Cloning International Law: The Science and Science Fiction of Human Cloning and Stem-Cell Patenting

I. Introduction

Scholars of international law and medicine have noted a gradual change in the nature of international governance in the field of biotechnology. ¹ While early regulation concerned general bioethical principles such as the rights of patients, and the duties of physicians under the Hippocratic Oath, more recent regulations have focused on specific technologies including organ transplantation, ² abortion, ³ new reproductive technologies, ⁴ palliative care and euthanasia, ⁵ psychiatric care, ⁶ genetics, cloning, and stem cell research. Taken together these regulations constitute an emerging field of global governance, whose significance and impact cannot be measured solely in terms of the enforceability of legal measures. International and transnational declarations as much as binding instruments constitute the complex web of norms through which we imagine the limits and seek to control the future of biotechnologies.

The growing role of international law and transnational law ⁷ in the regulation of biotechnologies is hard to deny. ⁸ What remains, however, in question are the reasons for this growing involvement and its significance beyond the question of efficacy. This question is intensified due to the fact that bioethical debates and especially those which concern reproductive technologies are some of the most hotly contested moral and political questions, and may call for national rather than transnational and international resolution. What are the conditions of possibility of processes of legal harmonization and homogenization and what is the significance of these processes?

To understand and judge the rise of international governance in the field of genetics and reproductive technologies we must first have a better understanding of the kind of challenge that these new technologies pose, and the expectations we have from law and international law to mitigate these concerns. We are accustomed to think of the problem of biotechnology, and modern technology more generally as stemming from the development of new technological instruments and scientific tools and their powerful consequences. I will refer to this conceptualization of the problem as the “instrumentalist” understanding of technology.

Under the instrumentalist approach, we think of biotechnology as a means impregnated with both promises and dangers. Whether a bane or a boon depends not on technology itself, but rather on the ends to which technology is put to use. Nuclear power, to take a known example, is in itself neither good nor bad. All may depend on its use – developing nuclear weapons is one thing, whereas developing nuclear energy is quite another. The same may be true for PGD (pre-implantation genetic diagnosis). When used for therapeutic ends the practice may be legitimate, when used for non-therapeutic sex selection (“family balancing”) it is more disputable, whereas if used for eugenic ends, would commonly be judged as illegitimate. ⁹ Obviously, there may be technologies, whose specific usages are more carefully inscribed in the technology itself, but all technologies under this account are means that can be used to advance more than one aim.

Thus understood, law’s role in the regulation of technology becomes quite clear. Left unfettered technology is likely to be used in the service of unwanted ends; law intervenes to limit the use of technology and to direct it solely to legitimate ends. Technology stands on one side of the means–end divide, whereas human control via legal regulation stands on its other. The instrumentalist approach has two premises: First, the problem of modern technology lies in the development of new means; second, its solution lies in the human ability to set proper ends.

The instrumentalist approach is especially prevalent when it comes to international regulation of biotechnology. The risks attributed to new biotechnological developments are often assessed as much higher than other threats, because they may endanger human existence, and threaten to irrevocably alter the human organism from within. ¹⁰ International legal governance becomes important because biotechnological threats may spread easily across national borders, and consequently the threat to humanity as a whole is greater. The role of international legal instruments is to increase the uniformity of regulation and to eliminate safe havens for bio-transgressors.

It may be hard to think of technology and law beyond the instrumentalist paradigm. Can we think of technology but as an instrument? And yet, what may be difficult to contemplate in the language of science and policy becomes self-evident when we turn to science-fiction. ¹¹ Science fiction commonly offers the reverse image of the instrumental approach, namely that of technological determinism. Human-made machines as much as human-founded legal and political institutions, which were created to serve human ends, escape human control.

A simple example is the classic protagonist of many science fiction stories – the human fashioned robot. ¹² The android can be described within the instrumentalist paradigm as a technology that is programmed to perform predetermined human goals. But science fiction begins, precisely where the instrumentalist depiction of the robot comes to an end. What characterizes robots in the world of science fiction is that they have a will of their own, which escapes human control. Furthermore, not only do robots set new ends for themselves, but the laws that are supposed to limit and direct their actions, often turn out to be as uncontrollable as the robots themselves. Asimov’s famous three laws of the robot provide a telling example. ¹³ Things go wrong not only when the robots fail to abide by the laws, but also when the laws are not properly programmed. ¹⁴

Here we come across a crucial distinction between modern technique and traditional human instruments. Whereas instruments may be described as human made solutions for resolving naturally given problems, modern technique is not merely a way of asserting control but has the tendency to run out of control. In these dystopian scenarios, rather than imposing control over technological and biotechnological innovations, human beings are overcome by them.

The point of departure of this article is to critically explore the two dominant approaches to the homogenization of international law: the instrumentalist approach promoted by legal realists and the deterministic approach advanced by legal surrealists, as well as offer a third frame of reference. Taking as a point of departure both legal scholarship and legal fiction, the article makes the following three claim. ¹⁵ First, that biotechnology is as much in need of control as it is a means of control. Biotechnology, so to speak, commonly “runs out of control.” Second, legal regulation does not only set limits for the use of technological means, but is itself a second-order technology for managing technological innovations. As a means of control, law raises the opposite problem of over-regulation and over-control. Third, and finally, once one follows the interrelationship of international law and emerging biotechnologies, it becomes questionable whether control is a proper way to frame this relationship between international law and biotechnology in the first place. At least at times, the homogenization of transnational law is neither an intended response to under-controlled technologies nor a fated outcome of over-regulation, but rather the unintended consequence of the interaction between international law, biotechnologies, and their increasingly homogenized and homogenizing environment, primarily but not exclusively, that of global economy.

In order to explore the variety of frameworks for understanding transnational legal homogenization and to gain a better grasp on the modus operandi of both law and biotechnology the article focuses on one case of an emerging biotechnology – namely, cloning. Cloning is paradigmatic because it signifies both a specific medical technique and the mode of operation of modern technique. As a specific technique it allows the reproduction of biological organisms, including humans. As a mode of operation it signifies the turning of given phenomena into human-induced processes, and in doing so seeks to control, if not outright eliminate, otherwise given differences. In the latter sense, cloning is equally applicable to biological organisms and cultural artifacts, including law. Seen from this perspective the homogenization of international law in the field of biotechnology is a telling case of the cloning of international law.

The article will begin with a science fiction account of cloning through a brief discussion of Aldous Huxley’s novel Brave New World. ¹⁶ I will then move to discuss two case studies of genetic regulation, which simultaneously address the problem of cloning and reproduce the problem on a different level. The first concerns human cloning and the 2005 United Nations Declaration on Human Cloning. ¹⁷ The second concerns stem-cell research and a more recent decision of the Court of Justice of the European Union (CJEU) in the case of Brüstle v. Greenpeace (Case C-34/10, Oliver Brüstle v. Greenpeace, judgment of 18 October 2011, not yet published), to impose a blanket prohibition on patenting the outcome of stem-cell research. The two cases represent the growing international governance of biotechnologies. Both regulations set limits on the use of specific biotechnologies either by an outright prohibition of the practice, or by refusing to patent its outcome. In both cases, the underlying justification for the regulation is the concern that regulation on a national level is an insufficient response to the rise of these technologies. There are, however, as we shall see, important differences between the two cases. Together they demonstrate three different constellations of the interplay between cloning and international law: international law versus cloning, international law as cloning, and the cloning of international law.

II. Cloning in Science Fiction

Aldous Huxley’s famous Brave New World presents in fictional prose the modern anxieties that cloning stirs. The novel has often been read in one of two ways: Either along the instrumentalist approach as a warning against the unfettered development of biotechnologies and a call for deeper reflection and closer regulation of its use or, alternatively, as a bleak prophecy of the inevitable outcomes of reproductive technologies along the lines of the deterministic approach. As we shall see, the novel, as all good literature, is irreducible to a simplistic moral lesson and opens new and less explored possibilities for understanding biotechnological cloning and its juridical counterpart, transnational legal homogenization.

The year is A.F. 632 (After Henry Ford). Huxley introduces us into a world which has been taken over by technology. And yet, it is a world quite similar to our own, it is governed neither by robots nor by Martians, but by scientists, who have consciously adopted the logic of modern technology to its fullest extent. Humans, not machines, are in control and technology does not undermine the free will of humans, but quite to the contrary empowers them, and places them in a position of controlling not only nature, but human development.

In this World State, socially desired behavior is ensured by a double process of genetic manipulation and postnatal conditioning, which takes place in a fertilization and education facility, the Central London Hatchery and Conditioning Centre. In the Hatchery humans are manufactured on mass scale in lab conditions using special reproductive techniques. Early in the book, the D.H.C. (Director of the Hatchery Centre) explains to the incoming students how the new institution overcame the “old viviparous days” replacing natural reproduction with industrial reproduction. Using the Bokanovsky Process every egg can reproduce up to ninety-six buds, each of which can further multiply. The bokanovskified egg will proliferate and divide, each bud growing into a perfectly formed embryo, and every embryo into a full-sized adult, making ninety-six human beings grow where only one grew before. In this process, the development of the eggs is arrested by X-rays, which cause the eggs to bud. A series of X-ray screenings could lead to multiple buddings.

The Bokanovsky Process is one of the major instruments of social stability, ‘‘Ninety-six identical twins working on ninety-six identical machines.’’ ¹⁸ A high degree of uniformity in the human product is guaranteed by using ova from a limited number of mothers. The ultimate aim of these new reproductive processes is social stability. ‘‘All conditions aim at making people like their inescapable social destiny.’’ ¹⁹

The production of uniformity in this brave new world comes in different forms, including through the manufacturing of difference. During the process of fertilization the embryos are distinguished into clear groups. The Alphas and Betas remain a longer time in the incubators, while the Gammas, Deltas and Epsilons are brought out again after only thirty six hours, to undergo Bokanovsky’s Process. Alpha babies are themselves divided into classes, Alpha and Alpha minus, while other groups are exposed to oxygen-shortage that keeps them below par and the lower the oxygen level the lower the class. ²⁰ Controlled differentiation is part of homogenization process. Modern technique is not about sheer identity, but rather about controlled uniformity and standardization.

Biotechnological cloning is only one way in which homogenization is produced in the novel. There is little coincidence that from the very first paragraph Huxley’s science fiction introduces both a new technology and a new political-legal order. The novel opens with a depiction of its setting, ‘‘A squat grey building of only thirty-four stories. Over the main entrance hang the words ‘Central London Hatchery and Conditioning Centre’, and in a shield, the World State’s motto, Community, Identity, Stability.’’ ²¹ For Huxley, the reproduction of human clones and the new organization of a homogenized world order belong together. The novel shows how the total mobilization of the biological, psychological, sociological and legal spheres takes place to promote the better functioning of society. ²²

What is telling about Aldous Huxley’s 1932 novel is the way in which it captures the complex relationship between humanity and technology and the complex ways in which cloning operates. First, as mentioned, the novel goes beyond both the instrumentalist and deterministic approaches. Technology is neither a neutral means awaiting human guidance, nor an independent force exerting power over human action. In Brave New World the problem of technique is not its employment in the service of ill-chosen ends, nor its overwhelming power to thwart human design and control. Rather, the new reproductive techniques seem to take a logic of their own and run out of control, precisely when they are being controlled and are put in the service of human betterment. What turns the new world into a dystopia is the human will to carry out the potential of new technologies to the full extent of their emerging capabilities.

Second, for Huxley, cloning means two related but distinguishable processes. The first is the cloning of human beings; the second is the cloning of human norms. Law and politics cannot be the solution to the problem of technique, since they are part of the problem. What this telling piece of fiction teaches us is that the problem of cloning – and more generally the problem of modern technology and biotechnology – does not pit law against technology, but rather allows the two to function in harmony. Legal regulations and political institutions are as much under the sway of transnational homogenization as human biology. The modus operandi of modern technique has its sway both over medical instruments and legal instruments.

Moving from the science fiction of human cloning to the reality of transnational and international law regulation, Huxley’s analysis will provide us with key insights for thinking about and beyond the instrumentalist and the deterministic approach to cloning. International law, as we shall see, is first a mechanism for controlling biological cloning (international law v. cloning), second a legal mechanism to promote moral cloning (international law as cloning), and ultimately a byproduct of economic and other homogenization processes unintentionally leading to transnational homogenization (the cloning of international law).

III. International Law v. Cloning

A recent article on the role of international law in the regulation of cloning concludes with the following observation:

Science cannot tell us what we should do, or even what our goals are, therefore, humans must give direction to science. In the area of genetics, this calls for international action to control the techniques that could lead us to commit species suicide. We humans clearly recognized the risk in splitting the atom and developing nuclear weapons; and most humans recognize the risk in using human genes to modify ourselves. Because the risk is to the entire species, it requires a species response. Many countries have already enacted bans, moratoria and strict regulations on various species-altering technologies. The challenge, however, is global, and action on the international level is required to be effective. ²³

The passage makes a few common assumptions about the need of international legal regulation of new biotechnologies in general, and of human cloning in particular. It captures the three main assumptions of the “instrumentalist approach”: first, new biotechnologies are a source of grave risk and danger. The source of concern lies in the nature of technology as a pure means, unable to set its own goals. Technology is merely an instrument, which may be employed to any end, including destructive ones. Second, and consequently, only the exercise of human control over technology can circumvent these risks and preempt the dangerous consequences of the abuse of biotechnologies. Law and legal regulation impose limits on the use of biotechnological means by setting legitimate ends. Third, the risks which biotechnologies in the genomic age impose cannot be prevented by local legislation and calls for global governance.

The need for global regulation is justified in different ways. One line of reasoning focuses on the universal effects of biotechnologies. Since biotechnology poses a global threat, it requires a global response. Anything less than global regulation would allow for “genetic havens” to thrive and put at risk humanity as a whole. ²⁴ A second line of reasoning, quite closely related, focuses less on the physical risk and more on the protected value. The field of biotechnology is concerned with possible violations of human dignity and human rights. Since human rights are universal and concern humanity as such, these values must be protected on the international level. ²⁵ A further argument concerns the fact that the genome is what is shared by all humans qua humans. Thus, for example, the Declaration on the Human Genome and Human Rights speaks of the human genome as “the heritage of humanity.” ²⁶ Scholars have interpreted in a similar way the Council of Europe’s ban on reproductive cloning, which will be discussed in more detail below.

The Protocol prohibits human cloning because it threatens human identity by sacrificing protection against the predetermination of an individual’s genetic constitution. Natural genetic recombination creates more freedom for humans by allowing for all humans to have a different genetic make-up. Genetic recombination would provide for evolutionary fitness of the species, unlike a genetically uniform human species which would be more susceptible to elimination by a plague or disease affecting individuals with a certain genetic composition. ²⁷

Modern biotechnology poses a threat to human freedom, but human freedom has a very specific sense under the instrumentalist approach. The latter associates freedom with the power of humans to avert the risks inherent in new technological innovations. Cloning poses a special risk to human freedom because it threatens to eliminate biological diversity and exposes the species to the dangers of physical extinction.

The above observations highlight important aspects of the relationship between biotechnology, law and international regulation, even if, in the final analysis, as I shall argue, they fail to grasp essential aspects of this relationship. The conceptualization of biotechnology as mere means, of legal regulation as setting legitimate ends, and of global regulation as a counter-response to biotechnologies’ threat to humanity, may all be correct, but fall short of capturing what makes modern technology, and specifically biotechnology, exceptional.

The instrumentalist approach suffers from two crucial blind-spots. First, technology is not merely a means to an end. Modern technology differs from traditional tools, or instrument, which can be found in all human civilizations since the stone-age, precisely because it is not merely lifeless clay. ²⁸ Whereas ordinary tools are ways by which humans master their world, technology is unique because it itself requires mastery. This is the case not because technology has a “life of its own,” as some science fiction seems to suggest. It is rather because – and here we come to the second blind-spot of the instrumentalist approach – technique is not limited to the technological instrument themselves, and humans as much as machines have come under its purview. ²⁹ It is in this sense that we speak of our world as a technological world. It is not simply a world which is populated by an overwhelming number of technological instruments and innovations, it is a world governed by technique as a way of thinking about the world and being in the world applicable to humans no less than to machines, to law no less than to technology. In this sense, technique is not a deterministic force externally governing human action, but quite to the contrary, one mode of human action.

The regulation of cloning is a telling example of how the instrumentalist approach is operative in international law, but as we shall now see, it also demonstrates how international law is not only a way of limiting cloning and its effects, but is itself a mechanism of cloning.

IV. International Law as Cloning

The successful cloning of a large mammal, in 1996, using the technique of nuclear transfer, made apparent the potential use of the same technology for human cloning. ³⁰ The possibility was no longer the figment of scientific imagination, and was now ever more within human reach. ³¹ Concerned groups and state representatives, most prominently Europeans, moved to pass national, transnational (EU), and international bans on the practice. ³² It soon became clear, however, that a distinction should be made between two different kinds of cloning – reproductive cloning and therapeutic cloning (also referred to as “research cloning”). The two use the same technology – the transfer of a cell nucleus into a reproductive cell – for different ends. ³³ In therapeutic cloning, adult cells are cloned for therapeutic ends, while reproductive cloning aims at the creation of a human being. Both forms of cloning have raised ethical concerns, but for most the more controversial of the two is reproductive cloning, which lies at the focus of our discussion. ³⁴

Reproductive human cloning creates a human embryo with the same nuclear genome as the living or deceased cell donor, and this genetic identity has been a source of great ethical concern and debate. Even among scholars, ethicists and politicians who fiercely object to cloning, there is wide disagreement concerning the grounds for judging the practice immoral. ³⁵ There is no need for us to reproduce the debate, but it is important to bear in mind the diversity of normative perspectives underlying what may often seem to be a harmonious agreement.

Though no Western country openly endorsed the practices, not all countries formally banned reproductive cloning. ³⁶ The silence of many countries on the question, along with a growing concern with the availability of the technology, led players on the international field to seek a ban on the practice. Indeed, both the European Union and the United Nations clearly expressed their opposition to the practice. The European prohibition on human cloning developed gradually. Its starting point was in June 1990 when the Secretary General of the Council of Europe proposed a convention on bioethics. Its goal was to achieve the harmonization of national law in accordance with international standards committed to the guarantee of human rights in face of developing biotechnologies. The Convention, which was signed and ratified in 1997 by 41 member and non-member states including Australia, Canada, Japan and the United States, laid out the general principles. The Council addressed the more specific question of reproductive cloning in an Additional Protocol to the Convention on January 12, 1998. ³⁷ Article 1 of the Protocol states that ‘‘any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited.’’ The Protocol defines “genetically identical” as “a human being sharing with another the same nuclear gene set” ³⁸ and prohibits reproductive cloning, but remains silent when it comes to therapeutic cloning. ³⁹

A similar development took place on the international level. The global governance of human reproductive cloning dates back to 1997, with the UNESCO Universal Declaration on the Human Genome and Human Rights. The Declaration, later endorsed by the UN General Assembly, ⁴⁰ addresses a variety of issues concerning the human genome. It opens with a statement concerning the human genome as underlying the fundamental unity of human kind. ⁴¹ The Declaration reaffirms the priority of human rights and dignity over genetic research and calls attention to the possible risks involved in genetic experimentation. ⁴² Article 11 of the Declaration is of special importance. It states that ‘‘Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted. States and competent international organizations are invited to co-operate in identifying such practices and in taking, at national or international level, the measures necessary to ensure that the principles set out in this Declaration are respected.’’ ⁴³

The Declaration presented a clear international voice against human reproductive cloning. Building on the moral force of a broad international consensus, it calls upon member states to introduce new measures on the national and international level in light of the Declaration. Though the Declaration has no binding force, it envisions and seeks to promote a world-wide ban on cloning. It designates international law as a vehicle to increase international legal uniformity. And yet, what seemed at first as a consensual solution soon raised new problems. As the problem of bio-metical cloning became more pressing, the challenge of internationally legal cloning emerged as an equally pressing challenge, one much harder to overcome.

The second wave of international regulation took off around a decade ago, when a handful of scientists around the world reported that experiments on human reproductive cloning were already taking place and that it was only a matter of time before their labs would actually reproduce human clones. ⁴⁴ The international community responded with a concerted effort to pass a binding regulation prohibiting human cloning.

Very few states defended the practice, but several opposed the measure, because they believed that therapeutic cloning too should be prohibited. ⁴⁵ For some representatives such as the Holy See, a ban on therapeutic cloning was equally wrong, because it required the destruction of the potential for life inherent in a stem cell. ⁴⁶ On March 8, 2005, the General Assembly adopted resolution 59/280, containing in its annex the text of the United Nations Declaration on Human Cloning by a recorded vote of 84 to 34, with 37 abstentions. ‘‘Member States are called upon to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life;’’ ⁴⁷ The phrasing is evidently a compromise between the two opinions, leaving undecided whether cloning, and specifically therapeutic cloning, is in fact incompatible with human dignity and the protection of human life.

It is not simply that a universal ban on cloning had failed. It is important to note that the reason it failed was precisely the objection to a form of “legal cloning” which would erase the moral differences that existed and continues to exist among different states. As in Huxley novel global regulation does not necessarily mean uniformity, but may also entail the controlled production of difference. This is typically the case in transnational law doctrines, which allow signatory states a margin of appreciation within which they may express their distinct moral views. Normative variations may often attenuate the reach of legal homogenization, but as we shall now see, moral homogeneity is not the only possible route to legal homogenization.

V. Cloning International Law

There is much that can be learned about the nature of biotechnology and law from Huxley’s visionary book. If there is one important point of great relevance that Huxley did not foresee, it is the growing role of the economy and the “free market” in the regulation of both law and biotechnology. The global economy no less than the world polity has come to play a central role in the cloning of international law. As Mark Frankel noted, “Aldous Huxley led us to believe that when it came to our genes and reproductive future, our worst nightmare was government involvement in procreative activities and society that devalued individual decision making.” But as we begin the twenty-first century, Frankel explains, we have come to realize a greater danger. “The discoveries of genetics will not be imposed on us. Rather, they will be sold to us by the market as something we cannot live without.” ⁴⁸

The recent decision of the Court of Justice of the European Union drives Frankel’s point home. In a highly controversial decision from October 18, 2011, in the case of Brüstle v. Greenpeace, the CJEU significantly restricted patentability of stem-cell research in Europe. ⁴⁹ The decision was triggered by a referral from the German Court (Bundesgerichtshof) to the CJEU in the matter of Brüstle v. Greenpeace (2011). ⁵⁰ The CJEU, denying patentability, based its decision on an interpretation of Article 6 of the Bioethics Directive 98/44, which states in Article 6(1), that ‘‘Inventions shall be considered unpatentable where their commercial exploitation would be contrary to order public or morality.’’ ⁵⁰ The Directive continues to list in Article 6(2) key instances of the prohibition, including the cloning of human beings and the ‘‘uses of human embryos for industrial or commercial purposes.’’ ⁵¹ The question before the CJEU was whether “human embryos” included stem-cell experimentation in cloning. ⁵² Since the directive was enacted prior to the rise of stem-cell research and cloning, it was unclear how wide to interpret the concept of “human embryo.” ⁵³ The Court held that the development of ES (embryonic stem) cell lines falls within the definition of research conducted on embryos, because ES cell lines are derived from fertilized ova in a process that destroys any potential for life the ova may have had. ⁵⁴

Since the Court’s decision is concerned with the legal regulation of patenting in an increasingly global economy, it may be helpful to recall some of the commercial implications of ES cell research. Many scientists have viewed ES cells as one of the most promising biotechnological breakthroughs of recent years. ES cells are unique in their plasticity, which allows these cells to be differentiated into all (in the case of totipotent ES) or almost all (in the case of pluripotent ES) tissues of the body. Currently stem cells are already being used in bone marrow transplantations, but many scientists believe ES cells will be used in the near future to treat spinal cord injury, degenerative diseases, and cancer. ⁵⁵ The commercial potential of stem cell research is widely acknowledged and consequently the importance of its patenting. ⁵⁶ There has been in recent years a gradual rise of the number of ES cell patents worldwide. ⁵⁷

The prohibition on stem-cell patenting differs from many other debates on biotechnological patenting, including the most recent decision of the US Supreme Court in the case of Pathology v. Myriad (Assn. for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S. June 13, 2013)), to restrict the patenting of the human genome. Often the concern is with the very possibility of patenting life forms, such as the debate concerning the patenting of genes ⁵⁸ and modified crops. ⁵⁹ In the case of stem cells, however, the moral concern, as mentioned, is the destruction of the life potential of the fertilized egg. Thus, the prohibition on patenting is an outcome of the suspect moral nature of stem-cell research. Consequently, the Court restricted patentability of stem cells themselves, but to all scientific and technological development that requires their use.

The CJEU offered a broad definition that included ‘‘any human ovum after fertilization, any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis.’’ ⁶⁰ The Court included in its definition of human embryos not only fertilized ovum, but also embryonic clones. ⁶¹ Furthermore, and as indicated above, the Court broadly interpreted the scope of the unpatentability and excluded not only procedures that involve embryos, but also the patenting of knowledge that required stem-cell research for its development, and thus the inevitable destruction of the fertilized egg. ⁶² The Court concluded:

Article 6(2)(c) of the Directive excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos. ⁶³

There are different ways to read the Court’s decision. A straightforward reading, one based on the instrumentalist approach to transnational law and biotechnology, may view the Court as banning immoral uses of technology. Law is thus understood as setting the legitimate ends for the use of morally controversial innovations. But this reading, as plausible as it may sound, does not capture the full complexity of the decision.

While the Court imposed a pan-European ban on patenting the outcome of ES cell research, moral considerations of the kind that were considered in the previous section, were not the ultimate ground for restricting patenting. This becomes clear once the Court’s decision on patenting is compared to the criminal regulation of ES cell research across Europe. As the Court knew all too well, the moral attitudes toward ES cell research and consequently to its criminalization greatly varies among EU countries. ⁶⁴ In some countries, most notably in Germany, the production of stem cell lines is criminalized. In others, including the United Kingdom, ES cell research is a state sponsored enterprise. ⁶⁵ The different regulations reflect different positions on the question of the beginning of human life and subsequently on the protection of the sanctity of life. Under German law, the potentiality for human life begins with the fertilization of the ova, whereas in the UK, this potentiality emerges only after fourteen days, when the embryo arrives at a more advanced stage of development.

Bearing this moral plurality in mind, the Court found itself in a legal bind. It was hard pressed to pass judgment on the practice and reluctant to rule on the sacredness of the pre-implanted embryo. Consequently, the Court could not base its decision on the general formulation of “ordre public,” which would have forced the judges to take sides in the debate and impose their moral views on all EU members. The Court found refuge in the more specific rule of Article 6(2)(c), which explicitly and specifically banned patenting of research on human embryos. This seemed to allow the Court to restrict patenting without committing itself to a moral stand, but in fact left the most important question open – how could its decision to equate embryonic stem cells with human embryos as defined in the regulation not be a moral judgment?

The Court never offered a satisfying explanation on why it thought it could avoid moral judgment on this matter. But where the Court remained silent, the Advocate General who consulted the Court on the matter was more explicit. If the Court was to declare a blanket ban on the patenting of embryonic stem cell research, the underlying reasoning had to be economics rather than morality. In his written opinion, the Advocate General Bot explained why framing the question as a moral one would require allowing for a margin of appreciation and why this was not the proper solution in this case,

If it were left to the Member States to define the concept of a human embryo, in view of the differences which exist in this regard, this would mean, for example, that an invention like that of Mr Brüstle could be granted a patent in some Member States, while the patentability of such an invention would be excluded in others. This would run counter to the main objective of the directive, which is to establish effective and harmonised legal protection of biotechnological inventions.

The reasoning of the Advocate General, which in all likelihood also guided the Court, is quite revealing. First, the Advocate General speaks of the need to harmonize legal protection of inventions rather than the legal protection of the embryo. In his eyes, this is a necessary interpretive move since moral harmonization has been ruled out given the diversity of moral positions among EU countries. Economic harmonization replaces, under his account, moral harmonization. Second and closely related, the Advocate General’s explanation reversed the more familiar relationship between economy and morality in the field of transnational patent law. Usually, the Court is asked to adjudicate between global economic harmonization as the main aim of transnational regulation and local moral consideration as the exception. Here global economic harmonization becomes the ultimate justification for moral harmonization and the two work in tandem. In other words, in Brüstle v. Greenpeace, moral homogenization is not an end in itself, but is rather the outcome of a well ordered economy. With the Court’s verdict transnational law is no longer the product of the cloning of morality and has become an economically produced clone.

To be sure, in its decision to restrict patenting the Court was not protecting economic interests. Quite to the contrary, the decision was a decisive effort to limit economic interests or, perhaps more accurately, to limit undue economic influence on legal regulation. Indeed, critics of the Court viewed the decision as lending a fatal blow to the economic interests of scientific and industrial development, which allegedly needed patenting in order to secure its investment. But the fact that the Court was confronting economic interests does not make the Court’s decision less influenced by the homogenizing effects of market economy. After all, the Court’s decision to enforce a trans-European ban on human embryonic stem cell research patents was motivated by its fear of market hegemony and not by a determination to enforce a moral hegemony. Moral homogenization, or “legal cloning,” turned out to be the effect rather than the cause of international regulation.

VI. Conclusion

This article has discussed the international regulation of biotechnology through the problem of cloning. The fear of cloning, in its varied manifestations, has an intuitive appeal. The elimination of all natural differences and their replacement with an artificially manufactured homogeneity undermines human plurality, a sine qua non condition of human freedom. ⁶⁶ The aim of the article and its contribution has been to show that there are as many different understandings of cloning in international law as there are of the relationship between biotechnology and human freedom.

Under the first account, the problem of biotechnology lies in its potentiality to harm and its use in the service of the wrong ends. Law’s role is to guard from such dangers by imposing constraints and limits on the use of technology. Since the risks are international, regulation too should be international. Being free is identified as having control, and the threat of technique is that it undermines this ability.

Science fiction, however, teaches that being free should not be confused with having control. When it comes to biotechnology the two often clash. The case of the international regulation of human cloning hints at what Aldous Huxley’s novel explicitly shows. International law, far from being the solution to the problem of cloning, is part and parcel of the problem itself. In Huxley’s novel, the power of machines to clone humans is mirrored in the commitment of the world state government to clone the social and legal order. Legal cloning as much as technological cloning emerges as a threat to human freedom. The problem of cloning is not loss of control, but appears to be over control.

And yet a closer examination of the international regulation of cloning takes us one step further. As we have seen, efforts at moral and legal homogenization are often met with resistance. States have different positions on biotechnologies, and judge differently their threats and promises. Even when countries agree, as in the case of reproductive human cloning, the underlying justifications may stand in the way of legal homogenization.

Thus, a third account of the relationship between cloning and international law emerges for which the prohibition on the patenting of stem-cell research is a case at point. Under this account, legal homogenization is not driven by moral harmonization, as in Huxley’s novel, but is rather a product of market economy. International law eliminates difference not in the name of shared norms, but simply because such laws are the only way to counter (and thus also adjust to) the homogenizing forces of a striving economy. Furthermore, under this last account, the problem of cloning is no longer a problem of control – neither of the absence of control nor of over control. Put differently, the homogenization of international law is not the outcome of a deterministic technological or economic process over which humans have no say, but nor is it a willed outcome of moral deliberation. International regulation is woven into a complex array of technological, economic, and moral forces which function together and reduce the friction that would have otherwise been created by the unregulated plurality of normative orders.