Minutes - TRIPS Council - View details of the intervention/statement

H.E. Ambassador Dr Pimchanok PITFIELD

201.  As the World Health Organization (WHO) declares an end to the public health emergency of international concern related to COVID-19, it is important to recognize that the pandemic is not over as a global health threat. In making the recommendation, the International Health Regulations Emergency Committee acknowledged that there remain uncertainties posed by the potential evolution of SARS-CoV-2. They advised that it is time to transition to long-term management of the COVID-19 pandemic. In this context, it is critical to continue addressing IP barriers related to COVID19 diagnostics and therapeutics to address concentration and promote diversification of production of these key medical tools. 202.  The World Intellectual Property Organization (WIPO) Patent Landscape Report of April 2023 highlights the significant IP barriers that still exist, which could hinder access to life-saving diagnostics and treatments, particularly in low- and middle-income countries (LMICs). 203.  The report notes that although there has been a significant increase in the number of patent applications related to COVID-19 diagnostics and therapeutics, a majority of these applications come from a handful of high-income countries, with only a small proportion originating from LMICs. This concentration of IP ownership could limit access to these crucial tools in LMICs, where they are needed most. In addition, the co-sponsors have extensively detailed IP barriers in numerous submissions such as IP/C/W/670, IP/C/W/671, IP/C/W/672, IP/C/W/673 and IP/C/W/674. 204.  It has been argued that demand for COVID-19 therapeutics and diagnostics is low and that the extension is therefore not necessary; this notion is misleading. There is massive unmet global health need for COVID-19 therapeutics and diagnostics. Demand for COVID-19 therapeutics and diagnostics is artificially suppressed. The US-based civil society organization Public Citizen has identified four factors that explain the anemic demand for these necessary tools. 205.  First, many patented tools are unaffordable for LMICs. The secrecy of supply agreements complicates country procurement decisions. Second, it is challenging for budget-constrained LMICs to compete with high-income countries to purchase products in initially limited and/or unreliable supply. Third, competing health priorities and strained resources limit the ability of governments to prioritize their country's COVID-19 response. Lastly, there are knowledge gaps regarding the available health technologies and the value of testing and therapeutics. In other words, supply challenges – high prices, opaque and delayed and unpredictable availability – constrain demand.1 206.  In the case of South Africa, lack of affordability had a direct impact on suppressing the demand for tocilizumab. Despite an expert panel finding that the treatment reduced deaths, the recommendation was that the drug not be used because it was "not affordable at the current offered price".2 At the cost of around USD 2,000 per patient, this life-saving therapy has been largely out of reach for African populations.3 207.  Where Paxlovid is concerned, estimated health need in LMICs exceeds market demand by over 8 million courses.4 It has also been estimated by the ACT-A Council Working Group on Diagnostics and Therapeutics that across ACT-A eligible LMICs, there will be an unconstrained need for 223 million antiviral treatments in 2023, compared to demand for 31 million treatment courses.5 This would result in 192 million COVID-19 infections in LMICs that would benefit from antivirals, but will ultimately not have access. 208.  IP barriers must be addressed in order to meet health need for therapeutics at affordable prices. For example, baricitinib – a potential alternative to tocilizumab – has been manufactured by generic manufacturers in India and Bangladesh at prices lower than USD 7, which is about 400 times cheaper than the price at which it is sold by the originator. This treatment is protected by patents in several countries including South Africa and Indonesia, thereby stifling the potential for widespread production and availability in LMICs.6 209.  In the case of diagnostics, highly concentrated production backed by patent thickets have resulted in high prices.7 For example, the estimated cost of production for the GeneXpert COVID-19 diagnostic test is just USD 3-5 per test, yet the price being charged is close to USD 15 in developing countries, over 3 times the estimated cost of production.8 210.  There are over 400 treatment and antiviral candidates in clinical development.9 Many of which could provide better clinical outcomes than existing treatments. It is critical that such treatments are widely available if we are to end the pandemic. 211.  As observed by Prof. Joseph Stiglitz, test and treat programmes in developing countries will be limited no matter how dire the need is, unless ample supplies of affordable diagnostics and treatments are readily available.10 212.  Three factors indicate that the need for new medicines is increasing: i. COVID-19 has become endemic so we need new medicines to deal with it. ii. New variants are emerging and vaccine effectiveness require more booster doses and perhaps some vaccines are not that effective against the variants. iii. We urgently need treatment for long COVID. Some studies show that 1 in 8 people develop symptoms of long COVID which can be incapacitating. Therefore the world needs medicines for prevention and treatment of long COVID. 213.  Given the experience of PPE, vaccines, diagnostics and current medicines, LMICs cannot rely on the goodwill of corporations. The way to treat people is to ensure sustainable supply of new effective medicines by enabling local production. 214.  Companies producing the two currently available antiviral medicines, and their mouthpieces behind national flags say that they have the capacity to supply LMICs, but in reality, little is available to people in those countries. Pfizer is allocating only 10 million courses of the antiviral Paxlovid for LMICs, including 4 million via UNICEF and 6 million via The Global Fund.11 This is hardly sufficient for the millions of potential users in LMICs. Moreover, so far only a few thousand doses have reached those countries. 215.  Finally, at the 8 June consultation and today, the idea of having a thematic workshop was mooted on the understanding that independent competent authorities such as the WHO would be a prominent role player in such a workshop. We would welcome the engagement.

The Council agreed to hold an Informal Thematic Session for Stakeholder Input as suggested by the Chair.
The Council took note of the statements made and agreed to revert to the item at its next meeting.
53. The Chair recalled that under paragraph 8 of the Ministerial Decision on the TRIPS Agreement, adopted on 17 June 2022, Members agreed to make a decision within six months from adoption, on whether to extend this Decision to cover the production and supply of COVID-19 diagnostics and therapeutics. The General Council had decided to extend this deadline and had kept the question of the duration of the deadline extension on its agenda, while substantive discussions should continue in the Council for TRIPS.
54. With respect to these substantive discussions, she said that Members' interventions during the March meeting of the TRIPS Council had illustrated that a wide variety of views persisted in regard to this issue. In her recent consultations on this question, delegations had largely recognized that substantive engagement will be more constructive once all Members have completed their domestic consultation processes but that, in the meantime, fact- and evidence-based discussions should continue. Some had explicitly pointed to the questions posed in papers circulated by Members as a good starting point.
55. In response to these views, she said she had held an informal open-ended meeting of the Council on 8 June 2023, where Members had continued their exchanges on the substance of the matter, including with reference to Members' various submissions in this regard.
56. She said she also explored with delegations the possibility to gather facts and take stock of developments relevant to the COVID-19 pandemic with outside stakeholders, such as international organizations, civil society organizations, business representatives and academia. Delegations were generally supportive of this idea to gather such input and experiences from within the competence of stakeholders, that was relevant to the COVID-19 pandemic. She said she had pointed out that this event could help inform not only the narrow question under paragraph 8 of the MC12 Decision, but also the broader mandate under paragraph 24 of the Ministerial Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics ().
57. The Chair said that, if Members so decided, such a one-day thematic session could be organized after the summer break in late September or early October. Her suggestion would be that she would develop a draft program together with the Secretariat which would then be circulated to Members for comments. In this context, she had well taken note of Members' preference for a balanced composition of participating stakeholders from diverse geographical and organizational backgrounds. It was also clear that external stakeholder participation would be limited to the thematic session itself, and that negotiations and substantive deliberations would remain reserved for Members.
58. She invited Members to continue their substantive discussions and to also share any further thoughts with regard to such an "Informal Thematic Session for Stakeholder Input on IP and COVID-19 and the MC12 Decision".
59. The representatives of South Africa; China; Djibouti, on behalf of the LDC Group; Bangladesh; Indonesia; Nepal; El Salvador; Peru; Tanzania, on behalf of the African Group; the United States of America; India; Switzerland; the European Union; Japan; Thailand; the United Kingdom; Brazil; Korea, Republic of; Cambodia; Singapore; and Hong Kong, China took the floor.
60. The Chair assured Members that the envisaged thematic session was not an attempt to delay a decision, but rather an effort to continue a fact- and evidence-based discussion that could support a decision when all Members would be ready to engage. She also said that, while there had already been a number of substantive submissions on this topic, more written submissions from Members on their experiences or on pertinent questions would be useful to support a robust discussion of the questions before Members.
61. As work at the WTO was expected to accelerate after the summer, she pointed out that a decision under paragraph 8 of the Ministerial Decision did not have to wait until MC13 and could be taken by the General Council at any time, even before the end of the year. Finally, she recalled that paragraph 8 of the Ministerial Decision and paragraphs 23 and 24 of the Ministerial Declaration on Pandemic Response were two separate mandates for Members to discuss. While the thematic session could provide inputs for both, and she did not exclude that Members would discuss both mandates together, she wished to highlight that the mandates had separate objectives and would have to be looked at separately. Paragraph 8 of the Ministerial Decision was aiming for an eventual decision by Members, while paragraph 24 of the Ministerial Declaration mandated general reflection on experiences during COVID-19, and reporting to the General Council.
62. The Council agreed to hold an Informal Thematic Session for Stakeholder Input as suggested by the Chair.
63. The Council took note of the statements made and agreed to revert to the item at its next meeting.
IP/C/M/108, IP/C/M/108/Add.1

1 See Public Citizen Prehearing Brief for Investigation No. 332-596: COVID-19 Diagnostics and Therapeutics and Flexibilities Under the TRIPS Agreement (Public Citizen) at page 10.

2 https://mg.co.za/africa/2021-08-26-unvaccinated-untreated-africa-may-not-get-its-fair-share-of-covid-19-drugs/

3 Ibid.

4 Public Citizen at page 10.

5 Report of the Access to COVID-19 Tools Accelerator Facilitation Council Working Group on Therapeutics and Diagnostics. “Unconstrained need is the total number of cases in LMICs in the next 12 months, regardless of a country's testing capacity, interest in the product, or capacity to roll it out”.

6 https://msfaccess.org/msf-responds-latest-who-recommendation-covid-19-therapeutic-baricitinib

7 https://msfaccess.org/sites/default/files/2021-07/IP_IssueBrief_Local-diagnostics-local-health-needs_ENG_13.7.2021.pdf

8 https://peoplesvaccine.org/wp-content/uploads/2022/11/A-fact-based-case-for-the-extension-of-the-TRIPS-COVID-19-decision.pdf.

9 https://www.bio.org/policy/human-health/vaccines-biodefense/coronavirus/pipeline-tracker.

10 https://www.scientificamerican.com/article/the-international-community-must-prioritize-covid-treatment-and-test-access/\;

11 https://www.reuters.com/world/pfizer-provide-10-mln-courses-covid-pill-developing-countries-the-global-fund-2022-03-02/.