Could you patent the sun? – Polio vaccine inventor, Jonas Saulk
By Harmit Sarai and Karen Segal
The World Health Organization (WHO) declared the COVID-19 outbreak a public health emergency of international concern on January 30, 2020, and a pandemic on March 11, 2020. At the time of writing, over 150 million people have been infected with SARS-CoV-2 (the virus which causes COVID-19) and the global death toll has exceeded three million people. Over the last two months, the number of new COVID-19 cases globally has almost doubled, nearing the pandemic’s peak infection rate. As the infection rate began multiplying faster, the epicentre of the pandemic shifted to developing countries like Brazil, Mexico, and India—all three countries have surpassed the United Kingdom and Italy in numbers of confirmed fatalities from the virus.
With the dangerous spike in new cases and deaths and fast-spreading SARS-CoV-2 variants, vaccines offer the best chances of ending this pandemic. The slow vaccine rollout and the unequal distribution of vaccines are unnecessarily prolonging the global pandemic and plunging the world’s population deeper into poverty. Further, vaccine distribution is marked by dramatic inequality between the world’s wealthy nations and the developing nations. Of the one billion vaccine doses administered globally, only 0.2% were administered in low-income countries. To drive down infection rates and death rates and protect fundamental human rights, including the right to health, greater and more equitable access to COVID-19 vaccines is imperative.
The most significant barrier to equitable distribution of vaccines globally is lack of supply, with wealthy countries dominating access to the limited available doses. Only a handful of pharmaceutical companies have developed successful vaccines, and these companies are incapable of producing a sufficient supply of vaccines to meet the demand worldwide. Of the vaccines that have been produced, the majority of the doses have been delivered to wealthy countries—many of whom have outstanding orders for far more vaccine doses than their countries could possibly use. In contrast, many developing countries are struggling to secure access to any vaccine or are only able to secure contracts for inadequate amounts.
By September of last year, 51% of the doses to be produced had already been reserved for a handful of countries with a combined population that is only 13% of the global population. By the end of 2020, 96% of the Pfizer-BioNTech vaccines had been bought by Western nations. By March 2021, Oxfam reports that rich countries were “vaccinating at a rate of one person per second,” while many poor countries will at best vaccinate only 20% of their population before the end of 2021. This problem is not limited to vaccines alone: a UN trade report indicates that middle-income and low-income countries have been priced out of access to COVID-19 related products, with “only a tiny fraction” of COVID-19 medical supplies reaching low-income countries. The same report describes the inequality in access to the vaccines as even more dire.
Despite the current deficit in vaccine supply and the fact that there is untapped production capacity in developing nations, intellectual property laws continue to prevent developing countries from producing generic vaccines for their own populations. They remain dependent on the limited supply produced by big pharmaceutical companies, which is being accessed predominantly by wealthy nations—essentially, the world’s poor are at the end of the queue for access to this life-saving medication. This grim inequality is taking a severe toll on human life and human rights and casts into stark relief the inequality between wealthy Western nations and the Global South. As Dr. Tedros Adhanom states: “The world is on the brink of a catastrophic moral failure—and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”
In an attempt to increase vaccine access among developing nations, on October 2nd, 2020, India and South Africa petitioned members of the World Trade Organization (WTO) to waive intellectual property rights and patent laws—as set forth in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)—on all COVID-19 vaccines and treatments until herd immunity is achieved. This would increase access to vaccines, as pharmaceutical companies would be unable to enforce intellectual property rights, and consequently, low-income countries would be able to manufacture and administer generic COVID-19 vaccines, saving more lives.
India and South Africa argue that “an effective response to the COVID-19 pandemic requires rapid access to affordable medical products, including diagnostic kits, medical masks, other personal protective equipment and ventilators as well as vaccines and medicines for the prevention and treatment of patients in dire need.” They argue that pharmaceutical companies must be compelled to share data and expertise on COVID-19 vaccines and treatments—that would otherwise be protected by intellectual property rights—with other vaccine manufacturers, particularly those in low-income and middle-income countries.
Regrettably, however, many wealthy WTO member states—including Canada, the United States, and the UK—have opposed this measure. Consequently, the WTO has not yet agreed to waive intellectual property rights enforcement for COVID-19 vaccine patents. Unsurprisingly, countries opposing the waiver are the home countries of the patent-holding companies, where hundreds of pharmaceutical lobbyists are also actively opposing the proposition.
These countries should understand that supporting the TRIPS Agreement waiver does not mean that pharmaceutical companies will go unrewarded. It is projected that the Pfizer-BioNTech COVID-19 vaccine will sell $15 billion worth of COVID-19 vaccines in 2021. Instead of only making billion-dollar companies richer, we also need to be vaccinating billions of people in developing countries, just as is being done in the developed countries of the world. As highlighted by South Africa at the April 22, 2021 TRIPS Council meeting, “If the opposition is just to protect the few more billions these companies will make, then the opposition is self-defeating and short sighted.” It is worth noting further that Pfizer BioNTech, Moderna, and Astra-Zeneca all received significant public funding for their research, causing advocates to argue that the results of this publicly funded research should also be publicly available.
Supporters of the proposal, including more than 100 countries in the developing world, argue that by issuing a waiver, the WTO would be enabling a rapid scale-up of vaccine production across the globe. Despite the tremendous success of the world’s wealthier countries in vaccinating their citizens, Oxfam reports that these “rich countries are siding with a handful of pharmaceutical corporations in protecting their monopolies against the needs of the majority of developing countries who are struggling to administer a single dose. It is unforgivable that while people are literally fighting for breath, rich country governments continue to block what could be a vital breakthrough in ending this pandemic for everyone in rich and poor countries alike.” Essentially, the purpose of this waiver is to prioritize saving human lives over protecting large corporate profit. Enforcing WTO intellectual property laws on pharmaceuticals and medical expertise during a global pandemic is a violation of human rights and is inimical to the global public interest.
This proposal is not only about the supply but also about the affordability of the vaccines. As pointed out by a group of UN human rights experts, the rise in “supply and vaccine nationalism,” which has nations scrambling to secure the largest possible volumes of vaccines for themselves at the expense of poorer countries, will also exacerbate the poverty facing the Global South:
“Low and middle income countries will have to devote more resources for obtaining the various products, leading to more debt and further reducing fiscal space for measures and policies for acute needs on health, food and social security, all crucial elements to address the situation of their population.”
Because COVID-19 vaccines are currently the best way to prevent the disease and control the pandemic, availability and access to these vaccines are essential to the right to health of all people. The human right to health is recognized by multiple international instruments, including the International Covenant on Economic, Social and Cultural Rights (ICESCR), which stipulates that all parties to the covenant “recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.”
The covenant goes on to state that the steps to be taken to achieve this right include those necessary for the “prevention, treatment and control of epidemics…and other diseases” and “the creation of conditions which would assure to all medical service and medical attention in the event of sickness.” Everyone is entitled to “enjoy the benefits of scientific progress and its applications” toward attaining the highest standard of health, without discrimination. Access to pharmaceuticals in the context of the COVID-19 global pandemic is fundamental to achieving the right of every human to the highest attainable standard of health.
Together with the ICESCR, a variety of other international instruments clearly protect the right of everyone to enjoy the highest attainable standard of health. The Universal Declaration of Human Rights (UDHR) was adopted by the United Nations General Assembly as the “common standard of achievement for all peoples and all nations.” The UDHR declares that human rights are universal and recognizes that all people have the right to medical care, a standard of living adequate for their health and well-being, and the benefits of scientific advancement. Additionally, the 194 member states of the World Health Organization formally recognize that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being, without distinction of race, religion, political belief, economic or social condition.”
By opposing the motion to temporarily waive intellectual property rights and patent laws for COVID-19 vaccines and treatments, wealthy Western nations have failed to take all possible measures for the prevention, treatment, and containment of the COVID-19 crisis, and consequently, are in breach of international human rights laws. The COVID-19 pandemic is an unprecedented crisis, and it calls for unprecedented action.
While Article 31 of the TRIPS Agreement grants governments the power to issue compulsory licences authorizing the national manufacturing of low-cost generic equivalents of patented medicines, these flexibilities for protecting public health are inadequate, given the urgency of the global pandemic. To issue compulsory licences, countries must follow a complex and time-consuming process. The rules permitting compulsory licensing apply only on a case-by-case and product-by-product basis, and unsurprisingly, this process is too limiting and slow for a worldwide crisis.
The TRIPS compulsory licensing regime also proved to be insufficient during the HIV/AIDS epidemic, which saw developing nations grappling simultaneously with a deadly outbreak of HIV/AIDS and the enormous costs of accessing remarkably expensive patented antiretroviral medications. One of the issues that exacerbated the problem is that Article 31(f) of the TRIPS Agreement stipulates that a country utilizing a compulsory licence must manufacture the product locally for its domestic market. To take advantage of this clause, the country must already have sufficient manufacturing capacity, but it can be challenging for some developing countries to set up pharmaceutical factories to manufacture products without the support of the international community.
In such circumstances, having a global coordinating body that assists these countries in scaling up their production infrastructure to produce COVID-19 vaccines, for example, would be a worthwhile initiative. A coalition of UN human rights experts, including the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, asserts that complying with their international human rights obligations requires states to ensure that technologies and intellectual property are widely shared to enable developing countries to scale up the development, manufacture, and distribution of vaccines.
The HIV/AIDS epidemic also represented a clear example of the inequalities in access to health care between rich and poor countries. The Western world could afford antiretroviral medications to treat its populations, while essential drugs were priced beyond the reach of developing countries. Patent holders were granted exclusive rights to the manufacture of these medicines and proceeded to charge a premium significantly in excess of their marginal costs of production. By the time resource-poor regions were able to access the medicines, the death toll from the HIV/AIDS epidemic had exceeded 10 million in Africa alone. To avoid an exact repetition of history, today’s world leaders need to immediately address the problem faced by low-income countries regarding access to COVID-19 vaccines and treatments.
When examined from the perspective of the right to health, the TRIPS Agreement waiver proposal induced by the COVID-19 crisis is fundamentally a human rights issue. The intellectual property rights protected by the WTO provide pharmaceutical companies with a monopoly over the production of vaccines and medical supplies, which restricts access to life-saving medications for billions across the globe. With the current pandemic, it is impossible to simultaneously enforce intellectual property rights and protect the human right to health. In these circumstances, COVID-19 vaccines should be affordable and accessible to all, without discrimination.
In pursuit of this goal, more than 140 world leaders and experts have signed an open letter requesting all governments to support a people’s vaccine for COVID-19. The letter demands that all vaccines, treatments, and tests be patent-free, mass-produced, fairly distributed and made available to every individual, in all nations, free of charge. As Helen Clark, former Prime Minister of New Zealand, phrases it: “The COVID-19 vaccine must not belong to anyone and must be free for everyone. Diplomatic platitudes are not enough—we need legal guarantees, and we need them now.” The Canadian government should join other world leaders and health advocates to support a people’s vaccine and ensure that human lives are prioritized over the profits of big pharmaceutical corporations. The world’s wealthy nations should not forget that, as long as there is COVID-19 anywhere in the world, it remains a threat to everyone on the globe.
Many medical experts argue that the fight against COVID-19 is a struggle to vaccinate as many people as possible before deadlier or vaccine-resistant variants emerge. According to Dr. Tedros Adhanom, “the more transmission, the more variants. And the more variants that emerge, the more likely it is that they will evade vaccines. We could all end up back at square one.” The world has witnessed the death toll inflicted by the existing variants, variants that slipped across our borders with ease. This means that a slow vaccine rollout significantly threatens to undermine all the progress that has been made in the fight against this virus and puts everyone—not just those in regions with lower vaccine access—at risk of prolonged suffering: business closures, isolation, separation from family, sickness, and death. It is difficult to imagine a more pressing time to prioritize the fight against a disease over corporate profits.
Intellectual property rights should never supersede the human right to health—a truth made even more glaring in the context of a pandemic costing millions of human lives. It is critical that governments, including Canada, and companies across the globe protect the right to health of every individual by sharing medical technologies, proprietary data, and expertise on COVID-19 vaccines and other medical supplies. A global pandemic demands that countries and companies work together to develop a pandemic response that works for everyone, not just the wealthy few. Such an effort requires the sharing of the most advanced scientific knowledge to jointly mitigate the impact of the crisis and expedite access to vaccines and treatments.