The world powers, the main vaccine producers, open the door for the first time to the suspension of the intellectual property rights of the vaccines against COVID-19. The first has been the United States, matching the announcement with the recent meeting of G7 ministers in London.
Taking a Copernican twist on the Trump administration and in light of the havoc the virus is wreaking in countries like India, the United States has said it supports releasing patents on vaccines.
This option has been debated for months in the World Trade Organization, promoted by countries such as South Africa or India. However, the “positive vote” of the Trump Administration gives a new dimension to the debate.
The European Commission has already said it is ready to study the issue. France and Germany have also been favorable, although with a little less enthusiasm.
The director of the World Health Organization Tedros Adhanom Ghebreyesus has celebrated it on his Twitter account. “I congratulate the United States on this historic decision to support vaccine equity, putting the well-being of people around the world first at this crucial time. Now let us all move quickly, in solidarity, to harness the ingenuity and commitment of the scientists who produced the life-saving COVID19 vaccines. ” In another tweet, Tedros published the statement from the US Trade Office calling it a “monumental moment.”
WTO Director Ngozi Okonjo-Iweala, in statements posted on the website of the organization that regulates world trade, said that “it is incumbent upon us to move quickly to put the revised text on the table, but also to initiate and undertake negotiations based on in the text”.
“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,” he said.
Co-sponsors of the idea traveled between different diplomatic missions to make their case, according to a Geneva trade official who was not authorized to speak publicly on the matter. The agreement remains at a standstill and the warring parties remain far apart, the official said.
The African Union also celebrates the “remarkable expression of leadership” that the United States has demonstrated.
So who is opposed to the liberalization of patents on vaccines?
If the major powers seem to agree, why hasn’t patent liberalization already taken place? Who is opposed?
Until now it was mainly the rich countries, which also control patents: the United States, the EU, the United Kingdom, Australia, Canada, Brazil, Norway, Japan, Switzerland … Despite the fact that 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 described as “a scandal that affects us all.”
Beyond the strategic national interests of the vaccine-producing countries, representatives of the pharmaceutical industry have not been slow to react by regretting a decision that in their opinion will not allow the manufacture and distribution of more vaccines and faster.
“The decision by the United States to support the temporary suspension of patents for vaccines against COVID-19 is” disappointing “, said the International Federation of the Pharmaceutical Industry (IFPMA).
“We are fully aligned with the goal of Covid 19 vaccines being shared quickly and equitably around the world. But, as we keep saying, a suspension is the simple but wrong answer to a complex problem,” the lobby statement continues. pharmacist.
“Suspending patents will not increase production or provide the practical solutions needed to combat this global health crisis,” IFPMA said. The industry also warns that lifting patents may jeopardize future innovation.
Stephen Ubl, president and CEO of 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 will 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.
“Giving countries in need a recipe book without the necessary ingredients, safeguards and considerable manpower will not help the people waiting for the vaccine,” he 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.
Is the problem the supply and distribution chains?
According to the pharmaceutical industry lobby, the motion being debated by the WTO and supported by many non-governmental organizations could even be detrimental by distracting from the real challenges facing production and distribution. According to IFPMA, the real problems are trade barriers, bottlenecks in distribution, a shortage of raw materials – on which the United States also promises to act – and the limited willingness of the richest countries to share the doses with the countries. Developing.
Rich countries have hoarded the available doses. However, letting the virus continue to evolve freely in the poorest countries puts at risk the usefulness of the vaccination strategy for the entire planet.
The arguments put forward by the IFPMA are the same ones that it had been defending since the debate began within the World Trade Organization. In a debate with industry professionals organized by the WTO, attended by IFPMA, pharmaceutical companies insisted that the problem was not so much intellectual property as trade barriers and manufacturing problems.
“Making vaccines is not just about patents,” said Sai Prasad, president of the Network of Vaccine Manufacturers of Developing Countries, which brings together laboratories from developing countries.
“It’s a very complex industry, with complicated science, very complicated manufacturing processes … We have to be very careful with whom we transfer technical knowledge,” he said, especially because of safety and quality imperatives.
“We don’t want to do anything to undermine confidence in vaccines,” said Michelle McMurry-Heath, president of the Biotechnology Innovation Organization (BIO), a group of biotech companies.
“We have to recognize that there are only a handful of labs in the world that have the expertise, and we have to focus our efforts on making sure they have access to the ingredients they need to produce the largest number of doses as quickly as possible,” he said .
Michael Yee, a biotech analyst at Jefferies Group, wrote to investors that the main access problems for developing countries are not patents or price, but an inadequate supply of the necessary materials and technical know-how to produce the vaccines and maintain high quality, something one of Johnson & Johnson’s contract manufacturers in the United States 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 continue to be in supply next year and beyond, Yee wrote. That’s in part because it takes time to make all of those components, and Moderna and Pfizer have commitments to buy them “from major suppliers in bulk for the foreseeable future.”
He added that Pfizer has already applied for authorization to sell its vaccine to India, which has rejected its application and asked for additional studies to be carried out. The United States, the European Union and many other countries have given such emergency authorization.
Something as trivial as a shortage of plastic bags or filters can ruin the job. The lipids that protect messenger RNA are sometimes lacking in Pfizer-BioNTech and Moderna vaccines.
The industry estimates that more than 100 vaccine ingredients are not currently available.
The IFPMA director insisted that there are some 275 production agreements between laboratories – sometimes rival ones – to reach the goal of 10 billion doses of vaccines produced by the end of the year.