February 1, 2011
Introduced by Sen. DUANE — read twice and ordered printed, and when printed to be committed to the Committee on Health. An ACT to amend the public health law and the general business law, in relation to medical use of marijuana. The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. Legislative findings and intent. The legislature finds that thousands of New Yorkers have serious medical conditions that can be improved by medically-approved use of marihuana. The law should not stand between them and treatment necessary for life and health. This legislation follows the well-established public policy that a controlled substance can have a legitimate medical use. Many controlled substances that are legal for medical use (such as morphine and steroids) are illegal for any other use. The purposes of article 33 of the public health law include allowing legitimate use of controlled substances in health care, including palliative care. This policy and this legislation do not in any way diminish New York state’s strong public policy and laws against illegal drug use, nor should it be deemed in any manner to advocate, authorize, promote, or legally or socially accept the use of marihuana for children or adults, for any non-medical use. This legislation is an appropriate exercise of the state’s legislative power to protect the health of its people under article 17 of the state constitution and the tenth amendment of the United States constitution. It is the legislative intent that this act be implemented consistently with these findings and principles, through a reasonable and workable system with appropriate oversight, evaluation and continuing research.
Article 33 of the public health law is amended by adding a new title 5-A to read as follows:
TITLE V-A – MEDICAL USE OF MARIHUANA
Section 3360. Definitions
1 3361. Certification of patients.
2 3362. Possession.
3 3363. Registry identification cards.
4 3364. Registered organizations.
5 3365. Registering of registered organizations.
6 3366. Reports by registered organizations.
7 3367. Evaluation; research programs; report by department.
8 3368. Registered organization assessments.
9 3369. Relation to other laws.
10 3360. Definitions. As used in this title, the following terms shall have the following meanings, unless the context clearly requires otherwise:
1. “Certified medical use” means the acquisition, possession, use, delivery, transfer, transportation, or administration of medical marihuana by a certified patient or designated caregiver for use as part of the treatment of the patient’s serious condition specified in a certification under section thirty-three hundred sixty-one of this title, including enabling the patient to tolerate treatment for the serious condition.
2. “Certified patient” means a patient who is certified under section thirty-three hundred sixty-one of this title.
3. “Certification” means a certification, made under section thirty three hundred sixty-one of this title.
4. “Designated caregiver” means the individual designated by a certified patient in a registry application.
5. “Public place” means a public place as defined in section 240.00 of the penal law, a motor vehicle as defined in section one hundred twenty-five of the vehicle and traffic law, an aircraft as defined in section two hundred forty of the general business law or a vessel as defined in section two of the navigation law.
6. “Serious condition” means a severe debilitating or life-threatening condition, or a condition associated with or a complication of such a condition or its treatment (including but not limited to inability to tolerate food, nausea, vomiting, dysphoria or pain).
7. “Medical marihuana” means marihuana as defined in subdivision twenty-one of section thirty-three hundred two of this title intended for a certified medical use.
8. “Registered organization” means a registered organization under sections thirty-three hundred sixty-four and thirty-three hundred sixty-five of this title.
9. “Registry application” means an application properly completed and filed with the department by a certified patient under section thirty three hundred sixty-three of this title.
10. “Registry identification card” means a document that identifies a certified patient or designated caregiver, as provided under section thirty-three hundred sixty-three of this title.
11. “Practitioner” means a practitioner who is a physician, physician assistant, or nurse practitioner, acting within the practitioner’s lawful scope of practice.
3361. Certification of Patients
1. A patient certification may only be issued if a practitioner who is caring for the patient for a serious condition certifies that: (a) the patient has a serious condition, which shall be specified in the patient’s health care record; (b) the patient is under the practitioner’s care for the serious condition; and (c) in the practitioner’s professional opinion, the patient is likely 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 be in writing and include (a) the name, date of birth and address of the patient; (b) a statement that the patient has a serious condition; the patient is under the practitioner’s care for the serious condition and, in the practitioner’s professional opinion, the patient is likely to receive therapeutic or palliative benefit from the primary or adjunctive treatment with medical use of marihuana for the serious condition; (c) the date; and (d) the name, address, federal registration number, telephone number, and the hand written signature of the certifying practitioner. The commissioner may require by regulation that the certification shall be on a form provided by the department if the commissioner determines that the department is making certification forms adequately available.
3. The practitioner shall give the certification to the certified patient, and place a copy in the patient’s health care record.
4. No practitioner shall issue a certification under this section for himself or herself.
5. A registry identification card based on a certification shall expire one year after the date the certification is signed by the practitioner; except that where a certified patient has a registry identification card based on a current valid certification, a new registry identification card based on a new certification shall expire one year after the expiration of the registry identification card based on the current valid certification. However, if the practitioner states in the certification that he or she believes the patient would benefit from medical marihuana only until a specified earlier date, then the registry identification card shall expire on that date.
1. The possession, acquisition, use, delivery, transfer, transportation, 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 the marihuana that may be possessed by a certified patient and such certified patient’s designated caregiver does not exceed a total aggregate weight of two and one-half ounces of marihuana. A designated caregiver may possess the quantities referred to in this subdivision for each certified patient for whom the caregiver possesses a valid registry identification card, up to five certified patients.
2. Notwithstanding subdivision one of this section: (a) possession of marihuana shall not be lawful under this title if it is consumed or displayed in a public place; (b) medical marihuana may not be smoked in any place where tobacco may not be smoked under article thirteen-E of this chapter; (c) except that in a health care facility, medical marihuana may be smoked by a patient of the facility, subject to other provisions of this title, in an area, and under circumstances, permitted by the facility, provided that the patient does not smoke in the presence of patients who are not certified under this title.
3. It shall be lawful under this article to give or dispose of marihuana, obtained under this title for the certified patient to the certified patient or designated caregiver for a certified medical use where nothing of value is transferred in return, or to offer to do the same. This prohibition on transferring or offering to transfer a thing of value shall not (a) apply to sale of medical marihuana to or by a registered organization under this article; nor (b) prevent a designated caregiver from being reimbursed for activities relating to caring for a certified patient, including, but not limited to, reimbursement for legitimate expenses relating to the purchase of medical marihuana from a registered organization under section thirty-three hundred sixty-six of this title.
3363. Registry Identification Cards
1. The department shall issue registry identification cards for certified patients and designated caregivers. A registry identification card shall expire as provided in section thirty-three hundred sixty-one of this title or as otherwise provided in this section. The department shall begin issuing registry identification cards no later than June first, two thousand twelve. The department may specify a form for a registry application, in which case the department shall provide the form on request, reproductions of the form may be used, and the form shall be available for downloading from the department’s website.
2. To obtain or renew a registry identification card, a certified patient shall file a registry application with the department. The registry application or renewal application shall include: (a) the original patient’s certification (a new written certification shall be provided with a renewal application); (b) (i) the name, address, and date of birth of the patient; (ii) the date of the certification; (iii) 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; (iv) the specified date until which the patient would benefit from medical marihuana, if the certification states such a date; (v) the name, address, federal registration number, and telephone number of the certifying practitioner; and (vi) other individual identifying information required by the department; (c) 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; a certified patient may designate up to two designated caregivers; (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; and (f) a reasonable application fee, as determined by the department; provided, that the department may waive or reduce the fee in cases of financial hardship.
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) an appropriate person approved by the department upon a sufficient showing that no parent or legal guardian is appropriate or available.
4. No person may be a designated caregiver if the person is under twenty-one years of age unless a sufficient showing is made to the department that the person should be permitted to serve as a designated caregiver.
5. No person may be a designated caregiver for more than five certified patients at one time. A designated caregiver shall carry a separate registry identification card for each certified patient for whom he or she is a designated caregiver. Each registry identification card shall contain the same registry identification number specified in this section.
6. The department shall issue separate registry identification cards for the certified patient and the designated caregiver (if one is designated in the registry application) within thirty days of receiving a complete application under this section, unless it determines that the application is incomplete or facially inaccurate, in which case it shall promptly notify the applicant.
7. If the department does not approve the designation of an individual as a designated caregiver, that shall not affect the approval of the application as to the certified patient.
8. A registry identification card shall contain: (a) the name, address, and date of birth of the certified patient and the designated caregiver (if one is designated in the registry application); (b) the date of issuance and expiration date of the registry identification card; (c) a registry identification number for the certified patient and a registry identification number for the designated caregiver (if one is designated in the registry application); and (d) a photograph of the individual to whom the registry identification card is being issued, which shall be obtained by the department in a manner specified by the commissioner in regulations; provided, however, that if the department required certified patients to submit photographs for this purpose, there shall be a reasonable accommodation of certified patients who are confined to their homes due to their medical conditions and may therefore have difficulty procuring photographs.
9. 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, or if he or she ceases to have the serious condition noted on the certification, within ten days of such change.
10. If a certified patient or designated caregiver loses his or her registry identification card, he or she shall notify the department and submit a ten dollar fee within ten days of losing the card to maintain the registration. The department may establish higher fees for issuing a new registry identification card for second and subsequent replacements for a lost card, provided, that the department may waive or reduce the fee in cases of financial hardship. Within five days after such notification and payment, the department shall issue a new registry identification card, which may contain a new registry identification number, to the certified patient or designated caregiver, as the case may be.
11. The department shall maintain a confidential list of the persons to whom it has issued registry identification cards. Individual identifying information obtained by the department under this title shall be confidential and exempt from disclosure under article six of the public officers law. Notwithstanding this subdivision, the department may notify any appropriate law enforcement agency of information relating to any violation or suspected violation of this title.
12. The department shall verify to law enforcement personnel in an appropriate case whether a registry identification card is valid.
13. If a certified patient or designated caregiver willfully violates any provision of this title as determined by the department, his or her registry identification card may be revoked. This is in addition to any other penalty that may apply.
14. (a) Registry implementation date. As used in this subdivision, the “registry implementation date” is the date determined by the commissioner when the department is ready to receive and expeditiously act on applications for registry identification cards under this section. (b) On and after the registry implementation date, upon receipt of an application for a registry identification card, the department shall send to the applicant a letter acknowledging such receipt. While the application for a registry identification card is pending, a copy of the registry application, together with a copy of the certification and a copy of the letter of receipt from the department, shall serve as and have the same effect as a registry identification card for the certified patient and designated caregiver if any, provided that a certification and application shall not serve as a valid registry identification card after the initial thirty day period under subdivision six of this section. This paragraph shall expire and have no effect one year after the registry implementation date.
3364. Registered Organizations
1. A registered organization shall be: (a) a pharmacy; (b) a facility licensed under article twenty-eight of this chapter; (c) a not-for-profit corporation organized for the purpose of acquiring, possessing, manufacturing, selling, delivering, transporting or distributing marihuana for certified medical use; (d) the department; (e) a local health department; or (f) a registered producer, which shall be a person or entity, with appropriate expertise in agriculture, registered for the purpose of acquiring or manufacturing marihuana and selling, delivering, transporting, or distributing it to another registered organization; a certified producer shall not sell, deliver or distribute marihuana to a certified patient or designated caregiver for that person’s use.
1-a. The department may contract, through a request for proposals process, with an entity to manufacture medical marihuana for sale to the department in the department’s capacity as a registered organization. An entity contracting with the department under this subdivision shall be deemed to be a registered producer when acting under that contract.
2. The acquiring, possession, manufacture, sale, delivery, transporting or distributing of marihuana by a registered organization under this title in accordance with its registration under section thirty-three hundred sixty-five of this title or a renewal thereof shall be lawful under this title.
3. A registered organization (other than a registered producer) may lawfully, in good faith, sell, deliver or distribute medical marihuana to a certified patient or designated caregiver upon presentation to the registered organization of a valid registry identification card for that certified patient or designated caregiver. When presented with the registry identification card, the registered organization shall provide to the certified patient or designated caregiver a receipt, which shall state: the name, address, and registry identification number of the registered organization; the registry identification number of the certified patient and the designated caregiver (if any); and the quantity of marihuana sold. The registered organization shall retain a copy of the registry identification card and the receipt for one year.
4. No registered organization may sell, deliver or distribute to any certified patient or designated caregiver a quantity of medical marijuana no larger than that individual would be allowed to possess under this title.
5. When a registered organization sells, delivers or distributes medical marihuana to a certified patient or designated caregiver, it shall provide to that individual a safety insert, which will be developed and approved by the commissioner and include, but not be limited to, information on: (a) methods for administering medical marihuana, (b) any potential dangers stemming from the use of medical marihuana, and (c) how to recognize what may be problematic usage of medical marihuana and obtain appropriate services or treatment for problematic usage.
3365. Registering of Registered Organizations
1. Application for initial registration. (a) An applicant for registration as a registered organization under section thirty-three hundred sixty-four of this title shall furnish to the department a description of the activities in which it intends to engage as a registered organization and any information the department shall reasonably require and evidence that the applicant: (i) and its managing officers are of good moral character; (ii) possesses or has the right to use sufficient land, buildings and equipment to properly carry on the activity described in the application; (iii) is able to maintain effective control against diversion of the marihuana; and (iv) is able to comply with all applicable state laws and regulations relating to the activities in which it intends to engage under the registration.
(b) The application shall establish the applicant’s status under paragraph (a), (b), (c), (d) or (e) of subdivision one of section thirty-three hundred sixty-four of this title, or its intention to qualify under paragraph (c) or (f) of subdivision one of section thirty-three hundred sixty-four of this title. (c) The application shall include the name, residence address and title of each of the officers and directors and the name and residence address of any person or entity that is a member of the applicant. Each such person, if an individual, or lawful representative if a legal entity, shall submit an affidavit with the application setting forth: (i) any position of management or ownership during the preceding ten years of a ten per centum or greater interest in any other business, located in or outside this state, manufacturing or distributing drugs; (ii) whether such person or any such business has been convicted, fined, censured or had a registration suspended or revoked in any administrative or judicial proceeding relating to or arising out of the manufacture, distribution, sale, or possession of drugs; and (iii) such other information as the commissioner may reasonably require. (d) The applicant shall be under a continuing duty to report to the department any change in facts or circumstances reflected in the application or any newly discovered or occurring fact or circumstance which is required to be included in the application.
2. Granting of registration. (a) The commissioner shall grant a registration or amendment to a registration under this section if he or she is satisfied that: (i) the applicant will be able to maintain effective control against diversion of marihuana; (ii) the applicant will be able to comply with all applicable state laws; (iii) the applicant and its officers are ready, willing and able to properly carry on the manufacturing or distributing activity for which a registration is sought; (iv) the applicant possesses or has the right to use sufficient land, buildings and equipment to properly carry on the activity described in the application; (v) it is in the public interest that such registration be granted; in the case of an applicant under paragraph (c) of subdivision one of section thirty-three hundred sixty-four of this title, the commissioner may consider whether the number of registered organizations in an area will be adequate or excessive to reasonably serve the area; and (vi) the applicant and its managing officers are of good moral character. (b) If the commissioner is not satisfied that the applicant should be issued a registration, he or she shall notify the applicant in writing of those factors upon which further evidence is required. Within thirty days of the receipt of such notification, the applicant may submit additional material to the commissioner. (c) The fee for a registration under this section shall be an amount determined by the department in regulations; provided however, if the registration is issued for a period greater than two years the fee shall be increased, pro rata, for each additional month of validity. (d) Registrations issued under this section shall be effective only for and shall specify: (i) the name and address of the registered organization; and (ii) which activities of a registered organization are permitted by the registration. (e) Upon application of a registered organization, a registration may be amended to allow the registered organization to relocate within the state or to add or delete permitted registered organization activities. The fee for such amendment shall be two hundred fifty dollars.
3. A registration issued under this section shall be valid for two years from the date of issue, except that in order to facilitate the renewals of such registrations, the commissioner may upon the initial application for a registration, issue some registrations which may remain valid for a period of time greater than two years but not exceeding an additional eleven months.
4. Applications for renewal of registrations. (a) An application for the renewal of any registration issued under this section shall be filed with the department not more than six months nor less than four months prior to the expiration thereof. A late-filed application for the renewal of a registration may, in the discretion of the commissioner, be treated as an application for an initial license. (b) The application for renewal shall include such information prepared in the manner and detail as the commissioner may require, including but not limited to: (i) any material change in the circumstances or factors listed in subdivision one of this section; and (ii) every known charge or investigation, pending or concluded during the period of the registration, by any governmental agency with respect to: (1) each incident or alleged incident involving the theft, loss, or possible diversion of marihuana manufactured or distributed by the applicant; and (2) compliance by the applicant with the laws of the state with respect to any substance listed in section thirty-three hundred six of this article. (c) An applicant for renewal shall be under a continuing duty to report to the department any change in facts or circumstances reflected in the application or any newly discovered or occurring fact or circumstance which is required to be included in the application. (d) If the commissioner is not satisfied that the applicant is entitled to a renewal of the registration, he or she shall within forty-five days after the filing of the application serve upon the applicant of his or her attorney of record in person or by registered or certified mail an order directing the applicant to show cause why his or her application for renewal should not be denied. The order shall specify in detail the respects in which the applicant has not satisfied the commissioner that the registration should be renewed. (e) Within thirty days of service of such order, the applicant may either submit additional material to the commissioner.
5. Granting of renewal of registrations. (a) The commissioner shall renew a registration unless he or she determines and finds that the applicant: (i) is unlikely to maintain or be able to maintain effective control against diversion; or (ii) is unlikely to comply with all state laws applicable to the activities in which it may engage under the registration; or (iii) is an applicant under paragraph (c) of subdivision one of section thirty-three hundred sixty-four of this title, in which case the commissioner may consider whether the number of registered organizations in an area is adequate or excessive to reasonably serve the area. (b) For purposes of this section, proof that a registered organization, during the period of its registration, has failed to maintain effective control against diversion or has knowingly or negligently failed to comply with applicable state laws relating to the activities in which it engages under the registration, shall constitute substantial evidence that the applicant will be unlikely to maintain effective control against diversion or will be unlikely to comply with the applicable state statutes during the period of proposed renewal.
6. The department may suspend or terminate the registration of a registered organization, on grounds and using procedures under this article relating to a license, to the extent consistent with this title.
3366. Reports by Registered Organizations
1. The commissioner shall, by regulation, require each registered organization that sells, delivers or distributes medical marihuana to a certified patient or designated caregiver to file reports of all such sales, deliveries or distributions by the registered organization during a particular period, on forms provided by the department. Reports shall be not more frequently than every six months. Each report shall include for each such sale, delivery or distribution: the date, the quantity sold, delivered or distributed; and the name, address and registry identification number of the certified patient and the designated caregiver (if any).
2. The commissioner shall, by regulation, require each registered producer to file reports of all sales, deliveries or distributions of medical marihuana by the registered producer during a particular period, on forms provided by the department. Reports shall be not more frequently than every month. Each report shall include for each such sale, delivery or distribution: the date, the quantity sold, delivered or distributed; and the name and address of the registered organization to which the sale, delivery or distribution was made.
3367. Evaluation; Research Programs; Report by Department
1. The commissioner may provide for the analysis and evaluation of the operation of this title. The commissioner may enter into agreements with one or more persons, not-for-profit corporations or other organizations, for the performance of an evaluation of the implementation and effectiveness of this title.
2. The department may develop, seek any necessary federal approval for, and carry out research programs relating to medical use of marihuana. Participation in any such research program shall be voluntary on the part of practitioners, patients, and designated caregivers.
3. The department shall report every two years, beginning two years after the effective date of this title, to the governor and the legislature on the medical use of marihuana under this title and make appropriate recommendations.
3368. Registered organization assessments.
1. Each registered organization shall be charged an assessment in the amount of seven and one-tenth percent of its gross receipts received from all medical marihuana sold, delivered or distributed, less refunds, on a cash basis. The assessment shall be submitted by or on behalf of the registered organization to the commissioner or his or her designee on a schedule to be determined by the commissioner.
2. The gross receipts tax owed by a registered organization under section twenty-eight hundred seven-d of this chapter, attributable to the sale, delivery or distribution of medical marihuana under this title, shall be deductible by the registered organization from any gross receipts assessment owed by it under this title.
3. The registered organization shall maintain the documentation necessary to establish what amount is owed pursuant to this section and such records shall be subject to audit by the commissioner or his or her designee.
4. No governmental agency operating as a registered organization shall pay an assessment pursuant to this section.
3369. Relation to other laws.
1. The provisions of this article shall apply to this title, except that where a provision of this title conflicts with another provision of this article, this title shall apply.
2. Nothing in this title shall be construed to require or prohibit an insurer or health plan under the insurance law or the public health law to provide coverage for medical marihuana. Nothing in this title shall be construed to require coverage for medical marihuana under article twenty-five of this chapter or article five of the social services law.
3. A person or entity shall not be subject to criminal or civil liability or professional discipline for acting reasonably and in good faith pursuant to this title.
Section 853 of the general business law is amended by adding a new subdivision 3 to read as follows:
(3) This article shall not apply to any sale, furnishing or possession which is for a lawful purpose under title five-A of article thirty-three of the public health law.
4. This act shall take effect immediately.