115. On 15 June 2021, the Directors General of the World Health Organization, World Intellectual Property Organization and the World Trade Organization issued a joint statement in which they underscored their "commitment to universal, equitable access to COVID-19 vaccines, therapeutics, diagnostics, and other health technologies". The three DGs underlined that this commitment is anchored in the understanding that this is an urgent moral imperative in need of immediate practical action. 116. We have learnt from the experiences of this pandemic that it is critical to scale up production and access to not only vaccines, but other tools, including therapeutics and diagnostics to prevent the spread of COVID-19 and to treat the disease and prevent deaths. These resources have been in acute shortage in many countries leading to very limited accessibility. The scope of products is also reflective of the national COVID-19 response strategies of many countries that acknowledge that the prevention, treatment and containment of COVID-19 involves a range of health products and technologies. Vaccines are necessary but not sufficient to respond to the pandemic. No country adopts only one intervention in this and any pandemic. Vaccinations, test and treat strategies and their related health products and technologies are urgently needed alongside other interventions. 117. In relation to therapeutics, WHO's consultations on COVID-19 therapeutics reveal that "[d]espite the great success of COVID-19 vaccine development, therapeutics are still urgently required" and that a range of therapeutics will be required including "drug combinations targeting specific aspects of infection, as well as suites of treatments targeting different disease processes (such as antivirals, immunomodulators and anti-coagulants)".2 The European Union COVID-19 therapeutic strategy also states that "vaccines will not eliminate the disease overnight and therapeutics will still be needed for patients in hospitals and at home, including people suffering from 'long COVID'. For these reasons, therapeutics will continue to play a significant role and complement the EU strategy for vaccines." Notably, several therapeutics have been approved, registered and have received national emergency use authorization or qualified for the WHO emergency use listing. 118. Since the currently available vaccines are not able to prevent infections, therapeutics play an important role in our effort to contain and treat COVID-19. In document , the co- sponsors have presented a preliminary patent landscape providing a non-exhaustive snapshot of the patent filing and granting status of five selected therapeutics candidates for COVID-19. In document as well as in document the co-sponsors have highlighted IPrelated challenges in the area of therapeutics and how restrictive voluntary licensing practices continue to pose supply challenges to countries. The WIPO patent landscape report has subsequently shed further light. 119. In relation to diagnostics, pillar 5 of WHO's Strategic Preparedness and Response Plan for COVID-19 considers testing to be the cornerstone of the management of the COVID-19 pandemic. Testing is critical to detect cases and investigate clusters of cases so that public health actions can be rapidly taken to isolate those infected, quarantine contacts and break chains of transmission. Testing allows for new COVID-19 variants to be identified to begin to build vaccines and therapeutics that can prevent or treat infection. Major gaps in testing are still putting lives at risk and threatening progress to end the pandemic. There is therefore a need to scale up testing and ensure immediate, equitable access to diagnostic tools in every country across the world. The co-sponsors have provided examples highlighting IP challenges in previous TRIPS Council meetings (see paragraphs 42-46 of document as well as paragraph 65 of document . 120. We commend Dr Ngozi Okonjo-Iweala, Director-General of the WTO, for the work undertaken towards the Ministerial Decision on the TRIPS waiver. Work conducted within the Secretariat such as the "Working Paper on Patent Related Actions Taken in WTO Members in Response to the COVID- 19 Pandemic" as well as the "Working Paper on Innovation and Patenting Activities of COVID-19 Vaccines in WTO Members: Analytical Review of VaxPaL", both provide rich information that Members may use in developing appropriate measures within their jurisdictions. Paragraph 8 of that Decision contains a clear Ministerial mandate for Members to decide on extension of the Decision to therapeutics and diagnostics within 6 months – that is, by 17 December 2022. 121. The co-sponsors have prepared a room document that sets out why it is important to expeditiously fulfil the paragraph 8 mandate. The room document also proposes a time frame for the consideration of the membership, aimed at assisting us to timeously fulfil the mandate set by Members at MC12. The time frame is indicative, and it has just been brought to my attention that 22 July is the last day of the WIPO General Assembly. Obviously this would have an impact on the ability of some delegation to participate, so this is indicative and we are happy for Members to reflect and provide a time frame that would be workable. 122. As stated by Dr Ghebreysus, Director-General of the WHO, "Vaccines alone will not end the pandemic". "Many countries need diagnostics, lifesaving therapeutics – including oxygen and support for vaccine rollout." The WTO membership has urgent work to do in order to emulate the commitment to universal, equitable access to COVID-19 vaccines, therapeutics, diagnostics, and other health technologies demonstrated by the trilateral DGs. Extension of the WTO Ministerial Decision on the TRIPS Agreement to cover therapeutics and diagnostics will be a significant step in the right direction. 123. We have heard some mention voluntary licenses as an alternative to full use of TRIPS flexibilities and extension of the Ministerial Decision on the TRIPS Agreement. Here I would state that our delegation appreciates the value of voluntary licenses. However, due to various limitations, voluntary licenses cannot be considered as the only means that Members should have at their disposal if we are to diversify production on an adequate scale. Some of the limitations involved with licensing include: lack of transparency, geographical limitations, and exclusivity. 124. South Africa is a co-sponsor of the Solidarity Call to Action and the WHO COVID-19 Technology Access Pool (C-TAP) together with 41 other countries. At the early stages of the pandemic, the Call to Action made three requests of holders of knowledge, intellectual property or data to existing or new therapeutics, diagnostics and vaccines, including. Namely, that they: a. Voluntarily license such rights on a non-exclusive and global basis to the Unitaidestablished and supported Medicines Patent Pool and/or through other public health research and development mechanisms, consortia or initiatives that facilitate global and transparent access; and/or voluntary non-enforcement of intellectual property rights, as appropriate, during the COVID-19 pandemic, to facilitate the wide-scale production, distribution, sale and use of such health technologies throughout the world; b. Facilitate equitable, affordable and timely access to their products for all countries; and c. Share voluntarily the relevant knowledge, intellectual property and data to enable widescale and worldwide production, distribution and use of such technologies and necessary raw materials through mechanisms such as the Technology Access Partnership (TAP) hosted by the UN Technology Bank or the Open COVID Pledge Initiative3. 125. These requests were largely unheeded, which has contributed to the concentration of production in a few locations and inequitable access to COVID-19 tools. The co-sponsors have consistently argued that business as usual approaches are ill-suited to situations of extreme urgency such as pandemics. We have also called for vigilance given the ever-present threat of new variants and sub-variants. The emergence of the highly transmissible BA.4 and BA.5 Omicron sub-variants as well as the BA.2.12.1 sub-variant, which was first detected in the United States of America in December 2021, have resulted in spikes in the number of infections in different regions. The impact of these spikes is yet to be determined but there are some initial indications that the risk to global health presented by the latest sub-variants is potentially greater than that of original BA.2. The ability to identify and treat these variants and sub-variants as well as those which continue to emerge will depend on the deconcentrated availability of therapeutics and diagnostics. Extension of the WTO Ministerial Decision to cover these crucial COVID-19 tools is urgent and will be a key facilitator in this regard.
