An expert's point of view on a current event.

Don’t Let Drug Companies Create a System of Vaccine Apartheid

To avoid repeating the pitfalls of the HIV/AIDS crisis, governments and the WTO must make COVID-19 vaccination a public good by temporarily waiving intellectual property rights and compelling emergency production.

South African trial volunteers wait for a potential vaccine against COVID-19
South African trial volunteers wait for a potential vaccine against COVID-19 at the Baragwanath Hospital in Soweto, South Africa, on June 24, 2020. SIPHIWE SIBEKO/POOL/AFP via Getty Images

It has been over one year since the World Health Organization issued a Public Health Emergency of International Concern declaration for COVID-19. Yet despite pledges of solidarity and mutual cooperation from world leaders and diagnostic and therapeutic manufacturers in 2020, everyone’s worst fears about the absence of genuine solidarity in this health crisis have materialized.

Globally, some 100 million people have become ill with COVID-19, and over 2 million have died. Due to multiple political factors, including the hoarding of supplies and knowledge, the world now faces the very real possibility of not achieving global population immunity anytime soon—at a time when new variants and strains are emerging, effectively disrupting health systems, lives, and livelihoods everywhere.

And yet, while the United States and many rich countries are beginning to attempt to bring their epidemics under control through the deployment of highly effective vaccines, Africa currently has little actual access to COVID-19 vaccines. This is eerily similar to the HIV/AIDS epidemic and crisis of access in the late 1990s and early 2000s, when the diagnostic and therapeutic tools to save millions of lives were there, but the will to share them was not—until activists all over the world stepped in.

Today’s situation is eerily similar to the HIV/AIDS epidemic and crisis of access in the late 1990s and early 2000s, when the diagnostic and therapeutic tools to save millions of lives were there, but the will to share them was not.

This month, the WHO also stated that globally, the number of COVID-19 vaccinations has now overtaken the number of reported infections. But, the organization reports, “more than three quarters of those vaccinations are in just 10 countries that account for almost 60% of global GDP.”

Around 130 countries, home to 2.5 billion people, had yet to administer a single vaccine dose as of Feb. 5, while, the WHO reports, “some countries have already vaccinated large proportions of their population who are at lower risk of severe disease or death.” This vaccine nationalism will therefore result in many countries without widespread access to vaccines until 2022 or even 2023, prolonging the pandemic and potentially causing as much as $9.2 trillion in global economic damages.

COVAX, the public-private partnership established to offer subsidized vaccine doses to poor countries (and to some self-financing middle-income nations), is run by Gavi, the Vaccine Alliance—a private foundation. Gavi indicates that only about 27 percent of the developing world’s most vulnerable populations are likely to benefit from COVAX vaccines by the end of 2021, further delaying the possibility of global population immunity anytime soon.

No rich country would accept a notion that only 27 percent of its population would benefit from a vaccination mechanism that is meant to pool supplies, and the rest of the world should not stand for it. In South Africa—where many of the front-runner vaccine candidates  have undergone trials—the first health care worker received a shot on Feb. 17, more than two months after Britain began vaccinating seniors.

A pernicious form of vaccine apartheid has emerged—characterized by prioritizing access for some countries and for some people, largely based on wealth and geography, and, in turn, resulting in a mostly self-created global supply crisis. In the middle of a global pandemic, this means that no one is safe. The project of global population immunity is now at risk.

Today’s crisis is a tragic repetition of the early years of the AIDS pandemic, which was also characterized by a lack of widespread access to affordable life-saving medicines resulting in avoidable death and suffering. The access-to-medicine movements of the late 1990s and early 2000s in countries such as Brazil, India, South Africa, and Thailand led to a direct confrontation with local and global patent regimes and, in turn, the multinational corporations holding patents.

These movements mainly focused on affordability and pricing; the ability to import generic versions; and the ability to legally rely on multiple suppliers simultaneously. As the world saw then, health care innovation and research will not reach those who are poor or uninsured unless direct action is taken. And while advances were made then, millions of Black and brown people and workers still need better access to diagnostics, PrEP (pre-exposure prophylaxis), and antiretroviral therapy—even today.

The vaccine shortage is deeply rooted in a global order that prioritizes intellectual property protection even in a time of a grave public health crisis.

The difference, of course, with COVID-19 is the current scarcity of vaccine supplies. Whereas with HIV/AIDS generic versions of antiretroviral drugs were available, their distribution was precluded by monopoly power and patents. (And in South Africa, the Thabo Mbeki government’s science denialism prevented widespread access for a long time.)

Today, vaccine access is limited for the very same underlying reasons: markets and patents. These reasons are deeply rooted in a global order that prioritizes intellectual property protection even in a time of a grave public health crisis. Rather than reciting tired pledges to respect intellectual property, it is time for governments to impose state licensing and other compulsory measures to firm up explicit cooperation and technology sharing given that there is no time to waste, especially governments that co-funded and co-developed front-runner vaccine candidates.

The world must not make the same mistakes of the AIDS crisis. The pandemic response should not have to rely on voluntary cooperation but urgent wartime measures, including compulsory ones.

The gap in equitable global coverage and African nations’ limited access to available supplies is in large part due to the fact that richer nations had placed multiple individual orders with multiple pharmaceutical companies as well as with COVAX, through advanced market commitments before clinical outcomes were available; these companies also agreed to serve some markets and countries before others, with limited timely sublicensing arrangements.

These one-sided and often nontransparent contracts are not rooted in any epidemiological or sound public health approach and are very similar to the disparities in access to antiretroviral drugs to treat HIV in the late 1990s and 2000s.

As with HIV/AIDS, patent monopolies are determining which countries will get access to certain vaccines, which companies will manufacture supplies, which regions will be prioritized, and which populations will benefit first. Governments that were in the driver’s seat negotiating with public institutions, using public funds with companies to accelerate important vaccine research last year, turned a blind eye to the need for equitable access, affordability, and manufacturing scale-up, and focused instead on narrow national supplies.

Despite initial commitments of global solidarity, vaccine nationalism is a key risk to global population immunity—so much so that both WHO Director-General Tedros Adhanom Ghebreyesus and U.S. infectious disease expert Anthony Fauci recently warned about its impact on the current global goal of vaccinating everyone. This nationalism is manifesting in three ways: through single country or regional deals, export bans, and a refusal to compel manufacturing scale-up beyond a handful of companies and for the benefit of only specific countries.

Worse still, the very institutions set up to address global access equity were at the outset undermined by the non-transparent conduct of richer nations and mostly refuse to condemn this behavior publicly.

Efforts by South Africa and India to ensure equal access continue to be blocked shamelessly by the very nations that have commenced their own selfishly nationalistic vaccination programs.

The South African and Indian governments have pushed since July 2020 to get a Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver at the World Trade Organization. Despite being backed by 140 nations, the effort continues to be blocked shamelessly by the very nations that have commenced their own selfishly nationalistic vaccination programs.

The TRIPS waiver is at the heart of the vaccine access battle. Implicit in the opposition by richer nations in the European Union—as well as the United States, Canada, Australia, Britain, Japan, and even Brazil—is an existential threat to the continuing practice of treating medicines as a commodity.

The glaring vaccine supply crisis has exposed why that approach is no longer correct or sustainable—medically and economically—during this and future pandemics. These countries’ opposition is rooted in the fear that if the COVID-19 waiver succeeds, it opens the door to a partial relaxation of patents that the industry may not be able to close, which will set a precedent for future pandemics.

That means pharmaceutical giants will not be able to defend monopoly protection and in turn the unfettered power to segment markets; unilaterally decide whether to cooperate or not in technology transfer; carry though exclusivity arrangements; determine sublicenses and the timing of sharing information or know-how; set prices with no reference to true production and research costs (despite often being co-funded by public institutions); demand unconscionable indemnities; and make huge profits now and in the future.

This is an industry that rarely commits to high levels of transparency. Even with HIV/AIDS, lawyers and activists had to challenge the often undisclosed terms and conditions of sublicensing agreements that had a direct impact on people’s health, and the nontransparent pricing practices of companies, to insist on research and development cost disclosure, at times using antitrust routes to challenge monopolies on life-saving medicines. Incidentally, no drug company or vaccine manufacturer has yet voluntarily entered the WHO’s technology access pool.

The White House has now activated the U.S. Defense Production Act albeit in a limited way, in an effort to scale up domestic capacity. While this is country-specific, it suggests a turning of the tide. Recently, after Tedros’s comments and warnings, Fauci also noted that the U.S. government could in fact help strengthen global manufacturing capacity with both policy intervention and the cooperation of pharmaceutical companies in relaxing some patents—following an open letter sent by the People’s Vaccine Campaign for South Africa to Fauci and others, signed by the Anglican archbishop of southern Africa, Thabo Makgoba.

This is a start—but forcing the pharmaceutical industry to put lives ahead of patents and profits will require even greater pressure from governments and civil society globally. As Doctors Without Borders has repeatedly emphasized, “not even a global pandemic can stop pharmaceutical corporations from following their business-as-usual approach, so countries need to use every tool available to make sure that COVID-19 medical products are accessible and affordable for everyone who needs them.”

The current TRIPS waiver request is rooted in what transpired 20 years ago during South Africa’s HIV/AIDS epidemic, when affordable generic drugs, made in countries where patents did not block production, began saving millions of people’s lives. At the time, many groups in the human rights and medical access community fought for that space to open up using antitrust measures, litigation, advocacy, and patent defiance campaigns. The eventual ability of generic manufacturers to enter low-income countries with high HIV burdens was a game-changer.

Without the temporary TRIPS waiver now, countries will be required to take individual domestic action and legal measures—while managing a pandemic. This is why the waiver is important, but also why all COVID-19 health tools and technologies should be regarded as global public goods, free from the barriers that patents and other intellectual property impose.

There will, of course, be resistance from companies and their lobbyists. The pharmaceutical industry is adept at evergreening and extending patent protections, and in some cases “gaming the patent system.” Moreover, it often creates the incorrect impression that all medical and public health innovation—supposedly for the broader public good—belongs to the industry alone. In fact, such innovation is dependent on co-funding, public investment, and public research. Without those contributions, the innovation needed to assist millions of vulnerable and sick people would be missing, and access to essential and life-saving diagnostics and therapeutics for many chronic conditions would be limited.

In a public health crisis such as COVID-19, patent and market exclusivity must be replaced with equitable access and the treatment of science as a public good. Otherwise, only the promise of patent protection will drive scientific innovation, continuing to benefit only the wealthy and powerful while millions die.

Fatima Hassan is a South African social justice activist and human rights lawyer. She worked on HIV/AIDS medicine access advocacy and litigation for many years with the AIDS Law Project and for the Treatment Action Campaign, clerked at the Constitutional Court of South Africa, served as special advisor to South Africa’s former minister of health and public enterprises, and is the founder and current head of the Health Justice Initiative based in Cape Town. Twitter: @_HassanF