Stem cell research policy

Stem cell research policy, a controversial topic, varies significantly throughout the world. There are overlapping jurisdictions of international organizations, nations, and states or provinces. Some government policies determine what is allowed versus prohibited, whereas others outline what research can be publicly financed. Of course, all practices not prohibited are implicitly permitted. Some organizations have issued recommended guidelines for how stem cell research is to be conducted.

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International bodies

The United Nations adopted a declaration on human cloning that can be interpreted as calling on member states to prohibit somatic cell nuclear transfer, or therapeutic cloning. In 2005, in a divided vote, "Member States were called on to adopt all measures necessary to prohibit all forms of human cloning in as much as they are incompatible with human dignity and the protection of human life."

The World Health Organization has opposed a ban on cloning techniques in stem cell research.

The Council of Europe's Convention on Human Rights and Biomedicine seems to ban the creation of embryos solely for research purposes. It has been signed by 31 countries and ratified by 18: Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Georgia, Greece, Hungary, Lithuania, Moldova, Portugal, Romania, San Marino, Slovakia, Slovenia, Spain, and Turkey.

The Hinxton Group

Medical researchers, ethicists and assorted spokespersons from 14 different countries have published a set of legal and ethical guidelines relating to stem cell research, in an effort to address conflicting international laws in this area [1] [2]. The ‘Hinxton Group’ met recently for the first time, in Cambridge, and published a consensus statement calling for a ‘flexible’ regulatory framework, which can simultaneously accommodate rapid scientific advance and at the same time accommodate the diversity of international approaches towards stem cell science (ibid.). It also recommends that, in countries which oppose embryonic stem cell research, scientists should be free to pursue their research elsewhere (ibid.).

In light of the controversy surrounding Hwang Woo-Suk, the Hinxton Group has additionally recommended a number of measures intended to prevent fraud in stem cell research. The group has requested that all authors of embryonic stem cell papers submit a statement of authenticity of any new cell-lines and that the source of stem cells be clearly specified (ibid.).

On the ethical issues surrounding embryonic stem cell research, the group has additionally recommended that an international database be created, containing guidelines for ethical practice, research protocols, consent forms, and the information provided to donors (ibid.).

However, the potential for an international consensus on these matters seems remote given the complexity and diversity of regulatory frameworks in this controversial area of science, both within nations and between nations.

ISSCR

The International Society for Stem Cell Research is developing guidelines for the conduct of stem cell research.

Nations

Embryonic stem cell research has divided the international community. In the European Union, stem cell research using the human embryo is permitted in Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving financial support - see below. Elsewhere, Japan, India, Iran, Israel, South Korea, and China are supportive, Australia is partially supportive (exempting reproductive cloning yet allowing research on embryonic stem cells that are derived from the process of IVF); however New Zealand, most of Africa (excepting South Africa) and most of South America (excepting Brazil) are restrictive.

US policy debate

Origins of policy debate in the U.S.

In 1969, the first human in vitro fertilization was accomplishd and in 1973, Roe v Wade legalized abortion nationwide. These developments prompted the federal government to create regulations barring the use of federal funds for research that experimented on human embryos. In 1995, the NIH Human Embryo Research Panel advised the Clinton administration to permit federal funding for research on embryos left over from in vitro fertility treatments and also recommended federal funding of research on embryos specifically created for experimentation. In response to the panel's recommendations, the Clinton administration, citing moral and ethical concerns, declined to fund research on embryos created solely for research purposes,^[1] but did agree to fund research on left-over embryos created by in vitro fertility treatments. At this point, the Congress intervened and passed the Dickey Amendment in 1995 (the final bill, which included the Dickey Amendment, was signed into law by Clinton) which prohibited all federal funding for research that resulted in the destruction of an embryo regardless of the source of that embryo. The Dickey Amendment remains the law to this day.

In 1998, privately funded research led to the breakthrough discovery of hESC (Human Embryonic Stem Cells). This prompted the Clinton Administration to re-examine guidelines for federal funding of embryonic research. In 1999, the president's National Bioethics Advisory Commission recommended that hESC harvested from embryos discarded after in vitro fertility treatments, but not from embryos created expressly for experimentation be eligible for federal funding[3]. Even though embryos are always destroyed in the process of harvesting hESC, the Clinton Administration decided that it would be permissible under the Dickey Amendment to fund hESC research as long as such research did not itself directly cause the destruction of an embryo. Therefore, HHS issued its proposed regulation concerning hESC funding in 2001. Enactment of the new guidelines was delayed by the incoming Bush administration which decided to reconsider the issue.

President George W. Bush announced, on August 9, 2001 that federal funds, for the first time, would be made available for hESC research on currently existing stem cell lines; however, the Bush administration chose not to permit funding for research on hESC cell lines not currently in existence, thus limiting federal funding to research in which "the life-and-death decision has already been made" [4]. The Bush Administration's guidelines differ from the Clinton Administration guidelines which did not distinguish between currently existing and not-yet-existing hESC. Both the Bush and Clinton guidelines agree that the federal government should not fund hESC research that directly destroys embryos.

Neither Congress nor any administration has ever prohibited private funding of embryonic research. Also, public and private funding of adult stem cell research has no restriction whatsoever.

Congressional response

In April 2004, 206 members of Congress, including many moderate Republicans, signed a letter urging President Bush to expand federal funding of embryonic stem cell research beyond what Bush had already supported.

In May 2005, the House of Representatives voted 238-194 to loosen the limitations on federally funded embryonic stem-cell research — by allowing government-funded research on surplus frozen embryos from in vitro fertilization clinics to be used for stem cell research with the permission of donors — despite Bush's promise to veto if passed. [5] On July 29, 2005, Senate Majority Leader William H. Frist (R-TN), announced that he too favored loosening restrictions on federal funding of embryonic stem cell research.^[2] On July 18, 2006, the Senate passed three different bills concerning stem cell research. The Senate passed the first bill, 63-37, which would have made it legal for the Federal government to spend Federal money on embryonic stem cell research that uses embryos left over from in vitro fertilization procedures. ^[3] On July 19, 2006 President Bush vetoed this bill. The second bill makes it illegal to create, grow, and abort fetuses for research purposes. The third bill would encourage research that would isolate pluripotent, i.e., embryonic-like, stem cells without the destruction of human embryos.

Current State of Federal Funding for hESC Research in the USA

Currently, the National Institutes of Health has 399 funding opportunities for researchers interested in hESC [6]. In 2005 the NIH funded $607 million worth of stem cell research, of which $39 million was specifically used for hESC [7]. Of the 514 currently recruiting clinical trials that are using stem cells as treatment, the federal government is supporting 206 of them; however, none of these trials are using hESC [8].

National Academies Guidelines for Human Embryonic Stem Cell Research

In 2005, the United States National Academies released its Guidelines for Human Embryonic Stem Cell Research. These Guidelines were prepared to enhance the integrity of human embryonic stem cell research in the public's perception and in actuality by encouraging responsible practices in the conduct of that research. The National Academies has subsequently named the Human Embryonic Stem Cell Research Advisory Committee to keep the Guidelines up-to-date. [9]

Emerging U.S. state-by-state approach

California voters in November 2004 approved Proposition 71, creating a US$3 billion state taxpayer-funded institute for stem cell research, the California Institute for Regenerative Medicine. It hopes to provide $300 million a year. However, as of June 6, 2006, there were delays in the implementation of the California program and it is believed that the delays will continue for the significant future. [10] On July 21, 2006, Governor Arnold Schwarzenegger (R-Calif.) authorized $150 million in loans to the Institute in an attempt to jump start the process of funding research.^[4]

New Jersey adopted S1909/A2840 in January 2004 Several states, in what was initially believed to be a national migration of biotech researchers to California ^[5], have shown interest in providing their own funding support of embryonic and adult stem cell research. These states include Connecticut [11], Florida, Illinois, Massachusetts [12], Missouri, New Hampshire, New York, Pennsylvania, Texas [13][14], Washington, and Wisconsin.

Other states have, or have shown interest in, additional restrictions or even complete bans on embryonic stem cell research. These states include Arkansas, Iowa, Kansas, Louisiana, Michigan, Nebraska, North Dakota, South Dakota, and Virginia. (States play catch-up on stem cells, USA Today, December 2004)

UK policy

Since the discovery of hESC in 1998, many nations have revisited their legislation regarding the permissible use of embryos in biomedical research. In 2001, the United Kingdom amended the Human Fertilization and Embryology Act to permit the destruction of embryos for hESC harvests but only if the research satisfies one of the following requirements:

1. Increases knowledge about the development of embryos,
2. Increases knowledge about serious disease, or
3. Enables any such knowledge to be applied in developing treatments for serious disease [15].

The United Kingdom is one of the leaders in stem cell research--in the opinion of Lord Sainsbury, Science and Innovation Minister for the UK. [16]. A new £10 million stem cell research centre has been announced at the University of Cambridge [17]

China policy

China has one of the most unrestrictive embryonic stem cell research policies in the world. In recent years, seeing the research opportunities that China's lax regulations provide, many expatriate Chinese scientists from the West are returning to China to establish stem cell research centers and laboratories there.[18]

As a result of the increased interest in this field of research, in 2003, the People's Republic of China Ministry of Science and Technology and Ministry of Health issued official ethical guidelines for human embryonic stem cell research in its territories. The guidelines strictly forbid any research aimed at human reproductive cloning and require that the embryos used for stem cell research come only from:

1. Spared gamate or blastocyst after in vitro fertilization (IVF) procedures;
2. Fetal cells from accidental spontaneous or voluntarily selected abortions;
3. Blastocyst or parthenogenetic split blastocyst obtained by somatic cell nuclear transfer technology; or
4. Germ cells voluntarily donated. [19]

American scientific journals Science and Nature have both reported in recent years that China's stem cell programs hold potential, and in 2004 a delegation from Britain's Department of Trade and Industry concluded more emphatically that Chinese research in the field was already world-class.[20] Funding for stem cell research by the Chinese government is extremely limited compared to Western nations, with the Chinese Ministry of Science and Technology planning to devote between US$33 million and US$132 million on stem cell research during the next 5 years. By contrast, the state of California alone has earmarked US$3 billion to fund stem cell research at California institutions during the next decade. However, it is simply cheaper to produce goods in China than in nearly any other country, and in sophisticated sectors such as medical research, the cost advantage is likely to be retained for quite some time.

Chinese cultural views

Perhaps more importantly, the cultural and national attitude on stem cell research differs greatly between China and the West. Most Chinese citizens do not view the embryo as containing any inherent moral value.[21] According to the accepted Confucian view, a person begins with birth; a person is an entity that has a body or shape and psyche, and has rational, emotional and social-relational capacity for a lifetime of learning and innovation. Therefore to the Chinese, a human embryo, lacking the characteristics of a person, cannot be equated morally to a person or a personal life.[22] Stem cell research in China thus is unlikely ever to be prone to the intense moral politicking that characterizes the field in the West. China's distinctive attitude toward the embryo, combined with its lax regulatory system, could help its researchers leap the gap between laboratory science and medical application in stem cell therapy developments.[23]

References

1. ^ "President Clinton's Comments on NIH and Human Embryo Research". U.S. National Archives. Retrieved on July 19, 2006.
2. ^ Connolly, Ceci (July 2005). ""Despite Bush Veto, Stem Cell Research Abounds"". Washington Post: A01. Retrieved on July 21, 2006.
3. ^ Kellman, Laurie. "Senate Approves Embryo Stem Cell Bill". Associated Press. Retrieved on July 18, 2006.
4. ^ Gledhill, Lynda. "Governor OKs stem cell research funds Schwarzenegger authorizes loans for $150 million", San Francisco Chronicle, 2006-07-21, pp. B-1. Retrieved on 2006-07-29. 
5. ^ chron.com article no longer available Unable to access, April 11, 2007