall expire and be deemed repealed January 1, 2008. SPONSORS MEMO: NEW YORK STATE SENATE INTRODUCER'S MEMORANDUM IN SUPPORT submitted in accordance with Senate Rule VI. Sec 1 BILL NUMBER: S5040 SPONSOR: LEIBELL TITLE OF BILL: An act to amend the public health law, in relation to medical use of cannabis; and providing for the repeal of such provisions upon expiration thereof PURPOSE: This bill would provide for regulated use of cannabis for certified medical purposes pursuant to a doctor's prescription. SUMMARY OF PROVISIONS: This bill would establish a new Title V-A of the public health law to provide for the regulated use of cannabis for certified medical purposes pursuant to a doctor's prescription as follows: 1. Creates a new section 3360 to provide for definitions for the new title; 2. Creates a new section 3361 to establish a certification procedure whereby physicians can certify certain seriously ill patients as being eligible to receive prescriptions for medical cannabis; 3. Creates a new section 3362 to authorize the regulated sale and possession of medical cannabis under the following circumstances: a. A certified patient may lawfully possess up to a 14 day supply of medical marihuana pursuant to a physicians prescription, where such possession is not in a public place, motor vehicle, vessel or aircraft; b. A registered organization (such as an approved pharmacy, health department or not-for-profit organization created for the purpose of lawfully selling, administering, delivering, or distributing medical marihuana) may lawfully manufacture or possess or manufacture medical cannabis for seriously ill certified patients; and c. A certified caregiver of a certified patient may lawfully sell, administer, deliver, dispense or distribute medical cannabis to a certi- fied patient, pursuant to a physician's prescription, for a certified medical use; 4. Creates a new section 3363 to define and regulate registered organ- izations that may lawfully sell, administer, deliver, or distribute medical cannabis; 5. Creates a new section 3364 to provide the process for the registra- tion of such register organizations; 6. Creates a new section 3365 to require reports by physicians on the use of medical cannabis; 7. Creates a new section 3366 to require the department of health to provide an evaluation and report to the legislature with respect to the use of medical cannabis; 8. Creates a new section 3367 to provide for the applicability of the sections of this new title; 9. Permits the commissioner of health to enter into agreements for the performance of this new title; and 10. Establishes an immediate effective date, a 180 day regulation peri- od, and an expiration, repeal and sunset of January 2008. JUSTIFICATIONOFF': _____ MEDICAL EVIDENCE HAS SHOWN THAT MEDICAL CANNABIS, COMMONLY KNOWN AS "MEDICAL MARIHUANA", CAN PROVE EFFECTIVE IN TREATING THE SIDE EFFECTS AND PAIN OF CERTAIN SERIOUS DISEASES AND CONDITIONS. LIKE MANY OTHER CONTROLLED SUBSTANCES, SUCH AS MORPHINE, SUCH DRUGS CAN BE EFFECTIVELY ALSO USED AS MEDICINES. THE MERE FACT THAT ANY SUCH SUBSTANCE CAN BE ABUSED FOR ILLICIT PURPOSES DOES NOT MEAN THAT IT SHOULD NOT BE AVAIL- ABLE AS A MEDICAL WEAPON IN A PHYSICIAN'S ARSENAL TO TREAT A SUFFERING PATIENT. THIS BILL WOULD PERMIT PHYSICIANS TO PRESCRIBE CANNABIS, UNDER SERIOUSLY REGULATED CIRCUMSTANCES, TO SERIOUSLY ILL PATIENTS WHEN AND IF OTHER TREATMENTS WOULD BE LESS EFFECTIVE. IN SO DOING, IT TAKES SEVERE PRECAU- TIONS TO PREVENT ITS AVAILABILITY AND DISTRIBUTION TO ANY PERSON BUT A SERIOUSLY ILL PATIENT WHO COULD BENEFIT FROM ITS USE AS A MEDICATION. ;.U ON;LEGISLATIVE HISTORY: New bill FISCAL IMPLICATIONS: None Noted EFFECTIVE DATE: This bill would take effect immediately; provided that the department of health shall promulgate rules and regulations necessary for the imple- mentation of the provisions of this act; and provided further, that the provisions of this act shall expire and be deemed repealed on January 1, 2008.