When it comes to the suspension of patents for Covid-19 vaccines, it’s big pharma against the world—or most of it, anyway.
Earlier this month, the US government expressed its support of a waiver to the international agreements governing intellectual property rights. The waiver, proposed in November 2020 by India and South Africa, would allow poor countries to produce Covid-19 vaccines without paying pharmaceutical companies for patent rights, at least until the pandemic is over. This would help increase the global supply of vaccines at a lower price, and make progress toward the goal of vaccinating the global population by the end of the year.
The proposal, to be negotiated through the World Trade Organization, gained the support of many countries, especially low- and middle-income, but found resistance among rich ones, including the EU, Switzerland, the UK, Australia, Canada and, initially, the US. However, the US lifted its opposition earlier this month to expand vaccine supply and access to bring the pandemic to a faster end. With the US government putting its weight behind the proposal, its approval is much more likely.
Waiving the Trade-Related Aspects of Intellectual Property Rights agreement (TRIPS), while also allowing the sharing of manufacturing know-how, is key to boosting the global production of Covid-19 vaccine, advocates say.
Ethically speaking, it’s even more urgent now than when the proposal was introduced. The world is experiencing a two-speed pandemic, with wealthy nations moving back toward normalcy, and poor ones experiencing new outbreaks and dealing with a lack of vaccines and therapeutics. It is a situation the World Health Organization (WHO) has denounced as “vaccine apartheid.”
But ethics aren’t the only reason to commit to expanding vaccination capacity by any means possible. As long as there are Covid-19 outbreaks, the chance that vaccine-resistant variants might emerge persists—as goes the global health community‘s mantra “Covid anywhere is Covid everywhere.”
Yet the pharmaceutical industry isn’t exactly on board with missing out on patent profits. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has expressed disappointment at the US’s stand, claiming the patent waiver won’t help produce more doses, and calling instead for a lowering of trade barriers that would make it easier for western manufacturers to sell vaccines to poorer countries.
“The TRIPS waiver […] could spur a spate of confusing, mutually inconsistent, and heavy-handed “compulsory” demands by governments all over the world for supply and technology transfer,” warned Michelle McMurry-Heath, the president of the Biotechnology Innovation Organization, in a statement.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the trade organization representing the biggest US drug companies, has published polling results that shows a majority of Americans oppose the waiver. But the framing of their questions betrays the not-so-subtle suggestion that suspending patents would create safety concerns—for those who would receive the vaccines.
In one survey, responders were asked whether poorer countries should be allowed to manufacture the vaccines even though they may be less safe. In another, they were asked whether they were concerned about the fact that other countries might not have the same quality standards as the US, or that the risk of getting counterfeit vaccines might be higher if production was expanded to poor countries. Unsurprisingly, a majority of people found these scenarios concerning.
The myth that making vaccines in poor countries might be dangerous is very dear to pharmaceutical companies. “Entities with little or no experience in manufacturing vaccines are likely to chase the very raw materials we require to scale our production, putting the safety and security of all at risk,” wrote Pfizer CEO Albert Bourla in a statement.
“The history behind this particular tactic of questioning the safety of manufacturers in other parts of the world has been played out on various occasions,” says Tahir Amin, the co-founder of I-MAK, a US-based organization working to increase global access to medicines
Perhaps the most egregious precedent is the dispute between big pharma and poor countries over the making of antiretroviral drugs for AIDS, which cost about $10,000 per person per year before the introduction of generics that brought the price down to $300 per person per year.
A famous episode of that battle culminated in court in 1998, when a coalition of multinational drugmakers and the South African Pharmaceutical Manufacturers Association sued the Nelson Mandela-led South African government for its attempts to encourage the local, patent-free production of more affordable AIDS medications, although eventually the charges were dropped. At the time, western pharmaceutical companies claimed drugs made in developing countries didn’t meet the necessary quality standards, though research repeatedly found that there was no reason to think so.
“Had it not been for generics manufacturers in the global south, we wouldn’t have gotten more people treated with antiretrovirals, and we’ve seen that generics are very much safe and the quality is not questioned,” says Amin.
Granted, vaccines are more difficult than oral drugs to produce, but big vaccine makers in developing countries including India—the biggest vaccine producer in the world—have long been used by UNICEF and other global development agencies to produce their vaccines, with constant scrutiny of their quality.
In fact, poor countries have even been able to develop their own vaccines, as is the case of the hepatitis B vaccine developed by Shanta Biotechnics in India. The price of the vaccine made by western countries ($23 per dose in the 1980s) was prohibitive, so a local pharmaceutical company set out to develop its own formulation, at a cost of $1 per dose. This led to a mass inoculation against the virus, with over 120 million doses distributed worldwide to poor countries.
“There is this ‘scientific racism’ that exists in the west, that we are still living in colonial times where science was only done by the rich global north,” says Amin.
The prejudice that vaccines and drugs made by poorer countries won’t meet the standards of wealthy countries doesn’t just extend to the manufacturing capacity, but to the quality assurance provided by the governing bodies of those countries. Effectively, the US pharma industry is claiming greater expertise at verifying the quality of pharmaceutical products than the national and international bodies working with producers outside the western world.
“Nobody wants to see poor quality vaccines, but in this spotlight, I think everyone that is coming up with a version of the vaccine is going to really check their manufacturing practices,” says Amin.
What makes the skepticism toward vaccines made in poor countries even more contradictory is that often the actual ingredients bought by western manufacturers to produce their drugs are produced in India or China. So the very same companies that are raising doubts about the quality of products made by manufacturers in poor countries trust them for their raw materials.