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How patent waivers could help solve COVID vaccine inequality

The World Trade Organization (WTO) General Council gathered virtually on Monday for the first of two days of talks amid increasing calls from civil society, states and nongovernmental actors to temporarily waive patents for COVID-19 vaccines and other coronavirus-related medical products.

Endorsing a waiver on Friday, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said: “If not now, when?”

At the core of the discussion stands a proposal (PDF) submitted in October by South Africa and India to suspend the WTO’s agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for the duration of the coronavirus pandemic.

The goal is to facilitate the transfer of technology and scientific knowledge to developing countries to ramp up the global production of vaccines and other necessary equipment.

“The biggest evidence [to endorse the waiver] is people that continue to die,” said Yuanqiong Hu, legal adviser for the Access Campaign for  Doctors Without Borders (Medecins Sans Frontieres, or MSF).

Several high-income countries and companies that have developed coronavirus vaccines have rejected the idea of a waiver for the duration of the pandemic.

On her first day in office on Monday, WTO Director-General Ngozi Okonjo-Iweala did not endorse either side, saying that dialogue on the proposal was “intensifying”.

Tedros Adhanom Ghebreyesus has endorsed a waiver [World Health Organization/Handout via Reuters]

Growing calls for waiver

Nearly one year into the pandemic, three-quarters of the current vaccine supply has been secured and administered by 10 countries that account for 60 percent of global economic growth, the WHO said in early February. By contrast, about 130 countries – home to 2.5 billion people – had not received a single dose, the United Nations health agency said.

The UN-backed COVID-19 Vaccines Global Access Facility (COVAX), a scheme designed to boost the distribution of vaccines to low-income nations, has since begun sending shipments to some countries. Ghana and the Ivory Coast each received hundreds of thousands of doses last week and dozens of other African countries are expected to receive shipments this week, but the disparity between high- and low-income countries remains vast.

The strikingly unequal distribution of vaccines has boosted support for India and South Africa’s proposal, which now counts 100 supporters among WTO members, including 58 official sponsors.

Last week more than 400 organisations in the United States joined forces, calling on US President Joe Biden to endorse the waiver, while 115 members of the European Commission issued a declaration (PDF) urging the European Union to drop its opposition to the temporary suspension. The African Union on Thursday backed the relaxing of rules on intellectual property (IP), calling it a “win-win for everybody”.

What are the arguments?

Several high-income countries – including the US, the United Kingdom and members of the European Union – pushed back at the WTO, arguing that waiving patents would hamper scientific innovation by deterring private investment and that existing regulations, which allow drugmakers to voluntarily engage in bilateral agreements with generic manufacturers, are already flexible enough when it comes to tackling a public health emergency.

Supporters of the plan disagree that a waiver would hamper scientific development, ­­­­­­­­and point out that vaccine developers received about $10bn in public and non-profit funding for their vaccine candidates, with five top companies securing between $950m and $2.1bn in funding commitments, mostly from the Coalition for Epidemic Preparedness Innovations (CEPI) and the US government, as reported by The Lancet medical journal.

In terms of developing countries’ production capacity, proponents of the waiver pointed to already existing networks, such as the Developing Countries Vaccine Manufacturers Network (DCVMN). Comprised of 41 members – including the Serum Institute of India, the world’s largest vaccine maker – the DCVMN has supplied some 3.5 billion vaccines to the globe annually.

“There is definitely capability out there but it won’t happen overnight,” said Tahir Amin, cofounder and co-executive director of I-MAK, a global non-profit organisation advocating for equitable access to medicines.

“Companies might have to do some restructuring and get funds. But by removing IP, then governments might make investments and within a year we could have a new setup,” said Amin.

“Considering mutations, more outbreaks – the fact that we need more manufacturers and not to rely on a few is imperative now,” he added.

A waiver would not just enable the establishment of a practical framework to scale up production amid a pandemic, but would send a strong public health message, according to Fatima Hassan, founder and director of the Health Justice Initiative.

“It is also a moral victory to say that we have a new order where IP cannot trump patients’ and public health’s needs – this is at the heart of it,” said Hassan, who has conducted public interest litigation against the South African government, private employers and pharmaceutical companies on behalf of people with HIV/AIDS in South Africa.

Age-old argument

The debate over intellectual property rights, while gaining traction in recent months, is not new.

At the peak of the global HIV/AIDS crisis in the 1990s, millions of people in the developing world died without access to necessary drugs that were available on the market but were prohibitively expensive due to patents’ rules.

It took a three-year fight before South Africa managed to import cheap antiretroviral drugs by removing some patent barriers after drug makers dropped a lawsuit accusing the country of infringing on international trade agreements.

In 2001, WTO countries reached a landmark agreement by passing the Doha Declaration, which allowed member states to seek compulsory licensing when faced with extreme emergencies. It meant that governments were allowed to waive IP rights without the licence owner’s consent.

Opponents to the waiver argue that compulsory licensing means that WTO members have sufficient flexibility regarding IP protections and that a temporary waiver is unnecessary.

But experts warn the procedure is lengthy and complicated and its use would likely be met with fierce political resistance.

When dealing with the production of complex drugs, such as mRNA vaccines, a manufacturer could seek a compulsory licence to overcome any patent barriers to producing the vaccine, but this will not give access to other elements needed to produce vaccines such as know-how, cell lines, and regulatory filings.

“For that to happen, direct technology transfer is necessary,” said Ellen ‘t Hoen, director of Medicines Law & Policy. And for that purpose, the WHO has established the COVID-19 Technology Access Pool (C-TAP), where companies can share their know-how.

“However, so far the C-TAP is empty,” said Hoen. “COVID-19 development has been largely funded with public money, so the request to share the know-how developed with this public financing is not only necessary but also reasonable.”

Compromise?

Supporters and opponents to the waiver plan have been engaging in a circular discussion without reaching a breakthrough, but “there is an understanding that something has to be done”, said South Africa’s WTO representative Mustaqeem De Gama.

While it may still take some time before finding a convergence between the two sides, De Gama said, there is hope that countries will show at the council “at least a willingness to address the text of the proposal to see if we can find a landing zone”. The issue will likely be discussed again at the WTO TRIPS Council meeting on March 10.

But despite the growing public support for the India-South Africa plan, Amin believes it is more likely that governments could strike a compromise by pressuring drug companies to grant more voluntary licences to manufacturers located in the Global South.

So far, the existing arrangements between drugmakers and manufacturers in the developing world include Johnson & Johnson with Aspen Pharmacare in South Africa, while AstraZeneca and Novavax have made deals with the Serum Institute of India.

After Monday’s meeting, Okonjo-Iweala urged WTO members to work with drugmakers to license more vaccine manufacturing in developing countries.

“I propose that we ‘walk and chew gum’ by also focusing on the immediate needs of dozens of poor countries that have yet to vaccinate a single person. People are dying in poor countries,” she said in a speech.

“The world has a normal capacity of production of 3.5 billion doses of vaccines and we now seek to manufacture 10 billion doses.”




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