USTR releases summary of five-month consultation on extending WTO TRIPS decision showing broad divergence of views
WASHINGTON – The Office of the United States Trade Representative today announced support for extending the deadline to decide whether there should be an extension of the World Trade Organization (WTO) Ministerial Decision on the TRIPS Agreement (Ministerial Decision) to cover the production and supply of COVID-19 diagnostics and therapeutics. USTR also announced that it will ask the United States International Trade Commission (USITC) to launch an investigation into COVID-19 diagnostics and therapeutics and provide information on market dynamics to help inform the discussion around supply and demand, price points, the relationship between testing and treating, and production and access.
“Over the past five months, USTR officials held robust and constructive consultations with Congress, government experts, a wide range of stakeholders, multilateral institutions, and WTO Members,” said Ambassador Katherine Tai. “Real questions remain on a range of issues, and the additional time, coupled with information from the USITC, will help the world make a more informed decision on whether extending the Ministerial Decision to COVID-19 therapeutics and diagnostics would result in increased access to those products. Transparency is critical and USTR will continue to consult with Congress, stakeholders, and others as we continue working to end the pandemic and support the global economic recovery.”
Supporters and opponents of extending the Ministerial Decision to COVID-19 diagnostics and therapeutics provided extensive views and arguments. USTR officials also reviewed and analyzed published information, opinions, and analysis. In both cases, the views concern both the system as a whole – whether existing WTO intellectual property protections are an impediment to access to medicines or a critical element of innovation – as well as the specific characteristics of the markets for COVID-19 diagnostics and therapeutics.
The United States respects the right of its trading partners to exercise the full range of existing flexibilities in the TRIPS Agreement, such as in Articles 30, 31, and 31bis, and the Doha Declaration on the TRIPS Agreement and Public Health, as well as the flexibilities in the Ministerial Decision. These existing flexibilities are available as part of the effort to scale up the production and distribution necessary to overcome the challenges of the ongoing COVID-19 pandemic.
Based on available data and public input, the USITC study will explore key issues such as:
- An overview of the products, focusing on WHO-approved COVID-19 diagnostics and therapeutics, including key components, the production process, intellectual property protections, and a description of the supply chain (including the level of diversification in the supply chain);
- Information on the global manufacturing industry for these products, including information on key producing countries, major firms, and production data, if available;
- Information on the global market for COVID-19 diagnostics and therapeutics, including information on demand and, to the extent practicable, an assessment of where unmet demand exists for key products and contributing factors; market segmentation; and supply accumulation and distribution;
- Data and information on global trade in COVID-19 diagnostics and therapeutics, if available, or if not, data and information on global trade in diagnostics and therapeutics generally; and
- A brief overview/background of the relevant aspects of the TRIPS Agreement and the United Nations (UN) Medicine Patent Pool (MPP) and a listing of countries seeking to use the Ministerial Decision and those utilizing access to COVID-19 medicines under the MPP.
As part of the Administration’s comprehensive effort to combat the pandemic, the United States supported negotiations that resulted in the WTO issuing the Ministerial Decision on the TRIPS Agreement on June 17, 2022. Since then, USTR officials consulted with Members of Congress and more than two dozen stakeholders, including public health advocates, organized labor, academics, think tanks, companies, and trade associations. USTR has summarized the diverse views heard during the five-month consultation period.