The Biden Administration is debating whether COVID-19 vaccine patents should be temporarily waived, given the devastating humanitarian crisis unfolding in India from the virus. There are two key factors that should drive the Biden team to agree to do so: first, there is strong precedent on waiving patents in the context of public health emergencies; second, the real-world effectiveness of most COVID-19 vaccines against symptomatic disease and transmission can temper the disaster. The Biden Administration will be making its decision on lifting some patent restrictions as early as May 5.
India faces a catastrophe, with over 350,000 new cases and 3,450 deaths (most certainly underestimated) from COVID-19 reported on May 3. Heartbreaking scenes in India of overflowing hospitals turning away dying patients and crematorium pyres burning all night are playing out against news of how fast many wealthy countries with rapid vaccine roll-outs will be getting back to normal life.
Pharmaceutical companies producing COVID-19 vaccines and holding patents are reaping billions of dollars in profit and are projecting further profit from sales of booster shots before scientists even know if boosters will be necessary. In October 2020 (prior to India’s current crisis), India and South Africa formally proposed to the World Trade Organization (WTO) Council for Trade-Related Aspects of Intellectual Property (TRIP) that IP provisions for COVID-19 vaccines be temporarily waived for India and other countries to mass produce these vaccines for their populations. On March 5, 2021 (as COVID-19 cases were just ramping up in India), CEOs from major pharmaceutical companies involved in COVID-19 vaccine production sent an open letter to President Biden urging him to reject this “unfortunate” proposal.
As an infectious diseases and HIV doctor, this debate sounds all too familiar, reminding me of how, despite the development of highly-effective antiretroviral therapies (ART), rigid adherence to patent laws directly led to millions of lives lost to HIV/AIDS in sub-Saharan Africa in the 1990s.. I witnessed plummeting AIDS-related mortality from the first half to the second half of my medical internship at a hospital in San Francisco that year, thanks to these new ARTs, a miracle afforded initially only to those with AIDS in wealthy countries. There are eerie parallels in 2021 where as a practicing infectious disease doctor I have seen, with the rapid distribution of highly active vaccines, the marvel of COVID-19 cases receding in the U.S., and COVID-19 wards emptying, a phenomenon being seen across wealthy countries with brisk roll-outs.
As the wealthy recipients of these extraordinary vaccines, we must demand more from the companies that make them and from our own government. The lessons of the fight against HIV clearly show us what happens when profits come before health for the neediest. For instance, Pfizer made $41.9 billion in 2000, a year when HIV activists and doctors were aghast that the company’s patented anti-fungal, fluconazole (which could be made for pennies), was priced so high that it remained unaffordable for countries in sub-Saharan Africa. Fluconazole was the only treatment for cryptococcal meningitis, an AIDS-related opportunistic infection with a high mortality rate if untreated. AIDS patients in Africa needlessly died of cryptococcal meningitis due to lack of access to this patented drug until South Africa openly defied patent laws in 2000.
Meanwhile, in 2000, the pharmaceutical industry spent $167 million on lobbying during the U.S. election campaign, in part to protect their patents. Those life-saving ART medications I mentioned earlier were not available for most poor countries for many years. In 2001, Kofi Annan, the UN Secretary General, said, “Some may think that because better medicines have been found, the AIDS emergency is over. Alas, no. For most people living with HIV/AIDS today, the $10,000 to $60,000 annual price tag of an antiretroviral regime belongs, quite simply, in another galaxy.”
As millions continued to die of AIDS in poor countries, the debate about waiving patents raged on during the early 2000s. The WTO’s TRIPS Agreement—ratified in 1995—had allowed for patent waivers and domestic production off patent in the setting of medical emergencies, but ART regimens remained out of range for the majority of poor patients in sub-Saharan Africa throughout this period. In early 2001, an Indian pharmaceutical company named Cipla decided to offer a triple-combination ART regimen at $350 per patient per year. South Africa sought to change its Patents Act in order to import these inexpensive generic drugs from India and was sued by multinational pharmaceutical companies fearing reduction in their profits. The Treatment Action Campaign (TAC, a long-standing HIV advocacy organization in South Africa) took the dispute to the world stage, claiming this lawsuit “hammered the message home that many of the multinational drug companies were abusing their market monopoly in the face of a catastrophic human disaster.” Under increasing international pressure, the lawsuit was dropped. Over the next decade, ART access to sub-Saharan Africa, often through waiving of patents and voluntary licensing, increased. In 2020, 26 million of 38 million people living with HIV worldwide have access to life-saving ART (although 690,000 deaths from AIDS were still recorded in 2019).
The decision on waiving patents for COVID-19 vaccines cannot take years, as it did with ART regimes—the decision needs to be made within days given the extent of the public health crisis in India. India supplied ART to a large part of the world; it is our duty to help India now. Indeed, if the decision had been made in October 2020, when India appealed for this temporary waiver on patents, India might have been in a very different position with COVID-19 today.
To date, only 9.4% of Indians have received their first dose of COVID-19 vaccine. Beyond public health measures, increasing the capacity for India to vaccinate its large population will make an immediate impact. In other countries where cases were rising as vaccination campaigns began (like Israel and the U.S.) cases started plummeting at a ~40% first-dose-vaccination “inflection point.” The U.S. has purchased over 1 billion doses combined of the two mRNA vaccines (Pfizer-BioNTech and Moderna) and the Johnson & Johnson adenovirus/DNA vaccine, many more than needed for its adult population. The country is now contemplating donation of excess vaccine to India (via the COVAX initiative, led by the World Health Organization) beyond the 60 million doses of AztraZeneca vaccine released recently.
Donation will be the fastest way to get vaccines to India and other countries in need. But waiving of pharmaceutical company patents seems like an obvious and urgent next step for India and other countries. As the United Nations Secretary General said in February, “vaccine equity is the biggest moral test before the global community” at this time. Let’s not fail it.
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