APPENDIX

World Health Organization : Statement on Cloning (March, 1997)

Report by the Director General : Dr. Hiroshi Nakajima

The recent announcement of the successful cloning of an adult sheep by a team of scientists in Scotland has raised great interest and also great concern in all sectors of society in all cultures. At this stage, WHO considers that it is necessary to try and clarify the issue so that a reasonable assessment can be made of the implications of this research.

The world “cloning” means the asexual production of genetically identical organisms or cell lines. It must be stressed, however, that this can refer to different situations. One situation involves the “splitting” of preimplantation embryos to produce copies of the same new individual. This is a procedure that has been used experimentally in laboratory animals by separating the cells of the embryo at the preimplantation stage of development and gowing them independtly and growing them independently of each other to produce indentical embryos. This mimics, to a certain extent, the situation that occurs naturally in the formation of monozygotic (identical) twins. It has been proposed as a means of producing large numbers of animal embryos of known genetic composition, for example for agricultural purposes.

Anoter situation involves the insertion of a nucleus from a cell of a mature individual into an enucleated unfertilized egg with the objective of producing a replica of an existing individual. This is a process that does not occur naturally and is the subject of the current controversy. This type of cloning had already been carried out with frogs in the 1960s. The recently reported studies on sheep has taken this process a stage further, into a mammalian species. This lastest development has raised the question of the possible application of cloning procedures to the human being.

WHO considers the use of cloning for the replication of human individuals to be ethically unacceptable as it would violate some of the basic principles which govern medically assisted procreation. These include respect for the dignity of the human being and protection of the security of human genetic material.

In 1992, the Special Programme of Research, Development and Research Training in Human Reproduction (HRP) convened a scientific group to review the technical aspects of medically assisted procreation and related ethical issues. The group upheld the right of everyone “to enjoy the benefits of scientific pgress and its applications” and the need “to respect the freedom indispensable for scientific research and creative activity”. But the group also stressed that “there is a universal consensus on the need to prohibit extreme forms of experimentation, such as cloning, interspecies fertilization, the creation of chimeras and, at present, alteration of the germ-cell genome”. WHO would like to propose that these guiding principle should serve as a starting point for the public debate required at national and international level to establish the necessary norms and safeguards.

However, opposition to human cloning should not lead to an indiscriminate ban on all cloning procedures and research. The cloning of human cell lines is a routine procedure in the production of monoclonal antibodies for diagnosis and research on diseases such as cancer.

Animal cloning also offers opportunities to advance biomedical research on dignosis and treatment of diseases affecting human beings. The availability of genetically identical organisms can help to elucidate the etiology of diseases and the interaction of genetic and non-genetic factors that account for their clonical variations. Nuclear transfer may be useful to study the process of ageing in animals, its consequences for the function of the genome, and the onset of age-dependent diseases. It should also make it possible to explore the so far completely unknown influence of cytoplasmic factors on the introduced nuclear genes and to investigate interaction between the nuclear and mitochondrial genomes.

Other potential applications of cloning might relate to the development and use of animals in which human genes have been introduced and to produce tissues and organs for transplantation. Transgenic sheep have already been used to produce human blood-clotting factors (factors VIII and IX). The cloning of animals could facilitate the production of these and other biologicals for medical purposes. A WHO Task Force was set up last year to review some of scientific, organizational and ethical aspects of organ transplantation, including xenotransplantation. Its next general meeting is scheduled for September 1997. The specific subject of genetic modification of animals for agricultural and food purposes is followed up by FAO and OECD with the participation of WHO in matters related to food safety.

While research on animal cloning and transgenic species may yield benefits which include therapeutic applications, we must at all times remain alert to their possible negative outcomes such as cross-species transmission of communicable diseases to man. WHO wants to emphasize the importance in all circumstances of observing the principle of caution and being able to reply on technical and ethical guidelines that will ensure that the health and dignity of the human being are fully protected. This requires careful scrutiny and a public and systematic debate that should involve all sectors and agencies concerned and take into account different social, economic and cultural environments.

WHO will take the lead in organizing this debate. We propose that the ethical aspects of health-related research and technology should be at the core of this debate. In our sphere of competence, we will focus initially on two priority areas : repreductive health and the biomedical applications of research on the human genome. Our objective would be to help assess current needs and practices, to review available techniques and procedures, and to help build consensus on the technical and ethical safeguards to be applied.

The Scientific and Ethical Review Group of the Special Programme of Research Development and Research Training in Human Reproduction will lead the work on ethical aspects of research in reproductive health. At its meeting from 23 to 25 April 1997, it will review the issue of cloning. This will be an important step towards organizing a series of national and regional consultation which will help to define the common values on which codes of good practice, guidelines and legislation must be based. The first of these consultations will take place at the beginning of April in Bangkok. WHO is seeking the broadest possible participation in this global process.

Resolution of the Executive Board of the World Health Organization

Ethical, scientific and social implications of cloning in human health

The Executive Board,

Having considered Chapter IX on Ethical, scientific and social implications of cloning in human health in the Director General’s report on implementation of resolutions and decisions1, and the information document on the same subject2,

RECOMMENDS to the Fifty-first World Health Assembly the adoption of the following resolution :

The Fifty-first World Health Assembly,

Recalling Resolution WHA50.37 on cloning in human reproduction;

Noting the general consensus reached at the national and international levels since the Fiftieth World Health Assembly regarding human cloning for reproductive purposes;

Noting in particular UNESCO’s Universal Declaration on the Human Genome and Human Rights and the Council of Europe’s Additional Protocol to the Convention on Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, which deal with the prohibition of cloning human beings;

Considering that the currently available infonnation from animal studies involving cloning through somatic cell nuclear transfer indicates that this would be an unsafe procedure for reproductive purposes in the human;

Recognizing that developments in cloning and other genetic procedures have unprecedented ethical implications and raise serious matters for concern in term of safety of the individual and subsequent generations of human beings,

1. REAFFIRMS that cloning for the replication of human individuals is ethically unacceptable and contrary to human dignity and integrity;

2. URGES Member States to take appropriate steps, including legal and juridical measures, to prohibit cloning for the purpose of replicating human individuals;

3. REQUESTS the Director General :

(1) to establish a study group with the aim of developing guidelines relating to the use of cloning procedures for non-reproductive purposes;

(2) to continue to monotir, assess and clarify, in consultation with other international organizations, national governments and professional and scientific bodies, the ethical, scientific and social implications of the use of cloning procedures in human health;

(3) to ensure that Member States are kept informed of developments in this area in order to facilitate decisions on national regulatory frameworks;

(4) to report to the 103rd session of the Executive Board and Fifty-second World Health Assembly on actions taken by the Organization in the this field.

Sixteenth meeting, 27 January 1998 (EBIOI/SR/16)

1. Document Eb I 0 1 / I 0.

2. Document EB I 0 1 /INF.DOC./3.

European Federation of Pharmaceutical Industries Associations

6 March 1997

PHARMACEUTICAL INDUSTRY AGAINST CLONING HUMAN BEINGS

The reported cloning of an adult sheep has raised widespread public concern about the possible misuse of this technology. The European Pharmaceutical industry fully shares this concern and urges that cloning human beings should be prohibited by law, as it already is in many individual Member States.

EFPIA represents the national pharmaceutical industry associations of 16 European countries and, through them, the interests of more than 2,200 pharmaceutical firms operating in Europe. This industry believes that genetic information should be used to prevent and cure diseases in order to meet patients’ legitimate expectations.

The pharmaceutical industry is away that this achievement will not be possible without the application of new technologies, such as cloning of cells, which is well defined and established as a valuable technique in the search of new ways to treat diseases. For example, new skin for burn victims, culturing replacements for diseased organs, alleviating paralysis by repairing injury spinal cord issues, and growing new health bone marrow cells for cancer victims.

Industry considers that behind every effort to push back the limits of science, man should remain the beneficiary and not the object of resarch itself. “We are against cloning human beings. We will back any initiative that addresses this specific concern”, said EFPIA President, Professor Rolf Krebs.

For Information : Brian Ager

Director General

EFPIA

Tel : +32 2 626 25 55

Fax : +32 2 626 25 66

European Society for Human Reproduction and Embryology (ESHRE)

Voluntary Moratorium on Cloning Human Beings         February 1997

The European Society of Human Reproduction and Embryology declares a voluntary five year moratorium on cloning human beings, where “cloning human beings” is defined as a the duplication of an existing or previously existing human being by transferring the nucleus of a diffrentiated, somatic cell into an enucleated human oocyte, and implanting the resulting product for intrauterine gestation and subsequent birth.

Overview

The recent demonstration that the nucleus of an adult sheep cell can be completely reprogrammed by the oocyte cytoplasm to generate a new adult sheep is exciting to developmental biologists because it demonstrates that the genetic information in mammals can remain intact in a differentiated adult somatic cell. In other words, nuclei of adult cells can be totipotent and capable of generating an entire adult organism. This had long been suspected from studies in amphibian embryos, but was not proved for any animal until the recent sheep study by Wilmut and co-workers (Nature 385 1997).

Basic Science Issues

The demonstration of totipotency in an adult mammalian somatic nucleus compels us to re-examine the process of cell differentiation. Specifically, it is important to study the means by which cells achieve a stable differentiated state and the extent to which differentiations can be altered by changing the cytoplasmic environment of adult nuclei. It is also important to identify the cytoplasmic factors in differentiated cells and in oocytes that regulate differentation or confer totipotency.

Human Heatlh and Biotechnology Applications

This demonstration of totipotency in an adult nucleus provides a major impetus for attempts to reprogram adult human cells so they can be used in cell-based therapies for human diseases. Thus, a full understanding of how cytoplasmic factors can reprogram adult nuclei holds great hope for developing novel strategies for repair and regeneration of human tissues, for example in treating diabetes, cancer and neurodegenerative diseases.

Application to Cloning Human Beings

The totipotency of adult nuclei could theoretically be applied to clone human beings, but there are major practical and ethical objections to carrying out such an act. First, based on current knowledge, the efficiency of embryonic development after nuclear transfer is so low, and the chance of abnormal offspring so high, that experimentation of this sort on human beings would be achieved of great risk to the offspring. Moreover, the deliberate generation of cloned human beings could infringe upon the dignity and integrity of human individuals. In response to these ethical concerns, federal and state representatives have introduced legislation intended to block cloning of human beings. Imprecise or misused technical languages in some of these resolutions could deter valuable research.

Resolution on Cloning Human Beings

We wish to encourage important new research on cell differentiation and nuclear-cytoplasmic interactions in laboratory animals, including mammals, to fully understand the implications of nuclear totipotency. We expect that further research using human cells will also be necessary to secure the benefits of insights from animal cloning and nuclear transfer research as applied to human health. By contrast, we would regard cloning a human being as an unethical and reprehensible act.

Historical precedent (with recombinant DNA technology) indicates that a voluntary moratorium is an effective means of preventing procedures that are potentially harmful or unsafe for humans.

Therefore, the membership of the European Society of Human Reproduction and Embryology declares a voluntary moratorium on cloning human beings. Members of the Society have no intention to attempt to clone human beings, where this act is defined as the duplication of an existing or previously existing human being by transferring the nucleus of a differentiated, somatic cell into an enucleated human oocyte, and implanting the resulting product for intrauterine gestation and subsequent birth. This moratorium shall be in effect for an period of five years, with subsequent reconsideration for possible extention.

German Council of Research, Technology and Innovation

Cloning of Humans : Biological foundations and Ethico-legal assessment

The successful generation, by Scottish breeders, of a mammal harboring the identical genetical material of another adult has created world-wide sensation and in some instances even scare. Many people ask about the meaning of this further step in a sequence of human interference in nature. Can this technique be applied to humans ? If this were so, should it not be prevented and how could it be prevented ? What are the limits imposed by our accepted ethical and legal principles ? Are legal interdictions currently in force sufficient to secure observance of necessary limits on a national and international scale ?

Answers to these questions require an explanation of the techniques of cloning and their possible application in humans (I), an assessment of its use in humans in the light of accepted ethical principles (II) an evaluation of its position within the legal system (III) before conclusions can be arrived at for further actions (IV).

* From a scientific point of view, it remains to be seen whether the possibility of cloning of mammals developed in Scotland will be confirmed. Should this be the case an application in humans cannot be considered impossible.

* From an ethical point of view, a first examination in the light of accepted ethical principles shows that cloning of humans is permissible neither in view of the legitimacy of the gaols nor with respect to the justifiability of the means.

* From a legal point of view, cloning of humans - by embryo splitting as well as by nuclear transplantation - is prohibited according to German laws. At all events, adjustments in the wording of the legal text are required for clarification.* The German legal position only has a limited applicability as long as international binding regulations have not been agreed upon. The human rights convention for biomedicine of the European Council appears to be a suitable foundation for such an urgently required international regulation going beyond EU regulations. This convention will allow embodiment of a suitable banin the projected protocol of embryo protection. Since this convention has been signed by member states of the Council of Europe only and by the USA and Canada, further international agreements will be required. An international ethico-legal discourse will be required to develop the framework for such agreements.

* An effective German contribution to this discourse will require an in-depth clarification of the mater and an intensive analysis of international positions and their recitals. This would entail a treatment not only of ethical principles and problems associated with their application but also treatment of aspects of philosophy of science and anthropology, as well as of social aspects of questions raised by cloning. This will be impossible without the participation of sciences involved in forming ethical propositions. To meet these requirements, the professional interdisciplinary ethical discourse in Germany should be developed and supported further.

Footnote

Also cell cultures e.g. human blood cells, which are generated by asexual propagation of single cells, are clones by definition. In the following text, only the generation of entire identical individuals or embryos capable of developing into such individuals will be treated since cell culture clones - including human cells - do not require further ethico-legal evaluation as longas they do not serve for cloning of individuals.

German Council of Research, Technology and Innovation

Cloning of Humans : Biological foundations and Ethico-legal assessment

The successful generation, by Scottish breeders, of a mammal harboring the identical genetical material of another adult has created world-wide sensation and in some instances even scare. Many people ask about the meaning of this further step in a sequence of human interference in nature. Can this technique be applied to humans ? If this were so, should it not be prevented and how could it be prevented ? What are the limits imposed by our accepted ethical and legal principles ? Are legal interdictions currently in force sufficient to secure observance of necessary limits on a national and international scale ?

Answers to these questions require an explanation of the techniques of cloning and their possible application in humans (I), an assessment of its use in humans in the light of accepted ethical principles (II) an evaluation of its position within the legal system (III) before conclusions can be arrived at for further actions (IV).

* From a scientific point of view, it remains to be seen whether the possibility of cloning of mammals developed in Scotland will be confirmed. Should this be the case an application in humans cannot be considered impossible.

* From an ethical point of view, a first examination in the light of accepted ethical principles shows that cloning of humans is permissible neither in view of the legitimacy of the gaols nor with respect to the justifiability of the means.

* From a legal point of view, cloning of humans - by embryo splitting as well as by nuclear transplantation - is prohibited according to German laws. At all events, adjustments in the wording of the legal text are required for clarification.* The German legal position only has a limited applicability as long as international binding regulations have not been agreed upon. The human rights convention for biomedicine of the European Council appears to be a suitable foundation for such an urgently required international regulation going beyond EU regulations. This convention will allow embodiment of a suitable banin the projected protocol of embryo protection. Since this convention has been signed by member states of the Council of Europe only and by the USA and Canada, further international agreements will be required. An international ethico-legal discourse will be required to develop the framework for such agreements.

* An effective German contribution to this discourse will require an in-depth clarification of the mater and an intensive analysis of international positions and their recitals. This would entail a treatment not only of ethical principles and problems associated with their application but also treatment of aspects of philosophy of science and anthropology, as well as of social aspects of questions raised by cloning. This will be impossible without the participation of sciences involved in forming ethical propositions. To meet these requirements, the professional interdisciplinary ethical discourse in Germany should be developed and supported further.

Footnote

Also cell cultures e.g. human blood cells, which are generated by asexual propagation of single cells, are clones by definition. In the following text, only the generation of entire identical individuals or embryos capable of developing into such individuals will be treated since cell culture clones - including human cells - do not require further ethico-legal evaluation as longas they do not serve for cloning of individuals.

Council of Europe :

Additional Protocol to the Convention on Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the prohibition of cloning human beings

The Member States of the Council of Europe, the other States and the European Community signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine.

Noting scientific developments in the field of mammal cloning, particularly through embryo splitting and nuclear transfer;

Mindful of the progress that some cloning techniques themsevles may bring to scientific knowledge and its medical application;

Considering that the cloning of human beings may become a technical possibility;

Having noted that embryo splitting may occur naturally and sometimes result in the birth of genetically identical twins;

Considering, however, that the instrumentalisation of human beings through the deliberate creation of genetically identical human beings is contrary to human dignity and this constitutes a misuse of biology and medicine;

Considering also the serious difficulties of a medical, psychological and social nature that such a deliberate biomedical practice might imply for all the individuals involved;

Considering the purpose of the Convention on Human Rights and Biomedicine, in particular the principle mentioned in Article 1 aiming to protect the dignity and identity of all human beings.

Have agreed as follows :

Article 1

1. Any intervetion seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited.

2. For the purpose of this article, the term humn being “genetically identical” to another human being means a human being sharing with another the same nuclear gene set.

Article 2

No derogation from the provisions of this Protocol shall be made under Article 26, paragraph 1, of the Convention.

Article 3

As between the parties, the provisions of Articles 1 and 2 of this Protocol shall be regarded as additional articles to the Convention and all the provisions of the Convention shall apply accordingly.

Article 4

This Protocol shall be open for signature by Signatories to the Convention. It is subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol unless it has previously or simultaneously ratified, acce pted or approved the Convention. Instruments of ratificaiton, acceptance of approval shall be deposited with the Secretary General of the Council of Europe.

Article 5

1. This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four Member States of the Council of Europe, have expressed their consent to be bound by the Protocol in accordance with the provisions of Article 4.

2. In respect of any Signatory which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.

Article 6

1. After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to this Protocol.

2. Accession shall be effected by the deposit with the Secretary General of the Council fo Europe of an instrument of accession whcih shall take effect on the first day of the monty following the expiration of a period of three months after the date of its deposit.

Article 7

1. Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe.

2. Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.

8. Article 8

The Secretary General of the Council of Europe shall notify the Member States of the Council of Europe, the European Community, any Signatory, any Party and any other State which has been invited to accede to the Convention of :

a- any signature;

b- the deposit of any instrument of ratification, acceptance, approval or accession;

c- any date of entry into force of this Protocol in accordance with Articles 5 and 6;

d- any other act, notification or communication relating to this Protocol.

In witness whereof the undersigned, being duly authorized thereto, have signed this Protocol.

Done at ………, this ………, in English and French, both texts beings equally authentic, in a singly copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each Member State of the Council of Europe, to the non-Member States which have participated in the elaboration of this Protocol, to any State invited to accede to the Convention and to the European Community.

Pontificia Academia Pro Vita : REFLEXIONS ON CLONING

25 Nov, 1997 : Liberia Editrice Vaticana (Extracts)

Ethical problems connected with human cloning

Human cloning belongs to the eugenics and is thus subject to all the ethical and juridical observations that have amply condemned it. As Hams Jonas has already written, it is “obth in method the most despotic and in aim the most slavish form of genetic manipulation; its objective is not an arbitrary modification of the hereditary material but precisely its equally arbitrary fixation in constrast to the dominant strategy of nature” (cf. Hans Jonas, Cloniamo un uomo : dall’eugenetica all’ingegneria genetica, in Tecnica, medicina ed etica, Einaudi, Torino 1997, pp. 122-54, p 136).

It represents a radical manipulation of the constitutive relationality and complementarity whcih is at the origin of human procreation in both its biological and strictly personal aspects. It tends to make bisexuality a purely functional left-over, given that an ovum must be used without its nucleus in order to make room for the clone-embryo and requires, for now, e female womb so that its development may be brought to term. This is how all the experimental procedures in zootechny are being conducted, thus changing the specific meaning of human reproduction.

In this vision, we find the logic of industrial production : market research must be explored and promoted, experimentation refined, ever renew models produced.

Women are radically exploited and reduced to a few of their purely biological functions (providing ova and womb) and research looks to the possibility of constructing articial wombs, the last step to fab ricating human beings in the laboratory.

In the cloning process, the basic relationships of the human person are perverted : filiation, consanguinity, kinship, parenthood. A woman can be the twin sister of her mother, lack a biological father and be the daugther of her grandfather. In vitro fertilization has already led to the confusion of parentage, but cloning will mean the radical rupture of these bonds.

As in every artificial activity, what occurs in nature is “mimicked” and “imitated”, but only at the price of ignoring how man surpasses his biological component, which, moreover, is reduced to those forms of reproduction that have characterized only the biologically simplest and least evolved organisms.

The idea is fostered that some individuals can have total dominion over the existence of others, to the point of having their biological identity selected according to arbitrary or purely utilitarian criteria - which, although not exhausting man’s personal identity, which is characterized by the spirit, is a constitutive part of it. This selective concept of man will have, among other things, a heavy cultural fallout beyond the numerically limited-practice of cloning, since there will be a growing conviction that the value of man and woman does not depend on their personal indentity but only those biological qualities that can be appraised and, therefore, selected.

Human cloning must also be judged negative with regard to the dignity of the person cloned, who enters the world by virtue of being the “copy” ‘even if only a biologicak copy) of another being : this practice paves the way to the clone’s radical suffering, for his psychic identity is jeopardized by the real or even by the merely virtual presence of his “other”. Nor can we support that a conspiracy of silence will prevail, a conspiracy which, as has already noted, would be impossible and equally immoral : since the “clone” was produced because he resembles someone who was “worthwhile” cloning, he will be the object of no less fateful expectations and attention, which will constitute a true and proper attack on his personal subjectivity.

If the human cloning project intends to stop “before” implantation in the womb, trying to avoid at least some of the consequences we have just indicated, it appears equally unjust from the moral standpoint.

A prohibition of cloning which would be limited to preventing the birth of a cloned child, but which would still permit the cloning of an embryo-foetus, would involve experimentation on embryos and foetuses and would require their suppression before birth-a cruel, exploitative way of treating human beings.

In any case, such experimentation is immoral because it involves the arbitrary use of the human body (by now decidedly regarded as a machine composed of parts) as a mere research tool. The human body is an integral part of every individual’s dignity and personal identity, and it is not permissible to use women as a source of ova for conducting cloning experiments. It is immoral because even in the use of a clone, we are in the presence of a “man”, although in the embryonic stage.

The moral reasons which led to the condemnation of in vitro fertilization as such and to the radical censure of in vitro fertilization for merely experimental purposes must also be applied to human cloning.

The “human cloning” project represents the terrible aberration to which value-free science is driven and is a sign of the profound malaise of our civilization, which looks to science, technology and the “quality of life” as surrogates for the meaning of life and its salvation.

The proclamation of the “death of God”, in the vain hope of a “superman”, produces an unmistakable result : the “death of man”. It cannot be forgotten that the denial of man’s creaturely status, far from exalting human freedom, in fact, creates new forms of slavery, discrimination and profound suffering. Cloning risks being the tragic parody of God’s omnipotence. Man, to whom God has entrusted the created world, giving him freedom and intelligence, finds no limits to his action dictated solely by practical impossibility : he himself must learn how to set these limits by discerning good and evil. Once again, man is asked to choose : it is his responsibility to decide whether to transform technology into a tool of liberation or to become its slave by introducing new forms of violence and suffering.

The difference should again be pointed out between the conception of life as a gist of love and the view of the human being as an industrial product.

Halting the human cloning project is a moral duty which must also be translated into cultural, social and legislative terms. The progress of scientific research is not the same as the rise of scientistic despotism, which today seems to be replacing the old ideologies. In a democratic, pluralistic system, the first guarantee of each individual’s freedom is established by unconditionally respecting human dignity at every phase of life, regardless, of the intellectual or physical abilities one possesses or is deprived. In human cloning, the necessary condition for any society begins to collapse : that of treating man always and everywhere as an end, as a value, and never as a mere means or simple object.

Human rights and freedom of research

At the level of human rights, the possibility of human cloning represents a violation of the two fundamental principles on which all human rights are based : the principle of equality among human beings and the principle of non-discrimination. Contrary to what may appear at first sight, the principle of parity and equality among human beings is violated by this possible form of man’s docmination over man, and the discrimination comes about through the whole selective-eugenic dimension inherent in the logic of cloning. The Resolution of the European Parliament (12 March 1997) expressly states the violation of these two principles and forcefully appels for the prohibition of human cloning and for the value of the dignity of the human person. Since 1983, the European Parliament and all the laws passed to legalize artificial procreation, even the most permessive, have always forbidden human cloning. It should be reached that the Church’s Magisterium has condemned the possibility of human cloning, twin fission and parthenogenesis in the 1987 Instruction. The basic reasons for the inhuman nature of possible human cloning are not W because it is an extreme form of artificial procreation in comparison to other legally approved forms, such as in vitro fertilization, etc.

As we have said, the reason for its rejection is that it denies the dignity of the person subjected to cloning and the dignity of human procreation.

The most urgent need now seems to be that of re-establishing the harmony between the demands of scientific research and indispensable human values. The scientist cannot regard the moral rejection of human cloning as a humiliation; on the contrary, this prohibition eliminates the demiurgic degeneration of research by restoring its dignity. The dignity of scientific resarch consists in the fact that it is one of the richest resources for humanity’s welfare.

Moreover, there is a place for research, including cloning, in the vegetable and animal kingdom, wherever it answers a need or provides a significant benefit for man or for other living beings, provided that the rules for protecting the animal itself and the obligation to respect the biodiversity of species are observed.

When scientific research in man’s interest aims to cure diseases, to relieve suffering, to solve problems due to malnutrition, to make better use of the earth’s resources, it represents a hope for humanity, entrusted to the talent and efforts of scientists.

To enable biomedical science to maintain and strengthen its relationship with the true welfare of man and society, it is necessary to foster, as the Holy Father recalls in the Encyclical Evangelium viatea, a “contemplative outlook” on man himself and the world, with a vision of reality as God’s creation and in a context of solidarity between science, the good of the person and of society.

“It is the outlook of those who see life in its deeper meaning, who grasp its utter gratuitousness, its beauty and its invitation to freedom and responsibility. It is the outlook of those who do not presume to take possession of reality but instead accept it as a gift, discovering in all things the reflection of the Creator and seeing in every person his living image” (Evangelium vitae, n. 83).

Prof. JUAN DE Dios VIAI, CORREA

President

Mons. ELIO SGRECCIA

Vice-President

National Bioethics Advisory Commission report to the President of the United States of America : June 9, 1997

EXECUTIVE SUMMARY

The ideas that humans might someday be cloned - created from a single somatic cell without sexual reproduction - moved further away from science fiction and closer to a genuine scientific possibility on February 23, 1997. On that date, The Observer, broke the news that Ian Wilmut, a Scottish scientist, and his colleagues at the Roslin Institute were about to announce the successful cloning of a sheep by a new technique which had never before been fully successful in mammals. The technique involved transplanting the genetic material of an adult sheep, apparently obtained from a fully differentiated somatic cell, into an egg from which the nucleus had been removed. The resulting birth of the sheep, named Dolly, on July 5, 1996, was different from prior attempts to create identical offspring from a pair of adult animals since Dolly contained the genetic material of only one parent, and was, therefore, a “delayed” genetic twin of a single adult sheep. This cloning technique, referred to in this report as “somatic cell nuclear transfer” is an extension of research that had been ongoing for over 40 years. The demonstration that a somatic cell’s gene expression could be “reprogrammed”, or that the full genetic complement of the cell could be reactivated well into the chronological life of the cell, is what sets the results of this experiment apart from prior work.

Within days of the published report of Dolly, President Clinton instituted a ban on federal funding related to attempts to clone human beings in this manner. In addition, the President asked the recently appointed National Bioethics Advisory Commission (NBAC) to address within ninety days the ethical and legal issues that surround the subject of cloning human beings. This provided a welcome opportunity for initiating a thoughtful analysis of the many dimensions of the issue, including a careful consideration of the potential risks and benefits. It also presented an occasion to review the current legal status of cloning and the potential constitutional challenges that might be raised if new legislation were enacted to restrict the creation of a child through somatic cell nuclear transfer cloning.

The Commission began its discussions fully recognizing that any effort in humans to transfer a somatic cell nucleus into an enucleated egg involved the creation of an embryo, with the apparent potential to be implanted in utero and developed to term. Ethical concerns surrounding issues of embryo research have recently received extensive analysis and deliberation in our country. Indeed, federal funding for hupman embryo research carried out in the private sector. Thus, under current law, the use of somatic cell nuclear transfer to create an embryo solely for research purposes is already restricted in cases involving federal funds. There are, however, no current federal regulations on the use of private funds for this purpose. NBAC did not reviw these particular issues in the context of this report. Instead, it focused its attention on the use of such techniques for the purpose of creating an embryo which would then be implanted in a woman’s uterus and brought to term. It also expanded its analysis of this issue to encompass activities in both the public and private sector.

In its deliberations, NBAC reviewed the scientific developments which preceded the Roslin announcement, as well as those likely to follow its path. It also considered the many moral concerns raised by the possibility that this technique could be used to clone human beings. Much of the initial reaction to this possibility was negative. Careful assessment of that response revealed fears about harms to the children who may be created in this manner, particularly psychological harms associated with a possibly diminished sense of individuality and personal autonomy. Others expressed concern about a degradation in the quality of parenting and family life if a child’s develpment was no longer fully unpredictable, especially if parents were to confuse the predictability of certain highly genetically determined physical traits with the predictability of their personality, cognitive capacity and character.

In addition to concerns about specific harms to children, people have frequently expressed fears that a widespread practice of somatic cell nuclear cloning would undermine important social values by opening the door to a form of eugenics or by tempting some to manipulate others as if they were objects instead of persons. Arrayed against these concerns are other important social values, such as protecting the widest possible sphere of personal choice, particularly in matters pertaining to procreation and child rearing, maintaining privacy, and the freedom of scientific inquiry, and encouraging the possible development of new biomedical breakthroughs.

To arrive at its recommendations concerning the use of somatic cell nuclear transfer techniques to create children, NBAC also examined long-standing religious traditions that guide many citizens’ responses to new technologies and found that religious positions in human cloning are pluralistic in their premises, modes of argument, and conclusions about human cloning. Some religious thinkers argue that the use of somatic cell nuclear transfer cloning to create a child would be instrinsically immoral and thus could never be morally justified. Other religious thinking contend that human cloning to create a child could be morally justified under some circumstances, but hold that it should be strictly regulated in order to prevent abuses.

The public policies recommended with respect to the creation of a child using somatic cell nuclear transfer reflect the Commissions best judgements about both the ethics of attempting such an experiment and our view of traditions regarding limitations on individual actions in the name of the common good. At present, the use of this technique to create a child would be a premature experiment that would expose the fetus and the developing child to unacceptable risks. This in itself is sufficient to justify a prohibition of clonign human beings at this time, even if such effots were to be characterized as the exercise of a fundamental right to attempt to procreate.

Beyond the issue of the safety of the procedure, however, NBAC found that concerns relating to the potential psychological harms to children and effects on the moral, religious and cultural values of society merited further reflection and deliberation. Whether upon such further deliberation our nation will conclude that the use of cloning techniques to create children would be allowed or should be permanently banned is an open question. Time is an ally in this regard, allowing for the accrual of further data from animal experimentation, enabling an assessment of the prospective safety and efficacy of the procedure in humans, as well as granting a period of fuller national debate of ethical and social concerns. The Commission, therefore, concluded that there should be imposed a period of time in which no attempt is made to create a child using somatic cell nuclear transfer.

Within this overall framework, the Commission came to the following conclusions and recommendations :

I- The Commission concludes that at this time it is morally unacceptable for anyone in the public or private sector, whether in a reasearch or clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning. We have reached a consensus on this point because of insufficient information on the safety and effectiveness of this method in humans. Indeed, we believe it would violate important ethical obligations were clinicians or researchers to attempt to create a child using these particular technologies, which are likely to involve substantial risk to the fetus and/or potential child. Moreover, in addition to safety concerns, many other serious ethical concerns have been identified, which require much more widespread and careful public deliberation before this technology may be used.

The Commission, therefore, recommends the following for immediate action :

* A continuation of the current moratorium on the use of federal funding in support of any attempt to create a child by somatic cell nuclear transfer.

* An immediate request to all firms, clinicians, investigators, and professional societies in the private and non-federally funded sectors to comply voluntarily with the intent of the federal moratorium. Professional and scientific societies should make clear that any attempt to create a child by somatic cell nuclear transfer and implantation into a woman’s body would at this time by an irresponsible, unethical and unprofessional act.

II- The Commission further recommends that :

* Federal legislation should be enacted to prohibit anyone from attempting, whether in a research or clinical setting, to create a child through somatic cell nuclear transfer cloning. It is critical, however, that such legislation include a sunset clause to ensure that Congress will review the issue after a specific period of time (three to five years) in order to decide whether the prohibition continues to be needed. If state legislation is enacted, it should also contain such a sunset provision. Any such legislation or associated regulation also ought to require that at some point prior to the expiration of the sunset period, an appropriate oversight body will evaluate and report on the current status of somatic cell nuclear transfer technology and on the ethical and social issues that its potential use to create human beings would raise in light of public understandings at that time.

III- The Commission also concludes that :

* Any regulatory or legislative actions undertaken to effect the foregoing prohibition on creating a child by somatic cell nuclear transfer should be carefully written so as not to interfere with other important areas of scientific research. In particular, no new regulations are required regarding the cloning of human DNA sequences and cell lines, since neither activity raises the scientific and ethical issues that arise from the attempt  to create children through somatic cell nuclear transfer, and these fields of research have already provided important scientific and biomedical advances. Likewise, research on cloning animals by somatic cell nuclear transfer does not raise the issues implicating in attempting to use this technique for human cloning, and its continuation should only be subject to existing regulations regarding the humane use of animals and review by institution-based animal protection committees.

* If a legislative ban is not enacted, or if a legislative ban is ever lifted, any effort to use the somatic cell nuclear transfer technique to create a child should be preceded by controlled research that is governed by the twin protections of independent review and by existing standards regarding protection of human subjects, including informed consent.

* The United States Government should cooperate with other nations and international organizations to enforce and common aspects of their respective policies on the cloning of human beings.

IV- The Commission also concludes that different ethical and religious perspectives and traditions are divided on many of the important moral issues that surround any attempt to create a child using somatic cell nuclear transfer techniques. Therefore, we recommend that :

* The federal government, and all interested and concerned parties, encourage widespread and continuing deliberation on these issues in order to further our understanding of the ethical and social implications of this technology and to enable society to produce appropriate long-term policies regarding this technology should the time come when present concerns about safety have been addressed.

V- Finally, because scientific knowledge is essential for all citizens to participate in a full and informed fashion in the governance of our complex society, the Commission recommends that :

* Federal departments and agencies concerned with science should cooperate in seeking out and supporting opportunities to provide information and education to the public in the area of genetics, and on other developments in the biomedical sciences where these affect important cultural practices and commitments.