After three months of dithering, the Biden administration eventually agreed to a temporary waiver of patent rights for the COVID-19 vaccines. The proposal by South Africa and India for a waiver on intellectual property rights in the World Trade Organization has found support from a large number of countries and more than 400 public health organizations. The proposal now faces opposition from the European Union countries, which had earlier portrayed themselves to be more progressive than the United States. This portrayal was not difficult to achieve under the Trump administration. The latest move by Biden has, however, wrong-footed the EU, leaving the bloc as the only public supporter of Big Pharma in the WTO.
While appearing to support the South Africa-India proposal, the Biden administration has considerably narrowed down the scope of the waiver to just patents in comparison to what was there in the original proposal in the WTO: to waive all intellectual property rights on COVID-19 vaccines, diagnostics, and medicine, including industrial designs, copyright and trade secrets. These waivers are required to scale up vaccines from research and development to production at an industrial scale. The Biden patent waiver is, however, limited to vaccines only. It leaves out patents on Remdesivir and various monoclonal antibodies that have shown efficacy against COVID-19. Without extending the vaccine patent waiver to other property rights, the stance by the Biden administration of waiving only vaccine patents is more optics than a real effort to ramp up the fight against COVID-19. The issue of knowledge transfers, to scale up vaccine manufacturing in other countries, still needs to be fought and won.
Even if it is at the level of optics, there are several reasons behind the United States’ sudden change in its position. The United States has been relatively isolated because of its America First policy of hoarding vaccines and vaccinating all Americans first before exporting the vaccines to the rest of the world. According to an article in the New York Times in March, the United States was sitting on “tens of millions of doses of the AstraZeneca vaccine,” which it was not using, while the WHO’s Access to COVID-19 Tools (ACT)-Accelerator program—and its vaccines pillar of COVAX, on which a large part of the world depends—has been facing difficulties getting vaccine supplies. And lastly, with India facing a huge surge in cases domestically and virtually stopping all vaccine exports, China has emerged as one of the only suppliers of vaccines to large parts of Africa, Asia and Latin America. This is endangering Biden’s plans of a grand alliance against China, isolating it globally.
The U.S.’s unstated geostrategic vision is to support the Western Big Pharma companies to dominate the markets of rich countries, and the market for the rich in the rest of the world who can afford premium prices. Moderna is slated to generate a revenue of $19.2 billion this year from the sales of the COVID-19 vaccines, while Pfizer-BioNTech will rake in $26 billion in sales, according to the Wall Street Journal. This is the market that the rich countries want to protect.
The United States was banking on its new Quad partner, India, to provide vaccines to the rest of the world through the WHO’s COVAX program. The COVAX program, though nominally run by the WHO, is dominated by Bill Gates and his various vaccine initiatives: the Bill and Melinda Gates Foundation, Gavi and the Coalition for Epidemic Preparedness Innovations (CEPI), which are co-leaders of the program. The Serum Institute of India, which is manufacturing two vaccines (Covishield, which is licensed from AstraZeneca, and Novavax), and Biological E, which will produce the Johnson & Johnson (Janssen) vaccine, were expected to provide about 2.6 billion to 3 billion doses per year from India for other countries, helping to vaccinate the global population.
This strategy faltered due to the utter incompetence of Indian Prime Minister Narendra Modi’s government to use the indigenous capability of the country for rapidly ramping up India’s vaccine production. The other constraint was the virtual U.S. export ban under the 1950 Defense Production Act, which denied Indian vaccine manufacturers the vital equipment and raw materials required to scale up production of COVID-19 vaccines. At the “current global vaccination rates of roughly 6.7 million doses per day,” and to achieve the much-needed herd immunity where up to 85 percent of the population has been completely vaccinated, will take about 4.6 years, according to an April article in the New England Journal of Medicine. China and Russia have effectively emerged as the only two countries willing to offer their vaccines and technology to other countries grappling to control the spread of the virus.
If the United States had banked on the Modi government’s ability to compete with China on the vaccine front, they backed the wrong horse. The Modi administration failed miserably not only to anticipate a second wave in India, but also to invest in ramping up production of its indigenous vaccine, Covaxin, which was developed by the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), in collaboration with Bharat Biotech, to increase the biopharmaceutical capacity of the country. Instead, the Modi government believed in the “magic” of the free market that would provide all the vaccines required without the need for any planning or government support.
The proponents of the patent monopoly, including Bill Gates, argue that a patent waiver is useless, as it is a lack of technology, knowledge and capital, not patents, that is holding up vaccine production outside the rich countries. If patents are not stopping vaccine production in other countries, then why did Big Pharma and the rich countries oppose the patent waiver in the WTO for the last six months? Why is there anger relating to the Biden administration’s current stand on patent waivers?
According to Big Pharma, a patent waiver on vaccines will disincentivize research and will be a huge blow to those who innovate. What they hide—and this is not new—is that most of the research money for the new vaccines has come from public funds. A Lancet paper published recentlyshows that governments and nonprofit organizations have given more than $10 billion for the development of the current crop of vaccines and other promising vaccine candidates. This does not include the billions of dollarsthat the U.S. and the UK governments paid to Pfizer and AstraZeneca for advance orders.
The argument of providing a monopoly to Big Pharma for incentivizing drug discovery is, therefore, a bogus one. Most of the research for the development of drugs and vaccines is supported by public funds and by government laboratories.
As far as the role of philanthropic money in developing private monopolies is concerned, it should be treated at par with public money as it comes out of tax-free dollars. Bill Gates and his initiatives—the Bill and Melinda Gates Foundation—deserve a special mention here as the foundation has a direct role in strengthening Big Pharma monopoly. It was Gates and the power he wields through the Bill and Melinda Gates Foundation, Gavi and CEPI that led Oxford University’s Jenner Institute to abandon its initial idea of making their vaccine technology available to any company on a nonexclusive basis. Instead, it signed an exclusive contract with AstraZeneca.
There are three major technology platforms that have emerged in the development of the current lot of successful vaccines. The first includes the “old-fashioned” inactivated virus vaccines like China’s Sinovac and Sinopharm and India’s Covaxin. The second technology platform (adenovirus-based) uses a relatively innocuous virus as a vector to carry a SARS-CoV-2 protein—for example, AstraZeneca, CanSino, Gamaleya National Center of Epidemiology’s Sputnik V and Johnson & Johnson. The third type is the mRNA vaccine that tells the body cells to produce the SARS-CoV-2 protein, as in the case of Pfizer-BioNTech and Moderna. All three of these technology platforms have produced successful vaccines.
Almost all of the Big Pharma arguments on why patent waivers are not of much use are for mRNA vaccine platforms. The argument by Big Pharma that countries such as India, China and South Korea—three of the largest generic vaccine manufacturing countries—do not have biologic capability is not correct, as the mRNA vaccines are not of immediate public health interest to most countries. The mRNA vaccines require an ultra-cold supply chain; otherwise, they degrade rapidly. The cost and effort involved in building such an ultra-cold supply chain preclude the use of mRNA vaccines in mass vaccination programs in most countries. What is of interest for most countries is the inactivated virus vaccines or the adenovirus vector vaccines.
The WHO-supported platforms—CEPI and Gavi—where Bill Gates has an outsized influence have focused much more on the new vaccine platforms, the mRNA and the adenovirus vector vaccine platforms, and not on the traditional inactivated virus vaccines. Dr. Ricardo Palacios of Butantan Institute, while speaking during a webinar organized by the South Centre on April 1, pointed out “that CEPI and COVAX funded largely newer vaccine technologies and had the tendency to disregard older technologies such as inactivated viruses”—for example, vaccines like China’s Sinovac and India’s Covaxin. These inactivated virus vaccines are effective, cost less and can be produced easily in many developing countries. Before we dismiss these vaccines as yesterday’s technology, it is relevant to note that this is still the vaccine platform for flu vaccinations across the world and is used to manufacture about 1.5 billion doses per year.
Meanwhile, the only novel part of the adenovirus vector vaccines of AstraZeneca, CanSino and Gamaleya’s Sputnik V is inserting a small spike protein snippet in the adenovirus vector and then growing the adenovirus as we do for the inactivated virus. Five companies in India, a consortium of South Korean companies, and another consortium of Chinese companies are planning to scale up the production of Sputnik V to about 1.5 to 2 billion doses per year.
For any company involved in biologics, this is pretty much routine technology. India has about 30 biologic manufacturers, and South Korea and China also have an established biologic industry. Bangladesh, Southeast Asia and Latin American countries also have biologic drug manufacturing capability, and can therefore become major manufacturers. Cuba has developed five vaccines, out of which two are in advanced clinical trials. According to the WHO’s Global Vaccine Market Report 2020, three Indian companies (the Serum Institute of India [SII], the Haffkine Institute [Haffkine], and Bharat Biotech [BBIL]) provide about 44 percent of the world’s vaccines by dosage. The argument by Bill Gates recently in a Sky News interview that “it’s only because of our grants and our expertise” that the Indians (or Koreans, Chinese, Latin Americans, Africans, Arabs, etc.) can produce the vaccines is just a racist view of the world. This is a repetition of the white man’s burden that cloaked the earlier genocidal colonial enterprise.
The question the world needs to ask is if we want to spend the next few years protecting the monopoly profits of a few Big Pharma companies, and thereby condemn the world to a much longer COVID-19 pandemic. Or do we believe that public health demands rapid sharing of knowledge so that the world’s population can be vaccinated within the next 6-12 months? If the latter doesn’t happen, new virus mutations will keep emerging, requiring updating the vaccines constantly, making this a never-ending game of snakes and ladders. This is of interest to Big Pharma, as it will create a perpetual money-making machine for them. But it is not so for the people around the world who believe that a caring world needs sharing of knowledge.