HIV/AIDS emerged as a major public health crisis in the 1980s. By the end of the decade, pharmaceutical manufacturers, in collaboration with academic researchers, had developed a series of new treatments to combat the virus. The treatments were effective.
They were also expensive. Many countries in sub-Saharan Africa, where HIV spread widely, strained their national budget to pay for the drugs. “If there was a better developed generic market for these products, it could have saved many peoples’ lives,” the medical historian Joseph M. Gabriel told me. Major pharmaceutical companies and their enablers labelled efforts to produce cheaper generic versions of HIV/AIDS drugs as “piracy,” and sued to protect their “intellectual property”—and deprive millions of people of cheap access to the medicine.
In December 2020, Pfizer, a multinational pharmaceutical company, and BioNTech, a biotech company based in Germany, obtained an emergency-use authorization for their Covid-19 vaccine from the U.S. Food and Drug Administration. As of December, 96% of Pfizer’s supply was purchased by rich countries representing less than 15% of the world population. At the same point, Moderna, another vaccine producer, had sent 100% of its supply to rich countries. AstraZeneca and Oxford University allocated 64% of their vaccine supply to developing nations, enough to vaccinate only 18% of the world population in the next year.
Many vaccine producers have made a show of their generosity—with immense benefits to their public reputations—but there is much reason for skepticism. Moderna announced it would no longer enforce patents on its Covid-19 vaccine. And yet, the humanitarian organization Doctors Without Border warns that, despite this pledge, the company could still protect “know-how, technology, and other components of vaccine development and manufacturing… under IP rules.” And the company has announced its plans to profit from its vaccine. AstraZeneca, for its part, has promised in multiple agreements that it would not profit off of its vaccine during the pandemic. Yet, its deal with Oxford University still allows it to take a 20% profit margin and grants it the ability to “end” the pandemic as it wishes simply by judging the pandemic to have concluded, thereby terminating those legal agreements. This could happen as early as July of this year.
Corporate interests have perpetually hindered efforts to achieve universal, quality healthcare in both developed and developing countries. Patent protections are one of the biggest stumbling blocks in the quest for healthcare equity. During the Covid-19 pandemic, as during the HIV/AIDS crisis, pharmaceutical companies are poised to prioritize profits over people by invoking intellectual property rights—despite their PR-minded assurances to the contrary. Millions more will die if we continue to treat intellectual property rights as more important than universal access to a publicly-funded vaccine. Instead of coddling the pharmaceutical industry and allowing drug companies to make obscene profits from publicly-funded research, governments should suspend intellectual property rights and demand that Covid-19 vaccines be made free and universal.
In the mid-19th century, prior to the American Civil War, physicians and reputable manufacturers considered patenting medical products to be unethical. Medical knowledge, once discovered, was deemed property of the public rather than the manufacturer, and according to Gabriel, the medical community saw monopolizing life-saving drugs for self-serving purposes as a form of quackery. In promoting high drug prices and encouraging competition among researchers, patents were seen as undermining the basic commitments of science, wrote Gabriel:
“[Orthodox physicians] described medical science as a benevolent process based on personal sacrifice, proper character and conduct, and the sharing of information among peers. Commercialism was thus juxtaposed to the supposedly gentlemanly character of the physician, and the open circulation of knowledge about healing goods within the medical community was central… to the conduct of medical science.”
This widespread “anti-patent” sentiment, which understood medicine as transcending commercial interests, was integrated into many prohibitions of patented products or items made with secret ingredients. In 1847, the newly founded American Medical Association’s (AMA) Code of Ethics stated, it is “derogatory to professional character for a physician to hold a patent for any surgical instrument, or medicine… whether it be the composition or exclusive property of himself, or of others.”
As a result of pressure from physicians, U.S. drug manufacturers generally adhered to the orthodox ethical standards of their day: they did not use patents, secret ingredients, or public advertisements, and they avoided the commercial promotion of products before the medical community approved them.
But as medicine became more chemically complex toward the end of the 19th century, the prevailing thinking around patents began to change. Chemical manufacturers, unconcerned with orthodox medical ethics, began releasing patented medical products while advertising them to the public. Foreign manufacturers likewise introduced medical products—which were often effective—with little concern for the distinction between science and commerce, wrote Gabriel. And U.S. manufacturers struggled to protect the increasingly significant investments they put into researching and developing new drugs. Some reformers in the medical community argued that patents actually resulted in better manufacturing standards. In 1912, the AMA ended their prohibition of physicians holding patents.
In today’s world, patents prevail. By controlling their “intellectual property,” pharmaceutical companies maintain exclusive rights to their drugs for at least twenty years. This means generic drug manufacturers cannot produce the medicines at lower prices without risking lawsuits or penalties in court. Moreover, in countries like the U.S., governments do not leverage their power to bargain with pharmaceutical companies to control prices. And even after patent protections lapse, pharmaceutical companies engage in “patent evergreening,” a process by which they file patents for additional, small changes to their drugs to lengthen monopolies and prevent the production of generic versions.
Patent protections are highly correlated with astronomically high drug prices. Researchers at MIT and Boston University found that for some cancer-treating drugs, prices dropped around 38-48% after patent protections expired. The deleterious effects of these high drug prices are well-documented. As of 2016, Americans with type 1 diabetes spent an average of $5,705 annually on insulin. Many working-class people must ration the drug, which can lead to diabetic ketoacidosis and other fatal complications. 2.2 million heart disease patients in the U.S. ration their medication annually, according to one study from Yale. The researchers found that this practice was especially common among women, those without health insurance, younger adults, and those that earn lower incomes.
The regime of astronomical drug prices has impacted developing countries in an especially dangerous way. Doctors Without Borders often cannot provide for its patients simply because drugs are too expensive or are no longer produced, both of which are a direct consequence of patent protections.
Patent protections are not just a problem in themselves, of course, but are also the product of a perverse effort to reconcile medicine to the profit motive. In the shadow of colonialism, developing regions without access to basic sanitation struggle with neglected tropical diseases like Hansen’s disease (leprosy), dengue fever, and cysticercosis. The Drugs for Neglected Diseases initiative (DNDi) does heroic work treating NTDs, but can only do so much in the absence of meaningful industry support. “A large number of big pharma companies have abandoned the field of infectious disease,” DNDi executive director Bernard Pécoul told a reporter. “Companies concentrate on the market that is attractive in terms of profit.”
Even in the United States, easily curable diseases plague communities that can’t afford to pay high drug prices. Residents of Lowndes County, Alabama, where 72 percent of people are Black and more than a third live below the poverty line, struggle with hookworm. In one study, one in three residents tested positive for traces of the intestinal parasite.
The treatment, two tablets of albendazole, can kill hookworm in a matter of days, and, notably, the patent for albendazole has expired. The drug costs four cents in Tanzania. Yet in the U.S., it costs $400. Since the parasitic disease is concentrated in low-income areas of the United States, drug companies see little profit potential in the drug and have ceded the market to Impax Laboratories, which, as the only manufacturer of albendazole, can charge whatever price it wants.
Researching vaccines is a pricey endeavor, but billions of dollars in funding from governments, nonprofit organizations, and the private sector allowed manufacturers to start making Covid-19 vaccines even before they knew of their efficacy—which, given the financial risks, would never happen with other drugs.
As researchers and manufacturers produced the Covid-19 vaccines in record time, developing countries have proactively tried to prevent the inequities that have defined global pharmaceutical production in the past. India and South Africa have petitioned the World Trade Organization to waive patent protections—thus allowing manufacturers to produce affordable, generic versions of the vaccines. “An effective response to the Covid-19 pandemic requires rapid access to affordable medical products,” says their proposal, known as the TRIPS Waiver. Of the WTO’s 164 members, one hundred support the proposal. Doctors Without Borders has defended the proposal as well and has called on governments and the pharmaceutical industry to “put lives over profits.” Yet the WTO, which has its “decisions taken by consensus among all member governments,” has declined to act on the petition. Unsurprisingly, high-income stakeholders such as the US, Japan, the UK, the EU, and Canada—whose governments have purchased nearly all of Pfizer and Moderna’s supply—have refused India and South Africa’s proposal.
The TRIPS waiver model has been proven to work. In May 2020, Gilead Sciences, a California-based pharmaceutical company, signed licensing agreements with five generic manufacturers in India and Pakistan to produce remdesivir, a drug used in treating Covid-19. The licensing agreements allowed these companies—Cipla, Hetero Labs, Jubilant Lifescience, Mylan, and Ferozsons—to reproduce generic versions of the drug in 127 countries. Not only has this resulted in steady supplies of remdesivir in many developing countries, but these supplies have come at a cheaper price, too. Before we shower Gilead in praise, remember that the company’s greed still leaves nearly half of the world’s population to pay remdesivir’s monopolized price.
In response to the TRIPS Waiver proposal, Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), wrote that it is “unclear” how suspending intellectual property rights will achieve a fair distribution of the vaccine. What certainly is clear, however, is that protecting intellectual property rights only safeguards pharmaceutical companies’ profits. What should we seek to prioritize: saving vulnerable lives or satisfying pharmaceutical companies’ greed amidst a pandemic?
And in any case, Cueni’s statement doesn’t stand up to scrutiny. Two decades ago, certain countries ultimately waived intellectual property rights for HIV/AIDS drugs, saving millions of lives, according to Doctors Without Borders. Suspending all intellectual property rights would end monopolization on Covid-19-related medical products, and “overriding monopolies on Covid-19 medical tools will allow global collaboration to scale-up manufacturing, supply, and access for everyone,” said Dr. Khosi Mavuso, Doctors Without Borders’ South Africa representative. “Governments cannot afford to waste any more time waiting for voluntary moves by the pharmaceutical industry.” (Via the Covid-19 Technology Access Pool founded by the World Health Organization, companies can donate their knowledge, patents, and technology. However, no pharmaceutical company has chosen to do so willingly.)
When developed countries turned down India and South Africa’s proposal, they expected developing countries to resort to compulsory licenses—by which a government requires a manufacturer to license the rights to produce a drug in question to other companies. While this method does make it easier to produce generic vaccines, there are flaws to the approach, Gabriel told me. Many countries don’t have laws regarding compulsory licenses, and the specifics vary significantly depending on the national government, specific policies, and manufacturers involved.
Another avenue to more equitably supply the vaccine is Covax, a program developed by the WHO, Unicef, the World Bank, and the Bill & Melinda Gates Foundation that works to secure and equitably distribute 2 billion doses and support on which sixty-seven countries rely. Yet Covax only has enough doses to vaccinate 10% of those sixty-seven countries’ populations, according to Oxfam International. Without resources in the Technology Access Pool and Covax, and given the convoluted nature of compulsory licenses, suspending intellectual property at the level of the WTO is crucial.
And then there is the fact that many of the Covid-19 vaccines are publicly funded—rendering any pharmaceutical industry claim to vaccine-related intellectual property rights that much less compelling. We’re paying for the vaccines, and curiously enough, we’re paying to buy them back. According to the New York Times, Moderna received $2.5 billion from the government for research purposes and preorders, where 100% of research costs were covered. Moderna also received support from the National Institutes of Health (NIH), a government-funded organization, and multiple vaccines’ central technology was developed by the NIH’s scientists. The United States and the EU have given AstraZeneca more than $2 billion, Pfizer has received $6 billion from American and European purchases, and BioNTech has received $455 million in grants from the German federal government. USA Today reported that total government funding for the vaccine has surpassed $9 billion. If massive amounts of taxpayer money fund vaccine development, shouldn’t all intellectual property rights be publicly owned?
“Now that we have tools to end the pandemic, what if they aren’t distributed fairly?” asked Cueni. “My colleagues in the pharmaceutical industry share this worry.” It is hard to take this statement seriously. The pharmaceutical industry can enable generic manufacturers to efficiently vaccinate people in rich and poor countries alike—if it so chooses. Wealthy governments can specify, in their billion-dollar deals, the suspension of intellectual property rights—if they so choose. Yet they have not thus far. Forced to choose between profits and preventing millions of deaths, Big Pharma and the governments of the developed world have made their values clear. ▩
