Intellectual Property Waivers for Drugs Daily Update

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US has massively increased global vaccine distribution

Nick Niedzwiadek, 9-22, 21, Politico, Biden announces 'partnership' with EU on global vaccine distribution effort, https://www.politico.com/news/2021/09/22/biden-eu-global-vaccine-distribution-513600 resident Joe Biden announced Wednesday the formation of a partnership between the United States and European Union to further the global Covid-19 vaccination effort. “The United States is leading the world on vaccination donations. As we're doing that, we need other high-income countries to deliver on their own ambitious vaccine donations and pledges,” Biden said at a virtual meeting with leaders of the United Nations, World Health Organization and countries including the United Kingdom and Canada. Biden said the partnership will allow the EU and U.S. “to work more closely together” and that one of its bedrock principals will be committing to “donating, not selling” vaccine doses to less-affluent countries. He also made official his administration's plan to purchase another 500 million vaccine doses to distribute to some of the world’s poorest nations. News of the additional supply trickled out earlier this week, and will bring the United States' total commitment to 1.1 billion doses. “Put another way, for every one shot we’ve administered to date in America, we have now committed to do three shots to the rest of the world,” Biden said at the summit. Biden also pledged that the U.S. will provide an additional $370 million “to support administering these shots and delivery globally,” as well as more than $380 million to Gavi, the organization overseeing the daily operations for the COVAX vaccination project. Biden also urged those assembled Wednesday to make sure they follow through on their vaccine commitments. Out of the 870 million vaccine doses countries pledged to donate at the G-7 this summer, only 15 percent have been shipped so far. The European Union has so far committed to donate 450 million doses by mid-next year. Almost half of that should be shipped by the end of the year, but the bloc is lagging far behind with only 28 million doses shipped so far. Last week Bruce Aylward, the top WHO official working on COVAX, said the world needs 2.4 billion additional doses to go into low-income countries in order for them to get 40 percent of their populations vaccinated by the end of 2021. Biden also proposed another confab sometime “in the first quarter of 2022” to assess their progress.

The IP waiver devastates US industry and transfers essential trade secrets to China and Russia, which threatens our national security and economy

Masoff, 9-17, 21, Adam Mossoff is a Visiting Intellectual Property Fellow in the Edwin Meese III Center for Legal and Judicial Studies, of the Institute for Constitutional Government, at The Heritage Foundation, a Professor of Law at the Antonin Scalia Law School of George Mason University, and a Senior Fellow at the Hudson Institute, The COVID-19 Intellectual Property Waiver: Threats to U.S. Innovation, Economic Growth, and National Security, https://www.heritage.org/economic-and-property-rights/report/the-covid-19-intellectual-property-waiver-threats-us-innovation The COVID-19 pandemic, as well as growing economic and strategic competition from China and other traditional competitors such as Russia, have made innovation, economic growth, and national security top policy concerns. All three are threatened by the Biden Administration’s support for the proposed intellectual property (IP) waiver at the World Trade Organization (WTO). The Biden Administration should retract its support for the continuing negotiations of the IP waiver, and, if it fails to do so, then Congress should refuse to enact any implementing legislation of this waiver of the international commitment to honor the protection of IP rights. As Heritage Foundation Research Fellow James Roberts explained recently, the IP waiver would facilitate the global theft of the patents that made possible the private investments necessary in creating new technologies like the mRNA vaccines that were invented and mass produced in unprecedented time.2 The IP waiver would obliterate international protection for patent rights while leaving unaddressed the real problems that are impeding global distribution of vaccines to those who still need these vital medicines—problems such as eliminating the trade restrictions prohibiting international distribution of vaccines and creating distribution and transportation infrastructures in the developing world necessary to distribute the vaccines in those countries. If the U.S. continues to support and ultimately implement domestically the IP waiver, this would threaten far more destructive consequences than just its impact on patents and the innovation spurred by this key legal tool in the U.S. innovation economy. The IP waiver threatens many forms of IP rights, such as justifying the coerced disclosure of the trade secrets in the vital technical know-how used in creating the cutting-edge mRNA vaccines. This not only destroys the economic value and competitive advantage represented by these trade secrets—and the billions in investments that made them possible—but once this information is disclosed, it is impossible to recover it as a valuable trade secret. The IP waiver raises broad concerns about innovation policy, economic policy, and even national security. The U.S. should oppose the IP waiver. Failing this change in foreign policy by the Biden Administration, Congress should refuse to implement the IP waiver domestically if the Biden Administration continues to pursue another disastrous foreign policy initiative on the heels of the debacle of the Afghanistan withdrawal. What the IP Waiver Is and Is Not There is much confusion about what the IP waiver would entail, both substantively and institutionally. This section describes what the WTO is, the international treaty from which IP protections would be waived, and the scope of the IP waiver. Last, this section will describe the effect of the IP waiver on U.S. innovators if the Biden Administration or Congress further pursues its goals under U.S. law. The WTO and TRIPS. After the Biden Administration’s May 5 announcement of its support for the IP waiver, negotiations about the specific text and requirements of the IP waiver are proceeding at the WTO.4 The WTO is the intergovernmental organization that facilitates international trade between countries, including administering the international treaty known as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.5 TRIPS is an international treaty entered into in 1994 that requires countries that are members of the WTO to adopt and maintain a minimum level of intellectual property protections because laws regarding patents, copyrights, trade secrets, and trademarks are domestic laws in each country and enforceable only within that country’s jurisdiction. TRIPS also harmonized these intellectual property protections between countries by ensuring a baseline of protections for all IP rights. If a member state of the WTO fails to implement in its domestic laws the legal requirements set forth in TRIPS for the protection of intellectual property rights, other member states can initiate proceedings at the WTO for violating TRIPS and seek authorization to impose trade-based sanctions against that member state. TRIPS is the international treaty that the IP waiver would affect, releasing countries from their obligations to protect IP rights relating to any technologies necessary to respond to the COVID-19 pandemic without the threat of WTO-authorized sanctions. In addition to requiring countries to enact laws that protect new innovations in medical treatments and high-tech devices, TRIPS has a mechanism and process in Article 31 for a country to impose compulsory licensing on patented products or services,6 “Compulsory licensing” occurs when a government authorizes someone to produce, sell, or use a patent without permission from the patent owner—imposing on the patent owner what would have been a “license” if the parties had negotiated an agreement in the free market. If a country imposes compulsory licenses on patent owners, TRIPS requires that the patent owner be paid “adequate renumeration,” or what is commonly referred to in the U.S. as “reasonable compensation.” The substantive conditions and processes for a member state enacting compulsory licensing under Article 31 are generally known as “TRIPS flexibilities.” TRIPS Flexibilities. To understand the currently proposed IP waiver that is being negotiated at the WTO with the support of the United States, it is important to recognize three key facts about TRIPS flexibilities. Article 31 in TRIPS is limited to only patents—and thus its authorization for compulsory licensing does not cover other intellectual property rights, such as the technical know-how that many companies protect as trade secrets. Article 31 imposes a number of conditions and limitations on a member state’s use of compulsory licensing, reflecting that this is an exception to the TRIPS rule regarding respect for and enforcement of patent rights, and that, therefore, compulsory licensing represents an option of last resort to achieving some overriding public interest objective. Following logically from the prior point, the requirements mandated by Article 31 can be as lengthy and costly as any lawsuit filed in the U.S., such as requiring, before a compulsory license is imposed, that a commercial licensee or the government have “made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time.”9 This substantive limitation of compulsory licensing to only patents and the procedural requirements set forth in Article 31 explain why the proposed IP waiver at the WTO is not a request by member states to authorize compulsory licensing of patented drugs and vaccines under Article 31. Rather, the IP waiver is a formal request to set aside all international protections under TRIPS for vaccines, drugs, or any other technologies necessary for the treatment of COVID-19 during the pandemic.10 Strictly speaking, the IP waiver applies to patents, copyrights, industrial designs, and confidential know-how required for making and using medical treatments and other technologies necessary to respond to the COVID-19 pandemic, and thus it does not apply to trademarks, geographical indications, layout designs, or the performance rights of musicians and firms working in the creative industries that distribute sound recordings. This is unprecedented. The WTO has never before approved a wholesale waiver of TRIPS. The WTO has never even initiated formal negotiations of such a proposal, which is identified as “text-based negotiations” at the WTO. After the Biden Administration’s announcement of U.S. support for the IP waiver, the WTO began text-based negotiations for the IP waiver in early June. The IP Waiver Includes All IP for COVID-19 Treatments, Including Trade Secrets. The IP waiver was first submitted to the WTO by India and South Africa in early October 2020. Their original IP waiver declared that the requirements and enforcement of TRIPS “shall be waived in relation to prevention, containment or treatment of COVID-19” for all relevant patents, copyrights, design protections, and trade secrets.11 After the U.S. announced its support for the IP waiver, India and South Africa (now joined by other member states) resubmitted a revised version in late May 2021, calling for the waiver of the requirements and enforcement of TRIPS for all “diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19.”12 The IP waiver would be in effect for at least three years from the date the WTO adopts it.13 Such proposals for waivers from TRIPS have been made before—or have been threatened—but none has made it past the proposal stage, as key member states in the WTO (such as the U.S., Germany, Switzerland, and the United Kingdom) have opposed such measures. As a result, member states instead negotiated compulsory licensing processes, as permitted under Article 31 of TRIPS for patented drugs. For example, this is what happened approximately two decades ago for patented drugs used for the AIDS virus (HIV), although this agreement is confusingly referred to by the WTO as a “waiver,” given that it provided a blanket approval for compulsory licenses under Article 31 and provided several exemptions from some requirements under Article 31 if a country imposed a compulsory license.14 India and South Africa have been active in the past in seeking to implement—and even to expansively construe—TRIPS flexibilities. Both have large generic drug industries that benefit from loosened international protections of patented drugs created by the innovators that invest tens of billions of dollars and tens of thousands of labor hours to create modern medical miracles, such as treatments for hepatitis and cancer. India and South Africa likely thought the past would repeat itself with this new proposal for an IP waiver for the COVID-19 pandemic: It would serve as a negotiating anchor, similar to an opening offer in a contract negotiation between companies, by setting forth what they would ideally prefer to receive. This was likely a result of two accidental features of the recent policy debates over health care. The first was the past negotiations at the WTO resulting in compulsory licensing of patents under Article 31 for the AIDS pandemic.16 See James Bacchus, An Unnecessary Proposal: A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines 2, Cato Institute Free Trade Bulletin No. 70 (Dec. 2020), https://www.cato.org/free-trade-bulletin/unnecessary-proposal-wto-waiver-intellectual-property-rights-covid-19-vaccines. The second was the prominence of patents in domestic policy debates over drug prices and access.17 The IP waiver goes far beyond the waiver of patent rights. The IP waiver currently under consideration by the WTO would waive all relevant IP protections required by TRIPS for anything required for the treatment of the COVID-19 virus. It would waive protections of anything deemed necessary for an effective medical response to the COVID-19 virus, including design protections, copyrights, and—most important—trade secrets. Tech Transfer. The waiver of IP protections for technical know-how and other confidential information is not an example of accidental overreach by the IP waiver advocates. This is essential to its function as a waiver of TRIPS for countries seeking to produce, sell, and use all vaccines, drugs, or other technologies, such as computer-based technologies, for responding to the COVID-19 virus. The reason is that the key to producing vaccines based on the mRNA platform is not found solely in the patented products and methods that comprise this new technology. As with all radical, cutting-edge technologies that push the boundaries of human knowledge and skills, there is extensive technical know-how in manufacturing mRNA vaccines. It is not enough to know what the mRNA platform is and how it functions biologically—a company or government agency must know how to mass produce billions of doses of safe and effective vaccines. Thus, a necessary function of the IP waiver is tech transfer—the transfer of technical know-how to foreign governments and companies so that they can effectively make, use, and sell the vaccines and other drugs to the populations in their own countries. The goal of the IP waiver was never limited to only the elimination of the enforcement mechanisms at the WTO for countries like India or South Africa in refusing to enforce patents in their countries. The goal of the IP waiver is the coerced transfer of technical know-how from the U.S. and European companies that invested billions in creating the mRNA platform to foreign governments and companies. This raises serious policy concerns for innovation, economic competitiveness, and national security, as will be addressed in the next part. The Threat to U.S. Innovation, Economic Competitiveness, and National Security Commentators have long recognized in the context of patents that failing to protect innovation properly destroys the promise of IP rights.18 People will not invest the billions required to create a new drug or vaccine—and to create the follow-on technologies and the commercial production and distribution chains necessary to distribute this drug in the health care market to patients—if the fruits of their productive labors are not secured to them. People easily recognize this moral principle in the context of a farmer investing a year of valuable labor to plant, grow, harvest, and then distribute a crop—and it applies equally to the modern biotech or pharmaceutical company that creates, develops, produces, and distributes a new drug. Disclosure of Trade Secrets. The threat to innovation is magnified exponentially in the context of forced disclosures of trade secrets that protect valuable technical know-how—the inventions and commercial information created through the productive labors of scientists and businesspersons. In contrast to a trade secret, a patent is a public document that fully discloses all relevant information about the invention so that someone skilled in the technical field can make and use the invention protected by the patent. Judges and scholars have long identified this as the quid pro quo of the patent system: The inventor receives a time-limited property right in a new and useful invention, and in exchange for this property right, society receives public disclosure of the invention.19 A trade secret is an entirely different matter altogether. Valuable technical or commercial information that is actively kept secret is protected under trade secrets law.21 Reverse engineering or independent discovery are permissible for commercially valuable information protected under trade secrets law.22 The law prohibits only piracy of the trade secret—the wrongful acquisition of the information through theft or other improper means.23 The law strongly protects trade secrets because once they are publicly disclosed, the proverbial cat is out of the bag. There is no way to take back the knowledge; as the popular Internet meme puts it, “there’s no way to unsee” what one has seen. Following disclosure, the trade secret is lost as a commercial asset that gave its owner a competitive advantage in the marketplace. Thus, the law strongly protects trade secrets. For example, the federal government recently enacted the Defense of Trade Secrets Act of 2016 to make it easier for trade secret owners to seek legal relief in federal court.24 This law was enacted partly in response to the growing threat posed by industrial espionage from foreign actors, such as China. Recent bipartisan legislation has been proposed to protect even more IP rights—including trade secrets—from theft by Chinese companies and government officials.25 The original policy debate about the IP waiver focused on the removal of the international enforcement mechanisms for patent protections. This is one reason why the CEO of Moderna, one of the creators of one of two mRNA vaccines for COVID-19, said that he “didn’t lose sleep” after the announcement by the Biden Administration that it would support the IP waiver proposal by India and South Africa at the WTO.26 He told reporters, “There is no idle mRNA manufacturing capacity in the world. You cannot go hire people who know how to make mRNA—those people don’t exist…. When we hire people that come from traditional pharma, we have to train them in the art of mRNA.”27 Id. (emphasis added). He knows the real value in the mRNA vaccines—the value in the mRNA platform itself—is in the technical know-how that has evolved over the two decades that it has taken for mRNA technology to be researched and developed. But his dismissive reaction was premature because the advocates for the IP waiver understood from the get-go that this was not about weakening or eliminating patent protections for vaccines, drugs, or other medical treatments for COVID-19. Of course, the evisceration of international respect for patent rights is one aspect of the IP waiver; there are certainly some patents on some drugs that foreign companies or governments would benefit from appropriating, such as the patent on Remdesivir, the first drug approved by the FDA to treat severe respiratory symptoms caused by COVID-19.28 However, if this effort was only about patent rights, then India and South Africa would have sought only an automatic mandate under Article 31 of TRIPS for immediate compulsory licensing for all patents covering COVID-19 medical treatments (what was achieved almost two decades ago for the AIDS pandemic).29 That is not the true goal of the IP waiver, nor is it what it states in its text. The Real Reason. The IP waiver is a complete waiver from international protections provided by the TRIPS agreement for a period of at least three years for any “health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19.” This covers the technical know-how and other trade secrets that have been created by the scientists at Moderna, BioNTech, Pfizer, and all other companies licensed to make and sell mRNA vaccines. In sum, the IP waiver would eliminate international commitments to and enforcement mechanisms for IP rights, including trade secrets. The IP waiver would not be automatically implemented in the U.S., but the Biden Administration, after supporting the IP waiver at the WTO, would very likely push for domestic implementation of its goals, such as the disclosure of trade secrets. Over 100 Congressional Democrats lobbied the Biden Administration to support the IP waiver before the Administration announced its support on May 5, 2021, and they will also push aggressively for domestic legislation to implement in the U.S. the goals of the IP waiver.30 See Members of Congress That Led Push for TRIPS Waiver Applaud Biden Administration Announcement (May 5, 2021), https://schakowsky.house.gov​/media/press-releases/members-congress-led-push-trips-waiver-applaud-biden-administration. In her statement after the Biden Administration’s announcement of its support for the IP waiver, Speaker Nancy Pelosi (D–CA) declared it a “moral imperative” that the U.S. do everything possible to “defeat [COVID-19] everywhere.”31 See Pelosi Statement on Biden Administration Support for Vaccine Patents Waiver at WTO (May 5, 2021), https://www.speaker.gov/newsroom/5521-3. Some people have suggested that the Biden Administration is merely engaging in political showmanship in the international arena with no real hope of implementation of any actual laws or policies in the U.S.,32 but that is highly unlikely to be the case. It would be anomalous for the Biden Administration to support the adoption of the IP waiver at the WTO and then refuse to undertake the domestic actions required to implement that IP waiver for U.S. owners of IP who are covered by the waiver—especially given that many U.S. companies are owners of the valuable trade secrets in technical know-how concerning how to make and distribute the mRNA vaccines. The charges of hypocrisy from the large contingency of developing countries at the WTO that the Biden Administration has courted favor with by supporting the IP waiver, as well as the resulting perception of another humiliating debacle in U.S. international policy, strongly suggest the Biden Administration, the Democratic leadership in Congress, and the numerous Democrats already supporting the IP waiver would push for implementing legislation in the U.S., and that this is not just political theater on the international stage. If this happens, such legislation could require a coerced tech transfer of the valuable technical know-how by the innovators who have worked for decades to create the mRNA platform as a means to create medical treatments and vaccines for diseases like the COVID-19 virus. The precise language of the IP waiver has yet to be settled upon, given the ongoing negotiations in the WTO. As currently worded, however, the proposal has at least two results that would kill the technical innovations that have driven the U.S. innovation economy and given the U.S. a competitive advantage in the global economy in both biotech and high-tech—as well as imperil its national security. Coerced Disclosure: Constitutional and Policy Concerns. First, the coerced disclosure of technical know-how to foreign companies (and even to foreign governments) requires violating the rights of American IP owners far beyond anything previously imagined. If the WTO adopts the proposed IP waiver currently under consideration, this would simply set aside the TRIPS agreement and the enforcement mechanism at the WTO to uphold in the international arena the multilateral respect among different countries for IP rights. Each country would then choose if—and how—to adopt in its own domestic laws the “moral imperative” imposed by the IP waiver, in Speaker Pelosi’s words. According to those arguing that the IP waiver imposes this moral mandate, legislation to implement the IP waiver in the United States would have to do more than just prohibit U.S. patent owners from enforcing their patents under U.S. law—such as filing lawsuits in court to prevent unauthorized imports of infringing products or services or seeking exclusion orders against infringing imports in the U.S. International Trade Commission. To truly implement domestically the IP waiver, at least as it is currently worded, this legislation would require coerced disclosure of the valuable trade secrets necessary to develop the facilities and to manufacture billions of doses of mRNA vaccines that are consistently safe and effective in preventing COVID-19 infections. Coerced Disclosure and Obamacare. It is not impossible for the federal government to do this, such as through regulatory mandates and tax incentives. Unfortunately, the Obama Administration provided the Biden Administration with a road map of how to accomplish this goal with the Obamacare tax incentives in the regulatory mandate to adopt health care insurance. Unfortunately, the Supreme Court confirmed this road map when it refused to strike down Obamacare as unconstitutional in 2012.33 Nonetheless, there are other constitutional hurdles that would need to be overcome by Congress and the Biden Administration in implementing a coerced disclosure of trade secrets. The Supreme Court has expressly recognized that trade secrets are protected property rights under the Fifth Amendment.34 As such, trade secrets cannot be coercively disclosed through regulatory mandates without triggering the requirement that the owner be paid “just compensation.”35 Unfortunately, this “regulatory takings” doctrine known as the “Penn Central inquiry” has proven to provide little to no protection for U.S. landowners who have suffered deprivations of economic value in their real estate resulting from regulations.36 In all cases brought before the Supreme Court, landowners have never won when the Supreme Court has applied the legal test for regulatory takings doctrine—known as the Penn Central inquiry. See Penn Central Transportation Co. v. City of New York, 438 U.S. 104 (1978). This legal doctrine is infamously problematic; the Supreme Court admits that it is “ad hoc” and that it is uncertain and unpredictable, except perhaps for the safe prediction based on case outcomes that the government always wins.37 The Supreme Court and Regulatory Takings. Given the nature of the regulatory-takings doctrine and the consistent outcomes in cases, it is easy to predict that the Supreme Court would find a coerced disclosure of a trade secret by regulatory decree, especially if accompanied by some form of “reasonable compensation,” to pass constitutional muster. If implementing legislation of the IP waiver functions through something like tax penalties or incentives, it is even harder to see the Supreme Court finding a constitutional qualm in this legislation: Again, think Obamacare. At the very least, it is always a big risk to pass legislation assuming a court will strike it down, especially when it comes to regulatory takings. It is therefore incumbent on Congress to refuse to enact this legislation in the first place. If it chooses to address concerns about global vaccine distribution invoked by the IP waiver’s advocates, Congress should create international relief programs to help construct infrastructure to distribute vaccines or eliminate the prohibitions on international exports of vaccines, personal protective equipment (PPE), and other pandemic-related goods. Congress should not enact any legislation that violates the rights of American IP owners. Hands-On Technical Know-How. There is another fundamental constitutional concern beyond ostensive regulatory takings concerns with the coerced disclosure of the trade secrets in mass producing safe and effective mRNA vaccines. As noted, the technical know-how in mass producing mRNA vaccines represents more than just the information itself. It cannot be taught abstractly through reading documents or online lectures. It requires trial-and-error practice and experiential learning. It requires the active, in-person teaching of the technical skills, which means operational oversight of an expert to guide the many attempts by students who are learning this practical knowledge. Teaching this technical know-how is not like teaching mathematics. It represents the acquisition of practical skills, like the training of an Olympic athlete, a professional athlete, a medical intern in a hospital, or a junior associate in a law firm. Legislation implementing requirements of the IP waiver that require disclosure of the technical know-how necessary to mass produce mRNA vaccines might mandate that U.S. scientists and engineers teach foreign scientists or government officials how to mass produce safe and effective mRNA vaccine doses. It is one thing to deny patent owners the legal right to sue for patent infringement or to compel a compulsory license in which the government imposes price controls via a “reasonable royalty” for this coerced transfer of the patented invention (as would occur under Article 31 of TRIPS). It is quite another to mandate that a U.S. company like Moderna actively ensure the transfer of its technical know-how to foreign scientists or government officials so that these foreign actors can effectively manufacture and distribute mRNA vaccines in those countries. Some argue that the IP waiver will require—or at least should be interpreted to require—the transfer of technical know-how.38 As the Moderna CEO put it so well, this information—which is currently protected as a trade secret—cannot simply be acquired by others from reading a patent or technical manual. This raises a whole new level of constitutional and policy concerns about how the U.S. government will achieve effective transfer of technical know-how under the IP waiver. Congressional Democrats, international activists, scholars, and even foreign governments will expect the U.S. to do so, given the Biden Administration’s express support for the IP waiver. IP Waiver: Undermining Innovation, Subsidizing Chinese and Russian R&D. In addition to the legal and policy concerns of how the U.S. government might seek to implement the IP waiver in compelling disclosure of the trade secrets representing the technical know-how in producing mRNA vaccines, there is a broader concern about the countries benefiting from this coerced scientific and technical training. Implementing the goals of an IP waiver would require more than surrendering patents, disclosing trade secrets, and training scientists in Brazil, India, or South Africa: Any member state of the WTO would no longer be required to honor its commitments to protect the waived IP rights. This could mean that Russia and China might seek to compel disclosure or demand the active transfer of the technical know-how or training. This leads to the second innovation policy concern raised by the IP waiver’s goal to surrender patents, disclose trade secrets, and transfer technical know-how necessary to effectively respond to COVID-19. As noted earlier, once a trade secret is disclosed, the value of the information is lost. More precisely, the competitive advantage in the information as a commercial asset is lost because it is now available to anyone in the world who wishes to learn it and act on it. A patent is an exclusive property right for 20 years, but the information is already public through the patent document itself, which is what prompts follow-on innovations during the term of the patent and further innovation once the invention falls into the public domain. The trade secret—the “secret sauce” in a company’s business model—is only valuable so long as it is kept secret. This year, the federal government began actively seeking to promote the growth of its innovation economy to ensure the continuation of the comparative advantages long enjoyed by the U.S. against the rising challenge represented by China. The U.S. Innovation and Competitiveness Act of 2021 (USICA) is a prime example of this concern. The USICA was approved by the Senate on June 8, 2021, and is awaiting a vote in the House, authorizing $250 billion in funding for research and development (R&D) in artificial intelligence and other new technologies, as well as in semiconductor chip production.39 Regardless of whether one agrees with the creation of federal industrial policy in the USICA, it represents a response to a mounting concern that the U.S. must focus more on promoting the innovation that grows the U.S. economy, creates jobs, and increases quality of life for all Americans—especially in the face of global economic and strategic competition from China.40 The Biden Administration’s support for the IP waiver at the WTO contradicts these innovation policy concerns that are prompting the USICA, which the Biden Administration also claims to support, albeit without much regard for coherence in innovation policy.41 For at least two decades, China has actively engaged in various forms of “tech transfer” to steal U.S. IP, such as engaging in outright industrial espionage or simply mandating under Chinese law that foreign companies engaged in economic activities in China turn over IP and other valuable know-how to Chinese companies or to the government.42 In a recent Senate hearing, William Evanina, the former director of the National Counterintelligence and Security Center, testified that the Chinese Communist Party was responsible for stealing between $300 billion and $600 billion in U.S. intellectual property and trade secrets in just 2020.43 Federal Bureau of Investigation Director Chris Wray stated last year that China’s concerted campaign of theft of American IP represented “one of the largest transfers of wealth in human history.”44 See Russell Flannery, China Theft Of U.S. Information, IP One Of Largest Wealth Transfers In History: FBI Chief, Forbes (July 7, 2020), https://​www.forbes.com/sites/russellflannery/2020/07/07/china-theft-of-us-information-ip-one-of-largest-wealth-transfers-in-history-fbi-chief/?sh=​3b99c0cf4440 The IP waiver would effectively transfer to China valuable patents, trade secrets, and tech know-how created through billions in investments and decades of labor by U.S. innovators. What China has only been able to steal or otherwise obtain through other improper methods over the years, the IP waiver would achieve under a U.S. law enacted to implement the perceived moral mandate of the IP waiver. Such a law would do the same for other global competitors of the U.S. who are member states of the WTO, such as Russia. This will not only massively harm the incentives to innovate in the U.S., it would also result in a multi-billion-dollar subsidy of basic research and development in China, Russia, and other countries who would immediately benefit from the technical know-how produced by the productive labors of the scientists and businesspersons in the biopharmaceutical sector during the past decades. The IP waiver strikes at the heart of the IP-based labors that are the principal drivers of the U.S. innovation economy, killing the incentives to create the technologies that create jobs, grow the economy, and, in the context of the life sciences, save lives and increase quality of life. In doing this—by anticipating forced disclosure of valuable technical know-how acquired from decades of R&D—the waiver could effectuate a massive tech transfer to other countries that did not invest in this R&D, nor create the valuable scientific insights and technological innovations that have produced modern medical miracles, such as mRNA vaccines. The forced waiver would kill the comparative advantage of the U.S. innovation economy, and further undermine U.S. competitiveness in the global economy at a time when the U.S. is just waking up to the challenge represented by economic and national competitors like China. The Economic and National Security Concerns About the IP Waiver Last, the waiver’s policy concerns go far beyond the subsidization of tens of thousands of labor hours and billions in investments to create the knowledge necessary to produce safe and effective mRNA vaccines. The mRNA technology is a platform technology—a technological discovery that has applications that go far beyond the current COVID-19 pandemic. Companies have begun investigating how to develop more mRNA vaccines to address viral scourges that have killed millions of humans around the globe.45 With incredible medical cures ranging from cancer to HIV to malaria, the mRNA platform is the invention that may fulfill the full promise of the biotech revolution that began in the U.S. almost four decades ago.4 Unauthorized Use by Global Competitors. If implemented domestically to the degree demanded by its advocates, the IP waiver would promote the disclosure of technical know-how in the mRNA platform to countries throughout the globe, including to China and Russia. As economic and strategic competitors—expressed in both words and deeds over many years—it is highly unlikely that China or Russia would respect the requirement in the IP waiver that these trade secrets be used only for COVID-19 medical treatments and only for three years or the length of the pandemic, whichever is longer. Unauthorized Transfer to Global Competitors. Even if China or Russia are prohibited somehow from directly receiving the technical know-how, there is nothing that would stop other countries or individuals in other countries from transferring the information to them after the direct disclosure and training by U.S. scientists in the technical know-how of how to produce mRNA vaccines. Again, once a trade secret is disclosed, it is lost by its owner to the world; information is transmissible as easily as it takes for digital signals to traverse the cables that carry international Internet traffic or as easily as it is for people with the knowledge in their heads to travel from one country to another country. Preventing trade secret misappropriation is a difficult endeavor within a single jurisdiction, and identifying or tracking information back to the original act of misappropriation can be onerous and costly for private companies seeking renumeration or other legal relief. On an international scale between nation-states, even with the threat of WTO trade sanctions, it may prove nearly impossible to catch malefactors—or even simply prove the unauthorized transfer by any reasonable measure of evidence. Any prohibitions or sanctions for unauthorized transfers of technical know-how in implementing U.S. legislation would represent oratory proclamations at best, tantamount to the Biden Administration’s demand in August 2021 that the Taliban create a “united, inclusive and representative” government in Afghanistan.47 Tyler O’Neil, State Department Calls for Taliban to Include Women in Its Government, Fox News (Aug. 16, 2021), https://www.foxnews.com/politics​/anthony-blinken-speaks-on-the-fall-of-kabul (reporting remarks by U.S. State Department spokesman, Ned Price). Simply put, U.S. laws have no control over actions undertaken in foreign jurisdictions by foreign citizens. Ultimately, any forced disclosure of the technical know-how in the mRNA biotech platform simply requires that Congress and U.S. officials have blind faith that China, Russia, or other countries will use these disclosed trade secrets solely for purposes of producing only vaccines and other medical treatments only for COVID-19. This reflects an astonishing level of naïveté in international politics—especially when dealing with a well-established economic and strategic competitor like China that has blatantly stolen hundreds in billions in U.S. IP or a country like Russia that has engaged in cyberattacks on U.S. institutions, illegally invaded Ukraine, and annexed the Crimea in 2014.48 National Security Implications. Beyond the obvious economic benefits of this massive tech transfer to these economic and strategic competitors—and the direct harm done to U.S. innovators—the national security concerns are equally palpable. The concern that COVID-19 was leaked from a government lab in Wuhan, China, experimenting with coronaviruses is still being investigated.49 There is also intelligence information that this government lab was working on “classified research for the Chinese military.”50 Michael R. Gordon & Warren P. Strobel, New U.S. Intelligence Report Doesn’t Provide Definitive Conclusion on Covid-19 Origins, Wall Street J. (Aug. 24, 2021), https://www.wsj.com/articles/biden-to-receive-report-on-coronavirus-origins-but-challenges-persist-in-how-to-deal-with-china-11629825758. There are many reasons why the lab leak theory remains very much in play. Unlike prior global disease outbreaks in recent years, the world still does not know—almost two years after the inception of a worldwide viral pandemic—where COVID-19 came from or who was Patient Zero. The reason is simple: China has obstructed international efforts to obtain the necessary information to answer these vital questions in better understanding and responding to COVID-19.51 See id. (reporting that an intelligence report on the origins of COVID-19 “didn’t yield a definitive conclusion on whether the new coronavirus jumped to humans naturally, or via a lab leak, in part because of the lack of detailed information from China”); China Blocks Entry to WHO Team Studying Covid’s Origins, Guardian (Jan. 5, 2021), https://www.theguardian.com/world/2021/jan/05/china-blocks-entry-to-who-team-studying-covids-origins; Dake Kang, Maria Cheng & Sam McNeil, China Clamps Down in Hidden Hunt for Coronavirus Origins (Dec. 30, 2020), https://apnews.com/article/united​-nations-coronavirus-pandemic-china-only-on-ap-bats-24fbadc58cee3a40bca2ddf7a14d2955. In fact, China has actively deleted publicly available data about COVID-19, such as removing gene data on COVID-19 from a National Institutes of Health database in June 2020.52 Given China’s pattern of obstruction during the course of almost two years in uncovering necessary information about the origin and first human cases of COVID-19, it is clear that China cannot be trusted with a powerful biotechnology platform like mRNA. As a strategic competitor, China has in fact already stolen innumerable military secrets in addition to its economic espionage.53 See Dustin Volz, U.S. Spy Agency Warns That Chinese Hackers Target Military, Defense Industry, Wall Street J. (Oct. 20, 2020), https://www.wsj.com​/articles/u-s-spy-agency-warns-beijing-s-hackers-aiming-at-u-s-defense-industry-military-11603206459; Jeff Daniels, Chinese Theft of Sensitive US Military Technology Is Still a ‘Huge Problem,’ Says Defense Analyst, CNBC (Nov. 8, 2017), https://www.cnbc.com/2017/11/08/chinese-theft-of​-sensitive-us-military-technology-still-huge-problem.html; U.S. Department of Justice, Chinese National Admits to Stealing Sensitive Military Program Documents From United Technologies (Dec. 19, 2016), https://www.justice.gov/opa/pr/chinese-national-admits-stealing-sensitive-military-program​-documents-united-technologies. Thus, the U.S. should refuse to turn over to China the technical know-how in using the mRNA platform—either directly to China or indirectly through disclosures to other countries that might then leak, sell, or simply trade this information to China in exchange for other strategic benefits. Recommendations In sum, the U.S. should stand fast in defense of the rights of American innovators, its innovation economy, and its national security interests. The Biden Administration should immediately withdraw support for the IP waiver at the World Trade Organization. Failing this, Congress should reject any attempt by the Biden Administration or congressional Democrats to use the IP waiver to eliminate or weaken IP rights under U.S. law. This is especially pressing when any IP transfers or disclosures would be made to an economic and strategic competitor like China that has already stolen hundreds of billions in U.S. IP—and which can easily use the biotech platform to fulfill its own economic or military goals. The IP waiver threatens the foundations of the U.S. innovation economy, as well as risks U.S. companies giving away biotech know-how to countries like China and Russia that could undermine U.S. economic and national security interests.54 In addition to China, Russia and Iran are very real security threats, as evidenced in the recent COVID-19 pandemic. See Volz, supra note 55 (“The NSA has previously implicated the Russian government in efforts to exploit one of the flaws to steal coronavirus vaccine research, for example, and private-sector researchers have said suspected Iranian hackers have attempted to breach systems using some of the bugs.”). The IP waiver should not be adopted by the WTO, and, if it is, the U.S. should refuse to adopt it in any form in domestic legislation. If the advocates for the IP waiver are truly concerned about promoting global distribution of vaccines, drugs, and other medical treatments or supplies in response to the COVID-19 pandemic, there are numerous actions the U.S. could take that would achieve these goals. Instead of supporting the IP waiver at the WTO, the U.S. should consider alternative measures to protect U.S. technological innovation, stimulate economic growth, and preserve national security. Therefore, the Biden Administration should: Eliminate trade barriers that have prevented international exports of vaccines and other health care materials such as PPE—as the Wall Street Journal recognized in its own critique of the IP waiver.55 Release for use in other countries the stockpile of tens of millions of doses of the AstraZeneca vaccine that are not being administered in the U.S. but has been approved for use in 70 other countries.56 Marshal international support for investment in developing countries to create the necessary commercial distribution chains and physical infrastructure to facilitate distribution of the more than 12 billion doses of vaccines that will be produced by the end of 2021.57 More than 12 billion doses of the COVID-19 vaccine are estimated to have been produced by the end of 2021. See Duke Global Health Innovation Center, Launch & Scale Speedometer: Vaccine Manufacturing, https://launchandscalefaster.org/covid-19/vaccinemanufacturing (“Our analysis of 2021 projections from Covid-19 vaccine makers indicates that more than 12 billion doses could be produced this year.”). Conclusion The IP waiver is an example of a solution in search of a problem. There is zero evidence that IP rights have impeded or otherwise hampered the distribution of any vaccines. The evidence is to the contrary: IP rights prompted the investment of billions of dollars over several decades in research and development, encouraged the creation of a knowledge infrastructure within the biopharmaceutical sector, and served as the foundation for innumerable commercial and information-sharing agreements that made possible an unprecedented health care response to the COVID-19 pandemic.5 By wiping out international commitments to the protection of IP rights, including patents and trade secrets, the IP waiver violates the primary maxim in healthcare, “first, do no harm.” The best way to end the COVID-19 pandemic, as well as other scourges and future pandemics, is to continue recognizing, supporting, and respecting IP rights like patents and trade secrets—the legal engines that have driven medical innovations for the past century.

Status quo solves – hundreds of millions of new doses being donated

Peter Sullivan, 9-17, 21, https://thehill.com/policy/healthcare/572758-us-to-buy-hundreds-of-millions-more-vaccine-doses-for-the-world-report,  US to buy hundreds of millions more vaccine doses for the world: report The Biden administration is planning to buy hundreds of millions more Pfizer COVID-19 vaccine doses to share with the world, The Washington Post reported on Friday. Details of the announcement were not yet clear, and White House COVID-19 response coordinator Jeff Zients declined to confirm the report or offer more details when asked during a press briefing on Friday. The reported move comes ahead of the U.N. General Assembly next week, where boosting vaccine access in lower-income countries will be a focus. The Post reported that the, alongside the meeting. The Biden administration has been under pressure from experts and advocates to do more to help vaccinate the world. Officials point to the 140 million vaccine doses that the U.S. has already donated, as well as the purchase already announced for over 500 million doses to be donated across this year and next.

Israel proves low vaccine success rate

Science 8-16, 21, https://www.science.org/content/article/grim-warning-israel-vaccination-blunts-does-not-defeat-delt Israel has among the world’s highest levels of vaccination for COVID-19, with 78% of those 12 and older fully vaccinated, the vast majority with the Pfizer vaccine. Stuart Winner, 9-14, 21, Health Ministry chief says coronavirus spread reaching record heights, https://www.timesofisrael.com/health-ministry-chief-says-coronavirus-spread-reaching-record-heights/ Health Ministry Director-General Nachman Ash said Tuesday that the current wave of coronavirus infections is surpassing anything seen in previous outbreaks and that he is disappointed that a recent downward trend appeared to be reversing. Ash’s remarks via video call to the Knesset Constitution, Law, and Justice Committee came as Health Ministry figures showed that over 10,000 new COVID-19 cases were diagnosed the day before and that the positive test rate was climbing. Pointing out that there is an average of 8,000 new infections each day, with occasional peaks over 10,000, he said, “That is a record that did not exist in the previous waves,” including the massive third wave at the end of last year. Ash expressed some pessimism, though he observed that, belying fears, there wasn’t a large spike in infections following last week’s Rosh Hashanah holiday — the Jewish New Year — or the opening of the school year at the beginning of the month. After bringing daily infections down to little more than a dozen a day in June, Israel has been battling to control a resurgence of COVID-19 in what has been its fourth wave of infections since the start of the global pandemic. By signing up, you agree to the terms “A week ago we were in a clear downward trend; in recent days we’ve been seeing that decline stop, and the virus reproduction number is [again] above 1,” Ash said of the so-called R number, which indicates how many people each virus carrier will infect. Values above 1 show that the outbreak is growing, below 1 that it is shrinking. “I hoped that we would see a clearer drop, but we are still not seeing it,” he said. Ash noted the number of seriously ill ranges between 670 and 700. Every day 70-80 new patients fall seriously ill, slightly fewer than in recent weeks. ADVERTISEMENT The number of patients on ventilators has climbed in the past ten days from 150 to 190, while the number of those on the more critical ECMO machines rose from 23 to 31, he said. Despite the numbers, Ash said that the so-called Green Pass restriction would be removed from open-air swimming pools, in part to help out parents searching for activities for their children during the holiday period when schools are closed. The holiday period, including the weeklong Sukkot festival, ends September 28. The Green Pass enables only those who have been vaccinated against COVID-19, recovered from the disease, or recently tested negative for the virus to access most indoor public places, as well as crowded outdoor attractions. Since children below the age of 12 are not eligible for vaccination, they — if they’re over the age of 3 — must get rapid virus tests to attend many recreation venues. The Knesset meeting was convened to discuss the Green Pass system. National coronavirus czar Salman Zarka, who also participated in the meeting, said that 50 percent of confirmed cases on Monday were children. He said that the Health Ministry was working on the assumption that it will in the future need to deal with a fifth wave of virus infections. Zarka said that the ministry will prepare by continuing to use the Green Pass system, asserting that it helps prevent the virus spread, while noting that it would be eased as morbidity drops off. ADVERTISEMENT “I hope that we will pass the month of September and stabilize in October,” Zarka said. “Then we will take a fresh look at the policy.” Coronavirus czar Prof. Salman Zarka attends a press conference about the coronavirus in Jerusalem on August 29, 2021. (Olivier Fitoussi/Flash90) Zarka said the ministry had urged the government to restrict large gatherings and ban events such as a major student festival in Eilat, crowds at soccer matches, and an annual pilgrimage by tens of thousands of Israelis to Uman, Ukraine, to visit the grave of a venerated rabbi. Officials feared that hundreds of pilgrims would return with the virus. Dozens of infected travelers have been caught with forged paperwork declaring they tested negative for COVID-19 before boarding planes home. “The cabinet sees things differently from us and decided that the events can be held,” Zarka said. Health Ministry figures released Tuesday showed there were 10,556 new cases diagnosed the day before and 690 patients seriously ill with COVID-19. The positivity rate from 178,000 tests for the virus was 5.93%, up from the 5.24% recorded on Sunday. In total there were 83,952 active virus patients in the country. With the death of 18 people on Tuesday, the toll since the start of the pandemic last year reached 7,297. The virus reproduction number, which is calculated to show the situation ten days earlier, was given as 1.01 for September 3. After weeks of steadily dropping, the “R rate” began to tick up again two weeks ago. On Sunday, several ministers were overheard prior to a cabinet meeting saying that some coronavirus-related restrictions were only aimed at incentivizing vaccination, rather than driving down morbidit

Investments in synthetic biology increasing

Dynuz, 9-16, 21, https://dnyuz.com/2021/09/16/biology-starts-to-get-a-technological-makeover/. Biology Starts to Get a Technological Makeover BOSTON — Two white-coated lab technicians, seated at work stations in a corner, are vastly outnumbered by the machines. Robotic arms calibrate liquids in microdrops. Small trays, with 96 tiny wells each, shuttle around the lab on magnetic tracks. Centrifuges whir. Gene sequencers hum. The highly mechanized lab — operated by Ginkgo Bioworks, a fast-growing start-up in Boston — is an engine room of synthetic biology, an emerging field that applies the tools of engineering and computing to make entirely new organisms or genetically turbocharge existing ones. ADVERTISEMENT Proponents of synthetic biology say the field could reprogram biology to increase food production, fight disease, generate energy and purify water. The realization of that potential lies decades in the future, if at all. But it is no longer the stuff of pure science fiction because of advances in recent years in biology, computing, automation and artificial intelligence. Money is pouring into the field. Research universities, government agencies and major chemical and pharmaceutical corporations like Bayer and Merck are pursuing projects in the area. Yet so are smaller companies like Ginkgo. Young synthetic biology companies raised nearly $8 billion last year from venture capitalists and initial public offerings worldwide, more than double the level in 2019, according to SynBioBeta, an industry newsletter. This year, total funding could surpass $30 billion, SynBioBeta predicts. Many companies specialize in one part of the field; they include gene sequencers like Illumina and Pacific Biosciences and DNA synthesizers like Twist Bioscience and Codex DNA. Others, such as Zymergen and Ginkgo, are more one-stop shops. “There is still a long way to go, but the vision of applying engineering to make biology faster, cheaper and more reliable is starting to become a reality — and a big business,” said John Cumbers, a molecular biologist who is the founder of SynBioBeta. ADVERTISEMENT Ginkgo, which plans to go public on Friday, 13 years after its founding, shows the progress and challenges of this developing industry. Ginkgo has raised more than $900 million in venture funding from investors including Bill Gates, General Atlantic, T. Rowe Price and Viking Global Investors. But it started as five people with a shared belief that biology could be made more like computing with reusable code and standard tools instead of the bespoke experiments of traditional biology. “The ultimate goal for Ginkgo is to make it as easy to program a cell as it is to program a computer,” said one of the founders, Jason Kelly, who is chief executive. But unlike the electronic bits of computing, the code of DNA in cells is physical. The biological debugging, compiling and testing tools required lab space and equipment. At the start, they picked up gear at fire sale prices, as biotech start-ups were folding in the wake of the national financial crisis. Four of the founders were freshly minted Ph.D.s from the Massachusetts Institute of Technology — three in biological engineering, one in computer science. The initial funding came from the fifth founder, Tom Knight, who put up $150,000. Mr. Knight is a renowned computer engineer who became a founding pioneer of synthetic biology. At M.I.T., he designed hardware and software for time-sharing, operating systems, artificial intelligence and networking on the predecessor to the internet. But in his 40s, Mr. Knight decided the next open frontier for engineering innovation was in cells, more so than in silicon. So he spent years studying biology. In 1998, with backing from the Pentagon’s research arm, Mr. Knight started a lab at M.I.T. in what he called synthetic biology. It took years after its founding for Ginkgo to become a business. Before private investors came in, the start-up relied on $10 million from federal science programs that back promising research. “Ginkgo wouldn’t exist today without translational research capital from the government,” Mr. Kelly said. Ginkgo landed its first paying customer in 2014. Today, the company has dozens of customers across a variety of industries, including food, agriculture and pharmaceuticals. Its work varies depending on the customer. It can supply expertise, enzymes or complete cells. During the pandemic, for example, it has taken on fast-turnaround projects like helping Moderna optimize enzyme production to accelerate the manufacture of its Covid-19 vaccine. But most Ginkgo projects are longer-term initiatives designed to greatly increase the efficiency or speed of a desired biochemical process in a cell.

Moderna IPR waiver proves waiving IPR won’t solve

Reuters, 9-15, 21, https://www.reuters.com/world/africa/exclusive-who-backed-vaccine-hub-africa-copy-moderna-covid-19-shot-2021-09-14/, EXCLUSIVE WHO-backed vaccine hub for Africa to copy Moderna COVID-19 shot Efforts to develop an African base for COVID-19 vaccine production will focus on trying to replicate Moderna's (MRNA.O) shot, but a lack of progress in talks with the U.S. company mean the project will take time, a senior WHO official told Reuters. The drive to produce vaccines in Africa is designed to help more developing countries access COVID-19 shots after rich nations bought up most of this year's supply. Moderna said last October it would not enforce patents related to its shot during the pandemic, raising hopes that other companies might be able to copy it and help boost COVID-19 vaccine production. In practice, though, it is hard to replicate a vaccine without the information on how it is made, and the World Health Organization-backed tech transfer hub in South Africa - set up in June to give poorer nations the know-how to produce COVID-19 vaccines - has so far not reached a deal with the company. "The talks have not yielded any results," Martin Friede, WHO Initiative for Vaccine Research coodinator, told Reuters. Moderna did not respond to a request for comment. The case highlights the challenges faced by the WHO as it battles to expand vaccine production to help address the glaring inequalities between rich and poor nations in the pandemic. More than three quarters of the 5.5 billion COVID-19 shots administered worldwide have gone to high and upper-middle income countries, which make up just over a third of the world's population. read more Currently only 3% of Africa is vaccinated, the African Union's top health official said last week, compared with more than half of the United States and three quarters of Spain. Friede said Moderna's vaccine had been chosen as an abundance of public information and its pledge not to enforce patents made the shot slightly easier to copy than some rivals. "We have to make a choice now. The deadline is upon us; time to start ordering chemicals. We've chosen Moderna," he said. But even if the hub manages without Moderna's help, it could take more than a year to get a distributable vaccine as clinical trials would only begin in the latter half of 2022, he added. In May, the United States said it would support waiving intellectual property rights for COVID-19 vaccines in order to help speed an end to the pandemic. But the idea has faced opposition from pharmaceutical firms, which argue they need to oversee any technology transfer due to the complexity of the manufacturing process. Pfizer (PFE.N) and its partner BioNTech (22UAy.DE) separately struck a deal in July for South Africa's Biovac to help make around 100 million doses a year of their COVID-19 vaccine for Africa. Their shot, like Moderna's, uses so-called mRNA technology. However, the deal is to "fill and finish" the vaccine, the final stages of production where the product is put into vials, sealed and packaged for shipping. It does not cover the complicated process of mRNA production, which Pfizer and BioNTech will do at their European plants. read more Neither responded to requests for comment. The WHO has been trying to persuade Moderna and Pfizer-BioNTech to join forces with its African tech transfer hub. But COVID-19 vaccine makers have warned that non-authorised producers would compete for vital raw materials and production gear that the established players - most of which have earned huge profits from vaccination - rely on. read more Hub consortium partner Afrigen Biologics will produce the initial batch of doses, before transferring the skills and technology to local manufacturing partner, Biovac Institute - both are Cape Town-based - which will mass produce the vaccines. "This is not something that we are asking industry to give us for free," Friede said about talks with the companies for access to information, adding that royalties, territorial limitations and other constraints could be built into a deal. Healthcare analysts doubt the plan can be mobilised quickly. "There are many steps which will require lots of iterations before they can be ready for prime time commercial grade production," said Prashant Yadav, a global healthcare supply chain expert at the Center for Global Development in Washington.

Pharma backlash is non-unique

Peter Sullivan, 9-15, 21, PhRMA launches 7-figure ad campaign against Democrats' drug pricing measures, https://thehill.com/policy/healthcare/572397-phrma-launches-7-figure-ad-campaign-against-democrats-drug-pricing-measures The Pharmaceutical Research and Manufacturers of America (PhRMA) announced Wednesday that it is launching a seven-figure ad campaign against the proposals moving through Congress to lower prescription drug prices. The group also released an open letter signed by the heads of all of its member companies pointing to the COVID-19 vaccines and treatments developed by the industry and arguing the proposals would “sacrifice future medical advances.” The moves are part of an aggressive campaign against the measures to lower drug prices backed by congressional Democrats, which threaten to take a large chunk of money out of the pharmaceutical industry. The Congressional Budget Office (CBO) estimated that House Democrats' leading bill, known as H.R. 3, would save the government almost $500 billion over 10 years on prescription drugs and lower the cost of drugs by about 50 percent by allowing the secretary of Health and Human Services to negotiate prices. The push from PhRMA, long known as a powerful force in Washington, comes as congressional Democrats are pressing forward with legislation to lower drug prices as part of their $3.5 trillion reconciliation package. The details of the final legislation remain unclear, though, particularly after three moderate House Democrats, Reps. Kurt Schrader (Ore.), Kathleen Rice (N.Y.), and Scott Peters (Calif.), said Tuesday they would vote against H.R. 3 in the House Energy and Commerce Committee and that they instead wanted a more scaled-back measure. Advocates have accused the three lawmakers of being beholden to the pharmaceutical industry. "Big Pharma will spend, do, and say whatever it takes to defeat any legislation that will curb its unilateral power to dictate prices of prescription drugs," David Mitchell, founder of the group Patients for Affordable Drugs Now, said on Tuesday Government use of WTO/IPR to deny access is immoral Human Rights Watch, 9-14, 21, https://www.hrw.org/news/2021/09/14/sharing-knowledge-technology-critical-curb-covid-19#, Sharing Knowledge, Technology Critical to Curb Covid-19 Wealthy governments and pharmaceutical companies are undermining a rapid and equitable public health response to Covid-19 vaccines, therapeutic drugs, and tests, Human Rights Watch researchers said in a paper published ahead of a World Trade Organization (WTO) meeting this week. Human Rights Watch also released a video about the subject. Governments and companies should urgently share knowledge and technology to save lives, protect the right to health, and ensure everyone can benefit from scientific research, especially with the highly contagious Delta variant. The paper, “COVID-19 Exposes Warped Global Health Power: The System Needs a Course Correction,” published on August 31, 2021 in the Business and Human Rights Journal, discusses how a handful of high-income countries that were lobbied by powerful pharmaceutical companies have stalled a proposal to temporarily waive global trade and intellectual property rules to expand access to lifesaving vaccines and other health care products. Drawing upon Human Rights Watch research and analysis on Covid-19 vaccine supply issues, it shows how governments have abdicated their responsibility to regulate pharmaceutical companies. Governments funding Covid-19 vaccine development with public money failed to condition these funds on affordability and sharing technology, leaving companies to decide how, when, and where they will manufacture, distribute, and price vaccines, Human Rights Watch said. Instead of sharing knowledge and technology, some governments are redistributing an inadequate amount of vaccines to poorer countries while letting companies set prices. “Waiting for the benevolence of wealthy governments and pharmaceutical companies has dealt a deadly blow to basic rights,” said Aruna Kashyap, associate business and human rights director at Human Rights Watch and a co-author of the paper. “It’s unconscionable that wealthy governments are reducing life-saving health care to a tradeable commodity and using their power at the WTO to make the right to health subservient to pharma and trade interests.” Access to Covid-19 vaccines remains deeply unequal. Three-quarters of the more than 5 billion vaccine doses administered worldwide have gone to just 10 countries, according to the WHO. While some rich governments have begun distributing third “booster” shots, only two percent of Africa’s population is fully vaccinated. The director-general of the WHO has called for a moratorium on booster doses to enable vaccines to reach people who have yet to receive their first dose. The pandemic has laid bare the dangers of having manufacturing capacity for life-saving vaccines concentrated in a few countries where governments have refused to prioritize and mandate intellectual property waivers and technology transfers for rapid diversified and global production. That has created deep inequities in access to the health products that can save lives. Months-long debates at the WTO have left the WHO and public health authorities throughout the world in limbo. In May, the United States signaled that it would support negotiations on the text of the waiver proposal. But the European Commission, representing the European Union member states, Switzerland, and several other high-income governments have consistently stalled and blocked efforts to swiftly adopt the waiver. Negotiations resume in Geneva on September 14. Meanwhile, shortages of vaccine supplies and inequitable vaccine distribution policies have led to vaccine inequity in a number of countries around the world, including India, Australia, Lebanon, Syria, Yemen, and Brazil. The proposal to temporarily waive global trade and intellectual property rules, which has the support of over 100 governments, if adopted by the WTO, would signal that, in the context of the ongoing pandemic, providing life-saving health care comes first. International law recognizes everyone’s right to benefit from scientific progress. Since the onset of the pandemic, United Nations human rights entities have repeatedly reiterated that states have an obligation to share the benefits of scientific research. Governments have obligations concerning international cooperation. They should refrain from actions that interfere, directly or indirectly, with the enjoyment of rights in other countries. This obligation extends to their actions in intergovernmental organizations like the WTO. Most governments have also sidelined WHO technology sharing pools. The WHO first created a voluntary technology sharing pool for Covid-19 medical products in May 2020 that would have allowed the sharing of vaccine technology to promote faster production and distribution. However, only 41 governments have endorsed the pool. Most others including the US, UK, Germany, and many other EU member states and the European Commission have yet to signal their participation in the pool. None of these governments have used their influence or leverage to convince any of the pharmaceutical companies whose vaccines they have funded to join the technology pool. The WTO is an intergovernmental organization that regulates and facilitates international trade between nations. Its promotion of trade and protection of intellectual property has historically taken priority over health, environment, or human wellbeing. This pattern has had lethal consequences during a pandemic by slowing a public response when at least 4.5 million lives have already been lost. “The Covid-19 pandemic has shown the system needs a long-overdue course correction so that the WHO is empowered, and not undermined, by the WTO,” said Margaret Wurth, senior researcher at Human Rights Watch and a co-author of the paper. “Participating in WHO technology sharing platforms and temporarily waiving intellectual property rules are critical ways forward.” States should not frustrate the efforts of other states to fulfill their human rights obligations, including when negotiating international agreements or participating in decisions as members of international organizations, such as by invoking intellectual property protections to slow vaccine distribution or production. In addition to violating their human rights obligations, obstructing a rapid health response is a huge setback to low- and middle-income countries’ ability to achieve the United Nations Sustainable Development Goals. The pandemic has prompted discussions about an international pandemic treaty that will take place in the coming months. Any pandemic treaty should include human rights protections, including triggers for automatic intellectual property waivers and mandate greater transparency and accountability of global procurement efforts. “We urgently need enforceable global health norms that de-commodify life-saving medical products and prioritize the health and safety of people instead of foot-dragging and equivocation,” said Kyle Knight, senior researcher at Human Rights Watch and the third co-author of the paper. “A powerful minority of wealthy governments has cynically prioritized their own and their companies’ interests while global infections and deaths soar.”  Waiving IPR is unconstiutional Deborah Collier, 9-14, 21, Acknowledging the Importance of Intellectual Property Rights on Constitution Day, https://www.cagw.org/thewastewatcher/acknowledging-importance-intellectual-property-rights-constitution-day The U.S. Constitution spells out the rights, privileges, and responsibilities of the American people. Friday, September 17, 2021, marks the 234th anniversary of the adoption of this venerable document. Among the rights spelled out in the constitution is the protection of intellectual property (IP), as noted in the General Welfare Clause, Article 1, Section 8. These are the only property rights included in the document: To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. These protections became even more important over the past two years, as pharmaceutical companies strived to develop new vaccines to combat COVID-19 and its mutating variants. The IP developed by these companies has been critical to the fight against this disease, and the vaccines have proven to be effective and instrumental against hospitalizations and death. Unfortunately, even with the success and investments made by companies to combat this and other diseases, there are some who try to diminish the IP rights for these companies. The World Health Organization (WHO) has pushed for broader dissemination of IP to combat the COVID-19 virus through IP waivers, as noted by Director General Dr. Tedros Adhanom Ghebreyesus, so that other countries will be allowed to produce vaccines regardless of the existence of patents for those drugs. However, once the WHO begins to pursue IP waivers for this pandemic, what is to say that additional IP waivers won’t be requested for future drugs to treat other diseases. Using IP waivers to gain access to drugs without having to invest the millions of dollars in research and development is not a new concept, in the 2014 book, Intellectual Property Rights: Making It Personal, CAGW noted that several U.S. trading partner governments were claiming they had a “moral obligation to make cheaper, generic drugs available to their populations,” including by limiting or voiding patents. On May 5, 2021, President Biden announced that he would support waiving intellectual property protections for COVID-19 vaccines under the Trade-Related Intellectual Property Rights (TRIPS) agreement. But, as noted by Michelle McMurry-Heath in an August 18, 2021 op-ed in STAT News, “Covid-19 vaccines are already remarkably cheap, and companies are offering them at low or no cost to low-income countries. Poor access to clinics and transportation are barriers in some countries, but the expense of the shot itself is not. In fact, if the World Trade Organization grants the IP waiver, it could make these vaccines more expensive.” Ms. McMurry-Heath is correct, and if the present administration continues down the path of devaluing IP rights for pharmaceuticals, the development of new innovative drugs and technologies that will drive the world into a better future and enable the U.S. to maintain its leadership in the global community will be severely harmed. Democrats in Congress are also pushing a serious threat to IP rights through the provisions of H.R. 3, which may be included in the House Ways and Means Committee provisions of the budget reconciliation legislation. The original bill includes a 95 percent, retroactive tax on pharmaceuticals if the manufacturer fails to agree to government-mandated prices. This tax “is tantamount to the theft of intellectual property and would destroy innovation in the pharmaceutical industry.” The nation’s Founding Fathers understood the value of intellectual property. Congress and the Biden administration must not remove or diminish IP protections for life-saving pharmaceuticals.

Limiting IPR the best way to advance synbio

Marcelle, 9-14, 21, Gillian Marcelle Managing Member, Resilience Capital Ventures, Keolu Fox Professor, University of California, San Diego (UCSD) Santanu Dasgupta Senior Vice-President, Reliance Industries, Lessons learned from COVID-19 vaccines could advance synthetic biology. Here's how, https://www.weforum.org/agenda/2021/09/lessons-learned-covid-19-vaccines-advance-synbio/ Recent debates around how intellectual property rights (IPRs) might be adapted to facilitate wider availability of COVID-19 vaccines constitute a “hinge event” with the potential to alter the mental models and practices in a wide range of science and technologically intensive fields. The international community has scolded or encouraged wealthy countries to take up their responsibilities and introduce mechanisms for affordable and equitable access to vaccines as public goods. We have seen the return to loud and boisterous activism, most notably the Vaccines for All campaign which has organized protests in London and other cities Synthetic Biology (SynBio) is a field combining principles of biology and engineering and shares many features with vaccines. SynBio is used to produce food and enhance nutritional value, create animal feed, medicines, biomaterials and for environmental remediation using algae or bacteria. Like vaccine production, quality requirements for SynBio are high, infrastructure is expensive, technological knowledge is becoming more specialized over time, and there are often long gestational periods and considerable financial risks involved in investment. These limitations lend themselves to terrains where industry actors use intellectual property (IP) regimes to assert and defend rights over technological knowhow. This traditional approach to securing and protecting IP has the effect of limiting access, adoption and dissemination of technologies, which is why this has become a point of contention in the COVID-19 vaccine global conversation. Vaccine production is highly concentrated in a few countries around the world especially for those produced using mRNA technologies. The approach taken to increasing global distribution has so far focused largely on persuading vaccine manufacturers to waive IPRs so that their products can be manufactured in other sites. Those arguing against this option suggest that IPRs are necessary as an incentive for research and discovery that led to the mRNA vaccines. Our intention is not to delve too deeply into the details of the COVID-19 vaccine discussion, as we write more options are being added to the mix. We are encouraged by the recent announcements of production hubs in Senegal and South Africa for the manufacture of COVID-19 vaccines through public, private and academic partnerships and believe this offers an example for global diffusion of other technologies such as SynBio. We will point the way for diffusion of SynBio, currently concentrated in very few countries, using market and non-market mechanisms. SynBio tools and technologies can spread more effectively around the world by widening the manufacturing base for products and services. Achieving this requires genuine partnerships that pay more than lip service to equity and take seriously the question: “Whose greater good are we prioritizing?” Achieving this transformation is a tough ask in a field that bears all the hallmarks of elitism and hyper-concentration. The recent marked increase in interest from investment firms – venture capitalists in particular – is likely to accentuate concentration and further limit progress unless we can encourage openness, technological independence, and democratization of emerging technologies. Another vision of a liberated Synbio is possible, one that prioritizes circular economic systems, data sovereignty and humanitarian development. To achieve this will require shifts in mindset and definitions of success. That’s what we turn to now.

The longer we wait to make vaccines available the greater the risk of mutations

Dan Diamond, 9-13, 21, Washington Post, White House lays out new global targets in coronavirus pandemic fight, https://www.washingtonpost.com/health/2021/09/13/biden-covid-global-leaders/ Public health experts have warned that outbreaks overseas are likely to spark new virus variants that could challenge the efficacy of treatments and vaccines. ‘Act now’ on global vaccines to stop more-dangerous variants, experts warn Biden The WHO last week condemned the disproportionate access to coronavirus vaccines as “unacceptable.” “Only 20% of people in low- and lower-middle-income countries have received a first dose of vaccine compared to 80% in high- and upper-middle income countries,” the global health organization said in a statement. Krishna Udayakumar, director of Duke University’s Global Health Innovation Center, said Biden’s targets were a “good starting point” to tackle challenges such as ensuring that 70 percent of the world’s population is vaccinated. “One missing part is leadership and accountability,” said Udayakumar, who had pressed the White House to hold the summit. “If the global covid response remains rudderless and fragmented, without real levers for accountability, all the well-meaning commitments in the world will have little impact.” Zain Rizvi, a law and policy researcher at the advocacy organization Public Citizen, said the targets were “important but insufficient,” warning that waiting until next year to achieve widespread global vaccination would lead to “millions of new infections, millions of new deaths, and millions of chances for the virus to mutate and escape the protection offered by existing vaccines.” “We need a real strategy, not just a vague commitment to expand manufacturing,” said Rizvi, who has argued that the White House should immediately share intellectual property that it obtained through a contract with vaccine manufacturer Moderna. “President Biden should marshal the resources of the U.S. government and direct corporations to share technology to help end this pandemic.” Waiving IPR is unconstiutional Deborah Collier, 9-14, 21, Acknowledging the Importance of Intellectual Property Rights on Constitution Day, https://www.cagw.org/thewastewatcher/acknowledging-importance-intellectual-property-rights-constitution-day The U.S. Constitution spells out the rights, privileges, and responsibilities of the American people. Friday, September 17, 2021, marks the 234th anniversary of the adoption of this venerable document. Among the rights spelled out in the constitution is the protection of intellectual property (IP), as noted in the General Welfare Clause, Article 1, Section 8. These are the only property rights included in the document: To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. These protections became even more important over the past two years, as pharmaceutical companies strived to develop new vaccines to combat COVID-19 and its mutating variants. The IP developed by these companies has been critical to the fight against this disease, and the vaccines have proven to be effective and instrumental against hospitalizations and death. Unfortunately, even with the success and investments made by companies to combat this and other diseases, there are some who try to diminish the IP rights for these companies. The World Health Organization (WHO) has pushed for broader dissemination of IP to combat the COVID-19 virus through IP waivers, as noted by Director General Dr. Tedros Adhanom Ghebreyesus, so that other countries will be allowed to produce vaccines regardless of the existence of patents for those drugs. However, once the WHO begins to pursue IP waivers for this pandemic, what is to say that additional IP waivers won’t be requested for future drugs to treat other diseases. Using IP waivers to gain access to drugs without having to invest the millions of dollars in research and development is not a new concept, in the 2014 book, Intellectual Property Rights: Making It Personal, CAGW noted that several U.S. trading partner governments were claiming they had a “moral obligation to make cheaper, generic drugs available to their populations,” including by limiting or voiding patents. On May 5, 2021, President Biden announced that he would support waiving intellectual property protections for COVID-19 vaccines under the Trade-Related Intellectual Property Rights (TRIPS) agreement. But, as noted by Michelle McMurry-Heath in an August 18, 2021 op-ed in STAT News, “Covid-19 vaccines are already remarkably cheap, and companies are offering them at low or no cost to low-income countries. Poor access to clinics and transportation are barriers in some countries, but the expense of the shot itself is not. In fact, if the World Trade Organization grants the IP waiver, it could make these vaccines more expensive.” Ms. McMurry-Heath is correct, and if the present administration continues down the path of devaluing IP rights for pharmaceuticals, the development of new innovative drugs and technologies that will drive the world into a better future and enable the U.S. to maintain its leadership in the global community will be severely harmed. Democrats in Congress are also pushing a serious threat to IP rights through the provisions of H.R. 3, which may be included in the House Ways and Means Committee provisions of the budget reconciliation legislation. The original bill includes a 95 percent, retroactive tax on pharmaceuticals if the manufacturer fails to agree to government-mandated prices. This tax “is tantamount to the theft of intellectual property and would destroy innovation in the pharmaceutical industry.” The nation’s Founding Fathers understood the value of intellectual property. Congress and the Biden administration must not remove or diminish IP protections for life-saving pharmaceuticals.

IPR waiver undermines cancer research

Andre Speigel, 9-13, 21, https://elkodaily.com/opinion/columnists/commentary-how-the-covid-ip-waiver-could-sabotage-crucial-cancer-research/article_65984110-036f-5fd4-ac66-45f2c08d16d0.html. Commentary: How the Covid IP-waiver could sabotage crucial cancer research, I’ll explain why. Technically, the waiver supported by the United States would only apply to IP on Covid vaccines. So what has this got to do with cancer? There are two consequences. First, intellectual property underpins scientists’ incentives to make discoveries. Without proprietary “armor” to protect research, rivals could blithely — and lawfully — use scientists’ know-how, data, or manufacturing processes. Second, waiving IP on underlying vaccine technology has ramifications for drug innovation. Since the same technologies are used for potential treatments for other diseases, vaccine-makers would have to give up IP on those projects too. Consider the Pfizer-BioNTech and Moderna vaccines. They use “mRNA” to promote an immune response to Covid-19, a technology that took decades to develop. With the successful rollout of mRNA Covid-19 vaccines, researchers in the United States and Germany now hope they can use mRNA to fight other viruses. Moderna has active trials for mRNA vaccines for Zika, HIV, and the flu. Cancer doctors and patients pray that mRNA is the key to a cure. Moderna, in fact, has two mRNA vaccine candidates for cancer. Researchers hope that mRNA could instruct the body to combat cancerous tumors like it fights a virus. With the IP waiver, Moderna’s mRNA technology could end up with rivals, leaving the company with greatly diminished incentives — and greatly diminished investment dollars — to continue with mRNA clinical trials, including ones for cancer. Advanced drug innovation could come to a halt. What investor would fund biotech startups if copycats can swoop in? This scenario is made especially distressing by the fact that the upsides of the IP waiver are negligible. Manufacturers need specialized facilities and hundreds of ingredients to make vaccines. Vaccine-makers have struck licensing deals to scale up production. Every facility on earth that can safely produce effective vaccines is already doing so. Getting rid of IP won’t make the scale-up go any faster. It could, however, unleash millions of shoddy copycats and event counterfeit vaccine doses. President Biden has shown how he can help vaccinate the world without holding mRNA research hostage. For instance, he has already agreed to donate 580 million of the United States’ surplus vaccine doses to COVAX — a WHO, CEPI, and Gavi co-led initiative to distribute Covid-19 vaccines to developing countries. With President Biden, the cancer community has an ally in the White House. And yet, with the IP waiver, he’s undermining the only industry that may find a cure for cancer.

COVAX redistributes to the rich and reforms don’t solve underlying reasons vaccines are denied

Jonathan Cohen, 9-13, 21, https://www.openglobalrights.org/the-moral-test-of-vaccine-justice/, The moral test of vaccine justice While low-income countries struggle to launch vaccination programs, wealthy countries are stockpiling surplus doses and beginning to recommend additional ones. Mechanisms ostensibly established to increase vaccine equity have recently shipped more doses to vaccine-rich United Kingdom and Europe than to the entire African continent. Calls for vaccine justice frame access to COVID-19 vaccines as a moral test: of humanity’s ability to share, of global solidarity over nationalism, of progress in ending racist exclusion from the benefits of scientific progress, and of the equal and inherent value of all human lives. Beyond an appeal to charity and benevolence—which will increase some coverage numbers—, these calls ask for structural change and redistribution that would achieve a deeper justice in access to health An Up Close series in OGR advocated a number of “practical solutions” to vaccine inequity, some of which envision deeper change to the status quo than others. Solutions like strengthening regional cooperation to negotiate with the pharmaceutical industry, fully funding the COVAX Facility, and harmonizing regulatory approval standards would pose little challenge to the structures that undergird vaccine manufacturing, financing, and delivery. Calls for vaccine justice frame access to COVID-19 vaccines as a moral test: of humanity’s ability to share, of global solidarity over nationalism, of progress in ending racist exclusion from the benefits of scientific progress, and of the equal and inherent value of all human lives. In contrast, solutions like reforming and regulating the pharmaceutical industry itself, issuing blanket waivers of intellectual property protections for COVID-19 vaccines, and rethinking systems of development finance begin to imagine a world in which health is reclaimed as a public good instead of a commodity. This “transformational human rights praxis” dismantles underlying logics of hierarchy, monopoly, and charity in the service of a fundamental redistribution of power in global health. But how sustainably do these solutions alter or redistribute the hierarchies of power that led to vaccine inequity in the first place? In this essay, I join my public health colleagues at the Open Society Foundations in suggesting that at least three structural shifts are required to formulate a just response to vaccine inequity—one that eradicates the roots of the current inequity, so as to avoid repeating the same mistake in future pandemics. From monopolies to shared capacity The capacity to produce or procure vast quantities of safe and effective vaccines at an affordable price has emerged as one of the single greatest determinants of vaccine access and equity worldwide. Four countries currently dominate global COVID-19 vaccine production—China, the United States, Germany, and Belgium—creating an artificial scarcity. Established in 2020 to help overcome vaccine inequity, the COVID-19 Vaccines Global Access (COVAX) Facility was neither intended nor designed to expand production capacity beyond a few wealthy countries. Predictably, it has failed to make a meaningful dent in vaccine inequity worldwide even after meeting its financing targets. Advocates for vaccine justice have described COVAX as doomed to fail, or worse, as one element of an elaborate smokescreen for rich countries’ and pharmaceutical companies’ reluctance to share their intellectual property. Breaking the monopoly on global COVID-19 vaccine production capacity requires a series of steps—like constructing new manufacturing plants in countries that do not have them and sharing manufacturing technology—for which political will has thus far proved elusive. A litany of excuses for failing to act with urgency on all of these steps, such as concerns about quality control or suggestions that technology transfer is impossible outside high-income countries, obscure the simple truth that the scarcity produced by production monopolies is extremely profitable for pharmaceutical companies, who have outsized power to set policies over the sharing of production. Pharmaceutical companies and their rich country enablers are not immune to pressure, however. While they have thus far refused to expand production, political actions such as the US support for a waiver of intellectual property on COVID-19 vaccines imply a recognition by some governments that it is insufficient to rely on rich countries to mass produce and donate surplus vaccines to the rest of the world. From charity to shared resources Fiscal independence represents a second and closely related factor in any country’s ability to achieve COVID-19 immunity through vaccination programs. Countries with the highest vaccination rates have typically been able to rely on their national treasuries to finance vaccine procurement, whereas those with the lowest vaccination rates remain largely reliant on bilateral aid, development banks, and surplus vaccine donations. In October 2020, the World Bank approved $12 billion for developing countries to finance vaccine deployment—a sum that the United States alone would exceed on its own “Operation Warp Speed” by that December. Indeed, by June 2021, the IMF estimated that it would cost $50 billion to finance the equitable manufacture and distribution of vaccines and generate the trillions of dollars in returns needed to finance a global economic recovery from COVID-19. Breaking the monopoly on global COVID-19 vaccine production capacity requires a series of steps—like constructing new manufacturing plants in countries that do not have them and sharing manufacturing technology—for which political will has thus far proved elusive. Just like breaking production monopolies, ending financial dependency between rich and poor nations requires transformational steps for which the main obstacle has been political will. These include not only emergency debt relief, but a broader shift from aid to global public investment. In the long run, what is needed is an end to economies of extraction that perpetuate inequalities between rich and poor nations. COVID-19 presents an opportunity and imperative to shift course. In practice, this means that national governments and regional institutions, such as the African Vaccine Acquisition Task Team and the South Asian Association for Regional Cooperation COVID-19 Emergency Fund, need to dedicate sufficient resources and investments to support vaccination, consistent with their human rights obligations. At the same time, G7 and G20 donors must commit additional financing for vaccines in addition to supporting measures to decentralize vaccine production. From individualism to shared responsibility A third and often neglected factor in vaccine justice is how countries approach the challenge of vaccine delivery and uptake. While much attention has been paid to generating individual demand for vaccines and overcoming vaccine “hesitancy,” equally if not more important is shaping the social, economic, and environmental determinants of whether individuals seek and receive access to vaccination programs. Non-individualized barriers to vaccine uptake are diverse and intersect with race, poverty, migration status, and underlying health conditions. These conditions, whether poor access to public transportation or denial of paid sick leave for vaccination, are changeable with political commitment. Not unlike sharing production capacity and democratizing development financing, altering these conditions requires public policy choices that implicate everyone’s participation and sacrifice. From an epidemiological perspective, the very premise of generating individual demand for vaccines ignores the scientific reality that any one individual’s protection from COVID-19 depends on community uptake of the vaccine. The health of vaccinated people is not solely in their hands—it is equally in the hands of those who are unvaccinated, who in turn may be facing social and environmental barriers to vaccination. In the effort to vaccinate the world, societies face a moral choice—between emphasizing individual responsibility to accept the vaccine and protect one’s own health, or fostering shared responsibility to achieve both community immunity and the social determinants of health. The latter choice is the choice of justice. It is the choice that recognizes our interdependence, shared humanity, and responsibility to one another—giving full effect to the public health maxim that “no one is safe until we are all safe.” Justice as sharing COVID-19 is far from the first public health threat that has animated calls for global justice. The movement for HIV treatment justice called for a similar dismantling of pharmaceutical monopolies that artificially inflated the price of life-saving medicines. The call for reproductive justice demanded a redistribution of the racial and gender hierarchies that limit reproductive choice even where the law does not explicitly do so. Today, the call for vaccine justice seeks similar redress for the racial and colonial roots of inequitable and profit-driven COVID-19 responses and their entrenched effects. The forces arrayed against vaccine justice—monopolies, charity, and individualism—stand in the way of a just response to other shared global problems. Whether responding to COVID-19, climate change, or the digital divide, we would all benefit from acknowledging and sharing our mutual capacities, resources, and responsibilities, rather than hoarding them for ourselves. Perhaps this is the lesson that the COVID-19 pandemic was meant to teach us. By trapping us into thinking that we need only take care of ourselves—as individuals or as nations—COVID-19 multiplied, mutated, and prolonged our suffering. The question is whether we will ever learn.

The ONLY way to stop new variants that overwhelm vaccines is to distribute drugs world-wide

Heyman & Brewer, 9-10, 21, Jody Heymann, M.D., Ph.D., is a distinguished professor of public health, public policy, and medicine; founding director of the WORLD Policy Analysis Center, and served as dean of public health at UCLA from 2013-2018; Timothy Brewer, M.D., MPH, is a professor of medicine and epidemiology at UCLA, and served as program director for the International Society for Infectious Diseases, as well as in an advisory capacity to the World Health Organization, The Hill, Fully vaccinating our nation won't end COVID — fully vaccinating the world will, https://thehill.com/opinion/healthcare/571705-fully-vaccinating-our-nation-wont-end-covid-fully-vaccinating-the-world In most high-income nations, people are focused on their own country’s vaccination rates. This is a reasonable place to start since current outbreaks are driven by the unvaccinated. Recent data from Los Angeles County showed that unvaccinated persons are five times more likely to become infected when exposed to SARS-CoV-2 than vaccinated persons, and 29 times more likely to be hospitalized with COVID-19. Studies from Scotland and elsewhere show unvaccinated persons also are more likely to spread SARS-CoV-2. But vaccinating high numbers of people in high-income countries will not end the global pandemic — not even close. The delta variant, responsible for 99 percent of current U.S. COVID-19 cases, was first detected in India. The Alpha variant, previously responsible for most U.S. cases, was first recognized in the United Kingdom. Beta came from South Africa, and Gamma from Brazil and Japan. The global tour continues with variants on the horizon that are worrying scientists: Eta (U.K./Nigeria); Iota (U.S.); Kappa (India); Lambda (Peru); and Mu (Colombia). After these variants, there will be more, including ones that are highly transmissible and vaccine-resistant. The only way to move past the pandemic is to eliminate the high transmission rates in countries around the world that create fertile soil for new variants. Until we do, the virus’s ongoing adaptation anywhere will put lives at risk everywhere. Importantly, this cannot be done without vaccinations. Using data from all 54 African countries, together with colleagues from around the world, we recently showed that hundreds of millions of people living in Africa lack the means to isolate if sick, quarantine if exposed, and face high barriers to physically distancing or handwashing to prevent COVID-19 spread. Across 54 African countries, our study found that 718 million people live in households with six or more people at home and 283 million people live in households where at least three people sleep in a single room, making physical distancing impossible. Eight hundred and ninety million Africans lack running water at home, and 700 million people do not have regular access to soap, limiting regular hand washing to prevent COVID-19 spread. In both Nigeria, Africa’s most populous country, and the Democratic Republic of the Congo, one of the largest, fewer than one in 100 persons are vaccinated. Living conditions that heighten the urgency of vaccine access are likewise found in other low- and middle-income countries with little access to vaccines. For example, in India, a country home to over 1.3 billion people where multigenerational households are common, just 11 percent of the population is fully vaccinated. Similarly, just 12 percent are fully vaccinated in the Philippines, home to the three most densely populated cities in the world. The only route to COVID-19 prevention for these and far more individuals and families in low- and middle-income countries around the world is universal access to vaccines. The bottom line is that each of us must also care about all the people globally who will become infected without vaccines — and the new deadly, highly infectious variants that will inevitably emerge and spread around our exceedingly interconnected world as a result. So what will it take to get vaccines to everyone worldwide? Everyone needs to pitch in. Countries that have surplus vaccines need to share them — and not stockpile extra for their own population while low vaccination rates persist in most countries worldwide. Currently, not only is there a vaccine shortage in many lower-income countries but in some cases, their limited supply is getting diverted to high-income countries with a surplus of doses. It endangers everyone when millions of Johnson & Johnson vaccine doses are sent from South Africa, where 10 percent of the population is vaccinated, to countries such as Spain and Germany, with vaccination rates of 72 percent and 62 percent, respectively. Companies and countries that have patents and intellectual property rights need to stop blocking others from reproducing vaccines, share the IP and accelerate the production of vaccines around the world. Preventing low- and middle-income countries from producing their own vaccines needlessly limits supply in areas with shortages, creating grave risks in those countries while jeopardizing health everywhere. Although the U.S. has come out in favor of waiving patent protections on COVID-19 vaccines, other vaccine-producing countries remain opposed. Government and donor funds are needed to support ramping up production of vaccines to ensure that vaccines are free, so cost is not a barrier to anyone, and to build the public health systems that are needed to support vaccine delivery and reduce spread in this pandemic and the next. Employers and countries have a key role to play in ensuring workers can take leave to get vaccinated, reduce spread and care for their own and family health when sick. Finally, where vaccines are available, everyone needs to step up and get immunized — everyone’s actions affect not only their health but that of their family, their community, and communities that touch them. CDC: Unvaccinated 11 times more likely to die from COVID-19 After nearly 550 days, Denmark lifts coronavirus restrictions There is no closing borders to viruses when economies are dependent on trade and exchange to survive. Failing to recognize and respond to the global nature of COVID-19 prolongs the pandemic for everyone. Getting the world fully vaccinated is within our reach — but it’s

IPR waiver necessary to distribute medicines and protect the credulity of the WTO

Cole Stangler, 9-10, 11, Jacobin, Joe Biden Is Still Fighting a Vaccine Waiver for the Rest of the World, https://jacobinmag.com/2021/09/joe-biden-vaccine-waiver-global-ip-world-trade In May, the Biden administration made a bombshell declaration, endorsing a call to temporarily suspend intellectual property (IP) rights on COVID vaccines that health and trade experts say could greatly improve access to shots in the Global South — a move that appeared to mark a turning point in the global fight against the pandemic. Months later, though, as the pandemic rages and the glaring gap in vaccine access grows, the effort remains blocked at the World Trade Organization (WTO). Any waiver for vaccines needs the green light from the organization’s TRIPS Council — the commission in charge of IP rights — and unanimous support from all 164 members. But as delegations return to Geneva after summer break, a long-circulated proposal backed by India and South Africa has yet to gain traction. Meanwhile, the Biden administration — which has deep ties to the pharmaceutical industry — has proven unwilling to share vaccine recipes with other countries, as we reported earlier this week. “It’s really upsetting watching this process,” says Hu Yuan Qiong, policy co-coordinator and senior legal and policy adviser for Doctors Without Borders’ Access Campaign. “Viruses disregard whatever game we’re playing in human society; they just carry on and mutate.” The deadlock is the product of multiple factors. Hostility from the United Kingdom and the European Union as well as criticism from Big Pharma have complicated efforts, but as experts tell us, so has the apparent unwillingness of the Biden administration to go beyond its four-month-old statement and actually start pressing for a waiver. “I’ve been working on trade policy for a while, and I know that when the United States wants something, they get it,” Burcu Kilic, a trade policy expert at Public Citizen, tells us. “The United States should [play] a proactive role in this discussion.” European Intransigence Amid Pharma’s Lobbying Blitz One immediate obstacle is the United Kingdom. As Hu from Doctors Without Borders says, Prime Minister Boris Johnson’s government has shown little interest in changing its position over the last few months. She says it’s effectively stuck to the talking points of AstraZeneca, pointing to the pharmaceutical company’s willingness to work with producers in the developing world as supposed evidence that a waiver is unnecessary. Appearing before the TRIPS Council in June, for instance, the British government argued that technology transfers and voluntary licensing “exemplified by the Oxford AstraZeneca vaccine” and its partnerships are “making real, positive impact.” In a statement, the UK said it was not “convinced how an IP waiver, if agreed, would increase the supply of COVID-19 goods.” Hu doesn’t buy it. “We’ve explained to them, ‘We’re not just talking about AstraZeneca vaccines, we’re talking about many vaccines and many treatments,’” she says of the UK. “Maybe a company like AstraZeneca has done a little bit more than another company, but that will not solve the global issue.” An ideal waiver on IP rights, she stresses, would also cover the two messenger RNA (mRNA) vaccines developed by Pfizer and Moderna, as well as medical equipment, technologies used for therapeutic treatment, and future vaccines. Lobbying disclosure regulations in the UK are relatively weak. Only lobbyists working for third-party firms are required to sign the country’s lobbying register, which, as a result, covers just a small fraction of the country’s lobbyists, most of whom are employed in-house. Still, British government departments are required to disclose information about meetings with external organizations — and, according to records compiled by Transparency International and consulted by us, no single external organization in the UK has met more with the British government since the beginning of 2021 than AstraZeneca. The Cambridge-based pharmaceutical giant beat out the country’s top business lobby, the Confederation of British Industry, and the Port of Dover, the massive seaport that has struggled to adjust to Brexit. In the meantime, the European Union also continues to oppose a proposed TRIPS waiver. While several national governments — including France and Spain — have said they support a waiver, what ultimately counts in Geneva is the stance of the EU’s executive branch, the European Commission. Rather than open up talks over the text backed by South Africa and India, the EU has offered up a separate proposal of its own, bogging down the discussion. EU officials maintain that a broad waiver on IP rights for vaccines doesn’t address the underlying problem of inadequate manufacturing capacity. According to this argument, even if producers in lower-income countries had the legal authority to start churning out COVID vaccines, they wouldn’t be able to, because they lack the factories or technological know-how. But Hu of Doctors Without Borders says that’s a red herring. Like many supporters of a temporary suspension in IP rights, she doesn’t claim a waiver will result in a transformation overnight. Instead, she views it as a launching pad to a scenario in which knowledge, data, and technology can flow more freely between states and manufacturers. “We can’t say, ‘Okay, you have a law,’ and then tomorrow start [producing]’ — it’s not going to happen that fast,” she explains. “But the earlier you open the door, the more certainty you can provide for the producers so they can prepare . . . the longer they don’t allow this door to open, the more problems we’ll face.” As we have previously reported, Big Pharma boasts a heavy presence in Brussels. Between March 2020 and May 2021, EU commissioners involved in medicine and vaccine issues met 140 times with pharmaceutical companies, and just once with an organization that supports a waiver on IP rights, according to the Corporate Europe Observatory, a watchdog group. Last year, Europe’s top pharmaceutical lobby spent more than €5.25 million on lobbying EU officials, the eighth-highest amount reported by any lobbying organization in the EU in 2020. For Hu, Big Pharma’s political influence helps explain the hostility from both London and Brussels to a waiver. “We strongly believe there is a direct correlation,” she says. Closely related political and ideological factors help drive pushback as well — especially when it comes to Europe’s largest economy and most prominent opponent of a waiver, Germany. The country is home to BioNTech, which developed the widely used mRNA shot alongside Pfizer. Even though the latter company has reaped most of the vaccine’s financial rewards, Burcu Kilic of Public Citizen says that officials in Berlin seem to regard vaccine development as a source of national pride. For many within Chancellor Angela Merkel’s ruling party, the Christian Democratic Union, there is a sense that lifting IP protections amounts to a slap in the face to national industry. “It goes beyond BioNTech,” Kilic says. “It’s about German inventions, German [small and midsize enterprises], Germany saving the world . . . it’s political, but it’s also emotional.” American Indifference Both Hu and Kilic argue the United States should be more aggressive — by putting pressure on its allies to back a waiver or, at the very least, by jump-starting serious negotiations. Up until now, the Biden administration has largely kept to the sidelines on the issue of IP rights. However, the US government may already have a strong case that it owns the IP on the Moderna vaccine, given its role in the shot’s development. The Biden administration could, in theory, share information about the dose with other producers — as the South Korean government has already requested. But even beyond the narrow issue of the Moderna shot, the American agency that negotiates trade policy, the United States Trade Representative (USTR), hasn’t issued a statement on the subject of a vaccine waiver since its widely celebrated declaration of support back in May. “That’s not usually what the United States or USTR does in these types of negotiations,” says Kilic from Public Citizen. “It’s like Lionel Messi saying, ‘I want to be in the World Cup,’ but then he’s not playing. You say you want a waiver, but you don’t do anything about it.” The USTR did not respond to a request for comment. In any case, the WTO’s TRIPS Council is slated to meet informally next week, on September 14. After weeks of inaction, that meeting could prove the impetus for progress, even if a full breakthrough doesn’t come until later in the year. Kilic remains optimistic that the deadlock will break. For one, she says political pressure is mounting on the United States, EU, and UK. But she also argues the future of the WTO is at stake — a fact that helps explain why the organization’s newly appointed director-general Ngozi Okonjo-Iweala has taken an active role in talks. “In the last decade, the WTO became a nonfunctional organization, and there’s pressure on the WTO and the WTO leadership to do something about that,” Kilic says. “[The director-general] knows that if they let this go, this’ll be the end of the WTO.” That doesn’t necessarily mean the result will be to the liking of those pushing for a broad waiver. Unlike India and South Africa, for instance, the United States has called for a waiver that covers vaccines alone — not medical equipment or other COVID-related treatments. Kilic also expects Big Pharma to start flexing its muscles in the coming weeks. If a deal at the WTO appears inevitable, industry will want to shape that outcome in its favor. She says much of the final outcome may depend on the Biden administration. “We need them to take the lead,” Kilic says of the United States. “I believe there will be something, but the question is, what will it be?”

Waiver won’t support redistribution and if components are produce everywhere there will be more vaccine nationalism

Swann & Koci, 9-10, 11, Here, Julie Swann, professor of industrial and systems engineering, and Matt Koci, a virologist and immunologist and professor in the poultry science department, both at North Carolina State University, weigh in on these questions and more:, WHAT ARE THE ETHICS OF GETTING A COVID-19 VACCINE BOOSTER?, https://www.futurity.org/ethics-covid-19-vaccine-booster-2625072/ I’ve heard several risk reduction and ethical arguments that Pfizer and Moderna should lift intellectual property protections to permit broader production and distribution of their vaccines. Could that make a significant difference for public health in the United States? Koci: Other countries being able to make their own vaccine would help make sure they aren’t dependent on the US. In the long run, that helps us here, as that would mean the case numbers would start to go down everywhere faster, which means fewer chances of new variants, which means the whole thing will be over sooner. But IP rights aren’t the thing holding these countries back from being able to make their own vaccine. They have to have the infrastructure. They have to have the expertise. If I gave you the blueprints for how to build a rocket ship, it would still take you years to build it. Back when we were focused on influenza as the next pandemic (1997-February 2020), the Biomedical Advanced Research and Development Authority (BARDA) developed a program to train scientists around the world on how to make influenza vaccine to increase total global capacity. In fact, NC State’s BTEC was one of the places these scientists came to train. This program greatly expanded the expertise and capacity around the world, but that took years. And making flu vaccine is not the same process as mRNA COVID vaccine. If the goal is to help these other countries produce their own vaccine, we need to do it based on what works for them and their infrastructure—not what works best in the US. Before December 2020, no human vaccine had to be kept at -80 Celsius. We didn’t even have the infrastructure. There are other COVID vaccines out there that seem to work as well as the mRNA vaccines, that are based on technologies that would be easier for other countries to start to produce. We need to work on getting them making those vaccines. We can work on helping develop their capacity to make and distribute mRNA vaccines once we have COVID behind us. Swann: There has been a lot of discussion about how best to increase vaccine manufacturing capacity worldwide. It is complicated, as location is just one piece of it. There are many components needed to produce vaccine like filters, chemicals, bioreactor bags, etc., and these have not been easy to source given the simultaneous demands for them. There must also be a trained workforce that can produce the different components and the whole. Producing everywhere is less efficient in terms of inventory, and if components are not produced everywhere then the system would still be subject to nationalism. We do need to continue to find ways to increase the supply of vaccine doses in the short term, while planning a system that is efficient, effective, and equitable over the long term. Given the experiences during COVID-19, I think we will see the US and many countries worldwide try to increase manufacturing capacity in or near their country, and for medical counter measures that go well beyond vaccine.

Waivers destroy R&D and crush the development of new pharma industries

Carol Mimura, 9-9, 21, Opinion: Gutting IP rights will upend university research, innovation, https://www.mercurynews.com/2021/09/09/opinion-gutting-ip-rights-will-upend-university-research-innovation/, Carol Mimura is the former executive director of the Office of Technology Licensing at the University of California, Berkeley, and current UC Berkeley Assistant Vice Chancellor for Intellectual Property & Industry Research Alliances. The Biden administration recently announced support for a push by the World Trade Organization to strip intellectual property protections from COVID-19 vaccines. That endorsement, though well-intentioned, should send shivers down the spines of university and corporate R&D lab workers across America. Especially since it follows on the heels of some policymakers’ attempts to seize American firms’ intellectual property, using a strained interpretation of a four-decade-old law. Gutting IP protections would eliminate the incentives for private sector investors to take initial discoveries — often made in university labs — and turn them into tangible medicines and medical devices that actually benefit patients. It’d be a disaster not just for health care workers striving to save people’s lives. It’d also prevent the commercialization of ground-breaking discoveries arising in universities — including those that could spawn entirely new industries. Advocates for stripping IP protections often point to successful drugs that initially benefitted from research at a university that was federally funded and thus should be “controlled” by the government. These IP rights, however, are currently protected by the University and Small Business Patent Procedures Act. This bipartisan legislation, enacted in 1980 and better known as the Bayh-Dole Act, allows universities to own and to license inventions that arose from federally-funded research. 9/11: Flight 93 hero Mark Bingham’s mother leaves behind surprising gift Universities license IP rights to private sector companies that commercialize research discoveries and make products available to the public. Before this law, the federal government (not universities) held the rights to such patents. Some 30,000 of those patents languished, gathered dust in federal filing cabinets, with fewer than 1 in 20 ever reaching the clinic or the open market. For Sens. Birch Bayh, D-Ind., and Bob Dole R-Kan., the purpose of the act was to “spur the interaction between public and private research so that patients would receive the benefits of innovative science sooner.” In the ensuing 40 years, their legislation has enabled universities and industry licensees to develop and bring to market more than 200 life-saving new medicines. Many such advances have arisen from research at the University of California, including UC Berkeley. I had a front-row seat to the ground-breaking T-cell research performed at UC Berkeley by James Allison that led — thanks in large part to the Bayh-Dole Act — to the monoclonal antibody ipilimumab and the birth of immunotherapy to attack a patient’s cancer cells. Today, Allison’s approach is used to treat 15 types of cancers, including Hodgkin lymphoma, colon cancer and breast cancer. All have witnessed the most recent fruit of the Bayh-Dole Act — mRNA technology from the University of Pennsylvania was licensed to Pfizer and Moderna, who used it to develop COVID-19 vaccines. Similarly, and thanks to the public-private sector bridge built by Bayh-Dole, research from UC Berkeley’s Robotics and Human Engineering Laboratory, licensed by SuitX, has created robotic exoskeletons that allow people living with paralysis or neurological disorders to walk. I fear that Biden’s IP waiver on Covid-19 vaccines, coupled with ongoing attempts to twist the Bayh-Dole Act to allow government officials to modify the terms of IP licenses that companies receive from universities, will disincentivize the private sector from investing in early-stage university inventions that are years away from becoming viable commercial products. An existing clause in the Bayh-Dole Act allows the government to “march in” and take away patents from licensees — but only in rare cases, such as when licensees are not commercializing an invention deemed potentially valuable. Many lawmakers want the government to use march-in rights to seize brand-name drug patents and relicense them to generic manufacturers. They have good intentions. Everyone wants to make prescriptions more affordable for patients. But if companies fear that the government will intervene after years of expensive R&D, they will not invest in the first place. Industry spends, on average, nearly $3 billion to bring a single drug to market; by contrast, the average federal grant to a university researcher whose work may lead to patentable material is in the range of $3 million — one-tenth of 1% of the upfront costs invested by the private sector. Hence, the level of investment by the federal government is exceptionally effective “seed money” for fostering innovation. Upsetting this relationship and partnership would be exceedingly deleterious. IP protections exist for a reason — because they work. We must not allow the admirable quest for health equity to kill the research goose that lays innovation’s golden egg.

US should distribute data needed for countries to reproduce COVID-19 drugs

Sam Mellins, 9-7, 21, Jacobin, Joe Biden Should Share US Vaccine Data With the Rest of the World, https://www.jacobinmag.com/2021/09/biden-vaccine-data-moderna-covid-intellectual-property The Biden administration may possess unilateral rights to the biochemical makeup and manufacturing process of the Moderna COVID-19 vaccine, a new report from advocacy group Public Citizen asserts. In a 2020 contract with Moderna, a division of the Department of Health and Human Services agreed to bankroll much of the vaccine development and manufacturing process, partially in exchange for “access to all documentation and data generated under this contract.” That documentation and data likely include the vaccine “recipe” and manufacturing process, the report finds. Disseminating that data would allow countries with fewer or less effective vaccines available to begin the process of manufacturing the Moderna jab, an important step in getting the worldwide pandemic under control, especially as the European Union continues to resist Joe Biden’s push for a temporary intellectual property waiver for COVID-19 vaccines. Wealthy vaccine-manufacturing countries like Germany, France, and the United States have pledged to fully vaccinate their own populations while also sharing doses with the developing world. But it’s not clear that a sufficient number of doses currently exist for them to make good on this promise. The European Union, for example, is on track to fall far short of its goal of donating 200 million doses to nonmember states by the end of the year. And, as of August, COVAX, the World Health Organization’s (WHO) vaccine sharing initiative, had distributed 188 million vaccines worldwide, just 19 percent of the 1.1 billion the WHO says are needed to end the pandemic. The more people that remain unvaccinated worldwide, the likelier it is that new variants will emerge, endangering vaccinated and unvaccinated alike. The Biden administration’s strategy for expanding worldwide vaccine access has largely relied on pushing for vaccine patent waivers through negotiations at the World Trade Organization (WTO). But those negotiations have been stymied by strong opposition from member states of the European Union, meaning that unilateral American action may be necessary to expand vaccine access on the necessary scale. Legally, the United States may already have the ability to do so. The terms between Moderna and the federal government specify that the government possesses rights to the vaccine technology developed under the contract, meaning that it can unilaterally publish or share the data with anyone. Furthermore, an essential component of the Moderna vaccine was invented and patented by US government researchers, meaning that the government could threaten a patent infringement suit against Moderna if the company refuses to share its vaccine know-how. “Moderna did not invent the vaccine by itself,” said Zain Rizvi, law and policy researcher at Public Citizen and author of the report. “This private corporation learned how to scale up and scale out manufacturing on the taxpayers’ dime. Public dollars should come with public obligations.” Moderna’s stock price has increased from $30 in March 2020 to $425 today. Government Rights to Vaccine Know-How Countries such as South Korea have expressed eagerness for the intellectual property (IP) that would allow them to make vaccines, and they are confident that their manufacturing sectors will be able to exploit it. But efforts to secure it have been rebuffed by the American government, Korean officials say. “We have asked Washington to transfer technology for vaccine production, but US officials said it is something that should be decided by the private sector,” one Korean official told the Financial Times. Korean biotech companies are poised to make significant investments in increasing the country’s vaccine manufacturing capacity. Making the Moderna production data available could provide a boost to these efforts. The question at the heart of his report, Rizvi said, is whether all of the data essential to the vaccine manufacture process is covered by the government’s contract. Parts of the process may have been developed before the contract went into effect or may be outside of the contract’s purview. The federal government would have only “limited” rights to this data and would need to compensate Moderna for its use. While Rizvi’s analysis argues that the government possesses “unlimited” rights to all necessary data, his report’s scope was limited by a lack of transparency in the government’s contract with Moderna, he admits. “The part of the contract that says what is limited-rights data is redacted. That’s a big problem, and the US government should clarify the scope of the rights it may hold,” he said. But judging from what is publicly available, it seems likely that the government possesses significant rights to the vaccine data. This is true of the Moderna vaccine because, unlike most other COVID-19 vaccine makers, Moderna was not a large pharmaceutical company before becoming a major vaccine supplier — in 2019, it produced fewer than one hundred thousand doses across all of its products. The contract between Moderna and the US government included federal support for increasing mRNA vaccine manufacture and expanding it to many more locations — meaning that the technology for how to do those things may be part of the data to which the US government possesses unlimited rights. “Based off of publicly available records, we can tell that the US government made pivotal contributions to Moderna’s scaling up and scaling out process,” Rizvi said. “These were not just minor modifications. They were substantial contributions.” The contract also required Moderna to provide the government with copies of documents submitted to the FDA that include the chemical recipe for the vaccine, a component as necessary as the technical know-how, states the report. Moderna is unlikely to respond favorably to a claim that their most valuable intellectual property is co-owned by the US government. “They’ll argue that some of the technologies that were used to develop the vaccine were things they’d already developed in earlier years . . . that the government had fewer rights in,” said James Love, director of Knowledge Ecology International, a nonprofit that researches intellectual property rights in health care technology. Should those arguments prevail, some purchase of Moderna’s intellectual property may be necessary. “There’s still space for buyouts to acquire what you don’t get through all those other measures,” Love said. Moderna did not respond to a request for comment. Secret Trump Deals? It’s also possible that Alex Azar, a former pharmaceutical executive who served as Donald Trump’s secretary of Health and Human Services, signed away the government’s vaccine rights to Moderna. Without access to the unredacted contract, it’s difficult to know for sure. But even if the Trump administration gave away the US government’s rights in the Moderna vaccine, the government possesses another point of leverage: patent rights over a key vaccine component. In 2016, a team of researchers working for the US government, Dartmouth College, and the Scripps Research Institute developed and patented a technology for producing antibodies that neutralize coronavirus spike proteins — a piece of molecular engineering essential in the development of the COVID-19 vaccines. Moderna and other pharmaceutical companies, including Pfizer-BioNTech and Johnson & Johnson, used this technology in developing its vaccines, but only Pfizer-BioNTech acquired the rights to the patent. This means that the threat of a patent infringement suit could be used to convince Moderna to share its vaccine tech, said Christopher Morten, a law professor Columbia University. “It’s an extra tool the US government has to cut a meaningful deal with Moderna,” Morten told us. “In exchange for waiving potentially multibillion-dollar liability that Moderna faces for using the US government’s tech without its permission, the US government could get Moderna to commit to sharing its process with the WHO.” Chemical and technical know-how aren’t the only obstacles to wider vaccine manufacturing. Even if the US government were to publish the data, some level of collaboration with Moderna might still be necessary to ensure that vaccines were being produced safely. “You really need to have deep technology transfer,” Love said. “People need to walk you through it and hold your hand, show you how things are actually done, and certify that you’re doing it the same way.” And material obstacles might arise as well. Shortages of both specialized biochemical products like lipid nanoparticles, essential to the manufacture of mRNA vaccines, and more prosaic items like glass vials could make it difficult to increase vaccine production on a global scale, even if all necessary knowledge became public. But while kinks in the supply chain might initially present obstacles, they’re likely not insurmountable. “I think the bottlenecks on inputs are kind of an exaggerated problem,” Love said. “In the short run, there are all kinds of supply problems and spikes in prices, and you can’t get what you need. But as prices rise, markets respond fairly fast.”

Lack of global vaccination increases the risk of more deadly variants

Stiglitz, 9-7, 21, Joseph E. Stiglitz, a Nobel laureate in economics and University Professor at Columbia University, is a former chief economist of the World Bank (1997-2000), chair of the US President’s Council of Economic Advisers, and co-chair of the High-Level Commission on Carbon Prices. He is a member of the Independent Commission for the Reform of International Corporate Taxation and was lead author of the 1995 IPCC Climate Assessment, COVID-19 and Human Freedom, https://www.project-syndicate.org/commentary/covid19-spike-in-us-reflects-misunderstanding-of-liberty-by-joseph-e-stiglitz-2021-09 But the US case is a true tragedy, because what’s currently happening here is so unnecessary. While those in emerging markets and developing countries are longing to get the vaccine (with many dying because they cannot get it), the US supply is ample enough to provide a double dose – and now a booster shot – to everyone in the country. And if almost everyone got vaccinated, COVID-19 would almost surely just “fade away,” as former President Donald Trump memorably put it…As we have been learning for the last 18 months, global health is a global public good. As long as the disease rages in some parts of the world, the risk of a deadlier, more contagious, more vaccine-resistant mutation grows.

The problem is the supply chains and ability to reproduce, not the availability of the drug

Michael M. Rosen is an intellectual property attorney and writer in Israel, and an adjunct fellow at the American Enterprise Institute, 9-5, 11, COVID-19 patent waiver challenges proliferate — and rightly so, https://thehill.com/opinion/healthcare/570744-covid-19-patent-waiver-challenges-proliferate-and-rightly-so First, the suspension of intellectual property (IP) rights will not quickly deliver shots in arms in the developing world, as the past four months have amply shown. The challenge of inoculating the Global South derives not from patents but from deficiencies in supply chains, especially for vaccines requiring refrigeration or deep freezing. Moreover, generic manufacturers cannot simply flip a switch and begin producing doses; instead, they must master the formulation of complex compounds (some of which involve mRNA), and their medicines must undergo local regulatory scrutiny for safety and effectiveness.

Developed world has all the vaccines

James Patton, 9-4, 21, https://www.washingtonpost.com/business/rich-countries-hog-vaccines-is-there-a-solution/2021/09/03/a0b95b8a-0ce3-11ec-a7c8-61bb7b3bf628_story.html, Rich Countries Hog Vaccines. Is There a Solution? Wealthy countries have hogged Covid-19 vaccines, providing a glaring illustration of how unfair the world can be. While 57% of people in high-income countries had received at least one dose of vaccine by Aug. 30, the figure in low-income countries was just 2%, according to the United Nations. Health advocates worry that the imbalance will be aggravated by plans in wealthy countries to provide booster shots to fully inoculated people to combat the super-contagious delta variant of the coronavirus. The uneven distribution -- which many scientists say will likely prolong the global health crisis -- has prompted proposals to expand production of Covid shots, reallocate rich countries’ excess doses, and ensure vaccines are deployed more equitably in future pandemics. 1. Why were some countries first in line? As inoculations were being developed, a number of affluent countries signed advance contracts with a variety of companies, securing the lion’s share of initial doses. The U.S., as part of its multibillion-dollar program hastening the development of Covid vaccines, also used wartime powers to require manufacturers to fill massive U.S. government orders first. The U.S., U.K. and European countries had the added advantage that companies with local manufacturing plants were the first to deliver vaccines with proven efficacy; China and Russia also rolled out vaccines early, before final trial results were in. 2. Where did this leave other nations? A number of middle-income countries, such as Turkey, Malaysia, Serbia and El Salvador, have now managed to procure enough supply to inoculate significant portions of their populations. But the poorest nations are still waiting for anything beyond a trickle of the life-saving doses. Because many lack the financial clout to secure contracts for Covid vaccines on their own, they depend for supplies largely on Covax, an initiative backed by groups including the World Health Organization that was designed to provide fair access to the shots for every country. And Covax has fallen short of its goals. 3. What happened with Covax? Covax uses funding provided by governments and donors such as the Bill & Melinda Gates Foundation to make its own contracts with vaccine manufacturers. But it has struggled to get hold of doses, especially after India -- home to the Serum Institute, the world’s biggest vaccine manufacturer -- pared back exports to supply the domestic market following a new wave of infections there in March. The original aim of Covax was to distribute at least 2 billion doses, two-thirds of them to lower-income nations, by the end of 2021. By Aug. 30, it had shipped just 11% of that. 4. Will countries with ample supplies share them? China and Russia were early to export vaccines as a tool of diplomacy, and in August China pledged to dramatically expand exports to 2 billion doses this year. In June, leaders of the Group of Seven nations upped their commitments so that in all they’ve promised to provide 2.3 billion shots to developing nations by next year. So far the actual contributions have been paltry. Health advocates say that billions more doses are needed and stressed that the speed of donations is as important as the quantity. They also worried that the flow of supply to the neediest countries would be interrupted by decisions in high-income nations to offer booster shots to people who’ve already been fully inoculated and to younger children. 5. What’s at stake? The coronavirus has flourished in some places where vaccines have been scarce. In addition to causing misery locally, that increases the risk of the emergence of additional, worrisome variants, which will inevitably make their way elsewhere and may not be neutralized by existing shots. Many countries short of vaccines are relying on continued lockdowns to suppress the virus, stifling economic activity, while wealthier countries have been opening up. It’s possible that sub-Saharan Africa, where doses are in shortest supply, will be spared the worst effects. Researchers noted in a paper published in July that Covid’s impact has been significantly lower in the region than elsewhere and argued that the main factors are the relative youth of the population and the low numbers of elderly living in long-term care facilities. Still, many African countries are struggling to combat Covid on top of a string of other health threats. And there’s no guarantee the next pandemic won’t target the young, making future vaccine rollouts a concern for African health specialists. Trying to just produce it and give it away won’t solve – need to distribute IP so that other countries can quickly respond to new variants. We also need to share IP for treatments to save lives Shaily Gupta, 9-3, 21, G20 leaders must demonstrate real-time international cooperation and action to control the ongoing COVID-19 pandemic, https://reliefweb.int/report/world/g20-leaders-must-demonstrate-real-time-international-cooperation-and-action-control As the pandemic remains out of control and with the emergence of new and more transmissible variants, the need to dramatically increase the global production and supply of vaccines is obvious. Vaccine-manufacturing capacity must be boosted in LMICs by utilising all policy and legal measures, including throughfull transfer of mRNA vaccine technology and know-howby the pharmaceutical corporations Pfizer (US), BioNTech (Germany), and Moderna (US). To dramatically boost vaccine supply in LMICs, and attain independent sustainability, full transfer of such technology needs to happen transparently and be open to all competent alternative manufacturers. G20 countries, particularly Germany and the US which host BioNTech, Pfizer and Moderna, should demand these companies share their mRNA vaccine technology and know-how with the WHO COVID-19 mRNA Vaccine Technology Transfer Hub based in South Africa. G20 governments should also provide financial and technical support to the Hub. In addition to vaccines, the world urgently needs access to newer therapeutics and diagnostics to reduce the number of hospitalisations and deathsin this pandemic. The slower and lower rate of vaccination in LMICs increases the risk of transmission and variant spread, locally and globally. In the face of ongoing and new waves of the virus around the world, health systems are being pushed to their limits, highlighting the urgent need for diagnosis andtreatment of people with COVID-19. Yet, new WHO-recommended COVID-19 therapeutics, such as tocilizumab (produced by Roche, based in Switzerland) and sarilumab (Regeneron, US), remain out of reach for people in LMICsdue to high prices, limited supply, intellectual property (IP) barriers, and absence of transparent access plans. MSF calls on G20 governments to take actions to overcome the market monopolies held by the pharmaceutical companies, and support biosimilars production to lower prices and ensure sustainable access to these important new therapeutics. Stop blocking the Waiver on COVID-19 monopolies Further, the G20 countries must support the ‘TRIPS Waiver’ proposal at the World Trade Organization (WTO), which if adopted would provide all countries with an expeditious way to remove key IP barriers and legal risks around production and supply of COVID-19 medical tools, including vaccines, treatments and diagnostics, during the pandemic. Nearly a year after the Waiver was first proposed by India and South Africa, and now supported by over 100 nations, a small group of high-income countries continues to oppose the Waiver. These countries – particularly the European Union (EU), UK, Switzerland, and Norway – must stop blocking this lifesaving pandemic initiative supported by a majority of the world. G20 health leaders should collectively acknowledge the limitations of relying on the pharmaceutical industry’s ‘good will’ to stem a global pandemic, and instead support the will of LMICs demanding self-reliance through the TRIPS Waiver. It is high time to move on from high-level statements and show true solidarity through action. Groundbreaking medical innovations have been made in the last year – but instead of being ‘global public goods’ for all, they are a luxury for only some. As this deadly and unprecedented pandemic persists, the world’s health leaders must show political courage and break the status quo – and do their utmost to make all COVID-19medical tools accessible for everyone. LMIC=Lower and Middle Income Country Pharma companies oppose patent waivers, triggering a backlash Brian Schwarz, 6-1, 21, https://www.cnbc.com/2021/06/01/big-pharma-launches-campaign-against-biden-over-covid-vaccine-patent-waiver.html, POLITICS Big Pharma lobbyists launch campaign against Biden over Covid vaccine patent waiver The lobbying group that represents several top pharmaceutical companies last month quietly launched a campaign against President Joe Biden and his decision to back waiving intellectual property protections for Covid-19 vaccines. The Pharmaceutical Research and Manufacturers of America, known as PhRMA, is a political advocacy group that represents more than 30 pharmaceutical firms, including Covid vaccine makers Pfizer and Johnson & Johnson. Late last month it started running a digital ad campaign on Facebook and Google targeting Biden’s decision, a CNBC search of the companies’ ad archives revealed. While PhRMA blasted the Biden administration’s move shortly after the announcement, the group didn’t officially announce a campaign against the waiver push. The details of the effort had yet to be reported. Proponents of waiving patent protections say it allows poorer nations to ramp up production of the Covid vaccine. After publication of this story, a PhRMA spokesperson released this statement to CNBC: “Biopharmaceutical research companies are committed to achieving equitable access around the world to COVID-19 vaccines, and that is why we’re educating policymakers and the public about our ongoing efforts to increase vaccine supply for global demand, the risks of waiving intellectual property protections, and the need to address the real issues driving vaccine inequity.” PhRMA’s ads on Google call out Biden by name. Each Google ad was live for up to five days through the end of May, according to the search engine’s ad transparency report. The Google ads link to articles written by PhRMA’s public affairs team and published on the group’s website. One of the posts bears the headline: “The Biden Administration allows politics to upend a pragmatic pandemic response.” The article claims that “not only will this policy do nothing to help save lives globally, it could have a damaging impact for American patients.” Another PhRMA post cites a Hill-HarrisX poll that shows that 57% of registered voters who took the survey are against the waiver. Facebook’s ad library shows that PhRMA spent over $245,000 since late April and throughout May on digital spots. A fraction of that spending went toward ads that ran at the end of May taking aim at Biden’s decision. The Facebook ads all had the same message: “Eliminating IP protections undermines our global response to the pandemic and compromises safety.” One spot had a potential reach of up to 1 million people, according to data from the social media giant. That ad targeted people in Maryland, Washington, D.C., and Virginia. The PhRMA Facebook ads are currently inactive. Even prior to launching the digital ad campaign, PhRMA was actively lobbying the Biden White House on the patent waiver issue. First-quarter lobbying disclosure reports, which span from the month Biden was inaugurated through March, show that PhRMA lobbied the Executive Office of the President as well as the Department of Health and Human Services on “international intellectual property and market access policy issues,” among other concerns. PhRMA spent just over $8.5 million on lobbying over the course of the first three months of 2021. Data from the nonpartisan Center for Responsive Politics shows the organization spent over $25 million in 2020 and nearly $30 million in 2019 on lobbying-related expenditures. This turns the case because developing countries need pharma company support for manufacturing the drugs; they can’t do it on their own Benjamin Fox, 9-3, 21, https://www.euractiv.com/section/health-consumers/opinion/the-brief-a-partnership-for-the-next-pandemic/, The Brief – A partnership for the next pandemic In reality, the IP waiver, as demanded by India and South Africa at the World Trade Organisation, would not be a silver bullet. Developing manufacturing capacity and supply chains cannot be conjured out of thin air. Instead, the EU could make the biggest difference by facilitating that development. At the German–hosted Compact with Africa summit last week, the EU indicated that it would help finance three vaccine manufacturing hubs across Africa, most likely in Senegal, Rwanda and South Africa. German pharma giant BioNTech has indicated its keenness to start manufacturing malaria and tuberculosis vaccines, and potentially COVID jabs, at the sites in Senegal and Rwanda. That is just the start of a long–term process, and one which will prepare Africa for the next rather than the current pandemic. Even so, African leaders have been asking for European support for domestic and regional manufacturing for years. It’s a role the EU should grab. Countries couldn’t reproduce the vaccines even if they had the formulas James Patton, 9-4, 21, https://www.washingtonpost.com/business/rich-countries-hog-vaccines-is-there-a-solution/2021/09/03/a0b95b8a-0ce3-11ec-a7c8-61bb7b3bf628_story.html, Rich Countries Hog Vaccines. Is There a Solution?
  1. What are the proposals for expanding vaccine access? A group of countries led by South Africa and India has called for the World Trade Organization to lift intellectual property protections for makers of Covid vaccines to enable additional plants to produce more shots. Vaccine companies argue that they are already expanding production and that the move would have little if any practical effect. Few countries have the trained personnel to produce Covid vaccines even if they had the formulas. Some advocates of the waiver say it can serve as leverage to push pharmaceutical companies to voluntarily share their expertise more broadly. The WHO proposes serving as a coordinator of technology transfers, facilitating training and helping countries organize the necessary investments in factories. Global health advocates argue that it’s vital not just for this pandemic but for the next one to expand vaccine production beyond the current concentration in the U.S., Europe, India and China. The African Union’s Centers for Disease Control and Prevention announced an ambitious plan in April to establish new vaccine factories with the aim of reducing the continent’s reliance on imports from 99% to 40% of supply by 2040.
Current donations are not enough Fierce Pharma, 9-3, 21, https://www.fiercepharma.com/pharma/response-to-recent-criticism-u-s-will-spend-2-7-billion-vaccine-manufacturing. Pharma Amid vaccine hoarding criticism, Biden admin plots $2.7 billion manufacturing push The U.S. has donated 130 million vaccine doses to other nations, Zients said. Biden has pledged to donate more than 600 million doses by mid-2022. Experts say 11 billion doses are needed to tame the virus worldwide. Securitization discourse has not strengthened the COVID-19 response Jones & Hameiri, 2021, Lee Jones is Reader in International Politics at Queen Mary University of London. His research focuses on state transformation, governance, security and political economy. His latest book, coauthored with Shahar Hameiri, is Fractured China: How State Transformation is Shaping China’s Rise (Cambridge University Press, 2021). Shahar Hameiri is Associate Professor in the School of Political Science and International Studies, University of Queensland. His research focuses on security, development and aid, governance, political geography and international relations. His books include Governing Borderless Threats: State Transformation and the Politics of Non-Traditional Security (Cambridge University Press, 2015), co-authored with Lee Jones, REVIEW OF INTERNATIONAL POLITICAL ECONOMY https://doi.org/10.1080/09692290.2021.1892798, COVID-19 and the failure of the neoliberal regulatory state “Major governments had apparently absorbed these messages and ‘securitised’ pandemic disease. For example, the US Homeland Security Council’s 2005 National Pandemic Strategy warned that a pandemic risked ‘overwhelming our health and medical capabilities, potentially resulting in hundreds of thousands of deaths, millions of hospitalizations, and hundreds of billions of dollars in direct and indirect costs’ (Homeland Security Council,” 2005, p. 1). The British government had also been planning for a pandemic for decades, starting with its 1997 Pandemic Influenza Plan (see Table 2). There is thus a yawning – and ostensibly puzzling – gap between discursive securitisation and hyper-preparedness, on the one hand, and the material reality of weak capacities, easily overwhelmed by COVID-19, on the other.

Neoliberalism is dying

James Meadway, 9-3, 21, Neoliberalism is dying – now we must replace it, https://www.opendemocracy.net/en/oureconomy/neoliberalism-is-dying-now-we-must-replace-it/ The broader point here is that the material base of the global economy has, in the past decade, been decisively reshaped around data technologies and a major new competitor economy outside of the West, and that this in turn has promoted a direct challenge to neoliberal norms of government across the globe. To the extent that the pandemic has accelerated the shift into the digital economy, and has expanded the range of government intervention, it has brought neoliberalism’s death rather closer. A post-neoliberal strategy for the Lef From the above analysis, a number of conclusions follow. Firstly, there are real changes happening in terms of how the global system operates, and these changes are having an impact on the behaviour of governments. It is too early to say that neoliberalism is dead, and a revival in some form – at least at the national level – cannot be completely ruled out. More likely we will be entering a period where some decidedly neoliberal institutions and practices survive amongst different forms, and potentially outlive any transitional period. Much as Britain’s National Health Service (NHS) has survived decades of neoliberal governments, even as the rest of society is privatised, it’s certainly possible to see (for example) its finance sector continuing to exist in a recognisably neoliberal fashion for an extended period of time. But the general tendency of capitalism, beginning with the 2008 crash and accelerating dramatically in the ongoing pandemic, is clear: neoliberalism is dying, if not yet dead. What does this mean for a post-neoliberal strategy for the Left? Firstly, an excessive focus on neoliberalism as a system of ideas, and, related to this, a fixation on its early combative years in the West, means the material conditions that sustained it as a form of government, which are now coming to an end, are often overlooked. Patents key to innovation/ R&D Sanjana, Khurana and Khurana, Advocates and IP Attorneys (K&K) is more than a full service Intellectual Property and Commercial Law firm, 9-2, 21, Compulsory Licensing In India Amidst The COVID 19 Pandemic: Will India Consider It?, https://www.mondaq.com/india/patent/1107588/compulsory-licensing-in-india-amidst-the-covid-19-pandemic-will-india-consider-it A pharmaceutical patent would allow pharmaceutical conglomerates to acquire royalties, protect the innovation behind the vaccine from commercial exploitation and monopolize the invention to a very large extent. Additionally, it would receive a protection of 20 years that would be provided by the WTO members since the filing date of the patent under the TRIPS agreement. Pharmaceutical patenting would fuel innovation and R&D while ensuring that the inventors behind the product are incentivized. This is essential in order to promote growth in the pharmaceutical industry, or any sector for that matter which would in turn play a pivotal role in contributing to the economic growth of a country. Developing countries should engage in compulsory licensing of (COVID-19) drugs

 

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