On the 12th of April 1955, the results of the largest clinical experiment in history were revealed. Called the Francis Field Trial, nearly two million children played a role in testing a novel polio vaccine that was found to be incredibly effective in preventing infection.
That same day, an interview aired with Jonas Salk, lead researcher on the vaccine project. In the interview Salk was asked who owned the patent for the polio vaccine and he famously replied, “… the people I would say. There is no patent. Could you patent the sun?”
The quote is often cited as a high-water mark for humanitarian innovation over capitalist profiteering but, as with most things, the truth behind the quote was a little murky. Recent scholarship suggests lawyers at the time in fact did attempt to patent the vaccine, and it was only the unique specificity of its development that ultimately hindered more direct capitalization.
Decades have passed since this iconic 20th century achievement, and as we wade through a traumatic new pandemic the issue of patents and vaccine ownership again rears its ugly head. Last year, questions over intellectual rights regarding vaccine development were largely hypothetical. The goal was simply to develop new vaccines to save lives. Questions over manufacturing, distribution and who owns what could come later.
By the end of 2020, in a marvel of scientific ingenuity, several effective vaccines had been developed. Now, several months into 2021 a chasm between rich and poor has become apparent.
As most developed countries are rapidly vaccinating their populations, poorer regions are yet to see even a single dose. One forecast suggests some parts of the world will not reach decent levels of population-wide immunization until 2024.
Pre-purchasing agreements have led to higher-income countries ordering billions of vaccine doses. The United States, for example, has already bought hundreds of millions more doses that it needs. While those doses are yet to be manufactured and delivered, many parts of the world will now rely on charitable donations of vaccine from richer nations if they want to immunize local populations any time soon.
So why can’t we just make more vaccines?
Certainly there are many complex factors hindering global manufacturing capabilities. From limited vaccine ingredients to technological complexities, the problem is not as simple as, "let's just make more vaccines."
But there is another problem hindering global vaccine supplies, and it’s a problem Jonas Salk managed to avoid all those decades ago. Intellectual property, patents, and the global pharmaceutical industry.
In early March more than 100 countries joined forces to argue intellectual property protections should be temporarily waived for COVID-19 vaccines. The proposal was debated, and ultimately blocked, at a recent World Trade Organization meeting.
Tripping over TRIPS
The idea was first floated back in October last year when South Africa and India presented a bid to waive an agreement known as TRIPS (Trade-Related Aspects of Intellectual Property). The proposal argued intellectual property rights over COVID-19 vaccines were stifling the ability of poorer countries to begin local manufacturing of vaccines.
Since October there have been no less than eight formal discussions over a temporary TRIPS waiver. Despite the proposal being supported by the majority of countries in the WTO, no consensus could be reached after hours of debate in early March. Further discussions have now been scheduled for April and June.
The TRIPS waiver was blocked by a small but powerful coalition of Western countries. The United States, Canada, Australia, the UK, Japan, Brazil and several European nations all opposed the proposal.
Those opposing the TRIPS waiver suggested this particular intellectual property protection was not hindering global vaccine supply. Instead it was broader resource hurdles slowing vaccine production. Removing intellectual property protections now would do little other than damage the prospects for private innovation in future times of crisis.
Speaking to The Conversation, Canadian public health expert Ronald Labonte argues the world has a significant untapped manufacturing capacity that is being directly hindered by intellectual property protections. Labonte also notes the few nations against the TRIPS waiver happen to also be the rich ones already serviced by vaccine purchase agreements.
“Most of them already having inked a number of their own bilateral vaccine, advanced purchase agreements, so they’ve taken care of themselves,” says Labonte. “Their argument is that existing TRIPS flexibilities for compulsory licenses or parallel importing is sufficient. And they also argue that patent holding companies well, they can issue voluntary licenses to other manufacturers to produce their products at negotiated prices, and indeed, many have done so with a number of other vaccine manufacturers.”
The argument that the supply problem is a broader issue of manufacturing technologies and raw materials, not one of intellectual property, was summed up by a UK delegate to the WTO with an official statement back in October. The statement questioned the benefits of even temporarily waiving the TRIPS agreement.
“A waiver to the IP rights set out in the TRIPS Agreement is an extreme measure to address an unproven problem. The UK is of the view that pursuing the proposed path would be counterproductive and would undermine a regime that offers solutions to the issues at hand. Multiple factors need to be considered to ensure equitable access for all to COVID-19 vaccines. These include increasing manufacturing and distribution capacity, measures to support or incentivise technology transfer, ensuring global supply chains remain open, and ensuring that effective platforms are utilised to voluntarily share IP and know how.”
Many pushing for a temporary waiving of COVID-related intellectual property rights realistically admit this will not be a single magic bullet that instantly increases the world’s vaccine supply. In a letter of support, the World Health Organization’s Director-General Tedros Adhanom Ghebreyesus makes it clear a TRIPS waiver would be one of many actions that could help poorer countries access vaccines.
“… boosting manufacturing won’t happen by itself,” says Tedros. “We are living through an exceptional moment in history, and must rise to the challenge. Whether it’s dose sharing, tech transfer, voluntary licensing as the WHO’s own COVID-19 Technology Access Pool initiative encourages, or waiving intellectual property rights as South Africa and India have suggested, we need to pull out all the stops.”
Idle factories and price wars
A recent Associated Press report found idle factories in India, South Africa and Denmark are all waiting on data and licensing deals from pharmaceutical companies. The report suggests these particular factories could begin manufacturing hundreds of millions of vaccine doses as soon as the companies holding the rights would let them do so.
Manufacturing resources may be waiting for licensing deals, but pharmaceutical companies are still profit-driven beasts and even the most philanthropically-minded company is still a for-profit business.
Bottom line: We have to get the entire world vaccinated, not just our own country. Otherwise, every year there’s going to be another threat as more mutants come.
Pfizer, for example, recently announced it would not be expanding its vaccine manufacturing capacity beyond its current established supply lines in US and Europe. India, a country with massive pharmaceutical manufacturing capabilities, had been in discussions for several weeks with Pfizer but recent reports suggested the company was not happy with the country’s restrictions on pricing and exports.
If Pfizer's COVID-19 vaccine were to be manufactured in India, the company must have control over where it sends the vaccine and how much it charges.
"At this time we are not in discussions for any additional local manufacturing for this vaccine," a Pfizer spokesperson recently said. "Once the pandemic supply phase is over and we enter a phase of regular supplies, Pfizer will certainly evaluate all additional opportunities available."
What is the “pandemic supply phase”?
The pandemic supply phase is an informal series of pledges from pharmaceutical companies promising COVID-19 vaccine prices will be kept low during the pandemic.
The makers of the Oxford/Astrazeneca vaccine were one of the only companies to explicitly pledge to sell doses at cost price during, and after, the pandemic. Pfizer, on the other hand, has not made a similar pledge.
Reshma Ramachandran, a physician-fellow from Yale University, believes Pfizer may already be looking to raise vaccine prices as soon as 2022.
“Pfizer told their investors recently that as soon as next year [when booster vaccinations will be required] they’re going to be moving away from “pandemic pricing” and towards price points that are on par with other vaccines that they have on the market, at $150 or $175 per dose,” says Ramachandran. “When insurance companies have to shoulder this cost, they're going to pass it down to us through our insurance premiums.”
Unfortunately, the nature of big pharma development in the 21st century means the solution to this intellectual property problem will not be simple. Mosoka Fallah, from Harvard Medical School, succinctly explains why these intellectual property protections can’t just be wholly eliminated without seriously damaging future development prospects.
“… the catch of this is that, if we allow of them to to give their IP, and there is another outbreak tomorrow would they have incentive to do research?” Fallah asks. “So the key trigger to think about is, how do we find means to meet these countries halfway, give them some funding for the R&D?”
Fallah’s solution includes the temporary TRIPS waiver, but also relies on rich countries making ethical decisions in how they distribute the vaccine doses they are accumulating. Overall, there may be enough vaccine doses currently being manufactured to distribute to everyone on the planet without extreme multi-year delays. We just need to act reasonably and distribute them equitably.
He argues every high-income country hoarding doses should share their vaccines around. And beyond the ethical argument, he suggests it is in everyone’s interest to quash this pandemic in all corners of the globe.
COVID-19 is a global problem. International borders cannot remain closed forever, and the most effective public health strategy for everyone is to make sure vaccines are evenly distributed.
Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, suggests mutant strains of the virus will continue to appear if vaccinations are not considered a global issue. Getting as many people vaccinated, in as many countries as possible, as quickly as we can, must be the priority, Fauci argues.
"Bottom line: We have to get the entire world vaccinated, not just our own country," says Fauci. "Otherwise, every year there’s going to be another threat as more mutants come."
“Small” in what sense?
“Social good” motivations will always be there and some companies will respond. But in order to respond, they must have the resources and IP to respond.l
Perhaps I missed it, but I did not see it mentioned in this story, there are at least two large multi-country consortiums focused on providing vaccines to less developed countries.