The world”s major vaccine-producing countries are for the first time opening the door to the suspension of intellectual property rights for COVID-19 vaccines.
The first was the United States, making the announcement to coincide with the recent G7 ministers’ meeting in London.
In a U-turn from the Trump administration and in view of the havoc the virus is wreaking in countries such as India, the US has said it supports releasing vaccine patents.
This option has been debated for months at the World Trade Organization (WTO), pushed by countries such as South Africa and India. However, the Biden administration’s backing gives a new dimension to the debate.
The European Commission has already said it is willing to discuss the issue. France and Germany have also been in favour.
The head of the World Health Organization (WHO) Tedros Adhanom Ghebreyesus welcomed the US’ announcement: “I commend the United States on its historic decision for vaccine equity and prioritizing the well-being of all people everywhere at a critical time. Now let’s all move together swiftly, in solidarity, building on the ingenuity and commitment of scientists who produced life-saving COVID-19 vaccines.”
WTO chief Ngozi Okonjo-Iweala, in remarks posted on the global trade body’s website, said “it is incumbent on us to move quickly to put the revised text on the table, but also to initiate and engage in text-based negotiations”.
“I am firmly convinced that once we can sit down with a real text in front of us, we will find a pragmatic way forward” that is “acceptable to all parties,” she said.
The co-sponsors of the idea shuttled between diplomatic missions to make their case, according to a Geneva trade official who was not authorised to speak publicly on the matter. The deal remains deadlocked and the warring parties remain far apart, the official said.
The African Union also welcomed the “remarkable expression of leadership” shown by the United States.
So who opposes lifting vaccine patents?
Until now it has mainly been the rich countries, which also control the patents: the US, the EU, the UK, Australia, Canada, Brazil, Norway, Japan, Switzerland.
This is despite the fact the Doha Agreement provides for the temporary lifting of intellectual property in the event of a public health emergency in what some NGOs such as Human Rights Watch have called a “scandal that affects us all”.
Beyond the national strategic interests of vaccine-producing countries, representatives of the pharmaceutical industry have been quick to react, deploring a decision that in their view will not allow more vaccines to be produced and distributed faster.
“The decision by the United States to support the temporary suspension of patents on COVID-19 vaccines is “disappointing”, said the International Federation of the Pharmaceutical Industry (IFPMA).
“We are fully aligned with the goal of rapid and equitable global sharing of Covid 19 vaccines. But, as we keep saying, a suspension is the simple but wrong answer to a complex problem,” the pharma lobby statement continues.
“Suspending patents will not increase production or provide the practical solutions needed to combat this global health crisis,” said the IFPMA. The industry also warns that lifting patents could jeopardise future innovation.
Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the US decision “will sow confusion among public and private partners, further weaken already strained supply chains, and encourage the proliferation of counterfeit vaccines”.
Dr Michelle McMurry-Heath, executive director of the Biotechnology Innovation Organization trade group, said in a statement that the decision will undermine incentives to develop vaccines and treatments for future pandemics.
“Delivering to countries in need a recipe book without the necessary ingredients, safeguards and considerable manpower will not help the people waiting for the vaccine,” she said.
Pfizer declined to comment on Biden’s announcement, as did Johnson & Johnson, which developed a single-dose vaccine intended to facilitate vaccination campaigns in poor and rural areas.
Moderna and AstraZeneca did not immediately respond to requests for comment.
Are supply and distribution chains the problem?
According to the pharmaceutical industry lobby, the motion being debated by the WTO and supported by numerous NGOs, could even be detrimental by distracting from the real challenges facing production and distribution.
According to the IFPMA, the real problems are trade barriers, distribution bottlenecks, shortages of raw materials — on which the US also pledges to act — and the limited willingness of richer countries to share doses with developing countries.
Rich countries have hoarded the available doses. But letting the virus continue to thrive in poorer countries puts the usefulness of the global vaccination strategy at risk.
IFPMA’s arguments are the same as those it has been arguing since the debate began at the WTO. In a discussion with industry professionals organised by the WTO, which IFPMA attended, pharmaceutical companies insisted that the problem was not so much intellectual property as trade barriers and manufacturing problems.
“Vaccine manufacturing is not just about patents,” said Sai Prasad, chairman of the Developing Countries Vaccine Manufacturers Network, which brings together laboratories in developing countries.
“It’s a very complex industry, with complicated science, very complicated manufacturing processes. We have to be very careful who we transfer expertise to,” he said, not least because of safety and quality imperatives.
“We don’t want to do anything that undermines confidence in vaccines,” said Michelle McMurry-Heath, president of the Biotechnology Innovation Organisation (BIO), a group of biotech companies.
“We have to recognise that there are only a handful of labs in the world that have the expertise, and we need to focus our efforts on making sure they have access to the ingredients they need to produce as many doses as quickly as possible,” she said.
Michael Yee, a biotech analyst at Jefferies Group, wrote to investors that the main access issues for developing countries are not patents or price, but an inadequate supply of the necessary materials and expertise to produce vaccines and maintain high quality, something one of Johnson & Johnson’s contract manufacturers in the US failed to do, ruining millions of doses.
“Manufacturing supplies, raw materials, vials, caps and other key materials are in limited supply for 2021,” and may remain so next year and beyond, Yee wrote. That’s partly because it takes time to make all those components, and Moderna and Pfizer have commitments to buy them “from major suppliers in large quantities for the foreseeable future.”
He added that Pfizer has already applied for authorisation to sell its vaccine to India, which rejected its application and asked for additional studies. The US, the EU, and many other countries have given such emergency authorisation.
The industry estimates that more than 100 vaccine ingredients are currently unavailable.
The IFPMA director insisted that there are some 275 production agreements between – sometimes rival – laboratories to reach the target of 10 billion doses of vaccine produced by the end of the year.