Biomedicine and international human rights law: in search of a

Biomedicine and international human rights law: in search
of a global consensus
Roberto
Andorno
1
I
"
Abstract
Global challenges raised by biomedical
significant
efforts over the last few years to establish common
biomedicallaw.
.This
In addition
preventing
given the role of "universal
Bioethical
issues; Internationallaw;
interventions
organizations
can be regarded as the beginning
ethics"
have made
of an international
of its principies into a human rights framework.
that human rights play in OUf world
to the general standards that are gradually being established,
two specific procedures: human germ-line
Keywords
standardsthat
One of the main features of this new legal discipline is the integration
strategy seems the most appropriate,
pluralism.
advances require global responses. Some international
a widespread
and human reproductive
of philosophical
consensus exists on the urgency of
cloning.
Treaties; Human rights; Gene therapy/ethics;
Germ cells; Cloning, Organism/ethlcs;
Consensus (source: Me5f1: NLM).
Mots
clés Enjeux éthiques;
humain/éthique;
Palabras
clave
germinativas;
Droit international;
Traités; Droits homme;
Traitement
génique/éthique;
Cellule germinale;
Clonage
Consensus (source: Me5f1: IN5ERM).
Discusiones
bioéticas;
Derecho
Clonación de organismos/ética;
I
I
internacional;
Consenso (fuente:
Tratados;
Derechos
humanos;
Terapia
de genes/ética;
Células
DeCS; B/REME).
BuUetin of the World Health Organization 2002;80:959-963.
Vairpage 962 le résuméen français.En Ia página 962 figura un resumenen espaiia!
~
Introduction
cultural
tru '\ 1 "
h
. h . lik
rfl
"
th
"Th
floodses down
gge across
lar umanng
fie valley
ts lSmaking
e anove
fie fields
owtngnver
ever moreat
those universal principIes with regard to biomedical issues, but
1t.1Sposs1ble through promotlon
of an open and COhstructlve
fertile"
~alogue
(1). With this simile, an Italian
expanding
force
of fie
human
to cover all new areas in which
human
recent
person
field
human
that individual
countries
alone
response
legal standards
dilemmas
impression
Oh such
sociocultural
and
issues
are effectively
religious
situation
enterprise
of setting common
although
difficult,
raised by science
borders.
mechanisms
Cultural
Europe
-that
to
new
countries
Rights
different
Human
with
Fortunately,
as it might
standards in fie biomedical
because
internacional
that some basic principIes
how-
seem. The
field,
human
trahscend
Educatlon,
.(U~ESCO)
and fie
research),
activity
present,
two
(2), fie
World
Council
(CIOMS)
internacional
on fie
instrument,
are perhaps
legal instruments
.the
elaboration
Declatation,
focuses
Convention,
fie
and Human
Convention
on
both of which were adopted
are just fie
of an internacional
which
exclusively
which
in fie
fie UNESCO
Genome
leveI,
in 1997 (4). Yet these two instruments
European
Associa-
Declaration
for Internacional
noteworthy:
Human
European
Rights and Biomedicine,
UNESCO
by
The World
Medical
and fie
rights
and inspired
Helsinki
Sciences
are particularly
Declaration
fie
relating to
on human
organizations.
fie famous
of
last few
examples.
(3) and, at fie
towards
over fie
bodies was preceded
of Medical
Sc1e~tlfic
Council
on some basic principIes
(WHO)
field ofbiomedicine
Universal
..
reguiatory
ofboth
most important
agreement
cntena..
which developed
on biomedical
At
to fie
recent
Organization
Organizations
and
has bee~ perce1~ed by some.1ntern~tl°.nal
of various internacional
tion (WMA,
wh!.internatraditlons
seem t~ p~oV1de fie 1deal arena for fie
th~ Uruted Natlons
The
is to identify
explain
cul~ral
have made s1gI11ficant efforts
fie initiative
Health
Thi~ would
Orgaruzatlon
and biomedicine
implemented.
responses
backgrounds.
is possible
in this
task. One mar even get fie
is not as desperate
law presupposes
address
regulations
to reach substantive
between
Sl~tlOn
bodies -part1cularl~
and
major challenge
1n whichdiffer~nt
o~ suc~ common
.This
biomedicine.
is needed to harmonize
search for common
ever, fie
rights
and far-reaching
appropriate
is an arduous
discove~
of
is needed to
just by crossingstate
cooperation
that it is impossible
sensitive
most
global1zed, a coherent
doinestic
and to establish
fie
fie
satisfactorily
increasingly
that such standards
Certainly,
v~ues are represented,
principIes
orgaruzatlons,
years to reach a consensus
cannot
area can be easily circumvented
c~tures:
of fie
Rapid advances
to fie new challenges
This is why internacional
be~e~n
tlonal
ethical and policy issues
are so formidable
algO be global. In addition,
bioethical
Probably
by fie
fie
Of course, fie
tends
new technologies.
As science becomes
ensure
which
and freedom
especially genetics.
new and complex
new challenges
and effective
illustrates
and society, and a legal response
avoid misuse of fie
should
dignity
is in need of protection.
rights is medicine,
for individuais
fiem.
fie
that needs to be "fertilized"
in this area present
The
academic
rights movement,
diversity.
is
not
on
first steps
biomedicallaw:
a legally
genetics,
fie
binding
while
deals with more general
the
issues,
1 Member of the UNESCOIntematianalBioethicsCommittee,Visiting Professarat the Departmentof MedicalEthicsand History of Medicine, Universityof Gôttingen,
Humboldtal!ee36, 37073-Gôttingen,Germany(email: randorn@gwdg.de).
Ref.No. 02-0308
Bulletin of the World Health Organization 2002, 80 (12)
959
I
Special Theme -Global
Public Health and International
Law
is only applicablein the Europeancountries that ratified it. This
is why the current situation offers an appropriate opportunity
to reflect on the possibility of a universal instrument on
bioethics. Some recent initiatives are already moving in this
direction.l
This paper argues for the human rights strategy that
characterizesthe emerginginternacionalbiomedicallaw. It also
describesthe current consensuson the urgency of preventing
two specific procedures:germ-line interventions and human
reproductive cloning.
Human rights as a legal framework
for international
bioethics
r
Perhaps the two most distinctive features of internacional
instruments relating to biomedicine are the very central role
given to the notionof"human dignity" and the integration of
the common standards that are adopted into a human rights
framework. This is not surpris~ if we consider that human
.ty
is one of the few common values in our world of
philosophical pluralism (.5). Moreover, in our time, a widespread assumption is that the "inherent dignity ...of all
members of the human family" is the ground of human rights
and democracy (6). It is indeed difficult, if not impossible,to
provide a justification of human rights without making some
reference,at leastimplicidy, to the idea of human dignity. This
notion is usually associated with supreme importance,
fundamental value and inviolability of the human person. In
the words of Kant, dignity means that people must alwaysbe
treated a~ end in themselvesand never only as a means(7).
Of course,attempts to explain and justify human dignity will
encounter enormous theoretical difficulties in our post..
modero world. However, lt seems that, at least for practlcal
reasons,we desperatelyneed this notion if we want to ensurea
civilized social life (8). As Dworkin argues, anyone who
professesto take rights seriously must accept "the vagUebut
powerful idea of human dignity" (9).
The reference to human dignity in the two aforementioned internacional instruments is impressive enough that
dignity is &:ometimes
referred to in the literature as "the shaping
principIe" of internacional bioethics (8, 10). Nevertheless,it
should be recognized that dignity alone is unable to provide a
concrete solution to most challenges raised by scientific
advances."Dignity" is not a magic word that can simply be
invoked to solve bioethical dilemmas. We should explain the
reasonsfor consideting that agiven practiceis in accordanceor
notwith the principIe ofhuman dignity. This can enableus to
see more clearly why the idea of dignity normally operates
through other ~ore concrete notions, such as informed
consent, bodily integrity, non-discrimination, privacy, confidentiality and equity, which are usually formulated in the
terminology of rights.
Another motive for this strategyis the currentworldwide
political consensuson the importance of protecting human
rights.Like the notion of dignity, but providing a more complete
and articulated formulation, human rights can be viewed in our
fragmentedworld as "the last expressionof a universalethics"
(11, 12)or as a "lingua franca" of internacionalrelations (13).
The global successof the human rights movement in
contemporarysocietyis probablydue to the fact that apractical
agreementaboutthe rights that should be respectedis perfecdy
compatible with theoretical disagreementon their ultimate
foundation(14).The UniversalDeclarationofHuman Rightsof
1948 is the best exampleof this phenomenon,becauseit was
drafted by representativesof particularlydiverse,evenopposed,
ideologies.Upon this stronglegislativefoundationhasbeenbuilt
an extensivenetwork ofhuman rights mechanismsdesignedto
develop internacionalstandards,monitor their implementation
and investigate violations of human rights. Today, the
?eclaration of 1948 c:an be consider~d as ':the s~le most
tmportant referencepotnt for cross-natlonaldiscussl0nofhow
to arder ow; futuretogether" (1.5).
It is true that global bodies often lack the ability to deal
with the violations of human rights. In spite of all its
weaknesses,however, the current human rights systemis the
only mechanismavailableto protect people. This is why the
integratión of some principIes relating to biomedicine into a
human rights framework seemsfully justified. It should not be
forgottenthatwhatisatstakeinsomebioethicalissues,suchas
human genetic engineering and reproductive cloning, is
nothing lessthan the preservationof the identity of the human
species. Thus, it is not an exaggerationto say that we are
confronted here with "the most im~rtant decision we will
evermake" (16). In other words~it seemsclear that, in the case
of conflict betweenthe preservationofhumankind Eramharm
and the protection of purely financial or scientific interests,
internationallaw shouldgive preferenceto the first option (17).
The consensus
b
t
on two
specific
issues
raised
"
Y gene IC avances
d
The emerging global consensus on bioethics is clearly
minimalist. When addressingthese 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, internacionalbodies
tend to lar down very generalprincipIesIike the requirementof
informed consent, the confidentiality of health information,
the principIe of non-discrimination for genetic reasonsand the
promotion of equity in the allocation of resources in health
care,especiallyto meet the needs of the most disadvantaged
populations.
The importance of setting generalprincipIes relating to
biomedicine should not be understated.General internacional
standards,far from being purely rhetorical statements, mar
constitute a first step towards promoting more concrete
regulations at a national leveI. It should not be forgotten that
national govemments, not internacionalorganizations,are the
primary agentsfor the realizationofhuman rights.
In any case,the internacionalconsensusis exceptionally
precise on two specific issues,becauseit aims to prevent some
potencial developments that raise the most serious concerns
for the futut;e ofhumanity: germ-line interventions and human
reproductive cloning. The lawmaking process,which is usually
accusedofbeing toa slow to keep up with scientific advances,
has on this occasion overtaken science, because legal
j
J
j
,
1 On30 March200I, the President
ofFrance,
Jacques
Chirac,madea statement
to theUnitedNationsCommission
on HumanRights
suggesting
thatthetimehad.come
to consider
the opportunity
ofa universal
instrument
onbioethics.
In February
2002,the UNESCO
International
Bioethics
Committee
setup a workinggroupto provide
adviceon thesameissue.
:
;
ê
960
Bulletinof the WorldHealthOrganization
2002,80 (12)
r
f
r
Biomedicine
provisions are being adopted to prevent two technologies that
do not yet existo
r
l
I
i
r
r
t
l~
-i
kr
f
~
~
and human rights
of those who preceded them. In other words, genetics shocld
not become the instrument for a kind of intergerierational
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).
Germ-line
interventions
The ethical reflections on germ-line interventions usual1ysttess
the fact that, unlike alterations of genes in somatic cells, which
affect only the tteated person. any alteration in germ cells
(gametes) or in earlyembryos before the stage of differentiation would be passed to the next generation. This distinction
Human reproductive
cloning
has serious moral relevance: although somatic cell gene therapy
Since the announcement that a sheep had been successfuliy
does not raise specific ethical questions, insofar as it does not
cloned Eramthe cell of an adult animal in 1997, concem about the
serve an enhancement purpose, germ-line interventions, given
possibility that the same technique could be applied to produce
their irreversible effects on future generations and their
genetica1lyidentical human beings has been widespread.
possible misuse for eugenic purposes, pose unprecedented
In the debate on human cloning, it is usual to make a
concerns. This is why most ethical and legal regulations that
distinction between "reproductive cloning" and "therapeutic
cover this issue sttongly discourage or frankly prohibit this
cloning" In the first case, the embryo obtamed by the cloningi
procedure.
procedure is ttansferred to a woman's uterus; this begins a
At the internationallevel, UNESCO Universal Declaraprocess that eventua1ly may lead to the birth of a baby
tion on the Human Genome and Human Rights provides that
genetica1ly identical to the cell danar. In the second case, the
germ-line interventions "could be conttary to human dignity"
embryo's inner mass is harvested and. grown in culture for
(Article 24).. Similarly,the European Convention on Human
subsequent derivation of embryonic stem cells that may have
Rights and Biomedicine states that "an intervention seeking to
therapeutic applications in the tteatment of serious degenmodify the human genome may only be undertaken for
erative disorders, such as Alzheimer's disease or Parkinson's
preventive, diagnostic or therapeutic purposes and only if its
disease. Although the consensus at the politicallevel is that
aim is not to inttoduce any modification in the genome of any
human reproductive cloning should be banned, no agreement
descendants" (Article 13).
about the ethical acceptability of therapeutic cloning has been
At the nationallevel, some legal provisions and guidereached. In this respect, some have argued thatthe creation of
lines that ban germ-line interventions have already been
embryos by cloning for the derivation of stem cells offers such
adopted by some countries -mostly
developed countries
significant potencial medicar benefits that research for such
(18). This ~tter circumstance is not surprising, because human
purposes should legal1ybe permitted (27). Others consider that
genetic engineering would be possible only where the financia!,
only embryos that remam after in vitto fertilization procedures[
human and technical means were available. In contrast,
should be used for that purpose, because they wi11be discarded
developing countries have more urgent problems to solve -anyway
(28). Still others are opposed to the use of either cloned
such as improving access to basic health caceservices -before
embryos or "spare" embryos Eram in vitto fertilization[
worrying about human genetic engineering. Nevertheless,
procedures, on the grounds that any deliberate desttuction of:,
some developing nations, such as Brazil and India, have algO human life is ethica1ly unacceptable (2.9). It is evident,
adopted ethical an.d !egal standards on this i~sue ~~
Law
therefor.e, tha~ the value we attach to hu~ai1 e~bryos remams
8974/95) (1.9). This lS probably due to the ffi1Xed sltuanon of
the key lssue m the debate on therapeunc clonmg.
these countries, in which a high levd of poverty and social
At theinternationallevel, the most recent initiative aimed[
inequity coexists with remarkable scientific and technological
at preventing human cloning was taken in December 2001 by
devdopments.
the United Nations General Assembly, when it established the
With respect to objections to germ-line genetic
Ad Hoc Committee on an International Convention against
engineering, it is important to note that they are of a different
the Reproductive Cloning of Human Beings (30). This
nature, depending on the purpose of the intervention.
initiative was a respónse to the request afilie
French and
In the case of germ-line interventions for therapeutic
German govemments to the United Nations to approve a
purposes -that
is, for preventing the ttansmission of diseases
worldwide ban on human cloning. The Committee met twice
-if
we leave aside the conttoversy on embryo research, the
in New York, once in February and once in September 2002 to
objection is not based on inttinsic ethical arguments, but on the
start the convention process, which is expected to conclude in
risks of serious and irreversible harm to future generations (20,
2003. The central issue, which remams unsolved, is whether
21). In addition to this, it is important to recognize that the idea
the convention should ban only reproductive cloning or
of eliminating "harmful"
genes Eram the entire human
whether it should algOinclude the creation of cloned human
population is more utopian than real. Such a global result, if
embryos for ~erapeutic ~urpose.s.
.
ever possible, could only be realized over thousands of years
Other 1mportant mternanonal mstruments that ban
and with recourse to massive coercive programmes, which
(mainly reproductive) human cloning have been adopted by
would be moral1y unacceptable (22).
UNESCO,
the Council of Europe, the World Health
.In the case of germ-line interventions for enhancement
Organization (WHO resolutions WHA50.37 (199'i) and
purposes, the objections are more fundamental and are based
WHA51.10
(1998)), the World Medical Association, the
on the idea that we do not have the right to predetermine the
European Union and the European Parliament (3, 31-36).
characteristics of future individuais. That means that people
At the national leveI, many countries have passed
should be free to develop their potentialities without being
provisions that prohibit human reproductive cloning, includbiologica1ly conditioned by the particular conceptions of
ing France, Germany,]apan, P.eru, Spam, Switzerland and the
"good" and "bad" human ttaits that were dominant at the time
United Kingdom (18).
Bulletin of the World Health Organization 2002, 80 (12)
961
.I
i
l
Special
Theme -Global Public Health and International Law
On the other hand, it is algOhelpful to consider the
arguments,mainly basedon utilitarian reasons,put forward in
favour of reproductive cloning. Cloning would allow infertile
couplesto have children who are biologicallyrelatedto one of
the parents and couples who are known carriers of genetic
diseasesto have children not affected by the risk of such
disorde~ (37).Itwould allowindividuals to "replace" someone
of special value to them -such
as a child who died
tur I (37) Th
uld b
" . ht t
.The
prema e y
.ere
wo
e a ng
o procreattve
autonomy", which would include reproduction by cloning (38,
39). Finally, cloning would allow families or society to
reproduce individuaIs of great genius, beauty or excepcional
physical abilities.
Most of the objections to human reproductive cloning
arebasedon the idea ofhuman dignity. Cloning would give the
creators unjustifiable powers over clones produced deliberatelyto resemblean existingindividual (or evena 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
eachother, clones might seemlike replaceable"copies" rather
than irreplaceableoriginaIs (42). Ooning is not just another
assistedreproductive technology -the cloned child would be
without genetic parents and therefore would be irrevocably
deprived of the possibility of relating bis or her existenceto a
"father", a "mother" or a "family" in the normal senseof these
terms (V-45). Finally, even on purely scientific grounds,
human reproductive cloning is consideredto be a dangerous
procedure:data on cloning of animaIsshows that only a small
percentage of attempts are successful,that many clones die
during gestationand that newborn clones are often abnormal
or die. Such devastatingconsequencesin humans make the
procedure ethically unacceptable(46).
Conclusion
.
human rights sttategy adopted by recent internacional
legal insttume?ts relating to biome~cine. see~s to be the
most approp~te way ~o manage bloethical lssues Eram a
~ob~ persr.ecttve.Certainly,~e sear~hfor a gl~bal consens~s
m this area ~snot f~ee Eram m:fficulttes,es~eclally~ecauselt
would. b~ lmpo~slble, and mdeed unfalr, to. l~pose. a
monolithic, detailed legal framework on soclettes Wlth
different sociocqitural and religious backgrounds. This is
why the harmonization of principIes about biomedical
activities must focus on some basic rules. This enterprise
seemsto be feasiblebecauseinternationallaw presupposesa
hard core of universal human rights. The major challenge
today, therefore, is to identify, through a constructive,
intercultural dialogue,the universalprincipIes that are relevant
to biomedical activities. The current internacional efforts
oriented towards the prevention of human reproductive
cloning and germ-line interventions show that new common
standards,which take into account not only the interests of
present individuaIs but algOthose of future generations,are
alreadyemerging in this area..
Conflicts of interest: none declared.
Résumé
Biomédecine et regles internationales en matiere de droits de I'homme: en quête d'un consensus mondial
Les enjeux mondiauxliés aux progresréalisésdans le domaine
biomédicalappellentdesréponses
mondiales.Cesdernieresannées,
certainesorganisationsinternationalesn'ont pas ménagé leurs
efforts pour définir des normes communesqui puissentêtre
considérées
comme les prémissesd'un droit internationalsur Ia
biomédecine.
L'une desprincipales
caractéristiques
de cettenouvelle
disciplinejuridiqueest I'alignementde sesprincipessur lesdroitsde
I'homme:une stratégie,semble-t-il,particulierement
adaptéedans
Ia mesureou lesdroitsde I'hommesontIa référenceuniverselleen
matiere d'éthique dans un monde marqué par le pluralisme
philosophique.Outre les normesgénéralesqui peu à peu voientle
jour,il existeun vasteconsensus
surI'urgentenécessité
d'empêcher
deux opérationsbien précises: les interventionssur Ia lignée
germinalehumaineet le clonagereproductifchezI'homme.
Resumen
La biomedicina y Ia legislación internacional en mate ria de derechos humanos: por un consenso mundial
Losretosmundialesque planteanIas progresosde Ia biomedicina EstaestrategiapareceIa másadecuada,dado el papel de «ética
exigen respuestas
mundiales.Algunasorganizaciones
internacio- universal»que Ias derechoshumanosdesempenanen nuestro
na.ieshan hechograndesesfuerzosdurante Ias últimosanospara mundode pluralismofilosófico.Ademásde Ias normasgenerales
establecernormascomunesque puedanconstituirel embriónde que se están estableciendogradualmente,existe un amplio
unalegislacióninternacionalen materiade biomedicina.Unade Ias consensorespectoa Ia necesidadurgentede prevenirdosmétodos
principalescaracterísticas
de esta nueva disciplinajurídica es Ia concretos,a saber, Ias intervenciones
en Ias célulasgerminales
integraciónde susprincipiasen un marcode derechoshumanos. humanasy Ia clonaciónreproductivahumana.
962
Bulletinof the WorldHealthOrganization
2002,80 (12)
Biomedicine and human rights
II
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