The General Council of the World Trade Organization (WTO) met virtually on Monday for the first of two days of talks amid growing calls from civil society, states and non-state actors to temporarily waive patents for COVID-19 vaccines and other coronavirus-related medical products.
Approving a waiver on Friday, the Director-General of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, said: “If not now, when?”
At the heart of the discussion is a proposal (PDF) submitted in October by South Africa and India to suspend the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for the duration of the coronavirus pandemic.
The aim is to facilitate the transfer of technology and scientific knowledge to developing countries in order to accelerate the global production of vaccines and other necessary equipment.
“The greatest proof [to endorse the waiver] these are people who continue to die, ”said Yuanqiong Hu, legal advisor for the access campaign for Médecins Sans Frontières (Médecins Sans Frontières, or MSF).
Several high-income countries and companies that have developed coronavirus vaccines have rejected the idea of an exemption for the duration of the pandemic.
On her first day in office on Monday, WTO Director-General Ngozi Okonjo-Iweala disagreed with either side, saying dialogue on the proposal “was intensifying.”
More and more calls for exemption
Almost a year after the start of the pandemic, three-quarters of the current vaccine supply has been secured and administered by 10 countries which account for 60% of global economic growth, the WHO said in early February. In contrast, around 130 countries – home to 2.5 billion people – had not received a single dose, the United Nations health agency mentionned.
The UN-backed COVID-19 Global Vaccine Access Mechanism (COVAX), a program designed to boost vaccine distribution to low-income countries, has since started sending shipments to some countries. Ghana and Cote d’Ivoire each received hundreds of thousands of doses last week and dozens more African countries are expected to receive shipments this week, but the disparity between high and low income countries remains vast.
The surprisingly uneven distribution of vaccines has bolstered support for the proposal from India and South Africa, which now has 100 supporters among WTO members, including 58 official sponsors.
Last week, more than 400 organizations in the United States joined forces, calling on US President Joe Biden to approve the waiver, while 115 members of the European Commission issued a statement (PDF) urging the European Union to drop its opposition to the temporary suspension. The African Union on Thursday backed the relaxation of intellectual property (IP) rules, calling it a “win-win for everyone”.
What are the arguments?
Several high-income countries – including the United States, the United Kingdom and members of the European Union – have pushed back the WTO, arguing that patent waiver would hamper scientific innovation by discouraging private investment; and that existing regulations, which allow drug manufacturers to voluntarily enter into bilateral agreements with generic manufacturers, are already flexible enough to cope with a public health emergency.
Supporters of the plan disagree that a waiver would hamper scientific development and point out that vaccine developers have received around $ 10 billion in public and nonprofit funding for their vaccine candidates, big five. companies securing between $ 950 and $ 2.1 billion in funding commitments, mainly from the Coalition for Epidemic Preparedness Innovations (CEPI) and the US government, such as reported by The Lancet medical journal.
Regarding the production capacity of developing countries, supporters of the waiver pointed to already existing networks, such as the Developing Country Vaccine Manufacturers Network (DCVMN). Comprised of 41 members – including the Serum Institute of India, the world’s largest vaccine manufacturer – DCVMN has supplied some 3.5 billion vaccines to the world each year.
“There is certainly capacity there, but it won’t happen overnight,” said Tahir Amin, co-founder and co-executive director of I-MAK, a global nonprofit that advocates for a equitable access to medicines.
“Companies may need to restructure and get funds. But by removing intellectual property, governments could then make investments and within a year we could have a new setup, ”Amin said.
“With the mutations, more epidemics – the fact that we need more manufacturers and not rely on a few is imperative now,” he added.
A waiver would not only provide a practical framework for increasing production in the midst of 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 in which intellectual property cannot trump patient and public health needs – it is at the heart of it,” said said Hassan, who has led a public interest lawsuit against the South African government. private employers and pharmaceutical companies on behalf of people living with HIV / AIDS in South Africa.
The debate over intellectual property rights, while gaining ground in recent months, is not new.
At the height of the global HIV / AIDS crisis in the 1990s, millions of people in the developing world died without access to necessary drugs available on the market but at prohibitive cost due to patent rules .
It took three years of struggle for South Africa to successfully import cheap antiretroviral drugs by removing some patent barriers after drug makers dropped a lawsuit accusing the country of violating international trade agreements.
In 2001, WTO countries reached a landmark agreement by adopting the Doha Declaration, which allowed member states to apply for compulsory licenses when faced with extreme emergencies. This meant that governments were allowed to give up intellectual property rights without the consent of the licensee.
Opponents of the waiver argue that compulsory licensing means that WTO members have sufficient flexibility in intellectual property protection and that a temporary waiver is not necessary.
But experts warn the procedure is long and complicated, and its use would likely meet fierce political resistance.
When it comes to producing complex drugs, such as mRNA vaccines, a manufacturer could apply for a compulsory license to overcome patent obstacles to vaccine production, but this will not provide access to other elements. necessary for the production of vaccines such as know-how, cell lines and regulatory repositories.
“For this to happen, direct technology transfer is needed,” said Ellen ‘t Hoen, director of Medicines Law & Policy. And to that end, WHO has created the COVID-19 Technology Access Pool (C-TAP), where companies can share their know-how.
“However, so far the C-TAP is empty,” Hoen said. “The development of COVID-19 has been largely funded by public funds, so the request to share the know-how developed with this public funding is not only necessary but also reasonable.”
Supporters and opponents of the waiver plan have engaged in a circular discussion without achieving a breakthrough, but “it is understood that something needs to be done,” said Mustaqeem De Gama, South Africa’s representative at the WTO.
Although it may still take some time to find convergence between the two sides, De Gama said, there is hope that countries will show the council “at least a willingness to address the text of the proposal. to see if we can find a landing. area “. The issue will likely be discussed again at the WTO TRIPS Council meeting on March 10.
But despite growing public support for the India-South Africa plan, Amin believes it is more likely that governments can find a compromise by pressuring drug companies to grant more voluntary licenses to manufacturers located in South.
So far, existing agreements between drug makers and manufacturers in developing countries include Johnson & Johnson with Aspen Pharmacare in South Africa, while AstraZeneca and Novavax have entered into agreements with the Serum Institute of India.
After Monday’s meeting, Okonjo-Iweala urged WTO members to work with drug makers to allow more vaccine manufacturing in developing countries.
“I suggest that we ‘walk and chew gum’ while also focusing on the immediate needs of dozens of poor countries that have yet to immunize a single person. People are dying in poor countries, ”she said in a speech.
“The world has a normal production capacity of 3.5 billion doses of vaccine and we are now looking to manufacture 10 billion doses.”