J 52 JILI 2010 92 Gauravsinghug Nliuacin 20200722 211850
J 52 JILI 2010 92 Gauravsinghug Nliuacin 20200722 211850
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to understand the genetic process of human cloning, in order to understand its impact.
II Meaning of cloning
The term cloning is an ambiguous one, as it can refer to various processes. It is well
known that many plants can clone themselves, and have presumably been doing so
since life began. In this paper cloning has been taken in the sense as referred in the
report of the Human Genetics Advisory Commission (HGAC) and the Human
Fertilization and Embryology Authority (HFEA)4 in which it is defined as ‘producing a
cell or organism with the same nuclear genome as another cell or organism’. This
definition assumes that, in this type of cloning, the entire genetic identity of an
individual is copied, although this is not strictly true because when Dolly was formed,
she inherited not only the geocentric material in the parental nucleus but also the
small amount of DNA which exists outside the nucleus of each cell and which in this
case come from the donor egg. Accordingly, the definition of cloning used in the above
report was not entirely accurate: it is vital that it should be pointed out. Nevertheless,
the definition in the report does make clear the general type of cloning to which it
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applies.
III Cloning process
The process of cloning indicates the taking of a cutting (as in plant breeding), and
also includes nuclear transfer, of genetically identical animals. Nuclear transfer
involves removing the chromosomes from an unfertilized egg and replacing them with
a nucleus from a donor cell. As it is the transfer of nucleus that determines almost all
of the characteristics of the resulting offspring, a clone will resemble its parents, i.e.
the animal from which the donor cell was taken.5 The same technique was used in
order to create Dolly. The nucleus from egg cell was removed and the same was
replaced with mammary cell of an adult sheep. After that an electric current applied
which caused the egg, its new nucleus to fuse and develop into an embryo. Later on,
the created embryo was implanted into surrogate
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Dolly which was only a lamb born from a series of implantation into surrogate ewes.6 If
the same technique applied in human beings, cloning would essentially be through
somatic cell7 of nuclear transfer. The process would involve transferring a human
diploid nucleus into a human ovum from which its own nucleus has been removed. The
donor nucleus could be taken from a fetal stem cell or adult somatic cell.8 This process
would require - a consenting donor as a source of DNA, nucleation of egg, fusion of
DNA, a woman to carry and deliver the child and a person or couple to raise the child.9
The process of cloning is being perfected in laboratories and the day does not seem far
when the successful creation of a human clone will be announced.
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therapeutic development for serious diseases such as cancer, heart disease and
reconstructive and cosmetic surgery are areas that might benefit from such new
technology.10
Solter of the Max-Planck Institute for Immunology is of the opinion that cloning
provides a revolutionary answer to current problems of rejection in organ transplants.11
Because some time the patient who needed an organ or tissue transplantation might
lack a medically suited donor. As Robertson 12 pointed out, the couples in this situation
have often conceived a child in the hope that she would have the correct tissue type to
serve, like a bone marrow donor for an older sibling. If the child's disease was not
genetic, a couple might prefer to clone the affected child to be sure that the tissue
would match. New York University bioethicist Jacob M. Appel has argued that “children
cloned for therapeutic proposes” such as “to donate some marrow to a sibling with
leukemia” might some day be viewed as heroes.13 Of course, this raises many ethical
questions which have been dealt in the course of the paper.
Cloning could also assist couples who are both infertile due to game tic
insufficiency. It could provide a viable alternative to embryo donation. In situation
where the male partner lacks gametes, the couple might prefer to opt for cloning,
rather than sperm donation.14 If the husband was source of the DNA and the wife
provided the egg that received the nuclear transfer and then gestated the foetus, they
would have a child biologically related to each other and would not have to rely on
anonymous
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(v) The process of cloning is likely to lead to severely disabled children. Bioethicist
Thomas Murray of the Hastings Centre argued that it is absolutely inevitable that
groups are going to try to clone a human being.25 But they are going to create a
lot of dead and dying babies along the way.26 It is likely that there would be a
great number of failures in the creation of living human clone, such as clones
without viable immune systems or other gross genetic failures.
(vi) In Aubrey de gray's proposed SENS (Strategies for Engineered Negligible
Senescence), one of the considered options to repair the cell depletion related to
cellular senescence is to grow replacement tissues from stem cells harvested
from a cloned embryo.
(vii) Cloning is also a crime against the clone, the crime of depriving the clone of
her “existential right” particularly, the right to ignorance of facts about her origin
that is likely to be paralysing for the spontaneity of becoming self. This advance
knowledge of the reason for her existence destroyed the clone's chances of
authentic growth, of answering the fundamental existential question, “who am
I”.27 The report of National Bioethics Advisory Commission (NBAC) also
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expressed this concern about the interest of the clone and it individuality.
(viii) From religious point of view, some Islamic scholars argue that cloning testifies
resurrection i.e. revival of life, however, it is not seen as a creative act, rather it
is considered destructive and satanic act as it bungles with divine creation.28
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for bringing a child into the world do not necessarily determine the manner in which
they raise them. Seeing their child grow and develop, they learn that he/she is not
merely an extension of themselves.
(xiii) Some scientists, including Richard Seed, suggests that human cloning might
obviate the human aging process.31 Preston Estep has suggested the term
“replacement cloning” to describe the generation of a clone of a previously living
person, and “persistence cloning” to describe the production of a cloned body for
the purpose of obviating aging, although he maintains that such procedures
currently should be considered as science fiction and current cloning techniques
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risk producing a premature aged child.32
VII Legal Aspect of Cloning
Despite the numerous potential beneficial application of human cloning technology,
governments of the world over have come down heavily on the very research, leave
alone commercial application of such technology. The reasons flow out of ethical and
social concern about cloning and possibility of misuse.
United States
Following the birth of Dolly, US President Bill Clinton announced an executive ban
on federal funding for “human cloning” on March 4, 1997. He also directed the
National Bioethics Advisory Commission (herein after mentioned as NBAC) to make
recommendations about human cloning. Pursuant to the recommendations of NBAC
and the announcement by Richard Seed (had the technology to clone a human being,
incidentally turned out to be a hoax), the cloning was banned for a period of ten
years.33 At the time, the fact that Seed was physicist with no expertise in cloning, no
institutional affiliation, and no funding, seemed inconsequential compared to what he
proposed he could do for a fee. The NBAC's recommendation of a five year moratorium
was in fact enacted
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in California.34 The impetuously drafted bills in both Senate (the Bond-First Bill) and
House (the Ehlers Bill), however, went far beyond restricting the cloning of humans.
These bills were to put an end to all cloning experiments that used human cells, in
particular, research into somatic cell nuclear transfer technology. These were opposed
by dozens of medical organization, (predictably) biotechnology companies, and
distinguished scientists.
In 1998, 2001, 2004 and 2007, the United State House of Representative voted
whether to ban all forms of human cloning, both reproductive and therapeutic. Each
time, there was division in Senate over prevention of therapeutic cloning but absolute
ban was accepted in respect to reproductive cloning. Some American states ban both
forms of cloning while some others outlaw only reproductive cloning.
Current regulations prohibit federal funding for research into human cloning, which
effectively prevents such research conducted in public and private institutions such as
universities which receive federal funding. However, there is currently no federal laws
in the United States which ban cloning completely, and any such law would raise
difficult constitutional questions similar to the issues raised in abortion cases.
European countries
The European Convention on Human Rights and Biomedicine35 promoted by the
Council of Europe prohibits any intervention seeking to create a human being identical
to another human being whether living or dead.36 The term ‘genetically identical’ is
defined as where a human being shares along with another the same nuclear gene set.
It is submitted that if legislation is eventually passed dealing with human cloning,
then this definition could usefully be adopted as it deals with the problem of some
genes coming from the DNA in the egg cell. The prohibition appears to cover
therapeutic as well as reproductive cloning because it provides (article 7) that the
prohibition on cloning of human beings covers all
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nuclear transfer methods seeking to create identical human beings. Two countries did
not sign the Protocol to the Convention. One was Germany, which asserted that it had
its own legislation - Federal Embryo Protection Act, 1990 that completely prohibits
experiments on human embryo. Another country which refused to sign the Convention
was UK. The reason was given by Baroness Hayman, when she replied to the debate,
that “whilst the government fully supporting the principle enshrined in the protocol, it
could not sign it because to do so would also mean signing the whole Convention
which contained the provisions relating to research on persons not able to give consent
which needed to be examined in the light of forthcoming legislation to be introduced
by the government following the Law Commission's working paper “Who decides”?.
The much of the pressure to legislate at least therapeutic human cloning comes
from commercial organizations. The Biotechnology Patents Directive37 expressly
prohibits patenting process for cloning of human beings.38 Once again the familiar
problem of definition rears its head because of the doubt whether an embryo which
has not yet reached the age of 14 days is included as a human being? However, large
firms may be reluctant to spend even huge sums of money when there is a doubt
about patentability. It is noteworthy that in November 1997 UNESCO brought out the
Universal Declaration on the Human Genome and Human Rights which provides, in
clause 11, that practices which are contrary to human dignity, such as reproductive
cloning of human beings, shall not be permitted.
United Kingdom
The precise legal position in the UK on cloning is uncertain. The starting point is the
Human Fertilization and Embryology Act, 1990, which absolutely prohibits certain
activities, such as cloning, although there is doubt about precisely what the Act means
by this. Other activities, such as the creation of an embryo ex utero or the storage of
embryos or gametes require a license under the Act. If any activity is not covered by
the Act, naturally it is not subject to legal regulation at all, and it may be that this
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is so in case of human cloning. Since 1990 human cloning was not known, so no
requirement was felt to legislate on the subject. The meaning of embryo has been
explained in the Act as a live human embryo where fertilization is complete39 and the
term fertilization stated that reference to an embryo includes an egg in the process of
fertilization.40 Section 3(3)(d) of the Act contains a prohibition on cloning per se by
providing that a license granted under the Act, cannot authorize replacing a nucleus
taken from the cell of any person, embryo or subsequent development of an embryo.
The difficulty here is that although those words appear to prohibit nuclear transfer
cloning, which is what precisely occurred in Dolly's case, is not covered because of the
word embryo. The Act, 1990 uses two terms; fertilization and embryo which do not
cover what is now understood by cloning. However, the Act allows certain activities
under a license, among which is the storing of gametes. Section 4(2) of the Act
provides that a license cannot authorize storing of using gametes in any circumstances
in which regulations prohibit their storage or use. This may not cover what happened
in Dolly's case because cell membrane was used to create Dolly, which was not
gamete. The final relevant part of the Act, 1990 is section 8(a) which provides that the
Human Fertilization and Embryology Authority must keep under review the information
about embryos and any subsequent development of embryos. Once again, although
these words were inserted to enable the HFEA to deal with developments probably
unforeseen when this Act was passed. (This question whether human cloning was
covered by the Act, 1990 exercised the minds of House of Common Sciences and
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Technology Committee.) In evidence, Ian Willmut (the creator of Dolly) accepted the
point made by chairman of the committee41 that the crucial thing is that the word
embryo be defined in law in such a way that science is clear as to what it actually
means. Bulfield put the point simply that ‘an embryo cannot be in the process of
fertilization because it is only an embryo after fertilization’.42 A memorandum
submitted by the Department of Health43 stated that it had been agreed with the HFEA
to make a joint approach to counsel on the definition of embryo as used in the Act. It
also stated that their current legal advice was that if a court was asked to consider the
matter it
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would be likely to come up with a broad construction which would bring the technique
used in the cloning of Dolly within the Act, 1990. The effect is that, at present, any
decision on whether to grant a license to permit reproductive cloning rests entirely
with a statutory body which, although subject to judicial review44 and is not subject to
any kind of democratic scrutiny or control. Moreover, one may arrive at this position by
the extremely dubious route of assuming that the courts will define the term ‘embryo’
so that it means something which at present it does not. The report recognized that
many persons find it unsatisfactory by stating that the government may wish to
consider the possibility of introducing primary or secondary legislation explicitly45
banning reproductive cloning. In response, the government simply stated that it will
keep under continuing review the adequacy of the existing safeguards and the
possible need for additional legislation, with a further detailed analysis in five years
time if necessary. In this regard, the government set up an expert advisory group.
Some confusion was also created in between the Human Genetic Advisory Commission
and the Human Fertilization and Embryology Authority reports by leveling some forms
of therapeutic cloning as cell nucleus replacement. The government asked the expert
advisory group to look at the recommendations in the report46 so that two additional
purposes for human embryo research should be added to those which are already in
the 1990 Act. This will permit the development of methods of therapy for (i)
mitochondrial disease and (ii) for diseased or damaged tissues of organs. These
additional purposes would be added by regulations made under section 45 of the Act,
1990 and would not therefore require fresh legislation.
On January 14, 2001 the British government passed the Human Fertilization and
Embryology (Research Purposes) Regulations, 200147 to amend the Human
Fertilization and Embryology Act, 1990 by extending allowable reasons for embryo
research to permit research around stem cells and cell nuclear replacement, thus
allowing therapeutic cloning. However, on November 15, 2001, a pro-life group won a
high court legal challenge, which struck down the regulation and effectively left all
forms
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of cloning unregulated in the UK.48 Parliament was quick to pass Human Reproductive
Cloning Act, 200149 which explicitly prohibited reproductive cloning. The remaining
gap with regard to therapeutic cloning was closed when appellate court reversed the
previous decision of the high court.50
The first license was granted on August 11, 2004 to researchers at the University of
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Newcastle to allow them to investigate treatments for diabetes, Parkinson and
Alzheimer deseases.51 The Human Fertilization and Embryology Act, 2008 a major
review of fertility legislation, repealed the 2001 cloning Act by making amendments of
similar effect to the Act 1990. The Act, 2008 also allows experiments on hybrid human
-animal embryo.52
Australia
Australia had prohibited human cloning,53 however, in December, 2006 a bill
legalizing therapeutic cloning and the creation of human embryos and the stem cell
research was passed by the House of Representatives. Within certain regulatory limits,
and subject to the effect of state legislation, therapeutic cloning is now legalised in
some parts of Australia.
United Nations
In 1997, UNESCO brought out the Universal Declaration on Human Genome and
Human Rights which provides54 that practices which are contrary to human dignity,
such as reproductive cloning of human being, shall not be permitted.
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On December 12, 2001, the United Nations General Assembly began elaborating on
International Convention Against the Reproductive Cloning of Human Beings. A broad
coalition of states including Spain, Italy, Philippines the United States, Costa Rica and
the Holy See sought to extend the debate to ban all forms of human cloning, noting
that, in their view, therapeutic human cloning violates human dignity. Costa Rica
proposed the adoption of an International Convention to Ban All Forms of Human
Cloning. Unable to reach consensus on a binding convention in March, 2005 a non-
binding United Nations Declaration on Human Cloning55 calling for the ban of all forms
of human cloning contrary to human dignity, was finally adopted.56 The declaration
solemnly affirms following:
1. Member states are called to adopt all measures necessary to protect adequately
human life in the application of life sciences.
2. They are called upon to prohibit all forms of human cloning inasmuch as they are
incompatible with human dignity and the protection of human life.
3. They are further called upon to adopt the measures necessary to prohibit the
application of genetic engineering techniques that may be contrary to human
dignity.
4. They are called upon to take all measure to prevent the exploitation of women in
the application of life science.
5. They are also called upon to adopt and implement without delay national
legislation to bring into effect the above.
VIII Conclusion
It is clear by the above discussion that the debate would by no means be silenced
by imposing a moratorium on it. The time is appropriate, however, to consider what
kind of policy is required to regulate the use of cloning technology and prevent undue
commercial exploitation of the
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process. Firstly, the question for consideration is whether state intervention is
required? Obvious answer is ‘yes’ because cloning, while enhancing the rights of a few
who take risk to exercise their procreative liberty, the lives of many others may be
affected, including that of clone,57 in utilitarian sense, rights and the interest of the
majority should prevail.
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that there was some compelling, countervailing need to benefit present or future
generations before such an experiment was permitted (for example, if the entire
species were to become sterile). The regulators would not have the burden of proving
that there was some compelling reason not to approve it. This regulatory scheme
would depend on at least a de-facto, if not a de-jure, ban or moratorium on such
experiments.
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Since then, thousands of babies have been born to infertile couples through this
method. It is submitted that skepticism about an idea alone ought not to preempt
informed debate. In area of human cloning, the extreme conjures images of wasted
embryos and deformed babies, of infinite life, of master races and duplicate of famous
scientist, artists and other celebrities. On the other hand, cloning has technology with
boundless implications for the treatment of infertility and diseases. There are merits in
both the arguments, though the truth probably lies somewhere in between and the
debate must go on till science tells all.
———
*
Head, Department of Law, Dean, School for Legal Studies, B.B. Ambedkar University, Raebareli Road, Lucknow
(U.P.).
1
Joshua Lederberg, “Experimental Genetics and Human Evolution”, 100(915) The American Naturalist 519-531
(1966) cited in http://en.wikipedia.org/wiki/Human_cloning.
2James Watson, “Moving Towards a Clonal Man: Is This What We Want?” The Atlantic Monthly (1971) Quoted in
en.wikipedia.org/wiki/Human_cloning.
3 Kelly Morris, “Studies Give Boost to Promise of Cloning Techniques” 352 The Lancet 293 (1998).
4
Both Commission and Authority established to report on regulation of nuclear replacement from unfertilized egg.
5I. Willmut, “The Uses and Ethics of Cloning” in David Calhaun (ed)., Britanica Book of the Year: Events of 1997,
1998.
6 I. Willmut, “Viable Offspring Derived From Foetal and Adult Mammalian Cells” 385 Nature 810-813 (1997).
7Somatic cells are the non-reproductive cell, they contain the full set of 23 pairs of chromosomes in the human
body.
8 Jerome P. Kassirer, “Should Human Cloning Research be Off-limits?” 339 New Eng J Med 905 (1998).
9 John A. Robertson, “Human Cloning and the Challenge of Regulation” 339 New Eng J Med 120 (1998).
10
“Cloning Fact Sheet” available at
http://www.oml.gov/techresources/Human_Genome/elsi/cloning.shml#organsQ. (visited on November 20, 2009).
11 D. Solter, “Dolly is A Clone and No Longer Alone” 394 Nature 315-316 (1998).
12 Supra note 9.
13 J.M. Appel, New York Time Magazine December 11, 2005 as quoted in en.wikipedia.org/wiki/Human_cloning.
14 D. Butter and M. Wadman “Call for Cloning Ban Sells Science Short” 386 Nature 8 (1997).
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15Andrea L. Bonnicksen, “Procreation By Cloning: Drafting Anticipatory Guidelines” 25 Journal of Law, Medicine &
Ethics 276 (1997).
16 “Cloning Touted as Infertility Solution” Washington Times, December 11, 1997 quoted in
en.wikipedia.org/wiki/Humancloning.
17 Available at http://www.newscientist.com/article/dn3393-dolly-the-sheep-dies-young.html. (visited on
November 20, 2009).
18 Supra note 9.
19 Ibid.
20 Arts. 15(1) and 15(3)(b) of International Covenant on Social, Economic and Cultural Rights, 1966.
21 Carl J. Friedrich, The Philosophy of Kant: Immanuel Kant's Moral & Political Writings, 154-229 (1993).
22 Ehreureich Barbara, “The Economics of Cloning” Times November 22, 1993 at 86.
23 Philip E. Dewitt, “Cloning — Where Do We Draw the Line?” Times November 08, 1993 at 64.
24 George J. Annas, “Why We Should Ban Human Cloning” 339 N. Eng J Med 123 (1998).
25 Available at http://www.scholieren.com/werkstukken/20448 (visited on November 20, 2009).
26 Codification Division, Office of Legal Affairs, United Nation (2005-05-18). “Ad-hoc Committee on an
International Convention Against the Reproductive Cloning in Human Being” available at
http://www.un.org/law/cloning. United Nation http://www.un.org/law/cloning/ (visited on January 8, 2007).
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47Available at http://www.statutelaw.gov.uk/content.apex?activeTextDocld=2523310 (visited on November 20,
2009).
48
S.D. Pattinson, Medical Law and Ethics (2006). Quoted in en.wikipedia.org/wiki/Human_cloning.
49“Campaigners Win Cloning Challenge” available at http://news.bbc.co.uk/1/hi/sci/tech/1657707.stm.BBCNews.
(November 15, 2001) (visited on September 06, 2008).
50
“Lords Uphold Cloning Law” available at http;//news.bbc.co.uk/2/hi/health/2846265.stm. BBC News Online,
March 13, 2003.
51
“HEFA Grants the First Therapeutic Cloning License for Research” available at
http://www.hfea.gov.uk./en/1048html (visited on September 06, 2008).
52“MPs Support Embryology Proposals” available at http://news.bbc.co.uk/2/hi/uk_news/politics/7682722.stm).
BBC news on lines. October 23, 2008.
53 The Prohibition of Human Cloning for Reproduction Act, 2002.
54
Art. 11 of UDHR.
55 Available at http://www.bioeticaweb.com/content/veiw/1267/765/lang.es/1. (visited on October 21, 2009).
56Codification Division, Office of Legal Affairs, United Nations “Ad-hoc Committee on an International Convention
Against the Reproductive Cloning of Human Beings.” Available at http://www.un.org/law/cloning/. United Nations,
http://www.un.org/law/cloning.
57
Rizwanul Haq, “Ethical, Moral and Legal Issues Involved in Cloning” 1 Supreme Court Journal 8 (1998).
58
The jurisprudence which is being evolved by the US courts on the liability of the tobacco industry in cases of
chain smokers contracting lung cancer, up to huge pecuniary amounts, poses an interesting analogy.
59
Supra note 24 at 125.
60
Supra note 8.
61 Ibid.
62
Supra note 5.
63
Russel, Scott, The Body as Property 198 (1981).
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