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Regulating human genomic
research in Africa: why a human
rights approach is a more
promising conceptual framework
than genomic sovereignty
Faith Kabata
1
* and Donrich Thaldar
1
,
2
1
School of Law, University of KwaZulu-Natal, Durban, South Africa,
2
Petrie-Flom Center for Health Law
Policy, Biotechnology and Bioethics, Harvard Law School, Cambridge, MA, United States
This article revisits the debate on the regulation of human genomic research,
with a focus on Africa. The article comprehensively examines the concept of
genomic sovereignty, which was invoked mainly in the global South as a
conceptual framework for state regulation of human genomic research. It
demonstrates that genomic sovereignty has no utility value in human genomic
research as it violates the rights of individuals and researchers. By analysing
Mexico’s regulatory approach based on genomic sovereignty and a divergent
regulatory approach, viz Finland’s human genomic research framework, we
show that a human rights approach is more promising as it aligns with the state
obligations under the right of everyone to participate in and benefitfrom
scientific progress and its applications in international human rights law. We
conclude by recommending that African states should anchor regulation of
human genomic research on a human rights framework based on the right to
science.
KEYWORDS
human genomics, genomic sovereignty, human rights, regulation, right to science, Africa
1 Introduction
Is state regulation of access to and use of genomic material the appropriate
governance framework for human genomic research? This article offers insights in
the debate on regulation of human genomic research. It does this by examining the
concept of genomic sovereignty to enquire if the concept has utility value in human
genomic research, particularly in relation to Africa. The short answer is “no.”The
longer answer, and specifically why the concept has no utility value, however, leads to
important questions on: the concept, its underpinnings, assumptions and weaknesses;
other divergent state approaches in regulation of human genomic research; and
questions on where state approaches to the regulation of human genomic research
should focus their attention.
To situate the discussion, the article revisits deliberations of the UNESCO International
Bioethics Committee during the drafting of the Universal Declaration on the Human
Genome and Human Rights. A member of the Committee stated (UNESCO International
Bioethics Committee, 1995):
OPEN ACCESS
EDITED BY
Alessandro Blasimme,
ETH Zürich, Switzerland
REVIEWED BY
Judit Sándor,
Central European University, Hungary
Bartha Maria Knoppers,
McGill University, Canada
*CORRESPONDENCE
Faith Kabata,
faithkabata@gmail.com
RECEIVED 19 April 2023
ACCEPTED 16 May 2023
PUBLISHED 30 June 2023
CITATION
Kabata F and Thaldar D (2023), Regulating
human genomic research in Africa: why a
human rights approach is a more
promising conceptual framework than
genomic sovereignty.
Front. Genet. 14:1208606.
doi: 10.3389/fgene.2023.1208606
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Frontiers in Genetics frontiersin.org01
TYPE Original Research
PUBLISHED 30 June 2023
DOI 10.3389/fgene.2023.1208606
“We are now proposing to include the human genome in the
common heritage of humanity. Legally speaking, this would be
a historic and revolutionary measure, fraught with implications
and attended by many consequences that would be beneficial to
humanity.”
Illustratively, the Universal Declaration on the Human
Genome and Human Rights refers to the genome as “heritage
of humankind,”thus seemingly opening the possibility of the
common heritage framework of governance (UNESCO, 1997).
In response to this, a number of countries in the global South
invoked sovereign claims over the genetic material of their
citizens as a perceived way of protecting it from foreign
exploitation by the global North. These claims were
embedded in the concept of genomic sovereignty, which
assumed a political and scientific agenda and was
incorporated into domestic legislation or guidelines in some
countries. Importantly, the concept put into sharp focus the role
of the state in regulating access to and use of genomic resources,
an issue that remains relevant for Africa.
The article flows as follows: Part 2 draws on an array of genomic
sovereignty literature to map out its argumentative logic, and
identify its themes and conceptual weaknesses. Part 3 examines
Africa’s academic engagement with genomic sovereignty, the
conceptual underpinnings, and critically assesses the concept.
Part 4 reviews Finland’s approach to human genomic research,
its philosophical underpinnings, and conducts a comparative
analysis of both the Mexican and Finnish approaches. Part
5 addresses the question of where approaches to regulation of
human genomic research should turn by exploring state
obligations in the right to science and specifically in human
genomic research. Part 6 summarises the article by offering
concluding thoughts.
The article uses the terms developing and developed countries
and global South and global North interchangeably, as they are used
in the literature referenced. The article also acknowledges that the
definition of genomic sovereignty in the literature relied on the
terms control and ownership of genetic resources interchangeably,
which is legally problematic.
2 Unearthing genomic sovereignty
In the context of global research, genomic sovereignty has been
referred to as the ability of a nation, people or state to own and
regulate access to and use samples, data and knowledge on human
genes (Slabbert and Pepper, 2010).
The term was coined by Mexican scientists, politicians and policy
makers as a biopolitical concept describing political sovereignty in
genome mapping and was aimed at protecting national genomics in
Mexico (Marìn-Schwartz, 2011). The concept was typified by
establishment of the National Institute of Genomic Medicine
(INMEGEN) in 2004; the mapping of the “Mexican genome”by the
INMEGEN between 2004 and 2009; and the framing of the policy agenda
into legislation to protect Mexico’s“genomic sovereignty”in 2008
(Vasquez and García-Deister, 2019). The legislation referred to as
Mexico’s policy on genomic sovereignty instituted amendments in the
General Health Law (Marìn-Schwartz, 2011).
The law was designed to regulate everything in the human
genome in Mexico. Accordingly, it restricted the movement of
biological samples outside Mexico for population genomics
studies without express authority from the Secretary of Health
and attached penalties of 15 years imprisonment and imposition
of fines for unauthorised movement (Marìn-Schwartz, 2011). In
addition, it implicitly addressed intellectual property in two ways:
first, if genetic material was taken outside Mexico without
authorisation no intellectual property claims would be
recognised; and second, if there were no benefits to Mexico,
intellectual property claims would not be recognised (Marìn-
Schwartz, 2011). Significantly, according to the proponents, the
law was not meant to impede research, but rather to spur
international research collaboration through a permit system
(Marìn-Schwartz, 2011). The import of the law was that the state
sought to control access to organ, tissue or human components of
living or dead persons. The most incisive criticism of the law on
genomic sovereignty is that it was anchored on the uniqueness of the
Mexican genome, which it assumed could be uniquely identified and
policed internationally (Marìn-Schwartz, 2011). This discussion is
fully taken up in part 2.2.
Beyond Mexico, the concept of genomic sovereignty also had
policy underpinnings in India and Thailand and it generated
some academic interest in South Africa. In India, genomic
sovereignty was similarly conceived as a policy and scientific
regime to prevent unapproved movement of genomic material
and data outside India based on the need to secure state
investment in genomic research and to ensure that local
researchers benefit from their discoveries (Sèguin et al.,
2008). The basic premise of India’s genomic sovereignty was
its population, which was viewed as a resource because of its
large size and its uniqueness given the practice of multi-
generational endogamy and the existence of proper
genealogical records (Sèguin et al., 2008). The genomic
sovereignty agenda was thus typified by review of Guidelines
for Exchange of Human Biological Material for Biomedical
Research Purposes, making it mandatory to obtain
government permission to export human biological material
(Hardy, 2011).
In Thailand, genomic sovereignty, though not as explicit as in
Mexico and India, was similarly conceptualised as a policy agenda to
protect the “Thailand genome,”specifically DNA samples, from
export (Sèguin et al., 2008). While legislative action was not
undertaken, there was debate among researchers on the need to
strengthen existing guidelines into law in order to limit export of
Thai DNA samples (Sèguin et al., 2008).
2.1 Conceptual underpinnings of genomic
sovereignty
From the foregoing, the concept of genomic sovereignty is
rooted in post-colonial discourses of dispossession. The concept
thus did not arise unexpectedly but should be regarded as an
extension of the continuing North/South tension over
dispossession and foreign exploitation of national resources.
Illustratively, Marìn-Schwartz (2011) indicates that while the
concept is traced to Mexico, it appears to have been adapted
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from arguments in international fora such as UNESCO in
relation to indigenous peoples’genetic heritage and tribal
knowledge. While sovereignty hasalwaysbeeninvokedby
states, groups or peoples claiming control of natural resources,
in this context it was bundled together with the catchword
genomic to refer to the new national resource, and hence
genomic sovereignty.
The argumentative logic that underpins genomic sovereignty is
that in the genomic era, national population genomes can be
mapped and controlled. Proponents of the concept thus conflate
population with territory and as states ordinarily exercise control
over national resources in their territory, then they argue that states
can assert control over the population genome in their territory as a
national resource (Marìn-Schwartz, 2011). This logic is premised on
the idea that the human genome has commercial and symbolic
value, and hence commercially as a source of economic revenue and
symbolically as a source of national pride and identity (De Vries and
Pepper, 2012).
Drawing from the logic of national resources and the history of
colonial dispossession, genomic sovereignty is grounded in the inter-
linked themes of: economic gain, national heritage and patrimony
(Hardy, 2011). The economic gain argument is anchored on bio-value
to be derived from the genomic revolution (Vasquez and García-Deister,
2019). For instance, Hardy (2011) captures this sentiment in relation to
India: “If oil in Alaska can be shared by everybody, (the) Indian genome
of India can be shared by everybody. But the fact is that (the) oil of Alaska
is not shared by everybody”. Strikingly, this comparison of the Indian
genome to oil depicts the view of the genome as a national resource and
the economic value attached to it, and hence the need to protect it from
foreign exploitation.
Similarly, in Mexico, Siqueiros-Garcìa et al. (2013) point out that
debate on the genomic sovereignty law drew from past foreign
exploitation of petroleum, archaeological resources and biodiversity.
Genomic sovereignty was thus to ensure that the Mexican genome
was analysed by Mexicans and for Mexicans.
Related to the economic argument is the theme of national
heritage, which is premised on the symbolic and cultural value of the
human genome. The theme is anchored on the idea that national
populations are biologically distinct from other populations, and
hence national populations are branded as biological units (Marin-
Schwartz and Mendez, 2012). National heritage is thus linked to self-
determination and national building for developing countries, with
the genetic make-up of the population viewed as a national resource
whose exploitation is a nation-building project to deliver specific
health outcomes for the national population and ensure
participation in the global knowledge-based economy (Benjamin,
2009;Vasquez and García-Deister, 2019). The utility of the nation
heritage theme achieved public support for genomic research for two
reasons. First, to justify heavy financial investment in genomics
research in light of more immediate public health concerns
(Benjamin, 2009;Vasquez and García-Deister, 2018); and,
second, to secure public uptake which is critical as a source of
biological samples (Hardy, 2011).
Finally, the theme of patrimony, which closely mirrors national
heritage, suggests protection from bio-exploitation. The central idea
is that the national genome can be defined, separated from other
populations, and the state can assert sovereignty over the national
genome based on patrimonial doctrines (Marin-Schwartz and
Mendez, 2012). In this sense, genomic sovereignty meant the
duty to protect the genome of populations based on the notion
of property. Illustratively, Mexico’s genomic sovereignty law
described the Mexican genome as a public good, a sovereign
resource, which implied that the Mexican government could
police and control it internationally (Marìn-Schwartz, 2011). In
addition, the patrimony theme alludes to protective control,
captured with the expression “genomics by Mexicans, in Mexico
and for Mexicans”(Vasquez and García-Deister, 2018).
2.2 Gaps in the concept of genomic
sovereignty
The concept of genomic sovereignty as discussed above
provokes several questions: Is the claim of a national genome
that can be uniquely identified and over which states can assert
sovereignty feasible in genomic research? What exactly does
genomic sovereignty relate to? Is it biological samples, data, or
both? Are genomic sovereignty laws and regulations enforceable?
The Human Genome Project determined that 99.9% of human DNA
is similar, with only a 0.1% variation. This unique pattern of variation
across populations is at the heart of genomic research. This leads to the
question of how the population of interest should be constituted, and how
should the population with the unique pattern of variation be mapped?
Genomic sovereignty is built on the assumption that the population of the
state–based on shared national identity–constitutes a unique genetic
mixture, distinct from other nations, which the state then seeks to
assert control over (Benjamin, 2009).
A good starting point for analysis on this is to adopt Marin-
Schwartz’s and Mendez’s observation in relation to Mexico (Marin-
Schwartz and Mendez, 2012):
“It is technically feasible to speak of sovereignty when we speak
of the individual genome, which is unique; but to speak of
sovereignty over the genome of a whole population is pretty
difficult. We cannot speak of a unique Mexican make-up, when
we are talking of shifting percentages of DNA fragments which
are shared by humanity and various populations across the
world.”
The picture that emerges from Marin-Schwartz’s observation is
that a nation state’s genetic make-up cannot be mapped, defined and
separated from that of other world populations. This point finds
support in De Vries and Pepper (2012) who also note that,
scientifically, genomic information for groups or populations in a
country is not unique or distinct. The non-existence of a unique
nation state’s genetic make-up raises questions that are at the core of
the concept of genomic sovereignty.
Turning to the related question of whether the state can assert
sovereign control over the genetic make-up of its population, Marìn-
Schwartz (2011) observes that the sovereignty claims made by the
state as policing genetic information, revoking intellectual property
rights, and surveillance over Mexican samples were impractical.
First, there is the issue of diasporic populations as law based on
sovereignty articulations is territorial, while in the context of
genomics, populations are fluid and are found outside state
boundaries. Secondly, there is the nature of genomic research in
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which genetic information flows in the international information
networks as part of large-scale transnational data sets which do not
conform to the territory of the nation state. Thirdly, the individual
and collective property rights dimension that arise make property
and patrimonial doctrines unsuited to regulate population genomics
(Marìn-Schwartz, 2011).
In the same strand of arguments, Vasquez and García-Deister
(2019) allude to the impracticability of sovereignty claims in the
context of genetic information flow by pointing out that, despite the
genomic sovereignty law, Mexican samples and DNA were analysed
and reduced into cloud data which flowed internationally without
being confined to the political boundaries of the state.
On the question of whether genomic sovereignty relates to
biological samples, data, or both, the text of Mexico’s genomic
sovereignty law was silent on data. However, Marìn-Schwartz
(2011) asserts that the proponents of genomic sovereignty viewed
data as also protected from export without government approval. He
observes that the proponents of Mexico’s genomic sovereignty
variously indicated that “... what is being protected is knowledge
about genes ...”. On the contrary, Siqueiros-Garcìa et al. (2013) are
categorical in their assertion that data is beyond the reach of
genomic sovereignty. In addition, Rojas-Martìnez (2015) states
that data is out of the scope of reach of Mexico’s genomic
sovereignty law. Similarly, in India, the Guidelines for the
Exchange of Human Biological Material for Research Purposes,
which are at the heart of the genomic sovereignty agenda, control the
export of human biological material (Ministry of Health and Family
Welfare [India], 1997), while in Thailand, the regulations control
export of human DNA samples (Sèguin et al., 2008).
It should be accepted that biological samples are the locus of data
and information. Even then, two strands of argument defeat
genomic sovereignty claims over control of genomic data. First,
prevailing state practice among research communities is to openly
share genomic data (Contreras and Knoppers, 2018). Marìn-
Schwartz (2011) alludes to this in his analysis on the
impracticability of Mexico’s genomic sovereignty policy, noting
that Mexico is part of the international open access network to
which it contributes. Secondly, and related to this, genomic research
favours large data sets which circulate in the international system
without being tied to nation states, and thus national data becomes
less valuable. For example, Vasquez and García-Deister (2019) in
their evaluation of Mexico’s genomic sovereignty find that after
publication of data on the Mexican genome mapping, international
collaborations shifted the research to large data sets resulting in de-
centring of the Mexican genome in favour of Latino genomic data.
Concerning enforcement of genomic sovereignty laws, it focuses
on the question of whether the concept is workable. This discussion
on the practicality of the concept is fully taken up in part 3.3.
Instructively, in the three countries, the laws, regulations and
guidelines that underpinned the genomic sovereignty agenda
were not enforced. In Mexico, a number of shortcomings in the
law informed this outcome. First, the non-existence of the unique
Mexican genome, which questions what was to be protected as
Mexican “uniqueness”(Marìn-Schwartz, 2011). Secondly,
Siqueiros-Garcìa et al. (2013) point to lack of institutional and
administrative procedures to implement the law. This view is
supported by Marìn-Schwartz (2011) who, based on participant
observation, points out that even if the law implicitly purported to
control intellectual property in Mexican genomic research, there
were no mechanisms put in place. Thirdly, there is the design of the
law, in that it sought to regulate population genomics, which is fluid,
while articulations of state sovereignty traditionally regulate fixed
objects (Marìn-Schwartz, 2011). Similarly, in India, lack of
administrative and institutional support hindered the
enforcement of guidelines protecting exportation of human
samples without government approval (Hardy, 2011).
3 African academics’engagement with
genomic sovereignty
3.1 Overview
The literature on genomic sovereignty by African academics is
dominated by the views of a South African academic, Pepper, and
his collaborators. Accordingly, this section explores in a
chronological fashion the development of the opinions of Pepper
and his various collaborators on the topic.
Spurred by developments in Mexico, the discourse on genomic
sovereignty gained international traction around 2010 (Marìn-
Schwartz, 2011). At this time, Pepper published his first article
on the topic. Slabbert and Pepper (2010) titled their article “A room
of their own: Legal lacunae regarding genomic sovereignty in South
Africa”and captured prevailing sentiments in the global South on
the need for these countries to protect their genomic resources from
exploitation by the global North. They linked genomic sovereignty
to access to and benefit sharing in genomic research, particularly
when genetic material originated from South Africa. They defined
genomic sovereignty as “the capacity of a people, a country or a
nation to own, to control both access to and use of samples, data and
knowledge concerning or emanating from genomic material”which
aptly captured the protection from foreign exploitation discourse. In
this regard, they highlighted the need for laws to regulate individual
data and the export of biological samples from South Africa.
Two years later, De Vries and Pepper (2012),inanarticletitled
“Genomic sovereignty and the African promise: Mining the African
genome for the benefitofAfrica”explored whether the concept can
protect genomic resources in the global South from exploitation by the
global North. Pointedly, by 2012, Mexico’s genomic sovereignty policy
had failed. In this article, De Vries and Pepper took a decidedly more
critical view of genomic sovereignty. The authors acknowledged the
appeal of the concept of genomic sovereignty in the African context, but
pointed out its conceptual limitations. They identified the limitations as:
lack of clarity on whom the final authority on access to and use of
genomic material rests and the role of the individual donor; inability of
states to represent the interests of the populations within their borders
equally, including the contestations by indigenous peoples on
representation of their interests; existence of ethnic groups across
geographical state boundaries; the assumption that the population of a
state is a unique biological unit; and the transnational nature of genomic
data. Based on these limitations, the authors argued that genomic
sovereignty is inadequate on its own to resolve the problems of
inequality and unfair distribution of benefits in African genomic research.
Furthermore, in 2017, while discussing the exporting of DNA,
Pepper alluded to the need to strike a balance between prevention of
exploitation and promotion of innovation. In the discussion on
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ownership of DNA, he mentioned the concept of genomic
sovereignty as referring to the “need to regulate ownership of
human genetic resources”(Pepper, 2017).
Beyond academic research, policy proposals that have alluded to
genomic sovereignty in South Africa have similarly been associated with
Pepper’s involvement in the development of such proposals. For
example, in 2011, the National Biotechnology Advisory Committee,
of which Pepper was a member, published a statement on genomic
sovereignty calling for publicdebateinSouthAfricaonregulationand
monitoring of human genomic material (National Biotechnology
Advisory Council [South Africa], 2011). Most recently, in 2018, the
Academy of Science of South Africa (ASSAf) published a report by a
consensus study group, led by Pepper, on human genetics and genomics
in South Africa. This report explicitly advanced the notion of an
individual’s DNA and genomic data as being “natural resources,”to
be managed by the state similarly to water or mineral resources
(Academy of Science of South Africa (ASSAf), 2018).
3.2 Conceptual underpinnings of genomic
sovereignty by African academics
What then underpins the concept of genomic sovereignty as espoused
by the African academics discussed above? A textual analysis of Pepper
and his research collaborators’academic work yields repetition of the
concepts: inequality; exploitation in export of samples; ownership of
genomic resources; and unfair distribution of benefits. Based on this, it is
therefore plausible to argue that the conceptual underpinnings of genomic
sovereignty by African academics are rooted in the history of colonial
dispossession, as in Mexico. De Vries and Pepper (2012) allude to this by
linking genomic sovereignty to concerns of “revival of colonialist relations
between Africa and the western world”in genomic research. In the same
strand of argument, these authors state that genomic sovereignty offers a
“conceptual framework”for genomic research by regulating ownership of
genomic material and samples (De Vries and Pepper, 2012).
Pepper and fellow researchers couch the concerns on
dispossession as inequality between local and international
researchers, arguing that local researchers do not benefit from
international research collaborations. According to these authors,
exploitation in the export of samples is comparable to exploitation of
natural resources such as oil and minerals, and can be addressed if
the concept of genomic sovereignty is enshrined into law.
De Vries and Pepper (2012), while discussing the conceptual
limitations of genomic sovereignty, also point out that the concept of
genomic sovereignty is inadequate on its own in achieving equity and
justice in genomic research. Rather, they highlight the need to develop
governance tools to ensure fair distribution of benefits among
researchers and populations. Pepper’sworkontheexportofDNAin
South Africa revisits genomic sovereignty in the context of regulation of
ownership of human genetic samples to guard against exploitation in
research,andpointsoutthatitremainsdebated(Pepper, 2017).
3.3 Critical assessment of genomic
sovereignty
A significant weakness in the literature discussed above is a
failure to consider human rights. Most prominently, as pointed out
by Thaldar et al. (2019), positing an individual’s genomic material
and data as “natural resources”—similar to minerals and water—can
be deemed offensive to individual dignity. In addition, the literature
discussed above fails to recognise and deal with the right to freedom
of scientific research, which is protected as a fundamental human
right in some African countries, such as South Africa, Kenya,
Morocco and Zimbabwe (Thaldar and Steytler, 2021). This
failure to consider human rights raises the question of whether a
legislative or policy move towards genomic sovereignty would
withstand constitutional scrutiny.
Moreover, in the case of genomic data, one also needs to
consider informational privacy rights. Various African countries
have enacted data protection legislation. These include some of
Africa’s most populous countries, such as Kenya, Nigeria, South
Africa and Tanzania. Genomic data will typically fall within the
scope of these statutes. Also, it is unlikely that genomic data can
be de-identified or anonymised (depending on the terminology
used in the specific jurisdiction) in order to escape the
applicability of these statutes. The informational privacy rights
protected in these statutes are therefore likely to apply to genomic
data. How does this effect genomic sovereignty? Informational
privacy rights belong to individuals,andaimtoprotectindividual
privacy interests. This stands in contrast with genomic
sovereignty, which aims to promote collective ethnic group
interests or state interests. It is not clear from the literature
discussed above how proponents of genomic sovereignty propose
to solve this philosophical dilemma.
Furthermore, to the extent that genomic sovereignty is understood
as entailing ownership of genomic material and data by the state, such
version of genomic sovereignty would amount to the
nationalisation—and expropriation—of property that is currently
privately owned. For example, in South Africa, genomic material is
currently owned by the research institution to which such material is
donated by a research participant (Thaldar and Shozi, 2022), and
genomic data, once sequenced and saved as a digital object, can also
be privately owned—likely by the research institution that performed the
sequencing (Thaldar et al., 2022). Therefore, if private ownership of
genomic material and data is replaced with state ownership, it means that
such genomic material and data are expropriated, which in turn triggers
legal protections of property rights. At the very least, the state would have
to offer financial compensation to the private owners. The property law
dimension of genomic material and data is a legal fact that cannot be
ignoredorwishedaway.
4 Finland’s state approach to human
genomic research
4.1 Finland’s human genomic research
infrastructure
This section discusses Finland’s human genomic research
framework as follows: biobanking infrastructure; framework for
availability and utilisation of genomic data, including the
National Genome Strategy; proposed genome centre and Genome
Act; and the Finngen project.
Finland’s framework on human genomic research traces back to
2006 when the Ministry of Social Affairs and Health established a
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working group to develop a law to regulate biobank operations in
Finland (Salokannel et al., 2019). The Finnish Biobank Act entered
into force in September 2013 and sets its objectives as supporting
research that uses human biological samples, promoting openness in
the use of the samples, and securing protection of privacy and self-
determination when processing the samples. It regulates all types of
biobanks and biological samples and information associated with
the samples. The scope of the Act covers: establishment and
operation of biobanks; collection of biobank samples and
information attached to the samples; storage and processing of
samples; rights of registered individuals to protect their privacy;
and registers for biobanking (Ministry of Social Affairs and Health
[Finland], 2013). The biobanks own the samples and are regarded as
common resources, to which researchers have access. The Act allows
broad consent for future research and secondary use of samples and
the linking of personal data with the biobank information (Ministry
of Social Affairs and Health [Finland], 2013). As of 2022, there are
11 registered biobanks in Finland, of which ten are public and one is
private. All biobanks must obtain a licence from the Finnish
Medicines Agency, Fimea (Ministry of Social Affairs and Health
[Finland], 2013).
In 2015, Finland launched the National Genome Strategy
which sets measures for incorporation of genomic data in the
Finnish healthcare system by 2020 (Ministry of Social Affairs and
Health [Finland], 2015). The Strategy is primarily focused on
data collection and utilisation and the establishment of a single
entity for management of genomic data. A key feature of the
Strategy is the establishment of a new public authority, the
genome centre, to promote responsible and equal use of
genomicdata.Thegenomecentrewillbemandatedto:setup
a national reference database of genomes; operate as a service
point for research agreements, contracts and commercialisation;
promote ethical practices in the use of genomic data by planning
and implementing consents; facilitate networking and
international collaboration; and initiate and stimulate public
debate on utilisation of genomic data. The genome centre is
envisioned as a permanent entity established through legislation,
theGenomeAct.ThemainobjectiveoftheGenomeActisto
facilitate responsible, equal and secure processing of genomic
data for the benefit of citizens (Ministry of Social Affairs and
Health [Finland], 2015). As of 2022, the Genome Act was still
being drafted.
In 2017, Finland launched the Finngen study, a national
public–private research project to collect and analyse genome
and health data from 500,000 participants of the Finnish
biobanks by 2023. The study is a partnership between
universities, hospitals, biobanks, the National Institute for Health
and Welfare, international pharmaceutical companies and the
Finns. As of December 2022, the total number of participants
was 342,499 (FINNGEN, 2017). The aim of Finngen is to build a
data resource that combines nationwide biobank data, national
healthcare data, and genome data.
Finland’s strengths which have enabled the establishment of the
above discussed research infrastructure are: high standard and
universal healthcare; uniform treatment practices; national health
registers; history of genetic research; and a population that is willing
to participate in genomic research (Ministry of Social Affairs and
Health [Finland], 2015).
4.2 Philosophical underpinnings of Finland’s
human genomic research framework
Finland’s human genomic research framework is founded on
individual (donor) sovereignty. Notably, Finland operates a welfare
public healthcare system for all residents. Writing on data donation
and exercise of sovereignty, Hummel et al. (2019) argue that
individual data sovereignty has both negative and positive
dimensions. The negative dimension of individual sovereignty
connotes the power to exclude others from personal data, while
the positive dimension includes the power to decide where your data
goes and how it is to be used. They compare individual sovereignty
to classical state sovereignty and posit that state sovereignty has both
external and internal dimensions, in which the external dimension
connotes no external inference, while the internal sovereignty means
the state has the power to govern within its territory as it wills.
Similarly, individual data sovereignty would mean the ability to
exclude others from personal data, and the ability to operate within
the informational self-determination sphere to pursue certain aims
and goals with one’s data. In addition, in the broad context of
sovereignty, they view power as the enabler of the exercise of
sovereignty. In the context of individual data sovereignty, power
means control over one’s individual data, that is, where it goes, who
can access it, and what it is used for. Viewed from this perspective,
individuals can exercise personal data sovereignty in its positive and
negative dimensions (Hummel et al., 2019).
Further, Hummel et al. (2019) argue that individual data
sovereignty can be facilitated in three ways: through consent,
representation, and organisational level constraints. On consent,
the authors state that informed consent would entail a balance
between research participation and respect for the self-
determination of the individual donor. In this respect they
highlight mechanisms that allow for opting out of biobanks and
withdrawing from research projects based on evolving preferences.
In relation to representation, they point to representation of an
individual donor’s will in the research governance processes to
further their interests. Finally, on organisational-level constraints,
they argue for supervisory oversight of institutions involved in data
collection and processing through impartial licensing schemes and
state legislation to ensure protection of the rights of individual
donors.
Returning to Finland’s human genomic research framework,
notably, the legal and policy documents expressly describe their
objectives or goals as enabling individual control over their own
genomic data. Illustratively, the Biobank Act sets out its objectives as
promoting openness in the use of human biological samples and to
ensure protection of privacy and self-determination in processing
the samples (Ministry of Social Affairs and Health [Finland], 2013).
Similarly, the Genome Act will establish the genome centre as a
national reference database, and has, as one of its principles, the
ability of individuals to control use of their genomic data (Tervo,
2021). The National Genome Strategy identifies the need for
legislation to guarantee individual rights to control, manage and
monitor own genomic data (Ministry of Social Affairs and Health
[Finland], 2015).
The research framework also contains features of individual
sovereignty in relation to control over use and management of their
data. For instance, the Biobank Act provides for access to
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information for registered individuals. This allows them, upon
request, to receive information on their samples such as whether
their samples are stored in the biobank and the criteria, who can
receive samples taken from them, who can access the samples, and
information on transferring the samples from the biobank (Ministry
of Social Affairs and Health [Finland], 2013).
In line with the three mechanisms to facilitate exercise of
individual sovereignty discussed by Hummel et al. (2019) on
consent, the Finnish research framework governing laws allow
individuals to exercise control through issuing of consent to
research participation. The Biobank Act’s provisions allow
individuals to voluntarily consent to the use of their samples and
data, to impose restrictions while issuing consent, and to cancel their
consent at any time without any penalties (Ministry of Social Affairs
and Health [Finland], 2013). In addition, the Act allows for change
of consent or prohibition of the use of samples at any stage of the
research process (Ministry of Social Affairs and Health [Finland],
2013). In this regard, it is arguable that individual data sovereignty is
exercised, as the individual manages and controls how, for what, and
by whom their samples are used.
In relation to organisational-level controls, the Finnish biobanks
are regulated and monitored at the national level. First, prior to
establishment, biobanks must obtain a positive statement from the
National Committee on Medical Research Ethics confirming that
the activities of the biobank comply with the protection of privacy
and self-determination requirements (Ministry of Social Affairs and
Health [Finland], 2013). Secondly, biobanks are supervised at the
national level by Fimea to ensure that they maintain transparency in
their biobanking activities (Ministry of Social Affairs and Health
[Finland], 2023). Thirdly, biobanks are required to appoint a
custodian whose duties are cast as obligations owed to the
individual sample/data donor (Ministry of Social Affairs and
Health [Finland], 2013). These organisational-level constraints
enable individual data sovereignty as individuals retain control
and management of how their samples and data are used.
4.3 A tale of two approaches to regulation of
human genomic research: Mexico versus
Finland
This section compares the above state approaches in the
regulation of human genomic research. It is likely that there are
more approaches and the choice of these two is random. Yet, both
Mexico and Finland represent archetypes for two approaches to
human genomic research that states have taken in the past decade in
terms of the differences that characterise them and the seemingly
unexpected similarities.
The general stance of Mexico’s approach may be described as
follows. Human genomic resources are akin to other natural
resources, and hence the need for the state to exercise a
protective barrier to prevent foreign exploitation. The state’s role
is thus viewed as to control and regulate access to and use of genomic
resources. This position is actualised through establishment of the
research institution INMEGEN, mapping of the national genome,
and incorporation of the concept of genomic sovereignty in law.
Conversely, Finland’s approach is that genomic data can be used
to improve the health outcomes of the Finnish people. The state’s
role is thus to put in place the requisite framework for genomic data
collection and utilisation. This position is actualised through the
establishment of a legal framework on biobanks, mapping of the
national genome, and establishment of the research framework
through the National Genome Strategy which proposes a national
genome centre and the genome law.
From the two approaches, this article identifies the following
themes as the basis of comparison: philosophical underpinnings of
the approaches; research infrastructure; and ownership of genomic
data. As already demonstrated, Mexico and Finland have stark
differences in their philosophical approaches. The Mexican
approach is premised on genomic sovereignty, understood as
state control of access to and use of genomic resources. This
philosophy is rooted in the belief that genomic resources are
national resources over which the state can exercise a protective
barrier from foreign exploitation. In practice, this philosophy was
embedded in the genomic sovereignty law which restricted export of
human biological samples without state approval and the
INMEGEN whose roles included surveillance of the samples. In
the end, Mexico’s approach, which was underpinned by genomic
sovereignty, proved impractical as it hindered international
collaborations, hence violating the rights of both researchers and
citizens generally. In addition, there was the inability of the state to
exercise control due to the nature of population genomics, which
defies territorial-based articulations of sovereignty. Finland’s
research framework is premised on individual sovereignty, in
which the individual donor of the samples and data exercises
sovereignty by controlling and managing how their genomic data
is used. The philosophy is rooted in human rights, in which
individuals exercise informational self-determination. It is
embedded in the legal framework on Biobanks and in the
National Genome Strategy and its proposed national genome
centre and genome, by vesting in individuals the power to
control and manage use of their data.
On the research infrastructure, there are striking similarities. Both
Mexico and Finland have established an institutional framework for
genomic research, the INMEGEN in Mexico and the proposed national
genomecentreinFinland.Inaddition,bothhavelawstogovernhuman
genomic research: in Mexico, the genomic sovereignty law, while in
Finland there is the Biobank Actandtheproposedgenomelaw.
However, the point of departure isontherolesoftheinstitutions
and the objectives of the laws, which reflect the philosophy that
underpins the overall state approach. In Mexico, the INMEGEN had
the role of centralising and controlling genomic research. Similarly, the
objective of the genomic sovereignty law was to restrict movement of
samples without state approval. On the contrary, in Finland, the
proposed national genome centre will facilitate international
collaboration by setting up the national reference database of
genomes with the necessary links to international databases and will
provide centralised services for research projects and agreements. It will
also plan and implement management of consents based on the
individual right to decide. The genome law will enable individuals to
control, manage and monitor the use of their genomic data.
Finally, how do the two state approaches deal with the issue of
ownership, which in Finland is not deemed problematic, but which
at the international level remains unsettled? In Finland, the general
proposition is that genomic data are owned by the research
institutions and biobanks. However, given that the research
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framework is underpinned by individual sovereignty, as discussed
previously, it is reasonable to argue that the ownership is more
nuanced and can perhaps be described as custodianship, given that
significant control vests in individual donors. The Mexican
proposition is the opposite. The issue of ownership of genomic
resources undergirds the research framework. Genomic resources
are viewed as national resources which can be subjected to exclusive
state control. This proposition on ownership explains the violation
of the rights of researchers and the complete disregard of the rights
of individuals in Mexico’s research framework, which, in many
states, would not pass constitutional scrutiny.
The foregoing discussion of the Mexican and Finnish
approaches to human genomic research demonstrates that state
approaches premised on genomic sovereignty are unworkable. First,
this approach is not aligned to state obligations under international
human rights law, specifically, the right to academic freedom for
researchers, the right to privacy and self-determination for
individuals, and the right to science. Secondly, the nature of
genomic research defies state control premised on the idea of
sovereignty, since sovereignty is territorial while polulations are
fluid. In addition, the nature of genomic research is transnational,
and hence obsession with national-level data is misplaced as
national-level data on its own has limited utility value.
Conclusively then, state approaches based on genomic
sovereignty should be abandoned.
In the next section, the article explores obligations of the state
under the right to science and in the specific context of human
genomic research, in an effort to map out proposals on where state
approaches should focus.
5 The right of everyone to enjoy the
benefits of scientific progress and its
applications in international human
rights law
5.1 State obligations flowing from the right
to science
The right of everyone to enjoy the benefits of scientific progress
and its applications (the right to science) finds textual expression in
the Universal Declaration of Human Rights (UN General Assembly,
1948) (UDHR) and in the International Covenant for Economic,
Social and Cultural Rights (UN General Assembly, 1966) (ICESCR).
Although not framed in identical wording, there are arguments in
favour of construing the right as encompassing the right of everyone
to access and contribute to knowledge and information and the right
of everyone to benefit from scientific applications (Boggio and
Romano, 2018;Yotova and Knoppers, 2020;Mancisidor, 2021).
In addition, the right is formulated as part of cultural rights, and
state practice has similarly evolved to treat the right as part of
cultural rights (UN Human Rights Council, 2009). Arguments made
in support of the right as a cultural right posit that both science and
culture involve production of knowledge, innovation and creativity
which support the full development of the person (Shaheed and
Mazibrada, 2021).
Unlike other socio-economic rights, the right to science has not
received much scholarly attention or in state implementation and
has thus been said to be characterised by stunted development
compared to other rights. Yotova and Knoppers (2020) citing
Schabas refer to the right as the “sleeping beauty of human
rights,”and Donders (2011), while discussing the reawakening of
the right, refers to the right as recently “having its dust blown off”.
Mancisidor (2021) notes that the textual positioning of the right at
the end of both the UDHR and the ICESCR and its characterisation
as a cultural right have contributed to its neglect. Even then,
advances in science and technological innovation in the past
decade have foregrounded the right. For instance, in the specific
context of human genomic research there is scholarly work invoking
the right in relation to genomic human research. Yotova and
Knoppers (2020) have reviewed state practice on the right and
argued that the right to benefit from science and its applications
supports genomic data sharing. Elsewhere, Knoppers et al. (2014)
anchor their proposal on an international code of conduct for
sharing genomics and clinical data on the right to benefit from
science and its applications. Below is a brief discussion on the right
to science that maps out the state obligations as a prelude to the next
section on state obligations in human genomic research.
A plain reading of the right to science as formulated in the
ICESCR reveals positive obligations requiring states to “recognize
the right of everyone to enjoy the benefits of scientific progress and
its applications.”The UN Committee on Economic, Social and
Cultural Rights (2020) elaborated on the elements of the right
and the ensuing state obligations. It lists the elements of the right
as: availability, accessibility, quality, and acceptability. Availability
connotes a requirement of scientific progress and the protection and
dissemination of scientific knowledge. Consequently, states have an
obligation for conservation, development and diffusion of science by
putting in place research infrastructure, funding research,
promoting open science, and making accessible the findings and
data of publicly funded research (UN Committee on Economic,
Social and Cultural Rights, 2020). Development has been interpreted
to mean state support for science while diffusion refers to equitable
distribution of the benefits and applications of science, and
conservation requires sustainable science that caters for present
and future generations (Frick and Dang, 2021). Accessibility
addresses the right of every person to access scientific progress
and its applications without discrimination. States are thus to
guarantee equal access to the applications of science to all,
information on risks and benefits of science, and opportunity for
all to participate in scientific progress (UN Committee on Economic,
Social and Cultural Rights, 2020). The American Association for the
Advancement of Science views accessibility as “a continuum of
access”with the public on one end of the spectrum and scientists
on the other (Frick and Dang, 2021). Quality relates to both creation
of scientific knowledge and access to the benefits and applications of
science. To this end, states are required to ensure ethical and
responsible development of science and that only certified science
is available to the general public (UN Committee on Economic,
Social and Cultural Rights, 2020). An example of state failure to
adhere to the element of quality in the application of science was the
alleged United Arab Emirates use of faulty algorithms in diagnosing
tuberculosis in its immigration procedures, which resulted in denial
of work permits for migrants (Frick and Dang, 2021). Acceptability
means respect for cultural diversity and pluralism in that the right to
participate in science and enjoy benefits of science and its
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applications should be implemented in a manner that accords with
specific cultural and social contexts. Acceptability also connotes
ethical standards including respect for dignity, privacy and
autonomy of individuals (UN Committee on Economic, Social
and Cultural Rights, 2020). Respect for cultural diversity can be
achieved by having community advisory boards in research projects
and multidisciplinary and plural ethical review boards.
While the right to science is to be achieved progressively and subject
to availability of resources, akin to otherrightsintheICESCR,theright
imposes obligations of a general nature on states which are of immediate
implementation. To this end, the right to science requires states not to
take retrogressive measures that impede enjoyment of the right. Such
measures include imposition of policies that impede conservation,
development and diffusion of science, the imposition of barriers to
citizen participation, and adoption of laws and policies that prevent
international collaborations (UN Committee on Economic, Social and
Cultural Rights, 2020). In addition, states have an immediate obligation
to eliminate discrimination in terms of participation in scientificprogress
and enjoyment of scientificbenefits and its applications. Consequently,
states should eradicate discrimination in the formulation and
implementation of policies on the right to participate and benefit
from science and its applications (UN Committee on Economic,
Social and Cultural Rights, 2020).
The specific state obligations under the triptych typology are
obligation to respect, to prevent or ensure, and to fulfil. Under the
obligation to respect, states and their agencies should desist from
interfering with the right to participate in and to enjoy the benefits of
science and its applications. States therefore should not misinform
the public on science and scientific research which could have the
effect of eroding public trust in science, create obstacles for
international collaboration among scientists, and arbitrarily limit
internet access which could impede access to and the dissemination
of scientific knowledge. The obligation to protect requires states to
prevent violation of the right to science by non-state actors,
including individuals and multinational corporations. The
measures states should take to protect include: preventing non-
state actors from applying discriminatory criteria in scientific
research; ensuring and guaranteeing ethical standards for persons
in scientific research; and protecting individuals in their familiar,
social and cultural contexts when their right to science is violated.
The UN Committee on Economic, Social and Cultural Rights (2020)
recognises the dominance of private enterprises in the right to
science and requires states to establish a legal framework that
imposes a duty of human rights’due diligence on multinational
corporations. In addition, states have extraterritorial obligations to
ensure that multinational corporations within their control do not
violate the right to science when acting abroad. On the obligation to
fulfil, states should put in place the requisite infrastructure—legal,
institutional, financial and administrative—for the right to science.
This includes: facilitating participation in international cooperation
programmes, facilitating access to the internet, funding research and
making scientific knowledge broadly available (UN Committee on
Economic, Social and Cultural Rights, 2020).
Under Article 15(4) which refers to the gains of international
cooperation in the right to science, states have an obligation to
promote and facilitate scientific researchers to participate in the
“international scientific and technical community”and to freely
share data (UN Committee on Economic, Social and Cultural
Rights, 2020). In addition, in recognition of the differences
among states in science and technology, the ICESCR imposes
special obligations on wealthier states to assist less wealthy states
(UN Committee on Economic, Social and Cultural Rights, 1990).
5.2 State obligations in respect of human
genomic research
Consistent with the idea of the interdependence and
interconnectedness of human rights, this section examines state
obligations in human genomic research from the prism of the right
to science while reading in the right to health. The section draws
from the approaches of Mexico and Finland in human genomic
research for contextualisation.
The chronicles of the Mexican and Finnish approaches to
human genomic research offer insights on its nature. It follows
that: it is driven by large datasets that are tied to other data; it is
characterised by transnational and public–private collaboration
specifically that nationally bound genomic data has limited
utility; it requires research infrastructure; and individual data and
the inherent ethical issues are crucial. What then are the state
obligations for the realisation of the right to science in this context?
At the outset, although ICESCR rights lend themselves to
progressive implementation, as discussed above, states have
immediate obligations. First, states are prohibited from taking
retrogressive measures in relation to human genomic research.
Retrogressive measures include removal of policies that are
necessary to support scientific research and legal and policy
changes that hinder international collaborations in science.
Revisiting genomic sovereignty in Mexico, the result of this
political and scientific policy agenda was that the law on genomic
sovereignty hindered international collaboration as scientists could
not share biological samples. While retrogressive measures may be
permitted under the ICESCR, for instance in the case of natural
disasters and severe recessions, they must be necessary and
proportionate. As discussed, the philosophical underpinnings of
genomic sovereignty are a postcolonial dispossession discourse
which would not support a reading of it as a permissible
measure. Mann et al. (2021) provide some direction on the
evaluation of retrogressive measures under the ICESCR rights,
such as a country’s level of development; economic recession;
whether the country is involved in international conflict; and
whether the country has sought assistance. Therefore, the
concept of genomic sovereignty negates the right to science as it
constitutes an unjustifiable retrogressive measure. The core state
obligations require the state to take measures that enhance
development, diffusion and the conservation of science. There are
valuable lessons from Finland’s approach in which the state has
facilitated research infrastructure, such as the national genome
centre. This will create a national reference database for genomes
with international links, thus allowing international collaborations
in line with the obligation to support science.
The second set of state obligations that is immediate and not
subject to progressive measures is non-discrimination. The
formulation of the right to science uses the term everyone.
Significantly, invocation of the term everyone in relation to
participation in science means that not only researchers but also
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the public must participate in science and scientific progress without
discrimination. States are thus directed to ensure that marginalised
segments of the population can participate in genomic research and
also enjoy the benefits and applications of scientific progress.
Flowing from non-discrimination in the right to science is the
requirement of participation. On the framework for participation,
Mann et al. (2021) point out two areas in which everyone can
participate: in active dialogue between scientists and the public to
create public trust and promote citizen science; and in data
donation. The question then arises on state obligations in this
regard. The element of accessibility in the right to science
obligates states to put in place measures for everyone to
participate in science. In addition, under the obligation to fulfil,
the state should put in place legal, institutional and budgetary
infrastructure that allows for participation of both citizens and
scientists. Furthermore, in relation to data donation, states have
an obligation to make data available through adoption of policies
that encourage citizens to participate in research. Drawing from
Finland’s approach, as discussed earlier, the philosophical
underpinning of Finland’s genomic research is individual data
sovereignty, which encourages data donation as citizens control
and manage their data in genomic research. This proposition finds
support in Finland’s legislation and policies, for instance the
Biobank Act, the proposed Genome Act and the National
Genome Strategy, which ensure that individuals control and
manage their data.
Moreover, on transnational data sharing, the element of
availability imposes a duty on states to support science. In
relation to human genomic research, this implies sharing of
data. Yotova and Knoppers (2020) also argue that the
obligation of states to diffuse scientific knowledge would
require states to share genomic data from a global public
goods approach. As pointed out earlier, the Mexican concept
of genomic sovereignty restricted transnational sharing of data of
the Mexican genome and ultimately inhibited development and
diffusion of science given that national genomic datasets have
little utility value for genomic research.
On the centrality of individual and the inherent ethical issues,
the key state obligations can be derived from the element of
acceptability and the state’s specific obligation to protect. The
element of acceptability requires states to ensure that scientific
research incorporates ethical standards that respect privacy,
autonomy and dignity of the individual, as well as minimisation
of harm and maximisation of benefits. Relatedly, the obligation to
protect requires states to prevent violation of rights by non-state
actors through adoption of legislation and judicial remedies in
instances of violation. To that extent, the approach taken by
states in human genomic research should ensure that individual
rights are respected and upheld. As demonstrated, the rights in issue
are individual privacy and informational self-determination and
human dignity. At the outset, it is also apparent that state
approaches to human genomic research anchored on genomic
sovereignty violate individual rights to human dignity by
regarding individual personal data as a national resource and also
violate privacy and informational self-determination by
disregarding the rights of individuals in relation to their
individual data. Taking lessons from Finland’s approach, the
nature of human genomic research demands that human rights
be at the core of the research infrastructure due to the centrality of
the individual from the perspective of genomic data and application
of the outcomes of scientific progress.
Finally, on the research infrastructure, the obligation to fulfil
imposes a positive duty on states to actively facilitate the
advancement of science. As noted, human genomic research is
reliant on research infrastructure such as institutional
frameworks for collecting and processing samples and data and
the supporting legal and policy framework, including international
linkages and collaborations. States therefore have an obligation to
allocate funding for research infrastructure. A key lesson from the
Mexican and Finnish approaches is the philosophical underpinning
that anchors the research infrastructure. As demonstrated,
philosophical underpinnings that view genomic resources as
national resources are inclined to establish research infrastructure
that hinders the right to science, as in the case of Mexico and
genomic sovereignty.
6 Conclusion
This article sought to enquire whether genomic sovereignty is
the appropriate governance framework for access to and use of
genomic resources. Debate on the governance framework for the
human genome remains unsettled 25 years after the adoption of
the Universal Declaration on the Human Genome and Human
Rights. While the Declaration appears to favour the common
heritage of mankind governance framework, at the time of
adoption a number of states indicated the need for further
deliberations. Twenty-five years on, developments in this
regard have remained stunted. However, in this time, state
practice in human genomic research has evolved to embody
divergent approaches, in some instances in response to the
proposed international governance framework and in others
motivated by the desire to participate in the bio-economy
heralded by the Human Genome Project. This article analysed
the divergent approaches by two states, Mexico and Finland.
While not conclusively settling the issue of the most appropriate
governance framework, the article brings out insights on which
approach best supports human genomic research and which
approach best enables a state to participate in the genomic
knowledge economy. A key finding is that given the centrality
of the individual in human genomic research, state-centred
approaches—anchored on the notion of state appropriation of
genomic resources—such as that embodied by genomic
sovereignty, cannot withstand human rights scrutiny and
should be abandoned.
Turning to the issue of human rights, the article argues that even
in the absence of a conclusive position at the political level on the
governance framework, states have legally binding obligations in
human genomic research under international human rights law. The
ICESCR guarantees everyone the right to science and imposes
certain binding obligations on states. Significantly, the ICESCR
enjoys near universal ratification and no state has placed a
reservation on the right to science (UN Office of the High
Commissioner for Human Rights, 2023). To this extent, state
parties have binding obligations regardless of the absence of a
conclusive international governance framework on human
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genomic research. The article once again demonstrates that state-
centred approaches to human genomic research violate the rights of
individuals and those of researchers, hence running foul of binding
ICESCR obligations. In addition, the article maps the state
obligations under the right to science—pointing to where state
approaches to human genomic research should focus.
Returning to the broader and vexing question of the appropriate
governance framework, individual personality rights, state
sovereignty and the common heritage concepts have always
seemed at odds in governance of human genomic research and it
often appears as if one should trump the other. This article, for a
start, points to the possibility of marrying these competing
regulatory approaches. Undoubtedly, the state remains the
primary site of accountability for protection of human rights. In
that regard states have a role to play in governance of human
genomic research by implementing the right to science and ensuring
the protection of the other rights at play. For the individual and their
personality rights, the Finnish approach demonstrates the possibility
of individuals taking control in the use of their genomic data and
samples.
Thetake-homelessonforAfricanstatesisthatgenomic
sovereignty has no utility value in human genomic research
and thus should be abandoned as the philosophical basis for
governing human genomic research, regardless of its superficial
appeal in light of Africa’s history of colonisation and
dispossession. Human rights offer a more promising approach.
First, African states have binding obligations under the right to
science—notwithstanding availability of resources. Also, taking
into account the indivisibility of rights, states have obligations
under the right to health to facilitateenjoymentofthehighest
attainable standard of health. Aswehaveargued,Africanstates
should implement their human rights obligations in the context
of human genomic research by putting in place the necessary
research infrastructure, including ethical and legal frameworks to
protect individual rights, and by facilitating international
collaborations to foster research.
Data availability statement
The original contributions presented in the study are included in
the article/Supplementary Material, and further inquiries can be
directed to the corresponding author.
Author contributions
All authors listed have made a substantial, direct, and intellectual
contribution to the work and have approved it for publication.
Funding
Work on this article was supported by the U.S. National Institute
of Mental Health and the U.S. National Institutes of Health (Award
Number U01MH127690) under the Harnessing Data Science for
Health Discovery and Innovation in Africa (DS-I Africa) program.
Acknowledgments
We are grateful to Bonginkosi Shozi, Freddy Mnyongani, Peter
Munyi, Claude Kamau, and Johanna Rahnasto for their insightful
comments while developing the article. Any errors are our own.
Conflict of interest
The authors declare that the research was conducted in the
absence of any commercial or financial relationships that could be
construed as a potential conflict of interest.
Publisher’s note
All claims expressed in this article are solely those of the authors
and do not necessarily represent those of their affiliated
organizations, or those of the publisher, the editors and the
reviewers. Any product that may be evaluated in this article, or
claim that may be made by its manufacturer, is not guaranteed or
endorsed by the publisher.
Author disclaimer
The content of this article is solely our responsibility and does
not necessarily represent the official views of the U.S. National
Institute of Mental Health or the U.S. National Institutes of Health.
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