[Ip-health] Statement of the European Union at the WTO General Council (27 July 2021): TRIPS Council matters - Status report on the considerations by the TRIPs Council on the revised "Proposal for a Waiver from certain provisions of the TRIPs Agreement for the prevention, containment and treatment of Covid-19” (IP/C/W/669/REV.1)

Thiru Balasubramaniam thiru at keionline.org
Thu Jul 29 02:29:29 PDT 2021


*4.         TRIPS Council matters*

*A. Status report on the considerations by the TRIPs Council on the
revised "Proposal for a Waiver from certain provisions of the TRIPs
Agreement for the prevention, containment and treatment of Covid-19”

The European Union thanks Ambassador Sørli for his status report. The
European Union is strongly committed to achieving our common goal: to
continue ramping up production, to share COVID-19 vaccines and medicines
more widely and faster, and to ensure equitable access to these products
for low – and middle-income countries.

The European Union is making every effort to fight the pandemic. The
European Union is the biggest producer of mRNA vaccines and is therefore at
the forefront of deliveries of vaccines to the rest of the world: so far,
more than 500 million doses have been exported from the European Union and
similar amounts have been delivered to Europeans.

The European Union and its Member States have also been the largest donor
to the COVAX facility: 3.2 billion EUR have been committed to support
equitable distribution of vaccines.

We already see enormous progress in the total global production of COVID-19
vaccines: according to Airfinity, a billion doses were produced by April
12, another billion were produced by May 26 and the third billion by June
22. It is clear that the production is accelerating and is therefore
realistic to expect that some 10 billion doses will be produced by the end
of 2021. For comparison, the total global output of all vaccines before
COVID was only 5 billion doses.

To support short-term actions for ramping up vaccine production, the
European Commission set up a vaccine task force in the EU whose objective
is to match supply with demand and to lift bottlenecks. Its main tasks are
to promote partnerships through matchmaking events. And this has brought
tangible results: we have seen that so far, technology transfer is working
well with a number of high-level partnerships announced recently. Fifty
three (53) EU manufacturing sites are already engaged in relation to the
COVID-19 vaccines, based on voluntary partnerships.

Important partnerships are forged also outside of the European Union Just
to give an example – recently Pfizer has signed a letter of intent with the
South African company Biovac, to manufacture the Pfizer-BioNTech COVID-19
Vaccine for distribution within Africa. Technology transfer, on-site
development and equipment installation activities will begin immediately.
It is expected that the facility will be brought into the supply chain by
the end of this year. Biovac will obtain drug substance from BioNTech’s
facilities in Germany, and manufacturing of finished doses will commence in
2022. At full operational capacity, the annual production will exceed 100
million finished doses annually. All doses will exclusively be distributed
to the fifty-five (55) Member States of the African Union.

Beyond the current crisis, it is also necessary to build resilience of the
health systems in those countries, which do not have their own
manufacturing capacity and are overly reliant on imports. To this end, the
European Union and its Member States are launching an initiative to develop
vaccine production in the African continent entailing investment in
infrastructure and production capacities as well as skills development,
supply chains management, and the necessary regulatory framework in order
to create conditions for technology transfer. The objective is to develop a
number of regional hubs distributed across the African continent. And we
have already identified promising projects in South Africa, Senegal and
Rwanda. One billion EUR has already been allocated from the EU budget and
the EU finance institutions to deliver on this goal.

On July 9th, the EU signed in Dakar a 6.7 million EUR grant in support of
Institut Pasteur Dakar, in Senegal, to produce the anti-Covid 19 vaccine by
early 2022 with a production capacity of 300 million doses of vaccines per
year. Rwanda is also receiving EU support to enhance its manufacturing
capacities and strengthen regulatory frameworks.

These are only examples showing the range of efforts and actions that are
taken – it is clear that the response must go beyond the matters related to
trade. But trade may and should play a role in enhancing access to COVID-19
vaccines and medicines.

The intense discussions in various fora have demonstrated that limited
manufacturing capacity, restricted access to raw materials and other inputs
as well as complex supply chains are the main bottlenecks as regards the
production and distribution of COVID-19 vaccines. In addition, having the
required know-how is key due to the complexity of the production process of
these vaccines. Last week, the WTO published information on the bottlenecks
regarding critical products to combat COVID-19 that confirms these findings.

Trade-related measures, if agreed swiftly, could address some of the
bottlenecks and make a real difference. We need to look into export
restrictions, minimise barriers to trade and put forward trade-facilitation
measures. We will further discuss these issues in a separate point of our
agenda today.

 Given the nature of the identified bottlenecks and the need for the
sharing of know-how, the European Union does not believe that the proposed
suspension of the TRIPS Agreement by the waiver proposed by South Africa,
India and a number of other WTO Members, is an appropriate and effective

The proposed waiver will not increase production of COVID-19 vaccines and
medicines, as it will not address any of the existing bottlenecks that have
been identified. It rather risks having counterproductive effects on our
common efforts to enhance access to such vaccines and medicines. In
particular, it will undermine the ongoing collaborations, which are based
on the well-established platform of intellectual property protection and
will have a chilling effect on future such collaborations.

In addition, the waiver may have harmful effects going forward when it
comes to fighting future pandemics and more generally on incentives for
research and innovation. The European Union has provided details on these
risks in the discussions in the TRIPS Council.

The intellectual property system is not an obstacle to the access to
COVID-19 vaccines and medicines. To the contrary, it has played the key
role in the development of these products and can play an enabling role in
deploying existing capacity or creating new capacity for the production of
COVID-19 vaccines and medicines. The European Union believes that it is
possible to enhance the role of the IP system while at the same time
maintaining the protection required for incentivising technology transfer
and investment in innovation, so that we can fight against new strains of
COVID-19 and any future diseases. It is to this end that the European Union
has put forward an alternative proposal to the proposal on the waiver – the
European Union proposal focuses on the clarification and facilitation of
the use of compulsory licensing system.

The compulsory licensing system provides for tools that can be used in
times of the pandemic to overcome potential IP-related obstacles, it also
provides enough legislative space to apply the system in a swift manner.
The proposal is meant to clear any doubts that may persist about the use of
the system and to indicate ways in which the system can be used in a fast
and simple manner that is fully adapted to the challenges of the pandemic.

We have proposed clarifications on the elements that we find most relevant
for the situation of the pandemic, that is the fast-track procedure that
omits negotiations with right holders; the support for manufacturers
wishing to supply to low- and middle-income countries at discount prices;
and the simple single notification to be made by the exporting country to
speed up exports. We have also emphasized that the European Union remains
open to discuss other aspects of the compulsory licensing system that merit
clarification and facilitation. This discussion has already started in the
TRIPS Council.

In our view, clarifications on the proposed aspects would provide the
necessary legal certainty to Members to intervene and swiftly grant
compulsory licences including for purposes of export to countries that are
lacking manufacturing capacity. Our approach would also promote production
and supply of those products to low- and middle-income countries at
affordable prices, including via the COVAX Facility.

Given the stalemate we are experiencing in the TRIPS Council, we encourage
all WTO Members to try to find convergence on the basis of the European
Union proposal as the one that is pragmatic, targeted and effective in
responding to the current needs while keeping intact the necessary
incentives for innovation. It is through the targeted approach proposed by
the European Union that we believe we can advance in our discussions on the
intellectual property element of the WTO response to the COVID-19 crisis
and finally pave the way for advancing on the other parts of the needed
comprehensive approach.

We are ready to discuss all the requirements of the compulsory licensing
system, requirement by requirement, to see what issues there are, how they
can be addressed and how we can make the system function. We thank all
Members for their engagement on our proposal and for their contributions,
questions and thoughts on it so far. We have received valuable feedback and
we are pleased to see the interest of various delegations on this approach.
And we look forward to our continued discussion and hope to be able to
agree on an outcome in advance of the November Ministerial Conference.

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

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