What is the ethics of animal cloning

Office for Technology Assessment at the German Bundestag

TA project

Animal cloning

Subject area: Bio and medical technologies
Analysis approach: TA project
Thematic initiative: Motion by the Bündnis 90 / Die Grünen parliamentary group
Status: completed
Running time: 1998 to 2000

Object of investigation and objective

A clone is an individual who is genetically identical to another. Cloning is a form of asexual reproduction of living things that is widespread in nature. In single cells and plants it is a completely normal process (division into two parts, vegetative reproduction); In higher vertebrates, genetically identical individuals can arise naturally in that embryos spontaneously split up in the early stages of division and the parts develop separately into independent individuals (twins or multiples). For the artificial creation of clones of higher organisms, there are basically two methods available, embryo division (embryo splitting) and cloning by nucleus transplantation into egg or embryo cells from which their own genetic material has been removed (nucleus transfer). Cloning processes (cloning techniques) belong to the field of biotechnology, namely to the (biotechnical) processes that do not change the genetic material within the cell nuclei. As a rule, however, cloning techniques are not isolated, but are used in conjunction with other (transgenic) biotechnology and genetic engineering. Some biotechnologies are an indispensable part of a cloning process, others are optional.

The aim of the project was to investigate

  • what influences the use of nuclear transfer-based cloning can have on basic biological research,
  • which contributions can be expected for the various application-oriented areas in medicine,
  • which effects are recognizable for animal breeding and agriculture,
  • and finally, which problem areas are to be identified and which conclusions can be drawn.

During the concept development it became apparent that a perspective restriction to purely technical, medical and economic aspects of the application of cloning in animals would have been unsatisfactory. Cloning also needs to be considered under legal and ethical aspects. The project therefore addressed the question of whether or which regulations animal cloning in Germany is subject to under current law and whether cloning may be subject to legal restrictions or even bans. In view of the possibilities that a further development of cloning techniques holds with regard to possible fields of application in humans (pharmaceuticals, transplantation, tissue engineering, etc.), there was also a reflection on the actions of doctors, biotechnologists and animal breeders in the field of tension between scientific and technical progress and ethical requirements necessary. The question of ethics was asked whether the conventional ethical principles as well as the classical arguments and relevant patterns of ethical judgment formation are sufficient for the moral evaluation of cloning.

Results

Biomedical research and application

Clones of higher organisms are of great interest for basic biomedical research as well as application-oriented medical research. Currently, four possible fields of application of nuclear transfer-based cloning for medical purposes are being discussed. A first area is so-called gene pharming, i.e. the use of transgenic animals to produce therapeutically useful (human) proteins, e.g. in milk. This is one of the possible main areas of application of nuclear transfer-based cloning for the foreseeable future, as it makes the generation of the corresponding transgenic animals more effective and more targeted compared to conventional methods. The advantages of these active ingredients obtained through biogenetic manufacturing processes, such as insulin or blood factors or other endogenous substances, are that these active ingredients can be obtained in a much more pure manner than with the conventional method using intermediate products from animals and humans. If such animals are available, the active ingredient can be produced in large quantities and relatively inexpensively. However, there are also risks for the animals due to the genetic (transgenic) manipulation, the biological activity of the protein produced and the cloning process itself. Risks for people can arise from changes to the products as well as from possible transmission of pathogens, so they must be ruled out as far as possible through careful drug testing.

Another area where cloning could potentially be used is in the creation of transgenic animals as animal models for human diseases. A major obstacle in the further development of animal models has been shown in the fact that so far only mice have succeeded in integrating genetically manipulated cells so stably into the germ line of a recipient animal that the genetic changes can be inherited. However, the physiological and anatomical differences between mice and humans are so great that the symptoms of the genetic modification introduced in the mouse often do not correspond to the clinical picture observed in humans. Cloning with the help of nuclear transfer using somatic cells opens up the possibility of inducing specific genetic changes in various species (gene targeting and gene knockout). In this way, it was also possible for the first time to create disease models in transgenic large animals which, depending on the disease to be investigated, could be superior to previous mouse models with regard to anatomical, physiological or genetic characteristics. It is generally expected that in the medium term this will contribute to a better understanding of the clinical pictures of genetically determined human diseases and to develop effective treatment options based on this.

Cloning could also make a technical contribution to the transplantation of the body's own (autologous) tissue and to so-called cell therapy. The optimal transplant tissue is easy to identify: its cells should be genetically identical to those of the recipient as far as possible. The patient's immune system then no longer recognizes it as foreign, and any problem of rejection would be eliminated. Therefore, an optimal solution would be to create genetically identical replacement tissue. Research suggests that this could now be achieved using core transfer-based cloning. In principle, another way of cultivating human replacement tissue is conceivable: With the help of the nuclear transfer method, an early embryo would be generated, from which pluripotent embryonic stem cells could be obtained in culture. In humans, however, it has not yet been possible to obtain such cells from embryos created in vitro. In addition, such a process would require the ethically and legally highly problematic creation and utilization of a human embryo, unless egg cells from animals could be used as recipients of the cell nuclei. But this development is still in its infancy and has its own problems, especially serious ethical problems.

A fourth area in which the use of (transgenic) cloned animals is conceivable is xenotransplantation (transplantation of animal organs into humans). However, in order to construct "donor animals", up to a dozen genes would have to be changed in pigs, for example. This is practically not feasible with conventional methods of genetic modification. Cloning could now make it possible to first provide cells in culture with the desired genetic changes, before a multiple genetically modified animal could be generated from them with the help of nuclear transfer-based cloning. But even if the "ideal" donor animal could be created in this way, the fundamental problems of rejection would probably persist. It is also uncertain whether the foreign animal organ actually fulfills its function in the human recipient. The problem of how animal viruses adapt to humans, with the possible consequences of epidemics, also remains.

Livestock breeding and agriculture

Cloning itself is not a breeding process, but a technique that enables the genetically identical reproduction of individuals. Cloning alone does not bring about any breeding or genetic progress in the resulting clones in relation to the original individual. The effectiveness of the cloning technique and the (breeding) value of the genetic material available for cloning are decisive for the economic efficiency and expediency of cloning in zootechnical use in agriculture. If the method of cloning adult animals can be developed into a routine process, this would also have implications for animal production, the extent of which is essentially determined by the cost of cloning. As long as the process is still very expensive, only individual top animals will be cloned, e.g. if an animal that is very valuable for breeding is lost (due to age or illness), the animal could be replaced by a clone of itself.

With the expected increase in genetic knowledge also in the field of livestock and the associated possibilities for creating transgenic animals, new strategies can be used in animal breeding and animal production in combination with nuclear transfer-based cloning. It is expected that with the help of these technologies also transgenic animals with modified (agricultural) characteristics can be »produced« more efficiently than previously possible. The most important goals of gene transfer in livestock breeding in connection with cloning are: quality improvement, gene pharming, increasing disease resistance and reducing costs. Increasing performance by means of gene transfer is no longer so important in agricultural livestock, as complex, multigenic characteristics are responsible for meat and milk production, which are difficult to change and can also be adequately processed with conventional breeding. In some cases, attempts are being made with gene transfer to improve feed conversion or to reduce fat formation, particularly in pigs. This is, for example, one aspect of the mainly desired improvement in the quality of animal products, as well as the desired change in milk composition: work is being carried out on increasing the protein content, especially casein, and reducing or completely removing milk sugar (lactose). Such milk would also be tolerated by people who are lactose intolerant. A continuation of this approach leads to the gene pharming already described. Due to the high disease-related costs in factory farming, the genetic modification of the disease resistance of animals in animal breeding is of great importance. By transferring specific disease resistance genes or by switching off gene locations that determine specific diseases, animal health and thus the quality of animal products could (theoretically) be improved.

In agricultural breeding practice, the introduction of (practical) cloning (especially in cattle breeding) could possibly lead to a restructuring of the breeding organizations. Both for cost reasons and because of the personnel qualification requirements, specialized, capital-intensive, profitably oriented breeding companies would presumably arise. It is questionable whether the existing breeders' associations will be able to carry out the biotechnical work in an efficient manner. Furthermore, as a result of the extensive use of cloning, changes at the level of the production stage with different effects depending on the types and sizes of farms would be expected. These could intensify the structural change within this sector and lead overall to a reduction in farms and jobs in the agricultural sector.

It cannot be ruled out that the effects of cloning on the structure of use of agricultural land will intensify the development tendencies observed in the agricultural sector since the 1960s: The full exploitation of possible performance advances through the most intensive and industrial economic methods leads to falling prices and, in addition to animal-related land requirements a further restriction of the agricultural area and a reduction in the usable agricultural area with a simultaneous increase in the number of processing companies and regions. For this reason, an increase in regional environmental pollution can also be expected in the highly competitive processing regions.

Legal Aspects

From a legal point of view, it is particularly important to answer the question of which regulations animal cloning is subject to in Germany (and abroad) and under which conditions cloning is legally permissible or not. There is no explicit consideration of cloning techniques in the Animal Welfare Act. The cloning of animals could, however, be covered by the regulations of Section 7 (1) TierSchG, as this paragraph contains provisions on animal experiments and the cloning processes are predominantly still in the experimental stage. However, the application and effects of this paragraph are discussed very differently: If the coring of the egg cell is not viewed as a genetic change in the legal sense, the transfer of the egg cell to the carrying animal does not constitute an animal experiment believes that cloning by means of nuclear transfer falls under the provisions of Section 7 (1) sentence 2 of the Animal Welfare Act, because this involves interfering with the genetic material and, moreover, the cloning attempts for the mutated animals (or carrier animals) are associated with pain or damage cloning attempts by means of core transfer would clearly require approval. The cloning of animals could also, and in particular, be restricted by Section 11 b TierSchG (torture breeding) if these processes have reached practical maturity and are used, for example, in the production and breeding of farm animals. However, this would only apply if, with the help of cloning, torturous changes were provoked in the animals, which would have survived in further breeding. According to the current legal opinion, a legal regulation of cloning seems to exist through § 7 and § 11b Animal Welfare Act insofar as this could be associated with suffering, pain or harm for the animals. However, a ban on cloning could only be considered if significant suffering for the animals can actually be determined.

From a constitutional point of view, a cloning ban would violate the fundamental rights of researchers and professionals under Article 5 (3) (freedom of research) and Article 12 (1) of the Basic Law (freedom of occupation). A cloning ban or other restrictions on cloning would also constitute an encroachment on the constitutionally guaranteed freedom of science. There is obviously no constitutional barrier that could justify the interference. According to Article 12 (1) of the Basic Law, a cloning ban would therefore be unconstitutional, as it would not be compatible with the public interest and would not be covered by the legal reservation in Article 12 (1) sentence 2 of the Basic Law. The cloning of animals is therefore permissible in principle under the current conditions and is only subject to limited restrictions under applicable law.

A new situation could arise if the state goal of animal welfare was included in the Basic Law. The draft of a corresponding constitutional article is currently being discussed in Germany. On November 28, 1997, the Federal Council approved a legislative proposal in the 13th German Bundestag to amend the Basic Law by introducing a state target for animal welfare. The Federal Council's motion aimed at inserting Art. 20b into the Basic Law with the aim of ensuring that "animals are respected as fellow creatures and protected from avoidable suffering and harm within the framework of the law." Understand animal experiments, but also in relation to intensive animal husbandry, animal transport or animal killing. This application was discussed in the Bundestag without a decision on the application. For a definitive decision, the current 14th legislative period remains to be seen. Should the corresponding article are included in the Basic Law, the cloning of animals could possibly violate a constitutionally protected good, animal welfare, since there could be a constitutional barrier for Article 5, Paragraph 3 of the Basic Law. At least, however, reference can be made to the fact that with a constitutional guarantee animal welfare in individual cases in d he application of the law and case law the necessary balancing of other, also constitutionally protected legal interests (such as freedom of research and science, but also freedom of occupation and guarantee of property) could be achieved. A "state target of animal protection" does not exclude the use of animals by humans, but it increases the demands on their necessary justification.

Ethical aspects

Different positions in the social discussion and evaluation of the cloning of animals can in part be traced back to different fundamental value assumptions. It also depends on these whether the cloning of animals is ascribed a new quality compared to conventional or other new methods of animal breeding, for example. For some theologically justified positions, cloning is, for example, an interference in creation that is not due to humans. Anyone who ascribes an "intrinsic value" or a "creature dignity" to animals will generally consider the cloning of animals to be at least morally problematic. From an anthropocentric perspective, the question of the safety of products produced with the help of the cloning process and the ecological (impoverishment of genetic diversity) and social (industrial mass production, capital concentration, new relationships of dependency) risks and dangers that may be associated with its use are in the foreground. Other positions see the cloning of animals more as a trend intensifier, which could already intensify undesirable tendencies that are already observable and induced by the use of other biotechnological and genetic engineering methods of reproduction, and not as a qualitatively new step in reproductive technology.

The various social positions stand for the effort to advertise a certain moral or ethical ideal and thereby possibly also to influence the political climate. In view of a moral consensus that is difficult to achieve, it is necessary to think about the ethical principles on which a possible use of animal cloning should be oriented. This means that not only a possible use of animal cloning must be ethically justified, but also a renouncement of the application of the (therapeutic) possibilities given by this process. From this perspective, the ethical assessment of cloning focuses on the question of whether the aims or purposes claimed for the cloning of animals and the means or methods used within their framework imply an interference in the sphere of interest of the animals concerned, and whether in this case the intervention can be ethically justified in the sense of the above considerations.

Ethicists generally consider the goals of biomedical research and application to be of high priority, which are of particular urgency or even vital necessity with regard to human health and which can only be achieved with the help of cloning higher animals. Objectives in the field of basic research can also be viewed as high-priority and justify cloning of higher animals, unless alternative methods are available. However, if cloning is associated with considerable suffering for the animal concerned, it must be checked whether the mere human interest in knowledge is a sufficient justification or whether justifications are only possible for certain goals, i.e. when they are necessary in order to address a significant human issue Avoid suffering. Subordinate to the goals mentioned, goals in the field of livestock breeding are mostly named, unless they explicitly serve to secure the food base of humans.

Conclusions and options for action

In applied research, nuclear transfer-based cloning opens up new ways of producing transgenic animals. Some therapeutically effective proteins can be produced inexpensively in this way. Obtaining the body's own replacement tissue appears to be very promising from a medical and ethical point of view, and corresponding research activities are therefore particularly worthy of funding. It is unclear whether it will be possible to create better models for investigating human diseases in farm animals, but because of its not insignificant medical importance, efforts should be intensified and supported in this area as well. Overall, the potential benefits of core transfer-based cloning for research and medicine appear to be relatively high.

In the field of agriculture, the (practical) creation of clones promises breeders animal-related increases in performance and quality while at the same time reducing economic costs. It is likely that the cloning process will reinforce the trends that have already existed to further optimize the performance potential of livestock, i.e. high-performance animals. With regard to the aspects of genetic progress and genetic diversity in animal breeding, the selection for specific performance characteristics with the help of cloning can aim at a standardization of the (breeding) animal population and thus at the same time inevitably result in general standardization. The "genetic status quo" achieved (and desired) in this way is therefore very likely also associated with a restriction in genetic diversity. Although, in principle, there is still a great need for research to more precisely record the status quo, suitable measures should already be taken now that may limit the "artificial" production of more and more offspring of individual animals. This applies to techniques from routine artificial insemination to cloning.

Furthermore, it can be assumed that the introduction of cloning in connection with other reproductive and genetic breeding techniques will trigger or intensify a considerable outsourcing of the production of breeding products (breeding animals) from farms to commercial enterprises. This would lead to a similar situation in animal breeding as in plant breeding, where a pyramid-shaped structure consists of a few breeding companies, a large number of propagation companies and many production companies. The pressure on the responsible bodies of the EU and on national governments to create favorable framework conditions for the commercial use of gene and cloning technologies will presumably increase. These include, for example, demands to abolish so-called »competition-distorting regulations« - such as quota regulations, funding ceilings or stock ceilings.

The consequences of a possible further acceleration of this noticeable development in the agricultural sector since the 1970s are not only quantitative but also qualitative. Politicians should ensure that a situation does not arise in which possible negative effects of specialization in animal breeding arise the different levels of breeding, labor market and farm structure would be more difficult or impossible to revise. Overall, the use of core transfer-based cloning in agriculture requires careful consideration of the pros and cons. With regard to the quantity and quality of human nutrition, there is no immediate need to clone animals for agricultural use. In addition, the currently foreseeable effects on the individual livestock - but also on populations (breeding stocks), races and possibly also species - are possibly just as serious as the effects on the agricultural structures and the socio-economic conditions of people working in agriculture.

From an ethical point of view, an assessment of the cloning of animals should in principle be based on the same criteria that are to be applied (or should be applied) as decisive in traditional animal breeding. In this regard, the establishment of a national ethics committee is also being discussed on various occasions, which would have to deal with the moral and ethical questions of the progress of biological and biomedical technology as a whole and the consequences of progress in biology and medicine in the non-human area. Their task would be to advise political decision-makers and to inform the public. Intensive cooperation with a national ethics committee in the human area, which is also being discussed, might also be desirable, possibly also a single ethics committee dealing with the entire human and non-human area of ​​scientific and technical developments in biology and biomedicine. Since large parts of the public fear that the cloning process will also be used on humans, the implementation of participatory processes for forming opinions and advising on politics (such as consensus conferences or citizens' forums) could be useful. The need for foresighted and timely considerations and, if necessary, legal regulations with regard to human cloning cannot be denied out of hand.

An analysis of the legal aspects of animal cloning showed that it is currently permitted and is only subject to limited restrictions under applicable law. In principle, animal protection relevance in Germany currently partially contradicts the actual claims of the Animal Welfare Act, and animal protection generally takes a back seat to the constitutionally guaranteed freedom of research. The developments in the area of ​​cloning can, however, in principle make clear the need to give animal protection a constitutional priority, if necessary.