Intellectual Property Waivers for Drugs Daily Update

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Reverse engineering solves inequity

AP, 10-25, 21, Africa trying to replicate Moderna's COVID vaccine in an attempt to lessen the gap of vaccine inequity, https://www.firstpost.com/world/africa-trying-to-replicate-modernas-covid-vaccine-in-an-attempt-to-lessen-the-gap-of-vaccine-inequity-10083471.html In a pair of Cape Town warehouses converted into a maze of airlocked sterile rooms, young scientists are assembling and calibrating the equipment needed to reverse engineer a coronavirus vaccine that has yet to reach South Africa and most of the world’s poorest people. The energy in the gleaming labs matches the urgency of their mission to narrow vaccine disparities. By working to replicate Moderna’s COVID-19 shot, the scientists are effectively making an end run around an industry that has vastly prioritized rich countries over poor in both sales and manufacturing. And they are doing it with unusual backing from the World Health Organization, which is coordinating a vaccine research, training and production hub in South Africa along with a related supply chain for critical raw materials. It’s a last-resort effort to make doses for people going without, and the intellectual property implications are still murky.

US pushing IPR waiver, EU opposes

I23.com, 10-22, 21, https://www.i24news.tv/en/news/coronavirus/1634901081-us-asks-wto-for-covid-vaccine-intellectual-property-waiver, US asks WTO for Covid vaccine intellectual property waiver The United States implored members of the World Trade Organization (WTO) to waive intellectual property rights for Covid vaccines to aid in the fight against the pandemic. With an intellectual property waiver, less developed nations could produce the doses, a measure which could stem the world’s vaccine inequality. “We ... need every WTO member to step up as well and support an intellectual property waiver, and every company must act ambitiously and urgently to expand manufacturing now,” White House spokesperson Karine Jean-Pierre said, according to Reuters. Over 100 countries support the initiative, but the European Union (EU) and several other nations do not back it. Although WTO Director-General Ngozi Okonjo-Iweala said formal discussions on the matter stalled last week, she believes the parties can “find a pragmatic compromise on the IP waiver.”

Africa unvaccinated, needs waiver

André van Wyk, 10-21, 21, Africa: How Intellectual Property Law is Holding Back Covid-19 Therapies, https://allafrica.com/stories/202110220116.html Africa remains largely unvaccinated from Covid-19, González said in an opening statement, adding that the continent remains at risk of successive waves of infection without access to the new Covid-19 treatments increasingly being used to save lives in richer countries. "Meanwhile, the United Kingdom and European Union members continue to block efforts to pass a waiver at the World Trade Organisation that would temporarily suspend IP protections on Covid-19 vaccines, medicines and other goods to help the world respond to the pandemic," González said. Menghaney began by giving an introduction to Covid-19 treatments and the IP issues related to them. "I wanted to talk about something that's been on the table for a very long time and that's medicines for Covid-19, but that's somehow been overshadowed by , of course, the activism that's been needed for vaccines and, indeed, it's the correct moment, I feel, when we know that Covid-19 is here to stay in our communities , but we will always need treatment and we need to start talking about them at this crucial juncture," Menghaney said. Menghaney proceeded by sharing her screen to display a series of slides depicting the challenges IP ownership has on Covid-19 treatments. "As a flashback to anyone who's been part of the HIV/Aids movement, we all know it's about competition - the more suppliers you have, the more affordable treatments are," Menghaney said, saying that this was something that was encountered with antiretrovirals and the licences required to manufacture them before intervention by the Competition Commission of South Africa. Menghaney also said that this could prove as a framework for lessons that could be applied to Covid-19. Menghaney continued by discussing the three major classes of medicines that people should be examined. The first of these are monoclonal antibodies. "Traditional thinking suggests that monoclonal antibodies are too expensive for developing countries, and traditionally they are reserved for high income nations," said Menghaney. She cited the use of Tocilizumab, a monoclonal antibody typically used for the treatment of rheumatoid arthritis, which has resulted in improvement in patients with severe Covid-19 pneumonia, according to the New England Journal of Medicine, as an example. Menghaney then pointed to Janus kinase (JAK) Inhibitors, medication meant for the treatment of rheumatoid arthritis, according to the U.S. National Library of Medicine. According to Menghaney, several JAK Inhibitors are being considered for the treatment of hospitalised Covid-19 patients. The World Health Organisation (WHO) is reviewing them as a class for guideline inclusion. "They have a very low production cost and can be generically produced in large parts of the world, not just in India," said Menghaney, though this is made difficult by the treatment's patents which are only set to expire in 2029. The last type of medication Menghaney spoke about are antivirals. Multiple compounds are currently in the process of being reviewed, like Molnupiravir which was approved by the U.S. Food and Drug Administration (FDA) for mild to moderate Covid-19 cases. "The cost to produce it generically is U.S.$20 compared to U.S.$700 from a firm like Merck," said Menghaney when speaking on the benefit of the cost ratio. While progress has been made in voluntary licensing for African countries, nations like Brazil and others in Central Asia have been excluded. González asked Menghaney to clarify what patents and licences are and how they matter with regard to access to medicine. "Patents, in simple terms, allow a patent holder to block someone else from making and selling a medicine, basically giving that person a monopoly. A licence is something granted to competitors allowing them to produce the same medication," said Menghaney. González elaborated on Menghaney's explanation to say that pharmaceutical giant Merck, which has recently produced a pill-based treatment for Covid-19, has granted voluntary licencing to some Indian manufacturers to allow generic production noting, however, that this was an exception and not always the case with countries being forced to seek compulsory licences to get the treatment they need. González opened the floor to de Carvalho, noting Brazil's long struggle to get compulsory licencing and asking him to expand on that. De Carvalho said that Brazil's situation is similar to that of South Africa with both being emerging pharmaceutical markets, the kind that companies seek many patents. "They charge a lot of money that undermine local public health policies and these countries are in a very difficult position to deal with diseases because the technology they need is very expensive," de Carvalho said. "One of the options countries have is compulsory licenses. This is useful in emergency situations where you need a fast solution to suspend a monopoly," said de Carvalho. This allows third parties to explore patented technologies without needing the authorisation of patent owners. "We do not regard it as patent infringement because when a compulsory licence is issued the patent holder still has some rights reserved, they receive royalties when other producers enter the market so there is a balance," de Carvalho added. However, this course is underutilised in many countries, according to de Carvalho, largely due to political reasons, along with pressure from pharmaceutical companies. "We want to make sure the Brazilian public health system can maintain a response to Covid-19. There will be a cut in the budget for vaccine purchase next year of 85% so we need to find ways to make it sustainable. The budget for Brazil is being reduced but companies like Pfizer are raising the prices with each new contract they make with the country so the inequalities are coming over and over again," said de Carvalho. González acknowledged how Covid-19 has exacerbated inequalities in Brazil before turning to Sehoma. "Compulsory licencing is not something South Africa has been able to do because of its patent law regime. What are the problems with South Africa's patent laws, where are we with reforms and why are we seeing this posturing by the country to waive IP protections while not attending to that same situation at home?" González asked. "We have seen South Africa spearhead the cause for a waiver on the global stage. On the contrary, we do not have our own house in order when it comes to fixing our own patent law to ensure access to lifesaving medicine," Sehoma said. While the government is currently in the process of amending the patent act, the process has been "shockingly slow", according to Sehoma. "In light of how we've been speaking about how IP is such a problem - even our president notes how IP is a barrier - there are still questions why we are not moving locally on this." Sehoma also acknowledged that South Africa lacks an easy-to-use administrative system to provide compulsory licenses. "I think abuses of patents have restricted and continue to restrict access to medicines for millions of people including those suffering from tuberculosis, cancer and hepatitis, and now the same is happening with Covid-19," Sehoma concluded. González asked Sehoma to comment on pharmaceutical companies' reluctance to adhere to the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver - which allows states to issue licenses to any third parties to produce and market the patented product without the prior approval of the patent rights holder (https://www.healthaffairs.org/do/10.1377/hblog20210712.248782/full/) - over their assertion that Africa has no capacity to produce vaccines. "We've shown how untrue that is through analyses and studies. Doctors Without Borders have noted this as well by showing the capacity we have in South Africa and across the continent to produce vaccines," said Sehoma, who likened the pharmaceutical companies' claims to being a myth to derail to getting African vaccine manufacturers to be able to be independent. "To me it's an issue of independence, it's an issue of relying on ourselves and being able to meet local needs," Sehoma said. González opened the floor to Twala by continuing the examination of major pharmaceutical companies who also claim that a reviewed patent system would be a hindrance to economies. "That's something we hear all the time," said Twala. "Underneath that broad, umbrella myth there are others given to support that. I think the key to busting that myth is really understanding context, specifically in terms of developed countries versus developing countries," Twala said. Twala went on to say that there are three categories or ways this can be considered - domestically, globally and thematically. "Domestically, some of the myths include the fact that flexible IP systems discourage development, local industry and innovation. What we've actually seen from development in western countries as well as Asian nations is that a big driver of their industrial development was flexible IP systems and now that these countries have achieved that development, they've effectively kicked the ladder by enforcing these stringent IP systems, so if we look at a country like South Africa, it's still developing and needs flexible IP systems to drive development versus a country like the U.S.," said Twala. Close SIGN UP FOR FREE ALLAFRICA NEWSLETTERS Get the latest in African news delivered straight to your inbox Top HeadlinesAfricaBusinessGovernance [email protected] By submitting above, you agree to our privacy policy. Twala added that economic growth through industrialisation would also be achieved through flexible IP systems. "We'd be able participate more fully in the fourth industrial revolution as well as respond to the need for medicines that are unique to Africa which form part of the neglected medicines in terms of the research and development and innovation that big pharmaceuticals make." Speaking on the second category, Twala said that with regard to the assertion that flexible IP systems would discourage foreign investment, research by SECTION27 found that South Africa has attracted less foreign direct investment than countries that offer weaker protections of IP and that foreign direct investment in the country between 1994 and 2007. "We saw over 35 manufacturing plants belonging to foreign pharmaceutical companies close in South Africa. What we've also seen is that when it comes to developing regions with lower labour and operating costs, pharmaceutical companies consolidate those type of costs which decreases foreign direct investment and the benefits countries get from that.," said Twala. Speaking on trade, Twala said that secondary patenting, otherwise known as 'evergreening', prevents local manufacturers in South Africa from producing generic products long after they're available in other countries. "A patent should have something innovative for it to be registered but what pharmaceutical companies do is that as a patent runs out they will then change an ingredient or something that isn't crucial for its efficacy so South Africa doesn't really investigate applications for patents, they then get granted extensions or new patents on the same products which help them to monopolise the market," Twala said. On the final category, Twala said that health-driven R&D (research and development) should be a key focus instead of profit-driven R&D, which leads to scenarios like evergreening. "About 12% of the disease burden is made up of neglected diseases and 4% of the therapeutics registered in 2011 actually addressed neglected diseases. So we see that we're really failing to deliver innovation in that response to our need and, particularly in Africa, we need innovation that responds to those neglected diseases and allows us to find solutions to that," Twala said.

US already leads in vaccine distribution

Anita Powell, 10-21, 21, https://www.voanews.com/a/us-hits-200-million-covid-vaccine-donations-worldwide-/6280310.html, US Hits 200 Million COVID Vaccine Donations Worldwide The United States on Thursday marked the successful distribution of 200 million COVID-19 vaccines to more than 100 countries, a move the White House says fulfills President Joe Biden's vow to become "the world's arsenal of vaccines." White House deputy press secretary Karine Jean-Pierre said this is just the start. In September, Biden announced plans to donate more than 1 billion vaccines to low- and lower-middle-income nations. "Donating vaccines is one urgent effort we are taking to tackle this pandemic globally, and we've committed to donate 1.2 billion (vaccines), along with lifesaving assistance to countries in need to enhance their ability to get shots into arms," she said Thursday. "We also reiterate support for an intellectual property waiver and bolstering manufacturing here at home and abroad." The U.S. Agency for International Development said it is also working to help provide nations in need with related items and support such as testing, treatment and protective equipment. "Americans have 200 million reasons to be proud," read a statement from USAID Administrator Samantha Power. "USAID is honored to be at the forefront of this global vaccination effort unprecedented in scale, speed, and complexity, to counter the worst pandemic in modern history." Those donations have come rapid-fire in a matter of months, with large tranches going out recently to lower-income nations. Last week, the White House announced it was donating 17 million doses of the one-shot Johnson & Johnson vaccine to the African Union, bringing the total donation to the 55-state body to 50 million doses. "The U.S. is far and above the leader in global vaccination efforts, and these doses are helping save lives and stop the spread of COVID," said Sarah Swinehart, senior communications director at the ONE Campaign, an anti-poverty group.

COVID-19 declining globally

Gene Quinn, 10-20, 21, COVID IP Waiver Attempts are Becoming Harder to Justify, https://www.ipwatchdog.com/2021/10/20/covid-ip-waiver-attempts-becoming-harder-justify/id=138993/ The good news is that the pandemic is coming under control, with the new cases, hospitalizations and deaths from the highly contagious Delta variant all dropping dramatically over the last five to seven weeks. In the U.S., for example, the peak of the Delta spike occurred on September 13, with 285,058 new cases that day and the 7-day moving average number of cases at 175,822 cases. Five weeks later, on October 18, the number of new cases dropped to 122,033 and the 7-day moving average number of cases is now 83,341, which corresponds to a 57.2% drop in the number of new cases and 52.3% drop in the 7-day moving average. Worldwide, the Delta spike occurred on August 20 with 789,936 new cases and on August 26 with a 7-day moving average of 661,827 new cases. On October 18, the number of new cases worldwide dropped to 425,922 and a 7-day moving average of 408,518, which corresponds to a 46.1% drop in new cases and a 38.3% drop in the 7-day moving average of new cases. The data on U.S. hospitalizations is equally hopeful. The Delta spike in COVID-19 hospitalizations occurred on September 3 and had 94,368 patients hospitalized. As of October 16, the last day for which hospitalization data is available as of this writing, the number of patients hospitalized with COVID in the U.S. is 50,572. This corresponds to a 46.4% drop in hospitalizations nationwide over the last seven weeks.

Very few donations

Reardon, 10-20, 21, Sara Reardon is a freelance journalist based in Bozeman, Mont. She is a former staff reporter at Nature, New Scientist and Science and has a master's degree in molecular biology., Will Giving COVID Booster Shots Make It Harder to Vaccinate the Rest of the World?, https://www.scientificamerican.com/article/will-giving-covid-booster-shots-make-it-harder-to-vaccinate-the-rest-of-the-world/ Despite having pledged to donate some excess doses to the developing world, wealthier countries have mostly been sitting on their stockpiles, many of which are in danger of expiring. Of the 1.2 billion doses the U.S. has promised to donate, it has only delivered about 190 million. On October 7 the WHO released a plan that would allow 40 percent of the world to be vaccinated by the end of the year, but the agency said this would require all countries to “commit to equitable distribution of vaccines.”

Developed country boosters don’t trade-off with developing country needs

Reardon, 10-20, 21, Sara Reardon is a freelance journalist based in Bozeman, Mont. She is a former staff reporter at Nature, New Scientist and Science and has a master's degree in molecular biology., Will Giving COVID Booster Shots Make It Harder to Vaccinate the Rest of the World?, https://www.scientificamerican.com/article/will-giving-covid-booster-shots-make-it-harder-to-vaccinate-the-rest-of-the-world/ There are, in theory, plenty of vaccine doses (either existing or in the works) for most of the world’s people to get the primary course very soon. Experts project that 12 billion doses will have been produced by the end of 2021 and that 11 billion will be sufficient to vaccinate 70 percent of the world. Even if the G7 nations—the U.S., U.K., France, Germany, Italy, Canada and Japan—and the European Union gave boosters to 80 percent of their residents older than age 12, more than one billion doses would still be available for donation to developing countries, according to data from the analytics firm Airfinity. “I’ve never seen a scenario where [wealthy] countries don’t have a surplus,” says Caroline Casey, the company’s lead COVID analyst.

COVAX distribution too slow

Reardon, 10-20, 21, Sara Reardon is a freelance journalist based in Bozeman, Mont. She is a former staff reporter at Nature, New Scientist and Science and has a master's degree in molecular biology., Will Giving COVID Booster Shots Make It Harder to Vaccinate the Rest of the World?, https://www.scientificamerican.com/article/will-giving-covid-booster-shots-make-it-harder-to-vaccinate-the-rest-of-the-world/ Many countries have promised to donate excess vaccines to developing nations and to COVAX, a collaboration among the WHO and two international nonprofit organizations (the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance) that formed to help equitably distribute vaccine donations throughout the world. COVAX had aimed to deliver two billion doses by the end of this year, but the donations pledged to it have been slow to materialize, and it is on track to fall 30 percent short of its goal. Its directors blame this on various government export bans, individual deals between suppliers and countries, production challenges and regulatory delays.

Deadly variants likely to arise among unvaccinatecd

Eric Saganowsky, 10-20, 21, https://www.fiercepharma.com/pharma/pfizer-strong-armed-governments-covid-19-vaccine-supply-talks-report-says Some experts argue that giving boosters to a large proportion of the population will further slow donations and cut into the supply. Pai adds that such a shortage could fuel another dangerous situation as well: deadlier variants of the virus are more likely to arise in unvaccinated people around the world than in people who have received a full vaccine course (even with no booster).

Drug companies trying to maximize profits

Eric Saganowsky, 10-20, 21, https://www.fiercepharma.com/pharma/pfizer-strong-armed-governments-covid-19-vaccine-supply-talks-report-says Pfizer is playing a leading role in producing vaccines against COVID-19, but new documents released by Public Citizen shine a light on the company's aggressive tactics when negotiating supply deals. In draft and final deals with the U.S., the U.K., Brazil and other countries, Pfizer retained rights to "silence" governments and "throttle supply" in an effort to "maximize profits" amid the world's "worst public health crisis in a century," Public Citizen concluded in its Tuesday report. For instance, in a deal with Brazil, Pfizer restricted the government from making “any public announcement concerning the existence, subject matter or terms of [the] Agreement” without a signoff from the drugmaker. Brazil also couldn't talk about the country's relationship with Pfizer without a signoff, Public Citizen said. Similar clauses exist in the company's deals with the U.S. and EU, but allow both parties to issue the final signoff, according to the consumer advocacy group.

Supply of COVID-19 vaccines will exceed demand, waiver useless

Jyothi Datta, 10-19, 21, a-firms/article37076923.ece, Collaborations only way out of the pandemic, say major pharma firms The IFPMA, however, points out that supplies are in place. “The vaccine production effort is estimated to reach 12.5 billion doses by the end of 2021 and double again to 24 billion doses by June 2022, at which time vaccine supplies will most likely outstrip global demand,” said a statement ahead of a meeting of the G-20 heads of state in Rome later this month. The numbers show that the premise of an IP waiver “to help address an assumed shortage of vaccines as the solution to vaccine equity has been overtaken by the facts”, said the IFPMA. The solution to vaccine equity resides in “dose sharing, continuing to optimise output through manufacturing scaling up and voluntary licensing; as well as working together to enable countries to efficiently and effectively vaccinate their people”, they said. Their statement comes even as public health voices, including the WHO and humanitarian organisation across the world, call out the lop-sided distribution of Covid vaccines, with developed countries receiving a lion’s share of the supplies. IFPMA members include Pfizer, Eli Lilly, Roche, Johnson and Johnson, Merck, AstraZeneca and Moderna, all of who have critical Covid vaccines, anti-virals, and biological therapeutic products in their portfolio. The association pointed out that Covid vaccine manufacturing output, driven principally by the US, the EU, China, and India, was over one billion vaccines each month. “The 9.3 billion Covid vaccine dose output by the end of October, and the estimated production of 12.5 billion by the end of the year, demonstrates the industry’s success in trebling global vaccine capacity in less than a year,” said the IFPMA, adding that about 300 voluntary collaborations were formalised during the pandemic period to support production. COVID-19 undermines women’s rights Kumundi Samuel, 10-18, 21, Opposition to the WTO TRIPS Waiver Proposal on COVID 19 Vaccines, https://dawnnet.org/publication/the-impact-the-eus-opposition-to-the-wto-trips-waiver-proposal-on-covid-19-vaccines/ COVID-19 is not only a health and economic crisis, but also a human rights crisis with disproportionate gender impacts.  It needs concerted international cooperation and solidarity to ensure that everyone, everywhere is protected; the multiple crises in the wake of the pandemic are mitigated; and the pandemic itself is effectively controlled and curbed. Central to this effort is equal, non-discriminatory global access to COVID-19 vaccines, medicines, and other products, and the removal of policy and institutional barriers that block access and exacerbate the adverse gender impacts of the pandemic. This Shadow Report, submitted in support of the Feminists for a People’s Vaccine Campaign,[1] focuses in particular on the impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), administered by the World Trade Organisation (WTO), and the opposition by a minority of countries, including Sweden through its membership in the European Union (EU), to a waiver from TRIPS implementation of intellectual property (IP) on COVID-19 vaccines, diagnostics, therapeutics and other needed medical products. This opposition has severe and disproportionate impacts on the rights of women and girls in low and middle-income countries, raising concerns about Sweden’s compliance with its:

IP blocks new COVID-19 treatments

Stephanie Nolan, 10-17, 21, New York Times, Will New Covid Treatments Be as Elusive for Poor Countries as Vaccines?, https://www.nytimes.com/2021/10/17/health/covid-treatment-access-molnupiravir.html Nearly a year after the first Covid-19 vaccination campaigns began, the vast majority of the shots have gone to people in wealthy nations, with no clear path toward resolving the disparity. News this month that an antiviral medication had proved effective against the coronavirus in a large clinical trial has brought new hope of a turning point in the pandemic: a not-too-distant future when a simple pill could keep infected people from dying or falling severely ill. The drug, molnupiravir, made by Merck, is easy to distribute and can be taken at home. The trial results showed it halved the risk of hospitalization and death among high-risk people early in their infections. The company, which is developing the drug with Ridgeback Biotherapeutics of Miami, has applied for emergency-use authorization from the Food and Drug Administration; a decision could come in early December. Unlike the vaccine manufacturers Pfizer and Moderna, which have resisted calls for license agreements to let overseas manufacturers make their shots, Merck will allow generic manufacturers in India to sell the pills at a far lower price in more than 100 poorer countries. Most nations in sub-Saharan Africa, where vaccination rates are as low as 3 percent, are covered by the deal. Drug-access advocates say the Merck licensing deal is an encouraging start but only a small step toward equity. Merck has begun production of the drug, but it is unclear how much of the generic product will be available next year. The agreements leave out many undervaccinated nations, such as Ukraine, that have been hit hard by Covid. And an antiviral must be combined with reliable, affordable testing, which is also limited in many places. Several other drug makers, including Pfizer, are expected to announce efficacy data from trials of similar medications; the companies said it was too soon to comment on whether they would enter similar agreements. All this means that treatments could remain largely with nations able to pay for early access, as they have done with vaccines. “A drug like this that is kept at room temperature, you could get it to even the remotest parts of the world —- it’s fair to say that this drug could prevent hundreds of thousands of hospitalizations and deaths,” said John Amuasi, an infectious disease expert and global health at the Kumasi Center for Collaborative Research in Tropical Medicine in Ghana. “But the barrier is going to be price. Look at how long it has taken for vaccines to reach Africa. My worry is that we are steadily on course to do the same with the drugs.” More than 18 months into the pandemic, Covid remains an illness largely to be endured rather than treated. The few medicines that have shown some benefit — such as monoclonal antibodies — are costly, complex to administer, and, in poor nations, scarce or absent. Yet without widespread vaccination, those populations remain vulnerable to Covid and need affordable medicines. The U.S. government bought much of the supply of the antiviral remdesivir last year after early research showed it might speed recovery from Covid. Now it is pursuing a similar strategy for molnupiravir: It has a $1.2 billion agreement to purchase 1.7 million courses of the drug if it receives F.D.A. authorization. That is 20 percent of what the company says it can produce this year. Other relatively well-off countries, including Australia, South Korea and New Zealand, have signed deals as well. Merck was criticized two decades ago for selling its H.I.V. drugs at prices unaffordable in Africa. This time, the company recognized the imperative of widening access early. “We really did have a responsibility that, if this drug was found to be a safe and effective oral drug that someone could take at home, we need to make sure that, especially in low- and middle-income countries where they don’t have the strongest health care systems, that this would have very wide access,” said Jenelle Krishnamoorthy, Merck’s vice president for global policy. The voluntary licenses the company negotiated with the Indian drugmakers offer the possibility that governments in the poorest nations could buy molnupiravir for well under $20 per five-day course, compared with $712 in the U.S. deal. The eight Indian companies are in clinical trials with their versions of the drug, and four confirmed to The Times that they expected to release results soon; one industry executive who was not authorized to speak on the record said he expected his firm to produce the drug for less than $10 per course. Suerie Moon, an expert on drug access issues, called Merck’s Indian generic licenses a positive precedent for Covid treatments —- and a smart business move for the company. “It’s not a coincidence that Merck has experience from H.I.V. — internally, with their leadership and culture, they know that if they don’t address the access challenges, they will be slammed,” said Dr. Moon, co-director of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva. We need a global effort. We need donors to step up with funds to make sure treatments reach everyone,” Janet Ginnard, the director of strategy, said. Unitaid and partners are preparing to make a provisional purchase agreement for a treatment such as molnupiravir, conditional on a recommendation by the W.H.O. But it is not clear what supply will be available, given the bilateral deals that have been struck or are being negotiated by the U.S. and others. “Countries will prefer to negotiate bilaterally or at a regional level rather than wait and rely on a global mechanism,” Dr. Moon said. She noted that as vaccine supply became a global crisis, lower-income countries took out loans to strike bilateral deals, and treatment purchases could be similar. Merck’s voluntary licenses for molnupiravir are all with companies in India, a concentration that could pose risks. Covax, the United Nations-backed alliance of organizations working to deliver vaccines to poorer nations, was relying on the Serum Institute of India to produce the bulk of shots. But after the virus surged in March, the Indian government banned vaccine exports, and those are only resuming now. There is also a supply-chain question: Licenses with the United Nations’ Medicines Patent Pool could see companies all over the world making generic treatments. But most medications’ raw materials are made in India and China, and they have faced crunches throughout the pandemic. Recent experience with vaccines suggests that if there is limited supply, those who can pay will have first access, said Mariângela Simão, a senior World Health Organization official. “The risk right now is that the rich countries dominate the market and buy all of these medicines,” she said. She said the W.H.O had been working on Covid treatment access with limited success. “We’ve had enormous difficulties. We talked to every company that has a product that potentially could be good, we have been discussing voluntary licensing through the Medicines Patent Pool, and there’s very little interest,” she said. “If there is not an opening on the part of industry to share technology now, when the world needs it most, when will it happen?” Testing will be an additional challenge. The drugs work best if taken as soon as symptoms appear, and patients must be sure they have the coronavirus. But testing is scarce in many places: The W.H.O. estimates that fewer than 15 percent of Covid infections are detected in Africa, for example. But if early antiviral treatment is made available globally, it could reduce spread. “Then you have fewer health systems incapacitated and a greater economic recovery for the benefit of everyone,” said Brook Baker, a law professor at Northeastern University who is part of a therapeutics access effort led by the W.H.O. “Even from a somewhat self-interested perspective, it’s shortsighted and counterproductive not to ensure access to these medicines.”

Faster for companies to increase production than to solve through sharing IP

AP, 10-11, 21, https://www.usnews.com/news/world/articles/2021-10-11/moderna-has-no-plans-to-share-its-covid-19-vaccine-recipe, Moderna Has No Plans to Share Its COVID-19 Vaccine Recipe The chairman of Moderna says the company has no plans to share the recipe for its COVID-19 vaccine because executives have concluded that scaling up their own production is the best way to increase the global supply. Moderna has no plans to share the recipe for its COVID-19 vaccine because executives have concluded that scaling up the company's own production is the best way to increase the global supply, the company’s chairman said Monday. In an interview with The Associated Press, Noubar Afeyan also reiterated a pledge Moderna made a year ago not to enforce patent infringement on anyone else making a coronavirus vaccine during the pandemic. “We didn’t have to do that," Afeyan said. ”We think that was the right, responsible thing to do.” He added: “We want that to be helping the world.” The United Nations health agency has pressed Moderna to share its vaccine formula. Afeyan said the company analyzed whether it would be better to share the messenger RNA technology and determined that it could expand production and deliver billions of additional doses in 2022. “Within the next six to nine months, the most reliable way to make high-quality vaccines and in an efficient way is going to be if we make them," Afeyan said. Asked about appeals from the World Health Organization and others, he contended that such pleas assumed ”that we couldn’t get enough capacity, but in fact we know we can.” Moderna “went from having zero production to having 1 billion doses in less than a year," Afeyan said, referring to the Massachusetts-based company's sprint to develop the vaccine and produce it in large quantities. "And we think we will be able to go from 1 to 3 billion" in 2022. "We think we are doing everything we can to help this pandemic,'' Afeyan added, citing the company's increasing output and its pledge on patent infringement. He noted that $2.5 billion (about 2.1 billion euros) and 10 years were spent in developing the platform that makes Moderna's COVID-19 vaccine. “Others joined the hunt when COVID-19 came along, and we're glad to see that the capacity therefore has been increased considerably beyond what Moderna would have been able to do” by itself, Afeyan said. Asked how successful he thought others might be if they started from scratch using Moderna patents, he declined to speculate. But “it's hard for me to imagine that they would be able to get any meaningful scale in a short time frame at the quality we would be able to do as a certainty” for 2022. Asked about recent criticism that Moderna has been furnishing its vaccine mainly to wealthy countries while low-income countries clamor for the product, Afeyan said the company supplied a “quite significant” output to poorer nations, mostly through its work with the U.S. government, which contracted early in the pandemic with the company for doses. Moderna is working with multiple governments "to help them secure supplies for the express purpose of supplying to low-income countries,'' the executive said. “There is more supply in the EU and the U.S. government than they will be able to use,” said Afeyan, who is also a co-founder of Moderna. Separately, Moderna made a commitment in May to Covax, the U.N.-backed vaccine program, to arrange for a total of 500 million does to go to poorer countries. He said probably 40 million doses would begin to ship in the last three months of this year, with the rest shipping next year. The COVID-19 vaccine is Moderna's only commercial product. The company announced plans last week to open a vaccine plant somewhere in Africa. Afeyan said he hopes a decision will be made soon on an exact location. Still, it could take years to get the plant up and running. Afeyan spoke on the last full day of a visit to Italy in which he met Pope Francis, who has appealed for universal vaccine access. He also appeared in Venice to promote a humanitarian prize. Co-founded by Afeyan, the Aurora Humanitarian Initiative aims to “empower modern-day saviors to offer life and hope” to those urgently needing basic humanitarian aid. Through the prize, the organization has awarded $5 million in grants to more than 30 humanitarian projects to help people recover from war, famine, genocide, human rights violations and other challenges.

Moderna, the best vaccine, is being kept out of the reach of the poor

Rebecca Robins, 10-9, 21, New York Times, Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor, https://www.nytimes.com/2021/10/09/business/moderna-covid-vaccine.html Moderna, whose coronavirus vaccine appears to be the world’s best defense against Covid-19, has been supplying its shots almost exclusively to wealthy nations, keeping poorer countries waiting and earning billions in profit. After developing a breakthrough vaccine with the financial and scientific support of the U.S. government, Moderna has shipped a greater share of its doses to wealthy countries than any other vaccine manufacturer, according to Airfinity, a data firm that tracks vaccine shipments. About one million doses of Moderna’s vaccine have gone to countries that the World Bank classifies as low income. By contrast, 8.4 million Pfizer doses and about 25 million single-shot Johnson & Johnson doses have gone to those countries. Of the handful of middle-income countries that have reached deals to buy Moderna’s shots, most have not yet received any doses, and at least three have had to pay more than the United States or European Union did, according to government officials in those countries. Thailand and Colombia are paying a premium. Botswana’s doses are late. Tunisia couldn’t get in touch with Moderna. Unlike Pfizer, Johnson & Johnson and AstraZeneca, which have diverse rosters of drugs and other products, Moderna sells only the Covid vaccine. The Massachusetts company’s future hinges on the commercial success of its vaccine. “They are behaving as if they have absolutely no responsibility beyond maximizing the return on investment,” said Dr. Tom Frieden, a former head of the Centers for Disease Control and Prevention. Moderna executives have said that they are doing all they can to make as many doses as possible as quickly as possible but that their production capacity remains limited. All of the doses they produce this year are filling existing orders from governments like the European Union. Even so, the Biden administration has grown increasingly frustrated with Moderna for not making its vaccine more available to poorer countries, two senior administration officials said. The administration has been pressing Moderna executives to increase production at U.S. plants and to license the company’s technology to overseas manufacturers that could make doses for foreign markets. Moderna is now scrambling to defend itself against accusations that it is putting a priority on the rich. On Friday, after The New York Times sent detailed questions about how few poor countries had been given access to Moderna’s vaccine, the company announced that it was “currently investing” to increase its output so it could deliver one billion doses to poorer countries in 2022. The company also said this past week that it would open a factory in Africa, without specifying when. Moderna executives have been talking with the Biden administration about selling low-cost doses to the federal government, which would donate them to poorer countries, as Pfizer has agreed to do, the two senior officials said. The negotiations are continuing. In an interview on Friday, Moderna’s chief executive, Stéphane Bancel, said “it is sad” that his company’s vaccine had not reached more people in poorer countries but that the situation was out of his control. He said that Moderna tried and failed last year to get governments to kick in money to expand the company’s scant production capacity and that the company decides how much to charge based on factors including how many doses are ordered and how wealthy a country is. (A Moderna spokeswoman disputed Airfinity’s calculation that the company had provided 900,000 doses to low-income countries, but she didn’t provide an alternate figure.) Nearly a year after Western countries began sprinting to vaccinate their populations, the focus in recent months has shifted to the severe vaccine shortages in many parts of the world. Dozens of poorer countries, mostly in Africa and the Middle East, had vaccinated less than 10 percent of their populations as of Sept. 30. ADVERTISEMENT Continue reading the main story In August, for example, Johnson & Johnson faced rebukes from the director general of the World Health Organization and public health activists after The Times reported that doses of that shot produced in South Africa were being exported to wealthier countries. Biden administration officials are especially frustrated with what they see as Moderna’s lack of cooperation, because the U.S. government has provided the company with critical assistance. Scientists at the National Institutes of Health worked with the company to develop the vaccine. The United States kicked in $1.3 billion for clinical trials and other research. And in August 2020, the government agreed to preorder $1.5 billion of the vaccine, guaranteeing that Moderna would have a market for what was an unproven product. While clinical trials last year found that the Moderna and Pfizer vaccines were similarly effective, more recent studies suggest that Moderna’s shot is superior. It offers longer-lasting protection and is easier to transport and store. Moderna’s shot is “essentially the premium vaccine,” said Karen Andersen, an industry analyst at Morningstar. “They’re in a position where they probably don’t need to sacrifice too much on pricing in a lot of these deals.” There is limited public information about the deals that Moderna has struck with individual governments. Of the 22 countries, plus the European Union, to which Moderna and its distributors have reported selling the shots, none are low income, and only the Philippines is classified as lower middle income. (Six are upper middle income.) Pfizer, by comparison, said it had agreed to sell its vaccine at discounted prices to 12 upper-middle-income countries, five lower-middle-income governments and one poor country, Rwanda. (Tunisia, for example, is paying about $7 per dose.) Only a handful of governments have disclosed how much they’re paying for Moderna doses. The United States paid $15 to $16.50 for each shot, on top of the $1.3 billion the government gave Moderna to develop its vaccine. The European Union has paid $22.60 to $25.50 for its Moderna doses. Botswana, Thailand and Colombia, which the World Bank classifies as upper-middle-income countries, have said they are paying $27 to $30 per Moderna dose. The lack of transparency about how much other governments are paying has put relatively poor countries in a weak bargaining position. They are “negotiating totally in the dark,” said Kate Elder, who advises Doctors Without Borders on vaccine policy. In some cases, Moderna has offered to provide poorer countries the vaccine at relatively low prices, but only after it has fulfilled other countries’ orders. In May, Moderna offered the African Union doses for about $10 each, according to a bloc official involved in the discussions. But the doses wouldn’t be available until next year, causing the talks to fall apart, according to two African Union officials. Dr. Ayoade Alakija, who helps run the African Union’s vaccine delivery program but was not involved in the procurement discussions, said Moderna’s attitude amounted to: “We’re here to make money. We’ve stumbled upon a good thing, and we’re not even trying to pretend that we’re trying to save the world.” Moderna’s Covid vaccine has been transformative for the company and its leaders. The company has said it expects its vaccine to generate at least $20 billion in revenue this year, which would make it one of the most lucrative medical products in history. Ms. Andersen, the Morningstar analyst, projected that the company’s profits on the vaccine could be as high as $14 billion. In 2019, Moderna reported total revenue of $60 million. Moderna’s market value has nearly tripled this year to more than $120 billion. Two of its founders, as well as an early investor, this month made Forbes magazine’s list of the 400 richest people in the United States. As the coronavirus spread in early 2020, Moderna raced to design its vaccine — which uses a new technology known as messenger RNA — and to plan a safety study. To manufacture the doses for that trial, the company received $900,000 from the nonprofit Coalition for Epidemic Preparedness Innovations.

Distribution would occur if there was a waiver

Jenny Lei Ravelo, Amruta Byatnal // 07 October 2021, Devex CheckUp: Could an IP waiver have averted millions of deaths?, https://www.devex.com/news/devex-checkup-could-an-ip-waiver-have-averted-millions-of-deaths-101774 A year has passed since India and South Africa submitted a proposal to the World Trade Organization to temporarily waive intellectual property protections for COVID-19 products. But despite the support of over 100 countries, including the United States, the proposal has yet to be adopted. COVID-19 has caused 3.5 million deaths since the waiver was put forward at the WTO. We wondered: What might have happened if the proposal had been quickly approved? • Some experts say additional investments — such as in the workforce — would still be needed in addition to IP. But others argue there are ways to address those. There are many potential manufacturing plants that can be retrofitted to produce COVID-19 vaccines, and there’s a retired corps of engineers globally that could provide expertise in the interim, Andrew Green reports. • If facilities were in place, the production process for a messenger RNA vaccine could begin within three or four months, says Suhaib Siddiqi, former director of chemistry at Moderna. With a $127 million investment and some expansion, existing facilities for injectable medicines could be producing up to 100 million mRNA vaccine doses in a 10-month period, according to modeling by Médecins Sans Frontières and Imperial College London. • These timelines are contingent on vaccine developers' willingness to share technology. But experts say there are ways to get companies to cooperate, such as tax breaks. Had steps been taken a year ago, “a lot of countries would be in a better spot,” Rachel Thrasher, a trade expert at Boston University’s Global Development Policy Center, tells Andrew.

Low income countries only have 1% of vaccines, waivers needed

UN Development Conference, 10-5, 21, UNCTAD15: COVID-19 must be the inequality ‘game changer’, https://unctad.org/news/unctad15-covid-19-must-be-inequality-game-changer By laying bare the shocking social and economic injustices the world has tolerated for too long, the COVID-19 pandemic could be “a game changer” in the fight against inequalities, world leaders said on 5 October at UNCTAD’s 15th ministerial conference (UNCTAD15). But only if the crisis leads to renewed solidarity among nations, panellists of UNCTAD15’s second World Leaders Summit dialogue warned, saying that so far recovery efforts have failed to live up to promises of collective action. For example, more than 75% of all COVID-19 vaccines produced to date have gone to high and upper-middle-income countries, with low-income countries receiving less than 1%. And more than 80% of recovery investment is being spent in developed countries. “It’s clear that such divergent trajectories, if not urgently corrected, will leave hundreds of millions of people out in the cold,” UNCTAD Deputy Secretary-General Isabelle Durant said as she opened the event, which brought together heads of state, UN agencies, investment banks and NGOs to discuss what’s needed to move from rhetoric to action. Speakers included Barbados Prime Minister Mia Amor Mottley, Caribbean Community Secretary-General Carla Barnett, UN High Commissioner for Human Rights Michelle Bachelet, Oxfam International Executive Director Gabriela Bucher and European Investment Bank President Werner Hoyer. A crucial test Speaking from a human rights perspective, Ms. Bachelet called efforts to end “vaccine nationalism” a crucial test for global commitments to end inequalities. She called for the recognition of COVID-19 vaccines as a public good, urging those in attendance to support UN Secretary-General António Guterres’s call for a global vaccination plan to reach 40% of people worldwide by the end of this year and 70% in the first half of 2022. Mr. Guterres’s plan calls for at least doubling vaccine production to ensure 2.3 billion doses are equitably distributed through the vaccine solidarity initiative, COVAX. Such a plan, Ms. Bachelet said, would require developed countries to share “the benefits of scientific progress” and allow flexibilities in trade agreements. Oxfam International head Gabriela Bucher agreed that vaccine equity was the first urgent step to be taken on a journey towards a more inclusive recovery. “Nothing is more urgent than breaking the monopolies that are restricting vaccine supply,” Ms. Bucher said. “That’s how we end this deadly pandemic.” To help boost supply, she called for waving intellectual property rules on COVID-19 vaccines at the World Trade Organization and urged pharmaceutical companies manufacturing the shots to transfer the needed technology to other qualified producers through the World Health Organization.

Innovations needed to fight new viruses, current vaccines won’t solve new viruses

Betsy McCkay, 10-4, 21, WSJ, To Prevent the Next Pandemic, Scientists Seek One Vaccine for Many Coronaviruses, https://www.wsj.com/articles/to-prevent-the-next-pandemic-scientists-seek-one-vaccine-for-many-coronaviruses-11633339802 Kayvon Modjarrad is out to win the war against this pandemic—and the next one. An emerging-infectious-diseases researcher with the U.S. Army, Dr. Modjarrad is pursuing a vaccine to protect against a range of coronaviruses that cause disease in humans—including Covid-19 variants that might elude today’s vaccines. The goal is to prevent the next new one from spreading around the globe. Such a shot might even stop coronaviruses that cause some common colds. His research team is one of roughly 20 groups around the world working on so-called universal, or pan-coronavirus, vaccines: shots that would block many related viruses at once, including ones that have yet to infect anyone. After years of battling Ebola, Zika, H1N1 pandemic flu and other new pathogens, Dr. Modjarrad and other emerging-disease experts say they want to have a vaccine in hand to blunt the next new pathogen to come along, whatever it may be. Kayvon Modjarrad’s research team is one of roughly 20 groups around the world working on pan-coronavirus vaccines. “It’s our way out not just of this pandemic but this cycle of epidemics,” said Dr. Modjarrad, director of the emerging-infectious-diseases branch of the Walter Reed Army Institute of Research in Silver Spring, Md. WSJ NEWSLETTER Three deadly new coronaviruses emerged in the past 18 years, including the virus that causes Middle East respiratory syndrome or MERS, and scientists warn another is likely. Many animals, including bats and rabbits, carry coronaviruses that can spread to humans. Millions of people around the world are being exposed to the pandemic virus, SARS-CoV-2, raising the risk that new, vaccine-resistant variants will arise, scientists say. “We need to work proactively on these viruses and many, many others,” said David Veesler, a University of Washington School of Medicine biochemist whose lab is testing an experimental vaccine against a group of coronaviruses. Scientists have spent years trying to develop a universal vaccine against influenza—without success yet. Coronaviruses, which mutate less often and have fewer distinct lineages, may be an easier target. But scientists say it could take years to develop one that protects against most of the coronaviruses that infect humans, with many challenges along the way. Recent studies have shown that the effectiveness of Covid-19 vaccines is decreasing, though experts say the shots still work well. WSJ explains what the numbers mean and why they don’t tell the full story. Photo illustration: Jacob Reynolds/WSJ The Coalition for Epidemic Preparedness Innovations, an Oslo-based organization that funds development of vaccines for epidemic diseases, is investing $200 million in grants for early-stage development of vaccines that protect broadly against dangerous coronaviruses. The U.S. National Institute of Allergy and Infectious Diseases, whose scientists are studying ways to make coronavirus vaccines, is awarding a further $95 million to other researchers, including $36 million to teams at Duke University, the University of Wisconsin, Madison and Brigham and Women’s Hospital in Boston. Several companies are developing multivalent Covid-19 vaccines, which would target SARS-CoV-2 variants. The Biden administration and other funders should give priority to the development of shots that would broadly protect against these variants, said Eric Topol, director of the Scripps Research Translational Institute in La Jolla, Calif. “What we really need is a global collaborative effort,” he said. ‘You have to prove that you can get to the moon before you try to go to Mars.’ — Kayvon Modjarrad, Walter Reed Army Institute of Research The vaccines now in development wouldn’t protect against all coronaviruses. The viruses are quite distinct from one another, making it a scientific challenge to create one vaccine that targets them all. Most researchers are focusing first on vaccines against sarbecoviruses, the group of greatest concern because it includes the pathogens behind Covid-19 and severe acute respiratory syndrome, or SARS. If they are able to successfully create a sarbecovirus vaccine, then the next step is making vaccines that block betacoronaviruses, which include sarbecoviruses and the virus that causes MERS, which was first detected in 2012 and has about a 35% mortality rate. The group also includes two viruses that cause common colds. “You have to prove that you can get to the moon before you try to go to Mars,” Dr. Modjarrad said. Recent studies of antibodies in people infected with SARS-CoV-2 are helping to speed vaccine development, said Dennis Burton, an immunologist at Scripps Research. He and other researchers have identified “broadly neutralizing antibodies” that ward off both the pandemic virus and close viral cousins. Vaccines can then be developed that generate those antibodies when delivered into patients, he said. To create a universal vaccine, researchers look for portions of viral pathogens that are the same, or conserved, on related viruses. Many are focusing on the spike protein of the coronaviruses they are targeting, which juts out from the surface of the virus and enables it to latch on to and infect human cells. The U.S. Army’s Dr. Modjarrad and his colleagues recently tested an experimental vaccine consisting of copies of a SARS-CoV-2 spike protein attached to a soccer-ball-shaped nanoparticle made of ferritin, an iron-storing blood protein. The vaccine protected macaques against the original pandemic virus, the researchers reported. The blood serum of the vaccinated macaques also fought off all the major SARS variants, Dr. Modjarrad said. The researchers are now analyzing data from an early-stage clinical trial of the vaccine in humans, Dr. Modjarrad said, and testing in mice a similar vaccine meant to protect against a larger number of betacoronaviruses, including the virus that causes MERS. David Martinez, a postdoctoral fellow at the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill, began designing a vaccine against SARS-like viruses in April 2020 as the pandemic took hold in the U.S. “I thought, we need to start thinking about preventing SARS 3,” he said. David Martinez in a lab at the University of North Carolina at Chapel Hill in June. He and his colleagues used messenger RNA, as Moderna Inc. and Pfizer Inc. and BioNTech SE did with their Covid-19 vaccines. Rather than genetic material from one coronavirus, they stitched together genetic codes from pieces of spike proteins of four SARS-like viruses: SARS-CoV, SARS-CoV-2 and two bat viruses. Dr. Martinez had to wait until November for the hybrid vaccines to be produced, because a critical component also needed for the Pfizer and Moderna vaccines was in short supply. When the experimental vaccine was tested on mice, it protected them against Covid-19 variants, bat coronaviruses and other viruses. The research team is seeking funding for an early-stage clinical trial in humans and is developing a vaccine against MERS and related betacoronaviruses, Dr. Martinez said. At the University of Washington, Dr. Veesler and his colleagues created a Covid-19 vaccine from a virus-like nanoparticle studded with copies of the portion of the virus’s spike protein that binds to a receptor on human cells. That vaccine is now in late-stage clinical trials. After identifying several broadly neutralizing antibodies against SARS-like viruses, the researchers set out to design a “version 2.0” of their vaccine, Dr. Veesler said. They attached to the nanoparticle copies of pieces of the spike protein from SARS-CoV-2 and three similar viruses: the one that causes SARS and two bat coronaviruses. When tested in mice, the vaccine showed it could provide broad protection against SARS-like viruses. The team is now refining the vaccine and plans further tests. The researchers also identified some antibodies that fight off a wider range of betacoronaviruses, including

Distribution barriers in Africa

Rodney Muhumuza, 10-3, 21, AP News, Distribution problems, hesitancy slow Uganda vaccination bid, https://apnews.com/article/coronavirus-pandemic-business-health-africa-coronavirus-vaccine-98444cf20969e725bd67030264375b77 GULU, Uganda (AP) — The light bulb hanging from the ceiling flickered on and off, infuriating the technician in this remote Ugandan town as he checked the refrigerators filled with vaccine doses to confirm they were still working. If the power supply didn’t stabilize, he said, he would have to requisition fuel and start the generator. “It keeps going on and off, like a disco light,” said the technician, Tony Elong. “This is our biggest problem. ... If I am not here and power is off for many hours, we are likely to lose the vaccines. It needs a timely response.” Power failures are rampant in northern Uganda’s Gulu district. For Elong the problem is urgent; two fridges were destroyed by power outages this year. It’s among the many logistical issues facing health officials as they expand COVID-19 vaccination into rural areas with the arrival of substantial doses in the previously vaccine-starved nation. ADVERTISEMENT Gulu, home to 325,000 people, has given out about 9,000 doses, with only 2,795 people fully vaccinated. The district had 30 AstraZeneca doses and 300 Chinese-made Sinovac ones as of Sept. 23, an artificial shortage in a country with a growing vaccine stock of millions of doses. In recent days, Uganda has received more than 2.2 million doses — including Pfizer and Moderna — from the United States, as well as 985,000 AstraZeneca shots from France, Belgium and Ireland. A total of 11,978,840 doses — donations and purchases via the African Union — are expected in Uganda by December, President Yoweri Museveni said last week. But Uganda’s central storage facility near the capital, Kampala, can only hold 5 million doses of the Pfizer vaccines requiring ultra-low temperatures, and some rural areas like Gulu aren’t equipped to handle either the Pfizer or Moderna shots. As supply grows, officials are trying to whip up enthusiasm for vaccines in rural districts where many, citing safety fears, would rather wait. John Nkengasong, head of the Africa Centers for Disease Control and Prevention, told reporters last week that while some African countries such as Rwanda and Zimbabwe are “doing well” in rolling out vaccines, others like Uganda are struggling, and the agency will be looking to community and religious leaders for help. Health systems in Africa are among the poorest in the world, plagued by chronic shortages of essential supplies, corruption and an unmotivated workforce. In Nigeria, Africa’s most populous nation, those challenges are exacerbated by insecurity, with vaccine distribution in rural areas, especially in the country’s volatile north, crippled by the threat of violence. Only 3% of Nigeria’s 200 million people have received their first dose. ADVERTISEMENT In Uganda, an East African nation of 44 million, authorities have ramped up vaccination in the Kampala area, but efforts have largely stalled in rural districts such as Gulu, hampered by hesitancy as well as refrigeration and other distribution problems. Museveni said last week that officials face dismissal in rural areas, which now account for most of the country’s 268 COVID-19 hospitalizations, if vaccines expire under their watch. “We are literally dancing around,” said Dr. Misaki Wayengera, head of a committee advising Uganda’s pandemic response, speaking of the slow vaccine rollout. The government rations doses to districts based on demand expectations, and supplies aren’t replenished until officials account for doses they previously received. As a result, shortages stemming from delays in reporting back vaccination data can occur. “The demand is there,” said Dr. Kenneth Canna. “But right now what is bogging us down ... is availability of the vaccine, both in the urban setting and in the rural setting.” Associated Press journalists reached a remote area of Gulu where a health center without running water had the district’s last supply of 30 AstraZeneca doses. Because a vial contains seven doses that must be accounted for, vaccines aren’t distributed until seven people are in line. So people come and go without a getting a jab. “You can’t open the vial when the people are few. If people are few, you will be wasting the vaccine,” said Okello Labedo, a clinical officer in charge of the Awach health center, speaking through a frayed mask. “The turnout among the elderly is very poor. I think it is because of the distance.” Amos Okello, a farmer who had waited several hours under a mango tree, expressed disappointment he would be going home without a shot after traveling many kilometers on a rented bike. “They said, ‘If you come alone you cannot get the vaccine,’” Okello said. “I can’t go and force someone from his home to come here and get the vaccine.” While it’s “important for me to get the vaccine, tomorrow I might not be able to come back,” he added. Patrick Okot, a commodities trader in Gulu who received his first AstraZeneca shot in May, said he considered traveling to another district for the second one, but is discouraged by the cost. “You might go there and you find that they also don’t have vaccines,” he said. Uganda’s goal is to vaccinate 4.8 million of its most vulnerable people — including those age 50 and above — but so far 348,000 are fully vaccinated, according to official figures. And only 37% of the country’s 150,000 health care workers are fully vaccinated, highlighting the slow rollout that led authorities to begin vaccinating students and others in a bid to prevent the expiration of doses. Authorities have warned schools won’t reopen until all teachers and staff are fully vaccinated, a mandate that briefly caused lines at rural vaccination sites. Yet many came hoping there would be no doses, underscoring hesitancy in the aftermath of reports of rare blood clots in a small number of people getting the AstraZeneca vaccine.

IP on all  COVID-19 vaccines and treatments must be waived

Doctors without Borders, 10-1, 21, Humanitarian organisation Doctors Without Borders compiled this listicle, 3 reasons why we need a waiver on monopolies of all COVID-19 medical tools, https://health-e.org.za/2021/10/01/3-reasons-why-we-need-a-waiver-on-monopolies-of-all-covid-19-medical-tools/ One year ago, and seven months into the COVID-19 pandemic, India and South Africa put forward the TRIPS Waiver proposal: a groundbreaking solution to lift intellectual property (IP) barriers on and ensure greater equity in access to any vaccines, tests, treatments or other medical tools needed to tackle COVID-19. 3.6 million people have lost their lives since the proposal was first introduced to the World Trade Organization (WTO). In the past year, the TRIPS Waiver has received a surge of global support and solidarity from civil society activists and over 100 governments, determined to make the Waiver a reality. Despite this overwhelming support, a small minority of high-income governments either do not support the Waiver, or only support a watered-down version of the proposal. For example, the EU and US both put forward counterproposals that would drastically narrow the Waiver’s scope and limit its potential impact. These counterproposals seek to waive only patents on vaccines, leaving out patents and other IP on tests, medicines, and other tools and still firmly under the control of pharma monopolies. Here are 3 reasons why governments must immediately waive all IP on all medical tools: 1) Vaccines alone cannot control the pandemic There are no ‘silver bullets’ when it comes to COVID-19: while vaccines play a critical role in controlling the virus, they are just one of the many tools we need to beat this pandemic. In addition to vaccines, the world urgently needs access to newer therapeutics and diagnostics to reduce the number of hospitalisations and deaths from COVID-19. With the slower and lower rate of vaccination in low- and middle-income countries due to access barriers, there is an increased risk of transmission and variant spread, both locally and globally. Simultaneously, health systems are being pushed to their limits by ongoing and new waves of the virus around the world, once again highlighting the need to improve access to diagnosis and treatment of people with COVID-19 and to respond to the pandemic with a comprehensive and multifaceted approach. 2) Patents and intellectual property are already a barrier to access A few treatments have been recommended by the World Health Organization (WHO) for treatment of COVID-19, and pharma monopolies are already proving to be a barrier to accessing them. Casirivimab and imdevimab, recently recommended by WHO for COVID-19 treatment, belong to the class of drugs called monoclonal antibodies (mAbs), which have been on the market for decades for other diseases and are often priced extremely high. Regeneron and Roche (responsible for pricing outside the US) have pegged casirivimab/imdevimab at the high price of US$820 in India, $2,000 in Germany and $2,100 in the US. Furthermore, although casirivimab and imdevimab were recommended only recently, Regeneron has already begun applying for patents on the drugs in at least 11 low- and middle-income countries. Independent developers of more affordable ‘biosimilar’ versions of mAbs often face patent barriers and regulatory challenges to introducing their products quickly to increase supply—something that is desperately needed as COVID-19 continues to rage across the globe. This has made production and supply of more affordable mAbs historically difficult, and it continues to undermine COVID-19 treatment access. We urgently need to increase global supply of COVID-19 medicines. To do that, more manufacturers must be able to produce them through the waiving of intellectual property rights, and sharing of technology and know-how by the pharma industry. 3) Limited supply of treatments is an urgent issue Like casirivimab and imdevimab, tocilizumab and sarilumab are mAbs recommended by the WHO for COVID-19. Produced by pharma corporations Roche and Regeneron respectively, tocilizumab and sarilumab are recommended for the treatment of critically and severely ill COVID-19 patients and can potentially reduce reliance on medical ventilators and oxygen – both of which are in short supply in many of the settings where MSF works. However, due to high prices and limited supply, these new therapeutics simply aren’t reaching everyone who needs them, as witnessed by MSF staff around the world. “Over the last few months, we have helplessly witnessed people in South Asia scrambling to get hold of tocilizumab for patients with severe forms of COVID-19.”- Leena Menghaney, Global IP advisor for MSF Access Campaign. Conclusion: We can’t wait any longer. The pandemic is a growing crisis in many developing countries and we can’t allow countries that have already vaccinated the majority of their eligible population while stockpiling vaccines, alongside pharma companies that have so far refused to fully share their vaccine technology and know-how, to block access to other medical tools as well. A solution in the TRIPS Waiver, supported by more than 100 governments around the world, exists: but a small minority of high-income countries shamefully continue to block it, or offer toothless alternatives. The world has already lost an entire year during which countless lives could have been saved by equitably increasing global access to COVID-19 medical tools. It’s time for ALL governments to get behind this groundbreaking proposal and support the TRIPS Waiver to save lives

Even a COVID-19 only waiver creates fear of a dangerous precedent

Bernard Malle, 9-27, 21,   The Irish Times, Covid-19 and vaccine patent rights, https://www.irishtimes.com/opinion/letters/covid-19-and-vaccine-patent-rights-1.4684987, Malee is from the Irish Pharmaceutal Health Care Association Sir, – I refer to an article by Christine Kelly (“Ireland must support waiver of Covid vaccine patents”, Opinion & Analysis, September 24th). The WTO Trade-related Intellectual Property Rights (Trips) Agreement has, since 1995, set a minimum standard of protection for intellectual property. A proposal, led by India and South Africa, to temporarily suspend the Trips Agreement for Covid-19 vaccines and treatments would not boost production. Manufacturing capacity expansion is enabled by identifying suitable partners with the skills, technology and know-how to make approved Covid-19 vaccines and treatments. Our industry has voluntarily formed hundreds of partnerships with expert manufacturers globally. Manufacturers are investing in their own sites to scale production. The result is we are moving from having too few Covid-19 vaccines, to having enough, to probably having more than the world needs in the future. The intellectual property waiver debate is a diversion: the real question is how can we work together to vaccinate as much of the world’s population as fast as possible? Two ways: surge production through on-site investments and voluntary, collaborative links between vaccines innovators and expert manufacturing partners, and share surplus vaccine doses in developed countries with less economically advanced ones. That is happening. The EU and the US are boosting their dose-sharing commitments, pledging to support for stronger vaccines delivery, investing in regional vaccines production and guarding against supply-chain disruptions. These steps move us towards more equitable global Covid-19 vaccines distribution. Waiving intellectual property rights for Covid-19 vaccines and treatments would set a dangerous precedent for the discovery of new medicines for other diseases. Certainty would be lost. Instead, we need to protect our scientists’ ability to turn cutting-edge research into transformative treatments

IP protections undermine vaccine manufacturing development

Pennsylvania News Today, 9-25, 21, https://pennsylvanianewstoday.com/gates-rockefeller-warns-leaders-about-the-effects-of-a-pandemic-nationwide/224488/, Gates, Rockefeller warns leaders about the effects of a pandemic | Nationwide Gates Foundation Suzuman emphasized bottlenecks in delivering vaccines at the national and local levels. “Often there is less emphasis on the need for a vaccine supply infrastructure, as there is so much emphasis on very important vaccine procurement,” he said. Kyle Knight, a senior health researcher at advocacy group Human Rights Watch, said the focus on local manufacturing and distribution capabilities was largely misguided. He called the international response to COVID an inappropriate “charitable” response that prioritizes commercial interests over human rights obligations. “When you have that power, you also have a moral responsibility to pay attention to the dynamics of the power that is causing the harm,” he said. He called the Gates Foundation dishonest about its focus on expanding local vaccine manufacturing plants and distributing them to medical centers. He said there is no reason for health departments around the world to make these investments as long as large companies hold vaccine patents. “The idea that the problem is the lack of infrastructure in poor countries is ridiculous,” he said. “The problem really lies upstream. It exists in this debate about the global health crisis that is occurring in multilateral trading institutions.”

IP on antibody treatment should be waived

Al Jazeera, 9-24, 21, https://www.aljazeera.com/news/2021/9/24/who-adds-regeneron-to-covid-19-treatments-urges-action-on-price, WHO backs Regeneron drug for COVID-19, urges action on price The World Health Organisation (WHO) has added the Regeneron antibody drug cocktail – casirivimab and imdevimab – to its list of treatments for people with COVID-19, urging the manufacturer to reduce the price and ensure equitable distribution. Clinical studies showed the drug combination was effective in patients who were not severely ill but at high risk of being admitted to hospital with COVID-19, or those with severe cases of the disease and no existing antibodies, the WHO said in a statement on Friday. It is the first drug against COVID-19 the WHO has recommended for use in non-severe high-risk patients to reduce the chances of the disease progressing. The antibody therapy secured emergency use authorisation in the United States in November last year after it was used to treat former President Donald Trump when he was admitted to hospital with COVID-19. The United Kingdom has also approved it, while it is under review in Europe. “WHO cautions in order not to exacerbate health inequity and limited availability of the therapy, patients who are non-severe and at higher risk for hospitalisation be treated and those that are severe or critical with seronegative status (those who have not developed natural antibodies against COVID-19 determined through accurate rapid tests) be treated; as these two patient groups are the patients that stand to benefit most from the treatment,” the statement said. The health agency urged Regeneron, which holds the patent, to lower the drug’s price and work on equitable distribution worldwide. It should also share technology to allow for the manufacturing of biosimilar versions, the WHO added. Swiss drugmaker Roche is working in partnership with Regeneron to produce the antibody treatment. Campaigners and public health experts have been urging pharmaceutical companies to lower prices and share intellectual property to ensure coronavirus treatments and vaccines, whose development is often funded by taxpayers, are available to those who need them most regardless of where they live. “It is simply not fair that people living in low and middle-income countries cannot access new COVID-19 treatments that can decrease the risk of death because of pharmaceutical companies’ monopolies and wishes for high returns,” Dr Elin Hoffmann Dahl, Infectious Disease Advisor, MSF Access Campaign, said in a statement. “Casirivimab and imdevimab were only conditionally recommended for COVID-19, but Regeneron has already begun applying for patents. Regeneron should instead set an example for all manufacturers of monoclonal antibodies by putting people’s lives before profits. People everywhere need affordable, sustainable access to lifesaving drugs in this pandemic, as well as in the future. The treatment belongs to a class of drugs called monoclonal antibodies, which have been on the market for decades for many other diseases, including cancers. Each one is tailored to target a particular disease. Regeneron has priced the antiviral cocktail at $820 in India, $2,000 in Germany and $2,100 in the US, and has filed patent applications in at least 11 low and middle-income countries, MSF said, noting that the company had developed the treatment with “significant” public funding and that the manufacturing cost for monoclonal antibody drugs was estimated to be less than $100 a gram when produced at scale.

Donations won’t solve, need to waive IP

Peter Sullivan, 9-24, 21, Lawmakers say Biden must do more on global vaccines, https://thehill.com/policy/healthcare/573713-lawmakers-say-biden-must-do-more-on-global-vaccines Lawmakers say Biden must do more on global vaccines © UPI President Biden is facing calls from lawmakers and advocates to go farther in helping vaccinate the world against COVID-19, even after pledging an additional 500 million doses at a summit on Wednesday. The additional 500 million Pfizer doses for the world that Biden announced at a summit seeking to rally global action on COVID-19 brings the total U.S. commitment to over 1.1 billion doses across this year and next. But some experts say that donating doses is not enough. To truly solve the glaring inequities in global vaccine supply, they say the Biden administration should push vaccine makers to share know-how to allow more countries to make additional doses themselves, and that the government should provide more funding to scale up vaccine manufacturing capacity. “Donations in and of themselves are a drop in the bucket of global need,” said Max Hadler, COVID-19 senior policy expert at the group Physicians for Human Rights. “The scale is so much higher than the scale world leaders are talking about right now,” he added. Groups like Oxfam, Doctors Without Borders, and Public Citizen made similar calls for Biden to do more after the summit. Lawmakers are also joining he push. “This is undoubtedly a step in the right direction, but I urge the President to take bolder action as soon as possible,” Rep. Raja Krishnamoorthi (D-Ill.) said in a statement in response to the announcement of the new donation of Pfizer doses. Krishnamoorthi helped lead a letter from 116 Democratic lawmakers in August calling for including $34 billion in Democrats’ coming $3.5 trillion package to ramp up global COVID-19 vaccine manufacturing and distribution. The package released by the House includes just $2 billion for vaccine manufacturing, though. Krishnamoorthi said in an interview Thursday that he would be working with colleagues to push “very strongly” to try to increase that figure as the Senate works on the package as well. “Administration officials understand, I’m confident, the value of leading on vaccine diplomacy; I just want to inject more scale and urgency into their efforts,” said Rep. Jake Auchincloss (D-Mass.), who also pointed to unspent funds the administration could use to boost vaccine manufacturing, and has called on the U.S. to develop a “Marshall Plan” for global vaccinations. Experts say that it is also in the U.S.’s self-interest to help vaccinate the world, given that as long as the virus continues to spread, new variants that resist vaccines’ protections could develop. Just two percent of the population in low-income countries is vaccinated, according to a tracker from the Kaiser Family Foundation, compared to 65 percent in high-income countries. United Nations Secretary-General Antonio Guterres this week called out the “obscenity” of global vaccine inequities, pointing to “over 90 percent of Africans still waiting for their first dose.” The White House notes that the almost 160 million doses it has already donated are more than have been contributed by the rest of the world combined. “We will continue to do more — share doses, scale manufacturing, invest in vaccines abroad,” White House Press Secretary Jen Psaki told reporters. “You heard the president talk about that. But we also need the world to do more, especially developed economies that can do more to contribute to this effort to defeat the pandemic.” Tom Frieden, the former head of the Centers for Disease Control and Prevention, said in an interview “there’s a lot to like” in what the Biden administration announced at the summit, but the “missing link” in the administration’s plans is forcing vaccine makers to share their know-how. He focused in particular on Moderna, given that it benefited greatly from U.S. taxpayer-funded research at the National Institutes of Health. “It’s got a formula that’s very important for the world,” Frieden said of Moderna. “That formula was bought and paid for by the U.S. taxpayers, and they are refusing to transfer technology to a consortia of manufacturers who could scale up manufacturing much faster than they can.” Frieden, who is now president of the global health nonprofit Resolve to Save Lives, said the Biden administration could use authority under the Korean War-era Defense Production Act, or under the 1980 Bayh-Dole Act, to step in and force Moderna to share its know-how abroad. A White House official said: “We strongly support companies manufacturing vaccines to share in the transfer of technological information.” But the official added that there can be other “limiting factors” complicating the situation. ADVERTISING For example, a Pfizer spokesperson pointed to scarce raw materials, saying, “Right now, virtually every single gram of raw material produced is immediately shipped to our manufacturing facilities.” “It is unrealistic to think that sharing ‘the recipe’ and know-how would immediately solve the supply challenges,” the spokesperson said, while noting Pfizer and other vaccine makers have already been working to ramp up their capacity. Asked about calls to share its know-how, a Moderna spokesperson pointed to a statement the company issued in October, saying it would not enforce its COVID-19-related patents and be willing to license its intellectual property, but specifying that would come down the line in the “post pandemic period.” In perhaps lower-hanging fruit, a bipartisan group of over 30 lawmakers, led by Rep. Susan Wild (D-Pa.), wrote to Biden this week calling for him to “swiftly” set up a process for sharing doses that will go unused in the U.S. with other countries. “Aside from altruism, it makes sense,” Wild said. “This pandemic doesn’t end until we stop it on a global basis.”

Donations won’t solve, need IP waiver

Madhukar Pai, 9-23, 21, , I am a Canada Research Chair of Epidemiology & Global Health at McGill University, Montreal, where I serve as Associate Director of the McGill International Tuberculosis Centre. I did my medical training in India and public health training in Berkeley. My research is mainly focused on improving the diagnosis and treatment of tuberculosis in low and middle income countries. I like to write about global health, technologies of relevance to global health, healthcare delivery challenges in low income countries, and inequities in healthcare. I serve as an adviser to non-profits such as WHO, Stop TB Partnership, FIND, and TB Alliance. I have written for HuffPost, The Conversation, STAT, Devex, Scientific American, Nature blogs, among others, Charity And Good Intentions Will Not End The Covid-19 Pandemic, Forbes, https://www.forbes.com/sites/madhukarpai/2021/09/23/charity-and-good-intentions-will-not-end-the-covid-19-pandemic/?sh=1ba777caf3a8 On the other hand, the problem with this charity-based approach is that rich nations have not delivered on what they already pledged. G7 countries have delivered only 14% of the total vaccine doses they had promised, according to the chief economist of the International Monetary Fund. Vaccination numbers reveal the real story. Although 6 billion vaccine doses have been administered globally, only 2% of people in low-income countries have received at least one dose. Several rich nations are offering third (booster) doses to their citizens, even as 3.5 billion people are waiting for their first dose. This will make it even harder for low- and middle-income countries (LMICs) to access vaccines. Vaccine coverage of population by income HTTPS://PANDEM-IC.COM/ Without widespread vaccination, it is impossible to protect any nation from the catastrophic consequences of the Delta variant, a variant that is highly transmissible and is associated with severe outcomes. India is a case in point. It is estimated that 3 - 5 million excess deaths might have occurred in India during the pandemic. Vaccine charity is not vaccine justice “Yesterday's summit was an important moment to galvanize and reset the global Covid-19 response,” said Elisha Dunn-Georgiou, President & CEO, Global Health Council. “That said, the necessary and immediate approach of donating vaccines will not be enough to end the pandemic. Charity alone is not sustainable and doesn’t help to achieve equity- not only in vaccine access, but in improved health systems and quality health care,” she emphasized. “President Biden in his initial speech to the United Nations stated it would take a “collective act of…political will” to fight this pandemic. Yet such will at the US-hosted COVID-19 summit was nowhere to be found as he and other leaders from wealthy nations continued to commit to ceding control of the limited COVID-19 vaccine supply to select manufacturers that have repeatedly relegated the Global South in vaccine access,” said Reshma Ramachandran, Physician-Fellow at the Yale National Clinician Scholars Program. “Had Biden been serious about ending this pandemic for everyone, everywhere, he would have demonstrated his tremendous capability in compelling the sharing of publicly-funded vaccine technology with other companies standing ready to help vaccinate the world,” she added. “Dose sharing is helpful, but rich countries cannot donate their way out of this crisis as there simply aren’t enough shots to go around,” said Akshaya Kumar at Human Rights Watch. “Without fixing the supply side of this problem, we’ll be stuck pushing this boulder up a hill only to watch it come crashing down once again,” she argued. “Big declaration of vaccines donations are nice statistics,” said Joanne Liu, former president of MSF. “But we need more than statistics - we need vaccines in people’s arms in LMICs,” she added. Silence on IP and technology sharing "It is very disappointing to see an approach that perpetuates a system of reliance on donations,” said Boghuma Kabisen Titanji, an infectious diseases expert at Emory University. “The notable silence on intellectual property (IP) sharing, technology transfer and capacity building to boost local vaccine production in LMICs shows a lack of interest in building a sustainable global response,” she argued. “I would like to see the Biden administration take concrete steps towards helping build regional self-sufficiency with respect to vaccine manufacturing,” said Celine Gounder, an infectious diseases expert at NYU. “You can't vaccinate the world with scarcity. The only way to vaccinate the world is to produce a lot more vaccine. And in building that manufacturing capacity, we should not lose out on the opportunity to build up the manufacturing capacity and know-how around the world so that every region can produce their own supply to protect themselves not only against SARS-CoV-2, but also against future infectious disease threats,” she elaborated. Zain Rizvi at Public Citizen believes the Summit could have been the moment for Biden to marshal the resources of the U.S. government and say how America and its partners would vaccinate the world. “But it was a missed opportunity,” he said. “Developing countries will get dose donations but not knowledge about how to make doses—-charity but not justice. The Biden administration can listen to the calls of the WHO to share doses, share technology, and share intellectual property. There is still time to end the pandemic quickly and prevent another possible wave of death and destruction,” he explained. “With his landmark support of the WTO TRIPS waiver, President Biden had pledged to support the swift transfer of IP to facilitate increased vaccine production and bring equity to global vaccine access,” said Priti Krishtel, co-founder of I-MAK. “This was the right, moral choice that the U.S. must follow through on. Anything less is a distraction,” she added. For the TRIPS waiver to happen, countries need to stop blocking the waiver, said Jason Nickerson with MSF Canada. “We need to not limit our focus to vaccines, but also recognize the importance of newer therapeutics and diagnostic tests that can reduce the number of hospitalizations and deaths,” he said. “The UN is not going to solve vaccine injustice. Neither is COVAX or WHO,” said Sophie Harman, a professor of international politics at Queen Mary University of London. “This only changes if countries are supported to produce their own vaccines. The waiver exists. Group of states need to test it (safety in numbers) & start producing vaccines,” she added. Corporate interests prevail, even during a global crisis “Biden cannot donate his way out of this crisis,” said Asia Russell, Executive Director, Health GAP. “He called for 'all hands on deck,' which should mean no policy option is off the table. But he's lying. In reality, Biden's policy decisions have been constrained by his absolute fealty to Moderna and Pfizer. So he is sitting on his hands, instead of doing what's needed most—compelling drug makers to transfer technology and know how in order to rapidly expand global supply,” she emphasized. Fatima Hassan, director of Health Justice Initiative, expressed her disappointment with the Summit, and spoke about the power that private corporations have. “Biden has again shown that he is deferential to private power and pharmaceutical power,” she said. She gave Moderna as an example. Moderna accepted $2.5 billion in taxpayer money to develop its Covid-19 vaccine. But they are yet to share their technology, or deliver even a single dose to a low-income country. “CEOs are more powerful than Biden, and corporate power is unchecked. We need the Boards of every pharma company to account,” added Hassan. Jason Nickerson concurs. “Throughout the pandemic, governments have relied heavily on the pharmaceutical industry’s “good will” to end the pandemic and demanded too little of them,” he said. “We are being fleeced by Pharma, middle men are making themselves a fortune and even global health leaders are now on an ego trip,” said Ayoade Alakija, co-chair of the Africa Union Vaccine Delivery Alliance. “We have failed to learn the lessons of HIV/AIDS,” she added. “The behavior of powerful states reflects a form of capitalist philanthropy, with no incentive to change the global regime of intellectual property rights,” write Joanne Liu and Ryoa Chung, in their recent article on Capitalist Philanthropy and Vaccine Imperialism. “Our leaders continue to do what is politically expedient, not what is necessary or right to end this pandemic,” said Sanjay Ruparelia, Jarislowsky Democracy Chair, Ryerson University, Toronto. “Pledges mean little if the vaccines are not released or do not arrive in time. And we need to support the IP waiver, to allow developing countries to produce the tests, vaccines, and treatments that our policies have deprived them of,” he added. How will we vaccinate the world? By now, every factory, anywhere in the world, capable of manufacturing vaccines must have been tapped to make the billions of vaccine doses that are needed to vaccinate the whole world. This has not happened, and the Covid-19 Summit did not provide a clear plan to make this a reality. So, while the goal of fully vaccinating 70% of the world’s population by next year is critically important, we must keep pushing leaders for more than pledges and goals. If rich countries continue to hoard vaccines, undermine COVAX, administer booster shots, block IP waiver, and avoid putting pressure on pharma companies to share vaccine technology, it is unlikely that the pandemic will end anytime soon. Without adequate vaccination, the delta variant will continue to have devastating consequences, especially in LMICs, where fragile health systems are falling apart, extreme poverty is rising, and millions have died already. World leaders, pharma companies, donors and partners have a once-in-a-century opportunity to show leadership and do the right thing. Will they do it, before it’s too late?

IPR waiver undermines cancer cures

Andrew Spiegel, 9-23, 21, How the COVID IP waiver could sabotage crucial cancer research, https://www.logandaily.com/comment/columns/how-the-covid-ip-waiver-could-sabotage-crucial-cancer-research/article_4f06ff17-d3b4-539a-a130-4e3512c1d3bb.html President Biden craves a cure for cancer. In a speech to Congress this spring, he vowed to “end cancer as we know it.” And as vice president, he helped start the Cancer Moonshot initiative. Yet by giving his backing to a global waiver of intellectual property rights for COVID-19 vaccines, President Biden may have endangered millions of Americans living with cancer. The Biden administration has said that it would join a World Trade Organization move to suspend IP safeguards for the vaccines. Its intentions are no doubt sincere, founded in the belief that a waiver will help rid the world of Covid. Yet the setting aside of IP protections has consequences that the administration seems to have overlooked. If adopted, the waiver won’t galvanize the supply of vaccines bound for the developing world – certainly not in the immediate term. What it will do is threaten scientific innovation that could lead to cures for cancer and other diseases. 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.

Pandemic will be over in a year

Reuters, 9-23, 21, Moderna chief executive sees pandemic over in a year – newspaper, https://news.trust.org/item/20210923052810-q5d40 ZURICH, Sept 23 (Reuters) - Moderna Inc Chief Executive Stéphane Bancel thinks the coronavirus pandemic could be over in a year as increased vaccine production ensures global supplies, he told the Swiss newspaper Neue Zuercher Zeitung. "If you look at the industry-wide expansion of production capacities over the past six months, enough doses should be available by the middle of next year so that everyone on this earth can be vaccinated. Boosters should also be possible to the extent required," he told the newspaper in an interview. Vaccinations would soon be available even for infants, he said. "Those who do not get vaccinated will immunize themselves naturally, because the Delta variant is so contagious. In this way we will end up in a situation similar to that of the flu. You can either get vaccinated and have a good winter. Or you don't do it and risk getting sick and possibly even ending up in hospital." Asked if that meant a return to normal in the second half of next year, he said: "As of today, in a year, I assume." Bancel said he expected governments to approve booster shots for people already vaccinated because patients at risk who were vaccinated last autumn "undoubtedly" needed a refresher. Its booster shot had half the dose of the original dose, which meant more of them would be available. "The volume of vaccine is the biggest limiting factor. With half the dose, we would have 3 billion doses available worldwide for the coming year instead of just 2 billion," he said. The composition of the booster shot remains the same as the original for this year because Moderna had not had enough time to change it. "We are currently testing Delta-optimized variants in clinical trials. They will form the basis for the booster vaccination for 2022. We are also trying out Delta plus Beta, the next mutation that scientists believe is likely." Moderna can use existing production lines for the new variants as for the original COVID-19 vaccine. The price of vaccination will stay the same, he said. (Reporting by Michael Shields Editing by Robert Birsel)

Pandemic will be over in a year

Reuters, 9-23, 21, Moderna chief executive sees pandemic over in a year – newspaper, https://news.trust.org/item/20210923052810-q5d40 ZURICH, Sept 23 (Reuters) - Moderna Inc Chief Executive Stéphane Bancel thinks the coronavirus pandemic could be over in a year as increased vaccine production ensures global supplies, he told the Swiss newspaper Neue Zuercher Zeitung. "If you look at the industry-wide expansion of production capacities over the past six months, enough doses should be available by the middle of next year so that everyone on this earth can be vaccinated. Boosters should also be possible to the extent required," he told the newspaper in an interview. Vaccinations would soon be available even for infants, he said. "Those who do not get vaccinated will immunize themselves naturally, because the Delta variant is so contagious. In this way we will end up in a situation similar to that of the flu. You can either get vaccinated and have a good winter. Or you don't do it and risk getting sick and possibly even ending up in hospital." Asked if that meant a return to normal in the second half of next year, he said: "As of today, in a year, I assume." Bancel said he expected governments to approve booster shots for people already vaccinated because patients at risk who were vaccinated last autumn "undoubtedly" needed a refresher. Its booster shot had half the dose of the original dose, which meant more of them would be available. "The volume of vaccine is the biggest limiting factor. With half the dose, we would have 3 billion doses available worldwide for the coming year instead of just 2 billion," he said. The composition of the booster shot remains the same as the original for this year because Moderna had not had enough time to change it. "We are currently testing Delta-optimized variants in clinical trials. They will form the basis for the booster vaccination for 2022. We are also trying out Delta plus Beta, the next mutation that scientists believe is likely." Moderna can use existing production lines for the new variants as for the original COVID-19 vaccine. The price of vaccination will stay the same, he said. (Reporting by Michael Shields Editing by Robert Birsel)

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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