IP measures in the context of COVID-19
At the request of South Africa, WTO members engaged in a discussion on the important role the WTO – and the TRIPS Council in particular – play in combatting the COVID-19 pandemic.
Developing and least-developed country members highlighted the challenges COVID-19 has presented in terms of access to medicines, vaccines and associated technologies. They called for the TRIPS provisions to be applied with a focus on the rights to protect public health and promote access to medicines for all. These delegations said the TRIPS Council must ensure that vaccines and new medical technologies are made accessible and available regardless of the level of economic development and that intellectual property rights (IPRs) are not a barrier to access. In their view, the COVID-19 crisis allows for the utilization of TRIPS flexibilities contained in the Doha Declaration on TRIPS and Public Health. They said the crisis calls for the removal of complexities in the TRIPS Agreement to improve the Declaration's effectiveness and to ensure benefits for members without domestic pharmaceutical manufacturing capacity.
Developed country members said that during the crisis the IP system had demonstrated its value in boosting scientific and international cooperation against the pandemic, and in promoting and incentivizing medical technologies innovation and research. The TRIPS Agreement, these members said, is the right tool to strike the right balance between innovation and safeguarding public health, including access to affordable medicines for all. The production of high-quality COVID-19 medicines and treatments has been possible based on a system that promotes collaboration and voluntary knowledge-sharing and licensing, while ensuring IPRs are respected, they said.
Members agreed on the relevance of the TRIPS Council as a forum for exchanging information, promoting cooperation and coordinating strategies at the multilateral level to respond effectively to the crisis. However, there was no agreement in including the issue of the COVID-19 response as a standing item on the agenda of future TRIPS Council meetings. Some members expressed their preference to include it on an “ad-hoc” basis in light of further developments.
Several members explained in detail some of the IP-related measures implemented in response to the pandemic. They thanked the WTO Secretariat for its efforts in compiling and updating the list of members' COVID-19 IP-related measures on the WTO website. This non-exhaustive list has been compiled by the WTO Secretariat from official sources. It represents an informal situation report and an attempt to provide transparency with respect to measures taken. The chair encouraged members to promptly provide updated information on these and other measures as appropriate, including through notifications to the TRIPS Council.
Technology transfer to LDCs
On behalf of the LDC Group, Chad submitted a document (IP/C/W/664) proposing a new template for annual reporting on technology transfer to LDCs under Article 66.2 of the TRIPS Agreement. This article 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 to help them create a sound and viable technological base.
The proposed template aims at simplifying the reporting process, synchronizing the current reporting variations, and providing precise evidence of the substantive contributions of developed country members. It is the view of the LDC Group that while some members have made efforts, the implementation of Article 66.2 continues to fall short of the letter and spirit of the TRIPS Agreement mandate. They noted that some reports submitted by developed country members continue to lack clarity on the nature of incentives and whether such incentives result in sufficient technology transfer to LDCs.
Some developed members claimed that it is difficult for governments to ensure technology transfer because technology is the subject of private contracts and rights. However, they expressed their willingness to discuss the new proposed template and to engage in constructive dialogue to improve the system.
In connection with Article 66.2, the chair announced that the WTO Secretariat is planning the 13th Workshop on Technology Transfer. This workshop is planned once again to be held back-to-back with the Council's meeting in February 2021.
Work Programme on e-commerce
South Africa submitted a communication (IP/C/W/665) which calls for reinvigorating the 1998 Work Programme on Electronic Commerce in line with the General Council Decision of December 2019 and inscribing this issue as a standing item on the agenda of the TRIPS Council. South Africa said this would facilitate a deeper discussion of issues that could be based on a catalogue of themes previously agreed by members.
South Africa stressed that IP can have an impact on development so the link between IP and development, as well as the relationship with the various Sustainable Development Goals (SDGs), needs to be mainstreamed into the discussion of the TRIPS Council. For example, the rapid deployment of smart devices and digital interfaces to 3D printing, wearables, automation, robotics and cloud computing are all contributions to a notable digitisation of the world economy, a trend which has been accelerated by COVID-19. In this context, said South Africa, the digital divide impedes the participation of developing countries in digital value chains while digital transformation is disrupting traditional sectors with severe socio-economic consequences.
Members recognized the value of this proposal and supported the initiative to reinvigorate the Work Programme but some delegations opposed including it as a standing item in the Council agenda. The Council has never stopped working on this issue and nothing prevents members from raising it when necessary, these delegations said.
IP and the public interest
Following up on past items on the intersection between IP and the public interest, South Africa proposed to address the topic of “Beyond access to medicines and medical technologies – towards a more holistic approach to TRIPS flexibilities” (IP/C/W/666). South Africa stressed that the use of TRIPS flexibilities to address a public health concern is usually seen as a matter concerning patents. However, in the context of the COVID-19 pandemic, it said this requires a more integrated approach that includes other types of IPRs, including copyright, industrial designs and trade secrets.
South Africa said the use of TRIPS flexibilities in other IP areas, beyond patents, is less understood at the national level. It stressed that the flexibilities may not be sufficient to address issues of access, particularly in the case of countries that have never utilized tools such as compulsory licences. South Africa highlighted the recent solidarity call to action by a group of World Health Organization (WHO) members to realize equitable global access to COVID-19 health technologies, through pooling of knowledge, IP and data. It noted, however, that limited, exclusive and often non-transparent voluntary licensing is the preferred approach of pharmaceutical companies. This is insufficient to address the needs of the current pandemic, it added.
Several developing countries joined South Africa in explaining the legal, technical and institutional challenges they face in using TRIPS flexibilities. They highlighted the lack of domestic manufacturing capacity that makes them dependent on imports to meet their medical needs, particularly in times of crises. Goods and services that are needed to tackle the COVID-19 pandemic include protective equipment such as masks, face shields and hand sanitizers. These products remain in critical shortage in many countries, these members said.
Developed countries urged other members to exercise caution and careful deliberation on issues related to compulsory licensing. They said these issues have significant implications that could negatively affect investment in, and research and development of, future treatments. They could also discourage investment into new markets, including investment in new manufacturing facilities, they said. These members noted that facilitating incentives for innovation and competition to develop, test and produce safe and effective therapeutics and vaccines, or other relevant products for the COVID-19 response will best achieve the shared objective of fighting the pandemic. This would include respecting IP rights and supporting industry-led collaboration and voluntary knowledge-sharing. .
Developed countries also indicated that voluntary pooling of rights and other voluntary licensing arrangements have provided for safe and effective diagnostics medicines and vaccines for the COVID-19 response. These measures have also scaled up the production of medicines and vaccines. In this context, the TRIPS Agreement already provides various avenues to address potential IP matters in the case of health emergencies should voluntary mechanisms fail, not only with regard to patents but also with regard to IP rights. Moreover, many right holders have voluntarily pledged or given access to IP in this crisis by facilitating access to key scientific journals or open source designs for personal protective equipment or design specifications for ventilators, they added.
Under this item, the World Health Organization (WHO) updated members on the COVID-19 Technology Access Pool (C-TAP). This compiles in one place pledges of commitments made under the Solidarity Call to Action to voluntarily share COVID-19 health technology-related knowledge, IP and data. The platform is intended to provide equitable access to life-saving technologies by promoting, through voluntary means, open innovation models and technology transfer, the WHO representative said. The platform also promotes equitable global access to fast-track product development and mobilizing efficient manufacturing capacity.
Non-violation and situation complaints
Members reiterated their well-known positions on the issue of non-violation and situation complaints. The issue concerns the longstanding discussion of whether members should have the right to bring dispute cases to the WTO if they consider that another member's action or a specific situation has deprived them of an expected benefit under the TRIPS Agreement, even if no specific TRIPS obligation has been violated.
Some members reiterated they favour continuing, or making permanent, the current moratorium. There is no place, in their view, for the application of non-violation complaints in the area of IP because of the legal insecurity and curtailment of flexibilities that could ensue. Other delegations expressed their preference for ending the moratorium. This is on the grounds that non-violation complaints are essential to maintaining the proper balance of rights and obligations within the TRIPS Agreement while helping to ensure that legitimate obligations are not circumvented or avoided.
All delegations expressed their willingness to consider concrete proposals. They underlined their availability to engage in a meaningful examination of this issue, following the decision by the General Council on 10 December 2019 to extend the moratorium until the 12th Ministerial Conference (MC12), tentatively to take place in Nur-sultan, Kazakhstan, in June 2021.
“It is my impression that a number of shared understandings regarding TRIPS non-violation could in fact be harvested from the past discussions. This might enable us to focus our engagement on formulating the areas of disagreement – and thus make at least some progress in framing the questions for ministers at MC12,” Ambassador Mlumbi-Peter said.
The WTO Secretariat reported to members on the WHO-WIPO-WTO launch on 29 July of the second edition of the Trilateral Study on Access to Medical Technologies and Innovation. Encouraged by the strong and positive feedback the study has received since its initial launch in 2013, the second edition will further contribute to an informed policy debate about what is needed to foster innovation that is responsive to pressing needs and to secure equitable access to essential medical technologies.
The chair reported that, since the last TRIPS Council meeting in February 2020, Niger and Barbados had deposited their instrument of acceptance for the protocol amending the TRIPS Agreement. To date, 131 members have accepted the TRIPS Amendment, which entered into force on 23 January 2017. The amendment secures for developing countries the legal pathway to access affordable medicines under WTO rules. The period for acceptance of the protocol was extended until 31 December 2021 by the General Council in December 2019.Distributed by APO Group on behalf of World Trade Organization (WTO).