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East Asian Science, Technology and Society: An International Journal (2020) 14:479–505

DOI 10.1215/18752160-8698019

Viral Sovereignty or Sequence Etiquette?


Asian Science, Open Data, and Knowledge Control
in Global Virus Surveillance

Lyle Fearnley

Received: 12 November 2019 / Accepted: 20 April 2020


© 2020 Ministry of Science and Technology, Taiwan

Abstract On several occasions, the People’s Republic of China refused to share influ-
enza viruses isolated on their territory with the World Health Organization pandemic
flu surveillance system. Scholars in STS and allied disciplines have described these
disputes as examples of growing conflict between global health norms of free exchange
and Asian state claims of viral sovereignty. However, the discussion has largely over-
looked the fact that laboratories in China freely shared genetic sequence data from
isolated viruses, even when they refused to ship physical samples, a fact that compli-
cates the opposition of open data and viral sovereignty with the different material forms
of the physical sample and the nucleotide sequence. This article provides a compre-
hensive comparison of the heterogeneous circulations of influenza virus samples and
virus gene sequences in global health influenza surveillance and argues this difference
is rooted in the different knowledge-control regimes designed for exchanging samples
and sequences. Engaging with debates on the position of Asian science within global
scientific circulations, the article suggests that Asian scientists confront a multiplicity
of global scientific infrastructures and do not necessarily rely on the authority of
nation-state sovereignty to reshape global exchanges.

Keywords genomics database ▪ global health ▪ pandemic influenza ▪ knowledge-


control regime ▪ moral economy ▪ COVID-19

Acknowledgments I thank the editor, Wen-Hua Kuo, and two anonymous reviewers for insightful com-
ments and questions. This article greatly benefited from feedback received at workshops organized by Itty
Abraham at the National University of Singapore and by Hallam Stevens at Nanyang Technological
University. Research and the writing of versions of this article were supported by a Fulbright-Hays Doctoral
Dissertation Research Abroad Fellowship and a Chiang Ching-Kuo Foundation Doctoral Fellowship.

L. Fearnley
Humanities, Arts, and Social Sciences, Singapore University of Technology and Design, Singapore
email: lyle_fearnley@sutd.edu.sg

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480 L. Fearnley

In the summer of 2018, as an industrial trade war loomed, American infectious disease
specialists suddenly criticized the People’s Republic of China (PRC) for halting a
somewhat more unusual trade. Under the headline “China Has Withheld Samples of
a Dangerous Virus,” the New York Times (Baumgaertner 2018) reported that the PRC
government had, for more than a year, failed to send biological samples of the emerg-
ing H7N9 avian influenza virus to laboratories in the United States, including the US
Centers for Disease Control and Prevention (CDC). In the article, Dr. Michael Callahan
pointed out that the failure to share influenza virus samples was “unlike shortages in
aluminum and soybeans,” since China’s actions could endanger global health security.
“Given that this flu virus is a potential threat to humanity,” agreed Andrew C. Weber, a
biodefense expert, “not sharing it immediately with the global network of [World
Health Organization] laboratories like C.D.C. is scandalous. Many could die need-
lessly if China denies international access to samples.”
Far from an isolated incident, disputes over the “sharing” of influenza viruses have
become an important topic in critical studies of global health and postcolonial Asian
science. About a decade earlier, at the height of fears that the H5N1 bird flu strain
would cause a global pandemic, the World Health Organization (WHO) had requested
member states to ship samples to central reference laboratories, including the CDC.
Although this was the accepted “ethos and practice” (Fidler 2008: 90) of WHO’s fifty-
year-old Global Influenza Surveillance and Response System (GISRS),1 both the PRC
and Indonesia refused to cooperate. Scholars have widely described these refusals as
unprecedented “assertions” (Fidler 2008) of rights by nation-states against global
health norms of cooperative research and shared surveillance. Sovereignty, these
scholars concluded, is at the center of the flu virus disputes: while on one side, global
health agencies claim the authority of “sovereign science,” in which pandemic pre-
paredness depends on “globally free-flowing information” (Hurlbut 2017: 2); on the
other, nation-states make claims to a “viral sovereignty” that “tethers” viruses (Hin-
terberger and Porter 2015)—and their potential biological values—to the sovereign
territory where they are isolated (Elbe 2010; Fischer 2013; Lakoff 2010; MacPhail
2009; Ong 2008, 2010; Stephenson 2010).
However, there is something often overlooked about all of these flu virus disputes:
both the PRC and Indonesia continued to share genetic sequence data from the isolated
viruses during the same time periods when they halted shipments of physical virus
samples. During the 2005 disputes, WHO criticized China for failing to share H5N1
viruses but commended China for posting virus ribonucleic acid (RNA) gene sequen-
ces from human and bird outbreaks “in international databases for scientists the world
over to access” (ProMed 2005). Indonesia, despite withholding all physical samples,
ordered that the sequence data from all H5N1 viruses isolated in Indonesia should be
posted to GenBank, the open access database. And in the 2018 H7N9 influenza virus
controversy, Thomas Bollyky and David Fidler (2018) point out that the PRC’s Center
for Disease Control and Prevention once again consistently “shared sequence data on
this strain,” and they highlight the discrepancy between China’s “participation in
global surveillance and reporting activities” (for sequences) and “its problematic shar-
ing of H7N9 virus samples.” If viral sovereignty “disrupts imperatives to share

1 Formerly known as the World Influenza Programme (WIP) or the Global Influenza Surveillance Network

(GISN). To reduce confusion, I will refer throughout to the GISRS, even when this would be anachronistic.

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Viral Sovereignty or Sequence Etiquette? 481

biological samples and data” by tethering these materials to their origins (Hinterberger
and Porter 2015: 362), influenza sequence information is unexpectedly “open” and
freely shared in contexts where physical samples of flu virus are not. This article offers
a detailed analysis of these differences in sample and sequence sharing to explore the
politics of global virus surveillance beyond the model of viral sovereignty.
As it turns out, controversies did emerge around the sharing of sequences, but the
disputes fell along different lines. In February 2006, several influenza researchers
publicly criticized the US Los Alamos National Laboratory for introducing a password
log-in system to one section of its formerly open-access Influenza Sequence Database
(ISD) and providing passwords to only around fifteen laboratories (including WHO
labs and the CDC). Much like in the sample sharing disputes, critics of the Los Alamos
ISD argued that “making significant information unavailable” posed a threat to global
public health.2 But the geography of secrecy differed: far from the “developing”
countries from “postcolonial contexts” (Hinterberger and Porter 2015: 372) previously
highlighted in discussions of influenza sharing disputes, a US laboratory and WHO
itself were accused of refusing to share. More importantly, the disputes over sequence
sharing were resolved in ways that also differed from the sample sharing disputes.
Rather than utilizing international law to negotiate a compromise between nation-
states and global health agencies—balancing viral sovereignty against sovereign
science—the resolution of sequence sharing disputes centered on the regulation of
reciprocity among individual laboratories, or what came to be referred to as “scientific
etiquette.”3
Despite the significant scholarly attention given to the flu-virus sharing disputes,
existing accounts have yet to analyze these differences in the circulation and regulation
of physical samples and nucleotide sequences. Although Amy Hinterberger and Nata-
lie Porter (2015) discuss both “viral sovereignty” and “genomic sovereignty” in their
article, they “emphasize overlapping relationships between people, substances, tech-
nologies, markets, and publics” (364) that apply to both viruses and genomes rather
than illuminating differences.4 In the only extensive discussion of the issues surround-
ing influenza sequence sharing, Stefan Elbe and Gemma Buckland-Merrett (2017: 36)
lump sample and sequence controversies together, arguing that “similar [political]
sensitivities” disrupted sharing in both cases. Yet when WHO established an interna-
tional policy to regulate the exchange of influenza virus samples after Indonesia’s
complaint, the Pandemic Influenza Preparedness (PIP) Framework explicitly excluded
“genetic sequences” from its purview (WHO 2011). As recently as 2019, the World
Health Assembly reaffirmed the exclusion of genetic sequence data from WHO’s
regulatory agreements (Saez 2019). During the past two decades, the same “impera-
tives to share” (Hinterberger and Porter 2015: 362) influenza viruses have been applied
to both physical samples and genetic sequence data, yet the circulation of physical
samples and genetic sequences continues to be governed differently.

2 FAO Animal Influenza specialist Ilaria Capua, quoted in Zamiska 2006a.


3 A second series of controversies has emerged around a subset of samples and sequences associated with
so-called gain of function research. I do not directly consider these disputes, because they have not appeared
in debates over the design of virus sequence databases. On these controversies, see Bennett 2015; Caduff
2012; Hurlbut 2017; Lakoff 2017.
4 Hinterberger and Porter’s discussion of genomic sovereignty focuses on human genome research and

does not discuss sharing of influenza genetic sequence data at all.

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482 L. Fearnley

If discussions of sample sharing debates have thus far revolved around the conflict
between open science and viral sovereignty, understanding the difference between the
circulation of physical samples and genetic sequences requires us to situate global
health politics within the ontological “tension between the biological and the infor-
matic” (Thacker 2005: 21) in the contemporary biosciences. Scholars have widely
discussed the ontological novelty of the genetic sequence code, which constitutes life
as information alongside of biological substance (Kay 2000). Although originally a
metaphor or concept—life as information—the genomics revolution has meant that
biological research and biotechnology now often work with life in informational
media, from computers to servers to online networks (Stevens 2013). The “inter-
changeability” of life from “wet” substance to “dry” information, what Eugene
Thacker (2005: 10) describes as “DNA’s mobility across the in vivo, in vitro, and in
silico contexts,” is both a promise and practice of contemporary biology. While iden-
tifying a “collapse of matter and message at the heart of the contemporary life sciences”
(Franklin 2000: 194), however, scholars also note that genetic sequence data does not
always carry the same meaning or value as biological substances. As Thacker (2005:
xx) continues, the “encoding” of biological materials and the “decoding of that digital
form (back) into biological material . . . form[s] an incomplete circle.” Indeed, a pos-
sible explanation for the different degrees of circulation of influenza virus samples and
influenza virus GSD is that samples are simply much more valuable for a range of
global health purposes, from surveillance to vaccine development, making countries or
scientists more reluctant to share them.
In fact, however, in recent years the growing interchangeability of virus samples and
sequences has meant that in global health, genetic sequence data is complementing, if
not completely replacing, material samples of viruses in three key domains: surveil-
lance; the creation of test-kits; and vaccine development. In influenza surveillance,
genetic-sequence-based classification is now equal to or more important than antigen-
based classification (for example, H5N1 viruses are subdivided into “clades” based on
phylogenetic analysis of sequences, with some clades considered more important
threats than others), and is utilized in both pandemic influenza screening and in sea-
sonal influenza vaccine seed-strain selection. Similarly, diagnostic test kits can now be
made based on sequence data alone: for instance, the first diagnostic tests developed for
the recent COVID-19 coronavirus were developed in Germany by researchers who
only had access to genetic sequence data uploaded to a database by Chinese research-
ers. Most powerfully, the development of reverse genetics techniques—in which
genetic sequence data is used to construct a living virus—suggest the increasing con-
vertibility of sequence and sample. Famously used to “resurrect” the 1918 pandemic
influenza virus in 2005, reverse genetics has also revolutionized vaccine development
by enabling the production of vaccines from sequence data, including the creation of
“recombinant” vaccines that draw sequence components from multiple strains.
Although the global health values of virus samples and sequence data are becoming
increasingly indistinguishable, a crucial difference between sample and sequence lies
in their modes of exchange. In a study of pandemic influenza research, anthropologist
Carlo Caduff (2012: 343) points out that influenza’s “biological bodies have increas-
ingly begun to circulate in informational forms, rather than corporeal ones” and notes
that the greater “ability of information to be detached from its original context” means
that sequence information circulates differently from the exchange of biological

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Viral Sovereignty or Sequence Etiquette? 483

substances. Caduff refers to this as the “iterability” of sequence information, and


suggests that this distinct ontological capacity for “decontextualization” poses chal-
lenges to the moral and legal regulation of scientific exchange (350). In this article,
I further develop Caduff’s insight into the distinct circulations of genetic sequence
information, but I do not treat this iterability as an ontological characteristic intrinsic to
sequence qua information. Rather, I draw attention to the technical and governmental
constitution of modes of exchange—what Stephen Hilgartner (2017) calls “knowledge-
control regimes”—that developed to enable and regulate the circulation of influenza
virus samples, on the one hand, and influeza virus GSD, on the other.

1 Two Knowledge-Control Regimes in Global Health

A knowledge-control regime, for Hilgartner (2017, chap. 1), is a “sociotechnical


arrangement that . . . allocates entitlements and burdens pertaining to knowledge,”
including control over the “social, spatial, and temporal distribution of ‘knowledge
objects.’” As Hilgartner indicates, the concept of a knowledge-control regime is similar
to that of moral economies of scientific exchange (Strasser 2011, 2019; Kelty 2012;
Kohler 1994), but is more expansive. A moral economy, as Chris Kelty (2012: 142n3)
explains, is “a community concerned with exchange, and in particular with the moral
rules and expectations governing exchange.” But a knowledge-control regime can
range from the informality of moral rules or etiquette to the formal requirements of
the strictly legal, and can include structures that encourage freedom of movement
(e.g., “open access”) as much as rules that restrict or qualify exchange. Furthermore,
knowledge-control regimes are “sociotechnical,” and include the technological infra-
structures that undergird exchange as well as the “lawlike” regulations and moral rules
that govern exchanges (Hilgartner 2017, chap. 1). Infrastructures, Brian Larkin (2013:
327) writes, are the “material forms that allow for the possibility of exchange over
space”: “they shape the nature of a network, the speed and direction of its movement, its
temporalities, and its vulnerability to breakdown” (328). An analysis of a “knowledge-
control regime,” in my usage, will describe the intersections of technical infrastructures
that shape the nature of circulation (including devices established to store, protect, or
transfer samples and sequences) and the laws or informal rules that regulate exchanges.
In the tradition of STS studies of technological systems, this article highlights how
these technical and social dimensions of exchange are coproduced.
The article compares the two distinct knowledge-control regimes developed to
enable and regulate the exchange of influenza virus samples and sequences. I do so,
in particular, by focusing on recent controversies that emerged over the form and extent
of circulation in these knowledge-control regimes, leading to parallel but distinct
processes of “regime change” (Hilgartner 2017, chap. 6).
Global influenza-virus surveillance was originally built on the exchange of virus
samples through WHO’s GISRS, an international structure of linked virology labora-
tories that dates to the founding of WHO in the 1940s. Under the GISRS, select
virology laboratories in member countries are designated as National Influenza Centers
(NICs) and instructed to isolate and prepare influenza viruses for shipment to WHO’s
World Influenza Center in London (or more recently, one of several WHO Collaborat-
ing Centers). As a WHO program, the GISRS fit within the geopolitical architecture of

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484 L. Fearnley

international health, including a hierarchical mode of governmental authority and what


David Fidler calls a “Westphalian” or territorial, state-based pattern of sovereignty
(Fidler 2003). Understood as a knowledge-control regime, the GISRS thus included
both technical infrastructures (sample preparation procedures, postal logistics) and
“law-like” elements of international hierarchy and interstate cooperation.
Scientists began to sequence genes, and then entire genomes, of influenza viruses
from as early as the late 1970s, and within a decade WHO began using genetic
sequence data as part of its influenza surveillance programs. However, the sequencing
of influenza virus genes was conducted by university and research labs, including but
not limited to GISRS labs, and genetic sequence data was never formally incorporated
within GISRS rules. Instead, influenza GSD was shared through a number of ad hoc
mechanisms, including large-scale and generic nucleotide sequence databases, such as
those that make up the International Nucleotide Sequence Database Collaboration
(INSDC, including GenBank) as well as by direct, person-to-person transfers (such
as fax and later e-mail). The first purpose-built infrastructure for sharing influenza virus
GSD was the Los Alamos Influenza Sequence Databases (ISD), created in 1997 after
the emergence of the HPAI H5N1 flu virus. The database aimed to collect all influenza
GSD in one place and encouraged the sharing of previously unpublished sequences. In
such a database, exchanges are not shipments but uploads: viruses are sequenced in
research laboratories and posted to databases using electronic networks, such as the
World Wide Web (Stevens 2015a). Initially, the ISD database was modeled on the
“open access” model of other nucleotide sequence databases (such as GenBank) that
was closely linked to traditions of research on model organisms, open-source software
development, and the emergence of a “hybrid culture” (Strasser 2011) between the
moral economies of credit, authorship, and property in the experimental and collecting
sciences. As a knowledge-control regime, it therefore combined a technical infrastruc-
ture rooted in online networks with moral assumptions about “open” sharing.
In 2004, the H5N1 virus reemerged and quickly spread throughout Southeast Asia.
In response, WHO declared that a pandemic could be imminent, and scientists around
the world increased demands for access to both physical samples and genetic sequen-
ces data of the influenza viruses isolated in Asia. This article provides the first com-
prehensive comparison of the different controversies that erupted when some actors
refused to share samples or sequences. Hilgartner (2017) describes the emergence of
new modes of control, or significant changes in governance, as processes of “regime
change.” I argue that the exchange of samples and sequences followed two distinct
trajectories of regime change, and chart how the closure of each controversy adopted
resources from within the different “governing frames” (Hilgartner 2017) that struc-
tured expectations about exchange within the the infrastructures of the GISRS or
nucleotide sequence databases.5 When disputes arose over the sharing of samples,
these disputes were negotiated in the terms of international law, including the frame-
work provided by the Convention on Biological Diversity, and focused on balancing
“sovereign science” with “viral sovereignty.” But when disputes arose over the sharing
of sequences, the conflicting parties adopted terms of reference from long-term debates

5 Governing frames, Hilgartner (2017, chap. 1) suggests, “tend to display sufficient stability” even when

change is occurring; they frame how debates about regime change are negotiated.

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Viral Sovereignty or Sequence Etiquette? 485

over intellectual property and scientific credit in the transnational field of genomics,
culminating in the construction of a novel flu-specific nucleotide sequence database—
known as EpiFlu—that aimed to link open access to sequences with a series of ethical
burdens to acknowledge and collaborate with original sequencing laboratories. In sum,
influenza genome sequences came to be tethered, to adopt Hinterberger and Porter’s
term, by the addition of ethical protocols to databases, rather than the assertion of legal
rights by sovereign states. This is an emerging knowledge-control regime that I call
sequence etiquette.
At stake, I suggest in my conclusion, are two distinct forms of globality in contem-
porary global health. Going beyond the demonstration that the global is locally pro-
duced, or results in hybrid forms through local encounters, this article contributes to
recent debates in postcolonial STS by illuminating the diversity of the global itself: the
multiple technical and moral infrastructures for making knowledge circulate around
the world (Anderson 2017; Fischer 2018; Kuo 2009; Lin and Law 2019). Understand-
ing this diversity of globality also enables new perspectives on scientific practice in
Asia, and in the case of this article, more specifically in the PRC. Thus far, the influenza
virus sample sharing disputes, understood as assertions of viral sovereignty, are inter-
preted as exemplifying a confrontation between Asian nation-states and global health
regimes (e.g., Ong 2008; Fidler 2008; MacPhail 2009; Stephenson 2010), and there-
fore as an instance of a broader contemporary tension between global circulations of
scientific knowledge and the restrictions imposed by mechanisms of national “bio-
sovereignty” that is characteristic of “Asian science” or “Asian biotech” today (Ong
2010: 40).6 But as this article shows, Chinese influenza researchers do not confront a
homogenous global science, and as a corollary, their practices of sharing or withhold-
ing samples and sequences are driven by objectives that may not be best understood in
terms of sovereignty. Instead, Chinese influenza researchers have played a key role in
reimagining sequence sharing in ways that go beyond previous models of open access,
not by drawing on sovereign logics to justify withholding, but by invoking ethical
protocols within databases to encourage fair distribution of credit for sequencing work.

2 Sharing Samples: International Hierarchy

After the end of the Second World War, the World Influenza Programme (hereafter,
GISRS) was one of the first initiatives undertaken by WHO to give moral visions of
“world health” a technical shape (Staples 2006). In August 1947, the fourth meeting of
the International Commission of the WHO included funds for a new “World Influenza

6 My claim is not that “Asian science” or “Asian biotech” are accurate generalizations across the diversity

of contexts in Asia but rather that the sample-sharing disputes have been interpreted in existing literature as
exemplifying a distinctive relationship between science and sovereign states in Asia. As Aihwa Ong (2010:
3) writes in her editorial introduction to Asian Biotech, “While specific biotech policies and styles vary by the
Asian countries considered here, there is a convergence of political thinking and of uses of the life sci-
ences. . . . Postcolonial nationalism in Asia is fundamentally about the regeneration of political and cultural
communities on the global stage. As state-led enterprises, biotechnologies are allied to nationalist efforts to
overcome past humiliations and to restore national identity and political ambition.” By showing how global
knowledge-control regimes are multiple rather than uniform, I aim to suggest one way in which the rela-
tionships between global science and Asian scientists might be more diverse as well.

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486 L. Fearnley

Centre.” Located in London, this WIC was equipped with cutting-edge equipment for
identifying and classifying varieties of influenza. But the WIC also relied on “an
international network of laboratories” to isolate and submit virus samples to London
(Kitler, Gavinio, and Lavanchy 2002). The rationale for such a program lay in the
recently discovered antigenic variation of the influenza virus, which allowed the flu to
escape both bodily immune defenses and mass immunization programs. Notes sub-
mitted by the virologist C. H. Andrewes to the meeting show that the hopes for rapid
vaccine development in a context of antigenic variation lay behind plans for the inter-
national exchange of influenza viruses. As he explained,
One might perhaps hope to isolate a strain from the beginning of an epidemic,
adapt it to growth in fertile eggs and produce a vaccine in time to be of use before
the epidemic is over. In practice, there is not nearly enough time to do this within
one country. But if it could be shown that a new—and especially lethal—strain
was spreading from country to country, the vaccine might be produced in time to
protect countries yet unattacked. The above arguments seem to show that many
problems concerning influenza can only be solved by international collaboration,
such as could be fostered by the World Health Organization. (WHO 1947: 194)
When the GISRS was founded in 1952, “25 countries already had some influenza
surveillance in place and were able to report data to the WHO” (Ziegler et al. 2018:
559). By 1956, the GISRS laboratory network consisted of two central reference
laboratories—the London WIC and the US flu lab in Bethesda, Maryland—and thirty-
six laboratories in member states (known as National Influenza Centers [NICs]). As
Michael Bresalier (2012) has argued, the key to this international system was the
extension of laboratory equipment and standard protocols to the member states. In
most Member State NICs, laboratories were equipped with assays and other techniques
that enabled them to make a “serological diagnosis as between Influenza A and B,
isolating a virus in eggs and drying it off to send to the centre” in London or Bethesda
(WHO 1948: 194). Scientists at the Centres, on the other hand, conducted more
detailed studies of antigenic variation, including identifying new virus types that
could cause pandemics. WHO then reported these results to the laboratory system in
the form of pandemic alerts, and in some cases distributed sample strains for vaccine
development.
Influenza researchers Alan Hay and John Macauley (2018: 552) have described the
GISRS as a “largely informal autonomous trust-based system.” Similarly, Ziegler et al.
(2018: 564) highlight a “highly collaborative ethos” in WHO’s influenza surveillance
system as a key to its effective function. Despite these paeans to scientific collaboration
and trust, however, the form of the GISRS network was framed within the (sometimes
contested) politics of international health. When virus samples are “shared,” they are
“sent” (or more accurately, shipped): the network is formed out of a series of one-to-
one correspondence relationships in a hub-spoke structure. WHO alerts and vaccine
strain distributions reverse the direction, but maintain the centralized structure of the
network. This hierarchical relation between the World Influenza Centre and National
Influenza Centres followed a broader pattern of top-down expertise and technical
assistance that characterized international health in that period (Cueto 2007; Packard
2016). Furthermore, despite WHO’s offers to distribute strain samples for vaccine
development, few laboratories in developing countries had the resources to produce

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Viral Sovereignty or Sequence Etiquette? 487

vaccines, which meant that the geography of sample sharing was not reciprocated with
an equally extensive geography of vaccine access. Finally, although the number of
laboratories expanded over the years, the structure of the system was closed: only
laboratories designated as NICs were included, a decision made based both on tech-
nical (laboratory capability) and political (such as membership in the United Nations)
considerations.
The 1957 “Asian” flu pandemic revealed, in a particularly incisive fashion, how
geopolitics influenced the structure of the system (Fearnley 2020). For although the
new virus strain was suspected of having emerged in the PRC, no reports or samples
were submitted by the PRC. Unlike more recent disputes, this was not because the PRC
withheld samples. Rather, from 1949 to 1971, mainland China (PRC) was not included
within United Nations programs, such as WHO, because during that period the China
seat at the UN was occupied by the Taiwan-based Republic of China (ROC). As WHO
official A. M.-M. Payne (1958: 29) noted, it was “ironical” that the virus emerged and
was first isolated in a country that was not part of the WIP, delaying WHO’s pandemic
preparations by several months.

3 Ownership of Viral Resources

Between the 1960s and the 1990s, the GISRS gradually expanded, growing to include
eighty-eight NICs as well as adding Collaborating Centers in Memphis, Tennessee
(focused on the Ecology of Influenza in Animals) and in Melbourne, Australia (Ziegler
et al. 2018: 562). The PRC rejoined the United Nations in 1972, including UN agencies
such as WHO, and began participating in international influenza research programs,
including the GISRS, soon thereafter. As a result, however, Taiwan was therefore
controversially excluded from the UN and WHO (Tseng and Wu 2010). On the
other hand, the technical infrastructure of the GISRS changed very little. As of
2017, authorized national laboratories were instructed to place virus isolates and
influenza-positive specimens in labeled sample tubes and ship sample tubes on dry
ice within a triple packaged system at −70 to −80 degrees Celsius to any Collaborating
Center (WHO 2017). During these years, the GISRS established itself as an interna-
tional health system that consistently, and without garnering much attention, served
two public health functions: first, continuing to monitor for unusual strains that could
indicate the onset of an influenza pandemic; and second, drawing on submitted strains
to assess, on an annual basis, the likely epidemic strain for development of seasonal
influenza vaccines (Ziegler et al. 2018: 560).
After the reemergence of avian influenza H5N1 in 2004, however, the GISRS
system fell into controversy, as the PRC and Indonesia both refused to share samples
isolated from cases of influenza in humans or animals. A primary cause of these
controversies was the unprecedented effort by WHO and several pharmaceutical com-
panies to develop a “‘pre-pandemic’ H5N1 vaccine” (Ziegler et al. 2018: 552) in
anticipation of a possible future human pandemic. The geographic discrepancy
between the countries where disease was occurring and the countries or companies
where the promissory values of vaccine production were accumulating—including
both monetary and public health values—became painfully clear. When WHO gave

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488 L. Fearnley

H5N1 viruses isolated by Indonesia to a for-profit vaccine company, Indonesia with-


drew from the GISRS and stopped sending viruses to WHO, instead seeking their own
independent collaborations with a multinational pharmaceutical company (Stephenson
2010). The PRC, for its part, frequently delayed shipment of viruses to WHO, while
meanwhile developing its own recombinant animal vaccines using H5N1 viruses iso-
lated in China.
As the controversy developed, an Indonesian former ambassador defended the
country’s actions by claiming that “viruses are, unequivocally, genetic resources sub-
ject to national sovereignty” (Hinterberger and Porter 2015: 365). By equating viruses
to genetic resources, the ambassador explicitly aimed to locate viruses under the terms
of the Convention on Biological Diversity (CBD) (Fidler 2008). First signed at the Rio
de Janeiro Earth Summit convened by the United Nations, the CBD developed an
approach to the environment that unites conservation of biodiversity, sustainable use of
its components, and the “fair and equitable sharing of benefits arising from genetic
resources.” The CBD extended the principle of national sovereignty over new biolog-
ical zones, so that, as Cori Hayden (2003: 53) points out, wild biological resources that
had previously been considered part of the global commons were “domained back into
nation-shaped spaces.”
Indonesia brought their claim to the World Health Assembly (WHA), WHO’s health
policy-setting body composed of health ministers from member states. After four years
of debate, the WHA issued the PIP Framework to resolve the dispute, which came into
effect on 24 May 2011. The PIP framework essentially aims to balance, “on an equal
footing,” “(1) the sharing of H5N1 and other influenza viruses with human pandemic
potential; and (2) access to vaccines and the sharing of other benefits” (WHO 2011: 6).
The PIP framework does not include virus samples within the regulatory domain of the
CBD but instead carves out a parallel, analogical domain where the principles of
national sovereignty are balanced against the urgency of global health security.
I want to highlight the mechanisms the PIP Framework introduces to achieve this
objective, the precise tools through which viruses are “tethered” (Hinterberger and
Porter 2015) to sovereign states. First, each virus—or more precisely, what the Frame-
work refers to as “PIP biological materials”—provided to the WHO Collaborating
Centre or Reference Laboratory must be accompanied by a Standard Material Transfer
Agreement (SMTA-1). The SMTA-1 defines and documents the Provider and the
Recipient laboratory, and details their different rights and obligations. An additional
document, SMTA-2, accompanies any exchange of virus materials between WHO and
any entity outside of WHO (primarily vaccine manufacturers), and it requires manu-
facturers commit to donation of vaccines to WHO and provide royalty-free licenses to
manufacturers in developing countries in exchange for access to viral resources (WHO
2011). Second, WHO developed an online Influenza Virus Traceability Mechanism
(IVTM) that showed where every virus sample originated from, and where it traveled
to, within the GISRS (WHO 2010). In Hinterberger and Porter’s (2015) terms, viral
sovereignty is documented and tracked in these systems, such that sovereign claims
become mechanisms for “tethering” the anticipated future values of the virus to the
national states where they originated. Viruses are still made to circulate through the
laboratory network, but sovereign claims to ownership of virus resources, certified by
SMTA and tracked online, enable certain benefits—especially vaccines—to circle
back to “originating” member states.

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Viral Sovereignty or Sequence Etiquette? 489

However, the PIP Framework does not apply to all influenza research objects, but
only to objects that it precisely defines as “PIP biological materials.” According to the
definition, “PIP biological materials . . . includes human clinical specimens, virus
isolates of wild type human H5N1 and other influenza viruses with human pandemic
potential; and modified viruses prepared from H5N1 and/or other influenza viruses
with human pandemic potential developed by WHO GISRS laboratories.” In a separate
clause, the Framework species that PIP biological materials include “RNA extracted
from wild-type H5N1 and other human influenza viruses with human pandemic poten-
tial and cDNA that encompass the entire coding region of one or more viral genes.” Yet
the PIP Framework explicitly excludes what it refers to as “genetic sequences,” which
it defines as “the order of nucleotides found in a molecule of DNA or RNA. They
contain the genetic information that determines the biological characteristics of an
organism or a virus” (WHO 2011: 8: my emphasis). In doing so, the Framework enacts
a boundary within the virus gene between RNA as material and as information.
Influenza viruses, in the informatic mode of sequences, are therefore excluded from
the regulations of the PIP Framework. Indeed, as Elbe and Buckland-Merret (2017:
45;) remark, the “question of whether genetic sequences data (as opposed to physical
specimens) should also be governed by the framework proved too sensitive to be
resolved during the initial negotiations for the PIP framework” (see also Gostin
et al. 2014). The text of the Framework specifically highlights a crucial tension that
could not be resolved: although “in some instances the publication of genetic sequence
data has been considered sensitive by the country providing the virus,” a situation
resembling the disputes over sample sharing, the regulation of sequence exchange
must also account for the “movement towards the use of public-domain or public
access databases” for sharing GSD (WHO 2011: 13). Due to these distinctive modes
of sequence exchange, the Framework excluded GSD from its legal obligations and
instead merely requested that the WHO director-general continue consultations to
determine “issues relating to the handling of genetic sequence data” (WHO 2011: 13).
As we will see, a completely different set of controversies developed around the
sharing of influenza genetic sequences. The form of these controversies, and their
resolution, reflected the distinct knowledge-control regimes that developed alongside
the infrastructures utilized for sharing influenza sequence data: nucleotide sequence
databases.

4 Sharing Sequences: Open Access

During the late 1970s, influenza researchers began sequencing influenza virus genes,
and later, entire virus genomes. By the late 1980s, WHO began using nucleotide
sequence data of key virus protein genes, such as the hemagglutinin protein, “as an
adjunct to” antigenic data from biological assays on virus samples, to improve the selec-
tion of virus seed strains for seasonal vaccine development (Ziegler et al. 2018: 562).
Some RNA sequences—primarily those already included in scientific publications—
were posted in the databases of the International Nucleotide Sequence Database Col-
laboration (INSDC), including GenBank, EMBL-Bank, and DDBJ. However, fewer
influenza viruses, and even fewer compete flu virus genomes, were posted to public
databases than was the case with other significant pandemic viruses, such as HIV (Bao
et al. 2008).

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In 1997, when the HPAI H5N1 flu virus strain first spread from chickens to humans,
leading to concerns that a flu pandemic was imminent, Los Alamos National Labo-
ratory (LANL) in the United States responded by designing and building a novel
influenza-specific nucleotide sequence database—the Los Alamos Influenza Sequence
Database (ISD). The project reflected new scientific potential for utilizing genomic
information to identify dangerous pathogens, predict disease emergence, and develop
targeted countermeasures.7 As database manager Catherine Macken explained after
the ISD was released in July 1998, the database at first included all of the influenza
sequences previously published in GenBank, but would also begin adding unpublished
sequences from laboratories around the world. Los Alamos hoped to provide a new
tool to global health agencies, including WHO. “Unless there is a central collection
point for all the published and unpublished influenza sequences,” Macken added,
“there is no way to make all the necessary data available to the research community”
(Los Alamos National Laboratory 1998).
By enabling global public access to pre-publication genetic sequence data, the Los
Alamos ISD invoked the model of the “open-access” database that scholars consider a
key legacy of the genomics revolution, and one of “the signature features of the Human
Genome Project” (Maxson Jones, Ankeny, and Cook-Deegan 2018: 696). In genome
projects, sharing of sequences not only increased in scale but also took on a qualita-
tively different form, the rapid upload of data to “publicly accessible online reposito-
ries” (Stevens 2015a: 839; see also Kelty 2012). As historians of the development of
nucleotide sequence databases have shown, the new sociotechnical capacities for
collecting and exchanging sequence data raised several moral and governance chal-
lenges, leading to the emergence and change of new knowledge-control regimes
(Strasser 2011: 2019; Hilgartner 2017; Maxson Jones et al. 2018).
Importantly, nucleotide sequence databases almost immediately became global
platforms. However, the form of globality in these databases differed from the inter-
national structure of WHO’s laboratory system. Hallam Stevens (2018) shows that the
developers of the first nucleotide sequence databases sought worldwide collaboration
from the very beginning, leading to “informal agreements” and later formal protocols
for sharing and synchronization across the three databases of the INSDC. As Stevens
argues, the “global” mobility of sequence data is in part a result of the concrete trans-
national negotiations among database managers in the United States, Europe, and
Japan that established common protocols for data submission, shared accession num-
bering schemes, and mechanisms for data format conversion. But its particular global
form also was derived from the technological tools used to build the sequence data-
bases, and in particular the use of internet networks to submit and access data (Stevens
2015a; Stevens 2015b). Unlike WHO’s GISRS, this global infrastructure for sharing
sequence data was horizontal rather than hierarchical, forming a distributed network of
many-to-many connections, and grew outside the geopolitical systems of international
law (see also Galloway and Thacker 2007). Rather than transfers up a hierarchical
ladder to a central node, any laboratory could upload data to the collection and could
access (and download) any data in the collection.

7 Although the role of a nuclear weapons laboratory in biological databases may seem unusual, in fact

LANL also built the original GenBank and hosted several other specialized biological databases.

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Above, I argued that WHO’s GISRS took a particular global form that was rooted in
the structure of international health governance, and disputes that emerged around
virus sharing therefore often played out in international law and politics. The disputes
around the construction of sequence databases were different. Instead of international
politics, Bruno Strasser (2011: 68) argues that “moral tensions between different con-
ceptions of credit attribution, data access and knowledge ownership structured the
debates on the establishment of a centralized database.” Broadly speaking, three
moral tensions structured debates around databased sharing of sequences and, in par-
ticular, the open-access, rapid data-sharing model. A first moral tension concerned the
ownership of sequences, and whether sequence data should be considered a proprietary
(commercial) product or a free public good (Rabinow 1996; Sunder Rajan 2006). A
second tension concerned issues of secrecy and security. The 1981 NIH grant for the
creation of GenBank was awarded to a group led by Walter Goad, a nuclear physicist
and molecular biologist at Los Alamos National Laboratory (LANL), most famously
home of the Manhattan Project to develop an atomic bomb. As a result, Goad pushed
for making GenBank highly accessible—offering “completely free and open access to
the information and programs we will be collecting”—in part because of his awareness
that many scientists remained suspicious of the “secrecy and security” at the national
laboratories (Strasser 2011: 85).
A third, and probably the most significant, moral tension involved the credit granted
for scientific work. As Strasser (2011: 83) has put it, database collections threatened to
“[run] against one of the essential values of the experimental sciences’ moral economy:
namely, that the production of knowledge deserves individual, not collective, credit.”
By making sequence data public, scientists worried that sequence databases could
undermine the ability of the originating researchers to benefit from the work of
sequencing, or what has become known as the problem of “scooping.” More precisely,
this tension revolved around the possible relationships between sequence publication
in databases and journal publication, including the technical question of precisely
when sequence data would be published (immediately and prepublication, or some
time after journal publication). Since the late nineteenth century, publication in scien-
tific journals has been the primary token of professional accreditation and career
advancement (Fyfe and Moxham 2016). If databases made sequence data public,
questions remained about what kind of publication this was, what kind of credit it
should generate, and how this would impinge on other kinds of publication.
Emerging from the partial, temporary resolution of these moral tensions was a new
knowledge-control regime: the Bermuda Principles for rapid, prepublication, and
open-access data sharing (Hilgartner 2017). The Bermuda Principles, developed at
the outset of the publicly funded Human Genome Project in 1996, called for daily
sharing of unpublished (preliminary) sequences by release onto individual laboratory
websites, immediate submission of any “finished annotated sequence” to public
sequence databases (e.g., GenBank), with the “aim to have all sequence freely avail-
able and in the public domain.”8 The norm of rapid data sharing was initially intro-
duced for largely pragmatic reasons, but later took on a strong moral dimension, as the

8 This quotation is from the first draft of the Bermuda Principles as written by John Sulston on a whiteboard

in Bermuda, 1996 (cited in Maxson Jones, Ankeny, and Cook-Deegan 2018: 739).

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492 L. Fearnley

creation of a genomic “commons” in the public domain helped distinguish the publicly
funded HGP from the private, patent-seeking endeavor of Craig Venter and Celera
Genomics (Maxson Jones, Ankeny, and Cook-Deegan 2018).
In its early years (1997–2004), the Los Alamos ISD adopted the same “open-
access” database model articulated by the Bermuda Principles for influenza sequence
sharing. Although framed as a tool for global health, the model for scientific exchange
of influenza genetic sequence data was therefore drawn from the field of human
genome research rather than WHO’s influenza surveillance system. Soon, however,
the threat of an emerging flu pandemic and WHO’s urgent need for sequence data
would raise concerns about the open access model, leading Los Alamos to restrict
access to the database in an effort to reconfigure data sharing in line with the specific
demands of global health security (Lakoff 2010).

5 Secret Sequences

When the H5N1 virus reemerged and spread out of China and across Asia in 2004,
experts once again warned that the world could be on the verge of a devastating
pandemic. In the meantime, the 2002 SARS epidemic had demonstrated the potential
utility of rapid genome sequencing of viruses during a pandemic (Fischer 2013). In
response, WHO began to call for enhanced sharing of virus samples and genetic
sequence data from cases of H5N1 in the PRC and Southeast Asia. As part of this
effort, WHO worked with Los Alamos to create a “special secured section” of the
influenza database devoted to H5N1 sequences. Only approximately fifteen laborato-
ries worldwide were provided passwords to access the H5N1 section of the database.
Without an invitation from WHO, no one would be able to access the influenza GSD
stored on the database. According to WHO, the closed database was meant to encour-
age more rapid and consistent sharing of sequences from reticent laboratories who
“worry about intellectual-property rights or not receiving a fair share of the scientific
credit” (Zamiska 2006a). Scientists with access to the database had to “agree not to
publish results without prior consultation” with the laboratory that originated the
sequences. By keeping access to the database limited, WHO hoped to ensure that
the central GISRS reference laboratories would all have access to key data, allowing
WHO to “track the virus and adjust risk assessments if necessary” (Enserink 2006).
Rather than an open- or public-access database, the updated Los Alamos ISD could be
described as a “private-access” database.
Quickly, however, controversy emerged when several scientists criticized the
restricted access to H5N1 sequence data. In part, this reflected the fact that the global
health community working with influenza sequence data now stretched well beyond
WHO’s selected labs, including bioinformatics centers, genomics institutes, and the
animal health researchers at the Food and Agriculture Organization (FAO)—for the
first time at the frontline in the effort to stop a flu pandemic “at source” in animal
reservoirs (Fearnley 2020). Ilaria Capua, a virologist who led the FAO’s animal influ-
enza laboratory in Italy, had sequenced the RNA genes from several HPAI H5N1
influenza viruses isolated from poultry and wild birds in Nigeria and Italy, where
new outbreaks had appeared. In February 2006, WHO offered Capua a password to
the private Los Alamos database, on condition that she submit her sequences to the

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Viral Sovereignty or Sequence Etiquette? 493

database. But Capua refused to submit the sequences, and instead posted them to the
open-access GenBank, and made them available for immediate release.9 Capua also
wrote an email letter to fifty colleagues around the world announcing the release and
arguing that “sharing sequences” was necessary for the scientific response to the H5N1
influenza outbreak. In the letter, published by Science on 3 March, Capua wrote:
Several of you have asked me to have (reserved) access to the sequence data on
the recent avian HPAI H5N1 strains we have isolated. This is to inform you that
we have decided to deposit the full HA sequence of the Nigerian and Italian
H5N1 viruses in a public database, as we truly believe that collaboration between
medical and veterinary virologists is essential to improve knowledge on the
H5N1 epidemic, and that sharing sequences will be beneficial to all. We invite
other scientists to follow our example, as we are convinced that information
generated with public funds should be used primarily to improve knowledge on
public health issues and that making significant information unavailable “until it
is published” could slow down the process of understanding the dynamics of this
epidemic—which is not what most of us are paid for. Accession numbers will be
available on the OFFLU website shortly. Please feel free to forward this email to
any colleagues you believe could be interested in accessing the sequence data.10
“If I agreed” to submit the data to the Los Alamos database, “it would have been
another secret sequence,” Capua told the Wall Street Journal (Zamiska 2006a).
Among scientists working on influenza, the response to Capua’s move was mixed.
On the one hand, scientists and agriculture officials from several countries wrote to
Capua or posted their own viral sequences in public databases in “solidarity” (Zamiska
2006a). Some experts from WHO and the CDC said they agreed with her decision. But
other scientists defended the private-access database, reanimating several of the same
moral tensions that have structured debates over data sharing in genomics more
broadly.
The core concern raised by many scientists was the loss of credit for scientific work.
Ian Brown, director of the UK Veterinary Laboratories Agency (an animal influenza
reference lab), admitted that he would not upload sequences onto GenBank until arti-
cles written by his lab are accepted for publication. He claimed that in a transnational
research context, the public release of sequence data could threaten his lab’s access to
viral samples from certain national governments, who were, in turn, concerned that
their scientists would not be credited or acknowledged if the data was used by other
labs. Virologist Robert Webster complained about an emerging division of labor in
which some “wet” biology labs conducted sequencing work and posted sequences to
databases, but other “dry” labs utilized these sequences to author and publish scientific
journal articles. Webster suggested that the real bioscientific labor took place in the
transformation of biological samples into informational sequences, not in the bioin-
formatic analysis done in front of computer screens. Speaking of his students, he said “I
want to give them time to bring this information together in a publication. But if it’s out
there [in a public database], the bottom feeders will use it, because there are bottom

9 GenBank allows researchers to either keep data private until publication or immediately release data to the

public. Capua chose immediate release.


10 “Text of Dr. Capua’s Letter Regarding Bird-Flu Samples” (suppl. to Zamiska 2006a).

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494 L. Fearnley

feeders” (Brown 2006). The Los Alamos ISD dispute centered on the merits and
problems of the open-access sequence database, a knowledge-control regime that to
some researchers was critical for improvement of public health knowledge, but to
others enabled only second-rate science and data scooping.

6 Adding Etiquette to Open Access

Ilaria Capua has gone on to become an outspoken proponent of “open science,”


has won many awards from popular science and humanitarian organizations for her
activism, and even became a deputy in the Italian parliament. However, the actual
transformation of influenza sequence sharing followed a more nuanced model of
accessibility and exchange than Capua’s strident calls to “free the data” could have
led one to expect.11 When a new database emerged out of these controversies, its
technical form and governance model differed from both the “open-access” (GenBank)
and “private-access” (LANL) models.
By the summer of 2006, several months after Capua’s email, the poor media cov-
erage of the LANL database was beginning to lead scientists to look for “a new home”
for sharing influenza virus data (Elbe and Buckland-Merret 2017: 37). On 1 August,
the Food and Agriculture Organization and the World Organization for Animal Health
together pledged to “systematically make avian influenza virus sequences accessible to
the entire scientific community” and called for “global sharing” of both samples and
sequences (FAO/OIE 2006). Meanwhile, Capua and others began working with an
unusual collaborator, the German former media executive and philanthropist Peter
Bogner, on building a concrete vision of an influenza sequence sharing public. In a
letter to the editor of Nature, Bogner, Capua, the CDC’s Nancy Cox, and nearly one
hundred other signatories outlined plans for a novel “consortium” of researchers
devoted to the rapid sharing of sequence data. The Global Initiative for Sharing
Avian Influenza Data (GISAID—later, Global Initiative for Sharing All Influenza
Data) would be modeled on other “community resource” projects, with the authors
specifically highlighting the International HapMap Consortium.
Scientists participating in the GISAID consortium would agree to share their
sequence data, to analyze the findings jointly and to publish the results collab-
oratively. Data would be deposited in the three publicly available databases
participating in the International Sequence Database Collaboration (EMBL,
DDBJ and GenBank) as soon as possible after analysis and validation, with a
maximum delay of six months. (Bogner et al 2006: 981)
Before long, however, Bogner, Capua, and others became frustrated with the lack of
detail provided in their manifesto. Indeed, allowing for a six-month delay in submis-
sion after virus sequencing was too slow and difficult to verify or incentivize within the
protocols of the ISDC, which relied on scientific journals to mandate sequence deposits
accompanying publication. In the end, Bogner, Capua, and GISAID decided to

11 “Free the Data!” was the headline of an article in the Italian news magazine La scienze that discussed

Capua’s critique of restricted access sequence databases (see Delfanti 2013, chap. 6).

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abandon GenBank and the ISDC, and set out to build their own database. GISAID’s
database design process included not only technical questions about how sequences
would be uploaded, stored, and displayed but also ethical and legal questions regarding
the terms and conditions for sharing and accessing sequences.
The protection of credit and scientific reputation stood at the center of the design.
Intriguingly, Bogner’s experience in the music and film industries provided helpful
models for balancing the rights of creators with the benefits of open exchange. Bogner
recollected “browsing Napster—the file-sharing network that used to allow people to
download free music—with the jazz musician Herbie Hancock. When the two found a
recording available for download that the musician hadn’t even released yet, ‘Mr.
Hancock was very disturbed’” (Zamiska 2006b).
Chris Kelty (2008) has remarked on the hard-to-overestimate importance for soft-
ware geeks of Recording Industry of Association of America (RIAA) attempts to
control Napster and online music sharing in and around 2000. Unlike Kelty’s inter-
locutors, though, Bogner is not an antiestablishment geek but a very establishment
(though friendly with jazz pianists) music industry type, offering him a quite different
perspective into the problems and potentials of sharing. For Bogner, unauthorized and
uncontrolled sharing (i.e., unregulated open access or “public domain”) posed threats
to producers, both in terms of monetary compensation for intellectual work but also in
terms of control over the materials that would become part of the public record. While
attempting to maintain the advantages of rapid sharing, Bogner consulted with legal
experts to determine the best ways to regulate use.
In the end, one simple technical feature differentiates GISAID and its EpiFlu data-
base from both GenBank and LANL: real-name user registration.12 Whereas GenBank
is available to any anonymous user with a computer and internet access, EpiFlu is
password protected and requires registration, including a “one time positive verifica-
tion of the individual’s identity” (Elbe and Buckland-Merrett 2017: 39). Unlike
LANL’s ISD, on the other hand, anyone can quickly and easily register for access to
EpiFlu. Neither fully open nor truly private, GISAID (n.d.) aims to regulate and govern
open access according to what it calls in its mission statement “the basic premise of
upholding scientific etiquette.”
To a social scientist, the term “scientific etiquette” seems to invoke Robert Merton’s
mid-twentieth-century model of scientific norms, if not even more remote seventeenth-
century understandings of virtuous gentleman scientists. Certainly, there is a genea-
logical connection: Merton was concerned, after all, with the balance between the
common ownership of scientific knowledge and the “institutionally specific reward
system” rooted in the distribution of credit and reputation to scientific producers
(Merton 1973; Kelty 2008). But in fact, the GISAID consortium adopted the term
from the much more recently issued 2003 Fort Lauderdale Agreement on “data-sharing
in community resource projects.” Although less well-known than the Bermuda meet-
ing that gave rise to prepublication data sharing, the 2003 gathering of genomics
researchers in Fort Lauderdale, Florida, reflected increasing concerns about ethical

12 Although it is not clear precisely where the idea for real-name registration came from, by 2006 several

major online services—most famously Facebook—already had some form of real-name registration. Unlike
most of these systems, however, GISAID not only requires positive identification but also automatically and
manually reviews and confirms this identity before granting access credentials.

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496 L. Fearnley

data use and “new questions about the meaning of openness itself” (Reardon et al.
2016: 1–2). The Fort Lauderdale Agreement called for the extension of prepublication
data sharing to other “community resource projects”: those projects “specifically
devised and implemented to create a set of data, reagents or other materials whose
primary utility will be as a resource for the broad scientific community,” such as
International HapMap. But while extending the scope of Bermuda’s call for rapid
data sharing, the Fort Lauderdale Agreement also set out new ethical guidelines for
balancing open-access distribution of sequence data with the demand to respect “sci-
entific etiquette,” specifically by granting the original sequencing laboratory the oppor-
tunity to “publish the first analysis of one’s own data” (Wellcome Trust 2003).
The concept of “scientific etiquette” invoked in the GISAID mission statement is
directly adopted from the Fort Lauderdale Agreement, but GISAID pioneered new
methods for enacting the principle in practice. The Bermuda and Fort Lauderdale
agreements are programmatic and manifesto-like statements about how scientists
should act, but they have no mechanism of enforcement. GISAID is different: it spells
out the precise ethical conditions imposed on data producers and data users in a Data
Access Agreement (DAA) that every user must agree to be “bound” to upon registra-
tion. On the one hand, upon submission of data (such as influenza genetic sequences) to
the database, data producers agree to grant both GISAID and any subsequent autho-
rized users of the database (who have also agreed to the DAA) an unrestricted license to
utilize the data, including collection, storage, modification, and display. The DAA also
distinguishes this use license from ownership, by qualifying that no ownership rights
are transferred by submission to the database. Legally, this clause is particularly impor-
tant because, as Elbe and Buckland-Merrett (2017: 39) point out, it means that data
submitted to GISAID cannot be considered “public domain.”
On the other hand, the DAA also requires any potential user to agree to several
conditions of use on that data. Although stating that data downloaded from the data-
base may be used to author publications, any published results also must acknowledge
the original source of the data, referred to as an Originating Laboratory, that isolated
the virus as well as the laboratory that produced the sequence data from the virus isolate
(if different from the Originating Laboratory). Second, the DAA also requires data
users to attempt to collaborate with the Originating Laboratory that isolated the virus
specimens. Finally, third, the DAA prohibits the exchange of data by data users beyond
the purview of the database, that is, to any third party who is not also an authorized user
(GISAID 2011).
Kelty (2012: 144) has argued that intellectual property was the “blind spot of open
systems,” and in the case of Free Software, eventually led to “vibrant experimentation
with copyright licensing” (178) such as the “hack” of copyright law (195), the GNU
Public License. Rather than copyright (or “copyleft”), which works in a legal domain,
GISAID employs the DAA as what might be called an ethical protocol13 to incite users
to acknowledge and seek collaboration with the producers of sequence data. Through

13 Alexander Galloway and Eugene Thacker have drawn attention to the importance of protocol as an

“emergent property of organization and control in networks that are radically horizontal and distributed.”
Protocols are “rules and standards that govern relationships within networks”; they govern “how things are
done” within a network through “distributed control” rather than “pyramidal hierarchy” or “sovereign fiat.”
I adopt the term protocol here to capture how the GISAID DAA governs use through a horizontal distributed

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the terms of the DAA, GISAID creates public access without public domain, and aims
to couple access with the etiquette of credit recognition and the spirit of collaboration.
And unlike Mertonian norms, or the Bermuda and Fort Lauderdale agreements that are
widely adopted in genomics research, GISAID makes this spelled out version of sci-
entific etiquette enforceable through its verified real-name user registration: authorized
use can be enforced, by taking action such as exclusion from the database in cases
where the DAA terms of use are violated.14
GISAID further linked the jurisdictional work of the DAA with technical work on
the design and development of a new, purpose-built influenza sequence database. In
late 2007, GISAID collaborated with the Swiss Institute of Bioinformatics (SIB) and a
Swiss bioinformatics company, SmartGene, to develop the EpiFlu database. By 3
October 2008, EpiFlu was referred to as “the world’s largest and most comprehensive
influenza database” (Associated Press 2008). Yet despite its global scale, WHO, the
primary global health agency, was barely involved in its development. In late summer
2008, WHO even refused to fund the database, despite funds sent by the United States
to WHO allegedly earmarked for GISAID and EpiFlu. One obstacle was tender
requirements, requiring an open call for which GISAID, a nonprofit, would apparently
be ineligible. But some WHO officials also had philosophical disagreements with
GISAID over how sequence data should be managed. WHO official David Heymann
argued genome sequence data should be in the “public domain” (as in GenBank), while
other WHO experts allegedly still “maintained it was important some genetic data
remained behind closed doors” (as in Los Alamos ISD) (Associated Press 2008). With
funding from WHO blocked, and challenges with continuing payments to the Swiss
SIB, GISAID decided to reestablish the EpiFlu database in Germany (Butler 2009).
The new database was designed by a Database Technical Group made up of experts in
genome sequencing at important research centers, such as the CDC and other WHO
Collaborating Centers in Beijing, Australia, and Japan, but without formal WHO
support. The entire initiative, including the EpiFlu database, was eventually formalized
as a German-based nonprofit association “Freunde von GISAID e.V.,” or “Friends of
GISAID” (Elbe and Buckland-Merrett 2017: 41).
In 2015, I attended a GISAID conference held in Singapore, currently one of the
national scientific partners supporting the maintenance and development of the EpiFlu
database. In particular, the Genome Institute of Singapore had helped develop a new
analytics tool, called FluSurver, that GISAID then provided for EpiFlu users. On the
side of the conference, Vithia, a PhD in biology who works at Singapore’s A*Star
Bioinformatics Institute, showed me how FluSurver works with the EpiFlu database.
Vithia recalled his early days in (wet-lab) biology, where “we would take a virus and
break it up into tons of tiny bits in order to analyze it.” Today, he explained, he does the
same thing only with a computer and the EpiFlu database—breaking the virus apart
into molecules based on the genetic sequences—it’s just “faster and easier” (pers
comm., 24 October 2015}.
We opened the EpiFlu database and looked at several sequences of the H7N9 strain
that was then causing global concern. After showing me some of the analytics tools that

mechanism rather than through the hierarchical closed structure of international health law. However, this
should not be understood as a complete adoption of Galloway and Thacker’s theory of networks.
14 On enforcement, see Elbe and Buckland-Merrett 2017: 39.

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can be used to compare similarities between sequences, such as BLAST, Vithia


explained that by clicking on a link next to every sequence, an excel sheet opened
with all of the information regarding the Originating Laboratory that had isolated the
virus, sequenced it, and submitted the sequence. This includes the name and address of
the laboratory as well as the names of the researchers who did the sequencing work.
There is also a “contact submitter” button at the bottom of every sequence page that
provides a direct way to contact the Originating Laboratory to initiate potential col-
laborations.
Vithia recalled that several years before, the A Star Bioinformatics Lab utilized the
EpiFlu database to conduct phylogenetic, sequence, and structural analysis of an H7N3
avian influenza virus that had killed one hundred thousand chickens in Mexico. During
this research, the Lab discovered that the H7N3 virus had acquired an “extended
cleavage site” associated with high pathogenicity, and that this likely resulted from
reassortment with host (i.e., the chickens’) RNA. Working only with the sequences
available on EpiFlu, and never setting foot inside a wet lab, they published these
findings in Virology Journal (Maurer-Stroh et al. 2013). In the publication, they sub-
mitted along with the article the Excel sheet listing the names of the Originating
Laboratories (Maurer-Stroh et al. 2013: 139).
By 2015, two very different knowledge-control regimes had developed for exchange
of virus samples and genetic sequence data taken from the same influenza isolates.
Disputes over sample exchanges had revolved around international law and sover-
eignty, and were resolved by striking a balance between the international exchange of
virus samples (within the GISRS laboratory network) and the distribution of benefits to
the countries that isolated viruses—a framework that is nicely described as viral sov-
ereignty. But disputes over exchange of sequences led to the development of a com-
pletely different knowledge-control regime. The intersection of “open-access”
sequence databases typical in genomics research with the urgency of global health
security drove a two-step process of “regime change” that resulted in a novel form of
knowledge control. Although global health agencies first sought to create a private-
access section of the Los Alamos ISD database, in response to criticism a wide range
of actors instead collaborated to innovate a new regime: one in which technical data-
base design and ethical protocols (such as a database access agreement) turned scien-
tific etiquette into explicit terms of use, made acknowledgement of sequencing labs
technically possible and convenient, and even made authorized use auditable and
enforceable.

7 Conclusion: The Etiquette of Proper Sequence

In recent years, the technological interchangeability of physical virus samples and


influenza genetic sequences has greatly increased. As it has become feasible to conduct
virus surveillance, build test kits, develop vaccines, and create antiviral drugs with
sequence data alone, some countries (including India and Indonesia) argued that WHO
should include influenza GSD within its definition of PIP biological materials regu-
lated under the PIP Framework, and therefore, under a regime of viral sovereignty.
As summarized in a WHO report, the ability to manufacture vaccines with sequence
data alone “creates a potential benefit-sharing ‘loophole’” (WHO 2018: 18), since

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Viral Sovereignty or Sequence Etiquette? 499

vaccine manufacturers would no longer need to sign SMTA agreements with WHO or
source countries if they did not use any physical materials exchanged through the
GISRS. However, although WHO has reasserted the principle that sharing of influenza
GSD should be treated “on an equal footing” with sharing of benefits, and has orga-
nized a series of Technical Working Groups devoted to the problem, WHO has thus far
also declined to include GSD within the definition of PIP biological materials (in which
sharing of benefits is legally required). This is because, as they note in a 2018 report,
the technical modes of electronic exchange for sharing GSD differ in significant ways
from the shipment of physical virus samples:
GSD can be used to conduct analyses or used to synthesize physical material to
develop influenza products. However, in many ways GSD differ significantly
from physical virus materials. For instance, like other types of information, GSD
can be shared and moved electronically. In contrast, physical materials are
shipped by carriers from one laboratory to the other. This difference makes it
significantly easier to share GSD than materials. . . . Monitoring all access to
GSD would not be feasible. GSD are intangible and can be shared via public and
private means including through databases, by email, in reports and publications.
They pass through multiple hands and can be modified, combined, or split.
(WHO 2018: 25)
Due to the enormous number of users who access GSD, and the wide variety of uses,
including users who “briefly look at a sequence online with no intent to use it fur-
ther, . . . download it for use in a risk assessment or research, . . . [or] reconstitute a
protein or a virus and develop a commercial product,” WHO would potentially have to
“conclude thousands of SMTA 2s” (WHO 2018: 25). Although discussions continue,
thus far WHO has made clear that the technical differences in the exchange of samples
and sequences demanded two distinct knowledge-control regimes. In concluding, I
now return to China’s management of the H7N9 strain of the influenza virus, and
explain why their participation in these two knowledge-control regimes differed.
In the summer of 2018, in the affair that I started this article with, American and
global health agencies criticized the PRC for restricting or delaying shipments of virus
samples of the H7N9 strain to certain labs in the GISRS network, particularly the US
CDC. At the same time, the PRC was widely praised for open sharing of genetic
sequence data from H7N9 virus isolates (e.g., Nature 2013). Bollyky and Fidler
(2018) describe the PRC’s “problematic sharing” of virus samples, but consistent
sharing of sequence data, as “confusing.” As I show in this conclusion, the PRC’s
different practices of exchange in 2018 were in fact direct consequences of the different
knowledge-control regimes—viral sovereignty and sequence etiquette—that devel-
oped around samples and sequences.
Within days of first reporting the H7N9 outbreak in 2013, PRC scientists submitted
numerous sequences to the GISAID EpiFlu database. However, a new affair quickly
emerged. Some time after uploading the sequence, the PRC lab submitted an article to
the New England Journal of Medicine (NEJM) reporting on their analysis of the
sequences. However, after submitting the article, they learned that they might be
“scooped”: another research group, led by Japanese virologist Masato Tashiro, had
submitted an article to the journal Eurosurveillance that included analysis of the
sequences posted by the PRC lab on GISAID’s EpiFlu database. Moreover, the Tashiro

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article would likely be published before the Chinese article. Although troubled, the
Chinese scientists did not respond by restricting further posting of sequences. Instead,
taking their complaint to the GISAID administrators,15 the Chinese successfully
“opened channels of communication” with the Japanese research group. On 7 April,
Tashiro sent a copy of the article to the Chinese laboratory and invited them to col-
laborate, but they declined. Instead, they asked Tashiro to delay publication of the
article, originally scheduled for 10 April, until after the PRC group’s NEJM article was
published. Gaining Tashiro’s agreement, the PRC group’s article was published on 11
April, with Tashiro’s article appearing in Eurosurveillance several hours later. “Sci-
entific etiquette is without doubt a key to keeping the rapid sharing of data a reality,”
pronounced the director of the China National Influenza Center (CNIC) following the
dispute (Butler and Cyranowski 2013).
Virus sample sharing has been another story, however. Indeed, after the emergence
of the H7N9 avian influenza virus in 2013, the PRC’s submissions of sample sharing
markedly decreased. As Bollyky and Fidler (2018) point out, the PRC was not excep-
tional in this regard, as sample sharing throughout the entire GISRS “declined by half”
after 2013. According to the report of a 2016 meeting of the PIP Framework Advisory
Group, “a marked decrease was noted in the number of non-seasonal influenza viruses
with pandemic potential (IVPP) that have been shared with the GISRS as compared
with the number of human confirmed cases” (WHO 2016). After seeking explanations
from three (unnamed) countries where “viruses are not being systematically shared,”
WHO suggested that the slow reporting stemmed from several causes, including
“lengthy national export procedures involving authorities beyond health” and “the
political nature of decision-making at country level.” Yet for China, the structure of
the viral-sovereignty regime itself lay behind the slow pace of virus sharing.
In 2008, the PRC had submitted an application for its China National Influenza
Centre (CNIC) to become one of the GISRS WHO Collaborating Centers (WHO CCs)
—that is, to join labs in Australia, Japan, the United Kingdom, and the United States as
the central nodes in the GISRS network. After improving performance according to
specified requirements, CNIC became the sixth WHO CC for Influenza in 2010 (Shu
et al. 2019). As a result, the PRC’s NIC was also now a WHO CC, and the PRC could
meet the legal requirements of the PIP Framework without shipping virus samples out
of the country. According to the PIP Framework’s primary clause, “Member States,
through their National Influenza Centres and Other authorized laboratories, should in a
rapid, systematic and timely manner provide PIP biological materials from all cases of
H5N1 and other influenza viruses with human pandemic potential, as feasible, to the
WHO Collaborating Centre on Influenza or WHO H5 Reference Laboratory of the
originating Member State’s choice” (WHO 2011: 12).
As WHO (2016) acknowledges in its report on the slowdown of virus sharing, “in
countries where there is both a National Influenza Centre (NIC) and a WHO Collab-
orating Centre (CC), viruses shared with the CC may not be shared with CCs outside
the country.” Although the logic of “viral sovereignty” initially helped to increase virus
sharing by enabling benefits to circle back to originating member states, this resolution
of the controversy retained the governing frame of international health, including its

15 And not, importantly, bringing a complaint to WHO or other international organizations.

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hierarchical structure and division of the globe into nation-state units. As a result, when
the PRC became a center, rather than periphery, of the GISRS laboratory network, the
PIP Framework no longer worked to enhance cross-border virus sharing but instead
actually reduced movements of viruses across the PRC’s borders.
PRC China’s “confusing” participation in global health surveillance for influenza—
its different sharing practices for samples and for sequences—is a consequence of the
multiplicity of knowledge-control regimes in global health security today. Rather than
presuming that recent Asian state forays into biotechnology and bioscience invoke
“ethical exceptions” to a unified global science or biocapital, it is crucial to examine the
multiplicity of global flows: how different knowledge objects are made to circulate
around the world—are made global—according to different patterns and regulatory
frames (Fischer 2013). While viral sovereignty remains rooted in the hierarchical and
state-based patterns of international health, sequence etiquette invokes a transnational
form, one patterned on the open structure of the internet and other distributed networks
(see also Kelty 2008; Galloway and Thacker 2007). Therefore, when Asian scientists
object to the patterns of global scientific flows and circuits, they need not always
“configur[e] a national scale of ethical exception” (Ong 2008: 119); they may, instead,
seek fair treatment and the credit that is due to data producers through procedural
protocols inscribed in database user agreements.

8 Postscript: Pandemic

On 31 December 2019, the PRC reported to WHO an outbreak of a pneumonia of


unknown cause in Wuhan, China. By 3 January 2020, Chinese laboratories identified a
novel coronavirus, which they named 2019-nCoV, in samples isolated from patients
with the pneumonia, and this was publicly announced on 8 January. Unfortunately, the
outbreak continued to spread throughout Wuhan, other parts of China, and eventually
the world. As of my writing in April 2020, the world is now amidst a global pandemic
caused by the novel coronavirus, currently renamed as SARS-CoV-2.
Much like during the SARS outbreak, the PRC has been accused of delayed report-
ing of information, suppression of whistleblowers, and denying teams of experts from
the United States and WHO entry into China. But there has been one notable differ-
ence: sharing of genome sequence data has, by contrast, been rapid and open. Chinese
laboratories probably first determined the genetic sequence of the coronavirus on or
around 3 January. On 10 January, only a week later, three distinct viral sequences were
posted to GISAID where they were openly accessible to any GISAID user anywhere in
the world. Remarkably, this was the first time the platform was used for the exchange of
any virus GSD other than influenza, and it appears to have been done spontaneously by
Chinese researchers. As a result, in contrast with the “competitive global coordination”
that Fischer (2013) describes during the 2002 SARS outbreak, in which labs across
the world raced “to be the first to sequence and genetically identify the virus”
(384), researchers worldwide have rapidly shared sequences and collaborated on bio-
informatics analyses throughout the COVID-19 outbreak. As the GISAID website
announced, “Laboratories around the world are generating in an unprecedented man-
ner, more and more genome sequences and related clinical and epidemiological data
associated with the newly emerging coronavirus (hCoV-19) [sic] rapidly made

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available via GISAID” (GISAID 2020). Already, the sequences shared by Chinese labs
on GISAID have enabled German researchers to develop diagnostic test kits for the
virus (within one week) that were adopted as the WHO standard, and facilitated several
teams to initiate vaccine research programs. In both cases, test kits and vaccines were
developed or begun with only sequence data shared on the GISAID database, not
physical virus samples. Although pandemic influenza preparedness was the crucible
in which these new distributed networks for sharing virus sequences developed, there
is no doubt that the COVID-19 outbreak is further illuminating the difference between
the multiple regimes of global exchange in global health security.

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Lyle Fearnley is assistant professor in Humanities, Arts, and Social Sciences at the Singapore University of
Technology and Design. Trained as a medical anthropologist, his first book is Virulent Zones: Animal Disease
and Global Health at China’s Pandemic Epicenter (2020).

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