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California Stem Cell Research Program (3)

Country: 
USA
Partner Institute: 
Institute for Global Health (IGH), University of California Berkeley/San Francisco
Survey no: 
(6)2005
Author(s): 
Anke Therese Schulz (UCSF) and Carol Medlin (Institute for Global Health, UC Berkeley and UCSF)
Health Policy Issues: 
Neue Technologien, Arzneimittelpolitik, Finanzierung
Reform formerly reported in: 
California Stem Cell Research Program
California Stem Cell Research Program (2)
Current Process Stages
Idee Pilotprojekt Strategiepapier Gesetzgebung Umsetzung Evaluation Veränderung/Richtungswechsel
Implemented in this survey? nein nein nein nein ja nein nein

Abstract

During this study period: the California Institute of Regenerative Medicine (CIRM) was established and headquartered in San Francisco; the CIRM acting president was named president; the CIRM began fundraising and awarding grants; and the CIRM continued its negotiations with the state and federal governments over regulatory issues. Ethical and regulatory questions surrounding stem cells research remain unresolved.

Neue Entwicklungen

 Suchhilfe

Characteristics of this policy

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

Purpose and process analysis

Current Process Stages

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

Initiators of idea/main actors

  • Regierung: State legislators became more supportive of stem cells research during this study period.
  • Bürgergesellschaft: The Independent Citizen?s Oversight Committee (ICOC) continued to strongly support the stem cells research program. Anti-abortion/pro-life groups continued to strongly oppose it. Public interest groups continued their support stem cells research, but called for more public involvement and oversight.
  • Wissenschaft: The scientific community maintained its strong support for Prop 71; however, researchers and bioethicists also began to call for increased oversight.

Stakeholder positions

Government

State legislature: Proposition 71 is a voter-based initiative that contains provisions for limiting government involvement in the stem cells research program. State legislators, however, have argued that government must become more involved in the California stem cells research program. Senator Deborah Ortiz (Democrat, Chair of the Senate Health Committee) and Senator George Runner (Republican, Member of the Senate Health Committee) have drafted several proposals, including a proposal to amend the state constitution. Thia amendment would increase public oversight of the stem cells research program by mandating stricter conflict-of-interest standards, and requiring taxpayers to be fully reimbursed for public investments in stem cells research. In June, Senate Democratic party leaders delayed these proposals, and voted to give the CIRM (and the  ICOC) an opportunity to develop their own regulatory guidelines.

Civil Society

The Independent Citizens' Oversight Committee (ICOC): The ICOC maintained its strong support for the stem cells program, and ist opposition toward government regulation (please see previous surveys for further details on the the ICOC). In this study period, the ICOC  began to more actively work on developing procedural and ethical guidelines for CIRM research activities. In an April press release, the ICOC announced its support for guidelines proposed by the National Academies of Science. In September, the ICOC initiated a public workshops program, held in several California cities, to involve the public in drafting guidelines for CIRM-funded stem cells research. On September 9, the  ICOC announced the CIRM's first awards for stem cells research. The awards establish the first CIRM training program in stem cells research, a three-year program to train pre-doctoral, post-doctoral and clinical fellows at 16 institutions across the state. The program will have an annual budget of approximately $12.5 million, and will train approximately 170 CIRM scholars annually. Anti-abortion/pro-life groups: Anti-abortion/pro-life groups filed several lawsuits during the previous study period, and these are still pending. In August, the Alameda County court consolidated these lawsuits in order to conserve judicial resources. This ruling was favorably received by the ICOC.

Public interest groups: Public interest groups were supportive of stem cells research, but continued to call for greater oversight. These groups supported Senator Ortiz's proposed state constitutional amendment (SCA 13) that was scheduled to go before the voters in November. Public interest groups maintained that SCA 13 will fill regulatory gaps in Proposition 71 by:  limiting exemptions from open-meetings laws for members of the ICOC; requiring working group members to disclose their economic interests and for an independent, external review by the state auditor of those interests; and providing for enhanced opportunities for public review of stem cells research. Public interest groups further argued that SCA 13 would tighten Prop. 71's intellectual-property provisions to make sure investors and taxpayers receive a fair return on their investments.

Scientific community

Researchers:

In this study period, scientists began to call for increased public oversight of stem cells research. In a September 23 interview, Dr. Arnold Kriegstein, director of a stem cell and tissue biology program at UC San Francisco, warned against proceeding with clinical trials without first settling the many scientific and ethical issues surrounding stem cells research. He said, "I fully understand the impatience of patients, spinal cord injury patients in particular, who are desperate for some form of treatment. But there is risk of proceeding too quickly here."

Bioethicists:

Bioethicists also warned against stem cells research without strict research guidelines. In a May interview, Marcy Darnovsky, associate executive director of the Center for Genetics and Society in Oakland (CA), stated that stem cells research should not be conducted without adequate safeguards. Similarly, Stanford bioethicists Mildred Cho and David Magnus argued that consent protocols used to recruit egg donors for stem cells research do not suffiently protect patients' rights.

Actors and positions

Description of actors and their positions
Regierung
State legislaturesehr unterstützendunterstützend stark dagegen
Bürgergesellschaft
Independent Citizens' Oversight Comittee (ICOC)sehr unterstützendsehr unterstützend stark dagegen
Anti-abortion/Pro-life groupssehr unterstützendstark dagegen stark dagegen
Public interest groupssehr unterstützendunterstützend stark dagegen
Wissenschaft
Researcherssehr unterstützendsehr unterstützend stark dagegen
Bioethicistssehr unterstützendunterstützend stark dagegen
current current   previous previous

Influences in policy making and legislation

The terms of Proposition 71 have not changed since the previous study period. Lawsuits challenging Proposition 71 have not been litigated, nor have any settlements been reached. The CIRM continued its raise funds for research, and the state legislature has temporarily discontinued its efforts to regulate CIRM-funded stem cells research.

In an effort to address regulatory and oversight concerns, the CIRM launched a public workshop campaign to involve California residents in the development of ethical, financial, and research guidelines for stem cells research.

In the background, the federal government continues to shape stem cells research policy in California. In May, the U.S. House of Representatives passed new legislation (by a vote of 238-194) to reverse President Bush's 2001 decision to severely limit stem cells research. This legislation enjoys strong bipartisan support in the Senate as well, but the bill has not yet come to a vote, and it is unclear whether there will be enough votes to override a presidential veto.

Legislative outcome

Enactment

Actors and influence

Description of actors and their influence

Regierung
State legislaturesehr großneutral kein
Bürgergesellschaft
Independent Citizens' Oversight Comittee (ICOC)sehr großsehr groß kein
Anti-abortion/Pro-life groupssehr großgroß kein
Public interest groupssehr großgroß kein
Wissenschaft
Researcherssehr großsehr groß kein
Bioethicistssehr großgroß kein
current current   previous previous
Independent Citizens' Oversight Comittee (ICOC), ResearchersState legislaturePublic interest groups, BioethicistsAnti-abortion/Pro-life groups

Positions and Influences at a glance

Graphical actors vs. influence map representing the above actors vs. influences table.

Adoption and implementation

The CIRM , the ICOC, and the scientific community are the primary actors involved in the implementation of Proposition 71. The state government remains only marginally involved.

To date, the primary "winners" in Proposition 71 have been scientific researchers, and biotechnology companies in the Bay Area. Biotechnology stocks surged on the Nasdaq on September 20, following a report that stem cells had been used to successfully treat paralysis in mice. San Francisco Mayor Gavin Newsom stated that, by sponsoring stem cells research in the Bay Area, he hopes this will support the local economy. He also expressed his desire that San Francisco will become an international center for stem cells research.

Monitoring and evaluation

Guidelines for monitoring the implementation of Proposition 71 are currently being drafted. Monitoring and evaluation studies have yet to be conducted.

Expected outcome

Stem cells research is experimental, and it is unclear what the long-term results will be. For now, Proposition 71 seeks to support stems cell research for treatment of debilitating human illnesses.

Impact of this policy

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

Stem cells research is expected to yield breakthrough treatments for debilitating human illnesses (e.g., Alzheimer's, paralysis, autism, and schizophrenia). Should the stem cells research program produce positive results, Proposition 71 will have ultimately have a strong impact on the quality of health care services in the U.S.. Currently, Proposition 71's effect on future health care costs, access, and distribution are unknown.

References

Sources of Information

Reform formerly reported in

California Stem Cell Research Program
Process Stages: Gesetzgebung, Idee
California Stem Cell Research Program (2)
Process Stages: Umsetzung

Author/s and/or contributors to this survey

Anke Therese Schulz (UCSF) and Carol Medlin (Institute for Global Health, UC Berkeley and UCSF)

Empfohlene Zitierweise für diesen Online-Artikel:

Anke Therese Schulz (UCSF) and Carol Medlin (Institute for Global Health, UC Berkeley and UCSF). "California Stem Cell Research Program (3)". Health Policy Monitor, 10/10/2005. Available at http://www.hpm.org/survey/us/d6/5