**[Chapter Seven]{.underline}**

**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: seeking both 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**

[1. The Scope of Policy]{.underline}

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 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.

# [2. A Legislative Complication]{.underline}

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
proceeded without the possibility of independent treatment. 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.

[1. Federal or State Jurisdiction?]{.underline}

We begin, as we should in America, by examining human cloning in the
context of our constitutional system and, in particular, of our special
form of federalism. In short, we must consider which level of government
has jurisdiction. Human cloning is not obviously a federal concern, nor
is it plainly outside the jurisdiction of the states; thus it might be
presumed to be a matter for regulation by the states alone. Certainly a
number of states have moved to legislate in this area. As of this
writing, twenty-two state legislatures have considered bills on cloning,
and six of them have passed laws on the subject. Of these, five directly
or indirectly prohibit both forms of human cloning, while one prohibits
only cloning-to-produce-children.[^2] It is possible to argue that human
cloning is one of those many issues, essentially local in nature, that
call more or less exclusively for the exercise of local self-government,
which in the American system means primarily government by the states.
And yet, a number of factors point to the need to consider a federal
policy as well.

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,[^3] that he
regards it as a federal issue; and President Bush has done likewise in
several public statements.[^4]

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.

For some or all of these reasons, we think it reasonable to conclude
that human cloning, of either variety, is a fit subject for debate and
action at the federal level.[^5]

[2. Seven Basic Policy Options]{.underline}

With respect to each form of human cloning, cloning-to-produce-children
and cloning-for-biomedical-research, there are two basic alternatives:
permit or prohibit. For each of these alternatives, there are again two
further possibilities: permit with or without regulation; prohibit
indefinitely ("ban") or for a limited time ("moratorium"). (The
alternative "permit with regulation" might or might not make permission
contingent upon getting the regulatory system *in place beforehand*.)
Among the numerous permutations and possibilities, we now take up seven
basic policy options that have been publicly discussed and that appear
to us worthy of consideration:

-   ***Policy Option 1**:* Professional self-regulation with no
    legislative action ("self-regulation").

-   ***Policy Option 2**:* A ban on cloning-to-produce-children, with
    neither endorsement nor restriction of
    cloning-for-biomedical-research ("ban plus silence").

-   ***Policy Option 3**:* A ban on cloning-to-produce-children, with
    regulation of the use of cloned embryos for biomedical research
    ("ban plus regulation").

-   ***Policy Option 4**:* Governmental regulation, perhaps by a new
    federal agency, with no legislative prohibitions ("regulation of
    both").

-   ***Policy Option 5**:* A ban on all human cloning, whether to
    produce children or for biomedical research ("ban on both").

-   ***Policy Option 6**:* A ban on cloning-to-produce-children, with a
    moratorium, or temporary ban, on cloning-for-biomedical-research
    ("ban plus moratorium").

-   ***Policy Option 7**:* A moratorium, or temporary ban, on all human
    cloning, whether to produce children or for biomedical research
    ("moratorium on both").

In considering each of these options, we bear in mind four basic
questions: (1) How would the policy be enforced and by whom? (2) On what
moral opinions, and on what views of the role of government, is it
based? (3) What are the arguments in favor? (4) What are the possible
objections? To avoid needless repetition, where two options are very
similar we refrain from repeating the same arguments at great length,
and instead focus on the major new points worthy of note.

\* \* \*

# 

# **[Policy Option 1]{.underline}: Professional self-regulation with no legislative action ("self-regulation").**

This option would enact no new legal restraints on human cloning, and
rely instead on self-regulation and private decision making. Passing no
law on the subject would maintain the legal status quo; it would leave
in place the existing moratorium on federal funding for either form of
human cloning, while also leaving private parties free to use private
funds to conduct either form of human cloning, as they see fit,
consistent with state law.

This approach would let physicians and patients decide privately whether
to engage in cloning-to-produce-children.[^6] It would rely upon the
people actually engaged in cloning-for-biomedical-research to establish
a mechanism for self-regulation and to prevent abuses. And it could
utilize tort liability to deter tragedies and mishaps, by holding people
legally responsible for harms inflicted upon a cloned child or his or
her mother.

This approach assumes that neither form of human cloning poses moral or
practical dangers sufficient to require public action. It assumes that
the harms of cloning-to-produce-children are not so grave as to merit a
legal restriction, and it sees no harm, or at least negligible harm, in
cloning-for-biomedical-research. It also assumes that government's role
in regulating scientific research and reproductive medicine should be
minimal; that federal legislation may cause more harms than it prevents;
that self-regulation provides sufficient safeguards against the worst
abuses of cloning techniques; that the subject is so complex that the
people best qualified to regulate it are the experts in the field
themselves; or that any more restrictive policy is unlikely to succeed
and likely to drive scientific talent overseas to more permissive
jurisdictions.

On the other hand, this hands-off approach would seem to ignore the
widespread public and congressional support for a ban on
cloning-to-produce-children, as evidenced in the July 31, 2001, vote in
the House of Representatives, where nearly every member voted for some
kind of federal ban on at least one form of human cloning. Of this
option, it may be asked: Is cloning-to-produce-children so morally
unproblematic that we could safely leave people free to try it? Would
tort liability really be sufficient to deter abuses? And can we afford a
laissez-faire policy on what is surely only the first of a series of
powerful new genetic technologies? For those who answer "no" to any of
these questions, it will be necessary to seek another option.

***Policy Option 2: A ban on cloning-to-produce-children, with neither
endorsement nor restriction of cloning-for-biomedical-research ("ban
plus silence").***

A second option would be to prohibit cloning-to-produce-children but
remain silent on cloning-for-biomedical-research. Such a policy would
prohibit the implantation rather than the creation of cloned human
embryos. By remaining silent on the question of creating cloned human
embryos, this approach would not establish an oversight mechanism or
other means of keeping track of cloned embryos or otherwise preventing
implantation before the act itself is undertaken. It would therefore
probably not require a new enforcement agency; enforcement of the ban
would presumably fall to the Department of Justice.

This approach assumes that cloning-to-produce-children is sufficiently
unacceptable as to merit legal prohibition, but minimizes or sets aside
the disputed question of cloning-for-biomedical-research. It seeks to
balance the responsibility for establishing public control over
potential misuses of technology with public tolerance for competing
worldviews and interests. It permits potentially valuable medical and
scientific research to go forward. It preserves the current federal
embryo-research policy, which (1) permits all embryo research to proceed
unimpeded with private funds, (2) permits research on certain embryonic
stem cell lines to proceed under federal guidance with public funds, and
(3) leaves open, for continued debate, the question of whether there
should be public funding for embryo and embryonic stem cell research.

# 

Against this option, it can be argued that it is not possible for the
government to be neutral on the question of
cloning-for-biomedical-research. It is difficult, if not impossible, to
write a statute banning the act of implanting cloned embryos without
tacitly sanctioning the creation of the cloned embryos in the first
place. Thus, a ban on cloning-to-produce-children not accompanied by
restrictions on cloning-for-biomedical-research could put the government
in the position of allowing the creation of a class of (cloned) human
embryos and then effectively mandating their destruction (or at least
their perpetual preservation in cold storage), a class of (cloned) human
embryos that it would be a felony to try to keep alive to birth. Also
such a partial ban could arguably make cloning-to-produce-children more
likely to occur. After all, without a regulatory system in place to keep
track of and govern the use of cloned human embryos, the ban on
implantation would be difficult to monitor and enforce. The commercial
production of embryos for research would be protected by industrial
secrecy. The transfer of cloned embryos to begin a pregnancy would be
virtually undetectable and protected by doctor-patient confidentiality.
Those charged with monitoring and enforcing the ban on
cloning-to-produce-children would not know who is doing what with cloned
human embryos. Moreover, actually enforcing the ban in the event of a
violation would be nearly impossible. Once a clonal pregnancy has begun,
there would be no real remedy except a forced abortion, an untenable
option.

***[Policy Option 3]{.underline}: A ban on cloning-to-produce-children,
with regulation of the use of cloned embryos for biomedical research
("ban plus regulation").***

This option would be similar to Option 2 ("ban plus silence"), but in
place of silence would require the establishment of a system of
oversight and regulation of cloning-for-biomedical-research. These
functions would be carried out by a regulatory agency (new or existing)
authorized to do some or all of the following things:

1.  Establish what may and may not be done with cloned human embryos
    once they are created, including a prohibition on implantation of
    cloned human embryos into human, animal, or artificial wombs.

2.  License and conduct prior review of all research involving cloned
    embryos.

3.  Establish guidelines for the protection of all human subjects
    participating in the research, including donors of eggs and nuclei.

4.  Register and track each individual cloned human embryo.

5.  Establish the number of days beyond which a cloned human embryo may
    not be grown in vitro, and enforce this requirement.

6.  Monitor and regulate financial transactions regarding cloned embryos
    and human oocytes used in cloning-for-biomedical-research.

7.  Monitor corporate, academic, and industrial
    cloning-for-biomedical-research, check for compliance, and enforce
    sanctions against violations of regulations.

To be effective, such a regulatory structure would have to be applied to
both federally funded and privately funded research. Its first purpose
would be to facilitate the ban on cloning-to-produce-children, by
keeping close track of all research using cloned human embryos. Its
second aim would be to enforce certain general standards for the
handling and use of cloned human embryos, to ensure that they are not
created for frivolous purposes, used irresponsibly, or treated in ways
that go beyond what American society deems morally acceptable.

This option assumes that neutrality on the question of
cloning-for-biomedical-research is neither possible nor desirable.
Instead, it assumes that a system is needed to regulate and limit the
use of cloned embryos---both in the interest of preventing
cloning-to-produce-children, and in the interest of establishing a clear
ethical framework for undertaking cloning-for-biomedical-research and
allowing that research to flourish. At the same time, such a system
would establish clear rules and limits to prevent abuses---for example,
experimentation on later-stage embryos and fetuses or attempts to
produce cloned children.

This new task could be assigned to an existing regulatory agency (or
combination of agencies), such as the Food and Drug Administration or
the National Institutes of Health, or, alternatively, it could be
carried out by a new regulatory agency devised specifically for the
purpose.

Establishment of a regulatory structure may be aided by the study of
models in other countries, such as the United Kingdom's Human
Fertilization and Embryology Authority (HFEA) or the Assisted Human
Reproduction Agency being brought into existence in Canada---taking into
account, of course, the important differences between their political,
economic, and health-care systems and our own.

Regulation, for these proponents, would limit the uses of cloned embryos
to especially promising and worthy biomedical research and would set
boundaries beyond which such embryos may not be grown or exploited. For
some proponents of this option, such oversight and regulation would be
aimed primarily at preventing the use of cloned embryos to produce
children. For others, regulation is called for to ensure that cloned
human embryos be treated not simply as a natural resource but with
appropriate measures of respect owed them as *human* embryos.

Against this option can be raised some of the same objections that were
raised against Option 2 ("ban plus silence"), namely, that it puts the
government in the new position of requiring the destruction of nascent
human life, and that it could, by allowing the production of cloned
human embryos, make cloning-to-produce-children more likely. It might
also be argued against this option that setting up a workable regulatory
structure is either impossible or impossible to do very quickly. After
all, the IVF and assisted-reproduction industry is today largely
unregulated in any way that could be called coordinated, comprehensive,
or systematic. The federal government has no experience in regulating or
keeping track of the number and fate of embryos produced in IVF
clinics.[^7] And the biotechnology industry has shown little enthusiasm
for outside regulation. Establishing an effective regulatory regime
could take several years of trial and error, during which time cloned
embryos might be mishandled or implanted in an effort to produce
children. There are also the dangers that regulatory bodies often prove
ineffective and unaccountable and that they are vulnerable to capture by
special interests that have a large stake, economic or other, in their
regulatory decisions but little incentive to respect the permanent and
aggregate interests of the nation. Establishing the regulatory body
overseeing human cloning-for-biomedical-research within the National
Institutes of Health, for example, would not be reassuring to those
concerned lest the fate of the embryo be always subordinated to the
imperative for research. In this view, regulation is not enough.

*Policy Option 4: Governmental regulation, perhaps by a new federal
agency, with no legislative prohibitions ("regulation of both").*

This option is similar to the regulatory half of Option 3 ("ban plus
regulation"), but the regulatory agency would also have authority to set
policy and guidelines regarding cloning-to-produce-children. In addition
to the functions listed in the description of Option 3, the regulatory
body would determine if and when human cloning techniques were
sufficiently safe to warrant attempts to produce children by human
cloning. The entity might also function as a licensing agency, setting
down clear guidelines delineating acceptable and unacceptable purposes
for such a practice (for example, it might choose to permit cloning to
"replace" a deceased child).

The major argument for this option is flexibility: as the science and
technology of human cloning proceeds in nonhuman animals, and as the
public's views develop in response to new information and new debates,
the nation will not be locked into a legislatively defined position that
might later appear to have been misguided. Either a congressional ban or
the refusal to enact a ban may prove to be a decision that will later
look undesirable and very hard to undo.

Against this option are many of the same objections raised against the
regulatory part of Option 3. Also, it may be argued that, given our
society's strong moral opposition to cloning-to-produce-children, any
decision to permit such a practice, even in exceptional cases, should
not be left to a regulatory body; it should rather require a decision by
people directly accountable to the voters. This option fails that test.

*Policy Option 5: A ban on all human cloning, whether to produce
children or for biomedical research ("ban on both").*

This option would ban the initial act of human cloning---the production
of cloned human embryos---regardless of the intended purpose. It would
thus prohibit both forms of human cloning.

Specifically, this approach would proscribe the act of producing cloned
human embryos by means of SCNT. Although enforcing the ban would be the
responsibility of law enforcement agencies---as would enforcing a ban on
cloning-to-produce-children---the "policing of laboratories" would
hardly be necessary. Financial and criminal penalties, along with the
inability to publish, patent, or profit from (the now illegal) work
involving cloned human embryos, would by themselves eliminate nearly all
incentive to clone. The ban would deter by subjecting to prosecution and
social stigma any researchers or institutions whose efforts to create
cloned human embryos came to public attention.

As we have seen in previous chapters, some proponents of this option
argue that the creation, use, and ultimate destruction of cloned human
embryos solely for research is morally unacceptable, either in itself or
because of its moral consequences. Others hold that a ban only on the
transferring of cloned embryos to a woman's uterus, even with additional
regulations, would fail to prevent the cloning of a child, and that
human cloning must be comprehensively stopped before it starts. Also,
any regulatory arrangements that allowed cloning-for-biomedical-research
within *legally* established limits would put the federal government in
the novel and morally troubling position of mandating the destruction of
nascent life.

In favor of this approach it can be argued that a "ban on both" would
steer scientists toward less morally troubling (and, in the view of
some, more medically promising) forms of biomedical research. Indeed,
some argue that pursuing cloning-for-biomedical-research might actually
hurt those whom it claims to help, by diverting valuable resources away
from more promising areas of research or more urgent health-care needs.
By taking this option, some proponents argue, America would send a
strong signal of moral leadership to the rest of the world, where the
human cloning question is also currently being debated. Besides, if
scientists ever clearly demonstrated a unique, pressing, and morally
powerful need for cloned embryos for research, the ban---like any
ban---could always be revisited.

Against this option it is frequently and vigorously argued that
prohibiting cloning-for-biomedical-research would cut off a promising
avenue of medical research. It is also argued that forbidding such
research here may simply drive American talent overseas and thus
diminish American scientific preeminence and economic strength.

***[Policy Option 6]{.underline}: A permanent ban on
cloning-to-produce-children, with a moratorium, or temporary ban, on
cloning-for-biomedical-research ("ban plus moratorium").***

This option would impose a permanent legal prohibition on
cloning-to-produce-children, by banning the creation and subsequent
transfer of cloned embryos into a woman's uterus. At the same time, it
would also prohibit the creation of cloned human embryos for any reason,
but would require a mandatory review of that latter prohibition after a
certain period of time (for example, five years). This option would lock
in a permanent ban on the activity virtually everyone opposes
(cloning-to-produce-children), while calling for continued and enlarged
debate on a question about which people currently differ
(cloning-for-biomedical-research).

The main benefits of a moratorium on cloning-for-biomedical-research are
that it would (1) allow time for research in related fields to proceed
and perhaps clarify the potentially unique benefits of
cloning-for-biomedical-research; (2) allow time for a regulatory
structure---whether narrow or broad in scope---to be developed, if
deemed desirable; and (3) allow time for further debate and deliberation
about the moral questions, to determine if the prohibition on
cloning-for-biomedical-research should be renewed, made permanent, or
abandoned after the moratorium expires. Rightly understood, a moratorium
should not be seen as an attempt to stall, but as an opportunity to
figure out how to do things right. And for those interested in exploring
and establishing regulatory arrangements, a moratorium, as a *de jure*
halt, would provide prospective researchers with an incentive to
recommend moral and legal guidelines before the moratorium would expire
and be up for possible renewal.

This option would also enable policymakers to take up the question of
cloning-for-biomedical-research in the larger context of the
embryo-research question, rather than in the narrower context of human
cloning.

This option captures much of the current public debate, in which there
is general agreement on the need to prohibit cloning for producing
children, but a great deal of uncertainty over the proper approach to
cloning-for-biomedical-research.

The arguments against this option are the same as those leveled against
Option 5 ("ban on both"), namely, that prohibiting
cloning-for-biomedical-research, even for a limited time, would cut off
a promising avenue of medical research and simply drive American talent
overseas. Others may object that the two uses of human cloning might
hereafter be delinked, a prospect that troubles some for both practical
and moral reasons (laid out in the discussion of the next option).

***[Policy Option 7]{.underline}: A moratorium, or temporary ban, on all
human cloning, whether to produce children or for biomedical research
("moratorium on both").***

The final option is a temporary form of Option 5 ("ban on both"), with a
mandatory review of the policy after a certain period of time (for
example, five years).

The main benefits of this option are the same as those listed above for
Option 6 ("ban plus moratorium"). But this option has what some consider
the additional virtue of keeping the two uses of cloning linked in the
policy arena. This has, they say, two major benefits.

First, on *practical* grounds, the policy on cloning for research will
bear heavily on the feasibility and efficacy of any ban on
cloning-to-produce-children, and therefore there is an advantage in
ensuring that the two are considered together. Because the availability
of cloned embryos would make enforcement of the ban on
cloning-to-produce-children more complicated and demanding, a ban on
cloning-to-produce-children should never be de-coupled from an identical
ban on cloning-for-biomedical-research.

Second, on *moral* grounds, some argue that permitting the creation of
cloned human embryos for research crosses an important line, and that
one use of cloned embryos should not be separated fully from the other
in public consideration. They hold that human cloning is a single thing,
and therefore should be taken up whole. They are concerned that, at the
end of the moratorium outlined in Option 6, the situation would be
transformed into Option 2 ("ban plus silence") or Option 3 ("ban plus
regulation"), with all the deficiencies that they think Option 3 holds.
For this reason, these opponents argue, it is more appropriate for both
forms to be considered together at the end of the moratorium period,
even if the eventual resulting policy does not treat them equally.

Once again, the arguments against this option are the same as those
leveled against Option 5 ("ban on both") or Option 6 ("ban plus
moratorium"); namely, that it would cut off, at least temporarily, a
promising avenue of medical research and drive American talent overseas.
In addition, some may object that linking the two uses of cloning
misrepresents the state of the public discussion on the subject and
places cloning-for-biomedical-research in the wrong context---causing it
to be considered always as a form of cloning, rather than as a form of
embryo research.

Finally, some do not want to forgo the present opportunity to enact a
*permanent* ban on cloning-to-produce-children; failure to do so now,
they argue, would seem to imply that cloning-to-produce-children is
perfectly acceptable.

\* \* \*

Having sketched out what we consider to be the most plausible options,
we now proceed to offer our own policy recommendations and our reasons
for them.

### ENDNOTES

[^1]: Presentation made by Dr. Patricia Baird, chair, Royal Commission
    on New Reproductive Technologies, at the June 2002 meeting of the
    President's Council. Transcript available at
    [http://www.bioethics.gov](http://www.bioethics.gov/).

[^2]: ^i^ As of June 2002, three states (Iowa, Michigan, and Virginia)
    ban both cloning-to-produce-children and
    cloning-for-biomedical-research. Two states (Louisiana and Rhode
    Island) ban cloning-to-produce-children, but also have
    embryo-research laws that appear to prohibit
    cloning-for-biomedical-research. One state (California) has banned
    cloning-to-produce-children until December 31, 2002, but has no
    embryo-research law and thus effectively permits
    cloning-for-biomedical-research.

[^3]: ^?^ Clinton, W.J., "Memorandum on the Prohibition on Federal
    Funding for Cloning of Human Beings, March 4, 1997" In *Weekly
    Compilation of Presidential Documents* (Volume 33, Number 10), p.
    281. Washington, DC: Government Printing Office, 1997.

[^4]: Bush, G.W., "Remarks on Human Cloning Legislation, April 10, 2002"
    In *Weekly Compilation of Presidential Documents* (Volume 38, Number
    15), pp. 608-610. Washington, DC: Government Printing Office, 2002.

[^5]: We prescind from trying to determine at length whether federal
    legislation limiting human cloning would infringe on what some
    believe is a fundamental constitutional right to attempt to
    procreate. Nor will we try to offer our own legal opinion about
    whether the Food and Drug Administration has existing authority that
    would enable it to regulate either form of human cloning, or both
    forms. These questions we are content to leave to others. Instead we
    proceed here on the assumption that, whatever the precise state of
    the law, Congress may (and we would argue, should) take the lead in
    determining federal cloning policy.

[^6]: ^i^ The Food and Drug Administration (FDA) claims that it has
    jurisdiction to regulate attempts to clone humans, because this
    would involve testing of a "biologic," and it threatens to go after
    anyone who tries to create a cloned child in the United States. But
    the FDA's claim to such authority is disputed, it being at least
    doubtful whether a cloned human embryo is to be regarded, under the
    governing statute, as a medical product or device. The FDA has never
    attempted to regulate the human uses of IVF embryos.

[^7]: ^i^ The FDA has never attempted to regulate the practice of IVF,
    intracytoplasmic sperm injection, preimplantation genetic diagnosis,
    or embryo research conducted with IVF-produced embryos.