State of California DRAFT RESOLUTION CALIFORNIA HEPATITIS C TASK FORCE
AN INITIATIVE FOR FEDERAL ASSISTANCE FOR COUNTY HCV COMMUNITY PROGRAMS
DECLARATION OF STATE OF HEALTH EMERGENCY
Resolution in support of Federal funding for California Counties Department
of Health Services between county HCV task forces and the local community
partnerships for testing, training, education, prevention, medical/Health
providers in recognition that this approach will best control the Hepatitis
C epidemic in California.
WHEREAS California’s public and private healthcare systems have
experienced increased demand for Hepatitis C services, including patient
and provider education and case management, and are under great economic
pressure to treat Hepatitis C, a life threatening liver disease affecting
over 1.8 percent of our population and estimated by the CDC, as affecting
over 600,000 Californians;
WHEREAS Hepatitis C affects Californians from all walks of life,
we believe, endorse and encourage the formation and implementation
of county task forces to address prevention, education, support,
and treatment for all California residents affected by this disease.
We affirm the principal that a community response in the form of
partnerships between federal, state, and county governments, policy
makers, health care providers, educators, the private sector, and
community based organizations is an effective way to reduce present
and future costs to communities and create new resources to eradicate
WHEREAS The Hepatitis C Strategic Plan: A Collaborative Approach
to the Emerging Epidemic in California (2001), developed by the Steering
Committee and Working Group for the Prevention and Control of Hepatitis
C in California, recommends the formation of community task forces
to address Hepatitis C prevention and control;
WHEREAS the leadership of the County Departments of Health in partnership
with local agencies has created model HCV Task Forces that encourage
cooperative efforts as a community response to this major health
WHEREAS the Board of Supervisors of many counties endorse this initiative
as a vital means to combat this epidemic through prevention and control
and to help restore community's financial health in the face of great
costs to treat this disease;
WHEREAS it is further noted that the Surgeon General of the United
States and the three previous Surgeon Generals have declared this
epidemic to be a major national health concern;
WHEREAS The State of California, Governor, Lt. Governor and the State
Senate and State Assembly unanimously support and encourage action
by our federal branches of government to assist and support federal
funding to California counties for their programs to effectively
reduce the spread of Hepatitis C that affects over 600,000 Californians;
RESOLVED That the State of California in recognition of this initiative,
further convey to the President of the United States therefore be
RESOLVED That California requires Emergency Federal assistance to
address Hepatitis C as a Public Health State of Emergency
By my hand and seal: Governor of the State of California
(California State Seal)
(Draft by Bill Remak revised 1/29/03)
CALIFORNIANS FOR STEM CELL RESEARCH AND CURES
YES! I support the California Stem Cell Research and Cures Initiative,
which will provide funds needed for the development of lifesaving
therapies and disease cures that could save the lives of millions
of California children and adults. You may list me publicly as a
member of the statewide coalition formed to pass this important measure.
*Name of Individual (please print) **Title (if applicable)
**Organization (if applicable) **Other Titles
(e.g., board members, past presidents, etc.)
*Mailing Address City Zip County
Signature Date Signed
Daytime Phone E-mail address
*Information required by California law for those making contributions
**For identification purposes only
Q YES! I am willing to support this effort in other ways. Please
contact me about how I may help. Q Contact by Phone Q Contact
Q I would like to make a contribution to the campaign. Enclosed is
a check for $______________.
Q I am willing to send letters to the editor of local newspapers.
Q Please add me to your volunteer list so I may hand out campaign
literature and recruit others to join the coalition.
Q Please add me to your speakers list so I may help by attending
events in and around my community.
Q Please add me to your e-mail alert list so I may receive regular
updates and pass them on to people in my e-mail address book.
Please mail or fax this completed form to:
Californians for Stem Cell Research and Cures
1438 N. Gower Street, Box 37
Los Angeles, CA 90028
Phone: (323) 468-3391
Fax: (323) 468-3393
Contributions to this committee are not tax deductible for federal
or state income tax purposes
ABOUT SIGNING THE MEMBERSHIP FORM
1. By signing the form, you are simply confirming that you can be listed
with other citizens who support the proposed initiative measure. This
is the only position and the only issue with which your name will be
2. The citizens on the list will include a broad-based coalition of
academic, civic, healthcare, public safety, business, and labor leaders
and other citizens from all walks of life.
3. Lists of citizens, businesses, and organizations supporting the
initiative measure may be used in association with materials such as
fact sheets, brochures, and possibly in advertisements about the amendment
and the measure. All statements in such materials will be based on
verifiable facts and information.
4. All lists will note that titles and affiliations of the citizens
included are provided for identification only.
5. Signing the position form does not obligate you to contribute time
or money to any campaign, or attend any meetings, or make any public
statements. More active involvement in efforts to support passage of
the proposed initiative measure or financial contributions to support
such efforts are welcomed, but are entirely voluntary.
6. Any public relations or political activities undertaken in support
of the proposed initiative measure will be conducted in strict compliance
with the spirit and letter of all relevant state laws, regulations,
and ethical standards.
CALIFORNIA STEM CELL RESEARCH AND CURES INITIATIVE
SEC. 1. TITLE
This measure shall be known as the “California Stem Cell Research and
SEC. 2. FINDINGS AND DECLARATIONS
The people of California find and declare the following:
Millions of children and adults suffer from devastating diseases or injury
that are currently incurable, including Cancer, Diabetes, Heart Disease, Alzheimer’s,
Parkinson’s, Spinal Cord injuries, Blindness, Lou Gehrig’s Disease,
HIV/AIDS, Mental Health disorders, Multiple Sclerosis, Huntington’s Disease
and more than 70 other diseases and injuries.
Recently medical science has discovered a new way to attack chronic diseases
and injuries. The cure and treatment of these diseases can potentially be accomplished
through the use of new regenerative medical therapies including a special type
of human cells, called stem cells. These life-saving medical breakthroughs
can only happen if adequate funding is made available to advance stem cell
research, develop therapies, and conduct clinical trials.
About half of California’s families have a child or adult who has suffered
or will suffer from a serious, often critical or terminal medical condition
that could potentially be treated or cured with stem cell therapies. In these
cases of chronic illness or when patients face a medical crisis, the healthcare
system may simply not be able to meet the needs of patients or control spiraling
costs unless therapy focus switches away from maintenance and toward prevention
Unfortunately, the federal government is not providing adequate funding necessary
for the urgent research and facilities needed to develop stem cell therapies
to treat and cure diseases and serious injuries. This critical funding gap
currently prevents the rapid advancement of research that could benefit millions
The California Stem Cell Research and Cures Act will close this funding gap
by establishing an Institute which will issue bonds to support stem cell research,
emphasizing pluripotent stem cell and progenitor cell research and other vital
medical technologies, for the development of life-saving regenerative medical
treatments and cures.
SEC. 3. PURPOSE AND INTENT
It is the intent of the people of California in enacting this measure to:
- Authorize an average of $295 million per year in bonds over a 10-year period
to fund stem cell research and dedicated facilities for scientists at California’s
universities and other advanced medical research facilities throughout the
- Maximize the use of research funds by giving priority to stem cell research
that has the greatest potential for therapies and cures, specifically focused
on pluripotent stem cell and progenitor cell research among other vital research
opportunities that cannot, or are unlikely to receive timely or sufficient
federal funding, unencumbered by limitations that would impede the research.
Research shall be subject to accepted patient disclosure and patient consent
- Assure that the research is conducted safely and ethically by including provisions
to require compliance with standards based on national models that protect
patient safety, patient rights and patient privacy.
- Prohibit the use of bond proceeds of this initiative for funding for human
- Improve the California healthcare system and reduce the long-term healthcare
cost burden on California through the development of therapies that treat diseases
and injuries with the ultimate goal to cure them.
- Require strict fiscal and public accountability through mandatory independent
audits, open meetings, public hearings and annual reports to the public. Create
an Independent Citizen’s Oversight Committee composed of representatives
of the University of California campuses with medical schools; other California
universities and California medical research institutions; California disease
advocacy groups; and California experts in the development of medical therapies.
- Protect and benefit the California budget: by postponing general fund payments
on the bonds for the first five years; by funding scientific and medical research
that will significantly reduce state health care costs in the future; and by
providing an opportunity for the state to benefit from royalties, patents,
and licensing fees that result from the research.
- Benefit the California economy by creating projects, jobs, and therapies
that will generate millions of dollars in new tax revenues in our state.
- Advance the biotech industry in California to world leadership, as an economic
engine for California’s future.
SEC. 4. Article XXXV is added to the California Constitution to read:
Section 1 There is hereby established the California Institute for Regenerative
Section 2 The Institute shall have the following purposes:
(a) To make grants and loans for stem cell research, for research facilities
and for other vital research opportunities to realize therapies, protocols,
and/or medical procedures that will result in, as speedily as possible, the
cure for, and/or substantial mitigation of, major diseases, injuries and orphan
(b) To support all stages of the process of developing cures, from laboratory
research through successful clinical trials.
(c) To establish the appropriate regulatory standards and oversight bodies
for research and facilities development.
Section 3 No funds authorized for, or made available to, the Institute shall
be used for research involving human reproductive cloning.
Section 4 Funds authorized for, or made available to, the Institute shall be
continuously appropriated without regard to fiscal year, be available and used
only for the purposes provided herein, and shall not be subject to appropriation
or transfer by the Legislature or the Governor for any other purpose.
Section 5 There is hereby established a right to conduct stem cell research
which includes research involving adult stem cells, cord blood stem cells,
pluripotent stem cells and/or progenitor cells. Pluripotent stem cells are
cells that are capable of self-renewal, and have broad potential to differentiate
into multiple adult cell types. Pluripotent stem cells may be derived from
somatic cell nuclear transfer or from surplus products of in vitro fertilization
treatments when such products are donated under appropriate informed consent
procedures. Progenitor cells are multipotent or precursor cells that are partially
differentiated but retain the ability to divide and give rise to differentiated
Section 6 Notwithstanding any other provision of this Constitution or any law,
the Institute, which is established in state government, may utilize state
issued tax-exempt and taxable bonds to fund its operations, medical and scientific
research, including therapy development through clinical trials, and facilities.
Section 7 Notwithstanding any other provision of this Constitution, including
Article VII, or any law, the Institute and its employees are exempt from Civil
SEC. 5. Chapter 3 commencing with Section 125281.01 is added to Part 5 of Division
106 of the Health and Safety Code to read:
California Stem Cell Research and Cures/Bond Act
California Stem Cell Research and Cures Act
125281.01 General – Independent Citizen’s Oversight Committee (“ICOC”)
This Chapter implements California Constitution article XXXV which established
the California Institute for Regenerative Medicine ("Institute").
125281.02 Creation of the ICOC
There is hereby created the Independent Citizen’s Oversight Committee,
hereinafter, the ICOC, which shall govern the Institute and is hereby vested
with full power, authority and jurisdiction over the Institute.
125281.03 ICOC Membership; Appointments; Terms of Office
(a) ICOC Membership
The ICOC shall have 29 members, appointed as follows:
(1) The Chancellors of the University of California at San Francisco, Davis,
San Diego, Los Angeles and Irvine, shall each appoint an executive officer
from his or her campus.
(2) The Governor, the Lieutenant Governor, the Treasurer and the
shall each appoint an executive officer from the following three categories:
(A) a California university, excluding the five campuses of the University
of California described in paragraph (1), that has demonstrated success and
leadership in stem cell research, and that has:
(i) a nationally-ranked research hospital and medical school; this criteria
will apply to only two of the four appointments.
(ii) a recent proven history of administering medical research grants and contracts
in an average annual range exceeding $100 million.
(iii) a ranking within the past five years in the top 10 United States universities
with the highest number of life-science patents or that has research or clinical
faculty who are members of the National Academy of Sciences.
(B) a California non-profit academic and research institution that is not a
part of the University of California, that has demonstrated success and leadership
in stem cell research, and that has:
(i) a nationally-ranked research hospital or that has research or clinical
who are members of the National Academy of Sciences.
(ii) a proven history in the last five years of managing a research budget
lifesciences exceeding $20 million.
(C) a California life-science commercial entity that is not actively engaged
researching or developing therapies with pluripotent or progenitor stem cells,
that has a background in implementing successful experimental medical therapies,
and that has not been awarded, or applied for, funding by the Institute at
the time of appointment. A board member of such entity with a successful history
of developing innovative medical therapies may be appointed in lieu of an executive
(D) only one member shall be appointed from a single university, institution,
or entity. The executive officer of a California university, a non-profit research
institution or life-science commercial entity who is appointed as a member,
may from time to time delegate those duties to an executive officer of the
entity or to the dean of the medical school, if applicable.
(3) The Governor, the Lieutenant Governor, the Treasurer, and the
Controller shall appoint members from among California representatives of California
regional, state, or national disease advocacy groups, as follows:
(A) The Governor shall appoint two members, one from each of the
following disease advocacy groups: spinal cord injury, and Alzheimer’s
(B) The Lieutenant Governor shall appoint two members, one from each of the
following disease advocacy groups: type II diabetes; and multiple sclerosis
amyotrophic lateral sclerosis.
(C) The Treasurer shall appoint two members, one from each of the following
disease groups: type I diabetes and heart disease.
(D) The Controller shall appoint two members, one from each of the
following disease groups: cancer and Parkinson’s disease.
(4) The Speaker of the Assembly shall appoint a member from among
California representatives of a California regional, state, or national Mental
disease advocacy group.
(5) The President Pro Tem of the Senate shall appoint a member from among California
representatives of a California regional, state, or national HIV/AIDS disease
(6) A Chairperson and Vice Chairperson who shall be elected by the ICOC members.
Within 40 days of the effective date of this Act, each Constitutional Officer
shall nominate a candidate for Chairperson and another candidate for Vice Chairperson.
The Chairperson and Vice Chairperson shall each be elected for a term of six
years. The Chairperson and Vice Chairperson of ICOC shall be full or part-time
employees of the Institute and shall meet the following criteria:
(A) Mandatory Chairperson Criteria
(i) Documented history in successful stem cell research advocacy.
(ii) Experience with state and federal legislative processes that must include
some experience with medical legislative approvals of standards and/or funding.
(iii) Qualified for appointment pursuant to Section 125281.03 (a) (3),
(4) or (5).
(iv) Cannot be concurrently employed by or on leave from any prospective grant
or loan recipient institutions in California.
(B) Additional Criteria for Consideration:
(i) Experience with governmental agencies or institutions (either executive
or board position).
(ii) Experience with the process of establishing
government standards and procedures.
(iii) Legal experience with the legal review of proper governmental authority
for the exercise of government agency or government institutional powers.
(iv) Direct knowledge and experience in bond financing.
The Vice-Chairperson shall satisfy section 125281.03 (a) (6) (A) (i), (iii)
and (iv). The Vice-Chairperson shall be selected from among individuals who
have attributes and experience complementary to those of the Chairperson, preferably
covering the criteria not represented by the Chairperson's credentials and
(b) Appointment of ICOC Members
(1) All appointments shall be made within 40 days of the effective date of
this Act. In the event that any of the appointments are not completed within
the permitted timeframe, the ICOC shall proceed to operate with the appointments
that are in place, provided that at least 65 percent of the appointments have
(2) 45 days after the effective date of this Act, the State Controller and
the State Treasurer, or if only one is available within 45 days, the other
shall convene a meeting of the appointed members of the ICOC to elect a Chairperson
and Vice Chairperson from among the individuals nominated by the Constitutional
Officers pursuant to section 125281.03 (a) (6).
(c) ICOC Member Terms Of Office
(1) The members appointed pursuant to section 125281.03 (a) (1), (a) (3), (a)
(4), and (a) (5) shall serve eight-year terms, and all other members shall
serve six-year terms. Members shall serve a maximum of two terms.
(2) If a vacancy occurs within a term, the appointing authority shall
appoint a replacement member within 30 days to serve the remainder of the term.
(3) When a term expires, the appointing authority shall appoint a member within
30 days. ICOC members shall continue to serve until their replacements are
125281.04 Majority Vote of Quorum
Actions of the ICOC may be taken only by a majority vote of a quorum of the
125281.05 Public and Financial Accountability Standards
(a) Annual Public Report
The Institute shall issue an annual report to the public which sets forth its
activities, grants awarded, grants in progress, research accomplishments, and
future program directions. Each annual report shall include, but not be limited
to, the following: the number and dollar amounts of research and facilities
grants; the grantees for the prior year; the Institute’s administrative
expenses; an assessment of the availability of funding for stem cell research
from sources other than the Institute; a summary of research findings, including
promising new research areas; an assessment of the relationship between the
Institute’s grants and the overall strategy of its research program;
and a report of the Institute’s strategic research and financial plans.
(b) Independent Financial Audit for Review by State Controller
The Institute shall annually commission an independent financial audit of its
activities from a certified public accounting firm which shall be provided
to the State Controller, who shall review the audit and annually issue a public
report of that review.
(c) Citizen’s Financial Accountability Oversight Committee
There shall be a Citizen’s Financial Accountability Oversight Committee
chaired by the State Controller. This committee shall review the annual financial
audit, the State Controller’s report and evaluation of that audit, and
the financial practices of the Institute. The State Controller, the State Treasurer,
the President Pro-Tem of the Senate, the Speaker of the Assembly, and the Chairperson
of the ICOC shall each appoint a public member of the committee. Committee
members shall have medical backgrounds and knowledge of relevant financial
matters. The committee shall provide recommendations on the Institute's financial
practices and performance. The State Controller shall provide staff support.
The committee shall hold a public meeting, with appropriate notice, and with
a formal public comment period. The committee shall evaluate public comments
and include appropriate summaries in its annual report. The ICOC shall provide
funds for the per diem expenses of the committee members and for publication
of the annual report.
(d) Public Meeting Laws
(1) The ICOC shall hold at least two public meetings per year, one of
which will be designated as the Institute’s annual meeting. The ICOC
may hold additional meetings as it determines are necessary or appropriate.
(2) The Bagley-Keene Opening Meeting Act, Article 9 (commencing with
section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government
Code, shall apply to all meetings of the ICOC, except as otherwise provided
in this section. The ICOC shall award all grants, loans and contracts in public
meetings and shall adopt all governance, scientific, medical and regulatory
standards in public meetings.
(3) The ICOC may conduct closed sessions as permitted by the Bagley-Keene Open
Meeting Act, Government Code section 11126. In addition, the ICOC may conduct
closed sessions when it meets to consider or discuss:
(A) Matters involving information relating to patients or medical subjects,
the disclosure of which would constitute an unwarranted invasion of personal
(B) Matters involving confidential intellectual property or work product, whether
patentable or not, including, but not limited to, any formula, plan, pattern,
process, tool, mechanism, compound, procedure, production data, or compilation
of information, which is not patented, which is known only to certain individuals
who are using it to fabricate, produce, or compound an article of trade or
a service having commercial value and which gives its user an opportunity to
obtain a business advantage over competitors who do not know it or use it.
(C) Matters involving pre-publication, confidential scientific research or
(D) Matters concerning the appointment, employment, performance, compensation,
or dismissal of Institute officers and employees. Action on compensation of
the Institute’s officers and employees shall only be taken in open session.
(4) The meeting required by section 125281.03 (b) (2) shall be deemed
to be a special meeting for the purposes of Government Code section 11125.4.
(e) Public Records
(1) The California Public Records Act, Article 1 (commencing with section 6250)
of Chapter 3.5 of Division 7 of Title 1 of the Government Code, shall apply
to all records of the Institute, except as otherwise provided in this section.
(2) Nothing in this section shall be construed to require disclosure of any
records that are any of the following:
(A) Personnel, medical or similar files, the disclosure of which would constitute
an unwarranted invasion of personal privacy.
(B) Records containing or reflecting confidential intellectual property or
work product, whether patentable or not, including, but not limited to, any
formula, plan, pattern, process, tool, mechanism, compound, procedure, production
data, or compilation of information, which is not patented, which is known
only to certain individuals who are using it to fabricate, produce, or compound
an article of trade or a service having commercial value and which gives its
user an opportunity to obtain a business advantage over competitors who do
not know it or use it.
(C) Pre-publication scientific working papers or research data.
(f) Competitive Bidding
(1) The Institute shall, except as otherwise provided in this section, be governed
by the competitive bidding requirements applicable to the University of California,
as set forth in Article 1 (commencing with section 10500), Chapter 2.1, Part
2, Division 2 of the Public Contract Code.
(2) For all Institute contracts, the ICOC shall follow the procedures required
of the Regents by Article 1 (commencing with section 10500), Chapter 2.1, Part
2, Division 2 of the Public Contract Code with respect to contracts let by
the University of California.
(3) The requirements of this section shall not be applicable to grants or loans
approved by the ICOC.
(4) Except as provided in this section, the Public Contract Code shall not
apply to contracts let by the Institute.
(g) Conflicts of Interest
(1) The Political Reform Act, Title 9 (commencing with section 81000) of the
Government Code, shall apply to the Institute and to the ICOC, except as provided
in this section and in section 125281.09(e).
(A) No member of the ICOC shall make, participate in making, or in any way
attempt to use his or her official position to influence a decision to approve
or award a grant, loan or contract to his or her employer, but a member may
participate in a decision to approve or award a grant, loan or contract to
a non-profit entity in the same field as his or her employer.
(B) A member of the ICOC may participate in a decision to approve or award
a grant, loan or contract to an entity for the purpose of research involving
a disease from which a member or his or her immediate family suffers or in
which the member has an interest as a representative of a disease advocacy
(C) The adoption of standards is not a decision subject to this section.
(2) Service as a member of the ICOC by a member of the faculty or administration
of any system of the University of California shall not, by itself, be deemed
to be inconsistent, incompatible, in conflict with, or inimical to the duties
of the ICOC member as a member of the faculty of administration of any system
of the University of California and shall not result in the automatic vacation
of either such office. Service as a member of the ICOC by a representative
or employee of a disease advocacy organization, a non-profit academic and research
institution, or a life science commercial entity shall not be deemed to be
inconsistent, incompatible, in conflict with, or inimical to the duties of
the ICOC member as a representative or employee of that organization, institution
(3) Government Code section 1090 shall not apply to any grant, loan or contract
made by the ICOC except where both of the following conditions are met:
(A) The grant, loan or contract directly relates to services to be provided
by any member of the ICOC or the entity the member represents or financially
benefits the member or the entity he or she represents.
(B) The member fails to recuse himself or herself from making, participating
in making, or in any way attempting to use his or her official position to
influence a decision on the grant loan or contract.
(h) Patent Royalties and License Revenues Paid To The State of California
The ICOC shall establish standards that require that all grants and loan awards
be subject to intellectual property agreements that balance the opportunity
of the state of California to benefit from the patents, royalties, and licenses
that result from basic research, therapy development and clinical trials with
the need to assure that essential medical research is not unreasonably hindered
by the intellectual property agreements.
(i) Preference for California Suppliers
The ICOC shall establish standards to ensure that grantees purchase goods and
services from California suppliers to the extent reasonably possible, in a
good faith effort to achieve a goal of more than 50 per cent of such purchases
from California suppliers.
125281.06 Medical and Scientific Accountability Standards
(a) Medical Standards
In order to avoid duplication or conflicts in technical standards for scientific
and medical research, with alternative state programs, the Institute will develop
its own scientific and medical standards to carry out the specific controls
and intent of the Act, notwithstanding Health and Safety Code sections 125300
(b), 125320, 125118, 125118.5, 125119, 125119.3 and 125119.5, or any other
current or future state laws or regulations dealing with the study and research
of pluripotent stem cells and/or progenitor cells, or other Vital Research
Opportunities, except Health and Safety Code section 125315. The ICOC, its
working committees and its grantees shall be governed solely by the provisions
of this Act in the establishment of standards, the award of grants and the
conduct of grants awarded pursuant to this Act.
The ICOC shall establish standards as follows:
(1) Informed Consent
Standards for obtaining the informed consent of research donors, patients,
or participants, which initially shall be generally based on the standards
in place on January 1, 2003, for all research funded by the National Institutes
of Health, with modifications to adapt to the mission and objectives of the
(2) Controls on Research Involving Humans
Standards for the review of research involving human subjects which initially
shall be generally based on the Institutional Review Board standards promulgated
by the National Institutes of Health and in effect on January 1, 2003, with
modifications to adapt to the mission and objectives of the Institute.
(3) Prohibition on Compensation
Standards prohibiting compensation to research donors or participants, while
permitting reimbursement of expenses.
(4) Patient Privacy Laws
Standards to assure compliance with state and federal patient privacy laws.
(5) Limitations on Payments for Cells
Standards limiting payments for the purchase of stem cells or stem cell lines
to reasonable payment for the removal, processing, disposal, preservation,
quality control, storage, transplantation, or implantation or legal transaction
or other administrative costs associated with these medical procedures and
specifically including any required payments for medical or scientific technologies,
products, or processes for royalties, patent or licensing fees or other costs
for intellectual property.
(6) Time Limits for Obtaining Cells
Standards setting a limit on the time during which cells may be extracted from
blastocysts, which shall initially be 8 to 12 days after cell division begins,
not counting any time during which the blastocysts and/or cells have been stored
125281.07 ICOC Functions
The ICOC shall perform the following functions:
(a) Oversee the operations of the Institute.
(b) Develop annual and long-term strategic research and financial plans for
(c) Make final decisions on research standards and grant awards.
(d) Ensure the completion of an annual financial audit of the Institute’s
(e) Issue public reports on the activities of the Institute.
(f) Establish policies regarding intellectual property rights arising from
research funded by the Institute.
(g) Establish rules and guidelines for the operation of the ICOC and its working
(h) Perform all other acts necessary or appropriate in the exercise of its
power, authority, and jurisdiction over the Institute.
(i) Select members of the working groups.
(j) Adopt, amend and rescind rules and regulations to carry out the purposes
and provisions of this chapter, and to govern the procedures of the ICOC. Except
as provided in subdivision (k), these rules and regulations shall be adopted
in accordance with the Administrative Procedure Act (Government Code, Title
2, Division 3, Part 1 , Chapter 4.5, Sections 11371 et seq.)
(k) Notwithstanding the Administrative Procedure Act (“APA”), and
in order to facilitate the immediate commencement of research covered by this
chapter, the ICOC may adopt interim regulations without compliance with the
procedures set forth in the APA. The interim regulations shall remain in effect
for 270 days unless earlier superseded by regulations adopted pursuant to the
(l) Request the issuance of bonds from the California Stem Cell Research and
Cures Finance Committee and loans from the Pooled Money Investment Board.
(m) May annually modify its funding and finance programs to optimize the Institute’s
ability to achieve the objective that its activities be revenue-positive for
the State of California during its first five years of operation without jeopardizing
the progress of its core medical and scientific research program.
(n) Notwithstanding Government Code section 11005, accept additional revenue
and real and personal property, including but not limited to gifts, royalties,
interest and appropriations that may be used to supplement annual research
grant funding and the operations of the Institute.
125281.08 ICOC Operations
(a) Legal Actions and Liability
(1) The Institute may sue and be sued.
(2) Based upon ICOC standards, Institute grantees shall indemnify or insure
and hold the Institute harmless against any and all losses, claims, damages,
expenses or liabilities, including attorneys’ fees, arising from research
conducted by the grantee pursuant to the grant, and/or, in the alternative,
grantees shall name the Institute as an additional insured and submit proof
of such insurance.
(3) Given the scientific, medical and technical nature of the issues facing
the ICOC, and notwithstanding Government Code section 11042, the Institute
is authorized to retain outside counsel when the ICOC determines that the Institute
requires specialized services not provided by the Attorney General’s
(4) The Institute may enter into any contracts or obligations which are authorized
or permitted by law.
(1) The ICOC shall from time to time determine the total number of authorized
employees for the Institute, up to a maximum of fifty employees, excluding
members of the working groups, who shall not be considered Institute employees.
The ICOC shall select a Chairperson, Vice-Chairperson and President who shall
exercise all of the powers delegated to them by the ICOC. The following functions
apply to the Chairperson, Vice-Chairperson and President:
The Chairperson’s primary responsibilities are to manage the ICOC agenda
and work flow including all evaluations and approvals of scientific and medical
working group grants, loans, facilities, and standards evaluations, and to
supervise all annual reports and public accountability requirements; to manage
and optimize the Institute’s bond financing plans and funding cash flow
plan; to interface with the California legislature, the United States Congress,
the California healthcare system, and the California public; to optimize all
financial leverage opportunities for the Institute; and to lead negotiations
for intellectual property agreements, policies, and contract terms. The Chairperson
shall also serve as a member of the Scientific and Medical Accountability Standards
Working Group and the Scientific and Medical Research Facilities Working Group
and as an ex-officio member of the Scientific and Medical Research Funding
Working Group. The Vice-Chairperson’s primary responsibilities are to
support the Chairperson in all duties and to carry out those duties in the
The President’s primary responsibilities are to serve as the Chief Executive
of the Institute; to recruit the highest scientific and medical talent in the
United States to serve the Institute on its Working Groups; to serve the Institute
on its Working Groups; to direct ICOC staff and participate in the process
of supporting all Working Group requirements to develop recommendations on
grants, loans, facilities, and standards as well as to direct and support the
ICOC process of evaluating and acting on those recommendations, the implementation
of all decisions on these and general matters of the ICOC; to hire, direct,
and manage the staff of the Institute; to develop the budgets and cost control
programs of the Institute; to manage compliance with all rules and regulations
on the ICOC, including the performance of all grant recipients; and to manage
and execute all intellectual property agreements and any other contracts pertaining
to the Institute or research it funds.
(2) Each member of the ICOC except the Chairperson, Vice Chairperson and President,
shall receive a per diem of one hundred dollars ($100) per day (adjusted annually
for cost of living) for each day actually spent in the discharge of the member’s
duties, plus reasonable and necessary travel and other expenses incurred in
the performance of the member’s duties.
(3) The ICOC shall establish daily consulting rates and expense reimbursement
standards for the non-ICOC members of all of its working groups.
(4) Notwithstanding Government Code section 19825, the ICOC shall set compensation
for the Chairperson, Vice-Chairperson and President and other officers, and
for the scientific, medical, technical, and administrative staff of the Institute
within the range of compensation levels for executive officers and scientific,
medical, technical, and administrative staff of medical schools within the
University of California system and the non-profit academic and research institutions
described in section 125281.03 (a) (2).
125281.09 Scientific and Medical Working Groups-General
(a) The Institute shall have, and there is hereby established three separate
scientific and medical working groups as follows:
Scientific and Medical Research Funding Working Group;
Scientific and Medical Accountability Standards Working Group; and
Scientific and Medical Research Facilities Working Group
(b) Working Group Members
Appointments of scientific and medical working group members shall be made
by a majority vote of a quorum of the ICOC, within 30 days of the election
and appointment of the initial ICOC members. The working group members’ terms
shall be six years except that, after the first six year terms, the members’ terms
will be staggered so that one-third of the members shall be elected for a term
that expires two years later, one third of the members shall be elected for
a term that expires four years later, and one-third of the members shall be
elected for a term that expires six years later. Subsequent terms are for six
years. Working group members may serve a maximum of two consecutive terms.
(c) Working Group Meetings
Each scientific and medical working group shall hold at least four meetings
per year, one of which shall be designated as its annual meeting.
(d) Working Group Recommendations to the ICOC
Recommendations of each of the working groups may be forwarded to the ICOC
only by a vote of a majority of a quorum of the members of each working group.
If 35 percent of the members of any working group join together in a minority
position, a minority report may be submitted to the ICOC. The ICOC shall consider
the recommendations of the working groups in making its decisions on applications
for research and facility grants and loan awards and in adopting regulatory
standards. Each working group shall recommend to ICOC rules, procedures and
practices for that working group.
(e) Conflict of Interest
(1) The ICOC shall adopt conflict of interest rules, based on standards applicable
to members of scientific review committees of the National Institutes of Health,
to govern the participation of non-ICOC working group members.
(2) The ICOC shall appoint an ethics officer from among the staff of the Institute.
(3) Because the working groups are purely advisory and have no final decision-making
authority, members of the working groups shall not be considered public officials,
employees or consultants for purposes of the Political Reform Act (commencing
with Government Code section 81000), Government Code sections 1090 and 19990,
and Public Contract Code sections 10516 and 10517.
(f) Working Group Records
All records of the working groups submitted as part of the working groups’ recommendations
to the ICOC for approval shall be subject to the Public Records Act. Except
as provided in this subdivision, the working groups shall not be subject to
the provisions of Article 9 (commencing with Section 11120) of Chapter 1 of
Part 1 of Division 3 of Title 2 of the Government Code, or Article 1 (commencing
with Section 6250) of Chapter 3.5 of Division 7 of Title 1 of the Government
125281.10 Scientific and Medical Accountability Standards Working Group
The Scientific and Medical Accountability Standards Working Group shall have
19 members as follows:
(1) Five ICOC members from the ten groups that focus on disease-specific areas
described in section 125281.03 (a) (3), (a) (4) and (a) (5).
(2) Nine scientists and clinicians nationally recognized in the field of pluripotent
and progenitor cell research.
(3) Four medical ethicists.
(4) The chairperson of the ICOC.
The Scientific and Medical Accountability Standards Working Group shall have
the following functions:
(1) To recommend to the ICOC scientific, medical and ethical standards.
(2) To recommend to the ICOC standards for all medical, socio-economic, and
financial aspects of clinical trials and therapy delivery to patients, including,
among others, standards for safe and ethical procedures for obtaining materials
and cells for research and clinical efforts for the appropriate treatment of
human subjects in medical research consistent with section 125281.06 (a) (2)
herein, and to ensure compliance with patient privacy laws.
(3) To recommend to the ICOC modification of the standards described in sub-paragraphs
(1) and (2) as needed.
(4) To make recommendations to the ICOC on the oversight of funded research
to ensure compliance with the standards described in subparagraphs (1) and
(5) To advise the ICOC, the Scientific and Medical Research Funding Working
Group, and the Scientific and Medical Research Facilities Working Group on
an on-going basis on relevant ethical and regulatory issues.
125281.11 Scientific and Medical Research Funding Working Group
The Scientific and Medical Research Funding Working Group shall have 23 members
(1) Seven ICOC members from the 10 disease advocacy group members described
in sections 125281.03 (a) (3), (a) (4), and (a) (5).
(2) 15 scientists nationally recognized in the field of stem cell research.
(3) The Chairperson of the ICOC.
The Scientific and Medical Research Funding Working Group shall perform the
(1) Recommend to the ICOC interim and final criteria, standards and requirements
for considering funding applications and for awarding research grants and loans.
(2) Recommend to the ICOC standards for the scientific and medical oversight
(3) Recommend to the ICOC any modifications of the criteria, standards and
requirements described in subparagraphs (1) and (2) above as needed.
(4) Review grant and loan applications based on the criteria, requirements
and standards adopted by the ICOC and make recommendations to the ICOC for
the award of research, therapy development, and clinical trial grants and loans.
(5) Conduct peer-group progress oversight reviews of grantees to ensure compliance
with the terms of the award, and report to the ICOC any recommendations for
(6) Recommend to the ICOC standards for the evaluation of grantees to ensure
that they comply with all applicable requirements. Such standards shall mandate
periodic reporting by grantees and shall authorize the Scientific and Medical
Research Funding Working Group to audit a grantee and forward any recommendations
for action to the ICOC.
(7) Recommend its first grant awards within 60 days of the issuance of the
(c) Recommendations for Awards
Award recommendations shall be based upon a competitive evaluation as follows.
(1) Only the 15 scientist members of the Scientific and Medical Research Funding
Working Group shall score grant and loan award applications for scientific
merit. Such scoring shall be based on scientific merit in three separate classifications—research,
therapy development and clinical trials, on criteria including the following:
(A) A demonstrated record of achievement in the areas of pluripotent stem cell
and progenitor cell biology and medicine, unless the research is determined
to be a Vital Research Opportunity.
(B) The quality of the research proposal, the potential for achieving significant
research or clinical results, the timetable for realizing such significant
results, the importance of the research objectives, and the innovativeness
of the proposed research.
(C) In order to ensure that Institute funding does not duplicate or supplant
existing funding, a high priority shall be placed on funding pluripotent stem
cell and progenitor cell research that cannot, or is unlikely to, receive timely
or sufficient federal funding, unencumbered by limitations that would impede
the research. In this regard, other research categories funded by the National
Institute of Health shall not be funded by the Institute.
(D) Notwithstanding subparagraph (C), other scientific and medical research
and technologies and/or any stem cell research proposal not actually funded
by the Institute under subparagraph (C) may be funded by the Institute if at
least two-thirds of a quorum of the members of the Scientific and Medical Research
Funding Working Group recommend to the ICOC that such a research proposal is
a Vital Research Opportunity.
125281.12 Scientific and Medical Facilities Working Group
The Scientific and Medical Research Facilities Working Group shall have 11
members as follows:
(1) Six members of the Scientific and Medical Research Funding Working Group.
(2) Four real estate specialists. To be eligible to serve on the Scientific
and Medical Research Facilities Working Group, a real estate specialist shall
be a resident of California, shall be prohibited from receiving compensation
from any construction or development entity providing specialized services
for medical research facilities, and shall not provide real estate facilities
brokerage services for any applicant for, or any funding by the Scientific
and Medical Research Facilities Working Group and shall not receive compensation
from any recipient of Institute funding grants.
(3) The Chairperson of the ICOC.
The Scientific and Medical Research Facilities Working Group shall perform
the following functions:
(1) Make recommendations to the ICOC on interim and final criteria, requirements
and standards for applications for, and the awarding of, grants and loans for
buildings, building leases, and capital equipment; those standards and requirements
shall include, among others,
(A) facility milestones and timetables for achieving such milestones;
(B) priority for applications that provide for facilities that will be available
for research no more than two years after the grant award;
(C) the requirement that all funded facilities and equipment be located solely
(D) the requirement that grantees comply with reimbursable building cost standards,
competitive building leasing standards, capital equipment cost standards, and
reimbursement standards and terms recommended by the Scientific and Medical
Facilities Funding Working Group, and adopted by the ICOC;
(E) the requirement that grantees shall pay all workers employed on construction
or modification of the facility funded by facilities grants or loans of the
Institute, the general prevailing rate of per-diem wages for work of a similar
character in the locality in which work on the facility is performed, and not
less than the general prevailing rate of per diem wages for holiday and overtime
work fixed as provided in Division 2, Part 7, Chapter 1 of the Labor Code;
(F) the requirement that grantees be not-for-profit entities;
(G) the requirement that awards be made on a competitive basis, with the following
(i) that the grantee secure matching funds from sources other than the Institute
equal to at least 20 percent of the award. Applications of equivalent merit,
as determined by the Scientific and Medical Research Funding Working Group,
considering research opportunities to be conducted in the proposed research
facility, shall receive priority to the extent that they provide higher matching
fund amounts. The Scientific and Medical Research Facilities Working Group
may recommend waiving the matching fund requirement in extraordinary cases
of high merit or urgency;
(ii) that capital equipment costs and capital equipment loans be allocated
when equipment costs can be recovered in part by the grantee from other users
of the equipment.
(2) Make recommendations to the ICOC on oversight procedures to ensure grantees'
compliance with the terms of an award.
125281.13 Appropriation and Allocation of Funding.
(a) Monies in the California Stem Cell Research and Cures Fund shall be allocated
(1) No less than 97 percent of the proceeds of the bonds authorized pursuant
to section 125282.05, after allocation of bond proceeds to purposes described
in subsections (a) (iv) and (a) (v) of section 125282.03, shall be used for
grants and grant oversight as provided in this chapter.
(A) Not less than 90 percent of the amount used for grants shall be used for
research grants, with no more than the following amounts—as stipulated
below— to be committed during the first ten years of grant-making by
the Institute with each year’s commitments to be advanced over a period
of one to seven years, except that any such funds that are not committed may
be carried over to one or more following years. The maximum amount of research
funding to be allocated annually as follows: Year 1, 5.6%; Year 2, 9.4%; Year
3, 9.4%; Year 4, 11.3%; Year 5, 11.3%; Year 6, 11.3%; Year 7, 11.3%; Year 8,
11.3%; Year 9, 11.3%; and Year 10, 7.5%.
(B) Not more than three percent of the proceeds of bonds authorized by section
125282.05 may be used by the Institute for research and research facilities
implementation costs, including the development, administration and oversight
of the grant-making process and the operations of the working groups.
(2) Not more than three percent of the proceeds of the bonds authorized
pursuant to section 125282.05 shall be used for the costs of general administration
of the Institute.
(3) In any single year any new research funding to any single grantee for any
program year is limited to no more than two percent of the total bond authorization
under this Chapter. This limitation shall be considered separately for each
new proposal without aggregating any prior year approvals that may fund research
activities. This requirement shall be determinative, unless 65 percent of a
quorum of the ICOC approves a higher limit for that grantee.
(4) Recognizing the priority of immediately building facilities that ensure
the independence of the scientific and medical research of the Institute, up
to 10 percent of the proceeds of the bonds authorized pursuant to section 125282.05,
net of costs described in clauses (a) (ii), (a) (iv) and (a) (v) of section
125282.03 shall be allocated for grants to build scientific and medical research
facilities of non-profit entities which are intended to be constructed in the
first five years.
(5) The Institute shall limit indirect costs to 25 percent of a research award,
excluding amounts included in a facilities award, except that the indirect
cost limitation may be increased by that amount by which the grantee provides
matching funds in excess of 20 percent of the grant amount.
(b) To enable the Institute to commence operating during the first six months
following the adoption of this measure, there is hereby appropriated from the
General Fund as a temporary start-up loan to the Institute three million dollars
($3,000,000) for initial administrative and implementation costs. All loans
to the Institute pursuant to this appropriation shall be repaid to the General
Fund within twelve months of each loan draw from the proceeds of bonds sold
pursuant to section 125282.05.
(c) The Institute’s funding schedule is designed to create a positive
tax revenue stream for the state of California during the Institute’s
first five calendar years of operations, without drawing funds from the state
general fund for principal and interest payments for those first five calendar
CALIFORNIA STEM CELL RESEARCH AND CURES BOND ACT OF 2004
125282.01. This article shall be known, and may be cited, as the California
Stem Cell Research and Cures Bond Act of 2004.
125282.02. As used in this article, the following terms have the following
(a) “Act” means the California Stem Cell Research and Cures Act” constituting
Chapter 3 (commencing with Section 125281.01) of Part 5 of Division 106 of
the Health and Safety Code.
(b) “Board” or “Institute” means the California Institute
for Regenerative Medicine designated in accordance with subdivision (b) of
(c) “Committee” means the California Stem Cell Research and Cures
Finance Committee created pursuant to subdivision (a) of Section 125282.07.
(d) “Fund” means the California Stem Cell Research and Cures Fund
created pursuant to Section 125282.04.
(e) “Interim Debt” means any interim loans pursuant to Sections
125281.13 (b), 125282.11 and 25282.12, bond anticipation notes or commercial
paper notes issued to make deposits into the Fund and which will be paid from
the proceeds of bonds issued pursuant to this article.
125282.03. (a) Notwithstanding Section 13340 of the Government Code or any
other provision of law, moneys in the Fund are appropriated without regard
to fiscal years to the Institute for the purpose of (i) making grants or loans
to fund research and construct facilities for research, all as described in
and pursuant to the Act, (ii) paying general administrative costs of the Institute
(not to exceed 3% of the net proceeds of each sale of bonds), (iii) paying
the annual administration costs of the Interim Debt or bonds after December
31 of the fifth full calendar year after this article takes effect, (iv) paying
the costs of issuing Interim Debt, paying the annual administration costs of
the Interim Debt until and including December 31 of the fifth full calendar
year after this article takes effect, and paying interest on Interim Debt,
if such Interim Debt is incurred or issued on or prior to December 31 of the
fifth full calendar year after this article takes effect, and (v) paying the
costs of issuing bonds, paying the annual administration costs of the bonds
until and including December 31 of the fifth full calendar year after this
article takes effect, and paying interest on bonds that accrues on or prior
to December 31 of the fifth full calendar year after this article takes effect
(except that such limitation does not apply to premium and accrued interest
as provided in Section 125282.13). In addition, moneys in the Fund or other
proceeds of the sale of bonds authorized by this article may be used to pay
principal of or redemption premium on any Interim Debt issued prior to the
issuance of bonds authorized by this article. Moneys deposited in the Fund
from the proceeds of Interim Debt may be used to pay general administrative
costs of the Institute without regard to the 3% limit set forth in (ii) above,
so long as such 3% limit is satisfied for each issue of bonds.
(b) Repayment of principal and interest on any loans made by the Institute
pursuant to this article shall be deposited in the Fund and used to make additional
grants and loans for the purposes of this Act or for paying continuing costs
of the annual administration of outstanding bonds.
125282.04. The proceeds of Interim Debt and bonds issued and sold pursuant
to this article shall be deposited in the State Treasury to the credit of the
California Stem Cell Research and Cures Fund, which is hereby created in the
State Treasury, except to the extent that proceeds of the issuance of bonds
are used directly to repay Interim Debt.
125282.05. Bonds in the total amount of three billion dollars ($3,000,000,000),
not including the amount of any refunding bonds issued in accordance with Section
125282.14, or as much thereof as is necessary, may be issued and sold to provide
a fund to be used for carrying out the purposes expressed in this article and
to be used and sold for carrying out the purposes of Section 125282.03 and
to reimburse the General Obligation Bond Expense Revolving Fund pursuant to
Section 16724.5 of the Government Code. The bonds, when sold, shall be and
shall constitute a valid and binding obligation of the State of California,
and the full faith and credit of the State of California is hereby pledged
for the punctual payment of both the principal of, and interest on, the bonds
as the principal and interest become due and payable.
125282.06. The bonds authorized by this article shall be prepared, executed,
issued, sold, paid, and redeemed as provided in the State General Obligation
Bond Law (Chapter 4 (commencing with Section 16720) of Part 3 of Division 4
of Title 2 of the Government Code), and all of the provisions of that law except
Section 16727 apply to the bonds and to this article and are hereby incorporated
in this article as though set forth in full in this article.
125282.07. (a) Solely for the purpose of authorizing the issuance and sale,
pursuant to the State General Obligation Bond Law, of the bonds and Interim
Debt authorized by this article, the California Stem Cell Research and Cures
Finance Committee is hereby created. For purposes of this article, the California
Stem Cell Research and Cures Finance Committee is “the Committee” as
that term is used in the State General Obligation Bond Law. The committee consists
of the Treasurer, the Controller, the Director of Finance, the Chairperson
of the California Institute for Regenerative Medicine, and two other members
of the Independent Citizens Oversight Committee (as created by the Act) chosen
by the Chairperson of the California Institute for Regenerative Medicine, or
their designated representatives. The Treasurer shall serve as chairperson
of the Committee. A majority of the Committee may act for the Committee.
(b) For purposes of the State General Obligation Bond Law, the California
Institute for Regenerative Medicine is designated the “board.”
125282.08. (a) The Committee shall determine whether or not it is necessary
or desirable to issue bonds authorized pursuant to this article in order to
carry out the actions specified in this article and, if so, the amount of bonds
to be issued and sold. Successive issues of bonds may be authorized and sold
to carry out those actions progressively, and it is not necessary that all
of the bonds authorized to be issued be sold at any one time. The bonds may
bear interest which is includable in gross income for federal income tax purposes
if the Committee determines that such treatment is necessary in order to provide
funds for the purposes of the Act.
(b) The total amount of the bonds authorized by Section 125282.05 which may
be issued in any calendar year, commencing in 2005, shall not exceed $350,000,000.
If less than this amount of bonds is issued in any year, the remaining permitted
amount may be carried over to one or more subsequent years.
(c) An interest-only floating rate bond structure will be implemented for Interim
Debt and bonds until at least December 31 of the fifth full calendar year after
this article takes effect, with all interest to be paid from proceeds from
the sale of Interim Debt or bonds, to minimize debt service payable from the
general fund during the initial period of basic research and therapy development,
if the Committee determines, with the advice of the Treasurer, that this structure
will result in the lowest achievable borrowing costs for the State during that
five-year period considering the objective of avoiding any bond debt service
payments, by the State's general fund, during that period. Upon such initial
determination, the Committee may delegate, by resolution, to the Treasurer
such authority in connection with issuance of bonds as it may determine, including
but not limited to the authority to implement and continue this bond financing
structure (including during any time following the initial five-year period)
and to determine that an alternate financing plan would result in significant
lower borrowing costs for the State consistent with the objectives related
to the State's general fund and to implement such alternate financing plan.
125282.09. There shall be collected each year and in the same manner and at
the same time as other State revenue is collected, in addition to the ordinary
revenues of the State, a sum in an amount required to pay the principal of,
and interest on, the bonds maturing each year. It is the duty of all officers
charged by law with any duty in regard to the collection of the revenue to
do and perform each and every act that is necessary to collect that additional
125282.10. Notwithstanding Section 13340 of the Government Code, there is hereby
appropriated from the General Fund in the State Treasury, for the purposes
of this article, an amount that will equal the total of the following:
(a) The sum annually necessary to pay the principal of, and interest on, bonds
issued and sold pursuant to this article, as the principal and interest become
due and payable.
(b) The sum necessary to carry out Section 125282.11 appropriated without regard
to fiscal years.
125282.11. The Director of Finance may authorize the withdrawal from the General
Fund of an amount or amounts not to exceed the amount of the unsold bonds that
have been authorized by the Committee to be sold for the purpose of carrying
out this article. Any amount withdrawn shall be deposited in the Fund. Any
money made available under this section shall be returned to the General Fund,
plus an amount equal to the interest that the money would have earned in the
Pooled Money Investment Account, from money received from the sale of bonds
for the purpose of carrying out this article.
125282.12. The Institute may request the Pooled Money Investment Board to make
a loan from the Pooled Money Investment Account in accordance with Section
16312 of the Government Code for the purposes of carrying out this article.
The amount of the request shall not exceed the amount of the unsold bonds that
the Committee, by resolution, has authorized to be sold for the purpose of
carrying out this article. The Institute shall execute any documents required
by the Pooled Money Investment Board to obtain and repay the loan. Any amounts
loaned shall be deposited in the Fund to be allocated by the Institute in accordance
with this article.
125282.13. All money deposited in the Fund that is derived from premium and
accrued interest on bonds sold shall be reserved in the Fund and shall be available
for transfer to the General Fund as a credit to expenditures for bond interest.
125282.14. The bonds may be refunded in accordance with Article 6 (commencing
with Section 16780) of Chapter 4 of Part 3 of Division 4 of Title 2 of the
Government Code, which is a part of the State General Obligation Bond Law.
Approval by the voters of the State for the issuance of the bonds described
in this article includes the approval of the issuance of any bonds issued to
refund any bonds originally issued under this article or any previously issued
125282.15. Notwithstanding any provision of this article or the State General
Obligation Bond Law, if the Treasurer sells bonds pursuant to this article
that include a bond counsel opinion to the effect that the interest on the
bonds is excluded from gross income for federal tax purposes, subject to designated
conditions, the Treasurer may maintain separate accounts for the investment
of bond proceeds and the investment earnings on those proceeds. The Treasurer
may use or direct the use of those proceeds or earnings to pay any rebate,
penalty, or other payment required under federal law or to take any other action
with respect to the investment and use of bond proceeds required or desirable
under federal law to maintain the tax-exempt status of those bonds and to obtain
any other advantage under federal law on behalf of the funds of this state.
125282.16. Inasmuch as the proceeds from the sale of bonds authorized by this
article are not “proceeds of taxes” as that term is used in Article
XIII B of the California Constitution, the disbursement of these proceeds is
not subject to the limitations imposed by that article.
125283.01 As used in this Chapter and in Article XXXV of the California Constitution,
the following terms have the following meanings:
(a) “Act” means the California Stem Cell Research and Cures Act
constituting Chapter 3 (commencing with Section 125281.01) of Part 5 of Division
106 of the Health and Safety Code.
(b) “Adult Stem Cell” means an undifferentiated cell found in a
differentiated tissue in an adult organism that can renew itself and may (with
certain limitations) differentiate to yield all the specialized cell types
of the tissue from which it originated.
(c) “Capitalized Interest” means interest funded by bond
(d) “Committee” means the California Stem Cell Research and Cures
Finance Committee created pursuant to subdivision (a) of Section 125282.07.
(e) “Constitutional Officers” shall mean the Governor, Lieutenant
Governor, Treasurer and Controller of California.
(f) “Facilities” means buildings, building leases, or capital equipment.
(g) “Floating-rate bond” means bonds which do not bear a fixed
rate of interest until their final maturity date, including commercial paper
(h) “Fund” means the California Stem Cell Research and Disease
Cures Fund created pursuant to Section 125282.04.
(i) “Grant” means a grant, loan or guarantee.
(j) “Grantee” means a recipient of a grant from the Institute.
All University of California grantee institutions shall be considered as separate
and individual grantee institutions.
(k) “Human Reproductive Cloning” means the practice of creating
or attempting to create a human being by transferring the nucleus from a human
cell into an egg cell from which the nucleus has been removed for the purpose
of implanting the resulting product in a uterus to initiate a pregnancy.
(l) “Indirect Costs” mean the recipient’s costs in the administration,
accounting, general overhead and general support costs for implementing a grant
or loan of the Institute. NIH definitions of indirect costs will be utilized
as one of the bases by the Scientific and Medical Research Standards Working
Group to create a guideline for recipients on this definition, with modifications
to reflect guidance by the ICOC and this Act.
(m) “Institute” means the California Institute for Regenerative
(n) “Interim Standards” means temporary standards that perform
function as “emergency regulations” under the Administrative Procedure
Act (Government Code, Title 2, Division 3, Part 1, Chapter 4.5, sections 11371
et seq) except that in order to provide greater opportunity for public comment
on the permanent regulations, remain in force for 270 days rather than 180
(o) “Life-Science Commercial Entity” means a firm or organization,
headquartered in California, whose business model includes biomedical or biotechnology
product development and commercialization.
(p) “Medical Ethicist” means an individual with advanced training
in ethics—who holds a PhD, MA or equivalent training and who spends or
has spent substantial time (a) researching and writing on ethical issues related
to medicine, and (b) administering ethical safeguards during the clinical trial
process, particularly through service on institutional review boards.
(q) “Pluripotent Cells” means cells that are capable of self-renewal,
and have broad potential to differentiate into multiple adult cell types. Pluripotent
stem cells may be derived from somatic cell nuclear transfer or from surplus
products of in vitro fertilization treatments when such products are donated
under appropriate informed consent procedures. These excess cells from in vitro
fertilization treatments would otherwise be intended to be discarded if not
utilized for medical research.
(r) “Progenitor Cells” means multipotent or precursor cells that
are partially differentiated but retain the ability to divide and give rise
to differentiated cells.
(s) “Quorum” means at least 65 percent of the authorized membership
who are eligible to vote.
(t) “Research Donor” means a human who donates biological materials
for research purposes after full disclosure and consent.
(u) “Research Funding” includes interdisciplinary scientific and
medical funding for basic research, therapy development, and the development
of pharmacologies and treatments through clinical trials. When a facilities
grant or loan has not been provided to house all elements of the research,
therapy development, and/or clinical trials, research funding shall include
an allowance for a market lease rate of reimbursement for the facility. In
all cases, operating costs of the facility, including but not limited to library
and communication services, utilities, maintenance, janitorial and security,
shall be included as direct research funding costs. Legal costs of the Institute
incurred in order to negotiate standards with federal and state governments
and research institutions; to implement standards or regulations; to resolve
disputes; and/or to carry out all other actions necessary to defend and/or
advance the Institute’s mission shall be considered direct research funding
(v) “Research Participant” means a human enrolled with full disclosure
and consent, and participating in clinical trials.
(w) “Revenue Positive” means all state tax revenues generated directly
and indirectly by the research and facilities of the Institute are greater
than the debt service on the state bonds actually paid by the state general
fund in the same year.
(x) "Stem Cells” mean non-specialized cells that have the capacity
to divide in culture and to differentiate into more mature cells with specialized
(y) “Vital Research Opportunity” means scientific and medical research
and technologies and/or any stem cell research not actually funded by the Institute
under Section 125281.11 (c) (1) (C) which provides a substantially superior
research opportunity vital to advance medical science as determined by at least
a two-thirds vote of a quorum of the members of the Scientific and Medical
Research Funding Working Group and recommended as such by that working group
to the ICOC. Human reproductive cloning shall not be a vital research opportunity.
SEC. 6. Government Code section 20069 is amended to read as follows:
(a) "State service" means service rendered as an employee or officer
(employed, appointed or elected) of the state, the California Institute for
Regenerative Medicine and the officers and employees of its governing body,
the university, a school employer, or a contracting agency, for compensation,
and only while he or she is receiving compensation from that employer therefore,
except as provided in Article 4 (commencing with Section 20990) of Chapter
(b) State service," solely for purposes of qualification for benefits
and retirement allowances under this system, shall also include service rendered
as an officer or employee of a county if the salary for the service constitutes
compensation earnable by a member of this system under section 20638.
SEC. 7. Severability
If any provision of this Act, or part thereof, is for any reason held to be
invalid or unconstitutional, the remaining provisions shall not be affected,
but shall remain in full force and effect, and to this end the provisions of
this Act are severable.
SEC. 8. Amendments
The statutory provisions of this measure, except the bond provisions, may be
amended to enhance the ability of the Institute to further the purposes of
the grant and loan programs created by the measure, by a bill introduced and
passed no earlier than the third full calendar year following adoption, by
seventy percent of the membership of both houses of the Legislature and signed
by the Governor, provided that at least 14 days prior to passage in each house,
copies of the bill in final form shall be made available by the clerk of each
house to the public and news media.
In light of the Governor's recent proposal to eliminate development of stem
cell research guidelines as part of his budget, we are asking all advocates
of stem cell research and their affiliates to contact the Governor's office
as soon as possible, with as many letters or communications as possible, asking
him to reverse his decision to repeal these guidelines.
Attached is a fact sheet on the Governor's proposal that may help in constructing
messages to the Governor.
The basic themes Sen. Ortiz is stressing in her letter to the Governor are:
Stem cell research guidelines are necessary to maintain and promote California's
position as a world leader in stem cell research;
* Scientific guidelines will help attract the best and brightest stem cell
scientists to California by further distinguishing California's program from
that of other states;
* The oversight provided by SB 322 (Ortiz) will help build public confidence
in the research and build support for public financing of the research, which
are vital to advancing the research and the cures and treatments that are dependent
on the research (feel free to list examples);
* Repeal of the guidelines sends a confusing message to researchers, patients,
their families, and the public about California's commitment to stem cell research;
* The minor investment required to develop the guidelines is dwarfed by the
enormous medical, scientific, and economic benefits that they will bring to
Letters and communications may be sent by letter, fax, and/or email to the
Governor Arnold Schwarzenegger
State Capitol Building
Sacramento, CA 95814
To assist us in following up with the Governor's Office, it would be helpful
if you could fax or email copies or your correspondence to Senator Ortiz's
State Capitol, Room 5114, Sacramento, CA, 95814;
Email copies can be sent to me at Peter.Hansel@sen.ca.gov
Thank you for your help with this. With your help we have a chance to overturn
Senate Health and Human Services Committee
Fact Sheet on Governor’s Proposal to Repeal
Stem Cell Research Guidelines
Summary of Governor’s Proposal:
The proposal is included in a memo dated January 9, 2004 from the Department
of Finance to the legislative budget chairs, outlining proposals for trailer
bill language to implement the Governor’s budget that was released last
The specific proposal would be to repeal the portions of SB 322 (Ortiz) that
require the Department of Health Services to develop guidelines to address
legal and ethical issues involved in embryonic stem cell research, to convene
a technical advisory committee, to collect information from local institutional
review boards (IRB)s on the number of embryonic stem cell research projects
reviewed and approved, and to report to the Legislature.
Significance of Issue:
SB 322 is significant for a number of reasons:
It helps implement the broader policy contained in SB 253 (Ortiz), which authorizes
stem cell research in all forms in California but states that consideration
of ethical and legal issues be given;
It further promotes California’s world leadership in stem cell research;
It ensures a check on inappropriate research, for example that venturing into
human cloning, and helps build public confidence in the research and public
receptivity to public financing for the research;
It is consistent with the recommendations of the California Advisory Committee
on Human Cloning, which recommended in January, 2002 that California permanently
ban human reproductive cloning but allow therapeutic cloning subject to reasonable
Due to the restrictions on NIH funding for embryonic stem cell research, there
are no federal guidelines for federally funded research; there are currently
no checks on privately funded research.
The Department of Finance estimates that implementation of SB 322 (Ortiz) would
entail $233,000 in initial costs to implement the bill, and ongoing annual
costs of $28,000 for monitoring and reporting functions. These costs include
staff time and contractor costs to convene the stem cell research advisory
committee; develop, print, and disseminate the guidelines; collect information
from local IRBs; and report to the Legislature.
Examples of issues to be addressed in guidelines:
Conditions under which unused embryos and eggs may be donated for research
Assurances that embryos, eggs, and somatic material have been donated with
Protections against conflicts of interest on the part of researchers and/or
fertility conflicts, e.g. through joint ownership or operating agreements;
Timetables for derivation of stem cells from developing embryos;
A means of ensuring that projects do not venture into the area of human cloning.
Governor Arnold Schwarzenegger
State Capitol Building
Sacramento, CA 95814
Re: SB 322
Dear Governor Schwarzenegger,
Hepatitis C is a very significant unmet medical need with several large pharmaceutical
companies actively researching new treatments. Worldwide, approximately 170
million people are currently infected with HCV, and it is estimated that this
number will increase to 500 million by 2010. There are a number of different
forms, or genotypes, of HCV with genotype one being the most predominant in
the United States as well as the most difficult to cure. The only treatment
currently available is a combination of ribavirin with interferon or pegylated
interferon. This treatment requires up to 48 weeks and causes severe side effects
for many patients. The success rate is very limited, especially against genotype
one, with a success rate that varies according to the patient's general health
and how advanced their liver disease is.
The CDC estimates that this particular liver disease may have infected over
650,000 Californians and most of them are unaware that they carry this illness.
Nearly 35% of persons who die from AIDS's succumb due to this disease. It is
estimated that larger proportions of hepatitis patients also suffer from Arthritis,
Diabetes, Heart Disease, Cancer and others that cause great suffering.
We are desperate to develop new and better treatments and vaccines with the
hopes to cure many serious major health concerns that plague our fellow citizens,
our health care system and overwhelm our medical providers. We have an opportunity
for California to emerge and excel as the leaders of Science and Medicine in
the recovery of our health and economy as well.
When we heard that you were considering repealing this historic landmark law,
SB 322 in an effort to reduce the budget, we were amazed that your promise
to serve the people of our great state might be overshadowed by concepts of
expediency on the short term. Sacrificing our long-term benefits to Californians
and the leadership to the chronically ill throughout the world is not the answer.
We implore you to not repeal this important law and to further support medical
research and a greater health consciousness in California.
Bill Remak, Chairman
California Hepatitis C Task Force
Governor Arnold Schwarzenegger
State Capitol Building
Sacramento, CA 95814
January 15, 2004 Re:
Dear Governor Schwarzenegger,
I am writing to express my grave concern regarding your proposed repeal
of SB 322. Do you know that more than 56 million Americans suffer from
heart disease? That more than 10 million suffer from some type of cancer?
More than 4 million Americans have Alzheimer’s disease, and that
number, as we all know, only stands to grow exponentially as our baby
boomers age. More than 16 million Americans suffer from diabetes, 40
million from arthritis, 17 million from depression, more than 3 million
Americans suffer from stroke and more than 28 million suffer from osteoporosis.
Each one of these can cause terrible suffering and pain, in addition
to the fiscal burden the illness places on the family, and ultimately,
on society. The cost of care for spinal cord injured Californians is
likely to exceed $1.2 billion.
Each one of these diseases can potentially be cured or substantially
mitigated by treatments developed through pluripotent and progenitor
cell research. Scientific leaders throughout the world agree that this
research must be supported. Even experts in the field of adult stem
cell research are quick to support simultaneous investigation into
pluripotent and progenitor cell research, knowing that adult stem cell
therapies have limitations.
We are desperate to develop new and better treatments and vaccines
with the hopes to cure many serious major health concerns that plague
our fellow citizens, our health care system and overwhelm our medical
We have an opportunity for California to emerge and excel as the leader
of Science and Medicine in the recovery of our health and our economy.
We cannot afford to continue to throw money at maintaining chronic
illness ~ our budget woes will only increase. The polio vaccine, developed
with NIH funds, saves this country, by some estimates, $30 billion
annually. Tuberculosis treatments developed with NIH funds save
the country $5 billion annually in institutional care costs. For
a variety of reasons, the NIH is unable to move forward in this most
promising area of research and we must step up to the plate. Fiscally,
morally, and ethically we must find cures. Research supported by SB
322 is regarded throughout the world as the most promising method of
finding those cures.
When I heard that you were considering repealing this historic landmark
law, SB 322 in an effort to reduce the budget, I was amazed that your
promise to serve the people of our great state might be overshadowed
by concepts of expediency on the short term. Sacrificing our long-term
benefits to Californians and the leadership to the chronically ill
throughout the world is not the answer. I implore you allow SB 322
to proceed as it was passed and to further support medical research
and a greater health consciousness in California.
Very Sincerely Yours,
Amy Daly, RN
3859 Bret Harte Drive
Redwood City, CA 94061-1115
 Statistics provided by the American Heart Association, American
Cancer Society, Alzheimer’s Association, American Diabetes
Association, Arthritis Foundation, Alliance for Aging Research, National
Depressive and Manic Depressive Association, National Stroke Association,
and Rutgers University study, “Spinal Cord Injury: An Analysis
of Medical and Social Costs” (1998, Demos Medical Publishing,
 Kirschner, Marc and others. 1994. "The Role of BioMedical
Research in Health Care Reform." Science, v. 266, no 5182, October
7, pp 49-51
 Wisconsin Association of Biomedical Research and Education (1995).
Bioscience Research, Development and Industry: Impact on Health and
Economic Growth in Wisconsin. Available on line at http://www.wabre.org
HEPATITIS C SHOULDN’T BE IGNORED DUE TO FEAR OF BIOTERRORISM
By Bill Remak - 1/25/2003
Chairman, California Hepatitis C Task Force
We all have heard post 9/11 bioterrorism threats centered on using anthrax
and smallpox as weapons. But the United States is presently under attack by
a “silent epidemic” that is much more insidious because it is doing
its killing right under our noses while efforts to combat it are at best, less
Hepatitis C (HCV) currently is killing at an annual rate five times higher
than the number that perished at the hands of terrorists at the World Trade
Center. To suggest that the liver-effecting virus could be used as a terrorist
threat may be a bit absurd. But after considering facts how this “silent
killer” is taxing our health care system, which is to define the meaning
Over the past five years our society has heard more and more about HCV. The
media has dubbed it the "silent killer" and the "silent epidemic" because
it takes 20 to 30 years under normal conditions until liver damage becomes
so serious it impacts a person’s life.
Most people are unaware they are infected until symptoms arise or their family
doctor chances upon some abnormal results from blood tests. Although complications
from HCV can cause cirrhosis, liver failure, liver cancer and death, doctors
estimate that 15 to 25 percent of those infected fight off the disease with
a healthy immune system.
The remaining percentage of people can respond to treatments currently being
used, and can be cleared of the virus 40 to 80 percent of the time depending
on what strain or genotype they have.
The most prevalent strain in the United States provides encouraging results
only in about 40 percent of the patients. When the disease has advanced too
far, the only options are surgical procedures and possibly a liver transplant.
But over 2000 men, women and children listed on the United Network for Organ
Sharing (UNOS) died while waiting for a liver transplant in 2002. This year,
thousands nervously await word of suitable livers fearing death as time runs
The HCV virus is transmitted through blood contact. Before 1992 there was no
test to detect the virus at blood banks. Those who received blood and those
who did not practice accepted sanitary precautions prior to that time were
at risk. How much at risk? More than five times greater than contracting HIV
or AIDS! Something to think about in this day and age where tattooing and piercing
is very commonly done by non-professionals who do not take proper health precautions.
The Center for Disease Control estimates that 1.8 percent of our general population
is infected with HCV. When you include the homeless and prison inmates that
number could swell as high as 2.2 percent.
But could this virus be transported and a delivery system be devised so terrorists
could damage or threaten our security, our way of life or our financial stability?
Not very likely, but it has not been studied. If used in this manner, it would
have to be done manually by an individual using infected blood to contaminate
others, spraying it on surgical equipment, injecting it into blood bags for
surgical use or directly into patients. That is feasible but not practical.
The disease used as a biological agent of “mass destruction” would
be ineffective in terms of immediate reaction.
A person exposed in a controlled setting such as a nurse accidentally stuck
by a contaminated syringe may take six to eight weeks before providing an accurate
We must consider that the conditions regarding our security systems in hospitals,
laboratories and blood banks need to be studied as an issue of national security.
We should look carefully at the potential possibilities of malicious transmission
of this virus.
The psychological ramifications of not knowing if one has been infected could
cause serious panic if citizens are not otherwise considered at high risk and
cannot find an explanation for their exposure. This issue undoubtedly needs
The cost of treating HCV today is staggering. Considering current rates of
chronic infection, state health care systems are powerless to absorb this great
financial strain. In any case, many believe that current treatments to rid
individuals of the disease will be improved and perhaps a vaccine will be developed
in 20 to 30 years. Why not sooner?
Hepatitis C is among the ten most costly diseases to treat. Increased action
and education must be utilized to keep this statistic from getting any worse.
How can we best be prepared? We are better off being in the know or at least
our government must invest some serious time and money to research this to
It is time to change our course! We should be saving lives; not taking them…this
is our right! ] 12/20/2002
(Edited by Rob Akers 1/25/03)
That was an interesting and thought provoking article you wrote about
the potential of bio-terrorism and blood borne pathogens like Hepatitis C.
Definitely something for our Government to think about!"
I wrote it to give some balance to this incredible focus on bio-terrorism
and an attempt to remind them that there is a bigger battle already going
on and not to dismantle our health system under the guise of war. That
would give terrorists an easy victory. Unless I created the thought of an
association, they just would not see it."
This topic requires this kind of language to get the point across."
Interesting article and I sent it out on the listserv."
I think it's a good idea to put this out. We need a mechanism to get
more attention. All the attention is given to small pox when really more
attention needs to be given to a "real" threat that is already at
As much as I hate to say it, we need to get people concerned...."
The article is provocative."
Nice job on your article re: Hepatitis C and bio-terrorism. Well written!
Dr. John Zweifler
Steve Kersker phoned me from Florida and I said I just wanted to get people
it and encouraged it to get distributed to as many as possible especially the
media. I told him
that it really isn't important who puts their name on it, as it is the issue
that is important. The
whole thing with this Homeland Security and Bio-terrorism hype is that our
executive branch is
oblivious to our plight as citizens who are faced with homelessness and
dying of treatable
diseases and reducing our education systems to rubble. Many more are suffering
will die in this "war" on distant soils. The money being tossed away would
otherwise cure cancer,
hepatitis, AIDS and other diseases, send a dozen people to the moon
and back, bring our economy back to stability, deal with our country's massive
substance abuse problem head on and reduce our staggering unemployment.
It is time we shout and take a stand and fight back using the democratic system
to do it. We are not being protected but rather we are being abandoned.
Tonight I watched 60 minutes in horror to learn that firms were pirating medications
patients, cancer, hepatitis and aids patients as these are the most costly
prescribed drugs, and
were diluting them and putting them back into the market place right under
the noses of the major
pharmaceutical manufacturers who knew about it and didn't even report it to
the FDA for fear
those consumers would go to their competitors!
Tampering With Prescription Drugs?
CBS News Online."
It's concise and makes it clearer that no one in its right mind would use HCV
as a weapon. I think there may be some room for further editing, but it may
start losing some of the message. A good effort. The only thing that leaves
me thinking is if the terrorism angle is the only one that can be used to perk
up the reader's interest. Ultimately the premise of HCV as a weapon is there
just for shock value, not as a serious concept. Even the comparison between
the WTC tragedy and the HCV deaths stands on uneasy ground in the mind of the
public, the latter lacking the visual and emotional impact of a jetliner striking
a tower and sending thousands of souls to their death. HCV is just as tragic,
but is played quietly and intimately within the lives of the sufferers and
I see California legislation as a reflection of the goals of the CDC National
Hepatitis C Prevention Strategy:
(A) To lower the incidence of acute hepatitis C in the United States
(B) Reduce the disease burden from chronic HCV infection.
Legislation required in California includes:
(1) harm reduction programs directed at persons at increased risk for infection
to reduce the
incidence of new HCV infections;
(2) counseling, testing, and medical evaluation and management of
infected persons to control HCV-related
chronic liver disease;
(3) surveillance to evaluate the effectiveness of prevention activities;
(4) education of health care and public health professionals to improve the
identification of persons at risk for
HCV infection and ensure appropriate
counseling, diagnosis, medical management,
(5) education of the public and persons at risk for infection about risk factors
for HCV transmission, and the need for testing and medical evaluation;
(6) clinical and public health activities to identify, counsel, and test persons
risk for HCV infection, and medical evaluation or referral for those found
to be infected;
(7) outreach and community-based programs to prevent practices that put
people at risk for HCV infection, and to identify persons who need to get
(8) surveillance to monitor acute and chronic disease trends and evaluate the
effectiveness of prevention and medical care activities; and
(9) research to better guide prevention efforts. Hepatitis C prevention activities
must be accessible to persons receiving health care services in both the public
and private sectors.The most effective means to prevent HCV infection and its
consequences is to integrate hepatitis C prevention activities into existing
services and public health programs.
In summary, legislation is needed to assist public education, testing, treatment
(when appropriate) and prevention efforts. Current law and the California
Hepatitis C Strategic Plan 2001 provides some sound recommendations, but
lacks a funding solution.
A high-risk population is our correctional institution population. Education,
testing and treatment when appropriate are a high priority in this population.
This should be applied prior to release to the general population.
Phyllis D. Borchardt, Director
Public Policy and Advocacy
California Hepatitis C Task Force
41597 Avenida de la Reina
Temecula, CA 92592
©2003California HCV Task Force Bill Remak