California Stem Cell Research Program (2)

• Abstract
• Characteristics of this policy
• Purpose and process analysis
• Expected outcome
• References

Abstract

In November 2004, California voters approved a $3 billion stem cell research initiative to be financed through the sale of state bonds. As the state begins setting up the California Institute for Regenerative Medicine (CIRM) to distribute the funds, as called for in the voter-approved measure, the state legislature is trying to gain greater oversight over the CIRM. Stem cell research opponents have filed lawsuits that have delayed the sale of bonds and the distribution of research grants.

Neue Entwicklungen

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral
current    previous

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Initiators of idea/main actors

• Regierung

• Bürgergesellschaft

• Wissenschaft

Stakeholder positions

Supporters:

Major support for the stem cell research initiative continues to come from the coalition of patients/patient advocates, stem cell researchers at universities and biomedical research companies in California, and state residents who believe that the initiative will reap economic benefits for California [see previous survey entitled "Stem Cell Research" for further discussion of specific stakeholder positions]. During the campaign, many of these groups were clustered into the "yes on 71 [the proposition authorizing the stem cell funding] campaign". Now, representatives from many of these groups have representatives on the Independent Citizens Oversight Committee that is working to develop guidelines for the distribution of research funding.

Opponents:

Opposition to stem cells research in general tends to be on ethical grounds.  Many if not most opposition groups are motivated primarily by these concerns, however, opponents also cite fiscal responsibility/ government transparency grounds [see survey entitled "Stem Cell Research" for further discussion of specific stakeholder positions]. Since the initiative's approval, the substance of most groups protests (whatever their underlying motivation) has focused on attacking the perceived lack of transparency, dearth of established ethical standards, and on conflicts of interest within the stem cells governing and oversight boards. 

Reformers:

The state legislature continues to be supportive of stem cell research but leery of spending state funds on it [see survey entitled "Stem Cell Research" for further discussion of specific stakeholder positions]. Now that voters have approved the expenditure of state funds a broad, bipartisan group of legislators lead by Senators Deborah Ortiz (a Democrat) and George Runner (a Republican) is trying to reform the stem cell initiative to give the state more oversight and to ensure that the state reaps the potential economic benefits of the research. Supporting the legislature's efforts at reform are open government advocacy groups, some women's groups on the basis of protecting egg donors, and consumer groups. The reform efforts have also garnered considerable editorial support from state newspapers.

Actors and positions

Regierung
Legislature	sehr unterstützend		stark dagegen
Bürgergesellschaft
Independent Citizen's Oversight Committee	sehr unterstützend		stark dagegen
Anti-Abortion/Pro-Life Groups	sehr unterstützend		stark dagegen
open government advocates	sehr unterstützend		stark dagegen
Wissenschaft
Researchers, public and private	sehr unterstützend		stark dagegen
current    previous

Influences in policy making and legislation

In November of 2004, California voters approved a nearly $3 billion stem cells research funding initiative ("Proposition 71") with nearly 60% of the vote. The proposition authorizes the state to establish the California Institute for Regenerative Medicine (CIRM), overseen by an Independent Citizens Oversight Committee (ICOC), which will sell nearly $3 billion worth of state bonds to fund stem cell research in the state. The CIRM will distribute and administer research grants. 

The important context for discussing legislative developments for the stem cell initiative is that it is a product not of legislative action but of the powerful voter initiative process in California. The voter-approved text of the stem-cell initiative specifically excludes the legislature from setting the terms and conditions for the distribution of grants. The initiative called for the establishment of the California Institute for Regenerative Medicine (CIRM) overseen by an Independent Citizens Oversight Committee (ICOC) to develop standards, guidelines and operating procedures. The bill clearly stated that the ICOC's standards did not have to conform to federal or state law, and that the legislature couldn't change the terms of CIRM operation for 3 years. After three years, a 70% majority in the legislature would be required to change terms. Thus, the legislature faces significant challenges as it seeks to win greater oversight over the CIRM, and to ensure that the state reaps the economic returns on its investment. 

Despite these limitations, the legislature has taken steps to try to regain some oversight over the CIRM. State Senator Deborah Ortiz (D), a supporter of stem cell research, has sought and obtained legislative approval of a non-binding oversight subcommittee within the senate health committee.  Moreover, Senator Ortiz (D), and another senator, George Runner (R), have proposed two bipartisan bills and a senate constitutional amendment to change the regulations that control the CIRM. The constitutional amendment would include strengthening conflict-of-interest and open meeting requirements for the CIRM, ensuring that potential treatments and cures be made available to Californians at low cost, and guaranteeing royalties from patents on research findings to be shared with the state. The legislation includes a bill to protect the health of women egg donors by limiting the number of times they could become donors and regulating egg donation from women undergoing fertility treatments. The second bill requires the state Auditor to review the finances of the CIRM and the ICOC. The bills must be passed by the senate and the assembly and then signed by the governor to take effect. The constitutional amendment must be approved by 2/3 of the house and senate and then go before voters and be approved by a majority to become law.

Legislative outcome

n/a

Actors and influence

Regierung
Legislature	sehr groß		kein
Bürgergesellschaft
Independent Citizen's Oversight Committee	sehr groß		kein
Anti-Abortion/Pro-Life Groups	sehr groß		kein
open government advocates	sehr groß		kein
Wissenschaft
Researchers, public and private	sehr groß		kein
current    previous

Positions and Influences at a glance

Adoption and implementation

Until it can generate its own funds from the sale of bonds, the California Institute for Regenerative Medicine (CIRM) has been established and run on a $3 million interest-bearing loan from the state treasury. The 29-member Independent Citizens Oversight Committee (ICOC) charged with developing the fiscal, ethical and organizational guidelines for the CIRM was appointed by the Chancellors of the 5 University of California campuses with medical schools, the Governor and other state officials. Staff of the "Yes on 71" campaign has served as the staff of the CIRM while the institute works to hire permanent staff.  Prompting some conflict of interest questions, the President of the Yes on 71 campaign (who has a personal and potentially an economic stake in stem cell research) serves as the chair of the ICOC. 

As well as working on the operational, ethical and financial guidelines and hiring staff, the ICOC has been searching through an open bidding process for a city where the CIRM can be permanently housed. The city selected will become the hub of stem cell research activity in the state, presumably reaping considerable economic benefits, thus, the competition is fierce. 10 cities in the San Francisco Bay Area have submitted bids, along with San Diego, Los Angeles and Sacramento. Public hearings on the bids will occur in early April, and the finalists will be decided and announced by the ICOC in May. 

As the ICOC begins to develop guidelines with which to govern the CIRM, some groups have complained about what they perceive as a disturbing lack of transparency. While some of the groups voicing the transparency concerns oppose stem cell research in general for ethical reasons, others have a history of working for openness in government, such as the group Californians Aware that has been working with the ICOC to ensure that they incorporate policies to ensure openness into their operational guidelines. Although the CIRM had initially intended to distribute its first research grants in the Spring of 2005, concerns about the lack of transparency and conflicts of interest for the ICOC members expressed through petitions and lawsuits have effectively slowed the work of the CIRM.

In the first case, public interest lawyers Charles Halpern and Phillip Lee filed a petition asserting that the ICOC had violated open meeting laws, and seeking salary caps for CIRM staff, more stringent rules to protect against conflicts of interest, open meetings of grant recommendation working groups, and to delay the awarding of grant proposals until these issues had been addressed. The petition was supported by the conservative consumer group The Foundation for Taxpayer and Consumer Rights (FTCR) among others. In response to the petition, the ICOC was forced to delay certain discussion (for example, the decision about who would be hired to head the CIRM) until the committee meeting could be properly publicly announced in compliance with state laws. However, despite the minor delays caused by the petition, the ICOC has rejected much of the substance of the complaint, stating that it will work to develop its own protections.    

Additional and more serious obstacles have come from two lawsuits that were filed contesting the constitutionality of the CIRM. The first suit was filed by the Life Legal Defense Fund (a group of anti-abortion lawyers) and asserts that the CIRM improperly distributes public funds without legislative oversight.  A second group opposed to stem cell research, Californians for Public Accountability and Ethical Science, filed a suit alleging that Proposition 71 is unconstitutional on two grounds: First, that because it allows research other than stem cell research, it violates the single-subject rule for propositions. Second, that the members of the oversight committee have serious conflicts of interest. State Attorney General Bill Lockyer has stated publicly that these suits are without merit. However, until the suits are resolved, the CIRM cannot sell bonds or begin distributing funds. Other similar lawsuits have taken 2-3 months to resolve.

Monitoring and evaluation

As the CIRM has not begun distributing grants, no monitoring and evaluation of the program goals has been undertaken. The ICOC, as well as a non-binding legislative oversight committee, will monitor the CIRM.

Expected outcome

Although public support for California's stem cell research funding initiative remains strong, opponents of the initiative have been able to slow the progress of the distribution of funds for the research. In order to avoid some of the same delays in the future, the CIRM will need to work to ensure that it maintains exceptional transparency and strong ethical standards. It is unlikely that anything the CIRM does will appease those who oppose stem cell research on ethical grounds, however. 

In California, several of the University of California (UC) Campuses, including UC Davis and UC Los Angeles have announced major expansions to accommodate stem cell research. The universities are partnering with research institutes preparing to apply for grants, and are recruiting stem cell researchers from around the United States and the world to come work in California.

Around the United State, in response to California's initiative, half a dozen other states have proposed similar stem-cell research funding initiatives since the passage of Proposition 71. These states are afraid of losing biotech industry jobs and researchers to California. The re-election of President George W. Bush, who reiterated his opposition to federal funding for stem cell research forces states that wish to foster stem cell research to fund the efforts themselves. This is especially true since recent studies have revealed that the existing stem cell lines available for research using federal funds are contaminated and can likely never be used in humans. Other states, mostly states that supported Bush in the November 2004 election, are considering bans on stem cell research in their states, demonstrating the still highly politicized nature of stem cell research in the United States.

There has been mounting pressure on President Bush from some members of the republican leadership in the United States House and Senate to soften his restrictions on stem cell research. Prominent scientists, including the head of the National Institutes of Health and the director of the National Heart, Lung and Blood Institute have recently offered strongly worded testimony in legislative hearings encouraging the legislature to permit expanded federal funding of stem cell research. This testimony has referenced California's stem cell funding, pointing out that restrictions on federal funding put the rest of the country is at a technological disadvantage. If the federal government were to lift its restrictions on stem cell research funding, California's competitive advantage in the field would be greatly diminished. However, the President and key members of the republican leadership remain staunchly opposed to any research that involves the destruction of embryos, thus, movement on this issue on the part of the federal government seems unlikely in the near future.

The continued debate about embryonic stem cell research in California  and the nation plays into a larger highly politicized national debate about where life begins and what constitutes life that extends to abortion rights, stem cell research, and right-to-die issues.

References

Sources of Information

California Institute for Regenerative Medicine Website http://www.cirm.ca.gov/

California Health Care Foundation www.californiahealthline.org

Reform formerly reported in

California Stem Cell Research Program Process Stages: Gesetzgebung, Idee

Author/s and/or contributors to this survey

Sarah Weston, Institute for Global Health; Carol Medlin, PhD, Institute for Global Health

Empfohlene Zitierweise für diesen Online-Artikel:

Sarah Weston, Institute for Global Health; Carol Medlin, PhD, Institute for Global Health. "California Stem Cell Research Program (2)". Health Policy Monitor, April 2005. Available at http://www.hpm.org/survey/us/d5/5