Posts Tagged: "World Trade Organization"

The House of Representatives’ Subcommittee on Courts, Intellectual Property, and the Internet today held a hearing titled “IP and Strategic Competition with China: Part II – Prioritizing U.S. Innovation Over Assisting Foreign Adversaries,” which focused on the World Trade Organization’s (WTO’s) agreement on a waiver of IP rights for COVID-19 vaccine technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) last June. All of the panelists agreed that COVID-19 is no longer a public health emergency and that an extension of the waiver to diagnostics and therapeutics is likely unnecessary.

The International Trade Commission (ITC) conducted an all-day hearing today featuring a range of stakeholders with interests in the World Trade Organization’s (WTO) pending decision on extending what has come to be known as the TRIPS [Agreement on Trade-Related Aspects of Intellectual Property Rights] waiver from strictly COVID-19 vaccine technologies to COVID-19 related therapeutics and diagnostics. The initial agreement on waiver came in June of last year and left most of those at the table unhappy. The decision presently applies only to “ingredients and processes necessary for the manufacture of the COVID-19 vaccine” and contemplates extending that to therapeutics and diagnostics no later than six months after the date of the decision, which would have been December 17, 2022. However, that was delayed in December amid concerns there wasn’t enough information to make an informed decision on extension.

When it comes to how to best increase access to medicines in l0w and middle-income countries (LMICs), compulsory licensing gets most of the attention. Academic articles, non-governmental organization (NGO) campaigns, conferences and United Nations (UN)-endorsed technical symposia assert it is the best approach. Certain World Trade Organization (WTO) members are pushing for COVID-19 treatments and diagnostics to be included in the waiver of intellectual property rights under the Agreement on Trade-Related Aspects of IP Rights (TRIPs waiver), which revolves around compulsory licensing. Brazil has recently amended its IP laws to make compulsory licensing easier. Despite its high political profile, compulsory licensing has rarely been used (mainly by a handful African countries in the mid 2000s to address the HIV pandemic). Even then, IP-respecting treatments available from global procurement bodies have proven cheaper. No country has yet seen the need for a compulsory license for a COVID vaccine.

A group of more than 160 charities, non-governmental organizations (NGOs), advocacy organizations, and others sent a letter today under the banner of the People’s Vaccine Alliance to World Trade Organization (WTO) Director-General Dr. Ngozi Okonjo-Iweala imploring the WTO not to accept the proposed delay of a decision to extend waiver of IP rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to therapeutics and diagnostics. The Office of the United States Trade Representative (USTR) on December 6 announced support for delaying the deadline on an extension decision.

A number of lower-income countries (LMICs) on Tuesday, December 6, proposed new text to the World Trade Organization (WTO) urging them to adopt it and proceed with an extension of the waiver of IP rights for COVID-19-related technologies under the Agreement on Trade-Related Aspects of IP Rights (TRIPS). The text was sent following the United States’ announcement on the same day that it supports a delay of the deadline to decide whether to extend the waiver to diagnostics and therapeutics pending an International Trade Commission investigation that the Office of the United States Trade Representative (USTR) has ordered.

The Office of the United States Trade Representative (USTR) this morning announced support for delaying the deadline to decide whether to extend a waiver of intellectual property rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to diagnostics and therapeutics. The USTR also said it has asked 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.”

On November 10, a group of Democratic members of congress sent a letter to United States Trade Representative Katherine Tai expressing concerns about extending a waiver of intellectual property rights under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement to therapeutics and diagnostics for the treatment of COVID-19. The letter comes as talks are heating up at the World Trade Organization (WTO) about such an extension, with the technical deadline for a decision being December 19. The letter poses seven questions for Tai to consider and respond to as she formulates the U.S. position on waiver extension, including whether the current waiver of IP rights for vaccine-related technology has been effective, how “diagnostics” and “therapeutics” will be defined, and that she provide a list of countries that have expressed interest in gaining access to American IP for COVID-related diagnostics and therapeutics.

A communication from the governments of Mexico and Switzerland to the World Trade Organization’s (WTO’s) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on Tuesday raised a number of questions about the prospect of extending a waiver of intellectual property (IP) rights for COVID-19 vaccine technologies to therapeutics and diagnostics. The Council met informally in September to discuss the extension, which technically has a deadline of December 19, six months after the Ministerial Conference decision finalizing a waiver on “patented subject matter required for the production and supply of COVID-19 vaccines” only. The final agreement contemplated extending the waiver to “the production and distribution of COVID-19 diagnostics and therapeutics” within six months of adoption.

With the World Trade Organization’s (WTO’s) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) set to meet informally on Monday, September 19, to discuss extending a waiver of IP rights for COVID-19 vaccine-related technology to diagnostics and therapeutics, the U.S. Chamber of Commerce and the Chamber’s Global Innovation Policy Center (GIPC) are urging the Biden Administration to oppose such a move in favor of “real solutions.” The GIPC’s President and CEO, David Hirschmann, and the Chamber’s Executive Vice President and Head of International Affairs, Myron Brilliant, sent a letter to U.S. Secretary of Commerce Gina Raimondo on Friday expressing confusion at the administration’s seemingly contradictory stances on intellectual property rights.

A terrible idea – wayward and ill-conceived, criticized by all economic, political and geopolitical fronts – has come to fruition. The World Trade Organization’s (WTO) TRIPs waiver on patents related to COVID-19 vaccines will disincentivize the entire industry from investing in vaccine production. To understand what happens next, let’s understand history first.

Following a week of round-the-clock deliberations, the World Trade Organization (WTO) this morning announced a deal on waiver of IP rights for COVID-19 vaccine technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The final text has made almost no one happy and largely mirrors the draft text going into negotiations, with a few key changes. With respect to open questions in the draft text, the final agreement indicates that all developing country WTO Members will be considered eligible to take advantage of the waiver, but that those with “existing capacity to manufacture COVID-19 vaccines are encouraged to make a binding commitment not to avail themselves of this Decision.” This language is primarily targeted at China, which has publicly stated that it would not use the waiver provision but had objected to language based on percentage of global vaccine exports that would have categorically excluded it. The draft text had encouraged members with vaccine export capabilities to opt out rather than to make a binding commitment.

The People’s Vaccine Alliance issued a statement today, one day before the World Trade Organization’s 12th Ministerial Conference is set to end, accusing the United Kingdom and Switzerland of being “major blockers of the TRIPS waiver for twenty months while millions have died without access to COVID-19 vaccines.” Anna Marriott, Policy Lead at the People’s Vaccine Alliance and Health Policy Manager at Oxfam, said the two countries “have repeatedly disrupted negotiations using the amendment process to ensure that any text is difficult to use or implement” and added: “It would be totally false for rich countries to shift the blame for the current state of TRIPS negotiations onto anybody else.”

The World Trade Organization’s (WTO’s) 12th Ministerial Conference is set to take place this week, June 12-15, at WTO headquarters in Geneva, Switzerland. As part of the four-day meeting, discussions around the latest text of the proposal to waive intellectual property (IP) rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccine technology will take place around the clock, and it is expected that some agreement will be reached. TRIPS Council Chair, Ambassador Lansana Gberie of Sierra Leone, said on June 7 that “delegations have entered into real negotiation mode in the last 24 hours,” and that she is “feeling cautiously optimistic now that we will get this text ready for adoption by ministers in time for the coming weekend.”

World Trade Organization (WTO) director-general Ngozi Okonjo-Iweala yesterday sent a letter to Ambassador Lansana Gberie, Chair of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), explaining that an informal group of delegates from the United States, the European Union, India and South Africa have reached a draft outcome document on the proposal to waive IP rights for COVID vaccine-related patented technologies. The text largely tracks that of a draft circulated in March, but some open questions remain for the broader membership to resolve.