[Ip-health] WTO TRIPS Council (October 2020): South Africa issues clarion call urging support for TRIPS waiver proposal

Thiru Balasubramaniam thiru at keionline.org
Fri Oct 16 21:10:15 PDT 2020


WTO TRIPS Council (October 2020): South Africa issues clarion call urging
support for TRIPS waiver proposal

Posted on October 16, 2020 <https://www.keionline.org/34235> by Thiru

On Friday, 16 October 2020, members of the World Trade Organization’s (WTO)
TRIPS Council held a three hour debate on the proposal (IP/C/W/669)
<https://www.keionline.org/34061> first tabled by India and South Africa
for a waiver from certain provisions of the TRIPS Agreement for the
prevention, containment and treatment of COVID-19. By Friday, Eswatini and
Kenya emerged as co-sponsors of the TRIPS waiver proposal.

>From informed sources, three blocs emerged from the discussions:

- WTO Members who supported the proposal, the vast majority of which were
least developed and developing countries (Tanzania on behalf of the African
Group, Chad on behalf of the LDC members, Bangladesh, Sri Lanka, Pakistan,
Venezuela, Honduras, Nepal, Nicaragua, Egypt, Indonesia, Argentina,
Tunisia, Mali, Mauritius and Mozambique);
- WTO Members who expressed their rejection of the text, the vast majority
of which were developed countries (European Union, United States of
America, Switzerland, Norway, Australia, Canada, Japan and the United
Kingdom), joined by Brazil;
- WTO members who welcomed the proposal but asked for further clarification
on some points, particularly with regards the possible economic impact of
the waiver and said they were consulting with capital in order to make a
more informed decision (Nigeria, Philippines, Turkey, Ecuador, China,
Thailand, Senegal, Jamaica, Colombia, Costa Rica, Chile and El Salvador).

At the end of Friday’s deliberations, South Africa made the following
procedural request:

It is clear that Members have different opinions regarding the waiver
proposal introduced at today’s TRIPS Council meeting, there is a need to
discuss this proposal further. According to Article IX.3(b) a request for a
waiver shall be submitted to the relevant Council for consideration during
a period which shall not exceed 90 days. We request that this item remain
open for discussion for the intervening period. This can be done on the
basis suspending this item and reconvening the TRIPS Council formally or
informally or through consultations that may be convened by you or a
combination of both modalities.

India’s opening statement on this item can be found here
<https://pmindiaun.gov.in/public_files/assets/pdf/TRIPS_Agreemnet.pdf> on
the website of the Indian Mission:

South Africa’s opening and closing statements are found below.

*TRIPS CouncilITEM 15First Intervention*


Thank you Chair for giving us the floor, as you indicated I have the honor
to introduce this proposal on behalf of the delegations of Eswatini, India,
Kenya and South Africa.

The COVID-19 pandemic is a clarion call for us to answer to the better
angels of our nature. High-minded language on solidarity and global public
goods however, has not been matched by tangible steps to share know-how and
intellectual property rights to facilitate deep technology transfer in the
COVID-19 response. Business as usual approaches will not bring back the
countless lives that were lost, neither will it ensure that IP barriers to
the prevention, containment and treatment of COVID-19 will be addressed

We have seen this before. At the height of the HIV crisis, prices set for
ARVs to treat HIV were simply too high and out of reach for many developing
countries. As death rates due to aids plunged in rich countries, infected
people across the developing world were left to die

Our leaders vowed that is would never happen again, the Doha Declaration on
TRIPS and Public Health reaffirmed flexibilities to accommodate access to
medicines. Even in light of this political undertaking and its translation
into the paragraph 6 system, prices of many life-saving diagnostics,
therapeutics, vaccines and other medical products remain out of reach of
most governments and its people.

In 2004 the highly pathogenic avian influenza H5N1 re-emerged, developed
countries had priority access, while affected developing countries did not.
Within 5 years another pandemic flu (H1N1) emerged and once again rich
countries placed large pre-orders of a vaccine buying almost all doses that
could possibly be manufactured. Many countries promised to donate vaccines,
most of them reneged and moved to secure their own countries’ supply. With
COVID-19 history is repeating itself.

Several months into this pandemic there are no meaningful global policy
solutions to ensure access. Given this present context of global emergency,
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.

All WTO Members are struggling to contain the spread of the pandemic and
provide health care services to those affected. Many developed, developing
and least developed countries have declared a national emergency with the
aim to curb the growing outbreak, and as advised by the WHO implemented
social distancing measures with significant consequences for society and
the economy. Notably, developing countries and least developed countries
are especially disproportionately impacted.

Madam Chair,

An effective response to COVID-19 pandemic requires rapid access to
affordable medical products including diagnostic kits, medical masks, other
personal protective equipment and ventilators, as well as vaccines and
medicines for the prevention and treatment of patients in dire need.
Shortages of these products has put the lives of health and other essential
workers at risk and led to many avoidable deaths. It is also threatening to
prolong the COVID-19 pandemic. The longer the current global crisis
persist, the greater the socio-economic fallout, making it imperative and
urgent to collaborate internationally to rapidly contain the outbreak. As
new diagnostics, therapeutics and vaccines for COVID-19 are developed,
there are significant concerns, how these will be made available promptly,
in sufficient quantities and at affordable price to meet global demand.
Critical shortages in medical products have also put at grave risk patients
suffering from other communicable and non-communicable diseases. The rapid
scaling up of manufacturing globally is an obvious crucial solution to
address the timely availability and affordability of medical products to
all countries in need. The emerging second wave of the disease underscores
the importance to finding global solutions that ensure equitable access.

There are several reports about intellectual property rights hindering or
potentially hindering timely provisioning of affordable medical products to
the patients. It is also reported that some WTO Members have carried out
urgent legal amendments to their national patent laws to expedite the
process of issuing compulsory/government use licenses, as evidenced by the
updated Secretariat report on national measures taken by WTO Members.
Beyond patents, other intellectual property rights may also pose a barrier,
with limited options to overcome those barriers. In addition, many
countries especially developing countries may face institutional and legal
difficulties when using flexibilities available in the Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). A
particular concern for countries with insufficient or no manufacturing
capacity are the requirements of Article 31bis and consequently the
cumbersome and lengthy process for the import and export of pharmaceutical

Madam Chair,

Internationally, there is an urgent call for global solidarity, and the
unhindered global sharing of technology and know-how in order that rapid
responses for the handling of COVID-19 can be put in place on a real time
basis. Our joint proposal requests a waiver to be granted to all WTO
Members so that they do not have to implement, apply or enforce certain
obligations related to COVID-19 products and technologies under Section 1
(copyrights and related rights), 4 (industrial design), 5 (patents) and 7
(protection of undisclosed information) of Part II of the TRIPS Agreement.
Let me stress that the proposed waiver would be applicable only to
COVID-19. The waiver is limited and does not suggest a waiver from all
possible TRIPS obligations, nor does it suggest a waiver beyond what is
needed for COVID-19 prevention, containment and treatment.

The waiver should continue until widespread vaccination is in place
globally, and the majority of the world’s population has developed immunity
hence we propose an initial duration of [X] years from the date of the
adoption of the waiver.

*Second intervention*

*Response to questions and issues raised by Members who took the floor.*

Madam Chair,

It has been exactly three hours since the last time I took the floor, good
evening colleagues. It has been a marathon session with many interventions
and discussion.

The Cosponsors would like to thank all Members and observers that had
intervened. We have heard many concerns raised by Members that intervened.
Given the time constraints, the Cosponsors would like to respond to some of
the general elements that have emerged out of today’s discussion. There are
more direct questions posed by delegation that could be answered at a later
stage and we will reach out to delegations concerned.

We want to stress that the protection and enforcement of intellectual
property are not absolute, Article 8 of the TRIPS Agreement recognises that
countries may adopt necessary measures to protect public health. COVID-19
constitutes an unimaginable global pandemic which requires swift and bold
action. COVID-19 is far from over and there is no certainty as to when
effective vaccines will be available in sufficient quantities to ensure
equitable access. COVID-19 is here to stay, as the EU pointed out in their
intervention, vaccines take up to 10 year to develop.

We explained the rationale for our proposal and believe that our proposal
demonstrates the existence of exceptional circumstance that justifies our
request for a waiver decision, clear terms and conditions governing the
application of the waiver.

The Waiver does not imply any change of the substantive treaty obligations;
it only temporarily suspends their operation for a period to be agreed by
Members and thus will be time-bound. It has a clearly defined scope related
to the implementation, application and enforcement of Sections 1
(Copyright), 4 (Industrial Designs), 5 (Patents), and 7 (Protection of
Undisclosed Information) of Part II of the TRIPS Agreement which are
aspects critical to the diagnosis, prevention, containment and treatment of

We further clarified that the date on which the waiver will continue to
apply until widespread vaccination is in place globally, and the majority
of the world’s population has developed immunity hence we propose an
initial duration of [X] years from the date of the adoption of the waiver.
This period can be negotiated.

Madam Chair,

*We heard the refrain from the EU and others that the TRIPS Agreement is
fit for purpose and its flexibilities are usable without limitation or any
problem? We once again contest this this notion.*

Delegations that have taken the floor to condemn this waiver proposal claim
that that TRIPs flexibilities already include the option to issue
compulsory licenses where necessary.

The proposal for a waiver on certain IP provisions offers an expedited,
open and automatic global solution that allows for uninterrupted
collaboration in development and scale up of production and supply and that
collectively addresses the global challenge facing all countries. Countries
should continue to use TRIPS flexibilities to safeguard public health,
including issuing compulsory licenses and placing limitations on or making
exceptions to exclusive rights.

However, the “case by case” or “product by product” approach required when
using flexibilities to address IP barriers at the national level could be
limiting during the pandemic. Some countries also face limitations with
respect to their national laws, pressures from their trading partners, or
lack the practical and institutional capacity required to exercise TRIPS
flexibilities during the pandemic quickly and effectively. The existing
mechanisms for compulsory licenses under Article31 and Article 31bis of the
TRIPS Agreement contain territorial and procedural restrictions that make
the practice of issuing product-by-product compulsory licenses a complex
process, making it difficult for countries to collaborate. Article 31
requires that compulsory licenses are issued on a case-by-case basis and
used predominantly to supply domestic markets, thereby limiting the ability
of manufacturing countries to export to countries in need.

Article 31bis requires that any product produced and exported under a
compulsory license be identified with specific packaging and quantities,
which can lead to unnecessary delays in the context of COVID-19 where
countries need urgent access to medical tools. There is even less
experience in areas such as industrial designs, trade secrets, algorithms
and copyright, applying compulsory licenses to such areas may be legally
complicated and novel.

Political pressure from two delegations that oppose the waiver proposal
have taken action to ensure that countries do not use compulsory licenses,
for example:

*EU IP enforcement report 2020*, issued right before the COVID19 pandemic,
put a number of developing countries, including India, Indonesia, Turkey,
Ecuador, under the spotlight of criticism for their laws allowing the use
of compulsory license if patent holding companies do not fulfil the
obligation of supporting production of medicines locally;

*USTR 2020 Special 301 report*, issued right in the middle of the COVID19
pandemic, continue to condemn countries who improve their laws on
compulsory license or make use of compulsory license – countries
specifically pressured for their law or their use of compulsory license
include Chile, Indonesia, Colombia, Egypt, India, Malaysia, Russia, Turkey,
Ukraine, El Salvador.

Madam Chair,

*Voluntary Licenses are somehow touted as the solution for COVID-19!*

IP rights can be exercised by their owners to decide on whether to grant a
license or withhold from licensing the technology, designs and knowhow
required for manufacturing or for further developing the products required
for COVID-19. By enforcing exclusive rights backed by IP, such as patents,
pharmaceutical companies slow down research and innovation. The use of
restrictive voluntary license terms limits the catching up and innovation
made by generic competitors.

Nine months into the pandemic voluntary approaches have proven to be
insufficient. For instance, despite receiving significant public funding of
at least US$70.5 million, Gilead has signed secretive bilateral licenses
for Remdesivir (a therapeutic for COVID-19 treatment) with a few generic
companies of it choosing that excludes nearly half of the world’s
population from its licensed territories. Much of Gilead’s supply has also
been reserved for very rich nations. As a result, to date, most developing
countries have barely received any supply of Remdesivir. The prices of
Remdesivir are also prohibitively high.

On the other hand, to date not a single company has committed to the
voluntary Covid-19 Technology Access Pool of WHO.

In cases where companies have made such commitments to issue voluntary
licenses, the lack of transparency of license agreements for products to
treat COVID-19 is substantial.These initiatives are ad hoc and are not a
sustainable way of addressing IP barriers.

While such companies can limit the production, quantity and export of
products produced under license to certain geographical areas thereby
excluding large parts of the world population. Nonprofit undertakings are
time bound, while such companies will decide when they think the pandemic
is over.

If we are serious to address access issues, production cannot be
concentrated in the hands of only a few manufacturers, in order to scale up
production, governments have a critical role to play.

Madame Chair,

*Various Members have asserted that the waiver proposal will impede
innovation and that it is improper and ill-conceived on the side of the
Cosponsor to bring a waiver proposal at this critical time.*

Never has there been a weaker case for the granting of monopolies.
Governments have been funding the development of COVID drugs and vaccines,
and no company is able to meet the global demand. In the context of
COVID-19, despite the billions of tax payer dollars invested in R&D, and
announcements that COVID-19 vaccines should be considered a public good, no
government has openly stated committed to this undertaking.

Monopoly-based and market-driven R&D in biomedical sector ignores unmet
health needs – no new medicine was developed for more than 40 years on TB;
no effective R&D in addressing antimicrobial resistance (AMR) despite of
the constant increasing of number of IP – patents granted in pharmaceutical
sector globally for zero value add.

The R&D of drugs is often a joint multi-stakeholder effort, benefitting
from significant amounts of public taxpayer money. For COVID-19, the search
for an effective treatment or vaccine is a global effort involving by
multiple actors – it is not the result of the pharmaceutical industry’s
efforts alone. Governments and public funding agencies around the world
have poured billions of US dollars of public money to support COVID-19 R&D,
especially for drugs and vaccines. However, by and large no conditions for
access or affordability have been included as a precondition to any of that
funding. Governments must attach strings to any public money given for
COVID-19 medical tools to guarantee that, if they prove safe and effective,
they are available to everyone. Today some Members have admitted that some
conditions had been set on companies, but none of it goes far enough to
ensure that IP rights assigned to companies benefiting from taxpayer money
do not abuse such rights down the line.

Madam Chair

*It was professed by Members that voluntary cooperative approaches will
solve the COVID-19 crisis through generous pledges to multi-stakeholder
collaborative platforms. We thank the EU and other delegations for their
generous support for these initiatives, including the donation of vaccines
and access to COVAX-facility to cooperate in the purchase of future
vaccines for the benefit of vulnerable countries.*

   - The Cosponsors agree that global cooperation and collaboration is key
   to addressing the COVID-19 pandemic, initiatives such as the COVAX facility
   are helpful but insufficient. Our waiver proposal is designed to work
   synergistically with such initiatives by enabling the rapid scaling of
   production by multiple producers across many countries, enabling the
   sharing of knowledge and transfer of technology with the aim of addressing
   the pandemic
   - COVAX at best provides very short-term, limited access to vaccines.
   Its approach is not sustainable in the medium and long term. The global
   needs are massive and can only be addressed with global sharing of
   technology, knowledge and related IP. Not by artificially limiting
   competition and supply which in turn only results in high prices in the
   medium and long term.
   - Notably wealthy nations representing just 13 percent of the world’s
   population have already cornered more than half (51 percent) of the
   promised doses of leading COVID-19 vaccine candidates. This creates
   significant uncertainty for universal access.
      - The EU together with some other wealthier nations and regions, have
      already pre-booked more than 51% of the global supply capacity of the
      potential future COVID19 vaccines – leaving limited share for developing
      countries and least-developed countries to share. It is this conduct that
      has created huge uncertainty to the guarantee of universal access to
      COVID19 medical tools and products;
   - Global equitable allocation and donation are separate issues from the
   waiver proposal that we put on the table.
   - While some initiatives such as COVAX is aiming to address the initial
   shortage of supply of medical tools for COVID19 treatment and prevention,
   its effects can be limited due largely to the following factors:
      - The model and the conducts reinforce the deep inequality in the
      global health architecture and do not provide a sustainable solution;
      - Both the investment to COVAX and donation commitment cannot solve
      the issue of the need to diversify, to the maximum level the global
      capacity of development, manufacturing and supplying COVID19
medical tools;
      - COVID19 reveals the deep structural inequality in access to
      medicines globally, and one of the root causes is that IP sustains
      dominating industry’s interests at the cost of lives


Madame Chair,

*We heard some Members saying that intellectual property is not a hindrance
but a help to end COVID-19; …. Suspending key protections of the TRIPS
Agreement would send the wrong message to industry investors.*
- Huge public funding has been poured into R&D for COVID-19 – more than 70
billion USD mostly from governments including many developing countries
governments; it is taxpayers in different countries who have invested the
- People around the world who are taking huge risk of joining in and
supporting the unprecedented R&D process and clinical trials;
- The incentive for people to take substantial risks in supporting and
joining clinical trials has nothing to do with IP, but the conscience and
common sense of contributing to the finding of a cure for all
- Industry has asked governments to take over their liability and request
for indemnity so that industry does not have to bear the risk but can make
all the profit without much value add.

*We also heard that intellectual property has enabled collaboration between
bio-pharmaceutical innovators and governments, universities and other
research partners to speed up progress on our most pressing unmet medical
needs, however the Cosponsors strongly contest this notion.*
- It is the pandemic – not IP – that has mobilized collaboration of
multiple stakeholders.
- It is knowledge and skills held by scientists, researchers, public health
experts and universities that have enabled the cross-country collaborations
– not IP!
- It is public funding, again, facilitated these collaborations – not IP!

I will leave it here in the interest of time and as we indicated at the
start of this intervention the cosponsors will reach out to other
delegations to address more specific issues and questions that may have
been raised.

*[Procedural Request]*

*Madam Chair,*

It is clear that Members have different opinions regarding the waiver
proposal introduced at today’s TRIPS Council meeting, there is a need to
discuss this proposal further. According to Article IX.3(b) a request for a
waiver shall be submitted to the relevant Council for consideration during
a period which shall not exceed 90 days. We request that this item remain
open for discussion for the intervening period. This can be done on the
basis suspending this item and reconvening the TRIPS Council formally or
informally or through consultations that may be convened by you or a
combination of both modalities.


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

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