SCA 13 Senate Constitutional Amendment - AMENDED BILL NUMBER: SCA 13
AMENDED BILL TEXT
AMENDED IN SENATE MAY 31, 2005 AMENDED IN SENATE MAY 23, 2005 AMENDED IN SENATE APRIL 26, 2005
INTRODUCED BY Senators Ortiz and Runner (Coauthors: Senators Cox and Dutton) (Coauthors: Assembly Members Benoit, Garcia, Jones, Laird, Leno, and Yee)
MARCH 17, 2005
A resolution to propose to the people of the State of California an amendment to the Constitution of the State, by amending Section 6 of, and by adding Sections 8 and 9 to, Article XXXV thereof, relating to biomedical research.
LEGISLATIVE COUNSEL'S DIGEST
SCA 13, as amended, Ortiz. Biomedical research.
The California Stem Cell Research and Cures Act, an initiative
measure, establishes the California Institute for Regenerative
Medicine, the purpose of which is, among other things, to make grants
and loans for stem cell research, for research facilities, and for
other vital research opportunities to realize therapies, protocols,
and medical procedures that will result in the cure for, or
substantial mitigation of, diseases and injuries. Existing law
authorizes the issuance of bonds, not to exceed $3,000,000,000, for
the purpose of funding this research.
Existing law establishes the Independent Citizen's Oversight
Committee (ICOC), composed of appointed members, that is required to
perform various functions and duties with regard to the operation of
the institute. Existing law also establishes various working groups
whose purposes are to make recommendations to the ICOC regarding the
making of these grants and loans.
This measure would require the chair and vice chair and any
appointed member of the Independent Citizen's Oversight Committee
(ICOC), the president and each employee of the institute, and any
member of any working or advisory group appointed to assist the
institute or its governing body to disclose his or her income
investments, and interests in real property in the manner set forth
in the Political Reform Act, or its successor, and except for
employees of the institute and any member of any working or
advisory group appointed to assist the institute or its governing
body , to divest themselves of, or place into a blind trust,
any financial or real property interest held by that person in any
organization that applies for funding from, or contracts with, the
institute or in any organization with a substantial interest in stem
cell therapy. It would also require the State Auditor
to review the financial disclosures made by each member of a working
or advisory group, in addition to the voting record of each member
regarding recommendations for applications for research and facility
grants and loan awards and regulatory standards, and submit an annual
report to the Legislature containing findings on whether any of the
votes made by these members may constitute, or have constituted, a
conflict of interest, as defined.
This measure would require that records and meetings be
subject to state open meeting and public record laws that are
applicable to state agencies, with certain exceptions.
This measure would require every contract, award, grant, loan, or
other arrangement entered into by the institute or the ICOC to ensure
that these financial arrangements do not result in a gift of public
funds, that loan, lease, or rental arrangement terms are consistent
with or below market rates for rent or interest, and that any
clinical treatments, products, or services resulting from the
biomedical research are made available, at the costs of producing
them, to California residents who are eligible to receive assistance
through state and county health care and preventive health programs.
The measure would require these financial arrangements to provide that the state recoup the full amount of its legal and administrative costs incurred with respect to patenting and licensing activities related to biomedical research, would require that the state be provided with its share of royalties or licensing revenues, derived from the development of clinical treatments, products, or services resulting from the research, that is sufficient to repay its expenses incurred in developing these treatments, products, or services, and would also require that these royalties or licensing revenues be transmitted to the state in an amount sufficient to repay the costs of issuing bonds incurred by the state in funding the biomedical research. Vote: 2/3. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.
Resolved by the Senate, the Assembly concurring, That the
Legislature of the State of California at its 2005-06 Regular Session
commencing on the sixth day of December 2004, two-thirds of the
membership of each house concurring, hereby proposes to the people of
the State of California, that the Constitution of the State be
amended as follows:
First— That Section 6 of Article XXXV thereof is amended to
read:
SEC. 6.
Except as otherwise provided in this article, 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.
Second— That Section 8 is added to Article XXXV thereof, to
read:
SEC. 8.
(a) The chair and vice chair and any appointed member of the
Independent Citizen's Oversight Committee (ICOC), and the
president and each employee of the institute , and any
member of any working or advisory group appointed to assist the
institute or its governing body shall disclose his or her
income, investments, and interests in real property in the manner set
forth in Chapter 7 (commencing with Section 87100) of Title 9 of the
Government Code, or its successor. The chair and vice chair and any
appointed member of the ICOC, and the president of the
institute , and any member of any working or advisory group
appointed to assist the institute or its governing body
shall divest themselves of or place into a blind trust, any financial
or real property interest held by that person in any organization
that applies for funding from, or contracts with, the institute or in
any organization with a substantial interest in stem cell therapy.
An organization with a substantial interest in stem cell therapy is
one for which, based upon publicly available information, more than
five percent of the organizations
organization's current annual research budget is allocated to
stem cell therapy.
(b) (1) Upon his or her appointment and each year at a time
specified by the ICOC, each member of a working or advisory group
appointed to assist the institute or its governing body shall
disclose to the ICOC his or her income, investments, and interest in
real property in the manner set forth in Chapter 7 (commencing with
Section 87100) of Title 9 of the Government Code, or its successor.
The ICOC shall provide the disclosures to the State Auditor. The
State Auditor, or his or her successor, shall review the disclosures,
in addition to the voting record of each working or advisory group
member regarding recommendations for applications for research and
facility grants and loan awards and regulatory standards, and submit
an annual report to the Legislature containing findings on whether
any of the votes made by these members may constitute, or has
constituted, a conflict of interest that requires or required the
member to recuse himself or herself from consideration of an
application or standard if the member is otherwise required under
existing law to recuse himself or herself.
(2) For purposes of this subdivision, "conflict of interest" means
the working or advisory group member, or a close relative or
professional associate of the member, has a financial or other
interest in an application or standard that is known to the member,
including a direct benefit of any amount deriving from an application
or standard, or a financial benefit of any type from an applicant
institution of over five thousand dollars ($5,000) per year,
including honoraria, fees, stock, or other benefits. For purposes of
this paragraph, "close relative" and "professional associate" shall
have the same meaning as those terms are defined under the National
Institutes of Health Conflict of Interest, Confidentiality and Non
Disclosure Rules.
(b)
(c) (1) Except as provided in paragraph (2)
paragraphs (2), (3), and (4) , meetings and
records of the institute, the ICOC, or any body established to govern
the institute, and any working or advisory group, are subject to
California open meeting and public record laws that are applicable to
state agencies.
(2) Notwithstanding paragraph (1), the ICOC, any body established
to govern the institute, and any working group or advisory group, may
conduct a closed session for the purpose of
(2) Notwithstanding paragraph (1), any
working or advisory group appointed to assist the institute or its
governing body that is charged with reviewing and recommending
medical research projects for funding may hold closed sessions when
necessary to conduct or carry out scientific peer review of any
research project submitted for funding, or for the purpose of
considering or discussing matters involving intellectual property or
proprietary information and matters involving prepublication
confidential scientific information associated with individual
research proposals submitted for funding. However, any working
or advisory group that is charged with reviewing and recommending
medical research projects for funding shall produce a
written summary that shall be a public record of the reasons for
recommending or not recommending any project for funding as well as
how each project recommended for funding will benefit residents of
California. The working or advisory group shall hold an open session
to allow public comment on its decision prior to submitting any
recommendation to the ICOC.
(3) Notwithstanding paragraph (1), the institute, ICOC, or any
body established to govern the institute, and any working group or
advisory group, may conduct closed sessions as permitted by the
Bagley-Keene Open Meeting Act (Article 9 (commencing with Section
11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the
Government Code), or its successor.
(4) Notwithstanding paragraph (1), records containing intellectual
property or proprietary information and matters involving
prepublication of confidential scientific information shall not be
subject to public record laws.
Third— That Section 9 is added to Article XXXV thereof, to
read:
SEC. 9.
(a) Every contract, award, grant, loan, or other arrangement
entered into by the institute or the Independent Citizen's Oversight
Committee shall ensure all of the following:
(1) Notwithstanding Section 6, the contract, award, grant, loan,
or other arrangement does not result in a gift of public funds within
the meaning of Section 6 of Article XVI.
(2) All clinical treatments, products, or services resulting from
the biomedical research are made available at the costs of producing
them to California residents who are eligible to receive assistance
through state and county health care and preventive health programs
including, but not limited to, the Medi-Cal and Healthy Families
programs.
(3) The terms of any loan, lease, or rental arrangement are
consistent with, or below, market rates for rent or interest.
(4) The State recoups the full amount of its legal and
administrative costs incurred with respect to patenting and licensing
activities related to the biomedical research.
(5) The State is provided a share of the royalties or revenues,
derived from the development of clinical treatments, products, or
services resulting from the research, that is sufficient to repay its
expenses incurred in developing the clinical treatments, products,
or services.
(6) In addition to royalties or licensing revenues described in
paragraph (5), royalties or licensing revenues are transmitted to the
State in an amount sufficient to repay any costs of issuing bonds
incurred by the State in funding the biomedical research.
(b) Nothing in this section shall be construed to preclude the
State from receiving any other benefits to which it would otherwise
be entitled under Chapter 3 (commencing with Section 125290.10) of
Part 5 of Division 106 of the Health and Safety Code, or its
successor.
source: http://info.sen.ca.gov/cgi-bin/postquery?bill_number=sca_13&sess=CUR&house=B&site=sen 7jun2005
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