pp. 41-50 in Bioethics in Asia

Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute

Copyright 2000, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

1.5. Legal limitations on research and its results? The cloning paradigm

Carlos M. Romeo Casabona.

Director, Inter-University Chair in Law and the Human Genome, BBV Foundation -Provincial Government of Biscay, Universities of Deusto and the Basque Country, Bilbao, Spain

1. Scientific developments in cloning

Speculation concerning possible applications of cloning is by no means new. Back in 1993 Jerry Hall and Robert Stillman (George Washington University, Baltimore, US) announced at a scientific conference in Montreal that they had obtained human embryos from other embryos (blastomeres) using cloning (1). The technique had already been in use for some decades experimentally, having been applied successfully in plants and superior animals. Thus, from the scientific standpoint, the news did not represent anything new in the way of biotechnology, save that human embryos had been obtained. However, the authors stressed that the embryos in their experiment were non-viable.

Early in 1997 Ian Wilmut from the Roslin Institute in Edinburgh (UK) published the results of a scientific experiment in which, for the first time ever, a sheep (known as Dolly) was cloned from the nucleus of a 6-year old adult -and hence differentiated (epithelial mammalian) cell (2). This was important in terms of innovation. For the first time in superior animals -three decades previously frog clones had been obtained- researchers had achieved a biological gregressionh in a somatic and therefore specialized cell, i.e., its totipotentiality, a trait which Nature reserves exclusively for the gametes (ovum and sperm) and for the fertilized egg during the early stages of development (3). What was most alarming about the experiment was that it could be repeated in the not too distant future using human cells, thus opening a further door to human cloning, for which other techniques, aside from those just mentioned, already exist.

Of great concern at present is precisely this possibility that humans might be cloned, given the developments achieved with the use of the technique in animals. These techniques may be perfected and subsequently easily extended to humans. The real debate on cloning has just begun, although when everything was purely speculative years ago such a possibility was rejected virtually to a human (4).

Let us recall that clone means ga group of organisms with an identical genetic make-up which are derived from a single individual as a result of non-sexual reproduction and are the same as said individualh (5). Cloning is the procedure whereby clones are produced, spontaneously or deliberately. It should not be forgotten that it exists in nature, particularly in certain plant species, as well as in several invertebrates and inferior organisms. Genetically identical monozygotic twins (although this is not always necessary) result from a kind of spontaneous division of the zygote. Techniques known to date involve embryo division in the early stages of development (in which case genetic identity extends also to the mitochondria), transfer of diploid nuclei to previously enucleated oocytes, eggs or zygotes. The transferred nuclei may also be from non-differentiated -totipotent- embryo cells or differentiated somatic cells (6). In these nuclei transfers, only the DNA -the genes- contained in the nuclei will be identical to that of the donor, but not the cytoplasm, or the mitochondrial RNA -or its genes- in the cytoplasm.

Many more possibilities are being opened up for the application of these cloning techniques in human material, even though we are still in the hypothesis stage. One such example is the use of such procedures to aid assisted reproduction, e.g. to obtain more preimplantation embryos from ones already formed when no further eggs can be obtained from the patient. In this case, the genetic make-up of the cloned child(ren) would be double, i.e. father and mother. One or more children could be born at the same time or in successive, chronologically close pregnancies. The recent experiment carried out on a mammal (Dolly) has served to fuel speculation that humans might be replicated from previous ones (born or dead). An adult might, for example, want to ensure that his/her children are genetically identical to him/her; parents might want to grepeath a child who has died or want to replicate a famous person).

Although not directly leading to reproduction, technically-speaking cloning is also taking place when we separate one or more embryo cells in the totipotent stage for genetic testing (preimplantation diagnosis). Given that the gsampleh and the original embryo are absolutely identical, the results obtained can be absolutely certain, provided the technique used is reliable. Another non-reproductive use (although it does improve insight into the mechanisms and processes of reproduction) is the cloning of non-embryo cells and tissues for research. Conversely, the transfer of a nucleus - e.g. of a zygote, but where the mitochondrion is carrying a serious disease- to a cell with a healthy mitochondrion would constitute a therapeutic use in a reproductive context, although it would not produce an individual that is genetically identical to another and the genetic make-up would be double (father and mother).

Another area giving rise to discussion is the use of human foetuses cloned from an adult which might then be used to obtain organs and tissues should the person develop a condition or disease which requires them.

A further future possibility is the combination of cloning and genetic engineering (gene manipulation) techniques to obtain human beings with predetermined biological -or mental- traits. Examples include humans free from certain diseases or even super or subraces. Regardless of whether or not associated with a cloning procedure, modifications of the human genome which might then be passed on to offspring have been banned by law in countries where this issue has been addressed or, at the very least, have been banned if they do not serve to help avoid or prevent serious hereditary disorders. Even here, however, reservations continue to be expressed in some quarters with regard to germ-line interventions, including those for therapeutic purposes.

2. Cloning: rejected by society and prohibited or penalized by legal systems

Although the experiment by Hall and Stillman triggered a great deal of controversy in world opinion, the cloning of a sheep produced even stronger reaction, so much so that several institutions and leaders expressed reservations or have even come out firmly against cloning. The Vatican has advocated a law to ban human cloning, and the LfOsservatore Romano urged countries not to bow to pressure from those quarters prepared to support the use of cloning techniques in experiments on humans. The President of the United States (7) urged the private sector to introduce a voluntary moratorium on such research and banned the use of federal funding for human cloning projects. He commissioned the National Bioethics Advisory Committee (NBAC) to draw up a report on the subject. The report was completed in June 1997 and contained very restrictive recommendations, including legal regulation. In the light of the recommendations, President Clinton announced he would be submitting to Congress a Bill banning anyone in the public or private sector from using cloning techniques to create children. In line with the Advisory Committeefs recommendations, the ban does not cover the cloning of DNA in cells or animal cloning and the entire situation will be reviewed in five years (8). In Italy the Ministry of Health has issued a decree prohibiting all forms of experimentation for animal and human cloning. A similar line has been taken by the Council of Europe and the World Health Organization, by the formerfs Steering Committee on Bioethics (9) and the European Commissionfs Group of Advisers on the Ethical Implications of Biotechnology (10).

Normatively-speaking, Spain was the first country to ban human cloning. This was originally set out as an administrative offense in 1988 (Law 35/1988, art. 20.2.B, sections k and l), and subsequently modified to become a criminal offense in the latest Penal Code of 1995 (gthe same punishment shall apply to the creation of identical human beings by cloning or any other procedure aimed at race selectionh, a term of imprisonment of between one and five years and suspension from public employment or position or professional practice for between six and ten yearsh, art. 161.2). What is generally prohibited in fact are not the techniques themselves (although in some countries they are banned completely) but rather the creation of identical human beings through cloning or other procedures designed to achieve race selection (the only two circumstances covered by Spanish law).

Little will be achieved, however, without supra or international normative or other measures. Happily, this is the approach being taken with a number of the implications derived from knowledge of the human genome, as evidenced by recent work at the Council of Europe and UNESCO. This work is perhaps still rather unclear or does not go far enough. In the Convention on Human Rights and Biomedicine (11) we do not find an express prohibition of cloning but we do in Article 11 of the Universal Declaration on the Human Genome and Human Rights (see earlier).

Let us look at how human cloning has been prohibited in some countries, even before the technique became possible or before it was considered to be feasible in the near future. Germanyfs Embryo Protection Law of 1990 states that g(1) Anyone who artificially makes it possible to generate a human embryo with genetic information which is identical to another embryo, foetus, human being or deceased person shall be deprived of his freedom for up to 5 years or shall receive a fine. (2) The same punishment shall apply to anyone who transfers to a woman an embryo of the type described in paragraph 1. (3) Attempts to do the above shall also be punishableh (Art. 6). Here we see that the offense is not just the birth of cloned children but the very creation of cloned human embryos.

In Britain, the Human Fertilisation and Embryology Act, also of 1990, prohibits (in fact, it says that a license cannot authorize) greplacing the nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryoh (art. 3.3.d). Under art. 41.1.b. any person who does so is guilty of an offense and is liable on conviction on indictment to imprisonment for a term not exceeding ten years or a fine or both.

In France, Law 94-653 of 29 July 1994 on respect for the human body stipulates that gnoone shall violate the integrity of the human species. All eugenic practices aimed at organizing the selection of persons are prohibitedh (art. 16-4); further on it sets out as an offense, with a term of imprisonment of 20 years, gthe application of a eugenic practice aimed at organizing the selection of personsh (art. 511.1). Although less explicit than in the two previous examples cited, it can be inferred that the prohibition extends also to the creation of human beings by cloning, to the extent that this also amounts to selection for eugenic purposes.

At its XIV International Penal Law Congress in Vienna in 1988, the International Association for Penal Law proposed that the cloning of human beings should be made a criminal offense (Resolution 6.9).

In several of its recommendations, the Council of Europe has also advocated prohibition to prevent the creation of identical beings by cloning: one Recommendation in 1986 prohibits gthe creation of identical humans by means of cloning or any other method, whether for race selection purposes or noth. Another one in 1989 makes reference to this Recommendation (12).

An indirect means of prohibition of cloning also exists in legal systems which, although not directly banning cloning or variations thereof, do nonetheless limit selection or predetermination of the sex of the future child to the avoidance of transmission of serious hereditary sex-related conditions (for example, the Council of Europe Convention of 1997, art. 14; Spainfs Law 35/1988, art. 20.2.B.n). Cloning might also be considered as being included under this restriction in that it already involves predetermining the sex of the child, which will be the same as the one used to obtain the genetic make-up or where one or more embryos are cloned from another. Although in this last situation, the sex of the future child need not be selected, it is in the case of any clones obtained from the embryo.

3. Reasons why human cloning should be rejected

In the light of what has just been said above, it would not be an overstatement to say that the mere prospect of human embryo cloning, whether for reproduction or not, has met with widespread opposition (13). However, what is really striking is the paucity of arguments on which these for the most part definitive and conclusive positions have been grounded.

One argument used frequently is the gviolation of dignityh, i.e. that the embryos or humans resulting from cloning would be made or turned into things. Even acknowledging the significance of this argument, it is nonetheless true, as I have indicated elsewhere on several occasions (14), that little attention is actually devoted to the question of just how human dignity is really affected or to how specific this cloning attack is on human dignity. Does it affect society? The persons born through cloning? The embryos themselves? Moreover, legally-speaking, the concept of human dignity poses difficulties also, not just in terms of the interpretation of the notion in legal appraisals (15), but also the fact that in some legal systems it is a fundamental right. This is true, for example, of Germanyfs Constitution of 1949 (art. 1.1), but not of its Spanish counterpart of 1978 (art. 10.1), a point made on various occasions by Spainfs Constitutional Court. In Spain human dignity underpins and is the underlying principle of fundamental rights and public freedoms in the strict sense of the term.

Let us turn to the reasons for why the different forms of cloning have met with opposition. We shall begin with a series of important aspects which are not directly related to the central issue here.

Firstly, it should be borne in mind that the use of cloning techniques in people in the short or medium term poses a further problem, over and above those currently being discussed, which will be examined below. The problem is that the technique is still rudimentary and could lead to many unsuccessful attempts (which would thus necessitate use of embryos and eggs in greater numbers) and the birth of a high proportion of children with defects. These are just two aspects which must not be overlooked when considering the possible use of the technique in humans. Furthermore, something which has to be considered in common with other human genome interventions, these techniques are by no means under control at present and little is known about potential side effects, manifestations of which may not be detectable in vitro or during pregnancy, but will emerge only after birth or when the cloned person reaches adulthood. By way of example, it is thought that there an increase in cancer rates may occur in offspring, and there may be a higher percentage of genetic abnormalities. What would be the biological age of a being (animal or human) cloned using the enucleation and somatic cell nucleus transfer procedure? Does the age-count begin as of the moment of birth or is it based on the biological age of the replicated being? This we do not know yet. First and foremost, these risks and other drawbacks make it necessary for researchers themselves to exercise responsibility.

There is another factor present in the controversy, albeit with longer term effects. As is known, genetic diversity is the best guarantee of the conservation of living species. It is this very variety which results in the presence of a gene or genes which are resistant to other pathogenic organisms or aggressive agents. Since time immemorial, humans -albeit intuitively- have been aware of the negative effects of pronounced endogamy or in-breeding. Hence, the references in Biblical tradition (Leviticus) to the prohibition of marriage between biologically-close relatives, for examples brothers and sisters, irrespective of whether they were legitimate or illegitimate (born out of wedlock). Similarly, the strict prohibitions on marriage we find, without exception, in cannon and civil law and the taboo which surrounds incest in our own culture.

I think also that in the current debate we are overlooking another aspect: the serious effects of using the technique with other living beings, particularly superior animals. The biological diversity of these species will be jeopardized if cloning is conducted on a mass scale (e.g. for livestock breeding). This diversity must be preserved, not merely for reasons of physical appearance, but also to guarantee the speciesf survival as part of living matter and as part of its equilibrium (16). Consequently, the development of this type of research and its use for livestock enhancement should be compensated by measures aimed at guaranteeing the preservation of the biological diversity of the species concerned.

Cloning of humans would eventually become a private decision as to offspring which would be taken by couples, one of many consumer choices facing our end of 20th century society. Anything that can be bought can be taken and used, or consumed. But this very idea of consumption carries with it the notion of something perishable, which leads everyone compulsively to consume anything new which appears. Here, however, the object consumed is a future child, one that must have its own personality and moral autonomy. The fact that another person is involved and affected by the choice makes interference in private decisions legitimate, both ethically and legally, because they are no longer purely private in this case. The need for outside assistance -the technique applied by a specialist- also means that there is a small but inevitable renunciation of privacy, and this, in the final analysis, makes it appropriate that society should be the one to weigh up the priorities to be given to the interests at stake (private life or privacy, on the one hand, and the well-being of the future child on the other), without this intervention being considered an unacceptable intrusion, and -if necessary- for the dilemma to be resolved against the interests of the parents.

Moreover, it now seems certain that the production of exactly identical beings is not feasible, from the biological standpoint since mitochondrial DNA is not always identical because of the technique used (as happens when a nucleus is transferred to an enucleated egg). Cytoplasm and nucleus influence each other, and other influences are possible in the womb environment (hormonal effects in the first days of pregnancy). Remember also that spontaneous genetic mutations cannot be ruled out either. Furthermore, human beings and their personalities are also the result of environmental factors related to their surroundings (cultural, family, social) and also to their era (the succession in time -generations- of living beings in general and humans in particular, with the corresponding cultural variations). In other words, if the principle of the individuality of the human person stems from each personfs biological and personal uniqueness (which result from development, education and the other factors just mentioned), only the first of these (biological uniqueness) might be affected by cloning, or by the cloned origin of the individual. Our fears might be allayed if we recall that not even monozygotic twins, i.e. with identical genetic content and identical in terms of time and, usually, also their surroundings, develop exactly the same personality.

Still, we should not disregard the homogenizing effect of cultural non-differentiation, which is much more harmful, in my opinion, to the unique development of personality and thus of the individual than biological cloning, even though the negative effects of such cloning should not be underestimated. This view has proven most attractive to date in totalitarianist ideologies and many countries of this type have concentrated their efforts in that direction.

Some years ago the German philosopher Hans Jonas referred to the ethical dilemmas associated with human cloning, stating that gthere is no desire more perverse (than self-replication), more scientifically utilitarian (than homogeneous working teams) or more scientifically fanatical (than identical research subjects) that would -if available- find willing takers among the children of Adam and Eveh (17). He realized at the time even then that ethical reflection should focus on the pursuit of a form of excellence deserving of perpetuation and reproduction, since this entailed implicitly a more noble goal than those just mentioned.

Legal experts and bioethics specialists have been unable to lay down clearly until now the main reason for rejecting the use of cloning techniques in humans, apart from a vague general reference to the fact that they constitute an attack on human dignity. Creating identical humans through cloning may undermine the identity and the nonrepeatable nature of a human being, its right to individuality and the very condition of being someone different to all others (18), if all this has been deliberately determined beforehand by another human being (19), even accepting the complexity and variability of human nature. However, as shall be shown below, this interest need not be considered to be violated in all cases. There is no disputing that the identity of a human being and his nonrepeatable nature are the result of a series of various biological and environmental factors. However, it is also true that his genetic make-up is also one of the bases of this nonrepeatable nature (which should not be taken to mean that natural born monozygotic twins should be in any way stigmatized). The problem is that no basis has existed for these legal interests, strictly speaking, in any subjective human or fundamental right, in national constitutions or even, until recently, in international conventions and declarations.

Nonetheless, the States party to the Council of Europefs Convention on Human Rights and Biomedicine -including twenty European countries, among them Spain- will find in the Convention, once it is included in the respective national laws, an excellent instrument for identifying and protecting these new subjective rights, because it proclaims not only the protection of the dignity of the human being, but also his identity and integrity, which must extend also to genetic integrity, something regulated specifically in article 13 of the Convention (20).

Having established that the identity of the human being is a subjective right, we are now in a position to infer a further element based on the very nature of the human condition, and on the dignity and the affirmation of the human being as an entity endowed with moral autonomy, one enjoying the right not to be predetermined. We then have to ask what material grounds exist to view as being harmful this attack on the identity and nonrepeatability to which every individual is entitled?

Once again, Jonasf perceptiveness will help us. For him, the ethical issue revolves around determining what it means to be a clone from the perspective of the person himself. gThe simple fact of the matter, and totally unprecedented aspect, is that the hypothetical clone knows, or believes he knows, too much about himself, and others know, or believe they know, too much about him. Both circumstances -his own and othersf knowledge/supposed knowledge- curtail the spontaneous nature of him becoming himself . The second circumstance is also an impediment to the authenticity of othersf relationships with himh (21). gIt makes little difference whether the supposed knowledge is true or false (indeed there is good cause to assume that it will be essentially false per se), it will be detrimental in terms of the person securing his own identity. Essentially, what is important here is that the cloned person thinks -has to think- that he is not what he is, in the sense of the term gto beh. In sum, the cloned product has been stripped beforehand of his freedom, which can only prosper under the protection of ignorance. To premeditatedly steal from a future human being this freedom is a heinous crime, which must not be committed even onceh (22). Jonas himself acknowledges that this does not happen with monozygotic twins, because they experience a situation simultaneously (each is a gnovumh about whom nobody knows anythingh) (23), and perhaps even with cloned twins resulting from a simultaneous pregnancy. To sum up, the main thrust of Jonasf argument is the knowledge-ignorance-freedom concatenation, where the right to ignorance is seen as an interest, something he considers to be a new ethical theory. This right emerged some years previously in the context of genetic research (e.g. with regard to predictive testing) as the right not to know. It has been given formal legal recognition (24) and I have had occasion to examine it from the standpoint of the protection of privacy (25).

Let us reiterate once again, however, that the biological (genetic) element is not the only or indeed the most decisive factor in the forging of personality. Each individual has his own history which is gradually created, not to be repeated, from birth, and even -psychologists have us believe- during pregnancy, in his own nonrepeatable environment (26). Still one would have to agree that Jonas is correct in expressing the compulsion of a certain subjective determinism over a repeated, not unique (27), person, a situation which is equally distressing and thus to be avoided. In proclaiming the free development of personality as one of the fundaments of public order and social peace (art. 10.1), the Spanish Constitution places the issue in this very context.

Something similar occurs with the use of other genetic procedures for race selection, the creation of specialized human beings or homunculi. Producing a host of theoretically identical beings constitutes an attack on the identity, the nonrepeatable nature and the genetic integrity of the individuals thus born, given that their genetic integrity has also been manipulated or at the very least selected.

We can see from the above that some of these possibilities call into question the re-emergence of eugenic thinking in manifestations not directly linked to the goal of enhancing the health of future individuals but rather for racist goals which have been firmly repudiated by the universal conscience.

Cloning performed by transferring a nucleus to an enucleated egg or zygote also constitutes an attack on the right of a child-to-be to have a biological (genetic) mother and father.

The use of cloning to aid assisted reproduction (e.g. to have sufficient pre-implantation in vitro embryos for transfer when, having obtained an egg from the patient and fertilized it, it is then difficult or impossible to obtain others) should not in itself be rejected out of hand since, in the strict sense, it need not necessarily involve genetic manipulation nor the replication of an existing or dead person, and thus does not affect in any way the latterfs identity, in the way mentioned above. Similarly, the person is not deprived of a genetic father and mother. In fact, nature is being emulated, as occurs with monozygotic twins, and it may be that even this outcome does not happen (28).

Similarly, no special problems arise with regard to the separation of one or various -totipotent- cells of a blastomere for genetic testing for diagnostic purposes, provided that the separation does not harm the integrity of the blastomere. As was said earlier, it is vital that the greatest technical guarantees be present.

Conversely, one should reject the keeping of frozen in vitro embryos for transfer to a woman for procreation after the birth of the first child born from the cloned set, regardless of whether said child is alive or dead. Or, in the case of a non-fertile couple where gametes cannot be obtained from one or both partners, if the aim is to have a child cloned from one member of the couple. It is also to be rejected as a means of grecoupingh a child who has died, or to obtain a child who is identical to someone the parents admire, or if the DNA is manipulated to create a more perfect child who could then be used to produce identical children afterwards, etc. Our imaginations could be stretched to entertain a host of such possibilities, albeit remote at present.

For all these reasons, consideration must be given to the costs and benefits of allowing such procedures, even in support of assisted reproduction techniques as mentioned just now, because of the risk of potentially serious deviations (29), unless it were possible to effectively differentiate between admissible techniques and prohibited ones. For other reasons, one should also reject the use of cloning as a procedure to help human reproduction, because this would be a way of making objects out of the person(s) born in this way (30). Some have even called into question the use of cloning as a diagnostic procedure for diseases possibly carried by in vitro embryos, prior to deciding whether to transfer the embryos for procreation (i.e. remove a blastomere cell). In this regard, I have already said above that, in my view, the only disputed aspect at present is the lack -for the moment- of sufficient technical guarantees to ensure the blastomere is not harmed in such a way as to render it useless for reproduction.

Let us recall what was stated above that genetic diversity can make a vital contribution to preserving the human species from certain infectious diseases or other external agents, to which a given genetic make-up might be vulnerable. However, this is merely a warning. The risks of impoverishment of the human genome are highly remote.

A last possibility, the creation of cloned embryos as sources of organs or tissues for transplantation should the person from whom the replicated genome is obtained fall ill, is ruled out because of the protection the law grants to in vitro embryos, specifically the prohibition of fertilization for any purpose other than procreation (31). My own view is that research efforts should be concentrated on xenotransplants, since although it involves the use of isolated human genes with animals, the procedure gives rise to fewer ethical reservations, some of which have more to do with the risks (for instance, the passing on of animal pathogens to humans -e.g. viruses) of all new innovative or experimental treatments for the patient-recipient than with the use itself of human genes (32).

4. Cloning and research freedom

We have attempted to show briefly but clearly how the creation of cloned humans, in the majority of the cases cited, constitutes an attack on socially accepted values. However, the question also arises as to whether prohibiting the creation of cloned embryos for research is an excessive curtailment of the freedom to conduct research.

It is generally acknowledged that the right to scientific production and research is an interest deserving of protection, but one which occasionally clashes with other individual and societal values. Scientific investigation is indeed underpinned by freedom of scientific enquiry, which is understood as meaning the right to engage in scientific creation and production, something which serves to satisfy primarily the interests of the scientist or researcher but also societyfs interest in promoting scientific progress for the general benefit to society. From this stems also another consequence which must be guaranteed and protected: the dissemination and circulation of scientific information and knowledge (33).

However, consensus on the scope of this right is by no means easy with respect to the acquisition of the aforementioned knowledge. There are three approaches, essentially (34): firstly, no restrictions should be imposed on obtaining information or scientific knowledge because it is not the knowledge itself which is harmful but the subsequent use made thereof. Secondly, research geared directly to obtaining certain knowledge and then to using it against individuals or society may be unethical and thus prohibition is justified. Thirdly, acquisition of knowledge per se should not be subject to restrictions of any kind although a subsequent use or application may be. This last approach is the most appropriate, if we add also the proviso that prohibition of certain procedures or methods for obtaining scientific knowledge is legitimate if human beings (including those conceived but not yet born), other human biological components or other interests deserving of protection (animals, for instance) are involved.

Therefore, although recognizing that scientific research is legitimate and advocating that it should be promoted effectively by the authorities and through private initiatives, this freedom, like all freedoms, is subject to limitations. Here too we are reminded that these limitations must be set out and based on both individual and collective interests, on the protection of a constitutionally protected interest or other legal provision. Put another way, the individualfs fundamental rights represent an unbreachable limit, even though certain exceptions may operate in specific situations. Each human being is himself a value that has to be respected irrespective of the benefits which might be obtained for others or for society as a whole (35).

That said, let us recall that cloning, as a scientific research and experimentation procedure, entails the use of human gametes and embryos. Any procedure which gives rise to embryos for research implies by definition that they will not be used for reproduction, and thus any possibility that an embryo on which research has been conducted might be transferred to the uterus of a woman is -or should be- excluded. This is a possibility that must be prohibited totally. Most legal systems prohibit the creation of embryos for a purpose other than research, and some even expressly ban their creation for experimental, research, industrial or commercial purposes.

The issue is directly liked to the positions adopted in connection with the general possibility of using embryos for research or experimentation, a subject which has failed to produce unanimously-accepted criteria. One result of this controversy is the provision of the Convention on Human Rights and Biomedicine, which reflects a rather open compromise position, given the lack of consensus achieved except in the case of the creation of embryos for experimentation, which is expressly prohibited: g1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2. The creation of embryos for research purposes is prohibitedh (art. 18).

The cloning of isolated genes or of a genome in the laboratory poses -or should pose- few objections as long as it does not lead to the formation of a viable zygote. Consequently, the application of cloning techniques in human cells or tissues for research should be allowed and, where necessary, supported within the context of general experimentation regulation, given that it can help provide crucial biological and medical information as well as further insight into cell structure and development, the processes of some diseases such as cancer, etc. The same is true also of other techniques involving the use of human genes in animals to obtain therapeutic products for humans, or experimentation with animals for medical purposes or for livestock enhancement etc., provided that the principles of good practice are adhered to (36).

By way of a last reflection on this subject, one might say that only when the survival of the human species is seriously endangered -an exceptional hypothesis conceivable only in the case of a catastrophe on a universal scale- would it be appropriate to subordinate individual interests to those of the human species.

References

1. J.L. HALL et al., gExperimental Cloning of Human Polyploid Embryos Using an artificial Zona Pellucidah, in The American Fertility Society conjointly with the Canadian Andrology Society, Program Supplement, 1993.

2. Ian WILMUT et al., gViable offspring derived from fetal and adult mammalian cellsh, Nature, Vol. 385, pp. 817 ff.

3. On this subject, see Juan Ram_n LACADENA, gLa clonaci_n: Aspectos cient_ficos y _ticosh, An. Real Acad. Farm., 63, 1997, pp. 273 ff.

4. Cf. Darryl R. J. Macer, Shaping Genes. Ethics, Law and Science of Using New Genetic Technology in Medicine and Agriculture, Eubios Ethics Institute, Christchurch - Tsukuba, 1990, pp. 314 ff.

5. Definition from LACADENA, gLa clonaci_n: aspectos cient_ficos y _ticosh, cit., p. 276; by the same author, gGenetic manipulation offences in Spainfs new Penal Code: a genetic commentaryh, in Law and Human Genome Review, no. 5, 1995, p. 213.

6. See LACADENA, op. cit., pp. 276 f.

7. Through the White House Press Office, 6 March 1997.

8. William J. Clinton, gHuman Values and Cloningh, article published in Spanish daily El Mundo, 22 June 1997.

9. See its Avis sur le clonage humain, 19 June 1997. The Committee calls for a Protocol to the Human Rights and Biomedicine Convention (see below) to cover gprohibition of cloning in humansh. This would prohibit all interventions aimed at creating a human being who is genetically identical to another living or dead human. For this purpose, egenetically identicalf is taken to mean a human with the same set of nuclear genes as another person (art. 1). It also proposes a gDeclaration on human cloningh by the forthcoming Second Conference of Heads of State and Government of the Council of Europe.

10. Cf. Group of Advisers on the Ethical Implications of Biotechnology, Opinion on the Ethical Aspects of Cloning Techniques, by request of the European Commission on 28 February 1997 (date of opinion, 28 May 1997; rapporteur Anne McLaren).

11. The Steering Committee on Bioethics, in the above-mentioned Opinion (Avis sur le clonage humain), acknowledges this lacuna in the Convention and proposes, among other alternatives, that it be reviewed and a new article included (art. 13 b), which is set out in identical terms to those outlined for the Protocol (see note 8 above). As we have seen, the Committee eventually did not opt for this solution, because it felt that it might appear to be a simple remedy for the lacuna in the text of the Convention, whereas the adoption of a protocol would be serve to demonstrate the capacity of the Convention to respond very quickly to a new scientific development.

12. Recommendation 1046 (1986) on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes, and Recommendation 1100 (1989) on the use of human embryos and foetuses in scientific research, respectively. See further on this concern, MACER, Shaping Genes, cit., p. 315 f.

13. As outlined in 1994 by John A. ROBERTSON, gThe Question of Human Cloningh, Hastings Centre Report, Vol. 24, No 2, 1994, pp. 6 ff. The author argues, however, that in most cases, cloning is not ethically censurable. Cfr. also MACER, Shaping Genes, cit., p. 315.

14. See for example Carlos Mar_a ROMEO CASABONA, El Derecho y la Bio_tica ante los l_mites de la vida humana, Ed. CERA, Madrid, 1994, pp. 44 ff and 67 ff; by the same author, Del Gen al Derecho, Servicio de Publicaciones de la Universidad Externado de Colombia, Santaf_ de Bogot_, 1996, p. 435.

15. See Pedro J. MONTANO, gLa dignidad humana como bien jur_dico tutelado por el Derecho Penalh, in Actualidad Penal, No. 19, 1997, pp. 419 ff.

16. The Group of Advisers on the Ethical Implications of Biotechnology, in the aforementioned Opinion (points 1.3 and 2.4) also raise this issue. However, LACADENA, gLa clonaci_n: Aspectos cient_ficos y _ticosh, p. 287, notes that the risk is highly unlikely, gbecause cloning mammals is such a difficult technique it will not be applied on a large scale, but rather only in very specific cases and circumstancesh. He adds, gwhen small cloned herds and flocks are produced they will be genetically different because they will have been created for different purposesh.

17. Hans JONAS, T_cnica, Medicina y Etica. La pr_ctica del principio de responsabilidad, Ed. Paid_s, Barcelona 1997, p. 124 (originally published asTechnik, Medizin und Ethik. Zur Praxis des Prinzips Verantwortung, Insel Verlag, Frankfurt, 1985).

18. For a treatment of the legal interests affected by genetic manipulation and those cited in the text, see Carlos Mar_a ROMEO CASABONA, gLa persona entre la Biotenolog_a, la Bio_tica y el Derechoh, in Folia Humanistica, No. 276, 1986, p. 6; by the same author, gL_mites penales de las manipulaciones gen_ticash, in El Derecho ante el Proyecto Genoma Humano, T.III, BBV Foundation (ed.), Bilbao, 1994, pp. 187 ff.

19. The same argument is advanced by the Steering Committee on Bioethics (Council of Europe) in its draft explanation to the Opinion referred to above.

20. The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, 19 November 1996 (opened for signature by 20 States in Oviedo on 4 April 1997) states in article 1 that gParties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicineh.

21. JONAS, T_cnica, Medicina y _tica, cit., p. 127.

22. JONAS, T_cnica, Medicina y _tica, cit., p. 128. In another work the same view was expressed although less clearly: gwhen someone is cloned from an existing individual his fundamental existential rights are violated, specifically the right not to know about himself but rather to get to know himself, carving out his own path, testing his own possibilities and surprising himself, etc, rather than knowing from the outset that he is a copy of someone who has already lived, who has already demonstrated all his potential (...) in this particular case it amounts to an unjustifiable crime against a basic existential right of the person (...) it is a special privilege of man that each person has his own personality and not a repetitionh. JONAS, T_cnica, Medicina y _tica, cit., p. 127.

23. JONAS, T_cnica, Medicina y _tica, cit., p. 126.

24. Cf. Human Rights and Biomedicine Convention, art. 10.2.

25. For example, Carlos Mar_a ROMEO CASABONA, gQuestions de droits de lfhomme dans la recherche en g_n_tique m_dicaleh, in …thique et g_n_tique humaine, Les Editions du Conseil de lfEurope, Strasbourg, 1994, p. 186; also, Del Gen al Derecho, cit., p. 91 f.

26. ROBERTSON, The Question of Human Cloning, cit., p. 11.

27. Jonas notes in this regard that gIt matters not that the genotype replica is actually the repetition of the life pattern. The donor was chosen for that particular purpose, and it is an idea which acts tyrannically on the subject. Neither is it a question of the true relation between innate nature and education in the formation of a person and his possibilities: the inter-relation is rendered false from the outset because the subject and the environment have received ginstructionsh for the representationh. JONAS, T_cnica, Medicina y Etica, cit., p. 128.

28. For instance, if only one of the transferred embryos implants successfully. Conceivably also, when the techniques are fully mastered, it may be possible to ensure a pregnancy by transferring one single embryo, provided that implantation is guaranteed. It may also be possible to obtain cloned embryos in vitro which are different to each other, and these could be kept in reserve in case of failed pregnancy attempts; in each attempt the embryos transferred would not be clones of each other.

29. See Juan Felipe HIGUERA GUIMERA, gJuridico-penal considerations on human embryo cloning (I)h, in Law and Human Genome Review, No. 1, 1994, pp. 68 f.

30. A view shared by the Group of Advisers on the Ethical Implications of Biotechnology in their Opinion (g... it raises serious ethical dilemmas, related to human responsibility and the use of human beingsh, section 1.18; in section 2.7, the Group reiterates its ethical objection, even where it would be understandable). This also seems to be the stance taken by the Council of Europefs Steering Committee on Bioethics, as expressed in its explanatory report, cited above. The Committee is of the view that even if in future it were possible theoretically to conceive a situation in which artificially cloned humans would not be used as mere objects, this in itself would not be a sufficiently solid argument to justify cloning. Moreover, given that natural genetic recombination can provide humans with greater freedom than a predetermined genetic make-up, it is in the interests of everyone to preserve the essentially random nature of the make-up of their own genes.

31. Moreover, if the disease is of genetic origin the embryo created will also be a carrier, thus requiring a prior genetic intervention which would introduce the additional problems present in gene therapy.

32. Nuffield Council on Bioethics, Animal-to-Human Transplant. The ethics of xenotransplantation, London, 1996.

33. Cf. ROMEO CASABONA, gQuestions de Droits de lfHomme dans la recherche en g_n_tique m_dicaleh, cit., pp. 183 ff; Pierre WIDMER, gQuestions de Droits de lfHomme dans la recherche en g_n_tique m_dicaleh, cit., pp. 191 ff.

34. Cf. ROMEO CASABONA, Del Gen al Derecho, cit, pp. 329 ff. Stella Maris MARTINEZ, Manipulaci_n gen_tica y Derecho Penal, Ed. Universidad, Buenos Aires, 1994, pp. 104 ff, takes a different approach and suggests four possible policies.

35. In this regard, the Council of Europefs Recommendation 934 (1982) on genetic engineering, states as follows: gFreedom of scientific enquiry -a basic value of our societies and a condition of their adaptability to the changing world environment- carries with it duties and responsibilities, notably in regard to the health and safety of the general public and of fellow academic workers, and to the non-contamination of the environmenth (principle 3.iii).

36. See Group of Advisers on the Ethical Implications of Biotechnology, Opinion, cit., points 2.2 and 2.3.

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