Posts Tagged: "TRIPS Waiver"

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.

Two major trade organizations representing global vaccine manufacturers are officially backing a proposal submitted to the G20 and G7 countries in July that they claim offers practical solutions for future pandemics to avoid the inequities that have been highlighted by the COVID-19 pandemic. The Berlin Declaration was proposed in July 2022 by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and calls on industry to commit to “reserve an allocation of real-time production of vaccines, treatments and diagnostics for priority populations in lower income countries and take measures to make them available and affordable.”

The People’s Vaccine Alliance, a coalition of over 100 organizations, issued a statement this week alleging that the pharmaceutical industry is attempting to tighten its control of the world’s pandemic response plans. In the statement, the organization argues that “enshrining pharmaceutical companies’ demands in a pandemic treaty or other pandemic preparedness plans would normalize global inequalities and tie the hands of governments in future health crises.” The Alliance released the statement in response to the International Federation of Pharmaceutical Manufacturers & Associations’ (IFPMA) July statement titled the Berlin Declaration – Biopharmaceutical Industry Vision for Equitable Access in Pandemics during the World Health Summit, where stakeholders from politics, science, the private sector, and civil society gathered in Berlin from October 16-18.

With all of the problems besetting us, you might think that the last thing we need right now is another give-away of critical technologies, but that could be about to happen. Negotiations are underway in Geneva over a proposal from “developing countries” that negating patent protections for our COVID-19 vaccines wasn’t good enough. Now they want to extend that foolish concession we agreed to earlier this year to any COVID therapy. You’d think it would be well understood by now that appeasement doesn’t foster gratitude, it only encourages the other side to push for more. We’ll soon see if we roll over again or not.

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.

Health and Human Services (HHS) Secretary Xavier Becerra may consider himself a lucky man (which would probably sound ironic to him at the moment). He just received three letters which aptly summarize the fork in the road he faces in deciding which way to turn in a critical policy decision. On June 23, Senator Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX), joined by 98 of their Democratic Congressional colleagues, sent him the latest in their series of letters urging him to use alleged existing authorities so that copycats can make expensive drugs to lower health care costs. That triggered an immediate rebuttal from six associations representing research universities and hospitals (including the Bayh-Dole Coalition, which I lead) and another from the Licensing Executives Society, USA & Canada, Inc. (LES), representing the licensing profession. It seems appropriate to let the letters speak for themselves, so let’s start with the Congressional letter, urging the Secretary to use tools they allege he already has to cut the Gordian Knot to lower drug costs.

During the last Presidential campaign, then candidate Biden famously promised to end fossil fuels. True to his commitment, President Biden has attempted to make the oil and gas industry less attractive to both corporations and investors. Unfortunately, clean energy is not ready as a solution for 21st century economies. But if the Biden Administration does want an alternative energy future, it better figure out how to fix a broken American patent system where virtually nothing is patent eligible, and it better also figure out how to keep the United Nations and developing countries from stealing proprietary rights of innovators. On the heels of the Biden Administration siding with developing nations in their effort to appropriate vaccine technology, UN Secretary-General Antonio Guterres is calling for all intellectual property on clean energy technologies to be busted, and the innovations handed over to developing nations for free.

Senate Finance Committee Chair Ron Wyden (D-OR), Ranking Member Mike Crapo (R-ID) and Senators Bob Menendez (D-N.J.), Charles Grassley (R-IA), Catherine Cortez Masto (D-NV) and Ben Sasse (R-NE) sent a letter today to U.S. Trade Representative (USTR) Katherine Tai asking that she “dramatically improve” transparency in the negotiations surrounding waiver of intellectual property rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The letter noted that details of the draft text of a waiver agreement were announced in March, before Congress had been briefed or shown the text. Most recently, a new draft was shared with all World Trade Organization (WTO) Member States that has caused controversy on all sides of the issue.

The U.S. Chamber of Commerce yesterday published a letter it sent to members of congress expressing strong support for both the “No Free TRIPS Act” and the “Protecting American Innovation Act.” According to the letter, if enacted, these bills “would prohibit the Administration from negotiating or concluding any modifications to the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, without the explicit authorization of Congress.” The Chamber is concerned about the potential impact of the proposed waiver of patent rights for COVID-19 vaccine technology. The letter comes after the European Union, United States, India and South Africa reached a compromise on language for waiver terms last month.

What does the invasion of Ukraine have to do with COVID-19? Would you believe intellectual property is the link? Stay with me on this; it’s an interesting story. Recently, it was confirmed that the Main Intelligence Department of the Ministry of Defense of Ukraine – apparently with some help from volunteer hackers – managed to breach the network of Russia’s most guarded nuclear power facility and make off with extremely valuable trade secrets. The Beloyarsk Nuclear Power Plant contains the world’s only two operational “fast breeder” reactors. More than 20 countries, including the U.S., Japan and France, have been working for decades on this technology, which is supposed to be able to extract close to 100% of the energy from uranium, compared to about 1% for light water reactors. In other words, this is a process that can produce large amounts of energy while completely consuming the fuel and creating virtually no nuclear waste. Whoever is able to commercialize it will make a fortune. So far, no one has come close to the Russians.

Dear Ambassador Tai: I write you again today for the fourth time about the Biden Administration’s waiver of international obligations under the Trade-Related Aspects of Intellectual Property Rights, or TRIPS agreement. Last week, several open-content organizations wrote to President Biden and argued that your proposed TRIPS Waiver should cover not just patents, but also copyright and other intellectual property rights. These organizations ask that you include copyright simply because it may apply to software, medicine labels, manuals, or “tools” associated with vaccines. The letter fails to address the importance of these protections to the economy, trade, and employment, the limitations placed on protections to ensure a balanced system, and how copyright protection facilitates the very innovation, creativity, and knowledge sharing that will make it possible for us to end this once in a lifetime pandemic. The inclusion of copyright is both unsubstantiated and unwarranted, and would impose devastating consequences on American creators, businesses and workers, while doing nothing to advance the objective of combatting COVID.

One-hundred-twenty-four professors and academics from around the world have penned an open letter supporting India and South Africa’s proposed waiver of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which they claim will help to combat the COVID-19 pandemic. According to a press release about the letter, the United Kingdom, Ireland, Australia, Brazil, Japan, Norway, Switzerland and the EU continue to oppose the waiver proposal. The United States expressed its support for waiver in May. Over the last several weeks, Europe has doubled down on its opposition to the proposal in ongoing talks.

On June 4, the European Commission submitted to the World Trade Organization (WTO) its proposal for improving access to COVID-19 vaccines and treatments in countries suffering from vaccine shortages. The plan was submitted as an alternative to other proposals that would eliminate international patent rights for COVID-19 vaccines and treatments under the premise that such action would improve vaccine access in poorer countries. While the EU alternative contemplates the possible use of compulsory licensing, it addresses supply chain issues that will help to inoculate the entire globe against COVID-19 much more quickly than any patent waiver could ever hope to accomplish.

All the fuss surrounding the proposal by India and South Africa to suspend the TRIPS Agreement to help them produce vaccines to fight COVID-19 has obscured some critical truths. In spite of the rallying cry “Patents versus People,” it’s not really about patents. And merely lifting TRIPS obligations will do nothing to address the current suffering of the world’s poorer populations. In fact, it would hamper efforts to secure global distribution of vaccines, as well as cause real harm in the long term.