Some International Perspectives
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.

National Jurisdictions
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.

The European Convention on Biomedicine and Human Rights
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.

Observations
Let me add four brief observations to be considered as we move to develop policy:

1. The need for policy in bioethics and the biosciences
2. The need to build public confidence
3. The overriding significance of the dignity of the individual
4. 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.

Nigel Cameron is Ethics and Policy Consultant to CARE and General Editor of CounterCulture

Reprinted with permission of Prison Fellowship, P.O. Box 17500, Washington, DC, 20041-7500.
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