[Ip-health] WTO TRIPS Council: India and South Africa submit draft decision text on a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19.

Thiru Balasubramaniam thiru at keionline.org
Fri Oct 2 09:23:08 PDT 2020


https://www.keionline.org/34061

WTO TRIPS Council: India and South Africa submit draft decision text on a
waiver from certain provisions of the TRIPS Agreement for the prevention,
containment and treatment of COVID-19.
Posted on October 2, 2020 <https://www.keionline.org/34061> by Thiru
<https://www.keionline.org/author/thiru>

On Friday, 2 October 2020, the World Trade Organization (WTO) published a
joint submission by India and South Africa on a draft decision text to the
WTO TRIPS Council on a waiver from certain provisions of the TRIPS
Agreement for the prevention, containment and treatment of COVID-19.

In their communication, IP/C/W/669
<https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True>,
India and South Africa presented the following request:

In these exceptional circumstances, we request that the Council for TRIPS
recommends, as early as possible, to the General Council a waiver from the
implementation, application and enforcement of Sections 1, 4, 5, and 7 of
Part II of the TRIPS Agreement in relation to prevention, containment or
treatment of COVID-19.

In terms of the duration of the waiver, India and South Africa frame their
request in the following manner. The waiver would apply to all WTO members
but would not prejudice “the right of least developed country Members under
paragraph 1 of Article 66 of the TRIPS Agreement.”

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.

Section 1 of part II of the TRIPS Agreement
<https://www.wto.org/english/docs_e/legal_e/27-trips_04_e.htm> pertains to
copyright and related rights; section 4 deals with industrial designs.
Section 5 of part II of the TRIPS Agreement pertains to patents; section 7
deals with the protection of undisclosed information.

The joint submission by India and South Africa is a timely initiative to
recalibrate the architecture of the WTO TRIPS Agreement to respond to the
COVID-19 pandemic. This ambitious proposal, if accepted by WTO membership,
would facilitate deep technology transfer for effective COVID-19-related
vaccines, therapeutics or diagnostic tests as the joint submission covers
patents, copyright, industrial designs, and undisclosed information
including know-how and trade secrets.

The next session of the TRIPS Council will take place on 15 October 2020 to
16 October 2020. It remains to be seen how other WTO members including
Canada, the European Union, Japan, Switzerland, the United Kingdom, and the
United States of America respond.

India and South Africa provided the following rationale for their request
for a TRIPS waiver.


   The World Trade Organization (WTO) has cautioned that the “pandemic
   represents an unprecedented disruption to the global economy and world
   trade, as production and consumption are scaled back across the globe”. We
   have witnessed a break down in global supply chains coupled with growing
   supply-demand gaps.


   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.


   The COVID-19 pandemic is now widespread, affecting most WTO Members. As
   at 1 October 2020, there were about 333,722,075 confirmed cases globally
   with 1,009,270 confirmed deaths. To date, there is no vaccine or medicine
   to effectively prevent or treat 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.


   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 joint WTO submission details the acute shortages of COVID-19 health
technologies faced by many countries.


   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 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.


   To meet the growing supply-demand gap, several countries have initiated
   domestic production of medical products and/or are modifying existing
   medical products for the treatment of COVID-19 patients. 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.

In relation to intellectual property, India and South Africa make it clear
that the joint submission encompasses more than just patents.


   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 Member States have
   carried out urgent legal amendments to their national patent laws to
   expedite the process of issuing compulsory/government use licenses.


   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
   products.


   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.

The draft decision text follows.
------------------------------

Annex: Draft Decision Text

WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION,
CONTAINMENT AND TREATMENT OF COVID-19

The General Council

*Having regard* to paragraphs 1, 3 and 4 of Article IX of the Marrakesh
Agreement Establishing the World Trade Organization (“the WTO Agreement”);

*Conducting* the functions of the Ministerial Conference in the interval
between meetings pursuant to paragraph 2 of Article IV of the WTO Agreement;

Noting that the coronavirus disease 2019 (COVID-19) is a new infectious
disease caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2);

*Recalling *that on 11th March 2020, the World Health Organization (WHO)
declared the 2019–20 coronavirus outbreak to be a pandemic, and it
continues to be a very high risk across the globe in all WTO Members;

*Noting with concern* the threat to human health, safety and well-being
caused by the COVID-19 pandemic, which has spread all around the globe, as
well as the unprecedented and multifaceted effects of the pandemic,
including the severe disruption to societies, economies, global trade and
travel and the devastating impact on the livelihoods of people;

*Recognising* the need for unimpeded and timely access to affordable
medical products including diagnostic kits, vaccines, medicines, personal
protective equipment and ventilators for a rapid and effective response to
the COVID-19 pandemic;

*Recognizing* also that the COVID-19 global pandemic requires a global
response based on unity, solidarity and multilateral cooperation;

*Noting* that, in the light of the foregoing, exceptional circumstances
exist justifying waivers from the obligations of the Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement);

*Decides* as follows:

1. The obligations of Members to implement or apply Sections 1, 4, 5 and 7
of Part II of the TRIPS Agreement or to enforce these Sections under Part
III of the TRIPS Agreement, shall be waived in relation to prevention,
containment or treatment of COVID-19, for [X] years from the decision of
the General Council.

2. The waiver in paragraph 1 shall not apply to the protection of
Performers, Producers of Phonograms (Sound Recordings) and Broadcasting
Organizations under Article 14 of the TRIPS Agreement.

3. This decision is without prejudice to the right of least developed
country Members under paragraph 1 of Article 66 of the TRIPS Agreement.

4. This waiver shall be reviewed by the General Council not later than one
year after it is granted, and thereafter annually until the waiver
terminates, in accordance with the provisions of paragraph 4 of Article IX
of the WTO Agreement.

5. Members shall not challenge any measures taken in conformity with the
provision of the waivers contained in this Decision under subparagraphs
1(b) and 1(c) of Article XXIII of GATT 1994, or through the WTO’s Dispute
Settlement Mechanism.


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


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