such as "Introduction", "Conclusion"..etc
The emerging global consensus on bioethics is clearly minimalist.
When addressing these sensitive issues, international instruments do
not pretend to provide a precise and definitive answer to the most
intricate questions posed by medicine and genetics. On the contrary,
international bodies tend to lay down very general principles like the
requirement of informed consent, the confidentiality of health
information, the principle of non-discrimination for genetic reasons
and the promotion of equity in the allocation of resources in health
care, especially to meet the needs of the most disadvantaged
The importance of setting general principles
relating to biomedicine should not be understated. General
international standards, far from being purely rhetorical statements,
may constitute a first step towards promoting more concrete regulations
at a national level. It should not be forgotten that national
governments, not international organizations, are the primary agents
for the realization of human rights.
In any case, the
international consensus is exceptionally precise on two specific
issues, because it aims to prevent some potential developments that
raise the most serious concerns for the future of humanity: germ-line
interventions and human reproductive cloning. The lawmaking process,
which is usually accused of being too slow to keep up with scientific
advances, has on this occasion overtaken science, because legal
provisions are being adopted to prevent two technologies that do not
ethical reflections on germ-line interventions usually stress the fact
that, unlike alterations of genes in somatic cells, which affect only
the treated person, any alteration in germ cells (gametes) or in early
embryos before the stage of differentiation would be passed to the next
generation. This distinction has serious moral relevance: although
somatic cell gene therapy does not raise specific ethical questions,
insofar as it does not serve an enhancement purpose, germ-line
interventions, given their irreversible effects on future generations
and their possible misuse for eugenic purposes, pose unprecedented
concerns. This is why most ethical and legal regulations that cover
this issue strongly discourage or frankly prohibit this procedure.
the international level, UNESCO Universal Declaration on the Human
Genome and Human Rights provides that germ-line interventions "could be
contrary to human dignity" (Article 24). Similarly, the European
Convention on Human Rights and Biomedicine states that "an intervention
seeking to modify the human genome may only be undertaken for
preventive, diagnostic or therapeutic purposes and only if its aim is
not to introduce any modification in the genome of any descendants"
At the national level, some legal provisions
and guidelines that ban germ-line interventions have already been
adopted by some countries — mostly developed countries (18).
This latter circumstance is not surprising, because human genetic
engineering would be possible only where the financial, human and
technical means were available. In contrast, developing countries have
more urgent problems to solve — such as improving access to basic
health care services — before worrying about human genetic engineering.
Nevertheless, some developing nations, such as Brazil and India, have
also adopted ethical and legal standards on this issue (Brazil Law
8974/95) (19). This is probably due to the mixed situation of
these countries, in which a high level of poverty and social inequity
coexists with remarkable scientific and technological developments.
respect to objections to germ-line genetic engineering, it is important
to note that they are of a different nature, depending on the purpose
of the intervention.
In the case of germ-line interventions
for therapeutic purposes — that is, for preventing the transmission of
diseases — if we leave aside the controversy on embryo research, the
objection is not based on intrinsic ethical arguments, but on the risks
of serious and irreversible harm to future generations (20, 21).
In addition to this, it is important to recognize that the idea of
eliminating "harmful" genes from the entire human population is more
utopian than real. Such a global result, if ever possible, could only
be realized over thousands of years and with recourse to massive
coercive programmes, which would be morally unacceptable (22).
the case of germ-line interventions for enhancement purposes, the
objections are more fundamental and are based on the idea that we do
not have the right to predetermine the characteristics of future
individuals. That means that people should be free to develop their
potentialities without being biologically conditioned by the particular
conceptions of "good" and "bad" human traits that were dominant at the
time of those who preceded them. In other words, genetics should not
become the instrument for a kind of intergenerational tyranny (23–25).
A second objection is that the procedure would profoundly affect our
own self-perception as "subjects" — that is, as autonomous beings —
which might lead us to consider ourselves as mere "objects" or
biological artefacts designed by others (22, 26).
Human reproductive cloning
the announcement that a sheep had been successfully cloned from the
cell of an adult animal in 1997, concern about the possibility that the
same technique could be applied to produce genetically identical human
beings has been widespread.
In the debate on human
cloning, it is usual to make a distinction between "reproductive
cloning" and "therapeutic cloning" In the first case, the embryo
obtained by the cloning procedure is transferred to a woman's uterus;
this begins a process that eventually may lead to the birth of a baby
genetically identical to the cell donor. In the second case, the
embryo's inner mass is harvested and grown in culture for subsequent
derivation of embryonic stem cells that may have therapeutic
applications in the treatment of serious degenerative disorders, such
as Alzheimer's disease or Parkinson's disease. Although the consensus
at the political level is that human reproductive cloning should be
banned, no agreement about the ethical acceptability of therapeutic
cloning has been reached. In this respect, some have argued that the
creation of embryos by cloning for the derivation of stem cells offers
such significant potential medical benefits that research for such
purposes should legally be permitted (27). Others consider that
only embryos that remain after in vitro fertilization procedures should
be used for that purpose, because they will be discarded anyway (28).
Still others are opposed to the use of either cloned embryos or "spare"
embryos from in vitro fertilization procedures, on the grounds that any
deliberate destruction of human life is ethically unacceptable (29).
It is evident, therefore, that the value we attach to human embryos
remains the key issue in the debate on therapeutic cloning.
the international level, the most recent initiative aimed at preventing
human cloning was taken in December 2001 by the United Nations General
Assembly, when it established the Ad Hoc Committee on an International
Convention against the Reproductive Cloning of Human Beings (30).
This initiative was a response to the request of the French and German
governments to the United Nations to approve a worldwide ban on human
cloning. The Committee met twice in New York, once in February and once
in September 2002 to start the convention process, which is expected to
conclude in 2003. The central issue, which remains unsolved, is whether
the convention should ban only reproductive cloning or whether it
should also include the creation of cloned human embryos for
Other important international
instruments that ban (mainly reproductive) human cloning have been
adopted by UNESCO, the Council of Europe, the World Health Organization
(WHO resolutions WHA50.37 (1997) and WHA51.10 (1998)), the World
Medical Association, the European Union and the European Parliament (3, 31–36).
the national level, many countries have passed provisions that prohibit
human reproductive cloning, including France, Germany, Japan, Peru,
Spain, Switzerland and the United Kingdom (18).
the other hand, it is also helpful to consider the arguments, mainly
based on utilitarian reasons, put forward in favour of reproductive
cloning. Cloning would allow infertile couples to have children who are
biologically related to one of the parents and couples who are known
carriers of genetic diseases to have children not affected by the risk
of such disorders (37). It would allow individuals to "replace" someone of special value to them — such as a child who died prematurely (37). There would be a "right to procreative autonomy", which would include reproduction by cloning (38, 39).
Finally, cloning would allow families or society to reproduce
individuals of great genius, beauty or exceptional physical abilities.
of the objections to human reproductive cloning are based on the idea
of human dignity. Cloning would give the creators unjustifiable powers
over clones produced deliberately to resemble an existing individual
(or even a dead person) just to satisfy the desires of third persons.
In this way, this procedure would become a new and radical form of
instrumentalization of people (40, 41). Although human beings
cannot be reduced down to just their genes, the fact is that, given
their physical similarity to the "original" and to each other, clones
might seem like replaceable "copies" rather than irreplaceable
originals (42). Cloning is not just another assisted
reproductive technology — the cloned child would be without genetic
parents and therefore would be irrevocably deprived of the possibility
of relating his or her existence to a "father", a "mother" or a
"family" in the normal sense of these terms (43–45). Finally,
even on purely scientific grounds, human reproductive cloning is
considered to be a dangerous procedure: data on cloning of animals
shows that only a small percentage of attempts are successful, that
many clones die during gestation and that newborn clones are often
abnormal or die. Such devastating consequences in humans make the
procedure ethically unacceptable (46).
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