Assembly Bill A7476

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  7476

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                              May 13, 2015
                               ___________

Introduced  by  M.  of  A.  GOTTFRIED  --  read once and referred to the
  Committee on Health

AN ACT to amend the public health law, in relation  to  medical  use  of
  marihuana; and repealing certain provisions of such law relating ther-
  eto

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  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 ille-
gal for any other use. The purposes of article 33 of the  public  health
law  include allowing legitimate medical use of controlled substances in
health care, including palliative care.
  Title 5-A of article 33 of the public health law, and  the  amendments
to  it  in  this  act, establish a medical model of care which regulates
medical marihuana as a recommended medicine in keeping  with  recognized
medical  public health and safety standards. This policy and this legis-
lation 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.
  Furthermore,  the  legislature finds that New York state has a signif-
icant and ongoing economic and non-regulatory interest in the  financial
viability  of  organizations  that  sell  marihuana for medical use. The

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD10875-01-5
              

A. 7476                             2

legislature finds that the financial  viability  of  such  organizations
would be greatly diminished and threatened by labor-management conflict,
such  as  a  strike  at a facility that cultivates marihuana, especially
because  of  the  need  for  enhanced  security concerning the products.
Replacements during a strike would be difficult  to  arrange  and  cause
delay  far  more  significant  than a strike elsewhere. Accordingly, the
legislature finds that  the  state  has  a  substantial  and  compelling
proprietary  interest  in  this  matter,  and  finds that labor peace is
essential for any organization to conduct business relating to the  sale
of medical marihuana.
  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; strong "seed to sale"  regulation  to
prevent  diversion,  abuse, and other illegal conduct; reasonable access
to and appropriate use of medical marihuana by certified patients; eval-
uation; and continuing research.
  S 2. Subdivisions 1, 7, 8, 12 and 15 of section  3360  of  the  public
health  law,  as added by chapter 90 of the laws of 2014, are amended 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 certif-
ication  under  this  title  including  enabling the patient to tolerate
treatment for the serious condition. [A certified medical use  does  not
include smoking.]
  7. [(a)] "Serious 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  sclerosis,
ALZHEIMER'S  DISEASE,  TRAUMATIC  BRAIN  INJURY,  DYSTONIA,  Parkinson's
disease, multiple sclerosis, damage to the nervous tissue of the  spinal
cord  with  objective neurological indication of intractable spasticity,
epilepsy, WASTING  SYNDROME,  CROHN'S  DISEASE,  POST  TRAUMATIC  STRESS
DISORDER,  RHEUMATOID  ARTHRITIS,  LUPUS,  inflammatory  bowel  disease,
neuropathies, Huntington's disease, 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.]
  8. "Medical marihuana" means marihuana as defined in subdivision twen-
ty-one of section thirty-three hundred two of this article, intended for
a  certified  medical  use[, as determined by the commissioner in his or
her sole discretion. Any form of medical marihuana not approved  by  the
commissioner is expressly prohibited].
  12. "Practitioner" means a practitioner who (i) is a physician, PHYSI-
CIAN  ASSISTANT OR NURSE PRACTITIONER, licensed OR CERTIFIED by New York
state and practicing within the state, ACTING WITHIN HIS OR  HER  LAWFUL
SCOPE  OF PRACTICE; (ii) [who] by training or experience is qualified to
treat a serious condition  as  defined  in  subdivision  seven  of  this

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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 commis-
sioner shall consider the inclusion of nurse  practitioners  under  this
title based upon considerations including access and availability. After
such  consideration the commissioner is authorized to deem nurse practi-
tioners as practitioners under this title.]
  15. "Individual dose" means a single measure of raw medical  marihuana
or non-infused concentrates to be determined and clearly identified by a
patient's  practitioner  for the patient's specific certified condition.
[For ingestible or sub-lingual medical marihuana products, no individual
dose may contain more than ten milligrams of tetrahydrocannabinol.]
  S 3. Subdivision 10 of section 3363 of the public health law, as added
by chapter 90 of the laws of 2014, is amended to read as follows:
  10. A registry identification card shall:
  (a) contain the name of the certified patient or the designated  care-
giver as the case may be;
  (b)  contain  the date of issuance and expiration date of the registry
identification card;
  (c) contain a registry identification number for the certified patient
or designated caregiver, as the case may be and a  registry  identifica-
tion number;
  (d)  contain a photograph of the individual to whom the registry iden-
tification card is being issued, which shall be obtained by the  depart-
ment in a manner specified by the commissioner in regulations; provided,
however,  that  if  the department requires 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  photo-
graphs;
  (e) be a secure document as determined by the department;
  (f) plainly state any recommendation or limitation by the practitioner
as to the form or forms of medical marihuana or dosage for the certified
patient; and
  (g)  any  other  requirements  determined by the commissioner IN REGU-
LATIONS.
  S 4. Subdivisions 4, 6 and 13 of section 3364  of  the  public  health
law, as added by chapter 90 of the laws of 2014, are amended and two new
subdivisions 14 and 15 are added to read as follows:
  4.  (a)  A  registered organization may lawfully, in good faith, sell,
deliver, distribute or dispense 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
name and registry identification number of the certified patient and the
designated  caregiver  (if  any);  the  date the marihuana was sold; any
recommendation or limitation by the practitioner as to the form or forms
of medical marihuana or dosage for the certified patient; and  the  form
and  the quantity of medical marihuana sold. The registered organization
shall retain a copy of the registry identification card and the  receipt
for six years.

A. 7476                             4

  (b)  The [proprietor of a] registered organization shall file or cause
to be filed any receipt and certification information with  the  depart-
ment  by electronic means on a real time basis as the commissioner shall
require by regulation. When filing receipt and certification information
electronically  pursuant to this paragraph, the proprietor of the regis-
tered  organization  shall  dispose  of  any   electronically   recorded
prescription  information  in  such  manner as the commissioner shall by
regulation require.
  6. When a registered  organization  sells,  delivers,  distributes  or
dispenses  medical  marihuana to a certified patient or designated care-
giver, 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 in individual doses,
  (b) any potential dangers stemming from the use of medical marihuana,
  (c) how to recognize what may be problematic usage of medical marihua-
na and obtain appropriate services or treatment for  problematic  usage,
and
  (d)   other   information   as   determined  by  the  commissioner  IN
REGULATIONS.
  13. The commissioner is authorized to  make  [rules  and]  regulations
restricting  the  advertising  and marketing of medical marihuana, which
shall be consistent with the federal regulations governing  prescription
drug advertising and marketing.
  14.  A REGISTERED ORGANIZATION MAY CONTRACT WITH A PERSON OR ENTITY TO
PROVIDE FACILITIES, EQUIPMENT OR SERVICES THAT ARE PART OF OR INCIDENTAL
TO THE REGISTERED ORGANIZATION'S  FUNCTIONS  OR  ACTIVITIES  UNDER  THIS
SECTION. ALL LAWS AND REGULATIONS APPLICABLE TO THE REGISTERED ORGANIZA-
TION  SHALL APPLY TO THE CONTRACT. THE REGISTERED ORGANIZATION AND OTHER
PARTIES TO THE CONTRACT SHALL EACH BE RESPONSIBLE  AND  ACCOUNTABLE  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.
  15. A REGISTERED ORGANIZATION  MAY  LAWFULLY,  IN  GOOD  FAITH,  SELL,
DELIVER,  OR  DISTRIBUTE MEDICAL MARIHUANA TO A REGISTERED ORGANIZATION,
IN ACCORDANCE WITH THE REGISTRATION OF BOTH REGISTERED ORGANIZATIONS.
  S 5. Subdivisions 1, 3, 8 and 9 of section 3365 of the  public  health
law,  as added by chapter 90 of the laws of 2014, are amended to read as
follows:
  1. Application for initial registration. (a) An applicant  for  regis-
tration  as a registered organization under section thirty-three hundred
sixty-four of this title shall include such information prepared in such
manner and detail as the commissioner may  require,  including  but  not
limited to:
  (i) a description of the activities in which it intends to engage as a
registered organization;
  (ii) that the applicant:
  (A) is of good moral character;
  (B)  possesses or has the right to use sufficient land, buildings, and
other premises (which shall be specified in the application) and  equip-
ment  to  properly  carry on the activity OR ACTIVITIES described in the
application, or in the alternative posts a bond of  not  less  than  two
million dollars;
  (C)  is  able  to  maintain  effective security and control to prevent
diversion, abuse, and other illegal conduct relating to the marihuana;

A. 7476                             5

  (D) is able to comply with all applicable state laws  and  regulations
relating  to  the  activities  in  which  it intends to engage under the
registration;
  (iii) that the applicant has entered into a labor peace agreement with
a  bona-fide labor organization that is actively engaged in representing
or attempting to represent the applicant's employees. The maintenance of
such a labor peace agreement shall be an ongoing material  condition  of
certification.
  (iv)  the  applicant's status under subdivision one of section thirty-
three hundred sixty-four of this title; and
  (v) 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 enti-
ty, shall submit an affidavit with the application setting forth:
  (A)  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;
  (B)  whether  such person or any such business has been convicted of a
felony or had a registration or license  suspended  or  revoked  in  any
administrative or judicial proceeding; and
  (C) such other information as the commissioner may reasonably require.
  3. Granting of registration. (a) The commissioner shall grant a regis-
tration  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 OR  ACTIVITIES
described in the application;
  (v)  it  is  in the public interest that such registration be granted;
the commissioner may consider whether the number of registered organiza-
tions in an area will be adequate or excessive to reasonably  serve  the
area;
  (vi) the applicant and its managing officers are of good moral charac-
ter;
  (vii)  the  applicant  has entered into a labor peace agreement with a
bona-fide labor organization that is actively engaged in representing or
attempting to represent the applicant's employees; and
  (viii) the applicant satisfies any other conditions as  determined  by
the commissioner.
  (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 addi-
tional material to the commissioner or demand a hearing, or both.
  (c) The fee for a registration under this section shall be  a  reason-
able  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.

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  (d)  Registrations  issued  under this section shall be effective only
for the registered organization and shall specify:
  (i) the name and address of the registered organization;
  (ii)  which  activities  of a registered organization are permitted by
the registration;
  (iii) the land, buildings and facilities that  may  be  used  for  the
permitted activities of the registered organization; and
  (iv)  such  other  information  as  the  commissioner shall reasonably
provide to assure compliance with this title.
  (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
or  facilities.  The  fee  for such amendment shall be two hundred fifty
dollars.
  8. The department shall begin  issuing  registrations  for  registered
organizations  as soon as practicable after the [certifications] CERTIF-
ICATION required by section thirty-three hundred  sixty-nine-b  of  this
title [are] IS given.
  9.  The  commissioner  shall  register  [no more than five] registered
organizations [that manufacture medical marihuana with no more than four
dispensing sites wholly owned and operated by such registered  organiza-
tion]  AND  FACILITIES TO PROMOTE REASONABLE ACCESS TO MEDICAL MARIHUANA
IN THE INTEREST OF CERTIFIED PATIENTS AND THE PUBLIC. DURING  THE  FIRST
TWO YEARS AFTER THIS TITLE TAKES EFFECT, THE COMMISSIONER SHALL REGISTER
NO  MORE  THAN  TWENTY REGISTERED ORGANIZATIONS THAT MANUFACTURE MEDICAL
MARIHUANA. The commissioner shall ensure that [such]  registered  organ-
izations  and dispensing sites are geographically distributed across the
state AND SHALL NOT REQUIRE THAT DISPENSING SITES BE OWNED  OR  OPERATED
BY   THE   REGISTERED   ORGANIZATION  LICENSED  TO  MANUFACTURE  MEDICAL
MARIHUANA. [The commission may register additional registered  organiza-
tions.]
  S  6. Section 3369 of the public health law is amended by adding a new
subdivision 5 to read as follows:
  5. A REGISTRY IDENTIFICATION CARD, OR ITS EQUIVALENT, THAT  IS  ISSUED
UNDER  THE  LAWS OF ANOTHER STATE, DISTRICT, TERRITORY, COMMONWEALTH, OR
POSSESSION OF THE UNITED STATES THAT ALLOWS THE MEDICAL USE OF MARIHUANA
HAS THE SAME FORCE AND EFFECT AS A REGISTRY IDENTIFICATION  CARD  ISSUED
BY  THE  DEPARTMENT,  SO  LONG  AS THE VISITING PATIENT'S CONDITION IS A
SERIOUS CONDITION, AS ATTESTED TO IN WRITING BY A PRACTITIONER. WHERE  A
REGISTERED  ORGANIZATION  DISPENSES MEDICAL MARIHUANA TO A PATIENT UNDER
THIS SUBDIVISION, A COPY OF THE ATTESTATION SHALL  BE  PROVIDED  TO  THE
REGISTERED ORGANIZATION.
  S  7.  Section 3369-a of the public health law, as added by chapter 90
of the laws of 2014, is amended to read as follows:
  S 3369-a. Regulations. 1. The commissioner shall make  regulations  to
implement  this title.  REGULATIONS UNDER THIS TITLE SHALL BE REASONABLE
AND CONSISTENT WITH THIS TITLE, THE LEGISLATIVE INTENT,  AND  VERIFIABLE
CLINICAL, LEGAL OR PUBLIC SAFETY CONSIDERATIONS.
  2. THERE IS HEREBY ESTABLISHED IN THE DEPARTMENT AN ADVISORY COMMITTEE
ON  MEDICAL  USE  OF  MARIHUANA (THE "ADVISORY COMMITTEE") TO ADVISE THE
COMMISSIONER ON MAKING REGULATIONS UNDER THIS TITLE AND ON  ANY  MATTERS
RELATING  TO  THE IMPLEMENTATION OF THIS TITLE AS THE COMMISSIONER SHALL
DETERMINE. THE ADVISORY COMMITTEE SHALL CONSIST OF FIFTEEN MEMBERS.  THE
MEMBERS  OF  THE ADVISORY COMMITTEE SHALL BE APPOINTED AS FOLLOWS: EIGHT
TO BE APPOINTED BY THE GOVERNOR, TWO TO BE APPOINTED BY THE GOVERNOR  ON
THE  RECOMMENDATION  OF THE TEMPORARY PRESIDENT OF THE SENATE, ONE TO BE

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APPOINTED BY THE GOVERNOR ON THE RECOMMENDATION OF THE  MINORITY  LEADER
OF THE SENATE, TWO TO BE APPOINTED BY THE GOVERNOR ON THE RECOMMENDATION
OF  THE  SPEAKER OF THE ASSEMBLY, ONE TO BE APPOINTED BY THE GOVERNOR ON
THE RECOMMENDATION OF THE MINORITY LEADER OF THE ASSEMBLY, AND ONE TO BE
APPOINTED  BY THE GOVERNOR ON THE RECOMMENDATION OF THE ATTORNEY GENERAL
OF THE STATE OF NEW YORK. THE ADVISORY COMMITTEE SHALL INCLUDE  BUT  NOT
BE LIMITED TO: HEALTH CARE PRACTITIONERS, PATIENTS OR REPRESENTATIVES OF
PATIENTS   WITH   SERIOUS  CONDITIONS,  EXPERTS  IN  THE  REGULATION  OF
CONTROLLED  SUBSTANCES  FOR  MEDICAL  USE,  MEDICAL  MARIHUANA  INDUSTRY
PROFESSIONALS  AND  LAW  ENFORCEMENT.  THE  ADVISORY  COMMITTEE SHALL BE
RESPONSIBLE FOR REVIEWING THE APPEAL OF ANY PATIENT OR  CAREGIVER  WHOSE
REGISTRY  APPLICATION  HAS  BEEN  DENIED BY THE DEPARTMENT. THE ADVISORY
COMMITTEE SHALL MAKE RECOMMENDATIONS REGARDING ANY SUCH  APPEAL  TO  THE
COMMISSIONER,  WHO  SHALL MAKE THE FINAL DETERMINATION. THE COMMISSIONER
MAY ALSO FORM SUBCOMMITTEES OF THE ADVISORY COMMITTEE.  THE COMMISSIONER
SHALL FORM A SUBCOMMITTEE TO ASSIST AND ADVISE THE COMMISSIONER AND  THE
ADVISORY  COMMITTEE  ON  CLINICAL MATTERS RELATING TO MEDICAL MARIHUANA,
INCLUDING BUT NOT LIMITED TO EXPANDING OR RETRACTING THE  CATEGORIES  OF
DISEASES TO BE CONSIDERED SERIOUS CONDITIONS FOR PURPOSES OF THIS TITLE,
THE  MEMBERS  OF  WHICH SHALL PREDOMINANTLY BE CLINICAL PROFESSIONALS IN
APPROPRIATE AREAS OF EXPERTISE AND SHALL ALSO INCLUDE REPRESENTATIVES OF
PATIENTS AND THE GENERAL PUBLIC. MEMBERS OF A SUBCOMMITTEE NEED  NOT  BE
MEMBERS  OF  THE  ADVISORY  COMMITTEE. MEMBERS OF THE ADVISORY COMMITTEE
SHALL SERVE FOR A TERM OF FOUR YEARS. MEMBERS OF  A  SUBCOMMITTEE  SHALL
SERVE  AT  THE  PLEASURE  OF  THE  COMMISSIONER. MEMBERS OF THE ADVISORY
COMMITTEE OR A SUBCOMMITTEE MAY RECEIVE REIMBURSEMENT BY THE  DEPARTMENT
FOR  THEIR  REASONABLE AND NECESSARY EXPENSES INCURRED AS MEMBERS OF THE
ADVISORY COMMITTEE OR A SUBCOMMITTEE. A PUBLIC EMPLOYEE MAY BE A  MEMBER
OF THE ADVISORY COMMITTEE OR A SUBCOMMITTEE.
  S  8.  Section 3369-b of the public health law, as added by chapter 90
of the laws of 2014, is amended to read as follows:
  S 3369-b. Effective date. Registry identification cards or  registered
organization  registrations shall be issued or become effective no later
than eighteen months from signing or until such time as the commissioner
[and the superintendent of state police  certify]  CERTIFIES  that  this
title  can  be  implemented  in accordance with public health and safety
interests, whichever event comes later.
  S 9. Sections 3369-c and 3369-d of the public health law are  REPEALED
and section 3369-e is renumbered section 3369-c.
  S 10. This act shall take effect immediately; provided that the amend-
ments  to  title  5-a  of  article  33  of the public health law made by
sections two through nine of this act shall not  affect  the  expiration
and  repeal of such title and shall expire and be deemed repealed there-
with.