COVID-19 POLICY REPORT

AUGUST 2021

ANOTHER TRIUMPH
OF SCIENCE, BUT
DEFEAT FOR ACCESS?

Ensuring innovation and equitable access

for COVID-19 treatments, other infectious
diseases, and future pandemics
Contents
Introduction 5

Hindering or enabling 7
equitable access
to medical innovations:
Key ‘hand-offs’ along
the innovation lifecycle

The urgent need for 11

COVID-19 therapeutics

Challenges in COVID-19 16
therapeutics and
recommendations for
immediate course-
correction

Conclusion: Getting it 21
right for future
pandemics and other
global health needs

Executive summary

The COVID-19 pandemic has brought devastating suffering and loss to families
and communities across the globe, and together with it, widespread damage and
disruption to economies and livelihoods. Patients and their families, as well as health
workers who have put themselves at tremendous risk to treat the sick, have faced
the gravest of circumstances – with shortages of everything from gloves, masks, and
tests to oxygen therapy and other treatments, intensive care beds, and vaccines.

This points to a truly global lack of preparedness in nearly every region of the world,
the fragility of supply chains, and the absence of effective research and development MANY OF THE
(R&D) coordination and globally agreed rules to ensure equitable access to CHALLENGES THAT
essential health tools. HAVE BEEN IDENTIFIED
IN RELATION TO THE
COVID-19 has given rise to never-before-seen levels of collaboration and rapid R&D SYSTEM AND
advances in biomedical science that have delivered life-saving technologies to fight ACCESS TO VACCINES,
COVID-19 – at breakneck speed. But it has also exposed the health consequences DIAGNOSTICS,
of racial and economic disparities within and between countries – and for millions AND THERAPEUTICS
of people in countries and communities still without access, new waves of COVID-19 FOR COVID-19 ARE
continue to cause great despair and claim millions of lives. ACUTE EXAMPLES OF
CHRONIC FAILURES.
The Drugs for Neglected Diseases initiative (DNDi) was established to address
a chronic challenge when it comes to meeting the R&D needs of neglected
populations. Many of the challenges that have been identified in relation to the
R&D system and access to vaccines, diagnostics, and therapeutics for COVID-19
are acute examples of the chronic failures that DNDi and our partners have faced,
and tried to overcome, for neglected populations over the past two decades.

2 DNDi
From the start of the pandemic, our teams have been working to leverage our
experience and partnerships to help ensure the greatest possible sharing of
research knowledge, identify effective treatments for COVID-19 – an area that
has been neglected and under-resourced in the global response to the pandemic –
and advocate for policies that will spur innovation and ensure equitable access
to the fruits of scientific progress for all people in need, no matter their income
or where they live.

This DNDi Policy Report urges the international community to learn the positive
lessons and avoid repeating mistakes that would hinder innovation of and access THIS DNDi POLICY
to COVID-19 therapeutics, offering a series of recommendations for immediate REPORT URGES THE
course-correction based on our experience as an R&D organization. INTERNATIONAL
COMMUNITY TO
These include the need to: LEARN THE POSITIVE
LESSONS AND AVOID
1. Increase political attention to and financing of COVID-19 therapeutics R&D to REPEATING MISTAKES
identify treatment options for all stages of COVID-19, including early treatment THAT WOULD HINDER
interventions – embracing in particular support and coordination for open drug INNOVATION OF
discovery and development of novel antivirals, host-targeted interventions, AND ACCESS TO
and repurposed compounds and robust testing of these options in comparable
THERAPEUTICS AND
adaptive platform trials.
OTHER HEALTH TOOLS
FOR COVID-19 AND
2. Transform governance structures of the Access to COVID-19 Tools Accelerator
OTHER PANDEMICS.
(ACT-A) to ensure equal representation from low- and middle-income countries
(LMICs); make sure ACT-A explicitly addresses intellectual property (IP)
barriers and improves transparency of development, production, and supply;
and support collaboration between ACT-A pillars to enable a ‘test-and-treat’
approach to early treatment.

3. Secure specific contractual commitments and enabling policies, such as a

temporary waiver on IP, to ensure rapid transfer of technology, large-scale
manufacturing, and equitable access to new and existing COVID-19 therapeutics
in addition to other health tools.

We then outline the specific ways in which the pandemic prevention, preparedness,
and response architecture that arises out of COVID-19 will need to be re-oriented in
the longer term to:

1. Guarantee sustained political attention to and financing of end-to-end R&D for

pandemics and all diseases and products of public health importance, with clear
priority given to areas most likely to be neglected by the market.

2. Re-imagine global health R&D coordination, collaboration, and financing to

support a more distributed, decentralized, and democratic approach to the
production of knowledge and innovation.

3. Ensure there are globally agreed norms and binding rules governing R&D
and equitable access to essential health tools to ensure the benefits of
scientific progress will be equitably shared and considered global public goods,
available to all.

The COVID-19 pandemic is nowhere near over and there are and will be ongoing
surges throughout the world due to inequitable access to vaccines and the continued
emergence of variants of concern. As we examine where we are and look to the
future, responding to the needs of those at highest risk of infection, illness, and death
today must remain the top priority.

COVID-19 POLICY REPORT 3

DNDi and COVID-19

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit R&D organization that discovers,
develops, and delivers new treatments for neglected patients. Since our creation in 2003 by Médecins Sans
Frontières (MSF) and public research institutions in Brazil, France, India, Kenya, and Malaysia, we have
developed nine new and improved treatments for six deadly diseases that have reached millions of people
utilizing an alternative, collaborative, not-for-profit R&D model.1

In response to the COVID-19 pandemic, DNDi has:

1. Co-founded and currently hosts the COVID-19 Clinical Research Coalition,2 a coalition of nearly
300 individuals and more than 200 institutions from over 85 countries, primarily from LMICs,
to prioritize, facilitate, and accelerate research for COVID-19 in LMICs;

2. Launched ANTICOV,3 a multi-country, adaptive platform trial conducted in 13 African countries

with 26 African and global partners to identify treatments for mild-to-moderate COVID-19
outpatients to prevent the need for hospitalization;

3. Joined a spontaneous, global, open drug discovery collaboration called the COVID Moonshot,4
participated in Work Stream 1 of the ACT-A Therapeutics Partnership to review the best therapeutic
candidates to take forward for clinical testing, and collaborated with various research consortia
working to identify novel, early-stage discovery projects to contribute to building the pipeline for new
treatments for COVID-19, other coronaviruses, and other pathogens of pandemic potential, including
projects originating directly from the Pandemic Response Box, released in 2018 by the Medicines
for Malaria Venture (MMV) and DNDi expressly for this purpose; and

4. Advocated for R&D to be driven by the public interest and for COVID-19 health tools to be developed
and delivered as global public goods, with equitable access for all.

DNDi was established to address a chronic challenge when it comes to meeting the R&D needs of neglected
populations. Many of the challenges that have been identified in relation to the R&D system and access to
vaccines, diagnostics, and therapeutics for COVID-19 are acute examples of the chronic failures DNDi and
our partners have faced, and worked to overcome, for neglected populations over the past two decades.

4 DNDi
Introduction

In just over one year, the novel coronavirus (SARS-CoV-2) has gone from being an
almost completely unknown pathogen to a complex global pandemic that has claimed
more than 4 million lives,5 disrupted economies and livelihoods, undermined critical
gains in global health and development, and shone a glaring light on the health
consequences of systemic racial and economic inequities within and between countries.

Far from being an acute and temporary crisis that can be eradicated, devastating
surges of infection, hospitalization, and death, long-term consequences and THE SCIENTIFIC
complications from the disease, the emergence of new variants of concern, RESPONSE TO
insufficient diagnostic capacity, and painfully slow and inequitable roll-out COVID-19 IS
of first-generation vaccines in LMICs mean that COVID-19 is here to stay. ENABLING MAJOR
ADVANCES AND
The scientific response to COVID-19 is enabling major advances and the development THE DEVELOPMENT
of new health technologies, particularly vaccines and diagnostics, at unprecedented OF NEW HEALTH
speed – shortening clinical development and regulatory timelines and quickly TECHNOLOGIES,
validating platform technologies and modalities in a way that may be transformative
PARTICULARLY
for other diseases.6
VACCINES AND
DIAGNOSTICS, AT
But it has also thrown into sharp relief the limited commitment of global health
funders and actors to prioritizing and financing research in LMICs; the serious power
UNPRECEDENTED
imbalances that determine who has a seat at the priority-setting and decision- SPEED.
making table in global health; and the lack of transparency and globally agreed rules
to ensure open sharing of knowledge, data, and technology and equitable access
to any new health tools developed.

Bringing together a constellation of global health agencies and foundations into a

formal partnership to accelerate the development, manufacturing, and distribution
of COVID-19 vaccines, therapeutics, and diagnostics, ACT-A was one of several
initiatives set up to respond to the pandemic early on. It has made important strides
as a response to the initial acute emergency phase but has also highlighted some
of the limitations of the approach that was adopted at the global level.

Despite the creation of COVAX,7 the vaccine pillar of ACT-A, dedicated specifically
to ensuring equitable access to COVID-19 vaccines in every country, only a
fraction of the more than 3.6 billion vaccine doses given globally have been
in low-income countries.8,9,10

In the early days of the pandemic, many political leaders made lofty promises about
ensuring global solidarity and equitable access to COVID-19 vaccines, diagnostics,
and treatments as global public goods.11 But faced with limited and highly
concentrated and controlled manufacturing capacity, most countries were unable
to secure sufficient volumes, especially of vaccines, and nationalism rather than
solidarity prevailed.

For example, high-income countries (HICs) have hoarded doses for domestic use –
in some cases stockpiling more than three to four times the number needed to cover
their populations12 – and offered jabs to healthy teenagers, incentives to the vaccine-
hesitant, and consideration of booster shots before the majority of the world’s
frontline health workers and those at highest risk of severe disease and death have
received even a single dose.

Only after a substantial proportion of their own populations were vaccinated – and
after intense international outcry – did G7 countries commit to gradually increase
sharing and purchasing of additional vaccine doses for LMICs. There has also been

COVID-19 POLICY REPORT 5

significant distribution of vaccines to LMICs from China and Russia, but even then,
these various efforts are too slow and fall far short of the estimated 11 billion doses
that are needed globally.13

In response to ‘vaccine nationalism’ there have been numerous calls for global
solidarity from the World Health Organization (WHO), the UN General Assembly,
and other multilateral organizations. There have also been a number of regional
initiatives – notably initiatives led by the African Union and Africa Centres for Disease
Control and Prevention (Africa CDC)14 and the COVID-19 messenger RNA (mRNA)
technology transfer hub in South Africa15 – and commitments to greater solidarity,
such as those agreed at the Summit for Vaccine Internationalism convened by
Argentina, Mexico, Bolivia, Cuba, and Venezuela as well as the regional governments
of Kisumu, Kenya and Kerala, India in June 2021.16

But despite the massive amounts of public funding that went into the discovery
and development of vaccines, funders have failed to use their leverage to ensure RENEWED PUBLIC
contractual conditions that would facilitate the sharing of technology, data, and LEADERSHIP AND
know-how – for example, through the WHO COVID-19 Technology Access Pool INTERNATIONAL
(C-TAP)17 and the Medicines Patent Pool (MPP) – in order to enable greater global COOPERATION
production capacity. IS REQUIRED TO
CORRECT COURSE
Pharmaceutical companies, meanwhile, have largely refused to non-exclusively
AND MOVE AWAY
license and share IP and know-how. Too little has been done to promote the
FROM A BUSINESS-
expansion and decentralization of vaccine manufacturing capacity in Africa,18
AS-USUAL, 'TRICKLE-
Asia, and Latin America to help meet regional and global needs.19
DOWN' APPROACH
These shortcomings and failures in the global response to the pandemic have
TO GLOBAL HEALTH
led many commentators – including WHO Director General Dr Tedros Adhanom INNOVATION
Ghebreyesus – to describe the situation as of mid-2021 as ‘vaccine apartheid’.20 AND ACCESS.

Indeed, if there is one central lesson from the past year, it is that there is urgent
‘unfinished business’ in global health when it comes to equitable access to health
tools and technologies. At almost every step when there was an opportunity to
do things differently, political and commercial choices were made that further
entrenched the status quo.

In order effectively to address COVID-19, future pandemics, and other emerging

threats – as well as long-standing epidemics and pandemics, neglected diseases,
and the ‘silent pandemic’ of antimicrobial resistance (AMR) – decisions about
whether and how to discover, develop, produce, allocate, and price essential
health technologies cannot be left to narrow national interests or market forces.

Renewed public leadership and international cooperation is required to correct

course and move away from a business-as-usual, ‘trickle-down’ 21 approach
to global health innovation and access.

This DNDi Policy Report urges the international community to learn the early
lessons – and avoid repeating the mistakes – of the past year when it comes to
innovation of and access to COVID-19 therapeutics – a deeply neglected area
within the COVID-19 response. Then, zooming out more broadly, it outlines the
specific ways in which the pandemic prevention, preparedness, and response
architecture that arises out of COVID-19 will need to be re-oriented to enable the
emergence of a more effective end-to-end biomedical innovation ecosystem that
ensures the benefits of scientific progress will be equitably shared and considered
global public goods, available to all.

6 DNDi
Hindering or enabling equitable access
to medical innovations: Key ‘hand-offs’
along the innovation lifecycle

The battle for equitable access to medical innovations has been raging since the
mid-1990s, beginning with the struggle for global access to antiretroviral therapy
(ART) for HIV, and repeating time and time again for other diseases – from hepatitis C
and cancer to diabetes and COVID-19.

HIV made clear to the world the significant capacity that exists in both the public
and private sectors in middle-income countries such as Brazil, Thailand, India, and
South Africa, to manufacture affordable, quality generic versions of antiretrovirals.
In several countries, this production capacity – made possible in part because
countries could refuse patenting of essential products such as medicines before
the World Trade Organization’s Agreement on Trade-related Aspects of Intellectual
Property Rights (TRIPS) was fully implemented – enabled large-scale access to
affordable ART, even in the poorest countries and communities, through national
programmes and major global health initiatives such as the Global Fund to Fight
AIDS, Tuberculosis and Malaria, the US President’s Emergency Plan for AIDS Relief
(PEPFAR), and Unitaid.

COVID-19 has made clear to a broader public that there is a complex chain of funders
and actors involved in the earlier stages of the scientific discovery and development
process, in many cases with a significant amount of the underlying research being
underwritten by the public sector 22 and conducted in public research and academic
institutions and within small biotech companies.

COVID-19 POLICY REPORT 7

The development of the first-generation COVID-19 vaccines illustrates this
complexity and can only be described as a triumph of science. For example, just
two months after the SARS-CoV-2 genome sequence was made publicly available
by Chinese researchers through the GISAID platform,23 Phase I trials of the first-
ever mRNA-based vaccine candidate began.24 Nine months after that, two mRNA
vaccines received emergency use authorization (EUA) from the US Food and Drug
Administration (FDA).25,26 A process that normally takes 10-15 years – the previous
record was the mumps vaccine, which was developed in 4 years 27 – had been
compressed to less than a year.

As of early July 2021, there are approximately 20 vaccines that have received full
regulatory approval or EUA or listing in at least one country,28 over a dozen of which
are approved in multiple countries (see Figure 1), and nearly 200 in pre-clinical or
clinical development.29,30

Figure 1: Some of the main COVID-19 vaccines that have been approved or received emergency use
authorization or listing in multiple countries worldwide

Developer How it works Status

Approved in several countries.

Pfizer-BioNTech mRNA
Emergency use in US, EU, other countries.

Approved in Switzerland.
Moderna mRNA
Emergency use in US, EU, other countries.

Adenovirus-based
Gamaleya Emergency use in Russia, other countries.
(Ad26 and Ad5)

Adenovirus-based Approved in Brazil.

Oxford-AstraZeneca
(ChAdOx1) Emergency use in UK, EU, other countries.

Adenovirus-based Approved in China.

CanSino
(Ad5) Emergency use in other countries.

Adenovirus-based
Johnson & Johnson Emergency use in US, EU, other countries.
(Ad26)

Approved in China, UAE, Bahrain.

Sinopharm Inactivated
Emergency use in other countries.

Approved in China.
Sinovac Inactivated
Emergency use in other countries.

Approved in China.
Sinopharm-Wuhan Inactivated
Limited use in UAE.

Bharat Biotech Inactivated Emergency use in India, other countries.

Source: The New York Times and the World Health Organization

8 DNDi
This rapid pace of vaccine development, particularly for the mRNA vaccines, is
due in part to (i) more than three decades of research into mRNA technology on BRINGING A PRODUCT
the part of academic scientists,31 (ii) two decades of significant public investment OUT OF THE RESEARCH
in research following two other coronavirus outbreaks – severe acute respiratory PIPELINE AND INTO
syndrome (SARS) in 2002 and Middle East respiratory syndrome (MERS) in 2012, THE HANDS OF
(iii) substantial public funding of pre-clinical and clinical development (including PATIENTS REQUIRES
the financing of multiple clinical trials in parallel), and (iv) important investments MULTIPLE ‘HAND-
at critical moments from the private sector (particularly biotech companies). OFFS’ ALONG
THE INNOVATION
All of this, combined with rapid, rolling regulatory review processes and massive LIFECYCLE.
pre-purchase commitments from the public sector to de-risk scale-up of
manufacturing – and a bit of luck 32 – translated academic discoveries into tangible,
life-saving innovations.

Why is such a feat of science – resulting in life-saving technologies so soon after the
emergence of a deadly global pandemic – benefiting only a fraction of those who
need it?

Bringing a product out of the research pipeline and into the hands of patients
requires multiple ‘hand-offs’ across the innovation lifecycle (see Figure 2). At each
stage of the R&D process, critical decisions are made that can either facilitate
or hinder availability, affordability, and access. What decisions get made at each
stage, and who gets to make them, is key.

Figure 2: Critical ‘hand-off’ points throughout the R&D process where commercial and policy
decisions can determine access

DISCOVERY TRANSLATION

 Screening
 Hit-to-lead Pre-clinical 
 Lead optimization Phase I 
Phase IIa/Proof-of-concept 

DEVELOPMENT

Phase IIb/III
Registration

ACCESS

 Manufacturing, procurement, and supply

 Policy adoption and programme implementation
 Phase IV

COVID-19 POLICY REPORT 9

Public and philanthropic R&D funders could have secured terms and conditions
with private companies to ensure open collaboration and transparent sharing of
the IP, research knowledge, and data that would have been necessary to safeguard
affordability, production, supply, and equitable allocation. While public information
on contracts for COVID-19 vaccine R&D and pre-purchases is limited, it appears
that funders either did not include such conditions,33 or did not choose to exercise
them.34 Instead, a combination of national interests and private commercial interests
inevitably led to gross inequities.

Despite the limited information about vaccine manufacturing and distribution

agreements that is publicly available, important differences between the approaches
taken can already be observed. Generally speaking, these are split between a highly
concentrated approach and a more distributed model (although most fall somewhere
in between).35

On one extreme is the highly concentrated approach taken, for example, by Pfizer/
BioNTech and Moderna, which have used a traditional market-driven model IF GLOBAL EQUITABLE
characterized by focusing primarily on HIC markets with high prices and little ACCESS IS TO BE
to no attention to transferring technology or ensuring affordability in LMICs. ENSURED, THERE
MUST BE A MORE
On the other side is the more distributed approach, including that taken by Oxford/ FORCEFUL ROLE FOR
AstraZeneca as well as Gamaleya Research Institute and Sinovac. For example, THE PUBLIC SECTOR
Oxford/AstraZeneca took a no-profit/no-loss approach to pricing for LMICs TO COORDINATE
during the course of the pandemic and sub-licensed their technology to the Serum AND APPLY
Institute of India and Fiocruz in Brazil 36 for production in and for LMICs, including
GLOBALLY AGREED
through COVAX. 37
RULES THAT WILL
ENSURE SUFFICIENT
Notwithstanding ongoing challenges with the model used by Oxford/AstraZeneca
– including a lack of transparency of its contractual terms and conditions with
SUPPLY, EQUITABLE
licensees, a reluctance to non-exclusively license relevant IP and know-how to any ALLOCATION, AND
manufacturer, and an over-reliance on one partner company, the Serum Institute AFFORDABILITY OF
of India – it shows that there is some willingness, though limited, to explore ALL ESSENTIAL HEALTH
alternatives to a business-as-usual approach. TECHNOLOGIES.

However, if global equitable access is to be ensured, there must be a more forceful

role for the public sector to coordinate and apply globally agreed rules that will
ensure sufficient supply, equitable allocation, and affordability of all essential
health technologies. In fact, those companies that have made some effort to ensure
equitable access, such as AstraZeneca, are due in large part to the willingness of
public sector or academic partners (such as Oxford) to introduce at least limited
‘access conditions’ in exchange for use of its technology. Without a more dramatic
shift in approach, there will continue to be a struggle for access to new treatments,
tests, vaccines, and other health tools – disease by disease, product by product,
country by country, company by company.

Global vaccine equity for COVID-19 is clearly the defining challenge of 2021. But
we cannot be satisfied with only one set of tools for pandemics and other infectious
diseases. There is always a need for diagnostic, therapeutic, and preventive tools.

10 DNDi
The urgent need for COVID-19 therapeutics

The need for treatments at all stages of COVID-19 is more pronounced than ever
given the slow pace of global vaccine roll-out and the spiralling COVID-19 crises
across Africa, South Asia and Latin America. It is further compounded by the possible
waning of immunity over time, uncertainty around the efficacy of vaccines for
immune-compromised individuals, and, critically, the continued impact globally of
new variants of concern.38

Yet the scientific advances for therapeutics have to date been few and far between.

Current therapeutic landscape

Although some progress has been made in terms of sharing of early information
about therapeutic candidates and the identification of dexamethasone, a THE NEED FOR
repurposed and affordable drug, as a life-saving treatment for severe cases TREATMENTS AT
requiring oxygen therapy, 39 the therapeutic toolbox for COVID-19 remains ALL STAGES OF
limited. Most initial research activities that aimed to quickly identify potential COVID-19 IS MORE
therapeutics have been disappointing. PRONOUNCED
THAN EVER.
Few of the repurposing candidates that initially held promise and that might have
offered immediate and affordable treatment options for people with COVID-19 have
panned out40 – although the search for already approved drugs that could be re-
directed to COVID-19 continues – and the same is true for convalescent plasma.41

Monocolonal antibodies (mAbs) initially received a great deal of attention and were
expected to deliver rapid antiviral options. mAbs remain an interesting potential
platform technology, particularly if second-generation mAbs can be delivered as

COVID-19 POLICY REPORT 11

single intra-muscular or sub-cutaneous injections – meaning via a single shot in the
arm, for example, as opposed to a complex and lengthy intravenous infusion – and
delivered at a lower dose so the cost of making them can be brought down.42 But to
date, the first-generation mAbs that have received FDA EUA or qualified for WHO
Emergency Use Listing (EUL) are expensive and only accessible in HICs (and even
then, in a limited fashion),43 and their efficacy is profoundly affected by mutations
of the SARS-CoV-2 spike protein.

Much more needs to be done to prevent and address all severe complications of the
disease and to prevent more patients from progressing to the point that they require
hospitalization, intensive care, oxygen therapy, or worse. Efforts are today rightly
focused on identifying novel antivirals, additional repurposed therapeutics, and
more affordable and adapted new approaches, such as second-generation mAbs
and other biologics.

For early treatment of COVID-19, before it progresses to severe disease, there is a

clear rationale emerging that a strong antiviral (or combination of antivirals with
different mechanisms of action) combined with host-directed therapies (anti-
inflammatories and immunomodulators) will be needed to account for the disease
evolution and host inflammatory response during the first few days of infection.44

These treatments should ideally be easy to take at home after rapid diagnosis –
effectively enabling ‘test-and-treat’ approaches at the community level.

Early treatment interventions must be appropriate for diverse racial and ethnic groups,
and other vulnerable and at-risk populations, such as pregnant and breastfeeding
women, or women who do not have easy access to contraception. In addition, much
remains to be learned regarding the pathogenesis and prevention of the chronic
consequences of COVID-19, or post-COVID condition, which may disproportionately
affect women and people with milder forms of the disease.

Rapid scientific progress in diagnostics – but unequal access in LMICs

As with vaccines, there have been rapid advances in the development of COVID-19 diagnostics. In a field
with previously limited research, the first diagnostic test was developed within weeks of the genome
sequence being made public and the first antigen rapid diagnostic test (Ag RDT) was granted EUL in
September 2020, less than 250 days after COVID-19 was declared a public health emergency of international
concern.45 However, despite unprecedented speed in the development of some diagnostics, there is growing
inequity in access to and use of these tools, potentially resulting in artificially low reporting of COVID-19
cases in many LMICs.46

Unequal access to COVID-19 vaccines coupled with the rise of variants of concern mean that there has never
been a more important time in this pandemic for the use and rapid scale-up of diagnostics. While in HICs there
has been an expansion of the use of Ag RDTs, including self-testing at home, in the workplace, and even in
pilots for large-scale events, the availability of such tools in LMICs stands in stark contrast, especially for
community-based testing. Although data are limited, testing rates in LMICs range from 0.1-15% of those in
HICs,47 hitting neglected populations the hardest because they often face the greatest barriers to accessing
health services.

There are a variety of reasons for low testing rates, including concerns about the lack of clear and explicit
recommendations in WHO guidelines for use of Ag RDTs for community-based testing in LMICs, leading
to a lack of prioritization of such testing in national guidelines and donor proposals.48 It has also been
noted that insufficient urgency has been given to EUL applications of many other brands of Ag RDTs. These,
together with efforts to scale up local production, would ensure increased supply and drive down prices.
In order to effectively deploy robust ‘test-and-treat’ strategies – particularly for use outside of healthcare
facilities to identify and treat early mild-to-moderate cases and reduce the need for hospitalization,
community-based testing is key.

12 DNDi
Boosting the search for novel antivirals
Despite a series of viral outbreaks over the past two decades – from SARS to MERS
to avian influenza and Ebola – and despite warnings from scientists that a ‘stockpile’
of broad-spectrum ‘Phase II-ready’ antivirals would be essential to respond to future
outbreaks – the antiviral medicine cabinet has remained stubbornly limited, with the
exception of antiretrovirals for HIV and direct-acting antivirals for hepatitis C.49

Apart from remdesivir (Gilead), which turned out to be of disappointingly limited use
despite much initial hype,50 and favipiravir (Fujifilm), with its known limitations due
to potential toxic effects on embryos and foetuses,51 very few promising new antiviral
drug candidates were ready to quickly test against SARS-CoV-2.

Even after more than a year, only a handful of direct-acting or host-directed antiviral
candidates have advanced through the research pipeline. Even fewer are in a late WILL NEW COVID-19
stage of clinical development. Promising new direct-acting antiviral candidates TREATMENTS,
include molnupiravir (Merck),52,53 PF-07321332 (Pfizer),54 and AT-527 (Atea, ONCE DEVELOPED,
Roche).55 The pace of development of these drug candidates has been impressive REPRESENT ANOTHER
despite the lack of early prioritization. TRIUMPH OF SCIENCE
– BUT THIS TIME
Major initiatives are being launched to boost antiviral drug discovery and ALSO A MODEL FOR
development, notably a recent USD 3.2 billion investment by the US government,
COLLABORATION
which includes a USD 1.2 billion pre-purchase agreement – for molnupiravir, now
AND KNOWLEDGE-
in Phase III trials – that is similar to purchase agreements many governments made
SHARING AIMED
for vaccines before proof of efficacy was established.56
AT GLOBAL EQUITY
With such massive new public investments in antiviral R&D and manufacturing, what
AND SOLIDARITY?
will be the public return? Will treatments be developed to facilitate access even in
the most remote and resource-limited settings? Will prices be affordable for all who
need access to antiviral treatments? Will companies collaborate to test their drugs
in combination with other needed treatments and to share their technology and
know-how to ensure large-scale manufacturing and access in LMICs? Will voluntary
licences such as those negotiated by Merck with several Indian generics companies 57
be sufficient to ensure such access in LMICs? What level of post-approval
surveillance will be required?

In summary, will new COVID-19 treatments, once developed, represent another

triumph of science – but this time also a model for collaboration and knowledge-
sharing aimed at global equity and solidarity?

The COVID Moonshot: A model for open pandemic preparedness drug discovery?

The ‘COVID Moonshot’58 demonstrates one clear example of how the antiviral research community might
re-align towards a drug discovery model focused and driven by global equitable access from the start.
Established by a diverse array of academic scientists early in the pandemic, they embraced a fully public
domain approach to open-source early discovery that was initially driven by the necessity of enabling multi-
party collaboration without losing time to negotiate contracts. This rapidly evolved into a single and shared
vision of no IP protection to ensure any resulting therapeutic was aimed first and foremost at being appropriate
for, and accessible to, people in LMICs.

This nimble, open approach has resulted in one of the most promising bespoke therapeutic opportunities
emerging for the existing pandemic, attracting major funding interest as well as generous in-kind
contributions, ranging from interested individuals through to major pharmaceutical companies. DNDi’s role
within this consortium – initially as curious observer, currently as core team member, and soon as consortium
lead – provides an opportunity to validate the viability of this model as a blueprint for more open pandemic
preparedness and response drug discovery.

COVID-19 POLICY REPORT 13

ANTICOV: The early treatment imperative

As of July 2021, numerous countries in Africa have been experiencing a devastating surge of COVID-19 cases,
with nearly 40 countries reporting dramatic increases in new cases, hospitalizations, and deaths – from
South Africa and Uganda to Nigeria and the Democratic Republic of Congo (DRC).59

A recent study suggests that COVID-19 mortality among critically ill patients throughout Africa is higher
than observed elsewhere – in large part due to the absence of critical care as well as co-morbidities such
as HIV, diabetes, and other chronic illnesses.60 This makes early intervention to prevent disease progression
all the more pressing.

ANTICOV, the multi-country trial in Africa that DNDi is coordinating with 25 African and global partners,
was established to try to address this need and is initially testing repurposed drugs, alone or in combination,
once they prove promising in pre-clinical or proof-of-concept studies.* The most promising therapeutic
options are selected in close collaboration with multiple partners, including from the ACT-A Therapeutics
Partnership and other experts.

Discussions are progressing to develop a similar trial to ANTICOV in India, where a catastrophic COVID-19
surge in 2021 has claimed hundreds of thousands of lives,61 and potentially also to expand ANTICOV to Latin
America, where infection, hospitalization, and death rates have been devastating, especially in countries
like Brazil, Peru, and Argentina.62

ANTICOV is an ‘adaptive platform’ trial, a flexible and innovative trial design that allows for treatments to be
added or removed as new evidence emerges. As of July 2021, ANTICOV is testing a new potential treatment
that combines the well-known antiparasitic nitazoxanide and the inhaled corticosteroid ciclesonide.

The trial was jointly reviewed with support from the African Vaccine Regulatory Forum (AVAREF),63 a platform
established by WHO in 2006, which was recently mandated to expedite clinical trial reviews for COVID-19.
Made up of representatives from each study country’s ethical and regulatory review bodies, AVAREF simplifies
and helps accelerate country-level approvals.

But it also highlights some of the challenges in undertaking research during this pandemic. Despite
incredible mobilization from countries and AVAREF, the consortium has faced multiple obstacles to moving
this trial forward, including due to slow, complex, and time-consuming processes to obtain all authorizations,
including for importation of treatments to test.

The absence of a simple, effective, and safe treatment for administration early in the course of the disease
is more critical than ever. There is an urgent need to ensure collaboration among the few ongoing platform
trials for outpatients – both to coordinate the drug candidate selection process and to share ongoing results
to ensure that all combined efforts will provide the data needed to inform policy recommendations and
clinical practice. DNDi is connecting with other major trials and co-coordinating a working group led by
WHO with other major adaptive platform trials.

In the future, this network may also serve as a model for other adaptive platform trial networks and as a
valuable platform for future therapeutic candidates and combinations for COVID-19.

* Major funding for ANTICOV is provided by the German Federal Ministry of Education and Research (BMBF) through KfW and
by the global health agency Unitaid as part of ACT-A. Additional support comes from the European & Developing Countries
Clinical Trials Partnership (EDCTP), under its second programme supported by the European Union withadditional funding
from the Swedish government, as well as from the Starr International Foundation and the Stavros Niarchos Foundation (SNF).

14 DNDi
Figure 3: ANTICOV participating countries and consortium partners

 Trial sponsors

BURKINA FASO CAMEROON

 Institut National de la Santé  Centre
et de la Recherche Médicale Pasteur du
SUDAN
(INSERM)/Agence Nationale Cameroun
 DNDi
de Recherche sur le Sida et
les Hépatites Virales (ANRS)

ETHIOPIA
 Institute of Tropical
MALI
Medicine Antwerp
 Ministry of Health,
Centre pour le
Développement des
Vaccins KENYA
(CVD-Mali)
 DNDi

GUINEA
 INSERM/ANRS

UGANDA
 Epicentre

CÔTE D’IVOIRE
 Centre Suisse de Recherches TANZANIA
Scientifiques  Ifakara Health Institute

GHANA
 B ernhard-Nocht-Institut
für Tropenmedizin

DR CONGO MOZAMBIQUE
 DNDi  B arcelona Institute for
Global Health (ISGlobal)

Along with:
•
A lliance for International Medical Action (ALIMA) • Institute of Endemic Diseases, University of Khartoum
(IEND)
• Bahir Dar University
• Kenya Medical Research Institute (KEMRI)
• Centro de Investigação e Treino em Saúde da Polana Caniço,
Instituto Nacional de Saúde (CISPOC) • Kumasi Centre for Collaborative Research in Tropical
Medicine (KCCR)
• Centro de Investigação em Saúde de Manhiça (CISM)
• Medicines for Malaria Venture (MMV)
• Centre for Research in Therapeutic Sciences (CREATES)
• Swiss Tropical and Public Health Institute (Swiss TPH)
• Centre Muraz, Institut National de Santé Publique
• Université de Bordeaux
• FIND, the global alliance for diagnostics
• University of Gondar, Ethiopia
• Infectious Diseases Data Observatory (IDDO)
• Institut National de Recherche Biomédicale (INRB)

COVID-19 POLICY REPORT 15

Challenges in COVID-19 therapeutics
and recommendations for immediate
course-correction

There have been several challenges that have hindered progress in COVID-19
therapeutics, which are closely linked to the overarching shortcomings and failures
of the global response outlined above.

First, there has been insufficient political and financial attention paid to
therapeutics research and regulation as a whole, and the majority of research
conducted has been highly fragmented and focused in HICs.

Throughout the pandemic, funding for drug discovery, clinical trials, production,
and distribution of therapeutics, including oxygen therapy, has been chronically
inadequate, in some cases playing ‘second fiddle’ to R&D for vaccines.64 It does not
help that there is a USD 3.2 billion shortfall for the Therapeutics Partnership of the
ACT-A.65 There is a risk that as HICs achieve high rates of vaccine coverage, their
focus may shift almost entirely to investing in surveillance, testing, and follow-
up vaccination, even as LMICs with profoundly limited access to vaccines may
increasingly need to prioritize treatment access as a means of coping with COVID-19.

Initially, WHO was not sufficiently empowered to play a strong normative role in
defining a priority research agenda for therapeutics or coordinating research. As a
result, since the beginning of the pandemic, multiple small, often under-powered,
heterogeneous trials have been conducted, resulting in fragmented sets of data
with often incomparable endpoints.

With the exception of a handful of international studies, such as the RECOVERY,66

SOLIDARITY,67 and DISCOVERY68 trials, this has meant that there has been no simple
way of easily and rapidly pooling and analysing data to adjust, adapt, or recommend
treatment options. This has led to a situation in which there has been insufficient
reliable clinical data – and therefore much confusion and controversy – on the
efficacy of potential therapeutic candidates, such as ivermectin, despite a number
of studies assessing this drug. This underlines the importance generally of larger,
well-coordinated, randomized-controlled and adaptive platform trials, that have
comparable endpoints, at different stages of the disease, in order to inform clinical
guidelines and practice.

This situation raises many questions, including around the ethics of conducting non-
informative clinical trials and the sharing of information. Today, we are at a crossroads.
For example, several large groups and consortia are simultaneously planning or
conducting large adaptive platform trials in outpatients, evaluating compounds to be
tested in this population and conducting regular interim analyses – yet until recently,
no mechanisms were in place to ensure rapid, real-time, efficient information- and
data-sharing that could inform clinical guideline development and clinical practice.

There are also a number of regulatory delays, challenges, and concerns that have
hindered progress on therapeutics (among other tools), especially when it comes
to addressing specific needs in LMICs.

There are issues related to the speed and coordination of approval of clinical
trials – for example, the WHO Ethical Review Committee, specifically dedicated
to rapid review of COVID-19 studies, has operated without the expected sense

16 DNDi
of urgency. The ANTICOV team received many non-critical review comments that
required lengthy back-and-forth exchanges. These comments ignored those of the
review boards of the very countries implementing the study and resulted in delays for
study start that were not equally seen in the UK for the RECOVERY trial, for example.

There are also bottlenecks related to the chronic under-resourcing of the WHO
prequalification programme and a potential for donors’ procurement requirements to
have unintended consequences on access to products that have not been either WHO
prequalified or approved by a so-called ‘stringent regulatory authority’. And there
are long-standing unresolved issues around the regulatory pathway for biosimilars,
such as for mAbs.69

Many of these issues require long-term policy fixes, but there are some immediate
steps that can and should be taken.

Immediate course-correction needed

ƒ ACT-A and other global health institutions, including WHO, should fully articulate
the resource needs and R&D priorities for COVID-19 therapeutics in order to give
funders a clearer picture of the needs and ensure ambitions and actual financing
are commensurate with needs. This should include:

f Large-scale adaptive platform trials and clinical trial networks, including

those based in and driven by LMICs;

f Efforts to reduce the dose and simplify routes of administration (ideally

intra-muscular or sub-cutaneous) for second-generation mAbs and other
newer therapeutic modalities to bring down costs and prices and reduce
logistical challenges;

f Support for pan-coronavirus open drug discovery – including through

novel collaborative approaches, not just closed, industry-led efforts –
to identify promising novel antivirals with the broadest possible spectrum
of activity and build the pipeline for COVID-19 and future viral pandemics,
including in particular pathogens of pandemic potential that are unlikely
to attract commercial attention, such as viral haemorrhagic fevers.

ƒ Global health actors should support the Outpatient Clinical Study Group set
up by WHO to facilitate sharing of expert methodologies for drug candidate
assessment, put in place transparent decision-making about the allocation
of compounds to different platform trials, share relevant data, and collaborate
on regulatory and safety monitoring.

ƒ Funders and global health actors should address regulatory delays and
challenges by, for example:

f Strengthening and acknowledging existing regulatory capacity worldwide,

supporting collaborative and regional approaches, such as AVAREF
and the proposed African Medicines Agency,70 and bolstering WHO
prequalification;

f Adapting donor-funded procurement systems so that countries are not

unreasonably constrained by requirements for ‘stringent regulatory
authority’ approval and/or WHO prequalification;

f Streamlining requirements and guidelines to accelerate authorization

of trials71 and the regulatory pathways for biosimilars.

COVID-19 POLICY REPORT 17

Second, the main body set up to accelerate the development and delivery of
COVID-19 treatments, the Therapeutics Partnership of ACT-A, has fallen short
in critical ways.

Like the vaccines and diagnostics pillars of ACT-A, the Therapeutics Partnership
was an important emergency response to the pandemic. But ACT-A’s ambitions have
been too modest across all three pillars. In the case of COVAX, the original goal was
to reach 20% of populations in need of vaccines. It is now clear that this was far too
modest a goal – and has been described by Dr Ayoade Olatunbosun-Alakija, Co-Chair
of the African Union’s Vaccine Delivery Alliance, as the result of a ‘colonial mindset’.72

Similarly, the goal for the diagnostics pillar was only set at 500 million tests per year
and for therapeutics, only 245 million treatments.73 These limited ambitions have been
justified by claims that ACT-A was never meant to provide a long-term solution but
rather to support countries during the acute phase of the crisis, with the assumption
that after this period, ‘normal market activity’ would meet the needs in LMICs.

ACT-A is also plagued by funding shortfalls – to the tune of USD 16.8 billion74 across
all three pillars as of June 2021.75 The structure that was set up relied too heavily on
an outdated international aid model driven by governments and global health actors
in HICs rather than a truly global approach.76 The governing bodies of ACT-A lack
equal representation for policymakers, experts, and civil society from LMICs – with
a resulting lack of prioritization and financing for research driven by and in LMICs.

In addition, it has opaque priority-setting and decision-making processes driven by

a handful of largely private actors – processes, for example, that determine which
technologies will be developed further.77 And to date, ACT-A has been unable or
unwilling explicitly to address the underlying structural causes of access inequities
that it was ostensibly set up to overcome, such as management of IP, licensing, and
technology transfer.

In its final report, the Independent Panel on Pandemic Preparedness and Response
recommended to ‘Transform the current ACT-A into a truly end-to-end platform
for vaccines, diagnostics, therapeutics, and essential supplies, shifting from
a model where innovation and access is left to the market to a model aimed at
delivering global public goods’,78 including ensuring its governance bodies include
representatives of countries across income levels and regions, civil society, and
the private sector.

As one of the organizations that has taken part in deliberations in the ACT-A
Therapeutics Partnership, we have seen the benefits of having a process by which
the latest scientific evidence from the pipeline is brought together and reviewed –
and the potential to link that with strategies to ensure access. However, we have also
seen the limitations of the approach and the consequences of the absence of certain
voices around the table.

For therapeutics, these limitations have played out in specific ways.

There was an insufficient focus initially on developing therapeutics for mild-to-

moderate cases in outpatients, even though such treatments would be particularly
useful in places with limited intensive care and hospitalization capacity.

There was also an over-emphasis on mAbs (arguably, to the exclusion of small

molecule antivirals or repurposing candidates), despite some feasibility and
price concerns and issues related to manufacturing and procurement. Significant
energy within the Therapeutics Partnership was consumed, for example, by the
‘agnostic capacity reservation’ with Fujifilm, which aimed to ensure some mAbs
manufacturing capacity was reserved for use in LMICs, even when it became clear
that the anticipated supply would only meet 2-4% of the global needs. This limited
any creative discussions about expanding supply through local manufacturing.

18 DNDi
There were also failures to anticipate and expediently address either the need for
oxygen therapy in LMICs – with little priority given to the need for oxygen until late
2020 and early 2021 – or the consequences of treating severe ventilated patients
with anti-inflammatory drugs, leading to secondary infections by fungi and bacteria, THERE WAS AN
such as mucormycosis (Black fungus) in India and Nepal and the subsequent need INSUFFICIENT
for access to antifungals, such as liposomal amphotericin B, that are unaffordable FOCUS INITIALLY
and in short supply.79 ON DEVELOPING
THERAPEUTICS
Given there is a renewed need to focus on therapeutics – and given that policymakers FOR MILD-TO-
are considering extending ACT-A – it is critical that these limitations are addressed in MODERATE CASES
the near-term. IN OUTPATIENTS.

Immediate course-correction needed

ƒ Across all its pillars, ACT-A and its participating institutions must make
immediate changes to governance structures to ensure equal representation
from the public sector, scientific and public health experts, and civil society
from LMICs in priority-setting and decision-making.

ƒ The ACT-A Therapeutics Partnership and other funders should actively support
identification of treatment options for all stages of COVID-19, including the
complications and long-term consequences of infection. This implies active
support for identifying new antivirals and host-targeted interventions, as
well as repurposed compounds, and active support for robust testing of these
options in comparable adaptive platform trials.

ƒ The ACT-A Diagnostics Pillar and Therapeutics Partnership should work closely
together to develop and support implementation of ‘test-and-treat’ approaches.

ƒ ACT-A should make addressing IP barriers a key transversal workstream across

all pillars and explicitly support the TRIPS waiver, non-exclusive licensing
via C-TAP and/or MPP non-enforcement declarations, compulsory licensing, etc.

ƒ ACT-A and other global health actors should take explicit steps to improve
transparency with respect to development, production, and supply of COVID-19
medicines, diagnostics, and vaccines, including transparency over priority-
setting and decision-making, contractual terms and conditions, costs of R&D,
costs of manufacturing, and prices paid.

Third, it is unclear if treatments needed for COVID-19 will come with a guarantee
of affordable access, sufficient supply, and equitable allocation globally, and
related commitments of adequate sharing of knowledge, data, and technology
to address the scale of global needs.

Unless specific contractual commitments and an array of rules and enabling

policies are proactively established to ensure rapid transfer of technology,
large-scale manufacturing, and equitable access, the very same challenges
that have stymied equitable access to vaccines (see Section II) will also hinder
availability, affordability, and access for future treatments.

COVID-19 POLICY REPORT 19

Immediate course-correction needed
ƒ Governments, particularly those that fund R&D, should use their leverage to
negotiate clear and transparent terms and conditions that ensure sharing of
research data, knowledge, and technology on a non-exclusive basis, enabling
adequate production scale-up to ensure sufficient supply, equitable allocation,
and affordability.

ƒ Governments should support a temporary waiver on IP for COVID-19

technologies (TRIPS waiver), which would support increased access to
such technologies globally by removing any risk of IP infringement for all
stakeholders. To that end, a waiver must cover all forms of IP (not only patents)
and apply not only to vaccines but also to all COVID-19 medical technologies
needed to protect health and save lives, including COVID-19 therapeutics
and diagnostics.

ƒ In the meantime, companies owning COVID-19 technologies also need to

increase their contributions and commit to either not enforcing their existing
IP or to sharing relevant know-how, technology, and IP by non-exclusively
licensing it to interested entities.

ƒ Where needed, significant domestic and international investments, including

from development banks, should be made to expand, build, and sustain
manufacturing capacity for treatments.

20 DNDi
Conclusion: Getting it right for
future pandemics and other
global health needs

A shifting global health architecture

A range of new global health institutions and global health security regulations and
frameworks have emerged in response to previous disease outbreaks. A handful of
these – namely the WHO R&D Blueprint and the Coalition for Epidemic Preparedness
Innovations (CEPI) – were specific attempts to address the lack of effective medical
countermeasures for pandemics and the challenges of coordinating R&D in such
emergencies. They drew on two decades of WHO and UN discussions and reports
critiquing chronic shortcomings of the biomedical R&D system.80

In the COVID-19 era, a new global health security and pandemic prevention,
preparedness, and response architecture is already emerging and continues NATIONAL
to evolve. In the future, this may include institutionalizing aspects of ACT-A or AND REGIONAL
changing the remit of existing global health initiatives such as the Global Fund APPROACHES
to Fight AIDS, TB, and Malaria, CEPI, or Gavi, the Vaccines Alliance. It could also MAY BE MORE LIKELY
include the birth of entirely new global, regional, or national initiatives, such as IN THE FUTURE TO
a Global Health Threats Council,81 financing mechanisms, and legal instruments, ENSURE MORE
such as an international pandemic treaty.82 DISTRIBUTED R&D,
MANUFACTURING,
National and regional approaches may be more likely in the future to ensure AND REGULATORY
more distributed R&D, manufacturing, and regulatory capacity given the global CAPACITY
system failures of the past and present and to respond to more regionally
concentrated outbreaks.

These initiatives and legal instruments – being debated and discussed among G7/
G20 countries, WHO, and between regional blocs and individual countries – must
be coordinated to secure an innovation and access ecosystem that drives research
to the areas of greatest need and ensures equitable access to health technologies.

But before we look to the future, we cannot forget that this pandemic is nowhere
near over and is in fact surging in many regions of the world. Responding to
the needs of those at highest risk of infection, illness, and death today must be
the top priority.

Recommendations for the future

COVID-19 has highlighted the life-and-death importance of ensuring appropriate
preventive, diagnostic, and therapeutic health tools are available to all. This is
true for a wide range of infectious diseases – from HIV, tuberculosis, malaria, and
hepatitis C to neglected tropical diseases (NTDs) and bacterial and fungal
infections – which have long been, or persistently threaten to be, of pandemic
or epidemic character.83

Climate change, population growth, and migration are all contributing to increased
interconnections between people, animals, and the planet and are changing disease
patterns and geographies. Resistance to existing treatments is also increasing,
sometimes at an alarming rate. Efforts to support innovation of and access to

COVID-19 POLICY REPORT 21

appropriate health tools for pathogens of pandemic potential therefore also warrant
a wider lens. Only with a broad ‘One Health’ 84 approach can comprehensive global
health security – which is resilient to all present and future threats, supports strong
health systems, and prioritizes the needs of the most vulnerable – be achieved.

The governments and other actors that will shape these responses at the national,
regional, and international level must take as a given two major points:

First, market-based approaches alone will not be sufficient to discover, develop,

and ensure access to necessary health tools. Traditional market incentives fail to
respond to, prioritize, and ensure R&D investments where the need is uncertain or COVID-19 HAS
demand may be low. This is a daily reality for millions of people who are affected by HIGHLIGHTED THE
diseases that do not represent a lucrative market for the pharmaceutical industry, LIFE-AND-DEATH
whether other pandemic threats, AMR, NTDs, or diseases that predominantly affect IMPORTANCE
children. Even where innovations have been developed, companies engage in a OF ENSURING
limited ‘contract manufacturing model’ of technology transfer, in which they retain all APPROPRIATE
control over IP, production, supply, and pricing. PREVENTIVE,
DIAGNOSTIC,
Second, major public and philanthropic funding for research – whether through
AND THERAPEUTIC
direct R&D subsidies or pre-purchase commitments – de-risks the R&D enterprise
HEALTH TOOLS ARE
and funders should therefore secure a public return on their public, or public
interest-driven, investments. This means requiring clear and transparent terms and
AVAILABLE TO ALL.
conditions that ensure open collaboration, affordability, availability, and equitable
allocation of essential health tools and embracing and financing alternative, needs-
driven R&D models.

22 DNDi
Governments need to ensure a more effective, equitable, and sustainable
innovation and access ecosystem that delivers global public goods and
guarantees equitable access for all.

They must therefore do the following:

ƒ Guarantee sustained political attention to and financing of end-to-end ‘purpose-driven’ innovation85,86

for all diseases and products of public health importance, with clear priority given to those populations
and pathogens most likely to be neglected by the market. Such focus and financing must avoid a ‘charity-
driven’ 87 or narrowly defined ’security threat’ approach88 and break the ‘cycle of panic and neglect’ 89
for pandemics in which there is a surge of attention and investment during a crisis followed by years
(or decades) of inaction when a threat is perceived to have subsided in certain regions or globally.

ƒ Re-imagine global health R&D coordination, collaboration, and financing to support a more distributed,
decentralized, and democratic approach to the production of knowledge and innovation as global public
goods in response to pandemics and other public health priorities. Such an approach would support R&D,
manufacturing, and regulatory capacity through regional and national networks and hubs, not only through
donor-driven global mechanisms, and would ensure greater parity between public and private actors and
between the ‘global south’ and the ‘global north’, especially when it comes to R&D priority-setting, decision-
making, and resource allocation.

ƒ Ensure there are globally agreed norms and binding rules governing R&D and equitable access to
essential health tools90 to guarantee such tools are made available as global public goods regardless
of where they are discovered, developed, or produced. R&D funders have unique leverage that is rarely
exercised to enforce and coordinate the application of these rules by requiring clear and transparent terms
and conditions in contractual agreements that will guarantee open sharing of research data, knowledge,
and technology; sufficient production, supply, and equitable allocation of health tools; and affordability,
including through pro-access management of IP rights.

With renewed public leadership and new models of international cooperation focused on these goals it will be
possible to achieve not only continued innovation to meet ever more pressing needs, but also equitable access
to the fruits of scientific progress for all people, no matter their income or where they live.

COVID-19 POLICY REPORT 23

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COVID-19 POLICY REPORT 27

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