1313.   In the last few weeks, we have seen breakthroughs on vaccines and new treatments that are creating a path to effectively fighting the COVID-19 pandemic. There are also encouraging details concerning the diverse initiatives of the industry to enhance and accelerate access through manufacturing and distribution collaborations and networks. 1314.   All of these unprecedented developments during this relatively short period of time are possible in part because of the global IP system. In our view, intellectual property has not been an obstacle in addressing the pandemic but rather has motivated global efforts through its incentivizing role in R&D to find new treatments and cures. 1315.   Intellectual property plays a key role in developing partnerships with respect to manufacturing, transportation, and distribution. These partnerships can help to facilitate access to innovative products. In particular, voluntary agreements on mutually agreed terms and conditions have effectively served to advance access to key innovations throughout this pandemic. 1316.   As a result, the United States does not support the proposal of India, South Africa, Eswatini, Kenya, Pakistan, Mozambique and the Plurinational State of Bolivia to waive TRIPS obligations in connection with patents, copyright, industrial designs, and the protection of undisclosed information in relation to prevention, containment, or treatment of COVID-19. 1317.   Given the need to provide the entire global population access to COVID-19 treatments, limits to manufacturing capacities and problems with supply chains are currently the most significant concerns, especially for vaccines.  We also must be concerned about the pandemic creating the opportunity for an increase in counterfeit health and safety-related products, which would harm rather than help. 1318.   The waiver proposal raises many questions given its broad nature. Bilateral meetings have helped to begin identifying the many issues the proposal implicates, and we will participate in future discussions to better understand and assess the scope, implementation, and impacts of the proposal. 1319.   With respect to the Council's status report to the General Council for next week's meeting, the United States supports the compromised language reached. The United States thanks South Africa for the communication circulated in document IP/C/W/670. Patent transparency of medical products helps to facilitate innovation and access. 1320.   A pragmatic approach to use patent transparency to improve access to medicines in general, and COVID-19 medical products specifically, is to identify specific problems regarding access to a particular medical product and apply effective, targeted solutions, such as licensing agreements authorizing generic manufacturing and/or procurement. 1321.   In fact, in the area of COVID-19 therapeutics, licensing by generics manufacturers already exists. It appears that one company has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to manufacture its drug for distribution in 127 countries. The co-sponsors of the waiver proposal are amongst the 127 countries that will benefit from these arrangements. 1322.   Other factors that are relevant to the access question include pricing and procurement policies, taxes, mark-ups and tariffs and other national policies that result in higher costs for consumers and for health systems. In fact, some countries continue to apply tariffs of up to 20% on pharmaceuticals and 10% on vaccines. South Africa's paper does not explore these critical factors. 1323.   As the United States has explained during past TRIPS Council interventions, the existence of a patent in and of itself is not indicative of an access barrier. The purpose of a patent system is not to exclude patients or potential markets. Moreover, we remind delegations that a vast majority of older medicines are not patented, yet remain out of reach for many patients. 1324.   Instead, South Africa has presented here a "[p]reliminary patent landscape of selected priority COVID-19 candidate therapeutics," which it acknowledges is a "non-exhaustive snapshot." The paper also aggregates some information from certain medicines based on news article links. However, there are limits to the paper as a way to thoroughly understand the current COVID-19 medical technology area. Identifying effective strategies to address COVID-19 is a complex challenge, requiring systematic analysis based on data and sound methodology. We look forward to continued discussion on these important issues. 1325.   The United States thanks the co-sponsors of its communication in document IP/C/W/671. The communication contains important fact-based inquires based on the proposal in document IP/C/W/669. In particular, we look forward to the response from the proponents on the IP challenges experienced that have impeded or prevented the timely procurement of COVID-19 diagnostics, equipment, therapeutics or vaccines and how those challenges are in relation to the TRIPS Agreement. This information would be helpful to understand the perceived TRIPS compliance hardships faced by Members such that a waiver for each obligation would be necessary. United States' statement at the informal meeting held on 20 November 2020 1326.   As we stated at the last TRIPS Council meeting, the United States is committed to working with international partners in identifying practical ways both to increase access to safe, effective, affordable, and lifesaving medicines around the world and to support policies that drive the development of new medicines. 1327.   Intellectual property encourages innovation, incentivizes research and development, and can facilitate manufacturing and distribution, thus helping to expand access to medicines around the world. These core features of intellectual property are necessary for the global community to find and develop treatments and cures for this deadly pandemic and to support economic recovery. 1328.   Specifically, intellectual property assists in putting partners and collaborators together with respect to research and development, manufacturing and voluntary technology transfer arrangements, and transportation and distribution. These partnerships drive access to innovative products and are facilitated by the intellectual property ecosystem. 1329.   Intellectual property is an important piece, but ultimately only one piece of addressing the issue of access to any potential therapy. We believe that intellectual property has not been an obstacle in addressing the pandemic but rather has motivated global efforts to find treatments and cures. 1330.   Given the need to provide access to the entire global population, limits to manufacturing capacities and supply chain issues are currently the most significant concerns, especially for vaccines. We also must be concerned about the pandemic creating the opportunity for an increase in counterfeit health and safety-related products, which would harm rather than help. 1331.   This proposal to waive TRIPS obligations on patents, copyright, industrial designs, and undisclosed information (including trade secrets) in relation to prevention, containment, or treatment of COVID-19 would be a broad and unprecedented step. 1332.   The number of provisions alone that would be waived is worth noting – if the waiver were granted as requested, at least 34 separate paragraphs of the TRIPS Agreement would no longer apply. This is a substantial departure from past WTO waivers. 1333.   The waiver proposal does not identify any specific measures for which it is requesting waiver. Instead, it states that the listed TRIPS obligations would be waived "in relation to prevention, containment or treatment of COVID-19." 1334.   Based on this language, it is unclear what measures would fall within or outside the scope of the waiver. 1335.   Given the waiver proposal's broad sweep, it is surprising that the request does not explain in detail why compliance with each of the identified TRIPS obligations creates an identifiable and undue hardship for Members, such that the waiver of each obligation would be necessary. 1336.   Turning to the effect of any such waiver, the indefiniteness and breadth of this request – with respect to both the provisions that would be waived and the potential measures that might be covered – makes it difficult to evaluate the impact the waiver would have on Members' respective commercial interests. 1337.   The United States recalls the G20 Ministerial Statement of March 30 of this year, which said: "We agree that emergency measures designed to tackle COVID-19, if deemed necessary, must be targeted, proportionate, transparent, and temporary, and that they do not create unnecessary barriers to trade or disruption to global supply chains, and are consistent with WTO rules." 1338.   Following the direction of the G20, the United States would appreciate if the proponents of the waiver proposal could provide further explanation to address the following questions: Proportionality and Problem Identification: 1339.   Could the proponents explain how the waiver is a proportionate response to COVID-19? 1340.   Could the proponents provide data that establishes that the identified TRIPS obligations have systematically hindered or blocked the prevention, containment, or treatment of COVID-19? Scope: 1341.   Could the proponents explain how Members would determine whether a measure is "relat[ed] to the prevention, containment or treatment" of COVID-19 and thus falls within the scope of the proposed waiver? 1342.   For example, if a measure waives an intellectual property right covering a given product or work, would the product or work have to be directly related to the prevention, containment, or treatment of COVID-19 in order to fall within the scope of this waiver proposal? Could the product or work be indirectly related? How indirectly related? Who would make this determination? Implementation: 1343.   How is the waiver proposal one that is "targeted" (as noted in the G20 statement), considering it implicates the suspension of at least 34 provisions of the TRIPS Agreement? 1344.   Could the proponents please explain in detail how the waiver would directly resolve issues related to COVID-19-related prevention, containment, or treatment in a Member? 1345.   Do the proponents have any data that would show how such a waiver would demonstrably reduce COVID-19 prevalence or impact during the acute phase of the pandemic? We note that new pharmaceutical manufacturing capacity typically cannot be established quickly. 1346.   How would the waiver of each of the identified TRIPS obligations be implemented by a Member? For example, how would the waiver of obligations related to undisclosed information be implemented? Does each proponent intend to implement legislation that would release undisclosed information submitted for regulatory purposes? 1347.   For undisclosed information such as trade secrets, will the proponents suspend their laws on trade secret theft? Have the proponents considered whether this would result in an increase in trade secret theft? 1348.   How do proponents plan to suspend rights that exist without formal government registration, such as copyrights? 1349.   If the waiver were to be implemented, how long do the proponents think it will take for there to be an impact in the prevention, containment, or treatment of COVID-19? What data are the proponents relying on to reach this conclusion? 1350.   How do proponents envision that Members would return to compliance with their TRIPS obligations after the waiver expires? Effects: 1351.   What are the expected impacts on Members' commercial and economic interests as a result of the waiver? 1352.   What effect do the proponents think that the waiver will have on innovation related to products that address the prevention, containment, and treatment of COVID-19? What would be the long-term implications for innovators' willingness to participate in future pandemic response efforts? 1353.   What are the expected impacts on authors, inventors, and other creators? 1354.   With respect to government funding comments: a. There has been significant investment from governments to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. b. However, as a general matter, the United States and many other governments cannot and do not develop these products by themselves. Governments generally do not have the required expertise, technical and logistical know-how, manufacturing capabilities, and experience in getting products quickly to market. c. The contribution of the private sector – both financially and in terms of research and development, and manufacturing – is essential to the production of these products. While governments may provide aid or funding, the production of these products remains a very high-risk investment for the private sector. d. The intellectual property framework provides the necessary legal and commercial incentives to drive private entities to undertake the risk and make the appropriate investments. Intellectual property plays an important role because when private entities are able to secure exclusive rights to a product they have developed, they have greater certainty about the expected return on their investment and are able to enter into partnerships to ensure efficient commercialization of the product. e. Without effective intellectual property protection, the development and commercialization of those products would likely not happen in an effective, efficient, and timely way, if it happens at all. United States' statement at the informal meeting held on 3 December 2020 1355.   Thank you chair for the status report language. We will review and provide potential comments by the due date. 1356.   The United States thanks the co-sponsors of communication IP/C/W/671. We find the inquiries to be helpful to the discussion on the proposal and will provide comments for the record at the formal meeting next week. We thank South Africa for its communication IP/C/W/670. We will provide comments for the record at the formal meeting next week. We thank the proponents for their comments this morning. In particular, we note that we have bilateral discussions tomorrow on the proposal for further exchanges on our questions. 1357.   With respect to some of the comments made by the proponents this morning, there were a couple of points I wanted to address. 1358.   On the government funding comment, and as the United States noted at the 20 November informal, there has been significant investment from governments to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. 1359.   However, as a general matter, the United States and many other governments cannot and do not develop these products by themselves. Governments generally do not have the required expertise, technical and logistical know-how, manufacturing capabilities, and experience in getting products quickly to market. 1360.   The contribution of the private sector – both financially and in terms of research and development, and manufacturing – is essential to the production of these products. While governments may provide aid or funding, the production of these products remains a very high-risk investment for the private sector. 1361.   The intellectual property framework provides the necessary legal and commercial incentives to drive private entities to undertake the risk and make the appropriate investments. Intellectual property plays an important role because when private entities are able to secure exclusive rights to a product they have developed, they have greater certainty about the expected return on their investment and are able to enter into partnerships to ensure efficient commercialization of the product. 1362.   Without effective intellectual property protection, the development and commercialization of those products would likely not happen in an effective, efficient, and timely way, if it happens at all. 1363.   With respect to voluntary licensing and purchasing schemes – both of these are pathways that can be the means to provide access to relevant products. Our common objective is to get safe and effective products to patients as quickly as possible. The mere existence of a product, especially a product to treat a global pandemic, does not do anyone any good if it is not reaching the global market. We are all working to get these products to market across the globe through various means and without unnecessary delays. Diversity in the deployment of these products facilitates that process, while being aware of the enormous raw material and vaccine supply demands. 1364.   The United States supports mechanisms for global efforts to accelerate development and access for COVID-19 products that are voluntary, complementary and mutually supportive. 1365.   Accordingly, intellectual property assists in putting partners and collaborators together with respect to research and development, manufacturing and voluntary technology transfer arrangements, and transportation and distribution. These partnerships drive access to innovative products and are facilitated by the intellectual property ecosystem.