WTO TRIPS Council Discusses National IP Measures and TRIPS Flexibilities in the Context of COVID-19

Nirmalya Syam
South Centre, SouthNews No. 327, 7 August 2020

A regular session of the TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) Council was held virtually on 30 July 2020. This session offered the first opportunity for the World Trade Organization (WTO) Members to discuss intellectual property (IP) related issues in the context of COVID-19. Discussions focused on national measures taken by various countries in relation to IP in response to COVID-19 as well as the scope of the use of TRIPS flexibilities across the spectrum of various IP rights in order to ensure rapid development, scaled up manufacturing of and affordable, timely and equitable access to various technologies and products required to respond to COVID-19. South Africa made a strong general statement pointing to the need to consider new bold measures that will comprehensively and expeditiously address IP challenges.

Members of the World Trade Organization (WTO) met at a formal session of the TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) Council on 30 July 2020 in a virtual meeting. This meeting of the TRIPS Council was chaired by Ambassador Xolelwa Mlumbi-Peter of South Africa.

A major focus of discussions in this session of the TRIPS Council was on national intellectual property (IP) measures taken by various countries in the context of COVID-19, and the scope of TRIPS flexibilities for IP rights in addition to patents, as they apply to technologies or products that are important for responding to COVID-19. The Council also discussed a proposal on IP and e-commerce by South Africa as well as other standing agenda items of the Council.

IP measures in the context of COVID-19

WTO Members discussed IP measures that have been taken by various countries in response to COVID-19. The discussions were based on a compilation of various measures taken by countries, prepared by the WTO secretariat.[1] Most of the measures included in the compilation prepared relate to IP office procedures to facilitate IP applications and their processing in the context of COVID-19. However, this compilation also includes substantive measures that have been taken by some countries to overcome any possible situation in which an IP right over a technology required for responding to COVID-19 prevents access to the same.[2]

Developing and least-developed country (LDC) Members highlighted the challenges presented by COVID-19 for access to medicines, vaccines and associated technologies and called for application of the TRIPS provisions with a focus on the rights to protect public health and promote access to medicines for all, particularly through the utilization of TRIPS flexibilities as reaffirmed by the Doha Declaration on TRIPS and Public Health. In this regard, developing countries and LDCs called 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. On the other hand, developed country members stressed on the value of the IP system in boosting scientific and international cooperation against the pandemic, and in promoting and incentivizing medical technologies innovation and research.

Intellectual property and public interest: beyond access to medicines and medical technologies towards a more holistic approach to TRIPS flexibilities

South Africa submitted a proposal calling for a discussion on the scope of TRIPS flexibilities in relation to IP rights in addition to patents that apply to the products and technologies required for responding to COVID-19. The communication specifically presents examples of cases where other forms of IP rights that are applicable to Big Data, Artificial Intelligence (AI), 3D printing relate to technologies beyond essentially medical technologies that are applicable to COVID-19. In this context, in the interest of ensuring that such IP rights do not impede the ability of countries to rapidly, effectively, affordably and safely develop and deploy such technologies in response to COVID-19, the communication proposes a discussion in the TRIPS Council to address the following questions:

• To what extent are TRIPS flexibilities embedded in areas outside patent protection well understood? If so, how are Members implementing such understandings in their national and regional laws?
• What are the likely difficulties that Members may face in dealing with a changing technology landscape where embedded IP rights may affect the dichotomy between IP rights as private rights and the public interest dimensions recognised in the TRIPS Agreement?
• What are the benefits and limitations of initiatives such as voluntary licenses and pledges to access much needed technology to deal with the COVID-19 pandemic?
• Are there circumstances where trade secrets can be shared more broadly? If so, what are those circumstances? Would national or international health pandemics fall within this category?

Several developing countries joined South Africa in explaining the legal, technical and institutional challenges they face in using TRIPS flexibilities. They highlighted that lack of domestic manufacturing capacity makes them dependent on imports to meet their medical needs, particularly in times of crises.

Developed countries 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 but also noted that 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.

The World Health Organization (WHO) secretariat provided an update on the COVID-19 Technology Access Pool (C-TAP), a voluntary patent pooling mechanism for health technologies for COVID-19.

General statement by South Africa

South Africa delivered the following general statement relating to both agenda item 3 – IP measures in the context of COVID-19; and agenda item 14 – IP and the Public Interest:[3]

“More than 16.5 million cases and 650 thousand deaths of COVID-19 have been confirmed globally. The global community is facing an extraordinary challenge. No country has been spared the devastating effects of Covid-19. Health and human toll are substantial and expected to continue to grow.

In this context we recall Resolution WHA73.1 of 19 May 2020, which recognises that COVID-19 pandemic has a disproportionately heavy impact on the poor and the most vulnerable, with repercussions on health and development gains, in particular in low-income countries. It further calls on cooperation between multilateral organisations and other stakeholders and the WHO Director General to identify and provide options that respect the provisions of relevant international treaties, including the provisions of the TRIPS Agreement and the flexibilities within the Doha Declaration on the TRIPS Agreement and Public Health, to be used in scaling up development, manufacturing and distribution capacities needed for transparent equitable and timely access to quality, safe, affordable and efficacious diagnostics, therapeutics, medicines, and vaccines for the COVID-19 response. South Africa welcomes the launch of the Trilateral Study on Access to Medical Technologies and Innovation, but notes with disappointment that it does not cover issues related to COVID-19.

The list of verified measures prepared by the Secretariat already indicate some steps taken by Members and supplemented by views Members will express during this TRIPS Council meeting and further meetings. A further step in concretizing this commitment is to hold a workshop as requested by the ACP Group which will give Members and other participants an opportunity to further discuss IP challenges with respect to access and to explore approaches to deal with COVID-19 in the context of intellectual property rights.

Curbing the pandemic and limiting the social and economic fallout is dependent on an unprecedented timely roll out of sufficient quantities of medical supplies to all countries in need including masks, personal protective equipment, ventilators, diagnostic kits as well as therapeutics and vaccines as they are identified. This requires global solidarity to transfer of technology and massively scale-up manufacturing globally. At present there are vast shortages of medical products within a country as well as between developed and developing countries. In light of possible second waves of the coronavirus, countries must take measures to ensure that they are able to restock medical products that will be needed to fight the virus.

On the subject of vaccines, there are already news reports of intellectual property disputes that could hinder the development and production of COVID-19 vaccines. We observe with great apprehension the rush by developed countries to sign deals to gain preferential access to vaccines, leaving many countries behind. Vaccine nationalism may address short term political demands of a country but drastically falls short of what is required to contain this pandemic. World leaders from the north and south have referred to vaccine as a global public good, that should be fairly and equitably available globally, leaving no one behind. Now is the time to put it into action.

The challenge before us is to produce an effective vaccine to meet the needs of the world population of 7.8 billion in as short a time frame as possible. This will require the sharing of knowledge and technology of successful vaccines so that the widest distribution at lowest cost can be achieved. Even the European Parliament Resolution entitled “The EU’s public health strategy post-COVID-19” which was adopted on 10 July 2020 acknowledges its importance as it calls for “maximum sharing of COVID-19 health technology-related knowledge, intellectual property and data to the benefit of all countries in the context of WHO’s Technology Access Pool (C-TAP). It also calls for strong support for the WHO’S Technical Access Pool (C-TAP), while incorporating collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for exploitation of final products, in all current and future calls for funding and investment. It further calls for enhanced dialogue with third countries and the issuance of compulsory licences in the event that such countries do not share their vaccines or therapeutic knowledge.

On the subject of vaccines, there are already news reports of intellectual property disputes that could hinder the development and production of COVID-19 vaccines. We observe with great apprehension the rush by developed countries to sign deals to gain preferential access to vaccines, leaving many countries behind. Vaccine nationalism may address short term political demands of a country but drastically falls short of what is required to contain this pandemic. World leaders from the north and south have referred to vaccine as a global public good, that should be fairly and equitably available globally, leaving no one behind. Now is the time to put it into action.

The challenge before us is to produce an effective vaccine to meet the needs of the world population of 7.8 billion in as short a time frame as possible. This will require the sharing of knowledge and technology of successful vaccines so that the widest distribution at lowest cost can be achieved. Even the European Parliament Resolution entitled “The EU’s public health strategy post-COVID-19” which was adopted on 10 July 2020 acknowledges its importance as it calls for “maximum sharing of COVID-19 health technology-related knowledge, intellectual property and data to the benefit of all countries in the context of WHO’s Technology Access Pool (C-TAP). It also calls for strong support for the WHO’S Technical Access Pool (C-TAP), while incorporating collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for exploitation of final products, in all current and future calls for funding and investment. It further calls for enhanced dialogue with third countries and the issuance of compulsory licences in the event that such countries do not share their vaccines or therapeutic knowledge.

In short, we are of the view that the WTO should be cognizant of IP obstacles across essential medical products needed to contain the pandemic and take urgent steps to address these barriers in a comprehensive manner. The WTO-TRIPS Agreement does provide a number of flexibilities that may be utilized by member states to overcome IP obstacles. In anticipation of such barriers, some WTO members have undertaken urgent changes to national patent legislation to make it easier to issue compulsory licenses. However, there are a number of challenges:

Firstly, IP barriers go beyond patents, and often flexibilities in other intellectual property such as industrial designs, copyright and trade secrets is often less understood and implemented nationally.

Secondly, developing country Members may face legal, technical and institutional challenges in using TRIPS flexibilities. This is especially true for countries that have never utilized flexibilities such as compulsory licenses.

Thirdly, when an exporting country is producing under a compulsory license mainly for export, the mechanism established by the 30 August 2003 decision, and later translated into an amendment of the TRIPS Agreement as Article 31bis, would be applicable. This mechanism waives the condition in Article 31(f) that a compulsory license should be predominantly for the supply of the domestic market. However, experience in using this mechanism is largely non-existent. In 2006, Medecins Sans Frontieres (Doctors without Borders) attempted to use the procedures to export HIV medicines from Canada to Rwanda but it concluded that the mechanism is neither expeditious nor workable. We also note that implementation of the Article 31bis mechanism at a national level is rather limited or may not achieve its intended objectives. Further some countries have opted out of using this system as importers, which may pose a challenge to access.

Several voluntary initiatives have emerged since the outbreak of COVID-19 including pledges and voluntary licenses. Some of these are commendable, but these are ad hoc initiatives, simply inadequate to systematically and comprehensively address IP barriers. IP holders of essential technologies may also decide not to participate in such initiatives.

The World Health Organization has launched the COVID-19 Technology Access Pool (C-TAP) calling IP holders to voluntarily issue global non-exclusive licenses or to voluntarily surrender intellectual property rights, to facilitate the widescale production, distribution, sale and use of such health technologies throughout the world. However, to date no company has committed to doing so. Instead limited, exclusive and often non-transparent voluntary licensing seems to be the preferred approached and these are insufficient to address the needs of the current COVID-19 pandemic.

“Business as usual” approaches are simply inadequate to tackle COVID-19. We need to consider new bold measures that will comprehensively and expeditiously address IP challenges. The following approaches can be considered:

Members must explore international collaborations and binding commitments to facilitate the open sharing and right to use technologies, know-how, data and global non-exclusive rights to use and produce COVID-19 medical products.

Members must take policy and legislative measures to ensure that patents and other intellectual property do not erect barriers to access to medicines, diagnostics, vaccines and medical supplies and devices. This includes addressing evergreening of patents by restricting the grant of secondary patents on known medicines and excluding from patentability second medical uses as being mere methods of treatment in terms of Article 27 of the TRIPs Agreement. Members are encouraged to take measures to facilitate the local manufacturing or import of essential medical supplies, devices or technologies including diagnostics, medicines and vaccines.”

[1] WTO, “Covid-19: Measures Regarding Trade-Related Intellectual Property Rights”. Available from https://www.wto.org/English/Tratop_E/Covid19_E/Trade_Related_Ip_Measure_E.Htm.
[2] See Nirmalya Syam, “Intellectual Property, Innovation and Access to Health Products for COVID-19: A Review of Measures Taken by Different Countries”, South Centre Policy Brief 80 (June 2020). Available from https://www.southcentre.int/policy-brief-80-june-2020/.
[3] Knowledge Ecology International, “WTO TRIPS Council (July 2020): South Africa leads discussions on COVID-19”, 1 August 2020. Available from https://www.keionline.org/33593.

Author: Nirmalya Syam is Senior Programme Officer of the Health, Intellectual Property and Biodiversity (HIPB) Programme of the South Centre.