[Ip-health] WTO TRIPS Council (informal): South Africa’s interventions on COVID-19, TRIPS flexibilities, and domestic manufacturing capacity

Thiru Balasubramaniam thiru at keionline.org
Sun Jun 21 09:59:10 PDT 2020


https://www.keionline.org/33388



WTO TRIPS Council (informal): South Africa’s interventions on COVID-19,
TRIPS flexibilities, and domestic manufacturing capacity
Posted on June 21, 2020 <https://www.keionline.org/33388> by Thiru
<https://www.keionline.org/author/thiru>

On Friday, 19 June 2020, the World Trade Organization (WTO) convened an
informal virtual Open-ended Meeting of the TRIPS Council. .

The following statements were delivered by South Africa at the virtual
open-ended informal meeting of the TRIPS Council.

In relation to TRIPS flexibilities, South Africa noted:

“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. 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. The outbreak has led to
a swift increase in global demand with many countries facing acute
shortages, constraining the ability to effectively respond to the outbreak.
Shortages of these products has put the lives of health and other essential
workers at risk, and is also threatening to spread COVID-19 further. It is
in this context that Members should assess to what extent TRIPS
flexibilities can be useful to deal with the pandemic.”

“However, many developing country Member States may also face legal,
technical and institutional challenges in using TRIPS flexibilities.
National patent laws may not even have the necessary provisions to issue
compulsory licenses in the public interest or government use licenses or
where such a possibility exists, Sometimes, provisions on compulsory
licensing in national legislation are subject to specific processes and as
such, the issuance of compulsory license may involve lengthy processes that
are time-consuming. We also note that lack domestic manufacturing capacity
to produce COVID-19 related pharmaceutical products, diagnostics and other
PPEs is lacking in most countries of the world, making them dependent on
imports to meet their medical needs.”

In relation to domestic manufacturing capacity, South Africa highlighted
the inadequacies of Article 31bis of the TRIPS Agreement intimating that it
was not fit for purpose in relation to the COVID-19 response.

In this context access to Article 31bis of the TRIPS Agreement many not be
effective in securing access to much needed pharmaceuticals, medical
devices, diagnostics and therapeutic technologies to address the health
impact of COVID-19. In this context, IP rights may constitute a barrier to
the diagnosis, treatment and overall management of COVID-19 and
co-morbidities. Multilateral cooperation is going to be critical in
ensuring an effective response to the pandemic and may require drawing from
both current and past experiences in finding an innovative solution to this
unprecedented crisis. In anticipation that intellectual property may pose a
barrier to access several ad-hoc unilateral initiatives have emerged.
However, these initiatives, while commendable, are simply inadequate to
address the IP barriers. Holders of protected technologies that are crucial
in the battle against COVID-19 may not participate in such initiatives and
voluntarily surrender their IP. Licenses granted under such schemes tend to
limit the number of countries that can be supplied by the licensee,
upper-middle income countries are often excluded. The role of governments
acting in the public interest will be important to address possible
obstacles to access to medicines and medical technology that could be posed
by IPRs. Madam Chair, this delegation together with others also highlighted
the nexus between intellectual property rights and public interest.

------------------------------


*19 June 2020*

*South Africa’s interventions at the open-ended informal meeting of the
TRIPS Council.*

We thank you once again for convening virtual open-ended meeting and for
the report of your meeting with a smaller group of members. We join others
in welcoming you to the TRIPS Council.

Furthermore, we would like to thank the Secretariat for the updated report
on COVID-19 measures taken in to trade-related intellectual property rights.


*ITEMs 1,2&4*

Madame Chair,

At the outset, we wish to align ourselves with the statement made by
Jamaica on behalf of the ACP. For efficiency reasons, we will address items
1,2&4 together.

*i. COVID-19*

The World Health Organisation (WHO) announced it as a public health
emergency of international concern on January 30, 2020 and as a pandemic on
March 11, 2020. Since this time the SARS-CoV-2 has spread across the world
and as of 18 June 2020, the number of fatalities linked to the virus stand
at 445 535, with 8 242 999 confirmed cases. COVID-19 cases exceed 200 000
on the African continent, South Africa is the most affected, accounting for
25% of the continent’s total cases. A recent analysis by the Western Cape
Department of Health (South Africa) indicate that health outcomes of 12 987
people with COVID-19 indicates that people living with HIV and people with
past or current tuberculosis infections have a two- to three-times greater
risk of dying of COVID-19. These data, the first to come from a country
with a high burden of HIV and tuberculosis. These co-morbidities are likely
to make the task of controlling the impact of COVID-19 so much more
difficult.

*ii. TRIPS Flexibilities*

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. 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. The outbreak has led to
a swift increase in global demand with
many countries facing acute shortages, constraining the ability to
effectively respond to the outbreak. Shortages of these products has put
the lives of health and other essential workers at risk, and is also
threatening to spread COVID-19 further. It is in this context that Members
should assess to what extent TRIPS flexibilities can be useful to deal with
the pandemic. The Doha Declaration on the TRIPS Agreement and Public Health
(Doha Declaration) reaffirms the right of WTO Members to protect public
health. It states: “We agree that the TRIPS Agreement does not and should
not prevent members from taking measures to protect public health.
Accordingly, while reiterating our commitment to the TRIPS Agreement, we
affirm that the Agreement can and should be interpreted and implemented in
a manner supportive of WTO members’ right to protect public health”.

However, many developing country Member States may also face legal,
technical and institutional challenges in using TRIPS flexibilities.
National patent laws may not even have the necessary provisions to issue
compulsory licenses in the public interest or government use licenses or
where such a possibility exists, Sometimes, provisions on compulsory
licensing in national legislation are subject to specific processes and as
such, the issuance of compulsory license may involve lengthy processes that
are time-consuming. We also note that lack domestic manufacturing capacity
to produce COVID-19 related pharmaceutical products, diagnostics and other
PPEs is lacking in most countries of the world, making them dependent on
imports to meet their medical needs.


*iii. Domestic Manufacturing Capacity*

In this context access to Article 31bis of the TRIPS Agreement many not be
effective in securing access to much needed pharmaceuticals, medical
devices, diagnostics and therapeutic technologies to address the health
impact of COVID-19. In this context, IP rights may constitute a barrier to
the diagnosis, treatment and overall management of COVID-19 and
co-morbidities. Multilateral cooperation is going to be critical in
ensuring an effective response to the pandemic and may require drawing from
both current and past experiences in finding an innovative solution to this
unprecedented crisis. In anticipation that intellectual property may pose a
barrier to access several ad-hoc unilateral initiatives have emerged.
However, these initiatives, while commendable, are simply inadequate to
address the IP barriers. Holders of protected technologies that are crucial
in the battle against COVID-19 may not participate in such initiatives and
voluntarily surrender their IP. Licenses granted under such schemes tend to
limit the number of countries that can be supplied by the licensee,
upper-middle income countries are often excluded. The role of governments
acting in the public interest will be important to address possible
obstacles to access to medicines and medical technology that could be posed
by IPRs. Madam Chair, this delegation together with others also highlighted
the nexus between intellectual property rights and public interest.

*iv. Work of the TRIPS Council*

We welcome an opportunity to discuss the implications of COVID-19 in the
TRIPS Council, especially in light of transparency obligations under
Article 63.1.

Given the important systemic implications that COVID-19 has on our work, it
would be important to keep this matter on the agenda and to give Members an
opportunity to discuss measures taken, while the work that the Secretariat
has undertaken in this area is useful to keep Members informed regarding
the latest developments regarding the epidemic, not only in the WTO but
also more broadly. Having said this, the Secretariat has a circumscribed
role in how information is collected, collated and disseminated, we welcome
the fact the all information contained in non-exhaustive list of
COVID-measures has been verified with Members. We also support the idea of
a possible seminar on COVID-19 and the impact of IPR on access to medicines.

It is important to emphasise the fact that COVID-19 goes well beyond the
traditional notions flexibilities related to access to medicines. The
pandemic call for a need of digital innovation, including epidemic
modelling to monitor and understand the spread and development of the virus
across populations, including tracking of cases and spreaders. This
underscores the importance of the 1998 Work Programme on Electronic
commerce, based on the existing mandate as set out in WT/L/274. We would
encourage delegations to take up the crosscutting issues of ecommerce in
the TRIPS Council as a matter of urgency.

In light of the above, my delegation believes there are good grounds to
convene a regular meeting of the TRIPS Council as soon as possible, as
other councils and committees have done, with an agenda that focus on
standing items, issues underscored by ministerial mandates, as well as
COVID-19 given the disproportionate effect it is likely to have on
developing countries and LDCs, we further wish to emphasize that LDCs
specific issues must continue to enjoy the highest priority in the TRIPS
Council.

*ITEM 3*

The WTO General Council meeting in December 2019 agreed to take note of the
work done by the Council for Trade-Related Aspects of Intellectual Property
Rights pursuant to the Ministerial Conference decision of 18 December 2017
on “TRIPS Non-Violation and Situation Complaints” (WT/L/1033), that the
TRIPS Council would continue its examination of the scope and modalities
for complaints of the types provided for under subparagraphs 1(b) and 1(c)
of Article XXIII of GATT 1994 and make recommendations to the 12th
Ministerial Conference.

South Africa is not a proponent for the application of draft modalities in
respect of NVC&S, however we remain open to discuss any ideas that
delegations may have in this regard. In the past we identified a few useful
elements that can inform a debate on NVC&S. We stand ready to work with
other Members to advance work in this important area.

*END.*


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


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