Bill Text: CA AB2679 | 2015-2016 | Regular Session | Chaptered
Bill Title: Medical marijuana: regulation: research.
Spectrum: Moderate Partisan Bill (Democrat 5-1)
Status: (Passed) 2016-09-29 - Chaptered by Secretary of State - Chapter 828, Statutes of 2016. [AB2679 Detail]
Download: California-2015-AB2679-Chaptered.html
BILL NUMBER: AB 2679 CHAPTERED
BILL TEXT
CHAPTER 828
FILED WITH SECRETARY OF STATE SEPTEMBER 29, 2016
APPROVED BY GOVERNOR SEPTEMBER 29, 2016
PASSED THE SENATE AUGUST 29, 2016
PASSED THE ASSEMBLY AUGUST 31, 2016
AMENDED IN SENATE AUGUST 19, 2016
AMENDED IN ASSEMBLY MARCH 18, 2016
INTRODUCED BY Assembly Members Cooley, Bonta, Jones-Sawyer, Lackey,
and Wood
(Coauthor: Assembly Member McCarty)
FEBRUARY 19, 2016
An act to amend Section 19353 of the Business and Professions
Code, and to amend Sections 11362.775 and 11362.9 of the Health and
Safety Code, relating to medical marijuana.
LEGISLATIVE COUNSEL'S DIGEST
AB 2679, Cooley. Medical marijuana: regulation: research.
(1) Existing law, the Medical Marijuana Regulation and Safety Act
(MMRSA), provides for the licensure of persons engaged in specified
activities relating to medical marijuana and establishes other
regulatory provisions. That act also requires each licensing
authority to prepare and submit to the Legislature an annual report
on the authority's activities and post the report on the authority's
Internet Web site.
This bill would require the report to also include the number of
appeals from the denial of state licenses or other disciplinary
actions taken by the licensing authority, the average time spent on
these appeals, and the number of complaints submitted by citizens or
representatives of cities or counties regarding licensees, as
specified.
(2) Existing law authorizes the creation by the University of
California of the California Marijuana Research Program, the purpose
of which is to develop and conduct studies intended to ascertain the
general medical safety and efficacy of marijuana, and if found
valuable, to develop medical guidelines for the appropriate
administration and use of marijuana.
This bill would specify that the studies may include studies to
ascertain the effect of marijuana on motor skills.
(3) Existing law, until one year after the Bureau of Medical
Cannabis Regulation posts a notice on its Internet Web site that
licensing authorities have commenced issuing licenses pursuant to the
MMRSA, exempts cooperatives and collectives who cultivate medical
cannabis for qualified patients from criminal sanctions for specified
activities related to the growing, sale, and distribution of
marijuana.
This bill, during that same period, would exempt collectives and
cooperatives that manufacture medical cannabis products from criminal
sanctions for manufacturing medical cannabis if the cooperative or
collective meets specified requirements, including using specified
manufacturing processes and possessing a valid local license, permit,
or other authorization.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 19353 of the Business and Professions Code is
amended to read:
19353. Beginning on March 1, 2023, and on or before March 1 of
each year thereafter, each licensing authority shall prepare and
submit to the Legislature an annual report on the authority's
activities, in compliance with Section 9795 of the Government Code,
and post the report on the authority's Internet Web site. The report
shall include, but not be limited to, the following information for
the previous fiscal year:
(a) The amount of funds allocated and spent by the licensing
authority for medical cannabis licensing, enforcement, and
administration.
(b) The number of state licenses issued, renewed, denied,
suspended, and revoked, by state license category.
(c) The average time for processing state license applications, by
state license category.
(d) The number of appeals from the denial of state licenses or
other disciplinary actions taken by the licensing authority and the
average time spent on these appeals.
(e) The number of complaints submitted by citizens or
representatives of cities or counties regarding licensees, provided
as both a comprehensive statewide number and by geographical region.
(f) The number and type of enforcement activities conducted by the
licensing authorities and by local law enforcement agencies in
conjunction with the licensing authorities or the bureau.
(g) The number, type, and amount of penalties, fines, and other
disciplinary actions taken by the licensing authorities.
SEC. 2. Section 11362.775 of the Health and Safety Code is amended
to read:
11362.775. (a) Subject to subdivision (d), qualified patients,
persons with valid identification cards, and the designated primary
caregivers of qualified patients and persons with identification
cards, who associate within the State of California in order
collectively or cooperatively to cultivate cannabis for medical
purposes, shall not solely on the basis of that fact be subject to
state criminal sanctions under Section 11357, 11358, 11359, 11360,
11366, 11366.5, or 11570.
(b) A collective or cooperative that operates pursuant to this
section and manufactures medical cannabis products shall not, solely
on the basis of that fact, be subject to state criminal sanctions
under Section 11379.6 if the collective or cooperative abides by all
of the following requirements:
(1) The collective or cooperative does either or both of the
following:
(A) Utilizes only manufacturing processes that are either
solventless or that employ only nonflammable, nontoxic solvents that
are generally recognized as safe pursuant to the federal Food, Drug,
and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(B) Utilizes only manufacturing processes that use solvents
exclusively within a closed-loop system that meets all of the
following requirements:
(i) The system uses only solvents that are generally recognized as
safe pursuant to the federal Food, Drug, and Cosmetic Act (21 U.S.C.
Sec. 301 et seq.).
(ii) The system is designed to recapture and contain solvents
during the manufacturing process, and otherwise prevent the
off-gassing of solvents into the ambient atmosphere to mitigate the
risks of ignition and explosion during the manufacturing process.
(iii) A licensed engineer certifies that the system was
commercially manufactured, safe for its intended use, and built to
codes of recognized and generally accepted good engineering
practices, including, but not limited to, the American Society of
Mechanical Engineers (ASME), the American National Standards
Institute (ANSI), Underwriters Laboratories (UL), the American
Society for Testing and Materials (ASTM), or OSHA Nationally
Recognized Testing Laboratories (NRTLs).
(iv) The system has a certification document that contains the
signature and stamp of a professional engineer and the serial number
of the extraction unit being certified.
(2) The collective or cooperative receives and maintains approval
from the local fire official for the closed-loop system, other
equipment, the extraction operation, and the facility.
(3) The collective or cooperative meets required fire, safety, and
building code requirements in one or more of the following:
(A) The California Fire Code.
(B) The National Fire Protection Association (NFPA) standards.
(C) International Building Code (IBC).
(D) The International Fire Code (IFC).
(E) Other applicable standards, including complying with all
applicable fire, safety, and building codes in processing, handling,
and storage of solvents or gasses.
(4) The collective or cooperative is in possession of a valid
seller's permit issued by the State Board of Equalization.
(5) The collective or cooperative is in possession of a valid
local license, permit, or other authorization specific to the
manufacturing of medical cannabis products, and in compliance with
any additional conditions imposed by the city or county issuing the
local license, permit, or other authorization.
(c) For purposes of this section, "manufacturing" means
compounding, converting, producing, deriving, processing, or
preparing, either directly or indirectly by chemical extraction or
independently by means of chemical synthesis, medical cannabis
products.
(d) This section shall remain in effect only until one year after
the Bureau of Medical Cannabis Regulation posts a notice on its
Internet Web site that the licensing authorities have commenced
issuing licenses pursuant to the Medical Cannabis Regulation and
Safety Act (Chapter 3.5 (commencing with Section 19300) of Division 8
of the Business and Professions Code).
(e) This section is repealed one year after the date upon which
the notice is posted pursuant to subdivision (d).
SEC. 3. Section 11362.9 of the Health and Safety Code is amended
to read:
11362.9. (a) (1) It is the intent of the Legislature that the
state commission objective scientific research by the premier
research institute of the world, the University of California,
regarding the efficacy and safety of administering marijuana as part
of medical treatment. If the Regents of the University of California,
by appropriate resolution, accept this responsibility, the
University of California shall create a program, to be known as the
California Marijuana Research Program.
(2) The program shall develop and conduct studies intended to
ascertain the general medical safety and efficacy of marijuana and,
if found valuable, shall develop medical guidelines for the
appropriate administration and use of marijuana. The studies may
include studies to ascertain the effect of marijuana on motor skills.
(b) The program may immediately solicit proposals for research
projects to be included in the marijuana studies. Program
requirements to be used when evaluating responses to its solicitation
for proposals, shall include, but not be limited to, all of the
following:
(1) Proposals shall demonstrate the use of key personnel,
including clinicians or scientists and support personnel, who are
prepared to develop a program of research regarding marijuana's
general medical efficacy and safety.
(2) Proposals shall contain procedures for outreach to patients
with various medical conditions who may be suitable participants in
research on marijuana.
(3) Proposals shall contain provisions for a patient registry.
(4) Proposals shall contain provisions for an information system
that is designed to record information about possible study
participants, investigators, and clinicians, and deposit and analyze
data that accrues as part of clinical trials.
(5) Proposals shall contain protocols suitable for research on
marijuana, addressing patients diagnosed with acquired
immunodeficiency syndrome (AIDS) or human immunodeficiency virus
(HIV), cancer, glaucoma, or seizures or muscle spasms associated with
a chronic, debilitating condition. The proposal may also include
research on other serious illnesses, provided that resources are
available and medical information justifies the research.
(6) Proposals shall demonstrate the use of a specimen laboratory
capable of housing plasma, urine, and other specimens necessary to
study the concentration of cannabinoids in various tissues, as well
as housing specimens for studies of toxic effects of marijuana.
(7) Proposals shall demonstrate the use of a laboratory capable of
analyzing marijuana, provided to the program under this section, for
purity and cannabinoid content and the capacity to detect
contaminants.
(c) In order to ensure objectivity in evaluating proposals, the
program shall use a peer review process that is modeled on the
process used by the National Institutes of Health, and that guards
against funding research that is biased in favor of or against
particular outcomes. Peer reviewers shall be selected for their
expertise in the scientific substance and methods of the proposed
research, and their lack of bias or conflict of interest regarding
the applicants or the topic of an approach taken in the proposed
research. Peer reviewers shall judge research proposals on several
criteria, foremost among which shall be both of the following:
(1) The scientific merit of the research plan, including whether
the research design and experimental procedures are potentially
biased for or against a particular outcome.
(2) Researchers' expertise in the scientific substance and methods
of the proposed research, and their lack of bias or conflict of
interest regarding the topic of, and the approach taken in, the
proposed research.
(d) If the program is administered by the Regents of the
University of California, any grant research proposals approved by
the program shall also require review and approval by the research
advisory panel.
(e) It is the intent of the Legislature that the program be
established as follows:
(1) The program shall be located at one or more University of
California campuses that have a core of faculty experienced in
organizing multidisciplinary scientific endeavors and, in particular,
strong experience in clinical trials involving psychopharmacologic
agents. The campuses at which research under the auspices of the
program is to take place shall accommodate the administrative
offices, including the director of the program, as well as a data
management unit, and facilities for storage of specimens.
(2) When awarding grants under this section, the program shall
utilize principles and parameters of the other well-tested statewide
research programs administered by the University of California,
modeled after programs administered by the National Institutes of
Health, including peer review evaluation of the scientific merit of
applications.
(3) The scientific and clinical operations of the program shall
occur, partly at University of California campuses, and partly at
other postsecondary institutions, that have clinicians or scientists
with expertise to conduct the required studies. Criteria for
selection of research locations shall include the elements listed in
subdivision (b) and, additionally, shall give particular weight to
the organizational plan, leadership qualities of the program
director, and plans to involve investigators and patient populations
from multiple sites.
(4) The funds received by the program shall be allocated to
various research studies in accordance with a scientific plan
developed by the Scientific Advisory Council. As the first wave of
studies is completed, it is anticipated that the program will receive
requests for funding of additional studies. These requests shall be
reviewed by the Scientific Advisory Council.
(5) The size, scope, and number of studies funded shall be
commensurate with the amount of appropriated and available program
funding.
(f) All personnel involved in implementing approved proposals
shall be authorized as required by Section 11604.
(g) Studies conducted pursuant to this section shall include the
greatest amount of new scientific research possible on the medical
uses of, and medical hazards associated with, marijuana. The program
shall consult with the Research Advisory Panel analogous agencies in
other states, and appropriate federal agencies in an attempt to avoid
duplicative research and the wasting of research dollars.
(h) The program shall make every effort to recruit qualified
patients and qualified physicians from throughout the state.
(i) The marijuana studies shall employ state-of-the-art research
methodologies.
(j) The program shall ensure that all marijuana used in the
studies is of the appropriate medical quality and shall be obtained
from the National Institute on Drug Abuse or any other federal agency
designated to supply marijuana for authorized research. If these
federal agencies fail to provide a supply of adequate quality and
quantity within six months of the effective date of this section, the
Attorney General shall provide an adequate supply pursuant to
Section 11478.
(k) The program may review, approve, or incorporate studies and
research by independent groups presenting scientifically valid
protocols for medical research, regardless of whether the areas of
study are being researched by the committee.
( l ) (1) To enhance understanding of the efficacy and
adverse effects of marijuana as a pharmacological agent, the program
shall conduct focused controlled clinical trials on the usefulness of
marijuana in patients diagnosed with AIDS or HIV, cancer, glaucoma,
or seizures or muscle spasms associated with a chronic, debilitating
condition. The program may add research on other serious illnesses,
provided that resources are available and medical information
justifies the research. The studies shall focus on comparisons of
both the efficacy and safety of methods of administering the drug to
patients, including inhalational, tinctural, and oral, evaluate
possible uses of marijuana as a primary or adjunctive treatment, and
develop further information on optimal dosage, timing, mode of
administration, and variations in the effects of different
cannabinoids and varieties of marijuana.
(2) The program shall examine the safety of marijuana in patients
with various medical disorders, including marijuana's interaction
with other drugs, relative safety of inhalation versus oral forms,
and the effects on mental function in medically ill persons.
(3) The program shall be limited to providing for objective
scientific research to ascertain the efficacy and safety of marijuana
as part of medical treatment, and should not be construed as
encouraging or sanctioning the social or recreational use of
marijuana.
(m) (1) Subject to paragraph (2), the program shall, prior to any
approving proposals, seek to obtain research protocol guidelines from
the National Institutes of Health and shall, if the National
Institutes of Health issues research protocol guidelines, comply with
those guidelines.
(2) If, after a reasonable period of time of not less than six
months and not more than a year has elapsed from the date the program
seeks to obtain guidelines pursuant to paragraph (1), no guidelines
have been approved, the program may proceed using the research
protocol guidelines it develops.
(n) In order to maximize the scope and size of the marijuana
studies, the program may do any of the following:
(1) Solicit, apply for, and accept funds from foundations, private
individuals, and all other funding sources that can be used to
expand the scope or timeframe of the marijuana studies that are
authorized under this section. The program shall not expend more than
5 percent of its General Fund allocation in efforts to obtain money
from outside sources.
(2) Include within the scope of the marijuana studies other
marijuana research projects that are independently funded and that
meet the requirements set forth in subdivisions (a) to (c),
inclusive. In no case shall the program accept any funds that are
offered with any conditions other than that the funds be used to
study the efficacy and safety of marijuana as part of medical
treatment. Any donor shall be advised that funds given for purposes
of this section will be used to study both the possible benefits and
detriments of marijuana and that he or she will have no control over
the use of these funds.
(o) (1) Within six months of the effective date of this section,
the program shall report to the Legislature, the Governor, and the
Attorney General on the progress of the marijuana studies.
(2) Thereafter, the program shall issue a report to the
Legislature every six months detailing the progress of the studies.
The interim reports required under this paragraph shall include, but
not be limited to, data on all of the following:
(A) The names and number of diseases or conditions under study.
(B) The number of patients enrolled in each study by disease.
(C) Any scientifically valid preliminary findings.
(p) If the Regents of the University of California implement this
section, the President of the University of California shall appoint
a multidisciplinary Scientific Advisory Council, not to exceed 15
members, to provide policy guidance in the creation and
implementation of the program. Members shall be chosen on the basis
of scientific expertise. Members of the council shall serve on a
voluntary basis, with reimbursement for expenses incurred in the
course of their participation. The members shall be reimbursed for
travel and other necessary expenses incurred in their performance of
the duties of the council.
(q) No more than 10 percent of the total funds appropriated may be
used for all aspects of the administration of this section.
(r) This section shall be implemented only to the extent that
funding for its purposes is appropriated by the Legislature in the
annual Budget Act.
