Yves here. This article highlights that India might engage in compulsory licensing if the most viable Covid-19 treatment turns out to be patent protected and the rights owner charges extortionate prices. But it seems unduly optimistic about vaccines. As we’ve highlighted, of the four common coronaviruses, immunity lasts only six months to 34 months. If immunity to Covid-19 is on the short end of this spectrum, a vaccine will be of limited value save to those likely to get high exposures, like medical professionals, flight personnel, and those who work in close quarters where it isn’t feasible for employers to put up barriers or invest in other protective measures.
By Prabir Purkayastha, the founding editor of Newsclick.in, a digital media platform and an activist for science and the Free Software movement. Produced in partnership by Newsclick and Globetrotter, a project of the Independent Media Institute
During an interview with Jonas Salk, the creator of the polio vaccine, CBS newsman Edward R. Morrow asked who owned the patent for the vaccine. “Well, the people, I would say,” said Salk. “There is no patent. Could you patent the sun?” This is what drives science and scientists like Salk: that science must be for the public good and not the private profit of companies.
While public domain science—universities or public research institutions—creates the key components of knowledge for most medicines or vaccines, it is appropriated by private companies, and governed by the World Trade Organization’s patents regime. The global stock market may have completely tanked in the last few months, but Gilead Sciences, the holder of the patent on the drug remdesivir, currently in clinical trials against COVID-19, has seen its share price rise by a whopping 20-25 percent in the same period. This rise may not last if the drug trials fail to show significant benefits.
Coronavirus might be devastating to many countries—including their people’s health and livelihoods—but it seems that pandemics are good for some companies and their stockholders. Riding the pale horse of apocalypse are companies that hold patents on N95 masks, lifesaving medicines, vaccines, and more.
I am not going to get into the debate of how many people are likely to get sick, and how sick they are going to be. The simple answer is that the number of COVID-19 fatalities, already more than 200,000, is likely to be in the millions. As Chris Giles shows in a Financial Times analysis using UK data, the death rates are far higher for this current period than any flu epidemic we have seen recently. And according to the Financial Times analysis, a large proportion of extra deaths is COVID-19 related. Harry Kennard, a researcher at the Lancet Countdown on Health and Climate Change, in a series of tweets with telling graphs using the UK data shows us the story of extra deaths during the COVID-19 pandemic there.
The world has forgotten what a pandemic looks like, as plague and flu epidemics as virulent and deadly as the one in 1918 have not been repeated for about a century. Now that we confront the SARS-CoV-2 virus, we realize humanity is only one genetic mutation occurring anywhere on the planet away from a new pandemic. Medicines and vaccines against viruses and bacteria are not just for the poorer countries, but also crucial for countries who thought they had left this history behind them.
There are three broad areas that are critical in our battle against the COVID-19 pandemic. They are personal protective equipment, critically the N95 masks; the drugs that are currently being tested against the SARS-CoV-2 virus; and the vaccines that will probably take another 12 months before they are available for the general public.
I will start with N95 respirators or masks that the frontline health workers—including doctors, nurses and other health staff—have to use to protect themselves. It is the lack of N95 masks and other protective equipment that has seen infections among hospital staff, with hospitals themselves becoming hot spots for spreading the infections. In India, the Delhi State Cancer Institute shut down for two weeks as 27 of its staff members tested positive for the virus. In Italy, 20 percent of the health care workers in Lombardy became infected due to a shortage of protective equipment.
So who are the world’s largest manufacturers of N95 masks? Eight of the top 10 global manufacturers of N95 masks are U.S. companies, with 3M and Honeywell topping the list. 3M holds a number of patents—according to the Guardian, “more than 400 patents for respiratory protection”—on the N95 respirator. Its share price is doing comparatively well even under the current stock market meltdown.
We are already aware of the importance of N95 masks with stories of shipments being hijacked by the U.S. even from the tarmac, and Trump threatening 3M with dire consequences under the Defense Production Act established in 1950 during the Korean War. The U.S. asked 3M to stop exports to Canada and Latin America, and ship to the U.S. on a priority basis masks produced in 3M factories abroad.
While protective equipment is critical for health care workers, for the general public worldwide, the question is: Do we have medicine that can cure us if we fall sick?
The short answer is that there is currently no medicine available, and it is unlikely any medicine tailor-made for this disease will be developed anywhere in a short period. What we are doing instead is trying to repurpose existing medicines that are likely to have some effect on the virus.
The World Health Organization (WHO) is currently conducting Solidarity clinical trials on a set of antivirals to see if they provide relief in helping the body to fight the virus. The sets of medicines being tested are: a) remdesivir, originally developed for Ebola; b) chloroquine or hydroxychloroquine, currently making headlines thanks to Donald Trump’s dangerous misinformation, and widely used as an anti-malarial drug, as well as for lupus and rheumatoid arthritis; c) lopinavir with ritonavir, used as an anti-AIDS drug combination; d) lopinavir with ritonavir plus the antiviral drug interferon beta.
Apart from the old anti-malarial drugs chloroquine or hydroxychloroquine, all others are currently under patent protection. Hydroxychloroquine is known to cause heart arrhythmia and there are therefore known dangers associated with its use. Remdesivir was originally developed against Ebola but did not work well and was mothballed. It appeared to show some benefits in COVID-19 cases, though the evidence for benefits is similar to the small French trial that used a combination of hydroxychloroquine and azithromycin. The standard double-blind trials for drug development are currently underway, but the results for remdesivir do not look promising.
What is important about all the other combinations being tested in WHO’s Solidarity clinical trials is that they are all under patent protection. If any of them works—except chloroquine or hydroxychloroquine—the patent holders will make a windfall, barring a Salk-like epiphany of the madness of profiting from the cure for a disease causing a global pandemic.
The key battle over the Uruguay round of trade negotiations that gave birth to the World Trade Organization (WTO) and Trade-Related Intellectual Property Rights (TRIPS) was whether or not countries like India who had disallowed product patents for medicines could continue to do so. Unfortunately, India and other developing countries lost that battle. In 1994 the TRIPS regime came into existence, with countries like India getting a moratorium of 10 years, after which they had to grant product patents.
Given these restrictions, is it possible that India could act as the global pharmacy for a new COVID-19 drug like remdesivir, as it does with AIDS drugs? It is India’s ability to supply AIDS drugs at $350 for a year’s supply—less than one-twentieth the cost of the global multinational corporations’ cost of $10,000-$15,000—that made it possible for millions of lives being saved in the developing world.
The short answer is that it is still possible to break the patent held by Gilead or other private patent holders by compulsorily licensing the medicine under a sovereign right that a country has during health emergencies. Fortunately, India has strong provisions for compulsory licensing that the Left was able to retain when the Indian Patent Act was changed to conform to the TRIPS requirements. The Left held sufficient votes in the Parliament to force the Manmohan Singh-led United Progressive Alliance (UPA) government to accept its demands. While the case in which pharmaceutical company Novartis was denied a patent for Glivec, a cancer-treating drug, in India as it fell foul of the evergreening section patents of the Indian Patent Act is better known, the Patent Act’s compulsory licensing provisions can be particularly useful in the current context. This provision can be used against any patent holder by issuing a compulsory license to a domestic producer, while paying them some royalty. During pandemics, the WTO allows countries to issue compulsory licenses and even import essential drugs from other countries. This enables countries faced with the COVID-19 pandemic, and who might lack domestic manufacturing capability, to import such drugs from countries like India.
In the past, whenever India has considered the use of compulsory licensing for producing, for example, life-saving cancer medicines, the U.S. has threatened India with dire consequences under the Office of the United States Trade Representative (USTR) Special 301 Report provisions. In 2019, the USTR went so far as to put India on its Priority Watch List for intellectual property issues including pharmaceuticals.
An effective solution would be for governments to compulsorily license medicines that might have efficacy against COVID-19. Whether Modi, who rushed hydroxychloroquine to the U.S. under Trump’s threat, will be willing to consider such a move against the U.S. remains to be seen.
Finally, the vaccine. While in the short run, we have lockdowns, physical distancing, contact tracing and quarantine as our temporary weapons for prevention, the only long-term preventive strategy is a vaccine. Herd immunity is not achieved from the entire population (or about 70-80 percent) being infected by the virus, as UK Prime Minister Boris Johnson previously believed, but by widespread vaccination. No major infectious viral disease—small pox, polio or measles—has been eradicated or contained without a vaccine.
And there is a major problem with vaccines and the for-profit pharmaceutical industry. Once the genome sequences are put in the public domain by countries, the private companies use these sequences to develop the vaccines, and, if they are successful, they can fleece the people and countries. This is the battle over the flu vaccine, where countries’ health systems submit the flu genomes that are being spread in their countries to public flu databases, but receive no or little benefits for doing so.
According to the WHO, as of April 23, there are six companies that have entered phase 1 or 2 trials to find a coronavirus vaccine, and another 77 in various stages of development. While most of the vaccine development is either publicly funded or funded by philanthropic institutions, the patent holders are mostly private companies.
So will the COVID-19 vaccines also sell like the flu vaccine for $20 a shot—bankrupting poorer countries to protect their people? Or will we follow what Salk said about the polio vaccine—that it belongs to the people? The U.S. position is clear: vaccines belong to companies even if their research was publicly funded. And if other countries wish to compulsorily license a successful vaccine using the pandemic exception of WTO/TRIPS rules, the U.S. can still use USTR Special 301 and Super 301 sanctions against them as they are threatening to do with India. And as we know from the history of U.S. sanctions, the U.S. believes that it has a right to sanction any country in the world, even if such sanctions violate international humanitarian law.