Human Cloning and Human Dignity:
An Ethical Inquiry
The President's Council on Bioethics
Washington, D.C.
July 2002
www.bioethics.gov
Chapter Seven
Public Policy Options
The connection between moral assessment and public policy, here as elsewhere, is hardly straightforward. The relation of morality to law is notoriously complex, especially in free societies such as our own in which citizens may live their lives according to their own moral views. At the same time, however, practices deemed seriously wrong and harmful are outlawed, from incest and sexual abuse to slavery and racial discrimination. In addition, law functions not only to encourage or discourage conduct but also as a moral teacher. It expresses the social norms of the community, whether by fostering public education and medical research or by discouraging dishonest business practices and teenage pregnancy. Whether and how the law should address any given morally charged topic is often a debatable matter, requiring careful study and prudent judgment. Not everything that is morally defensible should be encouraged by public policy; not everything that is morally troubling should be legally proscribed.
These general remarks apply also to the case at hand. The moral assessments of the previous two chapters do not carry self-evident policy recommendations. Even a thoroughly developed moral position on either or both of the uses of human cloning still leaves open the question of what public policy would be appropriate, prudent, and effective. One can be morally opposed to cloning-to-produce-children, yet also oppose making it illegal, say, because of hesitation to increase the police power of the state in matters of reproduction. Or one can have no personal moral objection to cloning-for-biomedical-research, but still find practical reasons to favor a moratorium on such activity, say, because one wants to develop regulatory institutions before allowing the research to proceed. Moral principle and judgment, though necessary, are not sufficient for deliberating about what to do about human cloning. Prudence is also required.
In this chapter, we consider a broad range of public policy options. We assess and compare these options in the hope of seeing our way clear, in the eighth and final chapter of this report, to offer recommendations that comport, not only with our ethical judgments, but also with our sense as citizens of what is prudent, practical, and appropriate for this country at this time.
The policy debate about human cloning is a particularly vivid example of the tension between competing public goods, between the goods served by biomedical science and technology and other moral and social goods important to community life. The desire to ban human cloning, whether for producing children or for biomedical research, arises primarily from moral and social objections made in the name of human dignity, individuality, and respect for life. The opposition to a comprehensive ban on human cloning arises primarily from a belief that cloning research may lead to new remedies for human diseases and disabilities, backed also by appeals to the principle of freedom for scientific inquiry and technological innovation. Assumptions about the relative merits of these competing goods, as well as about the broader relation between science and society, lie just beneath the surface of this debate. Wittingly or not, these assumptions inform how people think about the various policy options proposed for dealing with human cloning. A brief examination of the more general question of the relation between science and society might clarify the principles that should guide our approach to a national policy on human cloning.
I. Science and Society
Since its birth in the seventeenth century, modern science and especially modern medicine has been guided by a desire to improve and elevate the human condition. Unlike ancient science, which sought speculative knowledge of what things are purely as an end in itself satisfying to the knower, modern science from the start sought effective knowledge of how things work, in the service of what Francis Bacon called "the conquest of nature for the relief of man's estate." Since then, scientists have been increasingly motivated not only by a deep desire to know, but also by a desire to do: that is, to provide resources, know-how, and relief in humanity's pursuit of health, happiness, and comfort. Biomedical scientists especially have pursued a dual goal: to increase our knowledge and understanding of living nature and to help the sick and the suffering.
In exchange for the promise of great human benefits, the practice of science entered into an unprecedented relation to the larger society. Scientists gradually acquired a privileged standing in modern societies, first with protections against persecution and censorship, later with public recognition and financial support. But it deserves to be noted that, insofar as the public respect for science rests on its moral intention and its ability to deliver the goods that society wants, scientists tacitly subject themselves to public scrutiny and moral judgment of their work, both as to ends and to means. The tacit social contract between scientists and society freedom and support for scientists, benefits for all humanity is double-sided: on the one hand, the opportunity for scientists to be public benefactors and recognized as such; on the other hand, the need, in cases where values conflict, for scientists to defend what they do in terms of the community's judgments about the relation of scientific activity to other moral and social goods.
As we have noted in the previous chapters, in the twentieth century, biomedical science made tremendous advances, resulting in both greater knowledge of how the human body works and greater ability to affect its workings. The results have been so dramatic, and so beneficial, that in the United States today virtually no one questions the benefits of the modern scientific endeavor, especially in medicine. This consensus about benefits has expressed itself as consistently strong public support for public funding of basic research, as well as strong support for the freedom of scientists to set their own research agendas, limited only by their curiosity, their imaginations, and our commonly agreed-upon moral and ethical norms. The tacit "contract" or relationship between science and society recognizes and celebrates the great benefits of freedom for all involved.
But for all these great benefits and good purposes, there are also times when the activities of scientists or the products of scientific work can imperil society and its members. For one thing, the work of scientific research is by its nature experimental. Scientific inquiry involves action, not only observation or theory. For this reason, freedom of inquiry does not adequately describe the freedom that scientific work requires and is generally granted. It may be more accurate to say that scientists desire and often receive great freedom of action. Yet because scientists learn by doing, some of what scientists do can be dangerous or inappropriate. And because some of their actions may infringe on the rights, security, or dignity of individuals, or on the principles and interests of society as a whole, scientific freedom of action cannot be absolute.
In addition, many of the technological products of scientific research can be used to do harm as well as good. Just as society has moved in the past to restrict access to dangerous nuclear and biological agents, as well as to restrict public access to information about these things, so too will society be confronted with moral challenges by the new biomedical technologies. Technologies that disclose our genetic abnormalities or that alter the human genome, neurotropic drugs that can enhance (or destroy) memory or libido, computer implants in human brains these and many other technological possibilities now on the horizon may raise profound moral and social challenges to privacy, freedom, equality, dignity, and human self-understanding. As citizens we may indeed we must decide whether and where to limit potentially harmful research or technology even as we continue to desire and uphold free intellectual inquiry and technological innovation.
American society has done this in the past. The various codes of conduct for human experimentation, discussed at several points in this report, demonstrate some of the ways in which the polity has established important moral boundaries that biomedical researchers must respect. In addition, rules and restrictions governing the pharmaceutical industry, the practice of medicine, the sale of organs for transplantation, the handling of biohazards, the development of biological weapons, and numerous other areas of scientific and technological work show that even given our desire for scientific advance and our belief in the inherent value of freedom, the pursuit of research and technology has not been allowed to trump all other concerns.
Thus we conclude that in the realm of genetics and reproduction, as in many others, boundaries and regulations may be needed: lines may need to be drawn that none may cross, guidelines may need to be established that all must follow. Because the wisdom needed to decide how scientific knowledge and technology should be used is not something that science can provide by itself, these boundaries and regulations must be set by the whole community, democratically, through its representative institutions, and not only by those who are experts in the scientific work involved. Our analysis in Chapters Five and Six of the serious moral and social questions raised by human cloning has persuaded us that human cloning in both its forms is an appropriate area for public policy.
II. Public Policy Options:
General Considerations
A. The Scope of Policy
Having decided that human cloning is an activity fit for public policy decision, we still face many questions. Does it warrant legislative proscription, governmental regulation, professional oversight or self-regulation, or merely civil tort liability for bad results? And how broadly or narrowly should we delimit the domain in which human cloning is to be considered? Although the ethical analysis in this report has often concentrated on human cloning considered on its own, when considering public policy it is especially important to recall the larger contexts in which human cloning belongs. As we emphasized in Chapters One and Two, human cloning (in both its possible uses) would be but a special area of a larger domain of biotechnology, made possible by present and projected techniques of embryo research, assisted reproduction, genetic screening, and genetic engineering all of which are coming to be grouped under the field of "reprogenetics." As we contemplate possible policy options regarding human cloning, it behooves us to consider what cloning's place within this broader context might mean for public policy.
Many other countries have in fact taken up cloning in this broader context. In Germany, for example, this broader approach has taken the form of a series of legal proscriptions and restrictions, centered on the Embryo Protection Act of 1990. The act treats all embryo research together and prohibits all interventions not undertaken for the well-being of the embryo (including the creation of embryos specifically for research). The German system also includes specific rules for IVF procedures, and in general treats all interventions involving the human embryo under one rubric. Human cloning, for whatever purposes, is legislatively prohibited.
In the United Kingdom, too, policy on these subjects takes as its organizing principle the human embryo itself, though the approach here is regulative rather than proscriptive. The British system is centered around a regulatory body the Human Fertilization and Embryology Authority (HFEA), created in 1990 charged with monitoring and regulating essentially all of what has come to be called reprogenetics, including human cloning, both for producing children and for biomedical research. The HFEA regulates infertility treatment and clinical work; storage of gametes and embryos; and all embryo research, whether publicly or privately funded. It licenses these various activities, monitors compliance, sets standards of practice, establishes limits and requirements on the use of embryos for various purposes, and maintains a detailed information registry about both assisted reproduction and embryo research. Human cloning is treated within this broader regulatory scheme: cloning-to-produce-children is not permitted; cloning-for-biomedical-research is allowed, but only with cloned embryos no older than fourteen days.
Canada is completing the process of establishing a national system, combining
elements of legal proscription and governmental regulation, to govern
all technological activities used to help people have children as well
as the use of embryos in research. Some activities would be permitted
and regulated, others would be prohibited by law. The chosen point of
departure is not the human embryo, but rather the goods of human health
and dignity: to protect the health and safety of Canadians; to prevent
commercial exploitation of reproduction; and to protect human individuality
and diversity and the integrity of the human genome. A single broad regulatory
body, the Assisted Human Reproduction Agency of Canada, would issue and
renew licenses for assisted reproduction facilities, collect and analyze
health information, set policies, and monitor compliance. Among the prohibited
activities are all human cloning, whether to produce children or for biomedical
research. Human embryos no longer needed for infertility may be used for
stem cell research (with consent of the progenitors). But producing in
vitro embryos for research purposes is prohibited, except for efforts
to improve assisted reproduction procedures.1
Several other countries have approached this area of biotechnology with a similar broad outlook. The United States to date has not; indeed we lack any national monitoring, oversight, or regulatory system in this area. It may therefore be appropriate, in connection with thinking about specific policies for human cloning in the United States, to initiate discussions of a national policy for these related arenas. Doing so might allow us to regard the question of embryo research in its full scope, and to consider it together with the closely related issues that arise when the techniques of assisted reproduction come together with those of genetic diagnosis and potential genetic engineering. In putting forward its recommendations in the next chapter, the Council will take into account this broader context of related biotechnologies.
Yet, much as it would be desirable to consider public policy regarding human cloning in its larger context, it is for us also necessary to consider it on its own. Owing to the immediate concern over the prospect of cloning-to-produce-children, legislative proposals and public debate have largely treated the subject of human cloning in isolation though for reasons we have noted, it has overlapped with the controversy about embryonic stem cell research. Accordingly, the policy options presented below are drawn for the most part from the ongoing public and legislative debate about human cloning, and therefore direct themselves to legislative alternatives regarding cloning in particular.
B. A Legislative Complication
There is a complication that bedevils prospects for legislation regarding human cloning. Given that human cloning may be used for two very different purposes to produce children and for biomedical research one might think that these two different uses could be treated independently, just as we have done (for the most part) in the ethical analyses in Chapters Five and Six. The ethical issues of cloning-to-produce-children and cloning-for-biomedical-research differ considerably, and, as our own discussions have indicated, one's moral assessment of the second can be independent of one's moral assessment of the first. Some people who oppose cloning-to-produce-children may favor cloning-for-biomedical-research; some people who oppose producing embryos solely for research may object less forcefully to cloning-to-produce-children (should it ever become safe to attempt it). And people who oppose both uses may differ as to which they think is the worse. Given these variations, it would seem sensible to disaggregate the two forms of cloning and develop independent public policies for each.
But this is easier said than done. The reason is simple: both forms begin in the same way with the act of cloning (by somatic cell nuclear transfer [SCNT]) that produces a cloned human embryo. It is therefore difficult perhaps impossible to craft a public policy regarding one use of cloned human embryos that does not, at least tacitly but usually explicitly, also affect the other. A thoroughgoing attempt to prevent cloning-to-produce-children by banning the first step would also prevent cloning-for-biomedical-research. An attempt to promote cloning-for-biomedical-research might well have consequences for cloning-to-produce-children (for example, by improving the technique or by increasing the likelihood of attempts to initiate a pregnancy). An attempt to prevent cloning-to-produce-children at the step of transfer of a cloned embryo to initiate a pregnancy would tacitly approve the initial creation of cloned embryos for other purposes. Moreover, by imposing penalties on implantation while sanctioning creation, a policy that banned only transfer to a uterus would in effect require, by law, that cloned human embryos be destroyed.
Even if one thinks only of the task of statutory drafting, the difficulty persists. For if one wants to make a particular action illegal, one must specify precisely the act to be proscribed. It turns out to be very difficult to specify precisely and unambiguously the forbidden act of human cloning without touching both uses at once. "It shall be unlawful to attempt to clone a human being" is simple enough to say, but vexing to specify. The meaning of the term "human being" is contested: does it mean only a child or adult, or is an embryo too a human being, albeit in its primordial stage? The definition of "to clone" must specify either the initial act of somatic cell nuclear transfer or the birth of a cloned child. "Attempting to clone" will mean either somatic cell nuclear transfer itself or the transfer of the resulting cloned embryo to a woman's uterus.
There is, of course, one possible policy approach that could disentangle the two uses of human cloning, but it would require dealing with cloning-for-biomedical-research in a different context. Since cloning-for-biomedical-research is one form of embryo research another is research that uses embryos produced by IVF one could have a broad policy on all embryo research, which would then necessarily apply to research with cloned embryos. Several states have separate laws that cover research on all human embryos, cloned or not. In these cases, a law to deal with the special practice of cloning-to-produce-children could then be added without difficulty. And, as we have indicated, in the United Kingdom and several other countries, there is a broad regulatory system for handling all activities involving human embryos both for research and for initiating pregnancies into which further regulations regarding cloned embryos may easily be fit. But the legislative debates in Congress, both in 1998 and in 2001-2002, have not squarely addressed independent treatment of embryo research in general and cloning-for-biomedical-research in particular. That fact shapes our examination of specific public policy options.
III. Public Policy Options:
Specific Alternatives
What sort of policy regarding human cloning would be most appropriate in this country at this time? In approaching the various alternatives, we operate on the following premises.
First, given the seriousness of the subject, we favor a policy that makes an explicit and considered decision about whether to proceed. Should our society come to have no rules or guidelines regarding human cloning, it should do so deliberately, not by default.
Second, we need to decide whose decision and responsibility this should be. And while we may differ among ourselves on the answer to this question, we agree that whichever persons, institutions, or agencies of government have authority for the decision and any subsequent oversight, the responsible parties should be answerable to and held accountable by the people and their representatives. This is not an arena where secrecy or lack of accountability should be tolerated.
Third, whether one opts for permission with or without regulation or for legislative proscription, permanent or temporary, we believe that the following two balancing principles should be followed: (1) Because of the gravity of the issues at stake, whoever bears the power of decision needs to be persuaded that we should now proceed with human cloning, in either or both of its forms. (2) At the same time, we should not stand in the way of proceeding simply out of some vague fear of possible future harms of unknown magnitude; we should interfere only if the harms are deemed serious, important to the common good, and likely to occur.
A. Federal or State Jurisdiction?
For one thing, as we hope the foregoing chapters have made clear, human
cloning-to-produce-children has nationwide implications, with potentially
profound effects on individuals, families, and all of society. This view
is reflected in the efforts in Congress to legislate on the subject, first
in 1998 and again in 2001 and 2002. President Clinton made clear, in his
executive order on human cloning,2
that he regards it as a federal issue; and President Bush has done likewise
in several public statements.3
For another thing, the federal government plays an extensive role in funding and regulating scientific research. Insofar as there has been a role for government in the oversight of scientific work in America, it has generally been filled by the federal government, for reasons of scale and efficacy and also to some extent of historical accident. So long as this remains the case, questions relating to the funding and regulation of human cloning will, in practice, be addressed mostly or even solely at the federal level.
Moreover, it can be assumed that, if they remain legally permissible, both forms of human cloning would tend to enter into interstate commerce, thus bringing them within the purview of Congress, at least as far as its power to regulate interstate commerce allows.
Historically, when several or most of the states have proscribed some activity they regard as injurious to public health, safety, or morals (such as prostitution or the use of narcotic drugs), the federal government has tended to enact laws supportive of the states', or most of the states', moral proscriptions, either by restricting interstate commerce (as in the Mann Act relating to prostitution) or even by directly prohibiting the activity itself (as in the Federal Controlled Substances Act). Since the states have begun to act on human cloning, it has become valid therefore to ask whether federal legislation is also needed.
Finally, human cloning has become a subject of international law. A number of nations have moved to prohibit one or both forms of human cloning, and the United Nations is currently debating whether to promulgate an international convention to ban cloning-to-produce-children. Since only the federal government can make treaties or conduct foreign policy for the whole nation, it seems likely that at some point the United and not merely the separate States will be under pressure to legislate on this subject.