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AB-420 The California Cannabis Research Program.(2019-2020)

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Date Published: 06/11/2019 09:00 PM
AB420:v97#DOCUMENT

Amended  IN  Senate  June 11, 2019
Amended  IN  Senate  May 28, 2019

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Assembly Bill No. 420


Introduced by Assembly Members Lackey and Cooley
(Coauthor: Assembly Member Wood)
(Coauthor: Senator Wilk)

February 07, 2019


An act to amend Section 11362.9 Sections 11362.9 and 11480 of the Health and Safety Code, relating to cannabis, and declaring the urgency thereof, to take effect immediately.


LEGISLATIVE COUNSEL'S DIGEST


AB 420, as amended, Lackey. The California Cannabis Research Program.

If

(1) If the Regents of the University of California accept the responsibility, existing law requires the University of California to establish the California Cannabis Research Program, also sometimes referred to as the California Marijuana Research Program or the Center for Medicinal Cannabis Research, in order to develop and conduct studies intended to ascertain the general medical safety and efficacy of cannabis, among other duties. Existing law, the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA), an initiative statute approved by the voters at the November 8, 2016, statewide general election as Proposition 64, among other things, establishes the California Cannabis Tax Fund as a continuously appropriated fund consisting of specified taxes, interest, penalties, and other amounts imposed by AUMA. AUMA requires, after other specified disbursements are made from the fund, the Controller to disburse $2,000,000 to the University of California San Diego Center for Medicinal Cannabis Research.
This bill would specify that the program is hosted by the Center for Medicinal Cannabis Research. The bill would authorize the program to cultivate cannabis for its use in research, as specified. The bill would expand the purview of the program, which is funded by the California Cannabis Tax Fund, to include the study of naturally occurring constituents of cannabis and synthetic compounds and to require the program to develop and conduct studies to examine the effects of cannabis, cannabinoids, and related constituents, and other behavioral health outcomes. The bill would also authorize the controlled clinical trials to focus on examining testing methods for detecting harmful contaminants in cannabis, including mold and bacteria. The bill would require funds from the California Cannabis Tax Fund to be used only as authorized by the AUMA.
Existing law authorizes the program to 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 cannabis studies. Existing law prohibits the program from accepting funds that are offered with any conditions other than that the funds be used to study the efficacy and safety of cannabis as part of medical treatment. Existing law requires that a donor be advised that funds given for these purposes will be used to study both the possible benefits and detriments of cannabis and that the donor will have no control over the use of the funds.
The bill would specifically authorize the program to accept funds that may be used for the study, or support of the study, of the efficacy, mode of action, and safety of cannabis or natural or synthetic cannabinoids as part of medical treatment, and for the dissemination of information to inform health professionals and the public. The bill would also require nongovernmental donors to be given the specified advisory.
Existing law requires the President of the University of California to appoint a multidisciplinary Scientific Advisory Council to provide policy guidance in the creation and implementation of the program.
This bill would, instead, require the director of the center to appoint the members of the Scientific Advisory Council.
Existing law requires the program to report to the Legislature every 6 months detailing the progress of the studies.
This bill would, instead, require the program to report to the Legislature every 24 months.
(2) Existing law establishes a Research Advisory Panel that holds hearings on, and in other ways studies, research projects concerning cannabis or hallucinogenic drugs in this state. Existing law authorizes the panel to approve research projects, which have been registered by the Attorney General, into the nature and effects of cannabis or hallucinogenic drugs, and requires the panel to inform the Attorney General of the head of the approved research projects that are entitled to receive quantities of cannabis.
This bill would authorize the panel to authorize an institution conducting a research project to cultivate cannabis for the research project or to work with a commercial cannabis licensee to cultivate, test, manufacture, or procure cannabis or cannabis products for research projects.

This

(3) This bill would declare that it is to take effect immediately as an urgency statute.
Vote: 2/3   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 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 cannabis, its naturally occurring constituents, and synthetic compounds, 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 Cannabis Research Program, hosted by the Center for Medicinal Cannabis Research. Whenever “California Marijuana Research Program” appears in any statute, regulation, or contract, or in any other code, it shall be construed to refer to the California Cannabis Research Program.
(2) The program shall develop and conduct studies intended to ascertain the general medical safety and efficacy of cannabis and, if found valuable, shall develop medical guidelines for the appropriate administration and use of cannabis. The studies may examine the effect of cannabis on motor skills, the health and safety effects of cannabis, cannabinoids, and other related constituents, and other behavioral and health outcomes.
(b) The program may immediately solicit proposals for research projects to be included in the cannabis 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 the general medical efficacy and safety of cannabis.
(2) Proposals shall contain procedures for outreach to patients with various medical conditions who may be suitable participants in research on cannabis.
(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 cannabis, 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 cannabis.
(7) Proposals shall demonstrate the use of a laboratory capable of analyzing cannabis, 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 detection and analysis of various naturally occurring and synthetic cannabinoids, as well as 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, cannabis. 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 cannabis studies shall employ state-of-the-art research methodologies.
(j) The program shall ensure that all cannabis used in the studies is of the appropriate medicinal quality. Cannabis used by the program may be obtained from the National Institute on Drug Abuse or any other entity authorized by the appropriate federal agencies, the Attorney General pursuant to Section 11478, or may be cultivated by the program. program pursuant to Section 11480.
(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 cannabis as a pharmacological agent, the program shall conduct focused controlled clinical trials on the usefulness of cannabis 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 cannabis 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 cannabis or synthetic compounds that simulate the effects of naturally occurring cannabinoids. The studies may also focus on examining testing methods for detecting harmful contaminants in cannabis, including, but not limited to, mold, bacteria, and mycotoxins that could cause harm to patients.
(2) The program shall examine the safety of cannabis in patients with various medical disorders, including the interaction of cannabis 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 cannabis as part of medical treatment, and should not be construed as encouraging or sanctioning the social or recreational use of cannabis.
(m) (1) Subject to paragraph (2), the program shall, prior to 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 cannabis 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 cannabis 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 cannabis studies other cannabis 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 funds that are offered with any conditions other than that the funds be used to study the efficacy and safety of cannabis as part of medical treatment.
(3) The program may accept funds that may be used for the study, or support of the study, of the efficacy, mode of action, and safety of cannabis or natural or synthetic cannabinoids as part of medical treatment, and for the dissemination of information to inform health professionals and the public.
(4) A donor shall be advised that funds given for purposes of this section will be used to study both the possible benefits and detriments of cannabis or natural or synthetic cannabinoids and that the donor will have no control over the use of these funds. This paragraph applies to nongovernmental donors. Funding from governmental sources shall be governed by the rules of the funding agency.
(5) If funds are accepted to directly support clinical trials, the program shall adhere to the policies and procedures of the University of California that govern industry-sponsored trials.
(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 cannabis studies.
(2) Thereafter, the program shall issue a report to the Legislature every 24 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 director of the Center for Medicinal Cannabis Research 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.
(s) Money appropriated to the program pursuant to subdivision (e) of Section 34019 of the Revenue and Taxation Code shall only be used as authorized by the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA).

SEC. 2.

 Section 11480 of the Health and Safety Code is amended to read:

11480.
 (a) The Legislature finds that there is a need to encourage further research into the nature and effects of cannabis and hallucinogenic drugs and to coordinate research efforts on such those subjects.
(b) There is a Research Advisory Panel that consists of a representative of the State Department of Health Services, a representative of the California State Board of Pharmacy, the State Public Health Officer, a representative of the Attorney General, a representative of the University of California who shall be a pharmacologist, a physician, or a person holding a doctorate degree in the health sciences, a representative of a private university in this state who shall be a pharmacologist, a physician, or a person holding a doctorate degree in the health sciences, a representative of a statewide professional medical society in this state who shall be engaged in the private practice of medicine and shall be experienced in treating controlled substance dependency, a representative appointed by and serving at the pleasure of the Governor who shall have experience in drug abuse, cancer, or controlled substance research and who is either a registered nurse, licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code, or other health professional. The Governor shall annually designate the private university and the professional medical society represented on the panel. Members of the panel shall be appointed by the heads of the entities to be represented, and they shall serve at the pleasure of the appointing power.
(c) The Research Advisory Panel shall appoint two special members to the Research Advisory Panel, who shall serve at the pleasure of the Research Advisory Panel only during the period Article 6 (commencing with Section 11260) of Chapter 5 remains effective. The additional members shall be physicians and surgeons, and who are board certified in oncology, ophthalmology, or psychiatry.
(d) The panel shall annually select a chairperson from among its members.
(e) The panel may hold hearings on, and in other ways study, research projects concerning cannabis or hallucinogenic drugs in this state. Members of the panel shall serve without compensation, but shall be reimbursed for any actual and necessary expenses incurred in connection with the performance of their duties.
(f) (1) The panel may approve research projects, which have been registered by the Attorney General, into the nature and effects of cannabis or hallucinogenic drugs, and shall inform the Attorney General of the head of the approved research projects that are entitled to receive quantities of cannabis pursuant to Section 11478.
(2) The panel may authorize an institution conducting a research project, which is registered by the Attorney General, to cultivate cannabis for the research project or, notwithstanding any other law, to work with individuals licensed pursuant to Division 10 (commencing with Section 26000) of the Business and Professions Code to cultivate, test, manufacture, or procure cannabis or cannabis products for research projects.
(g) The panel may withdraw approval of a research project at any time, and when approval is withdrawn shall notify the head of the research project to return any quantities of cannabis to the Attorney General.
(h) The panel shall report annually to the Legislature and the Governor those research projects approved by the panel, the nature of each research project, and, where available, the conclusions of the research project.

SEC. 2.SEC. 3.

 This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:
In order to improve public health by allowing better research into the effects of cannabis, it is necessary for this act to take effect immediately.