[Ip-health] COVID-19: The world needs to back India and South Africa’s call to remove TRIPS hurdles

Priyam Lizmary Cherian priyamlizcherian at gmail.com
Thu Nov 19 02:33:13 PST 2020

PRASANNA S SALIGRAM <https://caravanmagazine.in/author/40864> AND PRIYAM
LIZMARY CHERIAN <https://caravanmagazine.in/author/40865>
16 November 2020

On 2 October, India and South Africa sent a joint communication to the
Trade Related Aspects of Intellectual Property Rights Council of the World
Trade Organisation, the multilateral institution formed to promote free
trade between countries. The communication asked
body to recommend a waiver of major intellectual-property provisions of the
TRIPS agreement for technologies to prevent, contain and treat COVID-19.
The proposal was made in the middle of the global race to develop medicines
and vaccines against the coronavirus.

The communication said, “It is important for WTO members to work together
to ensure that intellectual property rights such as patents, industrial
designs, copyright and protection of undisclosed information do not create
barriers to the timely access to affordable medical products including
vaccines and medicines or to scaling-up of research, development,
manufacturing and supply of medical products essential to combat COVID-19.”

At the heart of the debate about access to COVID-19 related vaccines,
diagnostics and medicines are the contentious provisions of the TRIPS
agreement. The WTO largely functions on the assumption that free trade
helps increase the wealth of the nations and is thereby one of the pathways
for poverty reduction. Intellectual-property rights or IPR recognised under
the TRIPS agreement include patents, trademarks, and copyrights. These
provisions provide monopoly rights to “innovator” companies, thereby
preventing competition. Such monopolies, when applied to health-related
products such as medicines, diagnostics, medical valves or even masks
hinder accessibility and affordability by denying the early entry of
generic products into the market.

For example, in 2013 the United States approved a drug from Gilead Sciences
called sofosbuvir meant to treat hepatitis C. The company got a patent in
several countries including the US, granting it market monopoly up to 2024.
As a result, a complete course of sofosbuvir cost $84,000 in the US. The
same course is available as a generic in Egypt
where there was no patent, for just $1,900. The ostensible reason for
granting patents to innovators is to encourage research and development and
reward path-breaking innovations. However, patents have been used more as
blanket commercial incentives resulting in the erosion of patient welfare.
Moreover, most basic molecular research is not done by pharmaceutical
companies themselves but in public universities funded by taxpayer money.
Gilead Sciences got funding
<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7528745/> through the
government-run National Institutes of Health in the US to develop
sofosbuvir and still applied for a patent.

Even before the COVID-19 pandemic, 50 percent of the world population lacked
to health technologies. Members of the WTO recognised public health
barriers that intellectual property rights and TRIPS created at the
organisation’s Doha ministerial summit in 2001. They agreed to allow TRIPS
provisions to be interpreted in such a manner as to protect public health.
The Doha Declaration
<https://www.who.int/medicines/areas/policy/doha_declaration/en/> that
emerged from the summit allowed use of provisions like compulsory
licensing, which allowed governments to suspend or revoke patent monopolies
and allow generic manufacturing during emergencies like the current

India and South Africa’s recent communication to the TRIPS council echoes
the Doha Declaration. It found support from most countries that identify
themselves at the WTO as least developed and developing—Egypt, Indonesia,
Bangladesh, Honduras, Tanzania on behalf of 43-member African Group, Chad
on behalf of the 36-member Least Developed Countries group, Sri Lanka,
Pakistan, Venezuela, Nepal, Nicaragua, Argentina, Tunisia, Mali, Mauritius
and Mozambique.

The WHO declared COVID-19 a pandemic on 11 March 2020. As of 1 October,
there were more than 330 million confirmed cases globally and had more than
one million deaths. Existing medicines that have been repurposed to treat
COVID-19 such as remdesivir, heparin, dexamethasone and favipiravir have
shown limited effectiveness. Ten months into the pandemic, there has been
no COVID-19 specific drug or vaccine developed.

The initial stages of the outbreak of disease saw attempts at global
solidarity. China, the country where the pandemic originated, shared the
coronavirus genome sequence with the WHO by early January 2020. Countries
contributed to the WHO’s fund for a pandemic response. However, as the year
progressed, things slipped to business-as-usual mode with international
business resorting to its profiteering approach to COVID-19 technology
development be it vaccines, diagnostics, medicines for treatment or related
equipment such as personal protection equipment or machines for support.

The World Health Organisation has deployed many tools to ensure fair and
equitable access to biomedical technology that can combat the disease. In
May 2020, the World Health Assembly, the decision-making body of the WHO,
passed <https://apps.who.int/gb/ebwha/pdf_files/WHA73/A73_R1-en.pdf>a
resolution calling for the “removal of unjustified obstacles” to “Equitable
Access to Covid19 Technologies”, known by its abbreviation EACT. The WHO set
COVID-19 Technology Access Pool or C-TAP initiative to gather
COVID-19-related technical and scientific information in an open-source
environment for faster deployment of vaccines, medicines and other
technologies. However, big pharmaceutical companies ridiculed
step. Albert Bourla, the chief executive of Pfizer, called the step
“nonsense” and “dangerous”.

The world will need vaccines for the global population of nearly eight
billion. Such a large number of doses cannot be manufactured immediately.
Anticipating unequal access to COVID-19 resources, the WHO created
allocation framework for fair, ethical and equitable access to COVID-19
health products. The framework defined a ‘priority group’ that covered
around twenty percent of the global population comprising frontline workers
such as doctors, nurses, community health workers, sanitation and other
essential workers, as well as the elderly and people with co-morbidities.
This priority population will require about two billion vaccine doses. The
world will still need a mechanism to manufacture, procure and equitably
distribute the rest of the six billion vaccine doses—maybe more depending
on whether more than one dose is required—to protect the global population.

The other global initiative around COVID-19 vaccines is the Access to
COVID-19 Technologies accelerator. ACT-A
<https://www.who.int/initiatives/act-accelerator> is a collaboration of the
WHO, the World Bank, the Bill & Melinda Gates Foundation which is a private
philanthropic organisation, Gavi which is the vaccine-focussed global
alliance, and global health organisations such as The Global Fund, Unitaid
and Wellcome. One of the pillars of ACT-A is its vaccine mechanism called
which is a pooled procurement system for COVID-19 vaccines. It has
identified certain eligible countries to which it will distribute vaccines
at heavily subsidised prices. COVAX guarantees access to vaccines only to
priority populations—around 20 percent of total population—in the groups of
low and middle income countries called LMICs and least developed countries
called LDCs. Countries will have to negotiate bilateral agreements with
manufacturers for vaccine doses meant for people outside this target
population at prices fixed by the company. Organisations like the BMGF
command considerable power given their financial strength, relegating WHO
to the margins in the COVAX partnership. This raises concerns of unequal
access to the eventual vaccine. Public health experts around the world have
raised questions about the BMGF’s accountability
the pandemic. The foundation played
role in Oxford University, which is a public university, handing over its
vaccine technology to AstraZeneca, a private pharmaceutical company.

The UN general assembly has reiterated that EACT is a global priority.
Oxfam, the international NGO, has called for a “people’s vaccine,” which
should be available to all people in all countries free of charge. However,
several high-income countries have entered into bilateral Advance Purchase
Agreement or APAs with vaccine manufacturers after anticipating the need to
look beyond COVAX for vaccine supply. This has given rise to a COVID-19
version of  vaccine nationalism
case in point is the United States’ APA deals with seven vaccine
manufacturers to secure 800 million doses at $10 billion and the United
Kingdom’s deals for 340 million doses. Countries that have the capacity and
companies working on COVID-19 tools are moving away from global solidarity,
threatening huge inequity in access to COVID-19 treatment related tools,
leaving LMICs and LDCs in the lurch.

High income countries will be able to buy vaccines for most of their
populations beyond the designated priority populations. However, LMICs and
LDCs that lack the same financial resources may not be able to afford so
many vaccine doses by entering into APAs within a short period of time. For
example, during the 2008 H1N1 crisis countries like France bought
<https://www.dw.com/en/rich-nations-stockpile-swine-flu-vaccines/a-4520907> out
a majority of H1N1 vaccines in the market. Meanwhile, LDCs had to wait
<http://news.bbc.co.uk/2/hi/health/8302416.stm> for vaccine donations.This
time too, LDCs may have to wait for the IPR of COVID-19 technologies to
expire for competition to bring down prices of the vaccine or wait for

Not surprisingly, pharmaceutical conglomerates have enthusiastically
participated in COVAX to safeguard their IPR and profit margins. The global
pharmaceutical industry has also been hinting at differential pricing by
which HICs will have to pay more and LMICs can pay less for medicines—a
form of cross subsidisation. The global health system cannot rely only on
the voluntary intent of pharmaceutical companies for COVID-19 drugs in
LMICs to ensure equitable access. Even during this global health emergency,
Gilead Sciences, which holds the patents for the drug remdesivir, entered
into unfair voluntary licenses with generic companies. That restricted the
number of countries the medicine can be supplied to and excluded
American countries.

The communication by India and South Africa to the TRIPS Council can
trigger opening up access to COVID-19 related technical and scientific
information. It can spur action that will allow countries to waive
intellectual property protection on copyright, industrial design, patents
and undisclosed information without the fear of sanctions for violation of
international trade rules. It is a call for solidarity and cooperation,
putting people before profits, during a health emergency that requires a
global effort. Without relying solely on voluntary mechanisms of
pharmaceutical corporations, LDCs and LMICs need to support the
communication for the waiver to ensure that they can use COVID-19 related
technology without fear or control by pharmaceutical corporations and
thereby protect the health of their people. It will also allow countries
like India and Brazil, which have production capacities, to quickly ramp up
manufacturing and distribution of vaccines and medicines. This could
potentially help supply other LMICs and LDCs.

The WHO and the Joint United Nations Programme on HIV and AIDs, known as
UNAIDS, have expressed their support for the waiver proposal. The TRIPS
council received differing opinions from member states at their meetings on
15 and 16 October. Two countries fully supported the move, some provided
general support seeking further negotiation on the proposal, and nine
members—the United States, Switzerland, Japan, Norway, the United Kingdom,
Canada, Australia, Brazil and the European Union—completely opposed the
move. If other WTO member countries support the proposal, they will be
effectuating the principles of EACT. They will also help speed up the
response to the pandemic by removing barriers to technical and scientific
information. The last two months of this year will be crucial as the WTO
rules require the member countries to further consider this proposal within
90 days of receiving the application for waiver. The waiver proposal will
expire on 31 December.

Countries need to be proactive to break monopolies, move towards a people’s
vaccine and allow open access to COVID-related tools. This is a better
strategy than depending on voluntary commitments and appealing to the
goodness of the pharmaceutical industry. The waiver proposal serves as a
step towards building precedence within the WTO for pandemic situations and
provide legal clarity for member states to develop policies that do away
with the intellectual property protections for COVID-19 tools in these
times of crisis.

*Prasanna S Saligram and Priyam Lizmary Cherian are associated with
Equitable Access to Covid Technologies Project of the People’s Health


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