American Journal of Law & Medicine

Ethos and economics: examining the rationale underlying stem cell and cloning research policies in the United States, Germany, and Japan.

I. INTRODUCTION

The governance of reproductive science is fraught with controversy in nearly every jurisdiction across the globe. Worldwide, legislators and policy makers have struggled to craft meaningful and ethical parameters for the regulation of this new and evolving area of biotechnology. In most countries, it is agreed that some form of regulatory oversight over reproductive technologies is necessary. There is far less consensus, however, as to the type of regulatory structure that should be established. Recent debates over reproductive science have focused on two of the most controversial practices in this area: embryonic stem cell research and cloning technology. Specifically, interested parties have struggled over whether these practices are so egregious that they should be altogether prohibited, or whether they ought to be permitted, but subject to particular legislative limits and regulatory oversight.

The difficulties that most countries have experienced in devising legislation pertaining to embryonic stem cell and cloning research emanate from the moral ambiguity that characterizes this area of science. Although embryonic stem cell research and cloning technology may ultimately yield pronounced medical and scientific benefit, if they are left unregulated and unsupervised, they may also threaten social health and well-being and devalue human dignity.

As a result of this moral ambiguity, legislators worldwide have faced competing pressures from proponents and opponents of stem cell and cloning science. Lobbyists on both sides of the debate have presented arguments to support their respective positions based on three concerns: cultural norms, scientific freedom, and potential economic gain. Recognizing each as valid and important, governments have frequently attempted to incorporate all three concerns into legislation addressing stem cell and cloning science. Yet, because these concerns are often conflicting, none can be satisfied entirely, thereby resulting in laws and policies that are ambiguous and internally inconsistent in an effort to achieve political compromise.

While most of the world views stem cell research and cloning technology as morally controversial, the debate surrounding the viability of these practices is shaped, in large part, by the ethos of a given place (i.e., cultural world view and fundamental values) and by domestic economic objectives and circumstances. This Article considers the ways in which cultural ethos and economic objectives impact law and policy by examining stem cell research and cloning technology regulation in the United States, Germany, and Japan. Although this area of science is subject to controversy in each country, the legislative and policy measures taken to address the competing forces underlying this controversy differ from one jurisdiction to another. This Article argues that the legal and policy distinctions in the United States, Germany, and Japan are due primarily to each country's unique prevailing economic and cultural circumstances.

The United States, Germany, and Japan are helpful paradigms through which we can consider how a country's ethos and economic circumstances shape its laws and policies. Given that each country has a distinct history and culture, they are useful models for considering the extent to which cultural, religious, and social experiences might affect the regulation of controversial biotechnological practices. At the same time, each of these three countries is an industrialized economic world leader that has historically promoted biomedical research and biotechnology within its borders. Therefore, they allow us to assess the impact that economic forces might bear on laws and policies related to science and technology, particularly, stem cell research and cloning technology.

This Article begins with an overview of the international debate concerning stem cell and cloning science. In Part II, I describe stem cell research and cloning technology and, specifically, discuss the differences between the two. In Part III, I explain the law and policy adopted by the United States, Germany, and Japan pertaining to embryonic stem cell research and cloning. In Part IV, I consider the link between these laws and policies and the cultural and economic realities of these three jurisdictions. This analysis will demonstrate how important cultural and historical dynamics have resulted in three, apparently different, legislative regimes affecting reproductive science. At the same time, economic forces in each country have prompted legislators and policy makers to create some degree of flexibility for scientists to engage in this area of biomedical research.

II. STEM CELL SCIENCE AND HUMAN CLONING

To fully appreciate the reasons underlying the controversy and moral ambiguity that accompany embryonic stem cell research and cloning technology, one must understand the scientific basis for each practice. Moreover, a broader understanding of the two will foster a better appreciation of the arguments marshaled on both sides of the debate on this topic. As such, this Article begins with a brief discussion of these scientific practices.

A. EMBRYONIC STEM CELL RESEARCH

Stem cells, unlike other cells in the human body, are capable of dividing and renewing themselves over an extended period of time. (1) From a single stem cell, scientists have been able to culture hundreds, and perhaps even thousands, of new stem cells. (2) Stem cells are also unspecialized, that is, they do not belong to any specific tissue structure, a fact critical to scientific research since, under certain physiologic or experimental conditions, these cells can be induced to differentiate into various cell and tissue types. (3) It is hoped that scientists soon will be able to use these new, healthy cells and tissues as replacements for their diseased counterparts. Because of this, scientists believe that stem cell research could ultimately lead to treatments and cures for a wide range of illnesses that currently plague humanity, such as Parkinson's disease, spinal cord injury, heart disease, diabetes, osteoarthritis, vision and hearing loss, and Duchenne's muscular dystrophy. (4)

While stem cells can be derived from human embryos, human fetuses, umbilical cord blood, and some tissues taken from the human body after birth, (5) much of the literature in this area specifically discusses human embryonic stem cells. In 1998, more than twenty years after having discovered how to obtain and derive stem cells from early mouse embryos, scientists discovered how to isolate stem cells from human embryos and grow them in culture in a laboratory. (6) Human embryonic stem cells are derived from the human embryo prior to implantation in the uterus during the blastocyst stage. (7) This stage is reached three to five days into the embryo's development. (8) At this point, the fertilized ovum has developed into a hollow ball of cells (i.e., a blastocyst). (9) Within the blastocyst is an inner cell mass comprised of roughly thirty stem cells, (10) the extraction of which destroys this very early embryo. (11)

The embryonic stem cell is not the only type of stem cell. A second type of stem cell is the human somatic stem cell, or the "adult" stem cell, which is an undifferentiated cell found in certain human tissues and organs, such as the brain, bone marrow, peripheral blood, blood vessels, skeletal muscle, skin, and the liver. (12) Adult stem cells can renew themselves and differentiate in a manner that allows them to regenerate the tissue in which they are found. (13) In addition, adult stem cells reportedly may have the ability to develop into the specialized cells of other tissues. (14)

While adult stem cells can provide a significant scientific benefit, embryonic stem cells are believed to have the greatest potential for medical research. Embryonic stem cells derive significant value because they are pluripotent, that is, they are able to differentiate into diverse cell types in the human body. (15) Adult stem cells, in contrast, are generally limited to differentiating into the different cell types of the tissue in which they reside. (16) In addition, large numbers of embryonic stem cells can be easily grown in culture, whereas adult stem cells are very limited in number in human tissue, and have not yet been grown in culture, an important fact given the large number of cells needed for stem cell replacement treatments. (17)

Because of their esteemed potential, embryonic stem cells have been the focal point of the debate over the moral propriety of stem cell research. Further complicating the morality of stem cell research in general, however, are moral ambiguities associated with embryonic stem cell research in particular. Specifically, the fact that, in many jurisdictions, the embryo lacks a clear moral and legal status has generated extensive debate over the propriety of using it as a stem cell source. This is particularly the case since the derivation of stem cells from an embryo requires that embryo's destruction. (18) Yet, the debate over embryonic stem cell research may be more acute, or more attenuated, depending on the nature of the embryo from which the stem cells are procured.

There are four possible sources of embryonic stem cells. First, embryonic stem cells may be acquired from "supernumerary" or "surplus" embryos. Surplus embryos have been created through in vitro fertilization ("IVF") in fertility treatment clinics in order to assist reproduction, but are subsequently donated for research. (19) Surplus embryos, however, cannot be used for research without the informed consent of the couple whose gametes were used to create the IVF embryos. (20) Second, embryonic stem cells can be obtained from embryos created through IVF for research purposes, not reproductive purposes. In this scenario, scientists would use donated ova and sperm to create the embryos in vitro and thereby create a source of embryonic stem cells. (21) Third, embryonic stem cells may be procured through somatic cell nuclear transfer ("SCNT"). This process, which is also known as "therapeutic cloning" or "research cloning," (22) requires the transfer of genetic material from an individual's cell into an ovum devoid of its own genetic material. The ovum is activated without fertilization in order to begin its development, and once the blastocyst stage is reached, stem cells can be isolated and cultured. Because the stem cells extracted from the cloned blastocyst were created from genetic material taken from the donor's very own cell, researchers expect that these stem cells, once differentiated and transplanted into this same individual, will not be rejected by his or her immune system, thus holding tremendous potential for treating illnesses. (23) Finally, embryonic stem cells may be secured through parthenogenesis, which involves stimulation in vitro of an ovum to initiate its division without actually fertilizing it. (24) Stem cells could ultimately be derived from an embryo created through this process.

The most controversial sources of stem cells, not surprisingly, are those embryos that were created specifically for biomedical research. As Soren Holm writes, "It has been argued that the use of spare embryos is less problematic than the use of embryos produced for research, and that at present the use of specifically produced embryos for stem cell research should not be allowed." (25) Surplus embryos (i.e., spare embryos) were created specifically for reproduction, and once they no longer serve this purpose, they will be discarded. Thus, committing these embryos to research is generally less controversial than the practice of creating altogether new embryos for scientific research, (26) which involves the creation of a potential human being that is destined to be used and then destroyed for research purposes. Even more controversial is the creation of embryos for stem cell research through SCNT. Not only does SCNT involve the creation of altogether new embryos for research, but, as described below, it also employs cloning technology. In particular, this same technique used to create embryos for stem cell research might ultimately be used to create a human embryo intended to be implanted in a uterus for the purposes of reproducing a human clone.

B. CLONING TECHNOLOGY

Although stem cell research and the science of cloning are often confused or amalgamated in the literature, the two are distinct practices. That said, stem cell research and cloning science are related by virtue of the fact that cloning is one method for creating a source of embryonic stem cells for research. As described above, SCNT carries cloning implications, as it involves the genetic replication of an individual's cell. The genetically replicated cell is then stimulated to begin dividing. Until now, SCNT has been promoted by scientists because it will allow for the creation of new human embryos--genetically identical to the donor of the original cell--from which stem cells can be extracted. At the same time, the cloned embryo created through SCNT might bear the potential to become a new human person, namely, a clone of the individual who donated the original cell. (27)

While scientists have successfully cloned non-human species using SCNT, the offspring reproduced through this technique have often been unhealthy or malformed. For example, in 1968, frogs were successfully cloned. (28) The majority of the offspring of those cloned frogs, however, were deformed. (29) Mammals have proven even more difficult to clone. (30) In fact, a cloned mammal was not born alive until the notorious birth of Dolly the ewe in 1997. (31) While Dolly's birth demonstrated the potential of SCNT, (32) this technique is far from perfect, as evidenced by the fact that out of the 277 adult cells fused with ova, only thirteen pregnancies resulted, of which only a single sheep was born alive. (33)

As noted above, SCNT is subject to extensive controversy because it involves the creation of embryos that are never intended to become human persons, but are destined for destruction. Moreover, SCNT is a technique that can be applied toward reproductive ends, namely, to create human clones. As Suzanne Rhodes has noted:

 
   The processes used in therapeutic cloning are similar to the 
   processes used in reproductive cloning. The goal of therapeutic 
   cloning, however, is not to create a human being but to create an 
   embryo from which stem cells can be harvested. These stem cells 
   could potentially be used to develop medical treatments. (34) 

The therapeutic objectives of SCNT are laudable, and, as a result, this practice has many proponents within the medical, scientific, and legal communities. (35) Yet, the potential for SCNT to be used to reproduce a human clone alarms many, thus inspiring frequent, forceful opposition to this technique. (36)

Although stem cell and cloning research are inherently controversial, the debate over these scientific practices has taken different manifestations across the globe. The following section of this Article describes policy initiatives taken in regard to stem cell and cloning science in three jurisdictions: the United States, Germany, and Japan. This discussion will enable us to consider the nature of the debate in each country, as well as the cultural and economic forces that have shaped it.

III. THE REGULATION OF EMBRYONIC STEM CELL RESEARCH IN THE UNITED STATES, GERMANY, AND JAPAN

A. THE UNITED STATES

The impact of cultural and economic forces on the regulation of embryonic stem cell and cloning research is perhaps nowhere better illustrated than in the United States. Law and policy regarding this science have consistently attempted to address and reconcile these often-competing forces. Politics have also played an important role, given that the various policy initiatives undertaken in this area have typically reflected the general outlook and objectives of the contemporary presidential administration.

1. Embryonic and Fetal Tissue Research in the Advent of Cloning

In the 1970s, embryonic research was oriented toward the study of fertility treatment through IVF. In 1979, the Ethics Advisory Board ("EAB") offered a report in which it concluded that embryonic research was ethically sound. (37) These findings, however, were largely ignored by federal legislators and the National Institute of Health ("NIH"); following its report, the EAB was disbanded. (38) Nevertheless, the 1975 federal regulation requiring all embryonic research to be approved by the EAB (39) remained in effect, thereby creating a de facto ban on federal funding for such research that continued until the mid-1990s (privately funded embryo research continued, however). (40) In addition, in 1988, a moratorium was placed on federal funding of research that purported to use fetal tissue. (41) Specifically, the Bush administration banned "experiments in which there is performed transplantation of human tissue from induced abortions." (42) This ban was adopted in response to American scientists who sought public support for research that would transplant fetal neural tissue into patients with Parkinson's disease. (43)

By the time a Democrat entered the White House, however, the American political position regarding embryonic stem cell research appeared to change. On his first day in office in 1993, President Clinton signed an executive order that officially lifted the Bush moratorium on federally funded research involving the transplantation of human fetal tissue. (44) One year later, Clinton convened the Human Embryo Research Panel ("the Panel") to consider the moral and ethical implications of funding embryo research. (45) The Panel concluded that federal funding was appropriate for research on donated embryos that had been created for fertility treatment, as well as embryos created specifically for studying fertilization and initial cell division. (46) Despite the Panel's conclusions, Congress was unwilling to support embryonic research of any kind, and issued a prohibition against the funding of research involving "the creation of a human embryo or embryos for research purposes or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death." (47) This became known as the "Embryo Research Ban." (48)

2. The Possibility of Human Cloning after Dolly

Upon the birth of Dolly, the controversy over embryonic research returned to the forefront of American politics and policy. (49) In response to news about Dolly, President Clinton requested that the National Bioethics Advisory Commission ("NBAC") investigate the ethics of nuclear transfer cloning technology. (50) One week later, President Clinton issued a memorandum entitled, "Prohibition on Federal Funding for Cloning of Human Beings," (51) which proclaimed that federal funds would not be allocated for human cloning. (52) The President urged the scientific and medical communities to follow this example and establish a voluntary moratorium on human cloning. (53)

In June 1997, the NBAC presented the President with its conclusions on cloning. (54) While the NBAC determined that the cloning of DNA, cells, tissues, and non-human animals using SCNT technology or other cloning techniques was not unethical, (55) it found human cloning to be morally problematic. (56) Further, in light of the safety concerns associated with reproductive cloning (e.g., the prospective dangers to the cloned fetus, the woman who carries the fetus, and the cloned person), the NBAC cautioned against proceeding with this scientific technique. (57) Finally, the NBAC agreed that federal funds should not be allocated to science oriented toward human reproductive cloning, and it urged private researchers to adhere to the voluntary moratorium established by President Clinton. (58) The commission, however, acknowledged that cloning technology may provide some medical benefit, and, thus, cloning for research was not subject to the funding prohibition. (59)

Although President Clinton drafted legislation based on the NBAC's recommendations, the bill failed after the commission's findings received little congressional support. (60) In fact, Congress has yet to pass legislation regulating or prohibiting human cloning. (61) Congressional leaders have failed to reach a consensus on whether human cloning should be banned altogether, or whether a prohibition should be restricted to reproductive cloning, while allowing research cloning to proceed. (62) In response to this federal stalemate, several states have passed, or have attempted to pass, legislation regulating cloning research conducted within their respective borders. (63)

3. Embryonic Stem Cell Research

In 1998, the importance of embryonic research in the United States became paramount after scientists discovered how to isolate stem cells from human embryos and grow them in culture in a laboratory. (64) In light of this development, President Clinton again turned to the NBAC to investigate whether supporting this research through federal funding was ethical. (65) In 1999, the NBAC released its report, endorsing federal funding of research involving the derivation and/or use of stem cells originating from surplus human embryos and aborted human fetuses. (66) Moreover, because this endorsement was in direct contravention to the Embryo Research Ban, given that the derivation and use of embryonic stem cells would result in the destruction of human embryos, the NBAC further suggested that an exception be made to the research prohibition. (67)

While the NBAC was completing its report on stem cell research, however, NIH Director Harold Varmus sought a separate opinion on the legality of deriving and using embryonic stem cells for research purposes from the Department of Health and Human Services ("HHS"). (68) The HHS concluded that research involving the use of embryonic stem cells was not prohibited under the Embryo Research Ban, for the research itself did not involve destroying or harming an embryo. The derivation (i.e., harvesting) of stem cells, however, was prohibited by the Embryo Research Ban, for it required the destruction of an embryo. (69)

Thus, although the NBAC had recommended allowing federal funding for both the derivation and use of human embryonic stem cells, ultimately, the NIH released guidelines in 2000 that distinguished between derivation and use. (70) The NIH guidelines, more strict than the NBAC's recommendations, barred federally funded researchers from deriving stem cells from embryos for research purposes. (71) The guidelines, however, allowed federal funding of research that used stem cells, provided that these stem cells were harvested through research supported by private money. (72)

While the NIH guidelines were being formed, legislation regarding stem cell research was introduced in the United States Senate. In January 2000, Senators Arlen Specter and Tom Harkin introduced Senate Bill 2015, entitled the Stem Cell Research Act. …

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