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California Family Bioethics Council v. Cali. Inst. for Regenerative Med Part I

California Family Bioethics Council v. Cali. Inst. for Regenerative Med Part I
03:18:2007



California Family Bioethics Council v. California Institute for Regenerative Medicine



Filed 2/26/07



CERTIFIED FOR PUBLICATION



IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA



FIRST APPELLATE DISTRICT



DIVISION THREE



California Family Bioethics Council,



Plaintiff and Appellant,



v.



California Institute for Regenerative Medicine et al.,



Defendants and Respondents.



A114195



(Alameda County



Super. Ct. No. HG05 206766)



Peoples Advocate et al.,



Plaintiffs and Appellants,



v.



Independent Citizens Oversight Committee et al.,



Defendants and Respondents.



A114282



(Alameda County



Super. Ct. No. HG05 235177)



Before us is an appeal from two consolidated actions challenging the validity of Proposition 71, the stem cell research initiative approved by a substantial majority of the voters at the General Election on November 2, 2004. Relying in significant part on the reasoning of California Assn. of Retail Tobacconists v. State of California (2003) 109 Cal.App.4th 792 (CART),[1] the trial court rejected the diverse challenges that appellants have directed to Proposition 71 and to the method of its enactment. We agree with the conclusions reached in the comprehensive opinion of the trial court[2] and shall affirm its judgment.



Factual and Procedural History



A. Summary of Proposition 71



Although section 1 of the proposition states that the entire measure shall be known as the California Stem Cell Research and Cures Act,[3] Proposition 71 in fact adds an amendment to the California Constitution, two separate acts to the Health and Safety Code, and expands the Government Code definition of state service.



Section 4 of the proposition adds to the Constitution article XXXV, establishing the California Institute for Regenerative Medicine (CIRM or the institute). The purpose of the institute, according to the constitutional amendment, is (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 diseases. [] (b) To support all stages of the process of developing cures, from laboratory research through successful clinical trials. [And] [] (c) To establish the appropriate regulatory standards and oversight bodies for research and facilities development. (Cal. Const., art. XXXV,  2.)[4]



Article XXXV further establishes 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. (Id.,  5.)[5] No funds of the institute, however, may be used for research involving human reproductive cloning. (Id.,  3.)[6] The constitutional provision provides further, 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. (Id.,  6.)[7] The final section of the constitutional provision provides that the institute and its employees are exempt from civil service. (Id.,  7.)



To implement the goals of the constitutional provision, Proposition 71 adds to the Health and Safety Code[8] the California Stem Cell Research and Cures Act ( 125290.10 et seq., hereafter the Cures Act or the Act) and the California Stem Cell Research and Cures Bond Act of 2004 ( 125291.10 et seq., hereafter the Bond Act).[9]



To govern the institute, the Cures Act creates an Independent Citizens Oversight Committee (ICOC), which is vested with full power, authority, and jurisdiction over the institute. ( 125290.15.) The ICOC consists of 29 members, 20 of whom are appointed by the Governor, the Lieutenant Governor, the Treasurer, or the Controller. Five are appointed by the chancellors of the five University of California campuses with medical schools. The Speaker of the Assembly and the President Pro Tempore of the Senate each appoints one member and the final two, a chairperson and vice-chairperson, are elected by the other ICOC members from persons nominated by the four constitutional officers. ( 125290.20, subd. (a).) There are stringent qualifications for appointment designed to ensure that all members possess appropriate experience and expertise and that persons knowledgeable in the various disease groups that may benefit from the research are represented. In general, the members must be executive officers of California academic or research institutions with an established ability to conduct stem cell research, executive officers of a qualified life science commercial entity, or representatives of disease advocacy groups.[10] Members are appointed for terms of either six or eight years, and may serve no more than two terms. (Id., subd. (c)(1).)



The ICOC is responsible for oversee[ing] the operations of the institute. ( 125290.40, subd. (a).) The statute provides a long list of the ICOCs functions, which include developing annual and long-term strategic research and financial plans for the institute, making final decisions on research standards and grant awards in California, ensuring the completion of an annual financial audit of the institutes operations, issuing public reports on the activities of the institute, establishing policies regarding intellectual property rights arising from research funded by the institute, establishing rules and guidelines for the operation of the ICOC and its working groups, selecting members of the working groups, adopting, amending, and rescinding rules and regulations to carry out the purposes and provisions of the Cures Act and the Bond Act and to govern the procedures of the ICOC, requesting the issuance of bonds from the California Stem Cell Research and Cures Finance Committee and loans from the Pooled Money Investment Board (id., subds. (b)-(g), (i)-(n)), and perform[ing] all other acts necessary or appropriate in the exercise of its power, authority, and jurisdiction over the institute (id., subd. (h)).



The Cures Act also provides for the creation of three scientific and medical working groups to advise the ICOC regarding research funding, accountability standards and facilities. Members of the working groups are appointed by a majority vote of a quorum of the ICOC. ( 125290.50, subds. (a), (b).) Different qualifications are specified for membership in each of the working groups to ensure the appropriate expertise in each group. ( 125290.55, 125290.60, 125290.65.)[11] The Cures Act also creates a Citizens Financial Accountability Oversight Committee to review the annual financial audit, the State Controllers report and the financial practices of the institute. This committee is chaired by the State Controller and includes public members who shall have medical backgrounds and knowledge of relevant financial matters and who are appointed by the State Controller, State Treasurer, President Pro Tempore of the Senate, Speaker of the Assembly and chairperson of the ICOC. ( 125290.30, subd. (c).)



Members of the ICOC and of the working groups are subject to conflict-of-interest rules, but the generally applicable Government Code provisions are qualified by standards set out in the Cures Act or authorized to be adopted by the ICOC for non-ICOC working group members. ( 125290.30, subd. (g), 125290.50, subd. (e); see also pp. 46-47, post.) Meetings of the ICOC must be held in compliance with the Bagley-Keene Open Meeting Act (Gov. Code,  11120 et seq.) and the award of all grants, loans and contracts, and the adoption of all standards must occur in public meetings. ( 125290.30, subd. (d).) The California Public Records Act (Gov. Code,  6250 et seq.) is, with certain exceptions, applicable to all records of the institute ( 125290.30, subd. (e)). Except for grants and loans approved by the ICOC, all institute contracts must be entered in accordance with the competitive bidding requirements applicable to the University of California. (Pub. Contract Code,  10500 et seq.) The rules and regulations that the ICOC adopts (other than interim regulations that were authorized for no more than 270 days) must be adopted in accordance with the Administrative Procedure Act (Gov. Code,  11371 et seq.). ( 125290.40, subd. (j).)



The Cures Act requires the ICOC to adopt standards applicable to all phases of its work, including scientific and medical standards to carry out the specific controls and intent of the act that shall govern the ICOC, its working committees and its grantees ( 125290.35, subd. (a)), standards for obtaining the informed consent of research donors, patients or participants (id., subd. (b)(1)), standards for the review of research involving human subjects (id., subd. (b)(2)), standards prohibiting compensation to research donors or participants (id., subd. (b)(3)), standards to assure compliance with state and federal patient privacy laws (id., subd. (b)(4)), standards limiting payments for the purchase of stem cells or stem cell lines (id., subd. (b)(5)), and standards setting a limit on the time during which cells may be extracted from blastocysts (id., subd. (b)(6)). While the ICOC has been granted broad discretion in these areas, the Cures Act places numerous limitations on the exercise of that discretion. The medical and scientific standards, for example, must comply with Government Code section 125315, concerning the information and options that must be provided to fertility treatment patients ( 125290.35, subd. (a)) and the standards concerning privacy must comply with state and federal privacy laws (id., subd. (b)(4)). Some of the standards must initially be generally based on standards of the National Institutes of Health, with modifications to adapt to the mission and objectives of the institute. (Id., subd. (b)(1), (2).) Other standards must comply with more specific criteria set out in the statute. (Id., subd. (b)(3), (5), (6).) As discussed more fully below (see pp. 42-43 & fn. 28, post.), the criteria that the Scientific and Medical Research Funding Working Group must use in evaluating grant and loan applications are specified in the statute ( 125290.60, subd. (c)). The Act also provides guidelines and priorities for the appropriation and allocation of institute funding ( 125290.70; see pp. 34-35, post). In addition, the institute is subject to financial and public accountability provisions, including the requirements that the institute issue an annual public report of its activities that must contain specified information, and commission an annual independent financial audit that must be reviewed by the State Controller and by the Citizens Financial Accountability Oversight Committee. ( 125290.30.)



The Bond Act contains the statutory authorization and framework for issuing bonds, obtaining interim financing, and managing funds for the operation of the institute.[12] Under section 125291.30, [b]onds in the total amount of three billion dollars ($3,000,000,000) . . . 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 . . . . The total amount of bonds that may be issued in a calendar year may not exceed $350,000,000, plus remaining permitted amounts from prior years. ( 125291.45, subd. (b).) The California Stem Cell Research and Cures Finance Committee (Finance Committee), which is chaired by the State Treasurer and also includes the State Controller, Director of Finance, the CIRM chairperson and two additional ICOC members, is created [s]olely 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 . . . . ( 125291.40.)



B. The Litigation



On April 6, 2005, plaintiffs Peoples Advocate and National Tax Limitation Foundation (collectively, Peoples Advocate) filed an action in the Alameda County Superior Court against the ICOC and individual defendants Robert Klein, as chairperson and interim president of the ICOC, Arnold Schwarzenegger, as Governor of the State of California, Cruz Bustamante, as Lieutenant Governor, Phil Angelides, as Treasurer, and Steve Westley as Controller.[13] The action seeks a declaratory judgment that the statutory components of Proposition 71 violate article XVI, section 3 of the California Constitution, which prohibits the state from disbursing state funds to entities not under the exclusive management and control of the state. Peoples Advocate asserts that the ICOC, which is empowered to disburse state funds through research grants and loans, is a private entity not under the exclusive management and control of the state. The statute, the complaint alleges, delegates the disbursal of huge sums of public money to the unfettered discretion of an institution whose governing board and working groups are unaccountable to the public.



On July 8, 2005, after the Finance Committee had authorized $3 billion in general obligation bonds, plaintiff California Family Bioethics Council, LLC (the Council) filed a complaint in the Sacramento County Superior Court against the institute, the Finance Committee and all persons interested in the matter of the legality of Proposition 71 and validity of actions, bonds and financing of CIRM. This reverse validation action under Code of Civil Procedure section 863 challenges the constitutionality of Proposition 71 and the validity of the proposed state general obligation bonds. The Council contends that Proposition 71 violates the single-subject rule; that Proposition 71 violated electoral due process by concealing from the voters the true scope and meaning of the initiative and its true costs; and that conflicts of interest inherent in the Cures Act violate fundamental principles of representative government, public policy and constitutional due process of law, represent an unconstitutional award of privileges and immunities to the ICOC members and their institutions, and violate existing conflicts of interest statutes and the common law. The Council also made the contention advanced by Peoples Advocate that the statutory provisions violate article XVI, section 3 of the California Constitution.



On August 4, 2005, the Alameda County Superior Court transferred the Councils action to Alameda County and consolidated it with the action filed by Peoples Advocate. The consolidated cases were tried before the court in February and March of 2006. The court received extensive documentary evidence, pre- and posttrial briefs from all parties, and the testimony of four witnesses. On May 12, the court issued a thorough statement of decision and entered judgment in favor of the defendants, finding that plaintiffs failed to show that Proposition 71, the California Stem Cell Research and Cures Initiative, is clearly, positively and unmistakably unconstitutional; that Proposition 71 and the bonds issued thereunder are valid; and that plaintiffs did not meet their burden to obtain any of the declaratory and injunctive relief sought in their complaints. Peoples Advocate and the Council filed timely notices of appeal.



Discussion



Between the two appeals, appellants challenge both the validity of the initiative process by which Proposition 71 was adopted, and the substantive validity of the provisions that were thereby enacted. Appellants disclaim any intention to question the merits or faults of stem cell research and we too shall avoid such considerations. (See AmadorValley Joint Union High Sch. Dist. v. State Bd. of Equalization (1978) 22 Cal.3d 208, 219 (Amador) [We do not consider or weigh the economic or social wisdom or general propriety of the initiative. Rather, our sole function is to evaluate [it] legally in light of established constitutional standards.].) After briefly reviewing the applicable standard of review, we shall consider first whether Proposition 71 violated the so-called single-subject rule and whether the ballot materials that accompanied the proposition were misleading and invalidated the results of the election. We shall then turn to the several reasons for which appellants contend that the statutory components of the measure violate either the California Constitution or other provisions of law. Finally, we shall consider appellants objections to the exclusion of certain evidence at trial.



A. Standard of Review



Peoples Advocate seeks a declaration that the Cures Act is unconstitutional and an order enjoining efforts to organize or operate the ICOC and prohibiting the named defendants from spending or releasing any public funds for any purpose connected with or relating to, the ICOC. It also seeks to enjoin these defendants from issuing, or causing to be issued, any bonds under the Bond Act. The Council similarly seeks a declaration that Proposition 71 is unlawful and an order enjoining its enforcement.[14]



Appellants challenges to the validity of the proposition and to the statutes enacted by the proposition present questions of law that are reviewed de novo. (CART,supra, 109 Cal.App.4th at p. 807.) This reviewing court therefore exercises its independent judgment, without deference to the trial courts ruling. [Citation.] [] We are guided by established principles for evaluating the constitutionality of initiative measures. We do not consider or weigh the economic or social wisdom or general propriety of the initiative, but rather evaluate its constitutionality in the context of established constitutional standards. [Citation.] [] Although the legislative power under our state Constitution is vested in the Legislature, the people reserve to themselves the powers of initiative and referendum. [Citation.] Accordingly, the initiative power must be liberally construed to promote the democratic process. [Citation.] Indeed, it is our solemn duty to jealously guard the precious initiative power, and to resolve any reasonable doubts in favor of its exercise. [Citation.] As with statutes adopted by the Legislature, all presumptions favor the validity of initiative measures and mere doubts as to validity are insufficient; such measures must be upheld unless their unconstitutionality clearly, positively, and unmistakably appears.  (Id. at pp. 807-808.)



The Council asserts that it is challenging Proposition 71 both facially and as applied. A facial challenge to the constitutional validity of a statute or ordinance considers only the text of the measure itself, not its application to the particular circumstances of an individual. [Citation]  To support a determination of facial unconstitutionality, voiding the statute as a whole, petitioners cannot prevail by suggesting that in some future hypothetical situation constitutional problems may possibly arise as to the particular application of the statute . . . . Rather, petitioners must demonstrate that the acts provisions inevitably pose a present total and fatal conflict with applicable constitutional prohibitions.   (Tobe v. City of Santa Ana (1995) 9 Cal.4th 1069, 1084, italics omitted.)



An as applied challenge seeks relief from a specific application of a facially valid statute . . . to an individual or class of individuals or seeks to enjoin the future application of the statute . . . in the allegedly impermissible manner it is shown to have been applied in the past. (Tobe v. City of Santa Ana, supra, 9 Cal.4th at p. 1084.) The result of a successful as-applied challenge to a particular statute is not the invalidation of the statute as a whole, but rather an order enjoining specific unlawful application of the statute. (Id. at pp. 1084-1086.) In general, a complaint that seeks to enjoin any application of the ordinance to any person in any circumstance constitutes a facial attack on the statute. (Id. at p. 1087.) Here, the Council challenges the validity of the entire proposition and Peoples Advocate challenges the validity of the Cures Act. Neither complaint identifies a specific application of any provision that it seeks to enjoin. Accordingly, as the trial court concluded, both complaints should be considered as presenting facial challenges, either to the proposition or to the included Act. Insofar as the trial court considered evidence with regard to the implementation of Proposition 71, including evidence of appointees qualifications and the process by which training grants were awarded, that evidence will be considered as providing context for the analysis of the challenged statutory provisions. To the extent that the trial court made findings that the Cures Act has thus far been implemented in conformity with the statute, those findings are subject to substantial evidence review. (See Board of Administration v. Wilson (1997) 52 Cal.App.4th 1109, 1127-1129; City and County of San Francisco v. Sainez (2000) 77 Cal.App.4th 1302, 1313.) However, appellants do not challenge the sufficiency of the evidence to support the findings and have not requested any form of relief short of invalidating either the entire proposition or the Cures Act. Therefore, the primary focus of this courts review remains the facial validity of these measures.



B. The Adoption of Proposition 71



1.The Single-subject Rule



The Council first argues that the proposition is invalid because it was enacted by a ballot measure that did not comply with the provision of the California Constitution limiting initiatives to a single subject matter. An initiative measure embracing more than one subject may not be submitted to the electors or have any effect. (Cal. Const., art. II,  8, subd. (d).) This single-subject rule is designed to avoid confusion of either voters or petition signers and to prevent subversion of the electorates will. (Senate of the State of Cal. v. Jones (1999) 21 Cal.4th 1142, 1156 (Jones); CART, supra, 109 Cal.App.4th at p. 809.)    An initiative measure does not violate the single-subject requirement if, despite its varied collateral effects, all of its parts are reasonably germane to each other, and to the general purpose or object of the initiative.  [Citation.] As we recently have explained, the single-subject provision does not require that each of the provisions of a measure effectively interlock in a functional relationship. [Citation.] It is enough that the various provisions are reasonably related to a common theme or purpose. [Citation.] Accordingly, we have upheld initiative measures  which fairly disclose a reasonable and common sense relationship among their various components in furtherance of a common purpose.   (Jones, supra, 21 Cal.4th at p. 1157, italics omitted.)



[T]he initiative process occupies an important and favored status in the California constitutional scheme and the single-subject requirement should not be interpreted in an unduly narrow or restrictive fashion that would preclude the use of the initiative process to accomplish comprehensive, broad-based reform in a particular area of public concern. (Jones, supra, 21 Cal.4th at p. 1157.) In evaluating a single-subject challenge to a measure the court should not attempt to predict whether each section actually will further the initiatives purpose. Instead, we inquire only whether the provisions are reasonably germane to the general purpose or objective of the initiative. (Calfarm Ins. Co. v. Deukmejian (1989) 48 Cal.3d 805, 841-842.)



The Council relies heavily on two Court of Appeal decisions that held initiative measures violated the single-subject rule: California Trial Lawyers Assn. v. Eu (1988) 200 Cal.App.3d 351 (CTLA) and Chemical Specialties Manufacturers Assn., Inc. v. Deukmejian (1991) 227 Cal.App.3d 663 (Chemical). In CTLA the court addressed a ballot measure that was predominately aimed at controlling the cost of insurance. One provision of the measure, however, would have protected insurance companies from laws regulating campaign contributions. The Court of Appeal held that the inclusion of this provision ran afoul of the single-subject rule. First, the express purpose of the initiative is to control the cost of insurance, not generally to regulate the practices of the insurance industry. Second, we cannot accept the implied premise of [the insurers] analysis, i.e., that any two provisions, no matter how functionally unrelated, nevertheless comply with the constitutions single-subject requirement so long as they have in common an effect on any aspect of the business of insurance. Contemporary society is structured in such a way that the need for and provision of insurance against hazards and losses pervades virtually every aspect of life. [The insurers] approach would permit the joining of enactments so disparate as to render the constitutional single-subject limitation nugatory. (CTLA, supra, at p. 360.) The court also took issue with the fact that the provision regarding campaign contributions was located . . . near the middle of a 120-page document, and consists of two brief paragraphs which bear no connection to what precedes or follows, calling it a paradigm of the potentially deceptive combination of unrelated provisions at which the constitutional limitation on the scope of initiatives is aimed. (Ibid.)



In Chemical, the ballot measure was directed at public disclosure of information concerning household toxic products, seniors health insurance, nursing homes, statewide initiative or referendum campaigns, and sales of stock or securities for corporations doing business with South Africa. The Court of Appeal rejected the contention that the measure was aimed at providing the public with accurate information in advertising, finding this articulation of the subject matter to be so broad that a virtually unlimited array of provisions could be considered germane thereto and joined in this proposition, essentially obliterating the constitutional requirement. [] In actuality, the measure seeks to reduce toxic pollution, protect seniors from fraud and deceit in the issuance of insurance policies, raise the health and safety standards in nursing homes, preserve the integrity of the election process, and fight apartheid; well-intentioned objectives but not reasonably related to one another for purposes of the single-subject rule. (Chemical, supra, 227 Cal.App.3d at p. 671.)



The Council argues that Proposition 71 violates the single-subject rule by authorizing not only stem cell research but also (a) authorizing research and regulation concerning unspecified other vital research opportunities, (b) revising conflicts of interest laws and legislating conflicts of interest exemptions, and (c) granting exclusive, executive, financial and regulatory powers beyond the scope of stem cell research. In rejecting this contention, the trial court correctly observed, The over-arching subject of Proposition 71 is stem cell research and funding. The initiatives purpose and intent includes funding stem cell research; setting standards for such research; and reducing the long-term health care cost in California through the development of therapies that treat diseases with the ultimate goal to cure them. In addition, the initiatives intent is to benefit the California economy by creating jobs and advancing the biotech industry through such research. The ICOC oversees the research, with representatives of [the University of California (U.C.)] and other California universities with medical research institutions, disease advocacy groups, and experts in the development of medical therapies. The trial court concluded that the subjects [the Council] argues violate the single subject rule are reasonably interrelated and do not violate the rule, aptly citing Amador, supra, 22 Cal.3d at page 231.[15]



Turning to the specific reasons for which the Council asserts that Proposition 71 covers more than one subject matter, the Council first points to the provision authorizing the institute 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 diseases.[16] (Cal. Const., art. XXXV,  2, italics added.) The Council argues that by allowing for broadly defined other vital research, the Cures Act covers not only stem cell research but other research that is not aimed at regenerative technologies.



The trial court concluded that funding other vital research opportunities is germane and related to the other provisions of the [Cures] Act in that it is limited to funding only those opportunities that will result in the types of cures sought by the Act. (Quoting Cal. Const., art. XXXV,  2, subd. (a).) The Council argues that this analysis impermissibly redefines the subject of Proposition 71 in general terms of scientific or medical research, rather than its professed subject of stem cell research. However, we agree with the Attorney General that the terminology in the measure to which the Council refers does not permit research over anything and everything that the ICOC decides may advance medical science.  The measure is plainly directed to research for which 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. (Prop. 71,  2.) 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 Institutes of Health shall not be funded by the institute. ( 125290.60, subd. (c)(1)(C).) Other vital research opportunities are sanctioned, as the definition of that phrase clarifies (see fn. 16, ante), to permit the ICOC nonetheless to authorize, upon approval of a supermajority of the Scientific and Medical Research Funding Working Group, research that may also be federally funded if within the stated purposes of the initiative.[17]



Research into stem cell therapy is in its infancy. As the understanding of the biology and biochemistry of stem cells expands it is to be expected that research will draw upon and overlap with studies in related fields of medicine, science, and technology. The authors of Proposition 71 understandably did not wish to create artificial barriers and limitations to the research that can be pursued in developing treatments and cures arising from the stem cell research. Research into related fields of medicine, science, and technology that will increase the understanding and facilitate the use of stem cell therapies quite clearly is both functionally related and reasonably germane to the stem cell research itself, whether or not additional federal funding becomes available. Far from creating a scattered and varied agenda united only by a vague and broad generalization, as was the measure in Chemical, supra, 227 Cal.App.3d 663, Proposition 71 authorizes research that is as specific as the circumstances permit and is reasonably limited to a single subject.



Moreover, the findings and declarations that appear in the opening provisions of Proposition 71 state that the Cures Act will close [the federal] 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. (Prop. 71,  2, italics added.) The analysis by the Legislative Analyst included in the November 2, 2004 Voter Information Guide explained, under the heading How Funding Would Be Spent,that [p]riority for research grant funding would be given to stem cell research that met the institutes criteria and was unlikely to receive federal funding. In some cases funding could also be provided for other types of research that were determined to cure or provide new types of treatment of diseases and injuries. (Italics added.) Rather than being hidden from the eye of the average voter, as was the objectionable provision in CTLA, supra, 200 Cal.App.3d 351, the inclusion of research into related medical technologies was explicitly addressed in the summary presented to the voters. This disclosure dilute[s] the risk of voter confusion or deception, one fundamental purpose of the single subject rule, and further militates in support of the validity of the measure. (Amador, supra, 22 Cal.3d at p. 231; Shea Homes Limited Partnership v. County of Alameda (2003) 110 Cal.App.4th 1246, 1257.)



TO BE CONTINUED AS PART II.



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[1]CART upheld against similar challenges the validity of an initiative enacting the California Children and Families Act of 1998 (Health & Saf. Code,  130100 et seq.; Rev. & Tax. Code,  30131 et seq.), increasing the tobacco excise tax, creating the California Children and Families Commission, and funding early childhood development and antismoking programs. (CART, supra, 109 Cal.App.4th 792.)



[2] Appellants have not renewed all of their arguments that were rejected by the trial court. We of course consider only those that are raised on appeal.



[3] The same title is used in the measure in two ways. Section 1 of the proposition states, This measure shall be known as the California Stem Cell Research and Cures Act.  Section 5 of the proposition adds to part 5 of division 106 of the Health and Safety Code a new chapter, chapter 3, which is entitled California Stem Cell Research and Cures Bond Act. Article 1 of the new chapter (Health & Saf. Code,  125290.10 et seq.), like the proposition itself, is entitled California Stem Cell Research and Cures Act. Article 2 (Health & Saf. Code,  125291.10 et seq.) is entitled California Stem Cell Research and Cures Bond Act of 2004.



[4] Section 3 of Proposition 71, which describes the purpose and intent of the proposition, provides, 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 state. [] 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 standards. [] 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 reproductive cloning. [] Improve the California health care system and reduce the long-term health care 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 Citizens 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 there search. [] 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.



[5] This provision goes on to provide the following definitions: 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 cells. (Cal. Const., art. XXXV,  5.) Health and Safety Code section 1644.9 provides, For purposes of this section, the phrase somatic cell nuclear transfer means the process in which the nucleus of a somatic cell of an organism is transferred into an enucleated oocyte.



[6] Human reproductive cloning is defined as 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. (Health & Saf. Code,  125292.10, subd. (k).)



[7] A separate section of the constitutional amendment provides, 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 in this article, and shall not be subject to appropriation or transfer by the Legislature or the Governor for any other purpose. (Cal. Const., art. XXXV,  4.)



[8] All further statutory references are to the Health and Safety Code unless otherwise indicated.



[9] The proposition also expands the definition of state service in Government Code section 20069 to include service for the California Institute for Regenerative Medicine and the officers and employees of its governing body. (Prop. 71,  6.) Section 7 of the proposition contains a severability provision. Section 8 provides that as of November 2007, the Legislature may amend all but the bond provisions of the initiative to enhance the ability of the institute to further the purposes of the grant and loan programs created by the measure, by a bill approved by 70 percent of the membership of both houses and signed by the Governor, provided that copies of the bill in final form are made publicly available at least 14 days prior to passage in each house.



[10] Five of the 29 members of the ICOC must be executive officers of specified University of California campuses, each of which has a medical school. (12590.20, subd. (a)(1).) Four others must be executive officers from other California universities that have demonstrated success and leadership in stem cell research and have a nationally ranked research hospital and medical school, a recent proven history of administering sizable scientific and/or medical research grants and contracts, or a recent ranking among the top 10 United States universities with the highest number of life science patents or who have research or clinical faculty who are members of the National Academy of Sciences. (Id., subd. (a)(2)(A).) Four others must be executive officers from a California nonprofit academic and research institution not part of the University of California that has demonstrated success and leadership in stem cell research, that has a nationally ranked research hospital or research or clinical faculty who are members of the National Acadamy of Sciences and a proven history in the preceding five years of managing a research budget in the life sciences exceeding $20,000,000. (Id., subd. (a)(2)(B).) Four others must be executive officers or board member from a California life science commercial entity with a background in implementing successful experimental medical therapies, not engaged in researching therapies with pluripotent or progenitor stem cells, and not having been awarded or applied for funding from the institute. (Id., subd. (a)(2)(C).) All of these executive officers are authorized to delegate their duties to another executive officer of the entity with which they are affiliated or, if applicable, to the dean of the medical school. Only one member may be appointed from a single university, institution or entity. (Id., subd. (a)(2)(D).) The remaining members must be representatives from a disease advocacy group concerned with specified diseases. (Id., subd. (a)(2)(B), (a)(5).) Still more stringent qualifications and additional criteria for consideration are specified for the chairperson and vice chairperson. (Id., subd. (a)(6).)



[11] Members of the 19-member Scientific and Medical Accountability Standards Working Group must include five ICOC members from groups focusing on specified disease-specific areas, nine scientists and clinicians nationally recognized in the field of pluripotent and progenitor cell research, and four medical ethicists. ( 125290.55, subd. (a).) Members of the 23-member Scientific and Medical Research Funding Working Group must include seven ICOC members from groups focusing on specified disease-specific areas and 15 scientists nationally recognized in the field of stem cell research. ( 125290.60, subd. (a).) Members of the 11-member Scientific and Medical Facilities Working Group must include six members of the Scientific and Medical Research Funding Working Group and four real estate specialists. ( 125290.65, subd. (a).) The chairperson of the ICOC is a member of each of the working groups.



[12] Section 125290.40, subdivision (n) of the Cures Act also authorizes the ICOC to accept additional revenue and property, including gifts, royalties, interest and appropriations, that may be used to supplement annual research grant funding and the operations of the institute. Section 125290.70 appropriates from the State General Fund $3 million as a temporary start-up loan for internal administrative and implementation costs. During the pendency of this litigation, which has precluded the issuance of the bonds authorized by the Bond Act, CIRM has received interim financing in the form of a loan from the General Fund and the sale of bond anticipation notes to private individuals and philanthropic foundations.



[13] The filing of the complaint followed the denial without prejudice of a petition for a writ of mandate that Peoples Advocate originally filed in the California Supreme Court. Defendants request for judicial notice of the writ documents is granted. Peoples Advocate later filed an amended complaint adding defendant Zach Hall, as interim president of the ICOC, and dismissing Governor Schwarzenegger and Lieutenant Governor Bustamante.



[14] The Council requests an order declaring that CIRM, the ICOC, and Proposition 71 on its face and as applied, violate California Constitutional, statutory and common law; that the unlawful and unconstitutional provisions of Proposition 71 are not severable from the initiative as a whole; that the existence and operation of the CIRM and the ICOC are unlawful and unconstitutional; . . . that the members of the ICOC are disqualified from holding public office on the ICOC board and that the chairperson and vice-chairperson are disqualified to be employees of the CIRM and that actions of the defendants to implement Proposition 71 and to fund and operate the [CIRM and ICOC] . . . are without lawful authority and invalid. The Council also seeks an order enjoining the defendants from implementing Proposition 71, enjoining the CIRM, the ICOC and its officers and members from all operations, actions and exercise of legal authority under Proposition 71, and enjoining defendants from raising or using any funds for the benefit of or to finance the activities of the CIRM or ICOC.



[15] In that case, our Supreme Court upheld the validity of Proposition 13 on the June 1978 ballot, also known as the Jarvis-Gann Property Tax initiative, which added article XIII A to the California Constitution. The court rejected the contention that the four major elements of the provision (a real property tax rate limitation, a real property assessment limitation, a restriction on state taxes, and a restriction on local taxes) constitute separate subjects, reasoning that each of them is reasonably interrelated and interdependent, forming an interlocking package deemed necessary by the initiatives framers to assure effective real property tax relief. (Amador, supra, 22 Cal.3d at p. 231.)



[16] Article XXXV, section 2 of the California Constitution is quoted in full on page 2, ante. Section 125292.10, subdivision (y) of the Cures Act defines a vital research opportunity as scientific and medical research and technologies and/or any stem cell research not actually funded by the institute under subparagraph (C) of paragraph (1) of subdivision (c) of Section 125290.60 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.



[17] Section 125290.60, subdivision (c)(1)(D) identically provides that notwithstanding subdivision (c)(1)(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.





Description Initiative that established, and provided for the funding of, public entity to conduct stem cell research did not violate constitutional requirement that initiative deal with a single subject, since provisions permitting funding of "vital research opportunities" beyond those specifically authorized by the initiative and exempting officials of the entity from conflict of interest laws are functionally related to the central purposes of the measure. Ballot analysis that explained measure in objective, nontechnical terms satisfied legal requirements. Authority conferred by Proposition 71 on Independent Citizen's Oversight Committee does not violate constitutional ban on state funding of private entities, as the majority of ICOC members are appointed by public officials, members who violate their public responsibilities are subject to removal by judicial process; measure imposes strict requirements as to how ICOC is to allocate moneys in the California Stem Cell Research and Cures Fund; and there are significant public and financial accountability standards to which the California Institute for Regenerative Medicine, which the ICOC oversees, is held.
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