“Our proposal relies on solidarity,” proclaimed Costa Rican President Carlos Alvarado Quesada on May 15, describing a World Health Organization-backed proposal put forth by his government for the pooling of research data, know-how, and intellectual property in the quest for a COVID-19 vaccine. Solidarity may seem like an obvious approach during a pandemic. But in health systems reliant on pharmaceutical monopolies and the patent system that upholds them, it’s actually a radical one. Americans have become increasingly familiar with the industry’s self-serving tactics over recent years, thanks to a slew of domestic controversies ranging from the opioid addiction crisis to the kind of price gouging that has greatly impaired access to insulin and has made Martin Shkreli a household name.
The first weeks of the pandemic immediately highlighted the distorting incentives of this kind of monopoly power in the delivery of essential health products, but on a global scale. And during a pandemic, the issues caused by patents go beyond pricing. The existing system leads to shortages of other life-saving goods, as individual patent holders normally do not possess the necessary manufacturing capacity to produce a given product at the scale needed. Thus the incentive is strong for countries to place national interests above the international solidarity necessary in times of global crisis.
For example, wealthy countries moved immediately to hoard facemasks and personal protective equipment. The Trump Administration apparently attempted to purchase the German company CureVac, in the hopes that, should their vaccine prove successful, Americans would have first dibs. Meanwhile, the pharmaceutical company Gilead, already well known for the exorbitant initial listing price of its hepatitis C drug Sovaldi ($84,000 per treatment), applied for, and obtained, “orphan drug” status for remdesivir, then seen as one of the more promising treatments for COVID-19. This status is reserved for medications treating rare diseases and provides additional market exclusivity. The company later withdrew the application, but only after enormous public pressure and uproar.
Things didn’t always work this way. Jonas Salk famously refused to patent the polio vaccine or earn any money from his discovery. When the vaccine entered the market in 1955, there were 450,000 cases of polio in the United States. By 1962, there were 910. He remains a potent symbol of medical research in the service of humanity over profits. And as Merrill Goozner chronicled in Democracy in 2019, the man who discovered insulin was imbued with a similar spirit. Frederick Banting, winner of the 1923 Nobel Prize for Medicine, famously declared that insulin “belongs to the world, not to me,” as he handed his cash prize to one of his co-inventors. His co-inventors, in turn, sold the drug to the University of Toronto for all of $1. Meanwhile, at the international level, trade was regulated by the GATT, which was established in 1947 with the goal of reducing or eliminating quotas or tariffs, but intervened little in matters of intellectual property, including patents for medicines.
Thinking began to shift in the early 1980s, with the introduction, domestically, of the Bayh-Dole Act, allowing third parties (i.e. pharmaceutical companies) to acquire government-funded research for medications. Internationally, by 1995 the GATT had morphed into the World Trade Organization. Meanwhile, the TRIPS Agreement, or the Trade-Related Aspects of Intellectual Property Rights, which the WTO was to administer, was entered into force. This introduced mandatory IP protection among member states, including for medicines.
Ever since, a debate has raged over the proper balance between the incentivizing power of patents for innovation and the monopolies that have limited access to medications, particularly in low- and middle-income countries. Patents helped to produce a number of blockbuster drugs for diseases mostly prevalent in wealthy countries during the 1990s, such as Lipitor for the prevention of cardiovascular disease and Rituximab, used to treat certain types of cancers and autoimmune diseases.
Yet in the early 2000s, the industry’s reputation took a massive hit when millions died unnecessarily across the African continent due to the exorbitant pricing of HIV/AIDS medications, which the patent system made possible. The damage was enough to stir up debate about the proper balance between IP protection and global public health needs, including at the WHO and WTO. To deflect from these discussions and this growing challenge to its patent regime, the pharmaceutical industry realized it desperately needed to recover its image through some form of concession. In 2000, for example, five pharmaceuticals companies put together the Accelerating Access Initiative, offering some discounted HIV medicines to low-income countries—although still at much higher prices than generics.
In 2001, low-income WTO members unsurprisingly still pushed for the adoption of the Doha Declaration on the TRIPS Agreement and Public Health. This declaration clarified “that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health,” and reaffirmed the use of certain flexibilities in the system to enhance access to essential medicines, including parallel importation as well as the use of compulsory licenses by national governments. A compulsory license allows for third-party domestic generic production without the consent of the patent holder in times of need. Countries around the world, including Brazil and Thailand, successfully began making use of such flexibilities to ensure access to antiretroviral drugs for HIV/AIDS patients.
This reckoning was not great enough, however, for the industry to stop pursuing many morally tenuous practices. These include unnecessarily extending patent terms as well as working to ease the conditions for patentability, allowing companies to generate great profits with little innovation, at the expense of patients. The system has also failed when it comes to “neglected” and “tropical” diseases, most common in developing and least-developed countries, for which profit margins are low or non-existent. Meanwhile, copious amounts of R&D funds are provided to these companies by our taxpayer dollars through national governments, international organizations, and teaching institutions, while companies experience soaring profits.
In recent years, these practices have become increasingly recognized and condemned not only by health experts and activists, but also by the public at large. By the time the pandemic hit, the pharmaceutical industry, and the patent system, were ripe for another reckoning. Whether they will face one remains to be seen. Following criticism from public advocacy groups, health experts, and some politicians, as well as negative media coverage, the industry and the governments that defend it began doing what they could to show the world that they would not repeat the mistakes of the HIV/AIDS pandemic, that they would focus on a strategy of global solidarity.
One of the most prominent symbols of this supposed commitment has been the Access to COVID-19 Tools Accelerator, headed by the WHO. The Accelerator sets up a partnership of global stakeholders with the stated goal of rapid and equitable development and distribution of health technologies. Notably, the Accelerator’s call to action also points out: “We remember lessons from the past, which have shown that even when effective tools are available to the world, too often some are protected, while others are not. This inequity is unacceptable—all tools to address COVID-19 must be available to all.”
At its May 4 launch, pledges for collaboration were made by a number of important players, including countries like France, Germany, and the UK, as well as organizations like the United Nations, the Bill and Melinda Gates Foundation, and GAVI—the vaccine alliance based in Geneva, which currently helps fund vaccines in 73 lower-income countries. Also involved, notably, was the International Federation of Pharmaceutical Manufacturers Associations. Although President Trump has completely forgone any pretense of international solidarity, other important global leaders like Angela Merkel and Emmanuel Macron went so far as to refer to an eventual vaccine as a “global public good.” As one part of this effort, the WHO revealed a plan on June 26 to purchase 2 billion doses of COVID-19 vaccines for the world’s “highest risk populations.” It would require, however, $11.3 billion in funding and purchasing commitments from high- and upper-middle income countries. Yet, as good as this may sound, unlike Costa Rica’s proposal, the Accelerator unfortunately also follows the usual pattern of providing copious amounts of public and outside funding while refusing to impose concrete demands on patent holders.
It is, therefore, President Alvarado’s global pool, also supported by the WHO, which has generated the greatest excitement among activists looking for deeper changes in the system. This proposal would demand actual enforcement measures from industry. The proposal, now known as the COVID-19 Technology Access Pool (C-TAP), was officially launched during a Solidarity Call to Action on June 1. Its supporters include UNITAID, UNAIDS, as well as the Medicines Patent Pool (MPP). The MPP was created in 2010 by the United Nations, along with the WHO, in order to encourage the licensing of essential medications for low- and middle-income countries. It provides a potent model, although on a smaller scale, for the pooling of research data for medicines. This data, along with that of the UN Technology Bank, is currently being drawn upon for use by C-TAP. As Peter Maybarduk, director of Public Citizen’s Global Access to Medicines Program explains, “This is why WHO leaderships is so important. The WHO gets it. The WHO C-TAP says: Put your knowledge in the pool and everyone can produce. Otherwise we’re just relying on whatever corporation is holding the IP for the vaccines that prove effective, and they will do what’s in their financial interest.”
It is not surprising, however, that we’ve seen pushback against C-TAP from many of the same players who so enthusiastically pledged their commitment to the Accelerator. This includes, of course, the pharmaceutical industry, which met before the Call to Action, during a press briefing organized by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) on May 28. Pharmaceutical CEOs were unanimous in their dismissal of the plan. Also absent from the Solidarity Call to Action were the same leaders who have been espousing their great belief in solidarity, including both Merkel and Macron. Finally, many important global health players, those with strong ties to industry, like the Coalition of Epidemic Preparedness Innovations (CEPI), a private-public partnership based in Norway—created, incidentally, after countries failed to respond properly to the Ebola crisis—have also been reluctant to endorse the pool.
But a system that relies solely on assurances of goodwill from pharmaceuticals will always be less than ideal in combatting global (or domestic) health challenges. In May, Gilead licensed remdesivir voluntarily to generic companies in India, Pakistan, and Egypt in order to produce on a larger scale, yet the agreement it came to still excludes about 70 countries and half the world’s population and much of this production is only just getting started. Most notably, in a potentially unsettling precedent, on June 29, Gilead settled on an agreement with the U.S. government for the distribution of remdesivir. Its price was set at $520 for one vial, or $3,120 for a course of treatment, despite about $700 million in NIH funding. Meanwhile, the agreement also prioritizes American patients. They alone will receive the drug exclusively through September, locking out the entire rest of the world. If deals like this become the template for distributing one or several vaccines, we could very well witness a response not unlike that which we saw at the beginning of the pandemic, one characterized by nationalistic hoarding and shortages.
Swiss company AstraZeneca is currently working, alongside Oxford University, on what many would consider one of the more promising deals to date. Despite not yet knowing the efficacy of the vaccine, production has already begun with the final goal of producing 2 billion doses. This would be accomplished thanks to a deal struck with India’s Serum Institute, one of the country’s largest manufacturers. Although 2 billion may sound like a lot, as Public Citizen’s Maybarduk notes, “What’s enough doses for the United States? Is it 330 million? Maybe it’s 600 million doses. Maybe it’s a billion doses of the first three vaccines that are produced, which could easily be the entire supply for the first couple of years and the entire world would just have to wait. So the difference between when the first person gets it and when the last person gets it, that could be several years.”
It’s still, in other words, a far cry from the kind of “people’s vaccine” that rescued us from polio. “Jonas Salk is, you dedicate it to humanity,” Maybarduk says. “The Oxford example is, we partner with companies that can produce at large scale for hopefully a good sector of the world’s population. But it’s still pretty limited. It’s better than what the other companies are doing, but it’s not dedicating it to humanity.” The company has also worked out agreements that could lead to nationalistic hoarding, and that may benefit wealthy countries to the detriment of the rest of the world. So far, it has fashioned individual deals to supply 300 million doses to the United States and 100 million to the UK by September if their August trials are successful. A European four-country vaccine alliance, known as the Inclusive Vaccine Alliance, has secured a promise of 400 million doses. It is no wonder, then, that it is low-income countries like Barbados and Mozambique that are the most enthusiastic supporters of C-TAP.
By failing to enforce the pooling of global research, and thus the sharing of all existing data and knowledge worldwide, we may also be causing important delays in the vaccine’s very discovery. As Maybarduk explains, “If you share the tech and know-how, if we teach the world how to make the vaccine, more people will get it quickly. And in a pandemic, that’s everything. Delay is not acceptable. Delay is the path we’re on today.” Yet, it doesn’t have to be this way, he says. Much of what happens during and post-COVID with regard to pharmaceutical monopolies rests on if, and how much, governments may finally be willing to intervene, and what they will require of the industry in exchange. Although it is almost certain not to happen, should the United States and Europe suddenly throw their support behind C-TAP, the current landscape for COVID-19 drug development would be radically altered.
At a national level, Senator Elizabeth Warren and Representative Jan Schakowsky have introduced the COVID-19 Emergency Manufacturing Act, which would allow the government to publicly manufacture protective equipment, drugs, and other medical supplies or to contract with other manufacturers to do so, scaling up production capacity. Two other important pieces of proposed legislation were introduced in late June, the MMAPP Act by Schakowsky and the Track Act by Representative Lloyd Doggett. The former would put in place a number of protections against pharmaceutical price gouging, while the latter would create a database of federal financial support for COVID-19 R&D, as well as making public the terms of any deals between the federal government and PhRMA. A recent FOIA investigation by activist group Knowledge Ecology International found that several government contracts with pharmaceutical companies researching COVID-19 drugs fail to enforce affordability and availability for new drugs, further highlighting the importance of this kind of legislation if we are to avoid the vaccine being doled out in the same manner as remdesivir.
It is also important to note that the vaccines currently being shortlisted by Trump’s “Operation Warp Speed” program will all have been developed and produced with large amounts of public funding. This is particularly true in the case of American company Moderna, which is developing potentially one of the more promising coronavirus candidates this side of the Atlantic. According to a recent Public Citizen report, federal scientists did more than lay out the basic research. They helped design and test the vaccine, working jointly with Moderna over several years. In fact, the NIH may actually have filed patents covering significant elements of this vaccine. And according to agreements between the NIH and Moderna, it seems likely that they maintain joint ownership. The company has claimed that it “is not aware of any IP that would prevent us from commercializing our product candidates.” But co-owning the vaccine would make it easier than usual for the agency to intervene. In other words, should Moderna be the first to succeed, but refuse to ensure its vaccine’s affordability or global availability, the U.S. government would have the legal right to step in. And it should.
Industry CEOs are continuing to make the argument for accelerated FDA approval, the use of digital medicine, or the use of shared clinical trial protocols to deflect from the need for broader changes to the patent system. The industry has also gone on the offensive when it comes to advertising. A Harris Poll conducted in mid-May found that COVID-19 had created a more positive view of the pharmaceutical industry among 40 percent of the population. It was also observed that those with a more favorable view had, by a margin of 20 percent, been exposed to more advertising from the industry.
Should the pharmaceutical industry be successful in convincing the world they are indeed the heroes of the story, simply by putting out safe and effective treatments for American patients, the American public could remain mostly in the dark about what delays were created or opportunities were missed along the way by eschewing a system of open knowledge on medicines. They could also remain in the dark about just how much it was actually public money and government scientists that were responsible for developing a vaccine. Alternatives to the existing monopoly system, those promoted by health groups including Doctors Without Borders, politicians like Bernie Sanders, and economists from Joseph Stiglitz to Mariana Mazzucato—including pools, prize funds, grants, or even government-run agencies—could remain on the margins of public debate. Yet should the pharmaceutical industry fail in this endeavor, the world is watching. The patent-based system that has too often locked away knowledge to the detriment of our health could be cracked open, and alternative mechanisms for acquiring and sharing life-saving knowledge may finally see the light of day.