[Ip-health] 23 February 2021: South Africa’s interventions at the WTO TRIPS Council

Thiru Balasubramaniam thiru at keionline.org
Sun Feb 28 23:42:57 PST 2021


https://www.keionline.org/35453

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23 February 2021: South Africa’s interventions at the WTO TRIPS Council
Posted on March 1, 2021 <https://www.keionline.org/35453> by Thiru
<https://www.keionline.org/author/thiru>

On 23 February 2021, South Africa delivered two detailed statements at the
WTO TRIPS Council’s most recent deliberations on a waiver from certain
provisions of the TRIPS Agreement for the prevention, containment and
treatment of COVID-19 (IP/C/W/669 <https://www.keionline.org/34061>).

South Africa did not mince words, taking aim at the current donor-driven
model of the COVID-19 response.

Irrespective of the amount of money any of the donor country may throw at
the problem, the model of donation and philanthropic expediency cannot
solve the fundamental disconnect between the monopolistic model it
underwrites and the very real desire of developing and least developed
countries to produce for themselves. Madam Chair, the problem with
philanthropy is that it cannot buy equality. Yesterday the DG of WHO warned
that: “Money is not the only challenge we face. If there are no vaccines to
buy, money is irrelevant. Even if we have the funds, we can only deliver
vaccines to poorer countries if high-income countries cooperate in
respecting the deals COVAX has done, and the new deals it is doing.” Even
in light of all the additional pledges of monetary support, the ACT
Accelerator still faces a gap of at least 22.9 billion dollars to fully
financed.

In response to WTO Members who interrogated South Africa on the vaccine
manufacturing capacity of the Global South, South Africa provided the
following riposte.


   I would once again like to thank all delegations that took the floor
   today. Some delegations wanted more details of manufacturing capacity that
   exist in the developing world. As we have pointed out at the last session,
   out of the 158 prequalified vaccines under WHO’s PQ program 72 vaccines are
   produced by vaccine manufacturers from developing countries. Similarly,
   LMIC countries have a substantial share in prequalified finished
   pharmaceutical products, active pharmaceutical ingredients and vaccines.
   This shows that significant quality manufacturing capability does exists
   including in developing countries and to ensure global supply, these have
   to be leveraged.


   Some delegations suggest countries who have unused manufacturing
   capacity on vaccine to pursue voluntary license agreement with vaccine
   developers for local production. Yet, what we have observed is that among
   some countries who do not support the waiver proposal, they have
   experienced difficulties in seeking local production licenses from vaccine
   developers. It shows, once again, that relying on voluntary license is not
   sufficient in this pandemic. Canada has just shared their experiences with
   originators having been rejected by several companies when approached for a
   voluntary license. Canada’s experience shows relying on voluntary licenses
   may be highly problematic and evidences the selective approach applied by
   originators and rights holders. Perhaps Canada can disclose the terms of
   its license agreement with Novavax to back up its claim that IP is not a
   barrier to access?

When Singapore and Switzerland used The Guardian’s paean to Adar Poonawalla
<https://www.theguardian.com/global-development/2021/feb/14/we-took-a-huge-risk-the-indian-firm-making-more-covid-jabs-than-anyone>to
assert that there were no IP or know-how barriers to scaling up manufacture
of COVID-19 vaccines, South Africa unearthed Sarah Wheaton’s July 2020
profile (Meet the Indian drug mogul who’s challenging the West over
vaccines, Adar Poonawalla is seizing on the COVID-19 fight to try to break
down the policies protecting Big Pharma
<https://www.politico.eu/article/adar-poonawalla-meet-the-indian-drug-mogul-whos-challenging-the-west-over-vaccines/>)
which provided a counter-narrative to Singapore’s and Switzerland’s claims.

We heard Switzerland and Singapore quote Dr. Poonawalla of the Serum
Institute. In a recent interview with Politico, Dr. Poonawalla believes
that the sheer urgency of the virus — and the fact that coronavirus
anywhere is a threat to people everywhere — should prompt a reassessment of
patent and intellectual property laws that limit access to immunizations in
the developing world, while simultaneously jacking up their price in
wealthier countries. “That’s become very evident today in the Covid
crisis,” “If you don’t allow, for example, an Indian producer to sell in
the U.S. because of some stupid rules and regulations, even though the
product is identical to a U.S. product, you’re going to have a supply
situation.” “And guess what,” he continued. “When you’ve got low supply and
high demand, what happens to the price? It skyrockets.”

South Africa’s statements are reproduced in full below.
------------------------------

South Africa’s intervention at the formal TRIPS Council meeting of 23
February 2021

Thank you Madam Chair for giving us the floor we thank you for your report
on the activities of the TRIPS Council’s consideration of the Waiver
Proposal and further consultations you held in small group formation as
well as the details put forward in the proposed oral report to be presented
to the General Council in March 2021. We would like to welcome the African
Group and LDC Group to the fold of cosponsors, the increase number of
delegations in our ranks demonstrate the growing importance of the Waiver
Proposal and the need to scale up access in order to ensure equitable and
timely access to COVID-19 medical products, including vaccines,
therapeutics, diagnostics and other equipment.

Moving forward, discussions cannot continue to be mired in the evidentiary
loop that we have been engaged in over the last few months, Cosponsors have
also made it clear that we want to move to text-based discussions, we stand
ready to discussion the scope and duration of our proposal in light of
comments and observations that Members have made.

A pandemic like COVID-19 has not been seen in a century, and much remains
unknown and evolving about the situation and the virus that causes it.
While many regard the virus as a sort of black swan, it was not entirely
unexpected and was preceded by several other viruses and semi-global
pandemics in recent times. As much as we may hope that something like this
will not happen again, the probability is there that the next event may be
even more cataclysmic. Many of the most serious global threats today
involve a high degree of uncertainty. Under such conditions, people are
notoriously unwilling to make sacrifices for others when the benefits are
uncertain. A good example of this type of behaviour is vaccine nationalism,
which denotes self-prioritization to the exclusion of others, as many rich
government have done on the assumption that individual action can yield
results on its own. However, this is not the case, the idea that a vaccine
rollout will be the deus ex machina is misplaced, we cannot put the virus
back into its bottle, we just cannot go back to the old normal.

According to available data, US, UK and the EU account for about 50% of the
over 200 million vaccines administered globally as at 22nd Feb. Countries
opposing the TRIPs waiver proposal account for 60% of the globally
administered COVID-19 vaccines. Reportedly, just 10 countries have
administered 75 per cent of all COVID-19 vaccines. More than 130 countries
have not received a single dose. The WTO has to pay need to the caution of
the Director General of WHO: “The longer it takes to suppress the virus
everywhere, the more opportunity it has to change in ways that could make
vaccines less effective – an opportunity to mutate”.

Sir Jeremy Farrar, the head of Wellcome Trust has also highlighted that
“Immunising a lot of people in a few countries while leaving the virus
unchecked in large parts of the world would simply allow more variants to
emerge in these places. And the more that happens, the higher is the risk
that the virus will evolve to an extent that our vaccines, treatments and
tests are no longer effective” adding that “We’ve got to understand this is
a global problem that must be dealt with globally.”

Our TRIPS Waiver offers a global solution. The world is facing its worst
ever crisis since perhaps World War II, and the response of WTO members
opposing the waiver proposal is to engage in “business as usual”
approaches, and for WTO to do nothing to address IP monopolies around the
technology and know-how, to scale up production and to bring this crisis to
an end.

Many of the opposing WTO members, under pressure from their pharmaceutical
industry have for more than two decades, been known to dissuade developing
countries from incorporating TRIPS flexibilities in their national law and
using such flexibilities to promote access, and yet now insistently assert
that such sufficient flexibilities exist, although we have presented
concrete arguments against it.

These same WTO members stress on “business as usual voluntary licensing” as
the way out of this pandemic and yet one year on, this “business as usual”
approach premised on voluntary, secretive, limited and restrictive
licensing has failed to leverage global expertise and capacity to scale-up
manufacturing and deliver equitable access. Instead this approach has
limited competition, and is artificially constraining global supply. These
“business as usual” approaches championed by opposing countries is not the
global solution but really the root cause of why to date we have
vaccinations that are “wildly uneven and unfair” as pointed out by the UN
Secretary General. At the current vaccination rate, it will take an
estimated 4.8 years to cover 75% of the population with a two-dose vaccine,
according to Bloomberg on the path to immunity around the world. And sadly,
this is probably an optimistic scenario. Cosponsors have often called for
the open sharing of vaccine manufacturing technology, IP and know-how
through the COVID-19 Technology Access Pool (CTAP).

Madam Chair, we want to clarify that as Cosponsors of the Waiver Proposal,
we have always said that we welcome global multilateral cooperative
initiatives such as the ACT-Accelerator. The objective of COVAX, its
vaccine arm, is laudable, as are financial contributions from WTO Members
to this end. However, we have to confront the limits of the architecture of
such an approach, it is not meant to address all the needs of developing
and least developed countries. A rather large gap exists between what COVAX
or ACT-A can deliver and what is required in developing and least developed
countries. In this case demand-side requirements outstrips supply-side
constraints. Irrespective of the amount of money any of the donor country
may throw at the problem, the model of donation and philanthropic
expediency cannot solve the fundamental disconnect between the monopolistic
model it underwrites and the very real desire of developing and least
developed countries to produce for themselves. Madam Chair, the problem
with philanthropy is that it cannot buy equality. Yesterday the DG of WHO
warned that: “Money is not the only challenge we face. If there are no
vaccines to buy, money is irrelevant. Even if we have the funds, we can
only deliver vaccines to poorer countries if high-income countries
cooperate in respecting the deals COVAX has done, and the new deals it is
doing.” Even in light of all the additional pledges of monetary support,
the ACT Accelerator still faces a gap of at least 22.9 billion dollars to
fully financed.

The Waiver Proposal constitutes a very real compromise that will
immediately enable countries to tap into unused production capacity by
accessing spare capacity in the developing world which will satisfy the
ongoing demand for COVID-19 vaccines (including therapeutics and
diagnostics) and will also negate the need for any donations from rich
countries. Take the Africa continent for example, as a whole Africa
currently imports more than 80 per cent of its pharmaceutical and medical
consumables. This is unsustainable and puts the continental population of
1.3 billion people at the mercy of a few monopolistic companies. This is a
recipe for disaster as we have witnessed not only with the COVID-19
pandemic but with all other diseases and pandemics that continue to affect
the continent.

We recalled in our intervention of 4 February 2021, in which we quoted a
study commissioned by the international Chamber of Commerce (ICC) Research
Foundation which found that the global economy stands to lose as much as
$9.2 trillion if governments fail to ensure developing country economies
access to COVID-19 vaccines. We have already argued that there are good
moral and legal grounds, as recognized under the TRIPS agreement, to pass
the waiver proposal. In addition, this study underscores the importance of
ensuring access by developing countries to effective vaccines in order to
mitigate the economic social and have consequences in the years ahead. We
have already indicated that the artificial shortage of vaccines is
primarily caused by the inappropriate use of intellectual property rights,
this cannot be allowed to continue. It is now apparent that poor countries
would have to wait a long time to access vaccines, during this time the
virus will mutate giving rise to strains that will undermine the efficacy
of existing vaccines. COVID-19 does not respect national borders; nor does
it care about the gross domestic product of a country, no country in the
world can insulate itself, even the best plans will be laid to waste. Let
us ensure that everyone has access to effective vaccines in the shortest
possible time.

In closing, as many cosponsors have reiterated, we are ready to go to a
text-based discussion in order to arrive at an immediate solution. This
will not only save lives but also enable us to return to a situation of
relative normalcy. No one is safe until everybody is safe.
------------------------------

Second intervention

I would once again like to thank all delegations that took the floor today.
Some delegations wanted more details of manufacturing capacity that exist
in the developing world. As we have pointed out at the last session, out of
the 158 prequalified vaccines under WHO’s PQ program 72 vaccines are
produced by vaccine manufacturers from developing countries. Similarly,
LMIC countries have a substantial share in prequalified finished
pharmaceutical products, active pharmaceutical ingredients and vaccines.
This shows that significant quality manufacturing capability does exists
including in developing countries and to ensure global supply, these have
to be leveraged.

Some delegations suggest countries who have unused manufacturing capacity
on vaccine to pursue voluntary license agreement with vaccine developers
for local production. Yet, what we have observed is that among some
countries who do not support the waiver proposal, they have experienced
difficulties in seeking local production licenses from vaccine developers.
It shows, once again, that relying on voluntary license is not sufficient
in this pandemic. Canada has just shared their experiences with originators
having been rejected by several companies when approached for a voluntary
license. Canada’s experience shows relying on voluntary licenses may be
highly problematic and evidences the selective approach applied by
originators and rights holders. Perhaps Canada can disclose the terms of
its license agreement with Novavax to back up its claim that IP is not a
barrier to access?

It is also worth noting that some of the non-vaccine producers have
recently been brought into vaccine production in Europe and Japan, such as
Bayer and JCR pharmaceutical in Japan. This has yet happened in developing
countries at large. While this kind of arrangements were made under
selective agreements between companies, this shows that it is practical to
explore and leverage the manufacturing capacity even beyond the usual
vaccine producers. Yet, relying on originator company’s voluntary
willingness is not sufficient. Leveraging the full capacity requires true
global collaboration of all countries so that both technological and legal
barriers to ensure scale up production and supply can be guaranteed. The
waiver proposal provides a legal enabler to facilitate this to happen.

We thank the EU for its statement, the facts and actions spoken about
remain vague. The EU does not support the waiver proposal, nor does it take
any action to ensure technology sharing and transfer by companies operating
in EU. It does not commit that it will no longer suppress developing
countries from using compulsory license and other flexibilities as it did
in its IP enforcement in third country report. It has not followed through
its rhetoric of treating vaccines as a global common good but rather
continue its inward-looking strategies in vaccine access including
activating an export authorisation scheme.

We heard Switzerland and Singapore quote Dr. Poonawalla of the Serum
Institute. In a recent interview with Politico, Dr. Poonawalla believes
that the sheer urgency of the virus — and the fact that coronavirus
anywhere is a threat to people everywhere — should prompt a reassessment of
patent and intellectual property laws that limit access to immunizations in
the developing world, while simultaneously jacking up their price in
wealthier countries. “That’s become very evident today in the Covid
crisis,” “If you don’t allow, for example, an Indian producer to sell in
the U.S. because of some stupid rules and regulations, even though the
product is identical to a U.S. product, you’re going to have a supply
situation.” “And guess what,” he continued. “When you’ve got low supply and
high demand, what happens to the price? It skyrockets.”

Some delegations continue to argue that Article 31bis could be used by
countries have no or insufficient manufacturing capacities to seek supply
under compulsory license for export issued by another country. Yet, as we
have heard from various developing country delegations, the current
provisions and requirements of Art 31bis are not fit for purpose during a
pandemic of this nature. The waiver proposal provides a quicker and easier
option in the pandemic.

On the question posed by Norway on a revised proposal from the Cosponsors,
the reason we called for a text-based discussion is because this will help
us to understand direct questions that members have on our proposal. We
invite delegations to raise particular concerns on elements they may have
concerns about and suggestions as to how we can arrive at a common landing
zone, including at the regular TRIPS Council meeting of 10 March 2021 and
subsequent informal and informal meetings. We once again call for our
deliberation to move to a text-based discussion.

END


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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