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The shortage and difficulty of accessing vaccines against covid-19 sparked a great debate between countries: would it be possible to break the patents of immunizers to lower the price of doses and ensure that billions of people are vaccinated in the next few months?
In October last year, India and South Africa brought a proposal to suspend patents for products to combat the coronavirus to the World Trade Organization (WTO), the body that regulates intellectual and industrial property across the globe.
The idea would be to facilitate vaccine production in poor countries and ensure that billions of people have access to the immunizer at the same rate as richer populations. Currently, the main vaccines against COVID-19 belong to American, European and Chinese laboratories, although some of them have been funded in part by the government and by philanthropists, and this is one of the arguments in favor of “breaking the patents “.
On the other hand, it is not clear how big the benefit that big pharmaceutical companies will obtain from vaccines; This calculation depends on the price of the doses and how many times the population will have to be vaccinated in the future. Typically, companies charge different amounts depending on the country, depending on what governments can afford. But there are also fears that too high a price could lead to accusations that companies are taking advantage of the humanitarian crisis caused by the pandemic.
In November, 99 countries supported the project in India and South Africa, but developed countries opposed it. The Brazilian government, reversing a historical position on the issue, sided with the richest in the discussion.
The initiative was supported by the Médecins Sans Frontières organization. Sidney Wong, executive director of the entity’s access to medicines campaign, said the dispute is a sign of the behavior of countries and companies. “Governments must ask themselves which side of history they want to be on when the books on this pandemic are written,” he told the UOL portal in November.
But what would be the possibility of “breaking” vaccine patents? Is there a legal means for this? Could Brazil do something about it? BBC News Brazil listened to patent experts and researchers on the subject to answer these questions.
In summary, the interviewees clarify: almost no movement in this direction would solve the vaccine shortage in Brazilian territory.
What is “patent breaking”?
Unilaterally “breaking a patent”, without negotiation, would violate international intellectual property treaties, and the act would possibly be punished.
The current rules of intellectual property were formulated in the WTO in 1994: they are called Trips, in the acronym in English. The agreement was championed by the United States and other wealthy countries, and standardized a series of patent rules that all WTO members must follow to participate in the body. One of them stipulates a minimum limit of 20 years for the patent of a drug to expire, for example.
Two years later, in 1996, Brazil approved Law 9,279, which regulates intellectual property in the country, already under the influence of Travel. Other countries, such as China and India, took longer to adapt to the new rules; Experts believe that this waiting period was essential for Indians and Chinese to become the world’s largest producers of medical supplies.
“The trips were an imposition of the rich countries to protect their patents and maintain capital in a hegemonic way. Brazil quickly followed the new rules, unlike other countries, which preferred to wait and invest in local production”, explains Roberta Dorneles, professor of the Department. of Collective Health of the Federal University of Rio Grande do Sul (UFRGS) and patent researcher in the pharmaceutical industry.
Compulsory license
On the other hand, pressure from emerging countries made it possible to apply an alternative to the Trips rules in times of emergency or of public interest: the compulsory license. This mechanism has already been used several times to combat anti-competitive practices in the area of technology, including the medication sector.
In a hypothetical case, a country like Brazil can claim that the Covid-19 pandemic is a health emergency and that there is great public interest in making vaccines cheaper to be applied to the entire population more quickly.
“The president can decree a national emergency and inform international laboratories that Brazil will compulsorily license the vaccine formula. Brazilian laboratories could then manufacture the vaccine, reducing the production price, but paying royalties to the patent holders”, explains Maristela Basso, professor of International Intellectual Property Law at the University of São Paulo (USP).
“The compulsory license is foreseen and recognized by the WTO. The international agreement allows this mechanism, and it has already been used on other occasions, including by Brazil,” says Roberta Dorneles, from UFRGS.
In 2007, during the government of Luiz Inácio Lula da Silva (PT), Brazil declared that the patent for efavirenz, a drug used in the treatment of AIDS, was in the public interest and would be required to license it. The drug belonged to the US laboratory Merck Sharp & Dohme.
At that time, the government stated that the amount charged by the laboratory was less than that practiced in other countries, exponentially increasing the expenses of the Unified Health System (SUS).
“There was a lot of pressure on Brazil, as companies threatened to leave the country if the government authorized the drug. But none of them kept their promise,” explains Reinaldo Guimarães, professor at the Center for Bioethics and Applied Ethics at the Federal University. of Rio de Janeiro (URFJ) and vice president of the Brazilian Association of Public Health (Abrasco). “This patent was interesting, because, in addition to the compulsory licensing of Brazil, it imported the technology to produce the drug in the country.”
The efavirenz case was the only “patent breach” in Brazil in the area of medicines, but it was not the first time that the country used compulsory licensing to lower prices. In 2001, 2003 and 2005, the country threatened to use the device against pharmaceutical companies, also for AIDS drugs, and managed to lower the values.
“History shows that the industry decided to negotiate prices and access to the drug when it was pressured by the declaration of emergency and public interest,” says Maristela Basso, from USP, who was a consultant to the Ministry of Health in the area of Patents when Brazil obtained the compulsory efavirenz license.
‘Breaking a patent does not solve the problem’ in the pandemic
When the patent relaxation project was discussed in the WTO, the government of Jair Bolsonaro (without a party) took no position. In other words, at the moment there is no information that Brazil plans to activate the compulsory license device for covid-19 vaccines.
On the other hand, experts believe that the vaccine license would not solve the problem of producing the immunizer in Brazil or in other developing countries, at least not in the short term. This is due to the technological and input lag, many of them imported from China and India.
“I don’t think licensing is at the center of the vaccine debate. This is an important tool, but I don’t think there is any political or technological feasibility to do it. Brazil would not have the technical capacity to produce these vaccines, especially those with messenger RNA, such as the Pfizer and Moderna versions, ”says Reinaldo Guimarães, from Abrasco.
Most vaccines are made with an attenuated or inactivated virus, which causes our immune systems to produce antibodies. CoronaVac, the first to be used in Brazil, works with the inactivated virus.
Genetic vaccines, such as those developed by Pfizer / BioNTech and Moderna, use messenger RNA technology. Instead of containing the virus or a part of it, they carry genetic information that “teaches” the cells of our own body to produce antibodies against the infectious agent.
Gustavo Morais, postgraduate professor in patents at the São Paulo Getúlio Vargas Foundation (FGV-SP), agrees with the analysis that Brazil would not have the industrial capacity to produce this more modern type of vaccine.
“I think the compulsory license will not be used. If the use of the technology were feasible for most countries, this article would have already been used, since practically all countries have this mechanism. But why not use it? Where are these? India, for example, has this prerogative and has not yet used it. There are many economic, political and ideological interests in this patent discussion, “he says.
Roberta Dorneles, for her part, believes that a possible change in patents would require a change in the position of the Bolsonaro government to face the pandemic that has killed more than 221,000 Brazilians as of this Thursday (January 28). “This is a political decision that requires a national project. But we have seen fewer and fewer resources for science and for Brazilian public laboratories. If they were more valued, I am sure that we would have the capacity to produce technology and supplies”, he says .
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