[Ip-health] South Africa on fire: closing innings at the WTO TRIPS Council (10 December 2020)

Thiru Balasubramaniam thiru at keionline.org
Thu Dec 10 22:27:05 PST 2020


https://www.keionline.org/34811

South Africa on fire: closing innings at the WTO TRIPS Council (10 December
2020)
Posted on December 11, 2020 <https://www.keionline.org/34811> by Thiru
<https://www.keionline.org/author/thiru>

On Thursday, 10 December 2020, the World Trade Organization (WTO) convened
a formal meeting of the WTO TRIPS Council to discuss a waiver from certain
provisions of the TRIPS Agreement for the prevention, containment and
treatment of COVID-19. This proposal is co-sponsored by: Bolivia, Eswatini,
India, Kenya, Mozambique, Pakistan, and South Africa.

South Africa took the floor at around 15h00 Central European Time (CET).
South Africa’s full intervention numbered over 3,700 words. The full
statement can be found here: South Africa Statement at the 10 December
TRIPs Council meeting
<https://www.keionline.org/wp-content/uploads/South-Africa-Statement-at-the-10-December-TRIPs-Council-meeting.docx>

South Africa opening with the following remarks.


   Madame Chair,


   Thank you for giving us the floor, like others we would like to thank
   you for the report presented this morning as well as your efforts to
   facilitate discussions on the waiver proposal. At the informal meeting of
   20 November and 3 December respectively, proponents reverted to questions
   posed by several delegations. We would like to ask that our responses
   during those meetings be made part of the record of today’s formal
   proceedings. Taken up in our intervention are some of crosscutting issues
   raised in document IP/C/W/671, which we will revert to in writing.
   Furthermore, I would like to thank all delegations that took the floor
   today. We have seen new members take the floor today who had not previously
   spoken, we are heartened by the level of engagement and welcome Bolivia to
   the ranks of the co-sponsors. Today some new issues arose from
   interventions, including questions from the delegation of Norway and
   Vietnam regarding possible modification of the scope of the waiver. The
   co-sponsors stand ready to discuss the scope of the waiver proposal. We
   welcome the United Kingdom’s statement regarding efforts to explore how
   products and technologies can be made available to the WHO C-TAP
   initiative. This is one of the avenues that our waiver supports in addition
   to all efforts to scale up production and access to COVID-19 products and
   technology. In the interim Madam Chair, there have also been noteworthy
   developments in policy guidance issued by the European Union through its IP
   action plan and pharmaceutical strategy which has direct bearing on our
   discussion in the TRIPS Council, which we will come back to later in our
   statement.

South Africa described bilateral procurement deals (such those negotiated
by the European Union, the United Kingdom, and the United States) as
reinforcing “vaccine apartheid” and enlarging “chasms of inequity.”

Those delegations opposing the waiver proposal have repeatedly suggested
that voluntary approaches offer the best solution. As would have been
emphasized, the TRIPS waiver proposal is supportive of any voluntary
licenses issued by companies, however the terms of such licenses are often
such that they may restrict access or reserve supply only for wealthy
nations. Similarly, for vaccines, bilateral deals are being signed by
pharmaceutical companies with specific governments but the details of these
deals are mostly unknown. Usually these agreements are for manufacturing of
limited amounts and solely supplying a country’s territory or a limited
subset of countries. Ad hoc, non-transparent and unaccountable bilateral
deals that artificially limit supply and competition cannot reliably
deliver access during a global pandemic. These bilateral deals do not
demonstrate global collaboration but rather reinforces “vaccine apartheid”
and enlarges chasms of inequity. Disparity in access is certain to continue
unless concrete steps are taken to address intellectual property barriers.
If what the EU, the US and Japan is suggesting, namely that the IP system
is responsible for delivery of vaccines in record time, it would fly in the
face of the heroic efforts of ordinary people, researchers, scientists and
government support and funding to enable this monumental feat. Not
companies, but ordinary people have generously donated their skills and
efforts to enable global collaboration by participating in vaccine trails,
may in developing countries, putting their lives at risk for the greater
good of mankind. Yet the irony does not escape us, these very people are
denied priority access despite the enormous sacrifices they made.

In relation to the deficiencies of the COVAX Facility, South Africa noted
the following.

We reiterate that the targets set by Act-A including the Covax is to
provide 2 billion vaccine doses (for 1 billion people) to the world by the
end of 2021, 245 million courses of treatment and 500 million diagnostic
tests to LMICs (excluding many developing countries) in 2021 are
insufficient to meet global needs of the 7.7 billion people of this world.
As we seen vaccine rollouts in the developed world, we cannot but continue
to wonder when equitable and timely access will become a reality, with more
than 90 % of all future production of likely vaccine candidates being
reserved for rich developed countries.

South Africa reminded the TRIPS Council on developments taking place at
WIPO’s discussions on patents and health (on that very day) at the Standing
Committee on the Law of Patents (SCP).

Up the hill at WIPO, we hear that the United States of America, has
objected to the update of WIPO’s review of existing research on patents and
access to medical products and health technologies to extend the
publication period of studies up to 2020. In light of the destruction
wrought by the COVID-19 pandemic, one wonders what the United States
concerns would be regarding an updated report by the WIPO Secretariat?

In its closing remarks, South Africa focused its attention on the
Pharmaceutical Strategy for Europe and the Intellectual Property Action
Plan.

On the subject of the transparency of R&D costs, South Africa asked the
European Union the following.


   We notice the recent IP action plan and pharmaceutical strategy
   published by the European Commission which urges EU members to use fast
   track compulsory license and explore coordinated compulsory license in EU.
   In launching the Pharmaceutical Strategy for Europe, Vice President Schinas
   underscored the importance that the transparency of R&D costs plays in
   ensuring access to affordable medicines. In his remarks to the press on 25
   November 2020, Vice- president Schinas said,
   “*Equally important, ensuring affordability of medicines will be
   guaranteed through bolstering transparency on R&D costs and expenditure on
   medicines in healthcare systems, finding a consensus on costing principles
   and addressing aspects that impede the competitive functioning of the
   markets mpacting on affordability.*“


   This principle resonates well with our submission to the October 2019
   TRIPS Council and the WHO Transparency Resolution (WHA72.8). Could the
   European Union provide more details on how it intends to ensure the
   “affordability of medicines” through the “bolstering of R&D costs”?

South Africa pressed the European Union to provide more details on their
support of voluntary measures, including the pooling of intellectual
property.

The EU IP Action Plan, released on 25 November 2020, reiterates the exigent
need to deploy COVID-19 technologies, “not only in Europe but also on a
global basis.” To this end, the EU IP plan calls for “voluntary pooling and
licensing of intellectual property related to COVID-19 therapeutics and
vaccines, in line with the recent resolution of the World Health Assembly
to promote equitable global access as well as a fair return on investment.”
Can the European Union elucidate further on how they intend to transform
this lofty rhetoric into concrete action? The EU IP Action Plan notes that
the Commission is “working on mechanisms that would enable and incentivise
the rapid pooling of critical IP in times of crisis”. Could the European
Union please explicate on these mechanisms that would enable the “rapid
pooling of critical IP in times of crisis.”

South Africa took note of President Ursula von der Leyen’s State of the
Union call for the establishment of an EU BARDA – including the provision
of march-in rights.

Following on from President Ursula von der Leyen’s State of the Union call
for the establishment of an EU BARDA, the EU’s IP action calls for the
development of an “effective framework for march-in rights, that should
guarantee that publicly funded IP is available in case of critical
shortages”. Could the European Union please provide details on the design
of these march-in rights?

On compulsory licensing, South Africa posed the following set of questions
to the European Union.


   We would counter the EU’s assertion, repeated once again today, that
   compulsory licensing should be used as “means of last resort and a safety
   net when all other efforts to make IP available have failed.” Nonetheless,
   could the European Union please provide further details on the EU IP Action
   Plan’s recommendation that EU Member States “establish fast-track
   procedures to issue compulsory licenses in emergency situations”?


   The Commission will explore with Member States the possibility of
   creating an emergency co-ordination mechanism, to be triggered at short
   notice when Member States consider issuing a compulsory license. What is
   the rationale behind this policy decision?


   In the European Union, data exclusivity and on certain products market
   exclusivity are granted. How does the EC want to make effective use of CL
   in this pandemic with these non-patent barriers in place?


   As the European Union has opted out of Article 31bis of the TRIPS
   Agreement, how would EU member states with no or insufficient manufacturing
   capacities make effective use of the compulsory licensing provisions of the
   TRIPS Agreement, especially in light of the IP Action Plan’s emphasis on
   establishing “fast-track procedures to issue compulsory licenses in
   emergency situations”?



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


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