Global

BioLabs
Report
2023 FEBRUARY 2023
 Executive
Contents summary
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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Executive summary 2
Trends and Key Messages BSL4 Labs

Since its inception in May 2021, The number of BSL4 labs We also identified two
Introduction 4 the Global BioLabs initiative is rapidly increasing, with notable trends regarding
most of the new construction specific characteristics of
has identified notable trends taking place in Asia. India BSL4 labs. First, about half
in global data on BSL4 and alone has announced plans of all BSL4 labs are less than
Chapter 1: N
 ew and Updated Trends 5 BSL3+ laboratories and on for four new BSL4 labs. 200 square metres in size, and
Additionally, approximately only nine of the labs are over
in Global BSL4 Lab Data biorisk management at both 75 percent of existing 1,000 square metres. In other
the national and international operational BSL4 labs words, roughly half of BSL4
Chapter 2: Introducing Global 8 level. Overall, there are several are in cities, where dense labs are less than the size of
trends that raise biosafety and populations could exacerbate a tennis court. Second, in
BSL3+ Lab Data the impact of an accidental terms of personal protective
biosecurity concerns given the release. Over 60 percent of equipment, the majority of
global boom in construction
Chapter 3: National Biorisk 10 BSL4 labs are government- BSL4 labs require personnel
of BSL4 and BSL3+ labs, run public health institutions, to work in full-body, positive
Management Scorecards particularly where biorisk primarily focused on human pressure suits with their own
health rather than on air supply. Only seven BSL4
management oversight is weak.
Chapter 4: Governance 18 biodefence. More than
half of the BSL4 labs that
labs conduct their work solely
in biosafety cabinets.
and Stability work with infected animals
– ABSL4 labs – are in
the United States.
Chapter 5: International Governance 20
of Biorisk Management

Chapter 6: Key Recommendations 21

 Executive
summary
continued
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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

with more resources, more Key Recommendations

BSL3+ Labs Biorisk Management International inclusive membership, and
and National Context Governance of official mandates that could #3  #7 #8 
‘BSL3+’ and ‘BSL3 The following
cover biorisk management, States should develop national The WHO should take States should leverage
enhanced’ labs are BSL3 Biorisk management Biorisk Management including the World Health
recommendations provide
concrete steps that laboratories, standards for field biosafety. three concrete actions to existing international biorisk
labs that adopt additional scores based on national International networks Organization (WHO), the national authorities, non- strengthen international management organisations,
physical and/or operational legislation reveal that #4 
play an important role in the World Organisation for governmental entities, and biorisk management oversight: such as IFBA, the European
biosafety and biosecurity biosafety governance is governance of biosafety and Animal Health (WOAH), international organisations States and their high- a. D
 evelop criteria and Research Infrastructure
precautions when carrying much stronger than biosecurity. Several informal, and Interpol, place biorisk can take to strengthen consequence biolabs should guidance for BSL3+ labs. on Highly Pathogenic Agents
out particularly risky research, biosecurity governance. multinational groups, including management lower down biorisk management. implement and share best (ERINHA), the Biosafety
but where the risks do not However, the weakest b. P
 rovide guidance
the International Experts on their list of priorities. practices and participate Level 4 Zoonotic Laboratory
necessarily warrant BSL4 component of biorisk on field biosafety.
Group of Biosafety and With a diverse array of #1  in peer reviews of biorisk Network (BSL4ZNET),
precautions. There is very management is dual-use Biosecurity Regulators actors with competing Labs conducting high- management practices c. Establish collaborating and IEGBBR, to strengthen
limited national biosafety research of concern; only (IEGBBR), the Global Health agendas, coordinated consequence work with in counterpart labs. centres for biorisk global biorisk management
guidance, and no international one of the 27 countries with Security Agenda (GHSA), action is often difficult and pathogens should adopt management in Africa, by providing education,
guidance, on what constitutes BSL4 labs has comprehensive #5
the Global Partnership’s (GP) agreement on key issues the international standard Southeast Asia, the Eastern training, and best practices
BSL3+ and little to no research national dual-use research States that do not already
Biosecurity Working Group is challenging to achieve. for biorisk management: Mediterranean, and the for the widespread adoption
demonstrating that these oversight legislation in place. have a national biosafety
(BSWG), and the International ISO 35001. Western Pacific so that of ISO 35001 and an
enhancements actually provide association should encourage
The boom in BSL4 lab Federation of Biosafety every WHO region has international mechanism
an adequate level of additional and support the creation
construction appears so far Associations (IFBA) emphasise #2  at least one such centre. to audit compliance
safety for the riskier research of one by biosafety and
not to have been accompanied biorisk management in their States should incorporate with the standard.
conducted in these labs. biosecurity professionals.
by strengthened biorisk missions, but have limited voluntary global standards
BSL3+ labs are primarily management oversight. membership or lack the on biorisk management into
utilised by public health authority and/or resources #6 
Additionally, most planned legislation and guidance,
institutions and universities, BSL4 labs will be in countries to mandate meaningful including the 2022 WHO States should provide complete,
and focus more on animal with relatively low scores changes at the national Global Guidance Framework regular, and transparent
health research than BSL4 for governance and stability. or international level. for the Responsible Use of the reporting as required by the
labs. The majority of BSL3+ Most countries with International organisations Life Sciences, the 2019 annual confidence building
labs are in Europe within operational BSL4 labs earned WOAH Guidelines for measures of the Biological
urban centres. higher scores for stability Responsible Conduct in Weapons Convention and
and effective governance. Veterinary Research, and under UN Security Council
the Tianjin Biosecurity Resolution 1540.
Guidelines for Codes of
Conduct for Scientists.
 This report GlobalBioLabs.org in Facts and Figures
is composed
Since its launch in May 2021, GlobalBioLabs.org has hosted over
of six chapters: 63,000 unique visitors, roughly half of which were from North America.
The site consistently hosts an average of nearly 2000 visits a month.
The website had over 30,000 visits in March 2022 alone—presumably
a response to the Russian invasion of Ukraine in February 2022 and
Russia’s unfounded allegations of bioweapon activities in Ukrainian
public health labs conducted by the United States and its allies.

Introduction
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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

63k
Chapter 1
Since its
The first chapter provides an update
on BSL4 labs around the world.
launch in
The biological risk landscape The Global BioLabs Initiative May 2021:
Chapter 2
is rapidly evolving and presents The Global BioLabs initiative Over the last year and a unique
The second chapter presents new
significant new challenges to was launched in May 2021 in half, we have updated this data on BSL3+ labs. visitors
response to increased public information as well as
preventing the accidental, interest in high-risk biological significantly expanded our
Chapter 3
reckless, or malicious misuse research and the facilities in scope to also include data
which it takes place. The aim on ‘BSL3+’ labs; assessments
of biology. At the same time, was to create an authoritative of the strength of biorisk
The third chapter provides an

2k
analysis of the strength of biorisk
oversight systems to ensure source on maximum management governance management policies, including
containment laboratories in each of the countries
that life sciences research is and biorisk management that has, or plans to have,
biosafety, biosecurity, and dual-use
research oversight, in countries housing
conducted safely, securely, and policies around the world. a BSL4 lab; indicators or planning to build BSL4 labs.
on the implementation
responsibly are falling behind. Initially, we focused on
effectiveness of biorisk
An urgent overhaul to realign
Biosafety Level (BSL) 4
management policies;
Chapter 4 visits
labs, where work takes place
biorisk management with with lethal and contagious profiles of international The fourth chapter examines the ability a month
pathogens for which there are networks of countries of countries to implement their biorisk
contemporary risks is needed. few or no effective treatments, and labs active in biorisk management policies by measuring the
like the viruses causing Ebola, management; and new strength of their governance and stability.
Lassa fever, and smallpox. We educational materials
on biosafety, biosecurity,

30k
identified how many BSL4 Chapter 5
labs there were, mapped them, and dual-use oversight.
This report presents our The fifth chapter examines the
and provided basic information
new data and resources, global biorisk management landscape.
about the individual labs such
as when they were established and it offers a set of policy
and what size they were. We recommendations Chapter 6
also provided indicators on the to strengthen biorisk
management at the
The sixth and final chapter provides visits in
biorisk management policies
and practices in place at these lab, national, and
recommendations for strengthening March 2022
global governance of biosafety,
labs and in their host countries. international level.
biosecurity, and dual-use research.

Report Roadmap
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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Chapter 1: Key Message:

BSL4 labs are rapidly
Philippines, and Singapore.
India alone has announced
plans to build four more BSL4
40
Figure 1.
Global proliferation

New and
of BSL4 labs.
increasing in number labs in addition to the two it Only BSL4 labs
currently has. For five of with a known year
In 2021, we identified 59 these countries, this will

Updated
in which operations

Cumulative Number of Operational BSL4 Labs

BSL4 labs that were in be their first BSL4 lab. began are included
operation, under construction,
or planned in 23 countries. By
The largest concentration of 30 in the graph

Trends in
BSL4 labs remains in Europe,
the beginning of 2023, that
with 26 BSL4 labs, one of
number had increased by ten
which is under construction in

Global BSL4
to 69 labs. There are 51 BSL4
the United Kingdom and one
labs in operation, three under
of which is planned in Spain.
construction, and 15 planned, 20
Asia has 20 BSL4 labs, 11 of

Lab Data
all spread over 27 countries.
which are planned in China,
The number of BSL4 labs India, Kazakhstan, Taiwan,
around the world has grown the Philippines, Saudi Arabia,
steadily since the 2001 Singapore, and Japan. North
anthrax letter attacks in America has 15, one of which
the United States and the 10
is under construction in
2003 SARS outbreak in the United States and two
Asia stoked fears of naturally of which are planned in
occurring and human-made Canada and the United

12 New
biological threats. The States. Oceania has four
COVID-19 pandemic has BSL4 labs, all operational 0
triggered another building and located in Australia. 1970 1980 1990 2000 2010 2020
boom for BSL4 labs. Since Africa has three, two
the start of the pandemic, operational in Gabon and Year
nine countries have announced South Africa, and one under
BSL4 labs planned
plans to build 12 new BSL4 construction in Côte d’Ivoire. across nine countries
labs. Most of these new labs South America has one since the start
will be built in Asia including planned BSL4 lab in Brazil. of the pandemic
in India, Kazakhstan, the
 Chapter 1: New and Updated Trends
in Global BSL4 Lab Data – continued

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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

In other words, over 60

Key Message: Key Message: percent of BSL4 labs are Key Message: Key Message: Key Message:
BSL4 labs are primarily The focus is public government-run public BSL4 labs specialising in There are more small Suits are favoured
located in cities health, not biodefence health research institutions, animals and insects are labs than large labs over glove boxes
15 percent are academic mainly in North America
Of the 62 BSL4 labs with BSL4 labs can serve labs, and less than 20 BSL4 labs vary greatly in BSL4 labs are generally
available location data, 46 several functions including percent are defence labs. Some BSL4 labs have terms of size (floorspace). designed as either a ‘suit lab’
are, or will be, based in diagnosis of suspected capacities for specialised Of the 46 labs where data is where personnel work in
urbanised population centres infections, scientific research A significant majority available, nine labs are over full-body, positive pressure
work with animals that
and 16 are, or will be, located to better understand the (54/65) of the labs where 1,000 square meters, 15 labs suits with their own air supply
have specific biosafety
in less populated areas. In properties of pathogens, data is available focus their are between 200-1000 square or as a ‘cabinet lab’ where
requirements. We have
other words, approximately and development of new work on human health. meters, and 22 laboratories personnel handle pathogens
collected data on two of
75 percent of BSL4 labs are and improved vaccines, Seven labs focus solely on are smaller than 200 square in a series of interconnected
these: ‘ABSL4’ (Animal
located in urbanised areas, therapeutics, and diagnostics. animal-related research, meters. In other words, biosafety cabinets or ‘glove
Biosafety Level 4) labs
exacerbating the impact of and four conduct both roughly half of BSL4 labs boxes’. Of the 49 labs where
We categorise labs into four and ‘ACL4’ (Arthropod
any accidental releases. types of research. Of the globally are less than 200 primary containment data
types: university-owned, Containment Level 4) labs.
We categorise urbanised 69 BSL4 labs, 51 are square meters. That is about is available, 41 are suit labs,
defence, public health, and operational, 15 are There are 15 BSL4 labs that
population centres as privately-owned. Of the 66 the size of a singles tennis seven are cabinet labs, and one
planned, and three work with infected animals
containing over 50,000 labs where ownership data is court or less than half the size uses both suits and cabinets.
are under construction. under ABSL4 conditions.
people living within available, 41 are government- of a professional basketball
More than half (8/15) of
2.5 miles of the lab. owned public health labs, court. About one fifth of
these are located in the
13 are primarily defence labs, BSL4 labs globally are the
United States. In addition,
very large labs usually

Over
ten are university-based Canada and China each
research labs, and two labs featured in media imagery of
have two ABSL4 labs and
are privately owned. maximum containment labs.
Australia, Germany, and India

60%
each have one ABSL4 lab.
There are two BSL4 labs with
special ACL4 containment
measures to work with
of BSL4 labs are infected arthropods like ticks.
government-run There is one ACL4 lab in
public health Australia and one in the
research United States.
institutions
 Chapter 1: New and Updated Trends
in Global BSL4 Lab Data – continued

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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Research Step 1 Step 4

Defining BSL4
Methodology Collate a list of BSL4 Contact labs directly to verify
for Global BSL4 labs from previous and complete the information There is no single definition
studies and reports of what constitutes a
Lab Data Step 5 ‘maximum containment’
Step 2 Contact an international lab. Physical containment
We followed a five-step
Analyse institutional group of experts to measures, as well as biosafety Want to Learn More?
process for collecting and biosecurity practices,
websites for information review the dataset Educational resources on
and confirming vary across countries.
such as lab construction requirements for biosafety
information
dates, publications, type of We defined BSL4 labs as precautions in BSL4 labs
on BSL4 labs:
lab, research focus, affiliation, meeting the criteria for are available in the
and ongoing research maximum containment Resources section on
as specified in the WHO GlobalBioLabs.org
Step 3
Laboratory Biosafety Manual.
Undertake literature and In general, this relates to labs
internet searches on designed to work with Risk
reported BSL4 labs for Group 4 pathogens that
additional data usually cause “serious
human or animal disease
and that can be readily
transmitted from one
individual to another,
directly or indirectly.
Effective treatment and
preventive measures are
not usually available.”
 1 out 4
BSL3+ labs deal exclusively
with threats to animal health
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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Chapter 2: Key Message:

Additional precautions are
There is very limited
national biosafety guidance,
and no international guidance,
Defining BSL3+: Key Message:
BSL3+ is principally utilised
Key Message:
BSL3+ labs focus

Introducing
BSL1, BSL2, BSL3 and (e.g. HPAI and 1918 pandemic
tagged on to BSL3 labs to on what constitutes BSL3+ by public health and more on animal health
BSL4 labs are defined in influenza) and certain types
and little to no research
enable riskier research international guidelines, of practices (e.g. using a higher academic labs research than BSL4 labs

Global BSL3+
demonstrating that these
regulations, and standards. than normal volume of samples,
A new addition to the Global enhancements provide an The 57 BSL3+ labs are evenly About a quarter of BSL3+
This is not the case, however, higher concentrations
BioLabs initiative is our global adequate level of additional divided between government- labs (13/57) focus their work
for ‘BSL3+’ labs—also referred of cultures, or increased

Lab Data
inventory of ‘BSL3+’ labs, or safety for the riskier research run public health labs and on animal health. Roughly
to as ‘BSL3 enhanced’ labs production of aerosols)
‘BSL3 enhanced’ labs as they conducted in these labs. university-based research labs, half of BSL3+ labs (32/57)
or ‘BSL3 plus’ labs. are involved. Examples of
are also referred to. These Unlike for BSL4 labs, with 40 percent, or 25 labs, in deal exclusively with threats
We identified the available enhancements to BSL3 labs
are BSL3 labs that adopt there is no requirement each category. The proportion to human health, compared
scientific literature, national can include additional training
additional physical and/or under the Biological Weapons of university-based BSL3+ with the bulk of BSL4 labs
guidelines, and reports from for staff, more rigorous
operational biosafety and Convention confidence- labs is significantly higher (54/65). The remaining
international organisations that emergency response plans,
biosecurity precautions when building measures to declare than for BSL4 labs, where quarter (12/57) conduct
recommend performing enhanced respiratory
carrying out particularly risky such labs and their activities. only 15 percent are university- research relevant to both
specific types of research in protection for personnel
research, but where the risks We have located 57 labs based research labs and over human and animal health.
BSL3+ labs. We found the against aerosols, adherence
do not necessarily warrant that self-identify as BSL3+. 60 percent are government-
enhancement requirements to clothing change, personal
BSL4 precautions. The most Roughly three-quarters of run public health labs. Of the
vary from one document to protective equipment (PPE)
common pathogen studied in these are based in Europe, remaining seven BSL3+ labs,
another. In general, however, use and shower-out protocols,
BSL-3+ labs is highly which has 21 BSL3+ labs, four are privately owned and
work conducted at the BSL3+ HEPA filtration of lab exhaust
pathogenic avian influenza and in North America, three are defence laboratories.
level usually involves work air, pass-through autoclaves,
(HPAI). BSL-3+ labs have which has 19 BSL3+ labs.
with biological agents that effluent decontamination
also been used to conduct The remaining BSL3+ labs
would normally be conducted systems, and strengthened
research on novel pathogens are located in Asia (ten labs),
in a BSL3 lab, but where access controls and monitoring.
such as the reconstruction South America (four labs),
of the 1918 influenza certain types of pathogens
Africa (two labs), and Oceania
pandemic virus, as well as (one lab). These labs are all
to conduct experiments to operational, except for one in
enhance the virulence or the United States which is still
transmissibility of potential under construction and one in
pandemic pathogens, more Brazil which is planned.
commonly known as ‘gain
of function’ research.
 Chapter 2: Introducing Global
BSL3+ Lab Data – continued

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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

The United States is home to Research Methodology

Key Message: the single largest concentration Table 1: Global distribution of BSL4 and BSL3+ labs for Global BSL3+ Lab Data
BSL3+ labs are of such labs with 28 BSL4 and
primarily located in cities BSL3+ labs in operation and BSL-4 BSL-3+ We followed a five-step process
three more under development. for collecting and confirming
An even higher percentage of Asia houses 19 operational Per Operational Planned/Under Per Operational Planned/Under Total information on BSL3+ labs:
BSL3+ labs are in urban areas BSL4 and BSL3+ labs. Region Construction Region Construction
compared to BSL4 labs. 80 Oceania houses five BSL4 and Step 1
percent of BSL3+ labs (46/57) BSL3+ labs, and Africa four, Europe 26 24 2 21 21 0 47 Want to Learn More?
Collate a list of BSL3+ labs
are in urbanised population and South America three. Educational resources
from previous studies and reports
centres. The remaining 11 on containment levels
labs are in non-urbanised Asia 20 9 11 10 10 0 30
Key Message: Step 2 as explained in Biosafety
areas, with a population of in Microbiological and
There’s a building boom Analyse institutional websites
less than 50,000 people living Africa 3 2 1 2 2 0 5 Biomedical Laboratories
of highest-containment for information such as lab
within 2.5 miles of the lab. of the US National Institutes
construction dates, publications,
labs in Asia type of lab, research focus, of Health and Centers
North 15 12 3 19 18 1 34
Key Message: 11 out of the 20 highest- affiliation, and ongoing research for Disease Control
America
Europe houses nearly containment facilities that and Prevention (CDC)
Step 3 are available in the
half of world’s highest- are planned or under
construction are in Asia. Oceania 4 4 0 1 1 0 5 Undertake literature and internet Resources section on
containment facilities GlobalBioLabs.org
Four are in North America, searches on reported BSL3+ or
Overall, when BSL4 and two in Europe, two in South enhanced labs for additional data
South 1 0 1 4 3 1 5
BSL3+ labs are added America and one in Africa. America Step 4
together, there are well over
100 highest containment Contact labs directly to verify
facilities that conduct high- Total 69 51 18 57 55 2 126 and complete the information
consequence research around
the world, with more planned Step 5
and under construction Contact an international group
(see Table 1). Europe is of experts to review the dataset
home to almost half of the
operational labs (45/106)
with roughly a third located
in North America (30/106).
 21 out of the 27 countries with BSL4
labs score high on biosafety governance

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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Chapter 3: While COVID-19

demonstrated that
The Global BioLabs initiative’s
Biorisk Management
scorecards are designed to
Key Message:
Biosafety governance
for the enforcement of
biosafety legislation and a
national list of dangerous
The lowest scoring metric is
inventory requirements, found
in 17 out of the 27 countries.
Table 2: Biosafety
scores by country

National no country is safe Biosafety (score out of 20)

provide concrete, quantifiable is stronger than pathogens. Countries that To ensure on-going promotion
from a pandemic indicators of how well countries
biosecurity governance score high on biosafety of biosafety, countries should
Country Score
and that all countries are implementing this concept. governance tend to have

Biorisk
have a national biosafety Australia 20
whistleblower protection Canada 20
need a strong public These scores are based Biosafety scores laws in place which could
association or be part of a
primarily on whether a regional biosafety association. France 19
health infrastructure,
Management
country has laws, regulations, We assess that 21 out apply to workers that report Additionally, countries should Germany 19
it is important to also or policies in place that of the 27 countries with issues with biosafety to participate in, and contribute Japan 19
ensure that pandemic address the metrics on our list. BSL4 labs—roughly 80 laboratory management or to, global biosafety efforts. United States 19

Scorecards
percent—score high on government regulatory
preparedness The score cannot and
biosafety governance overall authorities, even if these laws
Countries scoring high Brazil 18
activities are carried should not be interpreted as on biosafety governance
(Table 2). Two countries score are not specifically mentioned China 18
evaluating how comprehensively generally participate in
out safely, securely, or rigorously a country is medium and four score low. in the biosafety legislation. three or more international
Italy 18
and responsibly. implementing those laws Effective biorisk Countries scoring high initiatives such as the WHO’s Singapore 18
and regulations or the level management requires that on biosafety generally have Joint External Evaluations Spain 18
A new element of the of compliance by labs on their a whole-of-government most of the 12 metrics we (JEE), the International Taiwan 18
Global BioLabs initiative territory. On the other hand, biosafety system is in place measure as components of Experts Group of Biosafety United Kingdom 18
assesses the strength of since these are scores based on for human, animal, and effective biosafety governance and Biosecurity Regulators Sweden 17
biorisk management national governance measures, agriculture facilities. implementation (Table 3; (IEGBBR), the Global Health Kazakhstan 16
governance—encompassing they cannot capture biorisk This whole-of-government See section on Research Security Agenda (GHSA) South Africa 16
biosafety, biosecurity, and management policies at lower approach is generally created Methodology for National Action Package Prevent-3
Switzerland 16
dual-use oversight—in each levels of governments or through national biosafety Biorisk Management (APP3) on Biosafety and
Hungary 15
of the countries that has, or policies and practices within legislation. Countries that Scorecards for more details). Biosecurity, and other
plans to have, a BSL4 lab. In individual labs that are more score high on biosafety The highest scoring metrics similar initiatives. Republic of Korea 15
2022, the WHO endorsed stringent than national laws governance have legislation, are physical/engineering Russian Federation 15
biorisk management as an and regulations. laws, regulations, controls, occupational health, Belarus 14
overarching concept for administrative requirements, and transportation safety, Czech Republic 11
ensuring the responsible policies, or other government for which 22 countries Philippines 7
use of the life sciences. instruments in place for have applicable measures. India 5
biosafety. They also have a Côte D’Ivoire 3
dedicated entity responsible
Gabon 3
Saudi Arabia 1
 Chapter 3: National Biorisk
Management Scorecards
– continued

12 out of 27 countries with BSL4 labs

score high on biosecurity governance

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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Table 3: Scoring metrics on biosafety While only 12 countries International engagement Countries scoring high Table 4: Biosecurity scores by country
Biosecurity scores score high on biosecurity is a key part of an effective on biosecurity governance
Biosafety Only 12 out of the 27 governance, 17 countries biosecurity framework. All generally participate in Biosecurity (score out of 18)
Number of countries with BSL4 labs have national legislation countries, but particularly three or more international Country Score
Scoring metric countries score high on biosecurity on biosecurity, 16 countries countries with BSL4 labs, initiatives, such as the France 18
Governance Framework governance (Table 4). That is have national biosecurity should have signed and Australia Group (AG),
United States 18
1. National biosafety legislation 23 roughly 40 percent, or half of oversight entities, 22 have ratified the Biological the Global Partnership’s
Australia 17
the percentage scoring high a national list, and 15 have Weapons Convention Biosecurity Working
2. National biosafety oversight entity 22 Canada 17
on biosafety. Nine countries whistleblower protections. (BWC) and provide Group (GP BSWG),
3. National list 22 Japan 17
score medium for biosecurity Countries that score high annual, publicly-accessible the WHO’s JEE,
4. Whistleblower protections 15 ‘confidence-building IEGBBR, GHSA APP3, United Kingdom 17
governance and six score low. on biosecurity generally
Implementation have most of the 11 metrics measures’ submissions for and similar initiatives. China 15
As with biosafety, effective
5. Physical/engineering controls 22 we measure as indicators heightened transparency. Taiwan 14
biosecurity requires that a
6. Good microbiological practices 20 of essential biosecurity All countries should also be Kazakhstan 13
whole-of-government system
governance implementation complying with the United
7. Biosafety risk assessments 21 is in place for human, animal, Republic of Korea 13
(Table 5). More details on Nation Security Council
8. Administrative controls 21 and agriculture facilities. Singapore 13
how we measure biosecurity Resolution (UNSCR) 1540
9. Training 20 Countries that score high on Spain 13
is in the section on Research requirements to adopt
10. Personal protective equipment 19 biosecurity governance have
measures to prevent the Hungary 12
legislation, laws, regulations, Methodology for National
11. Occupational health 22 acquisition of biological Russian Federation 12
administrative requirements, Biorisk Management
12. Inventory 17 agents by non-states actors Sweden 12
policies, or other government Scorecards. The highest
13. Transportation safety 22 scoring metric is export and provide national reports Czech Republic 11
instruments in place for
14. Decontamination 21 controls, which 24 and action plans regarding
biosecurity. They also have a Belarus 9
15. Incident response plan 20 countries have, followed their implementation of this
dedicated entity responsible for Brazil 9
16. Incident reporting 21 by transportation security resolution. Countries should
the enforcement of biosecurity Germany 9
requirements, found in 20 also participate in, and
17. Biosafety Association legislation, a national list of
contribute to, global Italy 6
dangerous pathogens, and countries. The lowest scoring
National 16 biosecurity efforts. Switzerland 6
whistleblower protection laws. metrics are governance
Regional 8 India 5
measures related to DNA
None 3 screening, found in only two Philippines 4
18. International Engagement countries; information and South Africa 4
Participation in 3 groups 7 cybersecurity protections, Saudi Arabia 2
Participation in 1 or 2 groups 14 found in 11 countries; and Côte D’Ivoire 1
biosecurity risk assessment,
No participation 6 Gabon 1
found in 12 countries.
 Chapter 3: National Biorisk
Management Scorecards
– continued

Only one out of the 27 countries

with BSL4 labs scores high on
dual-use research governance

12
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Table 5: Biosecurity scoring metrics Table 6: Dual-use research scores by country

Biosecurity Biosecurity We assess that three countries Finally, we also assess Dual-Use Research (score out of 10)
Key Message: Statutory have dual-use research review self-governance measures,
Number of Number of Country Score
Scoring metric countries Scoring metric countries oversight of dual-use processes overseen by funders. as part of a stakeholder
As a cross-cutting insurance management and oversight Canada 9
Governance Framework 17. UNSCR 1540 research is rare
of proper governance, portion of dual-use research United Kingdom 5
1. National biosafety legislation 17 Part 1: Implementation of 20 countries should have governance. These self- United States 5
national legislation and domestic Dual-use Research
2. National biosafety oversight entity 16 whistleblower protection governance measures could Germany 4
control measures: 66-100% Only one out of the 27 laws in place which could include standards, guidelines,
3. National list 22 Australia 3
Part 1: Implementation of national 2 countries with BSL4 labs apply to workers that report best practices, codes of
4. Whistleblower protections 15 scores high on dual-use Taiwan 3
legislation and domestic control issues with dual-use research conduct or ethics, and/or
Implementation measures: 34-65% research governance (Table 6). to laboratory management research review processes, Hungary 2
Part 1: Implementation of 3 Two score medium and 24 or government regulatory introduced by professional Italy 2
5. Physical security 17
national legislation and domestic score low on dual-use authorities. We assess 15 societies, private, and/or Japan 2
6. Information and cyber security 11 research governance.
control measures: 0-33% countries to have statutory academic consortia, and Switzerland 2
7. Personnel reliability 14 whistleblower protections. other standard-setting
Part 2: National report 8 Only one country has national Brazil 1
8. Biosecurity risk assessments 12 and action plan dual-use research legislation in institutions. We identify
Awareness amongst Côte D’Ivoire 1
9. Inventory 15 Part 2: National report 16 place for oversight of research stakeholders also forms a 11 countries where
France 1
10. Export controls 24 but no action plan with especially dangerous crucial component of dual-use stakeholders have adopted
India 1
pathogens, toxins, pathogens governance. On-going self-governance measures.
11. DNA screening 2 Part 2: No national report 1 Kazakhstan 1
with pandemic potential and/ education and standardised
12. Training 16 or other dual-use research Republic of Korea 1
18. Membership in International training related to dual-use
13. Transportation security 20 (Table 7). Two countries research should be required, South Africa 1
Biosecurity Initiatives
14. Incident response plan 15 have dedicated entities in addition to awareness- Sweden 1
Member of 5 groups 6 with national oversight
15. Incident reporting 16 raising and capacity-building Belarus 0
responsibilities for dual-use for dual-use risk assessment China 0
International Engagement Member of 4 groups 3
research. A funder-based and mitigation. Three Czech Republic 0
16. BWC Member of 3 groups 4 oversight system is less countries have national Gabon 0
Ratified and public CBM 9 comprehensive than one awareness-raising measures.
Member of 2 groups 7 implemented by a national Philippines 0
Ratified and private CBM 16
agency, but it does provide Russian Federation 0
Ratified but no CBM 2 Member of 1 group 4 Saudi Arabia 0
monitoring of some potentially
Signed but not ratified 0 high-risk research. Singapore 0
Not signed 0 Member of 0 groups 3
Spain 0
 Chapter 3: National Biorisk
Management Scorecards
– continued

13
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Table 7: Dual-use research scoring metrics More than half the countries Compared to the overall Table 8: Overall biorisk Table 9: International biorisk management
Key Message: with BSL4 labs (15/27) fall biorisk management scores, management scores by country engagement score by country
Dual-Use Research The post-COVID building within the medium scale for the international engagement
Number of Overall Score (out of 48) International Engagement Score (out of 14)
boom in BSL4 labs is overall biorisk governance scores are strong. The only
Scoring metric countries and five countries score low. Country Score Country Score
so far not matched by country which earned less
Governance Framework Many of the countries than 30% of the available Canada 46 Canada 14
accompanying biorisk
1. National dual-use legislation 1 building new labs, some points is Taiwan, which is United States 42 Germany 14
management policies barred from participation
2. N
 ational dual-use research oversight for the first time (marked in Australia 40 United States 14
Entity with national 2 bold on Table 8), score poorly as an independent state in United Kingdom 40 Australia 13
Combined biorisk on biorisk management. many of the relevant regimes
oversight responsibility France 38 Japan 13
Funding agency review process 3
management scores However, since the labs are and groups. Over half of
countries with BSL4 labs Japan 38 Switzerland 13
No oversight 22 No country has a perfect not yet built, there is still time
to strengthen national laws (14/27) earned a high Taiwan 35 United Kingdom 13
3. Awareness-raising 3 score for overall biorisk
management governance. and regulations on biosafety, score for this metric. China 33 France 12
4. Whistleblower protections 15
Among the seven countries biosecurity and dual-use Germany 32 Republic of Korea 11
Stakeholder Management that score high on biorisk research to bring them up Singapore 31 Sweden 11
and Oversight management governance, to international standards. Spain 31 Czech Republic 10
5. Self governance measures 11 each have a minimum of The international biorisk Kazakhstan 30 India 10
two and a maximum of 13 management engagement Sweden 30 Italy 10
metrics in which they do score represents membership
not receive a point (Table 8). Hungary 29 Spain 10
in organisations relevant to
While these points may seem Republic of Korea 29 Hungary 9
biosafety and biosecurity
inconsequential when looking governance as well as the Brazil 28 Saudi Arabia 9
at the overall score, each extent of engagement in Russian Federation 27 Singapore 9
point not achieved within international treaty regimes Italy 26 Belarus 8
the scorecard represents a and multilateral accountability Switzerland 24 China 8
potential gap in governance (Table 9). The score was Belarus 23 Philippines 8
that could allow for a based on participation in the
biosafety or biosecurity Czech Republic 22 South Africa 8
AG, GP BSWG, WHO’s
incident or for research JEE, IEGBBR, and GHSA South Africa 21 Brazil 7
with dual-use potential APP3 as well as the BWC India 11 Kazakhstan 7
to be conducted without and UNSCR 1540. Philippines 11 Russian Federation 7
appropriate oversight or Côte D’Ivoire 5 Côte D’Ivoire 6
safety measures.
Gabon 4 Gabon 5
Saudi Arabia 3 Taiwan 4
 Chapter 3: National Biorisk
Management Scorecards “National legislation
– continued should require labs to
have control measures
for the physical security
of biological materials.”
14
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Research Methodology The biosafety risk assessments pathogens. Governance prevent unauthorised National governance We define dual-use research (1) ISO Standard 35001 On the interactive map
should take into account the should require that an access to or loss, theft, should cover additional to be life sciences research Biorisk management for available on GlobalBioLabs.
for National Biorisk activity or protocol-specific accurate, verifiable, and misuse, diversion or security measures of conducted for peaceful and laboratories and other org, raw scores for biosafety
Management information and should up-to-date inventory, intentional release of international importance. beneficial purposes that related organisations, (max 20), biosecurity (max
Scorecards be based on the unique or itemised record, of a biological agent or Governance should require could provide knowledge, (2) CEN Workshop 18) and dual-use research
context of those activities biological materials is biological material. export controls so that the information, methods, Agreement CWA oversight (max 10) were
The National and protocols, including specified, established, National legislation should transfer and export of certain products, or technologies 15793:2008 on converted to percentages and
factors related to facility, and maintained within materials, technology, or that could also be rounded to the nearest whole
Biorisk Management environment, and personnel. each lab. Oversight entities
require labs to have control
software abroad is restricted. intentionally misused
Laboratory biorisk
number. For example, a
measures for the physical management standard,
Scorecards assess Biosafety measures include should keep track of any Related to synthetic biology, to endanger the health ‘15/18’ for biosecurity became
security of biological materials. (3) WHO’s Joint
biorisk management physical/engineering safety incidents within There should be multiple national governance should of humans, non-human an ‘83’. Countries were then
controls, equipment, personal labs. National governance require a comprehensive animals, or the environment. External Evaluation, placed in rankings of high,
on the basis of 41 layers of physical security
protective equipment (PPE), should establish processes and integrated screening (4) N
 TI’s Global Health medium, and low for
metrics: 18 for and good microbiological for reporting, investigating,
to deter, detect, and delay an
framework that includes
Table 10 provides the
biosafety, biosecurity, and
intruder from gaining access scorecard with details about Security Index,
biosafety, 18 for practices (the working and taking action on incidents customer and sequence dual-use research oversight
to areas containing biological the metrics and total possible (5) the Global Health
biosecurity and five methods applied to eliminate and nonconformities. Any agents. Labs should also screening, as well as points for each component Security Agenda (GHSA)
(Table 11). Once overall-
for dual-use research. or minimise exposure to incidents regarding material be required to establish and follow-up screening when of biorisk management. scores were tabulated,
Action Package Prevent-3
biological material). Regular accountability such as lost maintain an information customer and/or sequence Points for metrics are awarded countries were given a
(APP3) on Biosafety and
We define biosafety and standardised approaches materials or occupationally security programme to screening raises a concern. based on publicly-available, category of high, medium,
Biosecurity, and
to include the principles, to training using a common acquired infections should be identify, protect, and control As with biosafety, biosecurity statutory measures such as or low based on the sum of
curriculum should be reported to a national entity governance should cover (6) the WHO’s Benchmarks their subcategory scores
technologies, measures access to sensitive information. laws, regulations, acts,
required. Labs should also responsible for biosafety risk assessments, inventory, for International Health (Table 12). Figure 2 provides
and practices of containment National governance must also standards, ordinances, and
be required to establish local oversight. Additional lab training, transport, and Regulations (IHR) the comprehensive list of all
that can be used to prevent ensure that only appropriate rules; points are not awarded
biorisk management oversight, policies should include incident response plans. Capacities. scoring for the countries
inadvertent release or and trustworthy personnel for guidance documents or
unintentional exposure to such as a biorisk management transportation safety, have access to dangerous Any incidents regarding voluntary guidelines. We pulled out cross-cutting covered by this research.
biological agents or biological committee or dedicated decontamination, and pathogens. Specific measures material accountability such standards and practices from
biosafety officers, and to incident and emergency as stolen materials or security Our selection of metrics
material. National biosafety should be required to these frameworks, and we
assign and communicate response plans. breaches should be reported was drawn from industry
legislation should require labs determine and provide included additional metrics
responsibilities and authorities to an entity responsible for best practices. We compared
to undertake assessments and We define biosecurity assurance that workers are such as whistleblower
for relevant roles. National biosecurity oversight. standards and practices in
prioritisation of biosafety risks to include the principles, reliable, trustworthy, and protection and dual-use
governance should cover six international frameworks
and to implement, maintain technologies, measures, and competent, and to identify research oversight structures.
inventory requirements to for biorisk management:
and document safety measures. practices that can be used to individuals who may
keep track of dangerous pose a security risk.
 Chapter 3: National Biorisk
Management Scorecards
– continued

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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Table 10: Global biolabs biorisk management scoring card

Global Biorisk Management Scorecard 48 points Global Biorisk Management Scorecard 48 points
Biosafety 20 points 13. Transportation safety 0=no applicable national governance,
1=related national governance
Governance Framework 4 points
14. Decontamination 0=no applicable national governance,
1. National biosafety legislation 0=no applicable national governance,
1=related national governance
1=related national governance
15. Incident response plan 0=no applicable national governance,
2. National biosafety oversight entity 0=no applicable national governance,
1=related national governance
1=related national governance
16. Incident reporting 0=no applicable national governance,
3. National list of dangerous pathogens 0=no applicable national governance,
1=related national governance
1=related national governance
4. Whistleblower protections that could be applied to laboratory 0=no applicable national governance, Biosafety Association 2 points
personnel with concerns about biosafety 1=related national governance 17. National or regional biosafety association 0=no biosafety association,
1=participation in regional biosafety association,
Implementation 12 points 2=national biosafety association
5. Physical/engineering controls 0=no applicable national governance,
1=related national governance International Engagement 2 points
18. Participation on global scale, e.g. engagement with WHO’s 0=no participation,
6. Good microbiological practices 0=no applicable national governance,
JEE, IEGBBR, GHSA APP3, or other similar initiatives 1=participation in 1 or 2 groups,
1=related national governance
2=participation in 3 groups
7. Biosafety risk assessments 0=no applicable national governance, Biosecurity 18 points
1=related national governance
Governance Framework 4 points
8. Administrative controls 0=no applicable national governance,
1=related national governance 1. National biosecurity legislation 0=no applicable national governance,
1=related national governance
9. Training 0=no applicable national governance,
1=related national governance 2. National biosecurity oversight entity 0=no applicable national governance,
10. Personal protective equipment 0=no applicable national governance, 1=related national governance
1=related national governance
3. National list of dangerous pathogens 0=no applicable national governance,
11. Occupational health 0=no applicable national governance, 1=related national governance
1=related national governance
4. Whistleblower protections that could be applied to laboratory 0=no applicable national governance,
12. Inventory 0=no applicable national governance,
personnel with concerns about biosecurity 1=related national governance
1=related national governance
 Chapter 3: National Biorisk
Management Scorecards
– continued

16
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Table 10: Global biolabs biorisk management scoring card – continued

Global Biorisk Management Scorecard 48 points Global Biorisk Management Scorecard 48 points

Implementation 11 points 17. United Nations Security Council Resolution 1540 1= <33% implementation of Operative Paragraphs 2 & 3,
2=34-65% implementation,
5. Physical security 0=no applicable national governance,
3=66-100% implementation
1=related national governance
6. Information and cyber security 0=no applicable national governance,
18. Membership in the following groups: 0=none, 1=1, 2=2, 3=3, 4=4, 5=5
1=related national governance
AG, GP BSWG, WHO’s JEE, IEGBBR, GHSA’s APP3
7. Personnel reliability 0=no applicable national governance,
1=related national governance
8. Biosecurity risk assessments 0=no applicable national governance,
Dual-Use Research Oversight 10 points
1=related national governance
9. Inventory 0=no applicable national governance, Governance Framework 9 points
1=related national governance 1. National dual-use legislation 0=no applicable national governance,
10. Export controls 0=no applicable national governance, 4=related national governance
1=related national governance
11. DNA screening 0=no applicable national governance, 2. National dual-use 0=no applicable national governance/oversight,
1=related national governance research oversight 2=funding agency review process,
3=entity with national oversight responsibility
12. Training 0=no applicable national governance,
1=related national governance 3. Awareness-raising 0=no applicable national governance,
1=related national governance
13. Transportation security 0=no applicable national governance,
1=related national governance
4. Whistleblower protections that could be applied 0=no applicable national governance,
14. Incident response plan 0=no applicable national governance,
to laboratory personnel with concerns about dual-use 1=related national governance
1=related national governance
15. Incident reporting 0=no applicable national governance,
1=related national governance Stakeholder Management and Oversight 1 point
5. Self-governance measures such as standards, 0=no applicable national governance,
International Engagement 3 points guidelines, best practices, codes of ethics, and 1=related national governance
(14 points into 0-3 score: 0=score lower than 4; 1=score between 4-7; 2=score between 8-11; 3=score between 12-14) research review processes, introduced by
16. Biological Weapons Convention 0=not signed, 1=signed, professional societies, private consortia, academic
2=ratified no CBM, 3=ratified and private CBM, groups, or other standard-setting institutions
4=ratified and public CBM
 rea

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Figure 2. Scoring metrics by country

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Taiw
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Category Sub-Category Specific

Rep
Rus
Aus

Ger
Cze

Ital
Fra
Cot

Uni
Uni
Ind
Chi

Sin
Phi
Bel

Sw
National Biosafety Legislation 1 1 1 1 1 0 1 1 0 1 1 0 1 1 1 1 1 1 0 1 1 1 1 1 1 1 1
National Biosafety Oversight Entity 1 1 1 1 1 0 1 1 0 1 1 0 1 1 1 1 1 1 0 1 1 1 1 1 1 1 0
Biosafety Governance Framework
National List 1 1 1 1 1 0 1 1 0 1 1 1 1 1 1 1 1 1 0 1 0 1 1 0 1 1 1
Whistleblower Protections 1 0 1 1 0 0 0 1 0 1 1 1 1 1 0 0 1 0 0 0 1 0 1 1 0 1 1
Physical/Engineering Controls 1 1 1 1 1 0 1 1 0 1 1 0 1 1 1 0 1 1 0 1 1 1 1 1 1 1 1
Good Microbiological Practices 1 1 1 1 1 0 1 1 0 1 0 0 1 1 1 0 0 1 0 1 1 1 1 1 1 1 1
Biosafety Risk Assessments 1 0 1 1 1 0 1 1 0 1 1 0 1 1 1 1 0 1 0 1 1 1 1 1 1 1 1
Administrative Controls 1 1 1 1 1 0 1 1 0 1 1 0 1 1 1 0 1 1 0 1 1 1 1 0 1 1 1
Training 1 1 1 1 1 0 0 1 0 1 1 0 1 1 1 0 1 1 0 1 1 1 1 0 1 1 1
Biosafety
Personal Protective Equipment 1 1 1 1 1 0 0 1 0 1 1 0 1 0 1 0 0 1 0 1 1 1 1 1 1 1 1 17
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Biosafety Implementation
Occupational Health 1 0 1 1 1 0 1 1 1 1 1 0 1 1 1 0 1 1 0 1 1 1 1 1 1 1 1
Inventory 1 1 1 1 1 0 1 1 0 1 0 0 0 1 1 0 1 1 0 1 0 1 0 0 1 1 1
Transportation Safety 1 1 1 1 1 0 1 1 0 1 1 0 1 1 1 0 1 1 0 1 1 1 1 1 1 1 1
Decontamination 1 1 1 1 1 0 0 1 0 1 1 0 1 1 1 0 1 1 0 1 1 1 1 1 1 1 1
Incident Response Plan 1 1 1 1 1 0 0 1 0 1 1 0 1 1 1 0 1 1 0 1 0 1 1 1 1 1 1
Incident Reporting 1 1 1 1 1 0 1 1 0 1 1 0 1 1 1 0 0 1 0 1 1 1 1 1 1 1 1
Biosafety Association National or Regional Biosafety Association 2 1 2 2 2 2 0 1 1 1 1 2 2 2 1 2 2 0 0 2 2 2 1 2 2 1 2
International Engagement Participation on global scale 2 0 0 2 1 1 0 2 1 2 0 1 1 2 0 1 1 0 1 1 1 1 1 2 1 1 2
Biosafety Total Score 20 14 18 20 18 3 11 19 3 19 15 5 18 19 16 7 15 15 1 18 16 18 17 16 18 18 19
National Biosecurity Legislation 1 1 0 1 1 0 1 1 0 0 1 0 0 1 1 0 1 1 0 1 0 1 1 0 1 1 1
Biosecurity Governance Framework National Biosecurity Oversight Entity 1 0 0 1 1 0 1 1 0 0 1 0 0 1 1 0 1 1 0 1 0 1 1 0 1 1 1
National List 1 1 1 1 1 0 1 1 0 1 1 1 1 1 1 1 1 1 0 1 0 1 1 0 1 1 1
Whistleblower Protections 1 0 1 1 0 0 0 1 0 1 1 1 1 1 0 0 1 0 0 0 1 0 1 1 0 1 1
Physical Security 1 1 1 1 1 0 1 1 0 0 0 0 0 1 1 0 1 1 0 1 0 1 1 0 1 1 1
Information and Cyber Security 1 0 0 1 1 0 0 1 0 0 0 0 0 1 1 0 1 0 0 0 0 1 0 0 1 1 1
Personnel Reliability 1 0 1 1 1 0 1 1 0 1 1 0 0 1 0 0 1 0 0 1 0 0 0 0 1 1 1
Biosecurity Risk Assessments 1 0 0 1 1 0 0 1 0 0 0 0 0 1 1 0 0 1 0 1 0 0 0 1 1 1 1
Biosecurity
Inventory 1 1 0 1 1 0 1 1 0 0 0 0 0 1 1 0 1 1 0 1 0 1 0 0 1 1 1
Biosecurity Implementation
Export Controls 1 1 1 1 1 0 1 1 0 1 1 1 1 1 1 1 1 1 0 1 1 1 1 1 1 1 1
DNA Screening 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
Training 1 1 1 1 1 0 0 1 0 0 1 0 0 1 1 0 0 1 0 1 0 1 1 0 1 1 1
Transportation Security 1 1 1 1 1 0 1 1 0 1 1 0 1 1 1 0 1 1 0 1 0 1 1 0 1 1 1
Incident Response Plan 1 0 0 1 1 0 0 1 0 1 1 0 0 1 1 0 1 1 0 0 0 1 1 0 1 1 1
Incident Reporting 1 0 1 1 1 0 1 1 0 0 1 0 0 1 1 0 0 1 0 1 0 1 1 0 1 1 1
International Engagement BWC; UNSCR 1540; Membership of AG, GP BSWG, GHSA APP3, IEGBBR, JEE 3 2 1 3 2 1 2 3 1 3 2 2 2 3 1 2 2 1 2 2 2 2 2 3 1 3 3
Biosecurity Total Score 17 9 9 17 15 1 11 18 1 9 12 5 6 17 13 4 13 12 2 13 4 13 12 6 14 17 18
National Dual Use Legislation 0 0 0 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
National Dual-Use Research Oversight 0 0 0 3 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 2 2
Dual Use Governance Framework
Dual Use Awareness Raising 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1
Whistleblower Protections 1 0 1 1 0 0 0 1 0 1 1 1 1 1 0 0 1 0 0 0 1 0 1 1 0 1 1
Stakeholder Oversight Self-governance Measures 1 0 0 1 0 1 0 0 0 1 1 0 1 1 1 0 0 0 0 0 0 0 0 1 0 1 1
Dual Use Total Score 3 0 1 9 0 1 0 1 0 4 2 1 2 2 1 0 1 0 0 0 1 0 1 2 3 5 5
 “In general, countries with well-established
democratic governments scored highest
on the national context indicators.”

18
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Chapter 4: The first index measures

the general quality of
governance in a country
Key Message: Countries
with operational BSL4 labs
Switzerland scored highest
on the Stability scorecard
with a score of 82, while the
There are 28 operational
BSL3+ labs in nine countries
that have a Governance
The data shows a positive
correlation between the
two scores, with a Pearson
context and biorisk
management, along with
grouping countries with

Governance and the other measures

its general level of stability.
generally score well on
governance and stability,
Philippines scored lowest with
a score of ten. The average
score greater than or equal
to 50. For countries with a
correlation coefficient of
0.61. Further, to assist with
similar opportunities for
improvement when it

and Stability
These indexes are based score is 50; the median 52. Governance score of less than visualisation, we divided comes to responsible
on data generated by the but the bulk of planned 50, there are six operational the plot into quadrants using management of their high
In general, countries with
World Bank, Transparency BSL4 labs are in countries BSL3+ labs in five countries. the 50th percentile and consequence facilities.
well-established democratic
International, Freedom that score in the bottom- governments scored highest In contrast, however, there percentage, respectively, It is worth reiterating
House, the Nuclear Threat half of these indexes on the national context are only 11 operational as the division between that the percentile rankings
The national biorisk management Initiative, Fund for Peace, indicators. The Governance BSL3+ labs in countries ‘upper’ and ‘lower’ scores for were calculated taking into
and others (see section on The Governance scorecard with a Stability score of national context and biorisk
scorecards provide a snapshot assesses to what extent a
and Stability scores were account exclusively countries
research methodology for greater than or equal to 50, management. It was rare for
of the status of national legislation national context). We country’s political system
usually congruous, with
while there are 23 operational countries to have both an
with operational or planned
only four countries yielding BSL4 labs. Rather than
and regulations, but they do not combined the scores that is effective, equitable,
a discrepancy greater than BSL3+ labs in countries with upper national context indicating the Governance
provide evidence of how well countries received from each accountable, and independent a Stability score of less than score and lower biorisk
20 points between the or Stability of a country
of these sources to create a (Table 13). Sweden scored 50. The United States, which management score, with only
these measures are being highest with a score of 94,
two scorecards. worldwide, our national
composite score indicating has a Stability score of less the Czech Republic falling
complied with or enforced how well governed and while Russia and Gabon There are significantly than 50 and accounts for 18 into this quadrant. Between
context indicators compared
countries responsible for
in a given country. To provide how stable the country is. scored lowest with a score of more operational BSL4 of the 38 operational BSL3+ the countries in the quadrant high-containment laboratories
a general sense of the ability nine. The average composite labs in countries that have labs, is the primary driver of with lower scores for both
Only countries with a Governance and Stability against each other. As a result,
score is 50, as expected this difference in the spread of categories, there are a
of countries with BSL4 labs operational or planned
with percentile scoring, score greater than or equal well-governed countries
the Governance and Stability combined seven planned
to effectively implement their BSL4 labs were included
while the median is 56. to 50. However, planned or metrics amongst BSL3+ labs. BSL4 labs and five operating
might have a seemingly
in the scoring. As the scores inaccurate ranking, but this
biorisk management policies, are percentiles, they were The Stability scorecard
under-construction BSL4 labs
We also calculated the BSL4 labs. It must be noted is comparative only to the
we created two indexes. are disproportionately located that these are very broad
then ranked against each assesses the level of domestic average of the Governance other countries evaluated.
in countries that score less groupings, distinguishing
other. A relatively low score is and international conflict, and Stability percentile
than 50 on both Governance only between scores above
therefore only relative to other government repression, scores for each country
and Stability (Table 14). and below the 50th percentile
countries with BSL4 labs, terrorism, political stability, and named this averaged
Similar trends exist for the and 50 percent. The spectrum
not to the rest of the world. and perceived government score the ‘National Context.’
distribution of BSL3+ labs is far more incremental than
legitimacy, among other This score was then plotted
across countries which scored indicated by these quadrants,
factors (Table 13). against the overall Biorisk
above the 50th percentile but the scatter plot proves a
for Governance (Table 14). Management scores to create
a scatter plot (Figure 3). useful tool for visualising the
correlation between national
 Chapter 4: Governance
and Stability – continued

19
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Table 13: Governance and Stability Table 14: Distribution of lab types and status by percentile cutoff in countries Figure 3. Quadrant scatter plot of national context percentiles against biorisk management score
composite scores by country with BSL4 labs that are operational, under construction or planned percentage (out of maximum possible score) for all countries with operational or planned BSL4 labs

Country Governance Stability Number of Labs in Countries with Percentile Score

Australia 83 68 Lab Type Metric Less Greater than/equal to 50
100
and Status than 50
Belarus 12 26 Canada

Brazil 26 23 Operational BSL4 Governance 12 39

United States
Canada 86 66
China 25 26 United Kingdom Australia

Côte d’Ivoire 16 18 Stability 20 31 France Japan

Czech Republic 56 80 Taiwan

France 63 52 China
Germany
Gabon 9 45 Planned and Under Governance 10 8 Spain
Kazakhstan Singapore
Construction BSL4 Sweden

Biorisk Management
Germany 81 72 Hungary South
Hungary 40 67 Russian
Brazil Korea
Italy
India 30 15 Stability 12 6 Federation

Italy 50 52 50 Switzerland
Belarus
Czech Republic
Japan 74 79 South Africa
Kazakhstan 22 42 Operational BSL3+ Governance 6 28*
Philippines 22 10
Republic of Korea 57 67
Russian Federation 9 17 Stability 23* 11
Saudi Arabia 29 25 Phillippines India
Singapore 77 79
South Africa 34 36 Planned and Under Governance 1 1
Spain 56 58 Construction Cote d’Ivoire
BSL3+ Gabon
Sweden 94 80 Saudi Arabia
Switzerland 91 82 Stability 2 0
0
Taiwan 71 75
0 50 100
United Kingdom 76 63
National Context
United States 60 35 *The United States has 19 operational BSL3+ laboratories.
 Chapter 4: Governance
and Stability – continued

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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Research Methodology Transparency International: M = The number of

for National Context Indexes Corruption Perceptions ranks below X
Index (2021) [Governance] (the country’s score)
We identified seven indexes World Bank: Worldwide R=T
 he number of
that measure national Governance Indicators (2020) ranks equal to X
attributes like government [Governance and Stability] (the country’s score)
accountability, civil unrest, Freedom House: Freedom in Y = The total number of ranks
terrorism incidence, the World (2021) [Governance]
and corruption: The Nuclear Threat Initiative:
Percentile ranking takes the
absolute scores identified in
Global Health Security
the indexes and ranks each
Index (2021) [Stability]
country’s scores relative to one
The Fund for Peace: Fragile another. Under this approach,
States Index (2021) [Stability] the index scores referenced
were also weighted equally.
Institute for Economics The major advantage of this
and Peace: Global Terrorism approach is that it enables
Index (2021) [Stability] cross index comparisons
through normalisation of the
Gibney, et al.: The Political
scores on a scale of 0 to 100.
Terror Scale (2020) [Stability]
Only countries operating or
planning BSL4 labs were
We normalised the involved in the percentile
scoring across the indices calculations, so the scores
by calculating percentile are relative to the subgroup of
rankings for each index relevant countries. Composite
using a standard percentile scores were then calculated
ranking equation: where by averaging the percentile
Percentile= rankings for each score to
M+0.5*R find the final “Governance”
* 100 or “Stability” composite score.
Y
 “At the international level, current biorisk
management efforts are fragmented across
regulatory, public health, and nonproliferation
domains with wide variation in the levels of
resources and attention devoted to biosafety,
biosecurity, and dual-use research oversight.”
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K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Chapter 5: International efforts to

govern and strengthen
biorisk management are
(GHSA), and the Biological
Security Working Group
(BSWG) of the Global
The 1972 Biological
Weapons Convention
(BWC) prohibits the
Between 2017 and 2021,
between 78 and 92 countries
submitted their CBMs and
remaining repositories for
the virus in the United States
and Russia and conducts

International conducted by a mix of formal

international organisations,
Partnership Against Weapons
of Mass Destruction; and
development, production,
stockpiling, acquisition,
35-40% of them made these
documents publicly available.
biennial biosafety and
biosecurity inspections of

Governance
such as the World Health international non-governmental and transfer of biological The World Health these facilities. WHO has also
Organization (WHO), the groups such as the International weapons. The treaty Organization (WHO) designated four public health
World Organisation for Standards Organization provides the foundation provides guidance on agencies—in the United

of Biorisk
Animal Health (WOAH), (ISO), the International for the global biological laboratory biosafety and States, United Kingdom,
the Food and Agriculture Gene Synthesis Consortium weapons nonproliferation biosecurity and the Canada, and Mexico—as
Organisation (FAO), and (IGSC), the European and disarmament regime. responsible conduct of life collaborating centres on

Management
Interpol; UN bodies such as Research Infrastructure on It has 185 member states sciences research to its 194 biosafety or biosecurity.
the UN Security Council’s Highly Pathogenic Agents and a small secretariat, the member states. In 2022, These centres produce
1540 Committee, the UN (ERINHA), the International Implementation Support WHO published the Global biosafety and biosecurity
Biorisk Working Group Federation of Biosafety Unit (ISU), which Guidance Framework for the manuals, develop biosafety
(UN-BRWG), and the Associations (IFBA), administers the treaty Responsible Use of the Life technologies and practices,
At the international level, current UN Secretary General’s and the InterAcademy meetings, the quinquennial Sciences. The framework conduct training and
biorisk management efforts are Mechanism for Investigation Partnership (IAP). review conference, and is intended to raise the education, and assist WHO
fragmented across regulatory, of Alleged Use of Chemical This section provides a collects the annual awareness of the diverse with capacity-building
and Biological Weapons declarations under the treaty’s activities in other countries.
public health, and nonproliferation (UNSGM); treaty-based
brief description of the
confidence building measures
stakeholders involved in
WHO also administers the
roles of key international the conduct, funding,
domains with wide variation in the initiatives such as the institutions. The next chapter (CBMs). One of these CBMs utilisation, and governance Joint External Evaluation
levels of resources and attention Biological Weapons provides recommendations (Form A) requires countries of life sciences research and (JEE) which is a voluntary,
devoted to biosafety, biosecurity, Convention (BWC); for strengthening the to provide information about biotechnology and to provide collaborative, multisectoral
informal, multinational maximum containment process to assess a country’s
and dual-use research oversight. groups such as the
authorities and capabilities
(BSL4) labs on their territory
them with conceptual and
capacity to prevent, detect,
of these actors to promote practical tools to develop,
There are few legally-binding International Experts safe, secure, and responsible or their high containment implement and promote and rapidly respond to public
requirements in any of these three Group of Biosafety and life sciences research (BSL3) labs if the country biorisk management at the health emergencies. The
fields and even fewer mechanisms Biosecurity Regulators and operation of does not have a BSL4 lab. individual, institutional, independent expert
(IEGBBR), the Biosafety Another CBM (Form E) evaluations that are the
for ensuring compliance with Level 4 Zoonotic Laboratory
high-consequence
requires countries to provide
national, and international
centrepiece of the JEE
research facilities. levels. In addition, WHO
such requirements. Network (BSL4ZNET), the information on legislation, supervises research with include an assessment of lab
Australia Group, the Global regulations, and other variola virus (the virus that biosafety and biosecurity.
Health Security Agenda measures related to biosafety causes smallpox) at the two
and laboratory biosecurity.
 Chapter 5: International
Governance of Biorisk
Management – continued

22
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

The International
Organization for
improvement. Moreover,
the standard is designed to
The Biosafety Level 4
Zoonotic Laboratory
Additional details
about many of these “Rather than focusing on
Standardization (ISO)
develops environmental,
produce a documentary
record that a national
Network (BL4ZNET)
comprises a dozen BSL4
key international actors
can be found in the Biorisk hardware or prescribing
safety, and other standards
for a wide array of products
regulatory authority or other
external entity can audit.
laboratories in five countries
that share knowledge,
Management Memo
series available in the specific practices, the
standard promotes
and processes. In 2019, ISO The Global Health Security provide training, and Publications section on
published the ISO 35001 respond to disease outbreaks. GlobalBiolabs.org.

the development of a
Agenda (GHSA) involves
biorisk management standard more than 70 countries The European Research Table 15 provides a list
for labs that work with Infrastructure on Highly

management system
and matches donors with of all countries with planned
dangerous pathogens. Rather recipients committed to Pathogenic Agents or operational BSL4 labs
than focusing on hardware or building public health (ERINHA) is a pan-European and their participation in

that prioritises biosafety

prescribing specific practices, capacities, including labs network of ten BSL3+ and international biorisk
the standard promotes the that comply with biosafety BSL4 labs that provide access management networks

and biosecurity across

development of a management and biosecurity measures. to their facilities for scientists (all of these states are also
system that prioritises The Biosecurity Working conducting research on active members and

the entire lab.”

biosafety and biosecurity Group (BSWG) of the dangerous pathogens. participants of the BWC
across the entire lab, Global Partnership Against The Australia Group is an and UNSCR 1540).
including commitments the Spread of Weapons of informal international forum Figure 4 provides a visual
by top management to Mass Destruction (Global that enables more than 40 depiction of the worldwide
provide adequate resources, Partnership), provides a countries to harmonise their level of participation in these
to communicate biosafety clearinghouse for biosecurity export control legislation different biorisk management
and biosecurity policy, to capacity-building programmes to prevent the proliferation networks and their
train staff, and to establish provided by more than of chemical and biological overlapping membership.
performance expectations. 20 countries. Through the weapons. The International
The standard also stresses International Experts Group Federation of Biosafety
the need for continual of Biosafety and Biosecurity Associations (IFBA)
improvement of practices Regulators (IEGBBR), is a non-governmental
and processes to determine national regulators from 11 organisation made up
the causes of incidents and nations share best practices of national and regional
other issues, to correct on biosafety and biosecurity. biosafety associations
problems so they do not recur, that provides training
to identify opportunities for and professional certification
improvement, and to in biorisk management.
recognise and award
 Chapter 5: International
Governance of Biorisk
Management – continued

23
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Figure 4: World map of membership by country in GHSA APP3,

BSL4ZNET, ERINHA, GP BSWG, IEGBBR, JEE and AG. Shading
indicates the number of organisations which the country
belongs to – no country is a member of all seven.
 Chapter 5: International
Governance of Biorisk
Management – continued

24
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Table 15: National membership in international biorisk management networks. Each of these international Furthermore, while these
Only countries with a planned or operational BSL4 lab are included actors has an important actors consult with each other,
role to play in biorisk they do not coordinate their
Countries APP3 BSL4ZNET ERINHA GP BSWG IEGBBR JEE AG management. However, activities in a meaningful
Australia       the resources and authorities way. As a result, not only is
Belarus of these actors is inversely there no single entity at the
proportional to the degree international level that has Want to Learn More?
Brazil
of their emphasis on the the mandate and capability More details about key
Canada      
biorisk management mission. to identify and mitigate the international actors and efforts
China full range of biorisks, but there
Côte d’Ivoire  Groups with a strong focus to govern and strengthen biorisk
on biorisk management, is no mechanism to manage management are explained
Czech Republic   the disparate efforts currently
such as IEGBBR, GHSA, in our Biorisk Management
France     BSWG and IFBA, tend underway to address these Memo series available in
Gabon  to have more limited risks in a comprehensive, the Publications section
Germany      memberships, resources, sustained, and impactful on GlobalBiolabs.org
and/or authorities while manner. While creating a
Hungary   
larger organisations with single, powerful entity with
India   the requisite authority and
more members and resources,
Italy    capability to strengthen
such as WHO, WOAH and
Japan     biorisk management globally
Interpol, tend to place biorisk
Kazakhstan  management lower down is intellectually appealing, it is
Philippines   on their list of priorities. In a long-term project requiring
Republic of Korea    addition, formal international a great deal of political capital
organisations and treaty-based with an uncertain outcome.
Russia
initiatives face constraints In the meantime, the existing
Saudi Arabia   institutions, both formal
imposed by the diverse
Singapore    and informal, have untapped
interests of their members
South Africa   and challenges achieving the potential that could be better
Spain     level of agreement necessary harnessed to strengthen
Sweden     to make significant changes biorisk management in the
to the organisation or treaty’s short and medium term.
Switzerland    
Taiwan authorities and capabilities.
United Kingdom      
United States      
 “Developing a culture of safe,
secure, and responsible working
practices is not a one-off event,
but a continual effort.”
25
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Chapter 6: Laboratory level

Key Recommendations
All labs, but particularly labs management is to adopt
conducting high-consequence the international standard
research, should cultivate for biorisk management
a strong culture of safety, known as ISO 35001. This
security, and responsible standard provides a template
Strengthening biorisk management requires research. This does not just for establishing a management
concerted effort by multiple stakeholders including apply to BSL4 labs; as this system to identify and
report has demonstrated, mitigate safety and security
labs that conduct high-consequence work with risks as part of a continual
high-consequence work
pathogens, national governments, and international with pathogens is also being improvement process.
actors such as intergovernmental organisations, conducted at BSL3+ labs, and Since the standard is more
treaty-based institutions, informal networks, and even lower containment level concerned with the risk
labs should also be nurturing assessment and mitigation
non-governmental organisations. process than specific
a culture of safe, secure, and
responsible working practices. containment or security
This dedication to biorisk measures, it is compatible
management should with existing national
encompass all levels, from biosafety and biosecurity
students and technicians laws and regulations. For
to principal investigators labs operating in countries
and laboratory directors. without comprehensive
Developing a culture of biosafety and biosecurity
safe, secure, and responsible laws and regulations, it
working practices is not provides a roadmap to
a one-off event, but a best practices in biorisk
continual effort. management. The standard
is low-hanging fruit since it
A concrete step that labs
has already been negotiated,
conducting high-consequence
is sitting on the shelf, and can
work with pathogens can
be adopted relatively quickly.
take to institutionalise the
importance of biorisk
 Chapter 6: Key
Recommendations
“Countries that do not already
– continued have a national biosafety association
should encourage and support the
creation of one by biosafety and
biosecurity professionals.”

26
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Sciences, the 2019 WOAH In addition to laws and Countries with high- It would not be difficult
National level Guidelines for Responsible regulations, countries and consequence research for governments and labs International level
At the national level, Conduct in Veterinary their high-consequence facilities should also to increase transparency by There are also high-impact
all countries with high- Research, and the Tianjin research labs should also provide complete, regular, making BWC CBMs publicly measures that can be adopted
consequence research facilities Biosecurity Guidelines implement and share best and transparent reporting available since the existence at the international level
(BSL4 and BSL3+) should for Codes of Conduct practices and participate in as required by the annual of these facilities is not secret to strengthen biorisk
have whole-of-government for Scientists. peer reviews of practices in confidence building measures and nearly every BSL4 management. We first
biorisk management systems, Standards for field biosafety counterpart labs. Countries of the BWC and under laboratory has a website. describe steps that can be
including comprehensive laws, are much less developed with experience in designing UNSCR 1540. While This measure would taken by the bulwarks of
regulations, and institutions than for laboratory biosafety. and operating high- most countries with BSL4 strengthen international global health and biological
that require multidisciplinary Field biosafety policies and containment laboratories facilities generally submit transparency and confidence, weapons arms control, the
risk assessments of proposed practices are designed to should share their expertise in these documents, there is and it would assist further WHO and the BWC, to
research for safety, security, prevent researchers from building risk-based laboratory no international requirement research to strengthen strengthen biorisk management
and dual-use implications. becoming exposed to an infrastructure that is fit for mandating this information, global biorisk management multilaterally. We then outline
The gold standard is a infectious disease while purpose, is safe and secure, and countries are not governance. Transparency a complementary ‘minilateral’
national-level government collecting biomedical and and can be maintained specifically encouraged to is also the best antidote to strategy to achieving this
entity or entities with environmental samples in over the long term. submit information on BSL3+ disinformation. Such objective by capitalising on
jurisdiction over public the field and handling wild Countries that do not labs. Confidence-building transparency is more the activities and capabilities
and private facilities that animals. Few, if any, countries already have a national information should be made important than ever given of less formal international
can enforce these laws have national field biosafety biosafety association should publicly available by all how maximum containment groups active in this domain.
and regulations. standards and there is encourage and support the countries. So far, only nine labs in multiple countries
no international guidance creation of one by biosafety of the 20 countries with have become the targets of
In adopting, implementing, operational BSL4 labs that disinformation in recent years.
reviewing, and updating available on this subject. and biosecurity professionals.
States should develop field These non-governmental submit confidence-building
national laws, regulations and measures make these reports
other measures on biosafety, biosafety standards as a groups can provide valuable
Want to learn more? matter of priority. support to labs that conduct public. Only 45 percent
biosecurity and dual-use (23/52) of the BSL4 labs in
high-consequence research
Educational resources on research, states should take operation provide links to
by, amongst other things,
disinformation related to into account relevant their publications on their
providing training and
biolabs and biological voluntary global standards on institutional websites.
professional certification,
weapons are available on biorisk management including
sharing best practices, and
bioweaponsdisinformation the 2022 WHO Global
supporting the expansion
monitor.com Guidance Framework for the
Responsible Use of the Life of professional networks.
 Chapter 6: Key “There is a great need for better
Recommendations
– continued
guidance on field biosafety given
ongoing and planned large-scale
efforts to collect thousands of viral
samples to identify novel zoonotic
and potentially pandemic pathogens.”
27
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

sorely need an international WHO region has at least one The World Health WHO could be made or equivalent international
Reinforcing multilateral effort to more clearly specify such centre. The purpose of Assembly should pass a directly responsible for this standards related to biorisk
approaches to biorisk the BSL3+ category. these centres would be to resolution to guide WHO’s oversight, in much the same management, what biorisk
management Second, the safe collection conduct and sponsor applied critical role in enhancing way that it conducts biennial management policies are in
of samples from wild and research in field and laboratory biorisk management, biosafety and biosecurity place at the facility,
WHO’s role in global biosafety and laboratory including endorsing the inspections of the two labs and whether they have
biorisk management could domesticated animals that
may be infected with a biosecurity, develop biorisk Global Guidance Framework, that store the remaining codes of conduct.
be strengthened in at least management policies and ISO 35001, and Tianjin samples of variola virus.
three ways. First, WHO zoonotic pathogen is an The CBM forms should
underdeveloped component practices, provide training Biosecurity Guidelines In an alternative iteration,
should use its convening and also be amended to include
of biosafety. There is a great on biorisk management, for Codes of Conduct WHO could organise
standard-setting powers to declaration of legislation,
need for better guidance on assist with capacity-building for Scientists; calling for regular biorisk management
lead an effort to develop regulations and other
field biosafety given ongoing programmes, and serve as the creation of WHO peer review exercises by
guidance on BSL3+ labs to measures relating to dual-use
and planned large-scale efforts forums for exchanging collaborating centres on international teams of
ensure that the physical and research as described in the
to collect thousands of viral information and sharing biorisk management; updating government and non-
procedural safety measures WHO Global Guidance
samples to identify novel lessons learned among the key the WHO biosafety manual government experts.
adopted by these labs are Framework for the
zoonotic and potentially stakeholders. The awareness- to include guidance on BSL3
evidence-based and The BWC can also Responsible Use of the
pandemic pathogens. WHO raising, training, and education enhancements and field
commensurate with the be leveraged to enhance Life Sciences, including
should lead an international activities sponsored by this biosafety; and requiring annual
level of risk associated with biorisk management through oversight, education,
effort to develop guidance for network should consider the progress reports from the
the research they conduct. increased transparency. Once awareness-raising, codes
field biosafety applicable to lessons learned from previous Director-General on measures
Given the number of WHO has provided guidance of conduct for researchers,
Risk Group 4 pathogens such activities. Together, taken by WHO to strengthen
BSL3+ labs already in on the criteria for what review by funding agencies,
and their most common these centres could form the biosafety, biosecurity, and
operation, the almost constitutes a BSL3+ lab, and prepublication review.
animal reservoirs, hosts, basis for a WHO-supported oversight of dual-use research.
complete lack of national the standard forms for In addition, states should be
and vectors. This guidance ‘Global Network for Biorisk Over the longer term, it
guidance on the type of submitting confidence- required to provide a
should be incorporated into Management’ which could would be desirable for an
enhancements that such building measures under description of how they
the next edition of WHO’s oversee the process of international system to be
labs need, and the lack of the BWC should be amended administer and enforce
Laboratory Biosafety Manual. implementing the WHO’s put in place to register high-
evidence-based research to require declaration of these the full range of national
Global Guidance Framework consequence biolabs and
evaluating whether these Third, WHO should labs since they are capable of implementation measures,
for the Responsible Use of provide oversight to ensure
enhancements provide establish collaborating conducting high-consequence including laws, regulations,
the Life Sciences at the that all research with high-risk
increased protection centres for biorisk research and there is minimal policies, institutions, codes
individual, institutional, pathogens, including potential
commensurate with the management in Africa, transparency about them. The of conduct, and other
and national levels. pandemic pathogens, is being
level of risk of the research Southeast Asia, the Eastern forms should also be amended measures, listed on the form.
performed at these labs, we Mediterranean, and the conducted safely, securely, to include whether declared
Western Pacific so that every and responsibly. labs comply with ISO 35001
 Chapter 6: Key
Recommendations
“A coordinated approach to enhancing global biorisk
– continued management that harnesses these minilateral groups
to promote adoption and implementation of ISO
35001 would have a powerful synergistic effect.”

28
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

of political, legal, or resource These groups complement— To promote this new activity, would have limited credibility to build confidence in the contribute to the biosafety
Adopting a minilateral constraints. By starting with a rather than replace— BSL4ZNET should establish internationally, especially for convention, improve national and biosecurity capacity-
approach to biorisk small core group of dedicated multilateral regimes, such a working group dedicated jurisdictions without proven implementation, and provide building programmes funded
management states, such a coalition can as the BWC and WHO. to biorisk management to track records for transparency an opportunity to share by GHSA and the Global
reach agreements on shared Overall, these types of complement its existing ones and accountability. Given its experiences and best Partnership by helping
Today’s biological threats objectives more quickly and initiatives enable more focused on scientific and regulatory expertise, IEGBBR practices. WHO’s JEE countries fix gaps and
are too diverse, urgent, and avoid problems posed by ambitious countries to engage operational issues. ERINHA could take on the mission includes an assessment of weaknesses in their biorisk
complex to be held hostage spoiler states and lowest- in a higher level of cooperation, should integrate dual-use of auditing laboratory a nation’s lab biosafety and management regulatory
by geopolitics and rigid common denominator albeit at the cost of inclusivity. research oversight into the compliance with ISO 35001 biosecurity capacities as part system that are identified
diplomatic rules. The outcomes. Minilateral ethical guidelines that govern using a peer-review model. of its peer review of a state’s by peer review.
Existing minilateral initiatives
international community initiatives can pursue many research conducted by its Peer review is the systematic progress in implementing the
on biorisk management could A coordinated approach
can supplement the traditional goals, including information- Labs in both networks should evaluation of the performance 2005 International Health
advance widespread adoption to enhancing global biorisk
multilateralism embodied by sharing, standard-setting, develop standards, guidelines of a state by other states for Regulations (IHR). However,
of ISO 35001 by integrating management that harnesses
WHO and the BWC with a policy-coordination, capacity- and codes of conduct based the purpose of helping the since biosafety and biosecurity
implementation of the these minilateral groups
minilateral approach. building, and implementation- on the 2022 WHO Global reviewed state improve its are just one category out of
standard into their missions. to promote adoption and
Minilateralism is a collective evaluation. As progress is GHSA and BSWG could Guidance Framework for the policies and practices and 19 reviewed by the JEE, implementation of ISO
action strategy that brings made, such initiatives can organise and coordinate Responsible Use of the Life comply with established this evaluation is not as 35001 would have a
together the smallest number expand in scope, raise their funding for projects to help Sciences, the 2019 WOAH international standards. comprehensive as those powerful synergistic effect.
of countries that can have standards, and invite new labs in low-income countries Guidelines for Responsible Peer review is integral to conducted in the nuclear
the greatest impact on an members to join. For adopt ISO 35001. IFBA, Conduct in Veterinary the international oversight safety and security fields.
issue. Comprehensive treaties example, minilateral groups which has already integrated Research, and the Tianjin of nuclear safety and nuclear In addition, the JEE is
supported by international have become enduring ISO 35001 into the training Biosecurity Guidelines security and is conducted by focused on the national level,
organisations have been the features of the nonproliferation and certification it offers for Codes of Conduct both international NGOs such not the policies and practices
gold standard for cooperation, regime despite the lack of to biosafety professionals, for Scientists. as the World Association of of individual labs. IEGBBR
but they can take many years international legal status or could offer educational and To maximise the potential Nuclear Operations (WANO) would be able to sponsor not
to negotiate or amend. bureaucracy. Although states training opportunities to of ISO 35001, which like all and by international only in-depth reviews of
In contrast, minilateralism are central to minilateralism, lab management on how to ISO standards is designed to organisations such as the national biorisk management
seeks to create a ‘coalition this approach can interact implement ISO 35001. Labs be validated by an outside International Atomic Energy legislation, regulations,
of the willing’ with the with and supplement participating in BSL4ZNET entity, there should be an Agency (IAEA). Several and institutions, but also
capability and motivation to efforts involving treaties, and ERINHA could become international mechanism to members of the BWC have laboratory-level management
take substantive actions that international organisations, test beds by adopting ISO ensure compliance. While also voluntarily trialled systems, policies, and
multilateral institutions cannot and nongovernmental actors. 35001, developing guidance national regulators could peer reviews of their practices as outlined in ISO
or will not undertake because on implementing the standard, act as the third-party, this compliance with the treaty 35001. IEGBBR could also
and sharing best practices
and lessons learned.
 Chapter 6: Key
Recommendations
“The dangers posed by an accidental or deliberate
– continued release of a pandemic-capable pathogen means
that strengthening international oversight of
high-consequence life sciences is critical.”

29
K I N G ' S CO L L EG E LO N D O N – G LO BA L B I O L A B S R E P O RT

Conclusion
Meet the team:
More countries are building
high-containment laboratories, Dr Filippa Lentzos is an Associate
Professor (Reader) and Director
developing dual-use biotechnologies, of the Science & International
and conducting risky research with Security graduate program in
pathogens. The dangers posed by an the Department of War Studies
at King’s College London.
accidental or deliberate release of a
pandemic-capable pathogen means
that strengthening international Dr Gregory D. Koblentz is an Mayra Ameneiros is a
oversight of high-consequence Associate Professor and research associate in the
life sciences is critical. Director of the Biodefense Department of War Studies
graduate program at George at King's College London.
Mason University's Schar School
Given the growing complexity of the biorisk
of Policy and Government.
landscape and the geopolitical constraints on
adopting a robust multilateral response, a
concerted effort to harness existing informal Becca Earnhardt is a presidential Ryan Houser is a doctoral
international mechanisms, while laying the scholar and doctoral student student in the Biodefense
groundwork for future multilateral initiatives, in the Biodefense program at program at the Schar School
offers the best chance to advance collective the Schar School for Policy for Policy and Government
action on ensuring that life sciences research and Government at George at George Mason University.
around the world is conducted safely, Mason University.
securely, and responsibly.
Joseph Rodgers is a doctoral Hailey Wingo is a research
student in the Biodefense program associate in the Department
at George Mason University. of War Studies at King's
College London.
Thank you
for reading
Want to Learn More?
Educational resources on BSL3+ and BSL4
labs, biosafety, biosecurity, and dual-use
research are available at GlobalBioLabs.org