India and South Africa Asks for TRIPS Waiver
on Covid-19
At the meeting of the Council for Trade-Related Aspects of Intellectual
Property Rights (TRIPS) on 15-16 October 2020, WTO members discussed how best to
use the global intellectual property (IP) system to tackle the COVID-19 pandemic.
Members also discussed the extension of the transitional period for least developed
countries (LDCs) to implement the TRIPS Agreement and a new proposal on the competitiveness
of micro, small and medium enterprises (MSMEs) through the protection of IP rights.
Some
40 members engaged in a substantive discussion on a proposal submitted by India
and South Africa for a temporary waiver of certain TRIPS obligations they said would
facilitate an appropriate response to COVID-19. The proposal suggests a waiver for
all WTO members on the implementation, application and enforcement of certain provisions
of the TRIPS Agreement in relation to the "prevention, containment or treatment"
of COVID-19. The proponents argued this would avoid barriers to the timely access
to affordable medical products including vaccines and medicines or to scaling-up
of research, development, manufacturing and supply of essential medical products.
The waiver
would cover obligations in four sections of Part II of the TRIPS
Agreement - Section 1 on copyright and related rights, Section 4 on
industrial designs, Section 5 on patents and Section 7
on the protection of undisclosed information. It would last for a specific number
of years, as agreed by the General Council, and until widespread vaccination is
in place globally and the majority of the world's population is immune. Members
would review the waiver annually until its termination.
According
to the proponents, an effective response to the COVID-19 pandemic requires rapid
access to affordable medical products such as diagnostic kits, medical masks, other
personal protective equipment and ventilators as well as vaccines and medicines.
The outbreak has led to a swift increase in global demand, with many countries facing
shortages, constraining the ability to effectively respond to the outbreak. As new
diagnostics, therapeutics and vaccines for COVID-19 are developed, there were significant
concerns about how these will be made available promptly in sufficient quantities
and at affordable prices to meet global demand.
The proponents
argued that many countries - especially developing countries - may face institutional
and legal difficulties when using TRIPS flexibilities, including the special compulsory
licensing mechanism provided for in Article 31bis, which
they saw as a cumbersome process for the import and export of pharmaceutical products.
Now was the time for the WTO as an organization to rise up to the collective call
for defeating the pandemic. The WTO would not succeed in its efforts to rebuild
the COVID-19 affected economies unless it acts now to first save those lives that
are going to build these economies. It is time for members to take collective responsibility
and put people's lives before anything else, they concluded.
While
a number of developing and least developed country members welcomed the proposal
as a contribution to the discussion, many were still studying it in their capitals
and asked for clarification on certain points, particularly regarding its practical
implementation and the possible economic and legal impact of the waiver at national
level. A number of developing and developed country members opposed the waiver proposal,
noting that there is no indication that intellectual property rights (IPRs) have
been a genuine barrier to accessing COVID-19 related medicines and technologies.
While
acknowledging that the sustained and continued supply of such medicines and technologies
is a difficult task, they observed that non-efficient and underfunded health care
and procurement systems, spiking demand and lack of manufacturing capacity are much
more likely to impede access to these materials. In the view of these members, solutions
can be legitimately sought within the existing IP system as the TRIPS Agreement
provides enough tools and sufficient policy space for members to take measures to
protect public health. The suspension of IPRs, even for a limited period of time,
was not only unnecessary but it would also undermine the collaborative efforts to
fight the pandemic that are already under way.
Given
this range of positions, the Council chair, Ambassador Xolelwa
Mlumbi-Peter of South Africa, said that the item would
remain suspended as members continue to consider the proposal. Requests for waivers
concerning WTO agreements must be submitted initially to the relevant council for
consideration. After 90 days, the TRIPS Council has to submit a report to the Ministerial
Conference. Given that the proposal was submitted on 2 October, the 90-day time-period
expires on 31 December 2020. The TRIPS Council meeting will be reconvened on the
item of the waiver proposal as appropriate before that date, the chair said.
There
was general appreciation among delegations for the WTO Secretariat's work in maintaining
the list of COVID-19 related IP measures on the WTO website and broad support for
a continued discussion and exchange on the basis of this compilation. In light of
this, it was agreed to revert to this agenda item at the next meeting of the Council
so that these exchanges can continue, including on the basis of the updated Secretariat document
of COVID-19 related IP measures.
Members
discussed a request by Chad, on behalf of the LDC Group, to extend the general transitional
period for LDCs to implement the TRIPS Agreement. This exemption has been previously
extended on two occasions. On 29 November 2005, a TRIPS Council decision extended
this general transition period until 1 July 2013. Subsequently on 11 June 2013,
the Council renewed the transition period until 1 July 2021.
Article 66.1 of the TRIPS
Agreement states that in view of the special needs and requirements
of LDCs, their economic, financial and administrative constraints, and their need
for flexibility to create a viable technological base, they shall not be required
to apply the provisions of the Agreement for a period that can be extended by the
TRIPS Council upon a duly motivated request by an LDC.
Chad
noted that the COVID-19 pandemic has further exacerbated the challenges that the
LDCs continue to face, such as lack of domestic financial resources, high debt levels
and fragile health systems, which can have far-reaching impacts on education, human
rights, employment, food security and economic development in the long term.
While
a majority of members supported in principle the extension of the transition period
for LDCs, others asked for more time to consult with their capital. The chair suggested
that the LDC Group consult with other members in order to provide further explanations
and to bridge differences as soon as possible given next year's deadline.
Following
up on past discussions on IP and innovation that have regularly been added to the
Council's agenda since 2012, the co-sponsors (Australia, Canada, Chile, the European
Union, Japan, Singapore, Switzerland, Chinese Taipei, the United Kingdom and the
United States, with the support of South Korea) proposed to discuss the topic of
“Making MSMEs competitive through inclusive protection of various IPRs".
The proponents
underlined the key role MSMEs play in most economies as major sources of innovation,
industrial competitiveness and international trade. In emerging markets, small companies,
such as start-ups, are able to create innovative products and services and to respond
quickly to drastic changes in technology and industrial structures. They also contribute
to open innovation through collaboration with large and medium-sized companies.
However,
most MSMEs lack IP awareness, human and financial resources, and experience in developing
IP strategies as they do not comprehensively register their IP rights. They also
lack resources and experience in enforcing their IP rights against infringement.
In this context, the debate aimed to facilitate the exchange of knowledge and experiences.
Members shared examples of MSMEs developing their business through building and
achieving optimal exploitation of the highest possible quality IP and on how governments
can support MSMEs' initiatives to expand their businesses by encouraging such IP
portfolios.
The Secretariat
is planning to once again hold a workshop on the implementation of Article 66.2
of the TRIPS Agreement regarding incentives for technology transfer to LDCs early
next year. Article 66.2 of the TRIPS
Agreement calls on developed countries to provide incentives to enterprises
and institutions in their territories for the purpose of promoting and encouraging
technology transfer to LDCs in order to enable them to create a sound and viable
technological base. The workshop will once again comprise two days of sessions,
and a reporting and review segment within the first TRIPS Council meeting of 2021.
Until then, members will have time to assess the information provided by developed
countries in their reports and discuss the LDCs' proposal regarding the template
for reporting on commitments under this article.
On TRIPS
non-violation and situation complaints (NVSCs) - whether members should be able
to bring complaints where they consider that another member's action, or a particular
situation, has deprived them of an expected advantage under the TRIPS Agreement,
even though no obligation under the Agreement has been violated - members reiterated
their well-known positions. The chair encouraged members to table submissions that
can assist in shaping the discussion and result in a meaningful outcome at the 12th
Ministerial Conference scheduled to be held in 2021. The Secretariat reported on
the NVSCs briefing session held on 3 September 2020, which provided information
on the origin and application of such complaints in the General Agreement on Tariffs
and Trade and the WTO, on the discussions in the context of the TRIPS Agreement
and on NVSC provisions in regional trade agreements. The briefing attracted over
90 participants across the globe and received positive feedback.
In the
context of the annual review of the Special Compulsory Licensing System in Article
31bis of the TRIPS Agreement, the Secretariat gave a presentation on the steps to
use the system. Since the entry into force of the Protocol Amending the TRIPS Agreement
on 23 January 2017, the annual review also responds to the requirements now incorporated
into the amended TRIPS Agreement. The chair said that the Protocol has been accepted
by 131 members and recalled that the current acceptance period runs until 31 December
2021.