California Stem Cell Research Program

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Purpose of health policy or idea

In September 2003, California lawmakers challenged federal law by approving two laws that sought to establish California as a national hub for stem cell research. The first of these laws called for the establishment of ethical and legal standards to regulate therapeutic stem cell research by 2005. The second requires the creation of a registry of embryos that are available to scientists for research purposes. A third bill, intended to provide up to $1 billion of state funding for stem cell research, was caught in the Senate Appropriations Committee and has not yet made it to the Senate floor for voting. Supporters of embryonic stem cell research have said that without a bill to authorize state funding, the new laws supporting stem cell research will be little more than symbolic.

A coalition of patient advocates and researchers are campaigning to put a proposal on the November ballot to create a $3 billion bond to fill the funding gap for embryonic stem cell research in California. By providing $295 million in state funds each year to California universities, institutes, and medical research companies, the measure aims to reinvigorate a field that has been hampered by the lack of public funding and the often-rancorous debate over human embryonic stem cell research. The proposal stipulates that funds only be provided to organizations that use stem cells derived from human embryos that are less than two weeks old. The initiative includes provisions to protect patient rights and privacy and specifically prohibits any funding for human reproductive cloning. The funds would be distributed by a 29-person advisory panel appointed by the governor, University chancellors and other officials with oversight from an independent citizen's oversight committee.

There are several non-financial and financial incentives under this initiative. First, supporters argue that the research holds promise for curing or alleviating chronic and degenerative conditions, such as Parkinson's disease, Alzheimer's disease, and spinal cord injuries. Financially, the State would share in royalties that result from the research, possibly generating state revenues for decades to come. Interest and principal payments would be postponed on the bonds for the first five years. Also, the research could lead to disease cures that significantly reduce state health care costs in the future. Expansion of stem cell research would also bring jobs and draw top scientists from other states.

Main points

Main objectives

Secure funding for the advancement of stem cell research in the state of California through the creation of a $3 billion bond.

Type of incentives

Promise of chronic disease cures, Royalties to the State, Jobs, Potential for reduced health care costs.

Groups affected

Patient advocacy groups and patients, Biomedical researchers, Universities & research institutions

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

Political and economic background

Citing ethical concerns, the Bush administration issued a directive in 2001 that banned the use of federal dollars for human embryonic stem cell research on cell lines created after August 1, 2001. Under this policy, private and state funds were still permitted to support research on embryonic stem cell lines created after this date. Stem cell research throughout the United States slowed dramatically during the following year. Many research institutions held back on all stem cell research as they negotiated the boundaries of the new funding rules that threatened loss of all federal funding if found in violation of the ban. Also limiting the advancement of stem cell research, the number of viable cell lines available for federally funded research shrunk from 75 to 15. Many researchers consider these 15 cell lines to be inadequate for continuing research because they were harvested using rudimentary techniques and are demonstrating marked variability that hampers progression of the science. Additionally, the federal government awarded only $10.7 million nationally for stem cell research in 2002.

In 2003, California lawmakers challenged these restrictive federal limits on research and passed measures that aimed to expand embryonic stem cell research. California became the first state to approve legislative measures that explicitly supported embryonic stem cell research. The bills enable embryos to be anonymously donated from fertility clinics for research purposes. They expressly ban the sale of embryos. Also, these bills call for the establishment of ethical and legal standards to regulate stem cell research. New Jersey soon followed suit, becoming the second state behind California to support stem cell research. Fearing "brain drain," several other states including Virginia, New Mexico and Oregon also began to pursue similar initiatives to ensure that their states' top scientists are not lured away by opportunities in other states.

In spite of the political support demonstrated by these policies, financial support for stem cell research in California has been limited. The bill intended to provide state funds for the research was stalled in the Senate Appropriations Committee last year and has not yet made it to the Senate floor to be voted upon. Although several research institutes have solicited private funds amounting to $23 million, state funds are expected to facilitate a more rapid expansion of stem cell research throughout the state. If voters approve this November ballot initiative, California would become the second state to fund embryonic stem cell research.  In February of 2004, the New Jersey governor announced that the state budget allotted $50 million for stem cell research over the next five years. California's bond proposal is calling for $3 billion over the next 10 years and represents the largest state fund dedicated to stem cell research in the country.

The political and economic fate of California's proposed bond is not clear. In spite of political support within the state, this proposed initiative could be nullified by pending federal legislation in the Senate that would ban all forms of stem cell research. Also, a state budget crisis may temper voter interest in approving another hefty bond. Funding for the establishment of ethical and legal standards for stem cell research already fell victim to budget cuts this year.

Purpose and process analysis

Current Process Stages

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

Origins of health policy idea

This initiative was introduced in February 2004 by a Los Angeles-based coalition of scientists, patient-advocates, and private financers to provide funds to fuel stem cell research in California institutions. This initiative is designed to provide funds to support a set of state Senate bills passed in 2003 that aimed to establish California as the national leader in stem cell research. Supporters of this initiative hope that stem cell research can expand and health benefits can be delivered with the availability of $3 billion in state funds over the next 10 years.

Attempts have been made to provide funds for stem cell research in California since the passage of the state legislation in 2003. A senate bill requesting up to $1 billion for stem cell research is currently stuck in the Senate Appropriations Committee until next session. Additionally, $23 million in private funds have been solicited by two research institutions in California. The state government of New Jersey announced a 5-year, $50 million plan to fund stem cell research in their state. At $3 billion over 10 years, this California initiative would provide the funds needed to establish California as the leader in this line of research.

Approach of idea

The approach of the idea is described as:
new:

Innovation or pilot project

Stakeholder positions

Patient/Disease Advocacy Groups: Patient and disease advocacy groups support the initiative with the claim that stem cell research holds the promise of treatments and cures for many diseases. In addition to the merits of stem cell research, they argue that treatments developed under the program could save the state billions of dollars in health care costs. A coalition of these groups and science groups drafted the proposed initiative and is currently collecting the necessary signatures to place it on the November ballot.

Scientists/Researchers: Although no individual research institution stepped forward to support the initiative, many individual biomedical scientists from a range of disciplines in these institutions have advocated for the expansion of stem cell research in the state. Like the patient groups, the scientists claim that the stem cell research could lead to new treatments for many diseases. The scientists also have interest in securing funding for and ensuring the legality of their research.

Religious/Fetus-Rights Groups: The Catholic Church, pro-life groups, and other groups oppose all embryonic stem cell research because it involves the destruction of embryos, advocating instead for the use of adult stem cells from bone marrow or other tissues.

Fiscal opposition: Opposition to this proposition has mounted on both religious/ethical and fiscal grounds. Fiscal opponents question investing in any debt-generating proposal when California is struggling with such an enormous budget deficit. No organized opposition coalition has yet emerged.

Legislature and Governor: The position of the legislature and the new governor is not entirely clear. Although the initial funding bill passed through the Senate, it became stuck in the Appropriations Committee last session. The new governor struck funding for one of the two stem cell bills during the budget cuts while keeping another intact. But because this would be a voter bond initiative, the support of the governor and legislature is not essential.

Influences in policy making and legislation

The proposed initiative will likely be on the November ballot for voter approval. If approved, the initiative goes into effect the day after the election. It is not subject to a Governor's veto, nor may it be amended or repealed by the Legislature without an approval vote from the electors.

Legislative outcome

pending

Adoption and implementation

If passed, the proposed initiative will create a new state agency to manage the cell research funds and activities. An advisory council will be appointed by the governor and will include top medical researchers, patient advocacy representatives, and financial experts. Also, a Citizen's Oversight Committee will be formed to ensure fiscal responsibility and public accountability. There is no mention in the proposal of any role for the opposition groups in the implementation of this initiative.

Universities, institutions, and private companies with stem cell research activities will need to apply for funds, increase staff, and expand research facilities. Continued attention to separate federal and state funds in accounting will be needed to ensure that no federal dollars are used for post-August 1, 2001 stem cell research.

The lack of clear legal or ethical guidance on the research mayreate major obstacles as research activities grow. Although the legislature has called for the creation of such state standards by 2005, the funding for this process was cut this year and now faces an uncertain future.

Monitoring and evaluation

The advisory council and oversight committee is expected to provide monitoring and evaluation of the distribution of the funds.

Expected outcome

With $3 billion over 10 years devoted to stem cell research, this initiative would undoubtedly place California at the forefront of stem cell research in the nation. This initiative's long-term goals of curing or alleviating many chronic diseases using stem cells, however, must contend with enormous technical challenges. To reach these technical challenges, political and economic challenges must first be overcome.  In spite of political support within the state, this proposed initiative could be nullified by pending federal legislation in the Senate that would ban all forms of stem cell research. Also, a state budget crisis may temper voter interest in approving another hefty bond. Funding for the establishment of ethical and legal standards for stem cell research already fell victim to budget cuts this year.

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch

References

Sources of Information

California Stem Cell and Research Initiative

http://www.curesforcalifornia.com/site/PageServer?pagename=facts_keyfacts

Kaiser Family Foundation Health Reports

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=2&DR_ID=22087

Author/s and/or contributors to this survey

Carol Kolb, University of California, Berkeley; Carol Medlin, Institute for Global Health, UCSF

Empfohlene Zitierweise für diesen Online-Artikel:

Carol Kolb, University of California, Berkeley; Carol Medlin, Institute for Global Health, UCSF. "California Stem Cell Research Program". Health Policy Monitor, April 2004. Available at http://www.hpm.org/survey/us/d3/3