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.
TRIPS transition period for LDCs
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.
IP and innovation: MSMEs competitiveness
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.
Members agreed on the following dates for meetings of the Council in 2021:
- 10-11 March 2021
- 8-9 June 2021
- 13-14 October 2021