A Dangerous Divide: The Growing Debate over the Suspension of Vaccine Patents

During the more than three decades Brazilian Senator Paulo Paim has been a member of parliament, he has always been a voice for people who look up at the world from below. Paim has introduced laws aimed at establishing a minimum wage and at ensuring equality for Black people and the disabled. “I am 71 years old,” he says. “I have fought so many battles. But none of them have been as important as this one.”

Paim’s message is printed in large blue letters on the white T-shirt he is wearing: “Breaking Patents Saves Lives!”

Brazil is among the countries that have been hardest hit by the ongoing coronavirus pandemic. More than 400,000 people have already lost their lives to COVID-19 in the country, with 20,000 additional fatalities every single day. At the same time, and this is Paim’s focus, the nationwide vaccination campaign is only slowly gaining momentum. Fewer than 10 percent of all Brazilians are completely vaccinated. And because supplies are limited, many large cities have suspended the administering of second doses in recent days.

For a long time, Brazilian President Jair Bolsonaro showed little interest in obtaining large quantities of vaccine. Bolsonaro thought the best way to protect the Brazilian population from COVID-19 was to simply allow the disease to spread through the country. Now that he appears to have come to the realization that it will be difficult to achieve herd immunity without the help of the vaccines, the people in his administration tasked with buying them find themselves confronted with a sold-out marketplace.

“Only One Path”

Brazil isn’t the only country suffering from the shortage. Vaccine is in short supply across Latin America, much like in Africa, and in India, which is currently suffering from a vicious wave of infection. Paim, a member of former President Lula da Silva’s Workers’ Party, points to his T-shirt.

“There is only one path out of this catastrophe,” he says. “Capacities around the world must be boosted and the production of vaccine accelerated. To do so, the pharmaceutical companies must share their knowledge and technology, so countries like Brazil can produce large amounts themselves.”

A deep divide currently runs through the world. Wealthy countries with plenty of vaccine are on the brink of returning to some semblance of normalcy and officials there are already talking about rolling out additional booster shots for the vaccinated starting in 2022. In poorer countries, where little vaccine is available, it currently looks like the pandemic will last until 2023 or even 2024 – meaning more lockdowns, school cancellations, economic crises and mass unemployment. And many thousands of deaths.

This divide isn’t just deeply unjust, it is also extremely dangerous – for everyone. For as long as the virus can spread, it will continue to produce new variants that may prove fateful for the entire world, including to those who have already been vaccinated.

The solution is as simple as it is complicated. Humanity needs more vaccine – a lot more, and quickly. And it must be available everywhere. The central question, though, is how best to fulfill that need. Pharmaceutical concerns, their critics, and governments are trying to find an answer, and not everyone has arrived at the same conclusion.

Two positions stand in opposition to each other. There are good arguments for each – and they could both be wrong.

Historical Precedent

A growing number of countries and international organizations would like to temporarily wrest control of vaccine patents from the hands of pharmaceutical companies. The hope is that production can be expanded as rapidly as possible without having to worry about intellectual property, licensing fees or legal challenges. Many poorer countries, after all, have their own pharmaceutical industries, which aren’t currently being used.

Those in favor of temporarily suspending patents point to the HIV/AIDS epidemic. When antiretroviral therapy came on the market in wealthy countries in the 1990s, it almost immediately stopped AIDS deaths. But the drug cocktail’s high price put it out of reach for HIV patients in Africa and almost all other poor countries, where millions of people subsequently died.

In November 2001, an international campaign against this inequity finally bore fruit. Since the Doha Declaration was issued by the World Trade Organization, it has been legal to copy and sell the HIV/AIDS drugs in more than 50 poorer countries. Per-capita treatment costs plunged by 99 percent in numerous developing and emerging countries, making the life-saving treatment affordable for those who needed it. Since then, Brazil has even been providing the drug cocktail at no cost.

India and South Africa are demanding the same principle be applied to COVID-19 vaccines. They submitted an application to the WTO in October 2020. The WTO General Council discussed the issue this week in Geneva, but the consensus necessary to implement it seemed out of reach – until U.S. President Joe Biden announced a spectacular reversal on Wednesday.

Katherine Tai, the U.S. trade representative at the WTO, announced that the U.S. would back the suspension of patents for coronavirus vaccines. “These extraordinary times and circumstances call for extraordinary measures,” she said in justifying the about-face. But she sought to temper high hopes, saying that the WTO negotiations would take time.

Immediately following her announcement, the stock prices for BioNTech, Moderna, Curevac and Pfizer all dropped, and those in favor of suspending patents celebrated. An imposing array of people and groups had pushed Biden to take the step, including Amnesty International, UNICEF, UNAIDS, Doctors Without Borders, Pope Francis and UN Secretary General Antonio Guterres.

An illustrious group of 176 former heads of state and government as well as several Nobel Prize laureates also wrote an open letter to Biden. Signatories included Mikhail Gorbachev, François Hollande and Gordon Brown, as well as Malala, the human rights activist, and Joseph Stieglitz, the globalization critic. “A WTO waiver is a vital and necessary step to bringing an end to this pandemic,” the letter read.

European Commission President Ursula von der Leyen is also suddenly prepared to discuss a suspension of patent protections. She had consistently been strictly opposed, as were countries like Britain, Switzerland, Japan – and even Brazil. They are all home to leading pharmaceutical companies and had long expressed the conviction that patent law is not a limiting factor when it comes to expanding production.

Skepticism from the Pharma Sector

The pharmaceutical companies have reacted with displeasure and disgust. For months, they have been insisting that they can only continue long-term research projects if they are able to earn money from that research. Withdrawing that right, they say, is a disincentive to such investments and could slow medical advances.

The Association of Research-Based Pharmaceutical Companies in Germany warned, with a threatening undertone, that without patent protections, “original manufacturers would no longer have an incentive to participate in making vaccines available worldwide as quickly as possible.”

Some economists agreed with them. The world would be better advised, they say, to provide the companies with bonus payments for producing additional vaccine doses. They argue that such an incentive system would be more effective than suspending patent protections.

And it’s true that the producers can’t be accused of dawdling on vaccine production. According to the London-based analysts at Airfinity, the pharmaceutical companies have already delivered 1.3 billion doses, just half a year after the first vaccine received emergency approval.

They have also been displaying an unusual degree of flexibility, signing more than 150 contracts with external producers to expand production. The AstraZeneca vaccine, for example, is being made by licensed producers in India, Brazil and Argentina. The French pharma-giant Sanofi is helping Moderna and BioNTech with vaccine packaging. The chemical multinational Bayer, which has no experience of its own in producing vaccines, is assisting the Tübingen-based company Curevac with production and delivery.

In normal times, pharmaceutical companies wage war against each other, but now they are working together closely. Cooperation with the World Health Organization (WHO), however, has apparently been more difficult: Since May 2020, the WHO has been home to a “technology access pool” called C-TAP, which is intended to encourage Western companies to share their vaccine knowledge and license-free products. The idea is for poorer countries to draw from the pool to produce imitation products. Thus far, not a single firm has made use of the pool.

COVAX, an international initiative designed to help 90 poorer countries gain access to free or discount vaccines, is doing better. The program, of which the WHO is a participant, has already distributed 50 million vaccine doses, many of which were donated either by vaccine producers themselves or by the countries where they are located. Still, the program is a long way from its goal of providing 2 billion doses in 2021. With the entire world yearning for vaccines, it is hardly surprising that the race is currently being won by those with money and power.

Complicated Process

But not every measure that appears promising at first glance is actually helpful. Last year, Moderna announced it would not be enforcing its patent rights during the pandemic. The company received high praise for the announcement, but the plaudits were premature. The company has taken few steps since then to share the secrets of mRNA vaccine production with other firms.

“Without proper guidance and expertise, just having access to intellectual property won’t necessarily mean more vaccines will be produced,” says Matt Linley, an analyst with Airfinity.

That is the primary hurdle, especially when it comes to mRNA vaccines, which have proven to be highly effective and which can be, at least theoretically, produced rapidly and in high volume. But the production of such vaccines is highly complex. They are completely new, and there is a lack of global expertise when it comes to the steps and ingredients involved. In contrast to AIDS treatments, it isn’t enough to simply post the recipe on the internet.

The U.S. produced BioNTech-Pfizer vaccine, for example, requires 280 components delivered by 86 suppliers in 19 countries. All those ingredients can only be combined to produce an effective vaccine when they arrive in the right place at the right time and if they are of sufficient quality. A single mistake in the process and the entire batch must be thrown out.

What, then, should be done? Will Biden’s decision to support patent suspension prove beneficial? Not necessarily, says Thomas Bollyky, a global health expert at the Council on Global Relations, a renowned Washington think tank.

Bollyky had been worried that the U.S. president might succumb to the temptation to temporarily suspend patents. But he wasn’t concerned on behalf of the companies. Instead, Bollyky, 47, believes Biden is following the path of least resistance and that his decision won’t help.

Bollyky would like to see countries pursue a much larger vision. Vaccine production must be expanded to many more countries, but not in a manner that sees pharmaceutical companies without experience in producing mRNA vaccines stumbling through the process as they search the world for vaccine components.

A Need for Leadership

The analyst would prefer to see a kind of international effort under the leadership of the wealthiest countries. He wants the G-20 – the group of the world’s 19 largest economies plus the EU – to quickly name a person and an agency responsible for the orderly escalation of global production. Bollyky has little interest in whether that takes place with or without patents.

The most important task of such a multi-national vaccine agency would be to expand functioning supply chains across borders and pool suitable partner companies that may not have quickly found each other without such an international effort. In almost all economies smaller than that in the U.S. or EU, says Bollyky, it is impossible to develop the kinds of supply chains that are necessary to manufacture a product as complicated as an mRNA vaccine. There would be a constant shortage of essential materials like special lipids, filters, pumps, vaccine bottles and needles.

Companies in these countries are thus dependent on international cooperation and coordination, on political support and on extremely generous credit conditions. Only when all of that is guaranteed can the rapid, global expansion of production capabilities be successful, says Bollyky.

The analyst, though, doubts whether the U.S. or the EU is really prepared to take on such a leadership role. Although time is of the essence, political leaders are hesitating, he says. “Right now there seems to be such hesitance on the part of global leaders to start planning for global vaccine production while they are still vaccinating their own citizens.”