[Ip-health] 10 March 2021: South Africa raises the banner for the TRIPS waiver at the WTO

Thiru Balasubramaniam thiru at keionline.org
Wed Mar 10 23:19:33 PST 2021


https://www.keionline.org/35578

10 March 2021: South Africa raises the banner for the TRIPS waiver at the
WTO
Posted on March 11, 2021 <https://www.keionline.org/35578> by Thiru
<https://www.keionline.org/author/thiru>

On 10 March 2021, the World Trade Organization’s (WTO) TRIPS Council
addressed the proposal for a waiver from certain provisions of the TRIPS
Agreement for the prevention, containment and treatment of COVID-19
(IP/C/W/669) under agenda item 12. This proposal is co-sponsored by 57 WTO
members. The Chair of the TRIPS Council, Ambassador Xolelwa Mlumbi-Peter
(South Africa) opened the deliberations on the waiver stressing the urgency
of the COVID-19 pandemic confronting humanity. “The world is in desperate
need of solutions. It can not be business as usual. This is an issue of
life and death. People are dying as we speak. We need to engage in
discussions to find solutions.”

In terms of procedure, she reminded WTO Members that the next formal
meeting of the TRIPS Council would be held on 8 June 2021 to 9 June 2021;
she proposed dedicated sessions on 15 April 2021 and 22 April 2021 to
consider the TRIPS waiver proposal noting this work would serve as positive
guidance to prepare for future pandemics.

After interventions by India, Maldives, Zimbabwe, Qatar, Pakistan, Egypt,
Nepal, Bangladesh, and Vanuatu, South Africa took the floor to deliver a
lengthy opening statement at the WTO TRIPS Council’s negotiations on a
waiver from certain provisions of the TRIPS Agreement for the prevention,
containment and treatment of COVID-19 (IP/C/W/669).

In terms of the way forward, South Africa proposed the following pathway
for text-based negotiations.


   In closing, we would once again call that we move to a text-based
   discussion. We have come a long way since October, we all agree that
   COVID-19 is an exceptional circumstance that requires common and inclusive
   actions. As you indicated Madam Chair, there are common understandings that
   are emerging, which could be captured in documentary form. We all realize
   that our destinies are intertwined and that we have to find better ways to
   collaborate, though we continue to disagree on how this can be done in the
   best way.


   Based on past practice of convening meetings in various formats and
   configurations, we expect that this practice will continue. Cosponsors will
   soon start a process to discuss possible approaches to the draft Waiver
   text which may lead to an amendment of the current text. We look forward to
   continue this engagement with all Members as a priority, we need to pass
   this Waiver as soon as possible. Let’s get it done and save lives.

In relation to exhortations to use compulsory licenses and other TRIPS
flexibilities, South Africa reminded the Council of the realpolitik world
of sanctions and other trade pressure being brought to bear against
countries the world over.


   Madam Chair,

   We keep on hearing the refrain from various Members that TRIPS
   flexibilities are available and should be use. The Vice President of the
   European Commission, Mr. Dombrovskis stated in a reply to a question from
   the European Parliament that “[If] voluntary solutions fail and IP becomes
   a barrier to access to treatments or vaccines, the TRIPS Agreement provides
   for a possibility to grant compulsory licences.” However, this is not a
   reality for many developing countries, whenever such flexibilities are
   invoked, political and other sanctions are used to counter such efforts.


   So far, we have had an extensive exchange in this Council on the
   importance of TRIPS flexibilities for safeguarding public health and the
   challenges of solely relying on mechanisms such as compulsory license for
   government use to manage IP challenges in this pandemic which is a
   multifaceted issue as we elaborated under IP/C/W/673.


   In the recent USTR Special 301 review process in late January,
   multinational pharmaceutical industry associations PhRMA and BIO have both
   submitted their comments on IP issues in other countries including those in
   the COVID19 pandemic. In these submissions, countries have been criticized
   simply because they have either used TRIPS flexibilities, or adapted
   emergency rules to facilitate the use of TRIPS flexibilities in the
   pandemic:

   — Russia and Hungary are criticised for their legitimate use of
   compulsory licenses on COVID19 medicine in a pandemic;

   — Hungary, Colombia and Indonesia, are criticised for their emergency
   regulations to ease the procedure of using compulsory license for
   government use in the pandemic

   — Netherlands is criticised for some legislative discussions on using
   compulsory license in the pandemic

   — European Commission/European Union is criticised for its consideration
   to improve effective use of compulsory license for access to medicines in
   its IP action plan

   — Chile is criticised for the Chilean Chamber of Dispute’s calling for
   the use of compulsory license in the pandemic

   — South Africa and India for our legitimate use of WTO law to submit the
   current waiver proposal.


   Madam Chair, we recall our questions under IP/C/W/674 and would
   appreciate delegates of the US and the EU to shed a light on whether the
   final report of Special 301 review this year and the upcoming EC report on
   IP enforcement in third countries will both refrain from criticising
   countries legitimate actions of using and discussing TRIPS flexibilities
   for public health safeguarding.

The full text of South Africa’s opening statement is reproduced below.
------------------------------

Madam Chair, thank you for giving us the floor. We would like to commend
you for your stewardship of this very important matter.

As indicated in previous meetings, 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. Cosponsors executed an intensive schedule of bilateral meetings with
various Members during the last two weeks. These meetings included not only
Members that support the waiver proposal but also those that have raised
concerns. We would like to thank Members for the positive spirit in which
these discussions took place and we hope that this will spill over into
broader discussions under the auspices of this Council. We therefor endorse
your call to shift gears and to move to a more solution-oriented approach.

In respect of the arrangements going forward, the practice of convening
both formal and informal meetings, both in small and big group format has
worked well. Thank you for confirming 15 and 22 April as possible dates for
further meetings, my delegation feels that we may have to resume some
meetings sooner than the dates indicated. Cosponsors will reach out in this
regard.

In a global pandemic, lifting IP monopolies will give governments and
manufacturers full freedom to operate and allow collaboration for the
development, production and supply of COVID-19 medical products including
therapeutics and vaccines, without being restricted by big corporation’s
“voluntary” willingness. The current ad-hoc, secretive and restrictive
business as usual voluntary licensing practices is limiting production and
artificially constraining supply with detrimental consequences for public
health, society, livelihoods and the economy globally. It is an abuse of
the intellectual property system for it has in the past one year failed to
leverage global production capacity. Passing this waiver makes ethical,
epidemiological, and economic sense.

Dr Tedros DG of the WTO proclaimed that* A me-first approach might serve
short-term political interests, but it is self-defeating and will lead to a
protracted recovery, with trade and travel continuing to suffer* (Op-ed
Guardian, 5 March 2021). *Flexibilities in trade regulations exist for
emergencies, and surely a global pandemic, which has forced many societies
to shut down and caused so much harm to business – both large and small –
qualifies. We need to be on a war footing, and it’s important to be clear
about what is needed.*

We have on several occasions raised concerns about relying on VLs as the
main tool for expanding supply for timely access. As with every effort to
contribute to dealing with COVID-19, all contributions are welcome. Madam
Chair, our experience with VLs is however less than positive. Some key
concerns with VLs are first the lack of transparency as the terms of the
license are usually confidential; second is the limited geographic scope
that even excludes many developing countries from being supplied under the
license agreement or allows for manufacturing only for purposes of export;
third is that the license is only offered to very specific manufacturers
presumably aiming to limit supply; fourth are the restrictive terms on the
source and production of active pharmaceutical ingredients (APIs). These
and other problematic terms and conditions that restrict production were a
commonplace even before the pandemic. They have been a challenge for access
prior to the pandemic and such approaches will not deliver to address the
access needs of this devastating pandemic. Disparity in access is certain
unless concrete steps are taken to address intellectual property barriers.

We have to learn from past mistakes and ensure that the experience of ad
hoc, secretive, limited and restrictive VLs does not repeat itself. The
pandemic has shone a harsh light on the skewed and unsustainable business
models with which the pharmaceutical industry maximises its profits at
expense of legitimate public interests. Despite generous contributions from
tax-payer money and pre-order purchases, companies are still allowed to
decide on critical elements such as the scale of production (and now
conveniently complain that demand outstrips supply) while setting ever
higher prices that cannot be justified on any rational basis.

It is well reported that South Africa has paid $5.25 a dose for a version
of the vaccine manufactured in India while it seems that the European
Commission paying only $3.50 per shot. Uganda seems to have paid $8.50 a
dose. Some of the explanations given for such price differentials include
arguments that high-income countries have a lower price because they have
invested in the research and development. However, none of these
explanations adequately explain why such large price differentials can be
justified. There are already suggestions by pharmaceutical companies of
post-pandemic hyper pricing strategies.

Prime Minister Rowley of Trinidad and Tobago said the following: *“History
is littered with instances of destructive behavior, disrespectful
dominance, imbalances and other forms of man’s inhumanity to man. But on
this rare occasion, when we are all yoked to an invisible destroyer, it is
my hope and plea that when the journal of this experience is written, it
would deviate from what is mostly the norm and record that on this
occasion, the rich took care of the poor. And the small and impecunious
were not trampled with disdain by those who could have done so simply
because they had the wherewithal to do it.”*

He called for global vaccine distribution based on models of “sharing and
caring” that provide equitable access to small countries like his and
“benefit of all humankind and not just the privileged, well-heeled few.” We
would do well to heed this call.

Madam Chair,

We keep on hearing the refrain from various Members that TRIPS
flexibilities are available and should be use. The Vice President of the
European Commission, Mr. Dombrovskis stated in a reply to a question from
the European Parliament that “[If] voluntary solutions fail and IP becomes
a barrier to access to treatments or vaccines, the TRIPS Agreement provides
for a possibility to grant compulsory licences.” However, this is not a
reality for many developing countries, whenever such flexibilities are
invoked, political and other sanctions are used to counter such efforts.

So far, we have had an extensive exchange in this Council on the importance
of TRIPS flexibilities for safeguarding public health and the challenges of
solely relying on mechanisms such as compulsory license for government use
to manage IP challenges in this pandemic which is a multifaceted issue as
we elaborated under IP/C/W/673.

In the recent USTR Special 301 review process in late January,
multinational pharmaceutical industry associations PhRMA and BIO have both
submitted their comments on IP issues in other countries including those in
the COVID19 pandemic. In these submissions, countries have been criticized
simply because they have either used TRIPS flexibilities, or adapted
emergency rules to facilitate the use of TRIPS flexibilities in the
pandemic:

— Russia and Hungary are criticised for their legitimate use of compulsory
licenses on COVID19 medicine in a pandemic;

— Hungary, Colombia and Indonesia,are criticised for their emergency
regulations to ease the procedure of using compulsory license for
government use in the pandemic

— Netherlands is criticised for some legislative discussions on using
compulsory license in the pandemic

— European Commission/European Union is criticised for its consideration to
improve effective use of compulsory license for access to medicines in its
IP action plan

— Chile is criticised for the Chilean Chamber of Dispute’s calling for the
use of compulsory license in the pandemic

— South Africa and India for our legitimate use of WTO law to submit the
current waiver proposal.

Madam Chair, we recall our questions under IP/C/W/674 and would appreciate
delegates of the US and the EU to shed a light on whether the final report
of Special 301 review this year and the upcoming EC report on IP
enforcement in third countries will both refrain from criticising countries
legitimate actions of using and discussing TRIPS flexibilities for public
health safeguarding.

In closing, we would once again call that we move to a text-based
discussion. We have come a long way since October, we all agree that
COVID-19 is an exceptional circumstance that requires common and inclusive
actions. As you indicated Madam Chair, there are common understandings that
are emerging, which could be captured in documentary form. We all realize
that our destinies are intertwined and that we have to find better ways to
collaborate, though we continue to disagree on how this can be done in the
best way.

Based on past practice of convening meetings in various formats and
configurations, we expect that this practice will continue. Cosponsors will
soon start a process to discuss possible approaches to the draft Waiver
text which may lead to an amendment of the current text. We look forward to
continue this engagement with all Members as a priority, we need to pass
this Waiver as soon as possible. Let’s get it done and save lives.


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


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