| Prepared
Witness Testimony The Committee on Energy and Commerce W.J. "Billy" Tauzin, Chairman Issues Raised by Human Cloning Research Dr. Nigel M. De S. Cameron Ph.D.
Nigel M. de S. Cameron Consultant
in Bioethics and Public Policy Founding
editor, Ethics and Medicine: An
International Journal of Bioethics; Dean, The Wilberforce Forum, Reston,
Virginia; Executive Chairman, The Centre for Bioethics and Public Policy,
London, England ncameron@wilberforce.org In
human cloning we confront the quintessential question of the new bioethics. The
challenge it poses is emblematic of the new bioscience and its agenda, which
offers both such promise for good, and such threat of harm, to the human community.
The means of human procreation itself now suddenly lies in our own hands:
nowhere is it clearer that we face a watershed for the human race. In
the four years since it was announced that Dolly the sheep had been cloned,
many nations have taken steps to prevent the application of the somatic cell
nuclear transfer technique, and in some cases other cloning techniques, to
human beings. These follow the earlier 1990 German statutory ban on cloning,
with a penalty of five years imprisonment. One of the most recent is Japan,
which takes effect in June of this year, and carries a 10-year sentence for
infringement, though no penalty for Japanese who travel abroad for the process
– since a Japanese. Other nations that have banned cloning include Ireland,
Israel, Italy, France, Argentina, Colombia, and Spain. Nations with current
legislative process include Korea, Canada, New Zealand, and Russia. The
European Convention on Biomedicine and Human Rights sets the questions being
raised in biotechnology firmly in the context of the human rights tradition in
European law, recognizing that the dignity of the individual is the prime
question at issue. The Convention has been amended to ban human cloning; as of
today, 29 European states have signed the protocol, and it came into force on
March 1 after ratification by the first five signatories. The full text of the
treaty and the protocol are included as an attachment to this testimony. The need for policy in bioethics and the
biosciences. The development of policy has lagged far behind the development
of technique and the growth of the commercial sector The need to build public confidence. This offers a
powerful support to the development of policy. The overriding significance of the dignity of
the individual. This states the central challenge confronting bioscience policy,
since these unfolding developments will offer a stream of benefits to some
individuals at potential cost to others. The importance of international agreement. Both human dignity,
and the worlds of bioscience and the biotechnology industry, are
indivisible, and there is urgency in the task of international agreement.
The European Convention on Biomedicine and Human Rights offers a model;
the present UNESCO process that has begun with a statement on the human
genome offers a process. United States House of Representatives Committee on Energy and Commerce Subcommittee on Oversight and Investigations March 28, 2001 ON THE CLONING OF
HUMAN BEINGS: Nigel M. de S. Cameron Consultant
in Bioethics and Public Policy Founding
editor, Ethics and Medicine: An
International Journal of Bioethics Dean,
The Wilberforce Forum, Reston, Virginia Executive
Chairman, The Centre for Bioethics and Public Policy, London, England ncameron@wilberforce.org In human cloning we confront the
quintessential question of the new bioethics. The challenge it poses is
emblematic of the new bioscience and its agenda, which offers both such promise
for good, and such threat of harm, to the human community. The means of human
procreation itself now suddenly lies in our own hands: nowhere is it clearer
that we face a watershed for the human race. The field of bioethics lies at the
meeting-point of ethics with several disciplines, including science,
technology, medicine, and policy. The challenge to policy is to maintain the
priority of what is ethical, and therefore to assert the fundamental values of
the human community as the context for these extraordinary new developments. It
has been said that if it does not prove possible for us to do this in the case
of human cloning, it is hard to have confidence in our capacity to address the
thousand issues that are standing in line for attention, in the unfolding
agenda of biotechnology. The distaste of the human community for cloning is
almost universal. And the stakes could hardly be higher, since we are
discussing experimentation on and the manufacture of human subjects. I shall briefly outline some
international policy approaches to human cloning, and then offer some
observations. In the four years since it was
announced that Dolly the sheep had been cloned, many nations have taken steps
to prevent the application of the somatic cell nuclear transfer technique, and
in some cases other cloning techniques, to human beings. But they were
anticipated in that one nation to which we should be most attentive in this
debate, since its experience in the twentieth century offers the world a
laboratory for misdirected science. In 1990 Germany enacted a statutory ban on
cloning, with a penalty of five years imprisonment. German prescience stands in
marked contrast to the reactive approaches of other jurisdictions, in which at
every point science and technology have outstripped the policy process, in a
pattern we may expect to see indefinitely repeated. Several major nations have now
enacted statutory cloning bans, or such enactment is in process. One of the
most recent is Japan, which takes effect in June of this year, and carries a
10-year sentence for infringement, though no penalty for Japanese who travel
abroad for the process – since a Japanese couple is said to be among those on
Zavos and Antinori’s list of clients, the responsible Japanese government
minister is reported to be seeking an amendment to cover extraterritorial
cloning involving Japanese nationals. Other nations that have banned cloning
include Ireland, Israel, Italy, France, Argentina, Colombia, and Spain. Nations
with current legislative process include Korea, Canada, New Zealand, and
Russia. In 1997, appropriately the year of
the Dolly announcement, the one international treaty on bioethics was opened to
signature. The European Convention on Biomedicine and Human Rights seeks as its
title suggests to set the questions being raised in biotechnology firmly in the
context of the human rights tradition in European law, recognizing that the
dignity of the individual is the prime question at issue. The Convention was
the result of a lengthy consultative process – I myself attended one
consultation in the late 1980s – and a product of the treaty process of the
Council of Europe through the work of its bioethics advisory committee. The Convention, while adopting the
European principle of subsidiarity in recognizing diversity within its
jurisdictions, adopts a series of key positions, including a ban on any profit
from trade in body parts; a ban on germline gene therapy (therapy that affects
subsequent generations); and a ban on the creation of human embryos for the
purposes of research (while requiring protections for other, “spare,” embryos
that are used for research purposes; in fact, the advisory committee originally
recommended to the Council of Ministers a ban on all deleterious embryo
research). The Convention provides for the
addition of subsequent protocols on fresh questions, and the first such
protocol to be drafted bans human cloning. That protocol went into effect on
March 1, after ratification by the requisite five signatories. It reads, in
pertinent part, Considering
that the cloning of human beings may become a technical possibility .. . . Considering
. . . that the instrumentalisation of human beings through the deliberate
creation of genetically identical human beings is contrary to human dignity and
thus constitutes a misuse of biology and medicine . . . Considering also the
serious difficulties of a medical, psychological and social nature that such a
deliberate biomedical practice might imply for the individuals involved . . . . Article
1 Any
intervention seeking to create a human being genetically identical to
another human being, whether living or dead, is prohibited. For the purpose
of this article, the term human being “genetically identical” to another
human being means a human being sharing with another the same nuclear gene
set. As of today, 29 European states
have signed the protocol, and it came into force on March 1 after ratification
by the first five signatories. The full text of the treaty and the protocol are
included as an attachment to this testimony. Let me add four brief observations
to be considered as we move to develop policy: The need for policy in bioethics and the biosciences The need to build public confidence The overriding significance of the dignity of the
individual The importance of international agreement The need for
policy in bioethics and the biosciences. It is curious, and
disturbing, that the development of policy – particularly here in the
United States – has lagged far behind the development of technique and the
growth of the commercial sector. In light of the detailed regulatory
regimes – that have wide and bipartisan approval – operating through
bodies such as the FDA, the USDA, and indeed the SEC, there is a powerful
argument that the stakes here are the highest of all. The need to
build public confidence. This offers a powerful support to the
development of policy, and is illustrated by a recent statement quoted
from Carl Feldbaum, president of the Biotechnology Industry Organization
(BIO), to the effect that “from the industry’s standpoint, attempting to
clone humans is a lose-lose proposition,” since whether it succeeds or
fails “it is likely to result in a backlash against mainstream biomedical
research.” (The Record, Bergen Co., NJ, 2/18/01). This concern reflects
the remarkable story of the popular European response to genetically
modified (GM) foods, widely dubbed “Frankenfoods” in the European media,
and largely rejected by European consumers. While the industry has not
been in the forefront of demands for regulation, a strong argument can be
made that its long-term interest vitally requires public confidence, and
that such confidence needs expression and confirmation through the policy
process. This offers a contrast to anti-science Luddism on the one hand,
and unrestrained exploitation on the other, and suggests a sound
regulatory context for the biotechnology industry. The overriding
significance of the dignity of the individual. From one perspective
this is such a statement of the obvious. Yet it actually states the
central challenge confronting bioscience policy, since these unfolding
developments will offer a stream of benefits to some individuals at
potential cost to others. That is of course the central role for policy in
a free society: to defend the individual against the encroachment of
others, including the state itself. Questions such as access to genetic
information (for insurance, employment, and other external purposes),
germline gene therapy (in which we change the genetic inheritance of the
next generation, a procedure summarily outlawed in the European
Convention), and so-called “therapeutic” embryo experimentation (in which
putative benefits to some are balanced against the destruction of
individual embryos), offer samples of the decisions that await us. The importance
of international agreement. Plainly, there is value in setting policy
within individual jurisdictions, and those states such as California,
Louisiana, Michigan, and Rhode Island that have banned human cloning are
to be commended for their initiative in asserting the common values of
their citizens. The same is true of nations. But both human dignity, and
the worlds of bioscience and the biotechnology industry, are indivisible,
and there is urgency in the task of international agreement. This was well
illustrated by the statement of Drs Zavos and Antinori that they intend to
press ahead with the birth of a cloned human baby, and locate in an
unnamed European country in which, one presumes, it is not illegal. The
European Convention on Biomedicine and Human Rights offers a model; the
present UNESCO process that has begun with a statement on the human genome
offers a process. The
Committee on Energy and Commerce |