350

27

The Challenge of Genetics

Human Rights on the Molecular Level?

Judit Sándor

27.1 Introduction
The editor of a groundbreaking book1 that explores the normative challenges posed by the recent
advances of genetic research, Sheila Jasanoff, provides in her introduction a very powerful meta-
phor for describing what has happened in the field of genetics since the completion of the
Human Genome Project. She claims that biological sciences have reached the phase of text-
uality. By this she means that, just like DNA sequences, genetic test results can also be written,
recorded, stored, read and matched with other textual and non-​textual information. She argues
that this post-​genomic period provides a transformative change in both law and the life sciences
that should be considered ‘bioconstitutional’. Since the completion of the Human Genome
Project in 2003, new legal challenges have emerged and law and ethics have provided two
different kinds of responses to the legal challenges that have been accelerated following the
completion of the Human Genome Project. One applied a ‘rhetoric of scepticism’ and vehe-
mently argued that ‘there is nothing new, nothing special’ about genetic research and genetic
data, while the other position emphasised novelty and the peculiarity of genetic data. From
these two radically different approaches, two substantially different legal conceptualisations
follow. The first does not see any necessity to adopt new legal norms or formulations of new
human rights in the field of genetics. The other approach argues that new legal norms need to
be articulated, including new human rights.
Generally speaking, legal responses to this issue have tended to follow the former position and
to be sceptical of new rights. Roberto Andorno seems to fall in line with this position to a certain
extent: he does acknowledge ‘extensions of traditional human rights into the specific field of
genetics’ throughout, but it is only the ‘right not to know’ that he classifies as ‘entirely new’.2 This
is hardly surprising: an important element of legal thinking is that, in the face of new challenges,
the law should not set up new legal institutions automatically, but rather endeavour to embed
the new knowledge among existing legal principles with a view to maintaining proper consist-
ency. If the legal system were turned upside down for every technical novelty or innovation, the
basic construction of the rule of law would collapse due to the loss of predictability. This is why
there is always a lesser drive for innovation in law than in the natural sciences. If a technical
or scientific novelty emerges, legal thinking will often turn to incorporation and interpretation

1
S. Jasanoff (ed.), Reframing Rights: Bioconstitutionalism in the Genetic Age (Cambridge, MA: MIT Press, 2011).

2
R. Andorno, in this volume, p. 345.

350
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Genetic Rights 351

(Andorno’s ‘extensions’3), rather than to the establishment of a new legal right. One purpose of
this comment will be to show that this may not always be the best course of action.
The underlying reason for this is the prevalence of many difference perspectives on the issues
raised by genes and genomes. At the most basic level, there is disagreement even over the pre-
liminary question whether we are facing a human rights problem in the field of genetics, or
whether it constitutes a field which simply requires a more technical form of regulation on
safety and logistics of research.4 Even if the perspective of human rights is accepted in principle,
many dilemmas remain, for different conceptualisations remain possible in the course of legal
argument. Whether as ‘promise’ or ‘fetish’,5 genes have been labelled passionately by academics
and scientists across disciplines. Some see genes as vague but valuable entities and as such raise
the issues of ownership and property. Some interpret genes as a form of personal data, capable
of revealing significant information about the individual. Finally, genes can be seen as tools for
diagnosis and therapy.
The following sections will elaborate on these issues. I will begin by briefly considering both
the merits and the limits of an approach based on human rights, such as the account given by
Andorno. I share his sympathy for framing issues relating to genetics as human rights. However,
as the examples given above indicate, I am less convinced that the reference to an indeterminate
and contested framework of pre-​existing rights is sufficient to allow for much guidance in prac-
tice. To demonstrate this, I will showcase various problems associated with genetic knowledge,
broadly conceived, and the disagreement that comes with them. My conclusion will be that the
deliberate codification of new rights is necessary to enshrine the results of public debate, thus
acknowledging novelty in a stronger form than Andorno does.

27.2  Merits and Limits of the Human Rights Approach

Andorno’s starting point is that ‘the recourse to human rights principles to address dilemmas
arising from genetics … is justified’.6 In what way are human rights helpful? James Nickel, on
whose theory Andorno relies, defines human rights as basic moral guarantees that people in all
countries and cultures allegedly have simply because they are people.7 Human rights norms as a
global ‘lingua franca’ would thus provide an excellent frame for ethically challenging situations
in which basic human conditions are altered by biomedical interventions. By providing key eth-
ical concepts and fixing common basic norms, they would constitute a response to situations in
which frequent technological and scientific changes amid ethical plurality would otherwise not
allow for a detailed or immediate reaction to new issues.

Ibid., pp. 337, 342.

3

See Directive 2004/​23/​EC of the European Parliament and of the Council of 31 March 2004 on setting standards of
4

quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human
tissues and cells; Commission Directive 2006/​17/​EC of 8 February 2006 implementing Directive 2004/​23/​EC of
the European Parliament and of the Council as regards certain technical requirements for the donation, procure-
ment and testing of human tissues and cells; Commission Directive 2006/​86/​EC of 26 October 2006 implementing
Directive 2004/​23/​EC of the European Parliament and of the Council as regards traceability requirements, notifica-
tion of serious adverse reactions and events and certain technical requirements for the coding, processing, preserva-
tion, storage and distribution of human tissues and cells.
K. Sunder Rajan, Biocapital: The Constitution of Postgenomic Life (Durham, NC: Duke University Press, 2006),
5

p. 138.
Andorno, in this volume, p. 335.
6

James Nickel, Making Sense of Human Rights: Philosophical Reflections on the Universal Declaration of Human
7

Rights (Berkeley: University of California Press, 1987).

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352 Judit Sándor

A large number of established rights or concepts related to rights may be connected to the field
of genetics in various ways: genetic research, testing, modification or genome editing influence
our notion and expectations of privacy, access to personal information, access to new therapy or
even to enhancement. Genetic rights may have both an individual and a collective dimension,
and may resonate with social welfare. For instance, the right to decide on genetic testing is an
individual decision, while access to health care based on genetic information also contains a
collective dimension in that it becomes relevant for the general provision of health care services.
Finally, there is the question of the duty-​bearer. In general, it is states, not private persons, who
have a duty to respect human rights. In the case of genetic rights, the state may provide a regu-
latory infrastructure, but in many cases companies and private health care providers are more
directly connected to the situation in which genetic rights should be guaranteed.
Within this complex web of rights claims, several concepts stand out as being of particular
relevance for identifying genetic rights and thus demarcating ethical boundaries. Most import-
antly, according to Brownsword and Goodwin,8 human dignity is the key boundary-​marking
concept: ‘reference to human dignity is ubiquitous in debates about technological regulation,
particularly where application of scientific knowledge touches upon the foundations of life,
and, in particular, human life.’ Human dignity thus plays a key role in formulating the direction
of new rights in the field of genetics. A further recurring element is nature, which is also used
as a moral boundary marker against technological development. Furthermore, discussions on
property are also relevant with regard to genetics. Property, including intellectual property, is
presented as a boundary marker to determine what should be done with our genes.
Framing dilemmas within the field of genetics as issues of human rights and connecting
them to established human rights principles may thus carry significant advantages. However,
the rights framework also has its limits. One of these is recognised by Andorno: the relevance
of genetic dilemmas for future generations.9 Since political cycles tend to be short (typically
around four to five years between parliamentary elections), it is very difficult to force successive
governments to fulfil obligations to future generations. Furthermore, in many societies where a
conservative view prevails on the right to life, these rights are used to reopen rather than to settle
the debates on abortion, on research on human embryos, etc. This is why I agree with Andorno
that it would be premature, at this point in time, to speak of transgenerational genetic ‘rights’ of
future generations.
However, the point about rights sparking debate rather than settling it indicates a more gen-
eral limit of the human rights framework. Against the backdrop of differing conceptualisations as
discussed above, genetic rights in human rights conventions and declarations may be interpreted
very differently, or may be considered to have different implications depending on the political
context. Wiktor Osiatnyński, a Polish human rights scholar, correctly pointed out that ‘[d]‌espite
the proliferation of declarations, covenants, and other international agreements in the majority
of countries in today’s world, human rights still are an ideal rather than the norm. Likewise, the
presence of human rights in constitutions does not translate into actual respect for all human
rights’.10 Actual respect requires consensus on the concrete interpretation of human rights –​yet
even the brief survey of human rights principles relevant to genetic issues conducted above
serves to illustrate that a variety of perspectives or points of emphasis remain possible. Rights

8 R. Brownsword and M. Goodwin, Law and Technologies of the Twenty-​ First Century:  Text and Materials
(Cambridge: Cambridge University Press, 2012), p. 191.
9 Andorno, in this volume, pp. 347f.
W. Osiatyński, Human Rights and Their Limits (Cambridge: Cambridge University Press, 2009), p. 70.
10

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Genetic Rights 353

may therefore provide less guidance than it at first seemed, and their use as a ‘lingua franca’ is
limited accordingly.

27.3  The Case of Genetic Knowledge

To illustrate the limits of human rights, I  would like to take up the debate surrounding
various aspects of genetic knowledge, broadly understood. In this field, legal issues are mostly
concentrated around the problem of how new genetic information affects our basic human
relations, family ties, decisions about reproduction, insurance, employment and intellectual
property. To be more precise: how should genetic knowledge be conceptualised, what kinds of
rights can be established with regard to genetic knowledge, who should have access to the rele-
vant data and who is to control this intrinsically individualised, wide-​ranging information that
can easily be obtained by others? Is it the genetic sample itself that should be protected, or rather
the data that can be revealed during an examination of the sample –​or both? These questions
showcase that the mere presence of a human rights framework does not, of its own accord, pre-
vent controversies on concrete points. I will present these controversies, first at the general level
of conceptualisation, then with regard to two specific genetic rights, and finally with regard to
their limitation in cases of conflicting rights.

27.3.1  General Problems of Conceptualisation

At the most general level, the dilemma could be phrased as follows: what is the legal nature of gen-
etic information, genetic data and genetic samples? How should they be conceptualised: should
genetic samples be treated as property, information or some combination of the two? To answer
these questions, we need an account of why genetic knowledge is important and how, if at all, it
differs from other medical knowledge.
A common response is this: it is important for individuals to be aware of their genetic data
and information because these data support more accurate diagnoses of any detectable illness
or disease, and give insight into the individual’s future with the identification of certain suscep-
tibility factors. Genetic information has brought about specific problems both in interpreting
this kind of data, as well as protecting genetic data.11 Another characteristic of the situation is
that in comparison with other medical data containing certain medical parameters of the person
concerned, genetic data carries additional information.12 For example, as Andorno indicates,
information on a hereditary disease may have a serious impact on the lives and decisions of
family members who may not have wanted to subject themselves to test examinations.
However, many distinguished social scientists, even bioethicists,13 do not subscribe to these
special claims associated with genetic regulation. In order to challenge the legitimacy of special
regulation, they point out that many characteristics of the data – their predictive value and par-
ticular sensitivity, for e­ xample –​can also be ascribed to other types of data in health care. On this

11 W. F. Mulholland and A. S. Jaeger, ‘Genetic Privacy and Discrimination: A Survey of State Legislation’ (1999) 39(3)
Jurimetrics 317.
12 See ECtHR, S. and Marper v. the United Kingdom (Appl. nos. 30562/​04 and 30566/​04), judgment, 4 December 2008,
para. 72.
13 S. Holm, for example, had already challenged this approach to genetic exceptionalism in his book chapter published
in 1997: S. Holm, ‘There Is Nothing Special about Genetic Information’, in A. K. Thomson and R. Chadwick (eds.),
Genetic Information: Acquisition, Access and Control (New York: Kluwer Academic, Plenum Publishers, 1999).

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354 Judit Sándor

view, there would be less reason for specific regulation, much less specific human rights. Even
at the most foundational level, then, there is disagreement.

27.3.2  Indeterminacy and Controversy Regarding Various Rights

Let me now provide some more specific examples of disagreement in the field of genetic
knowledge. Consider, first, the prohibition of genetic discrimination. As Andorno notes,14 this
is codified, for example, in Article 11 of the (legally binding) Oviedo Convention: ‘Any form of
discrimination against a person on grounds of his or her genetic heritage is prohibited’.15 What
Andorno does not mention, however, is that although the threat of genetic discrimination exists
in several fields of life, the interpretation of this concept is not as evident as that of racial discrim-
ination.16 Any person belonging to the genetic minority with respect to a specific characteristic
may belong to the genetic majority in terms of another property. Nevertheless, being a part of
the genetic minority may bring about positive social judgment, such as in the case of rare gen-
etic properties that are regarded to be favourable –​or negative social judgment in the opposite
scenario.17
Genetic properties differ from most other characteristics that constitute the basis of discrim-
ination in that they remain, in most cases, invisible. However, if others know about them, then
they may cause uncertain, unforeseeable disadvantages to the person concerned and serve as a
basis for various abuses: this is why genetic discrimination connects back to the broader issue
of genetic knowledge. For example, if an employer becomes aware that some employees are
genetically more susceptible to certain illnesses or diseases, it can easily be presumed that these
employees would find themselves treated in a less favourable manner in spite of the fact that
these characteristics do not constitute any monogenic irregularity, but just an increased level of
susceptibility.
In the field of genetic discrimination, both science and law have so far failed to provide
clear and coherent guidance for interpretation despite the general commitment to prevent dis-
crimination. For example, in an important book published in 2006, Keith Wailoo and Stephen
Pemberton analysed the racial and medical context of Tay-​Sachs disease, cystic fibrosis and
sickle cell disease.18 It emerged that Tay-​Sachs disease is associated with Jewish Americans, cystic
fibrosis with Caucasians and sickle cell disease with African Americans. When race can be
connected to genetic data in this way, it is difficult to see how public health could avoid the trap
of a new kind of stigmatisation.
A further example is the right to be warned about genetic risks. Legal rules relating to informed
consent have tended to follow a model based on individualised information: this means that
information is provided only to the patients themselves (provided that they are capable of

14 Andorno, in this volume, pp. 342f.

15 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of
Biology and Medicine, Oviedo, 4 April 1997, in force 1 December 1999, ETS No 164, available at: https://​www.coe.int/​
en/​web/​conventions/​full-​list/​-​/​conventions/​treaty/​164. The European Union has been also surprisingly quick in codi-
fying the prohibition of genetic discrimination: see Charter of Fundamental Rights of the European Union, Nizza,
7 December 2000, in force 1 December 2009, 2000 No. C 364/​1, Art. 21.
See also P. R. Billings et al., ‘Discrimination as a Consequence of Genetic Testing’ (1992) 50(3) American Journal of
16

Human Genetics 476.
17 J. Beckwith and J. S. Alper, ‘Reconsidering Genetic Discrimination Legislation’ (1998) 26 Journal of Law, Medicine
and Ethics 205.
18 K. Wailoo and S. Pemberton, The Troubled Dream of Genetic Medicine: Ethnicity and Innovation in Tay-​Sachs, Cystic
Fibrosis, and Sickle Cell Disease (Baltimore: The Johns Hopkins University Press, 2006).

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Genetic Rights 355

acting), while family members may be informed only if the patient expressly consents to this. It
seems, however, that genetic information will potentially re-​establish the provision of informa-
tion not just to an individual, but also to their family. In the case of certain diseases, there are few
people who undergo routine medical screening. Yet, when such a disease appears in a family, it
is regarded as a reason for family members to take screening examinations and prevention more
seriously, especially when the disease is known to be hereditary.19 With the enlarging scope of
genetic knowledge, more and more diseases are likely to involve the obligation of physicians to
warn family members of the patient.20
This issue clearly illustrates why some commentators argue in favour of rights that are spe-
cifically tailored to the field of genetics. However, it also makes clear that there are difficult
value choices to make in each individual situation. The deviation from the classic model of
individualised consent is controversial. It contrasts, for example, with the ‘right not to know’
which Andorno treats at length.21 He acknowledges that this right is not absolute, but must be
overridden when the health of blood relatives is at stake. This raises the more general issue of
conflicts between rights.

27.3.3  Conflicts between Rights

The conflict between the right to be warned about genetic risks and the right not to know is just
one example of ethical tensions in the field of genetics. Another is the tension between indi-
vidual rights over a gene sequence and freedom of genetic research. The latter is mentioned,
for example, in Article 15 of the UNESCO Declaration: ‘States should take appropriate steps to
provide the framework for the free exercise of research on the human genome with due regard
for the principles set out in this Declaration, in order to safeguard respect for human rights, fun-
damental freedoms and human dignity and to protect public health. They should seek to ensure
that research results are not used for non-​peaceful purposes.’22
The Myriad case, ultimately decided by the Supreme Court of the United States,23 illustrates
the harm which may be caused by gene patents: for example, individuals may be denied access
to genetic tests because a patent holder exercises exclusionary rights over a gene sequence.
The debate on what is patentable within life sciences hardly seems to be settled. According to
Judge Robert W. Sweet, who ruled in the Myriad case at the level of the District Court, ‘DNA’s
existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the
body nor the information it encodes. Therefore, the patents at issue directed to “isolated DNA”
sequences found in nature are unsustainable as a matter of law and are deemed unpatentable’.24
This view was based on the interoperation of what is ‘natural’ and what is ‘artificial’ and thus
demonstrates the relevance of foundational conceptualisations for legal argument. Where rights

C. Lerman et al., ‘Family Disclosure in Genetic Testing for Cancer Susceptibility: Determinants and Consequences’
19

(1998) 1 Journal of Health Care Law and Policy 353.

S. J. Durfy, T. E. Buchanan and W. Burke, ‘Testing for Inherited Susceptibility to Breast Cancer: A Survey of Informed
20

Consent Forms for BRCA1 and BRCA2 Mutation Testing’ (1998) 75(1) American Journal of Medical Genetics 82.
21 Andorno, in this volume, pp. 345f.
22 Universal Declaration on the Human Genome and Human Rights, 1997. The Declaration was adopted unanimously
and by acclamation at UNESCO's 29th General Conference on 11 November 1997. Official text available at https://​
unesdoc.unesco.org/​ark:/​48223/​pf0000122990.
Supreme Court of the United States, Association for Molecular Pathology v.  Myriad Genetics, Inc., 569 U.S. 576
23

(2013), 133 S.Ct. 2107.

District Court for the Southern District of New York, Association for Molecular Pathology et al. v. USPTO et al.,
24

702F. Supp. 2d 181, 192–​211, 2010 U.S. Dist. Lexis 3518 (emphasis added).

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356 Judit Sándor

conflict, the possibility of differing responses depending on one’s perspective becomes particu-
larly clear: even if a right is accepted in principle, its ambit may still be severely curtailed by
setting up a counter-​right.25
Another new field of genetics which will soon require the development of legal norms is the
increasing spread of genome editing techniques that may soon reach the human application.
Recently the Nuffield Council published a report26 on genome editing and human reproduc-
tion. If this technology turns out to be safe and applicable in the field of human reproduction,
it may fundamentally change the notion and scope of the right to life, reproductive rights, par-
ental rights, the principle of non-​discrimination and the right to privacy.

27.4  Conclusion: The Value of a New Catalogue of Genetic Rights

I agree with Roberto Andorno that ‘genetic rights’ already appear, although sporadically, in sev-
eral binding and non-​binding legal instruments, including sui generis human rights law. I see the
role of human rights differently, however. Andorno seems to be of the opinion that the current
legal framework is sufficient and that general human rights can, in many cases, be extended or
interpreted in such a manner as to provide solutions to genetic issues. In my view, by contrast,
a new catalogue of human rights with more specific provisions would offer a better framework
for incorporating new rights that may already have emerged in ethical and political debates.
Interpretations of human dignity and general human rights such as the right to privacy may be
helpful, of course, but on the whole, the scientific developments associated with genetics raise
too many new legal questions to simply stretch the interpretation of established human rights;
rather, they require a specific response. Most human rights norms in the biomedical field so
far constitute a reaction to serious violations of basic ethical norms in research and patient’s
rights in the twentieth century: lack of consent, pain and humiliation of research participants.
Andorno rightly connects the emergence of bioethics to the aftermath of the Second World
War. Nowadays, the focus has shifted:  the prevalence of information and the possibility of
transforming human nature (by means of e.g. genome editing or gene therapy) demand a new
human rights approach.
I would submit that human rights are a process and that they develop constantly. It goes
without saying that it would be a mistake to immediately reformulate general human rights in
face of the latest advances in the technology of genome editing, since the assessments of its eth-
ical implications are still ongoing. However, some solutions for conflicting legal interpretations
have been agreed upon widely and compromises have been reached. Such compromises are
rights in the pipeline, so to speak, and they may further develop and become widely accepted
in the future. The human rights framework may not be able to provide answers to detailed
questions on licensing, or on specific applications of the given technology, and so on; but to offer
guidance at all, more specific compromises that were reached need to be retained in the form
of a new human rights catalogue. Such a catalogue would then in turn influence the further
interpretation of established human rights: in that regard, a parallel can be drawn to the way in
which the European Court of Human Rights already takes provisions of the Oviedo Convention
into account when interpreting the more general European Convention on Human Rights.27

See generally e.g. Martti Koskenniemi, The Politics of International Law (Oxford: Hart, 2011), pp. 133–​152.
25

Nuffield Council on Bioethics, Genome Editing and Human Reproduction: Social and Ethical Issues, July 2018,
26

available at http://​nuffieldbioethics.org/​project/​genome-​editing-​human-​reproduction.
See for example ECtHR, Parrillo v. Italy (Appl. no. 46470/​11), judgment, 27 August 2015, para. 182.
27

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Genetic Rights 357

In my view, advocating for new human rights in the field of genetics is based on two major
arguments. One is that –​as mentioned above –​we simply cannot ignore the tremendous change
that has occurred in the life sciences since the Human Genome Project. As the DNA of more
and more patients are studied and used for research purposes, it becomes necessary to develop
new ways of protecting the rights of human beings: hence new human rights. The second argu-
ment is the transnational nature of genetics. Legislation at the national level simply cannot
respond to the complex data collection mechanisms of biobanks that use, for example, genetic
sources from indigenous populations, and intend to patent genetic tests that are based on their
genetic samples. A transnational response in the form of what Andorno calls a global ‘lingua
franca’28 is therefore necessary: hence new human rights.
I share the worries expressed by Andorno about the inflation of human rights.29 But I would
conclude that reopening, to a certain extent, the catalogue of human rights that have developed
after the Second World War would actually reinvigorate the interest in human rights. An entirely
new generation of people has been born since the post-​war human rights norms were formulated
with the intention of protecting the human subject in biomedical research. The interpretation
of these norms in genetic contexts may result in misunderstanding due to the lack of concrete
guidance. The lack of interest in, and scepticism towards, human rights might be the result of a
disconnect between the abstract formulation of human rights and the concreteness of everyday
experience, with its various concerns, doubts and fears. We are witnessing incremental progress
in the field of genetics and it seems that some ethical norms should be ‘upgraded’ to the level
of human rights. The human rights approach may help to avoid discriminatory use of genetic
data in genetic and ethnic profiling, testing and screening. If we accept the challenge of refor-
mulating the catalogue of human rights for the twenty-​first century, then we should take into
account scientific advances and the related ethical, social and cultural concerns. At the same
time, however, research methods applied by the life sciences should always be subject to critical
assessment by society at large, and law is the main instrument for ensuring that such criticism
gains social force. The extension of human rights on a cellular level should therefore likewise
proceed carefully and critically.

Andorno, in this volume, p. 339.

28

Ibid., p. 336.
29

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