BILL NUMBER: SB 1565	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senators Kuehl and Runner

                        FEBRUARY 22, 2008

   An act to add Section 125293 to, the Health and Safety Code,
relating to reproductive health.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1565, as introduced, Kuehl. California Stem Cell Research and
Cures Act.
   The California Stem Cell Research and Cures Act (the act), an
initiative measure approved by the voters at the November 2, 2004,
statewide general election as Proposition 71, establishes the
California Institute for Regenerative Medicine (CIRM), 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 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, including, but not limited to,
establishing standards applicable to research funded by the
institute. Existing law prohibits amendment of Proposition 71 by the
Legislature unless the amendment is approved by the voters, or the
amendment is accomplished by a bill introduced after the first 2 full
calendar years and approved by a vote of 70% of both houses, and
only if the amendment enhances the ability of the institute to
further the purposes of the grant and loan programs.
   Existing provisions of Proposition 71 provide that the ICOC shall
establish standards that require that all grants and loan awards
under the act shall be subject to intellectual property agreements
that balance the opportunity of the state 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.
   This bill would require that intellectual property standards that
the ICOC develops shall include a requirement that each grantee and
the licensees of the grantee submit to the CIRM for approval a plan
that will afford uninsured Californians access to any drug that is,
in whole or in part, the result of research funded by the CIRM, and
would require that any plan subject to that approval shall require
that the grantees and licensees thereof sell drugs at a price that
does not exceed any benchmark price in the California Discount
Prescription Drug Program.
   Existing law establishes the Milton Marks "Little Hoover"
Commission on California State Government Organization and Economy, a
multimember body appointed by the Governor and the Legislature with
various duties that include making recommendations to the Governor
and the Legislature to promote efficiency in government operations.
   This bill would require the commission to conduct a study of the
governance structure of the California Stem Cell Research and Cures
Act. This bill would, by July 2, 2009, require the commission to
submit, to the appropriate committees of each house of the
Legislature, a report on the results of the study and recommendations
of ways the governance structure of the ICOC could better ensure
public accountability and reduce conflicts of interest, consistent
with the purposes of Proposition 71 and would require the commission
to make the report available to the public.
   Vote: Appropriation: no. Fiscal committee: yes. State-mandated
local program: no.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 125293 is added to the Health and Safety Code,
to read:
   125293.  (a) The intellectual property standards that the ICOC
develops shall include a requirement that each grantee and the
licensee of the grantee submit a plan to the California Institute for
Regenerative Medicine (CIRM) that will afford uninsured Californians
access to any drug that is, in whole or in part, the result of
research funded by the CIRM.
   (b) The ICOC shall require submission of the plan required by
subdivision (a) before a drug is placed into commerce. The plan shall
be subject to the approval of the CIRM, after a public hearing and
opportunity for public comment.
   (c) (1) Any plan subject to subdivision (a) shall include a
requirement that each grantee and any licensee of the grantee that
sells drugs that are, in whole or in part, the result of research
funded by CIRM and that are purchased in California with public funds
shall sell those drugs at a price that does not exceed any benchmark
price in the California Discount Prescription Drug Program (Division
112 (commencing with Section 130500)), as it exists on January 1,
2008.
   (2) Paragraph (1) shall not preclude any public agency from
obtaining prices that are lower than the price determined as
described in paragraph (1) through negotiation, bulk purchasing, or
any other purchasing arrangement and shall not be construed to
conflict with, or preempt, any other provision of state or federal
law or regulation that would result in lower drug prices.
   (d) For purposes of this section, "drug" includes any article
recognized in the United States Pharmacopeia or supplement thereof,
the National Formulary, or any supplement thereof, and to any article
intended for the diagnosis, cure, mitigation, or prevention of
disease in humans or animals, or any article intended for use as a
component thereof, and shall include therapeutic products, including,
but not limited to, blood, blood products, cells, and cell
therapies.
  SEC. 2.  (a) The Commission on California State Government
Organization and Economy shall conduct a study of the governance
structure of the California Stem Cell Research and Cures Act, an
initiative measure approved by the voters at the November 2, 2004,
statewide general election (Proposition 71), including the membership
of the Independent Citizens Oversight Committee and the relative
roles of the committee and the California Council of Regenerative
Medicine.
   (b) By July 2, 2009, the commission shall submit, to the
appropriate committees of each house of the Legislature, a report on
the results of the study required by subdivision (a) and
recommendations of ways the governance structure of the Independent
Citizens Oversight Committee could better ensure public
accountability and reduce conflicts of interest, consistent with the
purposes of Proposition 71. The commission shall make the report
available to the public.