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Breaking of COVID-19 vaccine patents exposes only the tip of the iceberg

A bill that allows the temporary breach of patents on vaccines against COVID-19 approved by the Senate provoked many discussions and split opinions


Breaking of vaccine patents against Covid-19 would streamline immunization in poor countries. Rich countries resist relinquishing patents on COVID-19 vaccine

In October, India and South Africa brought an initiative to the World Trade Organization (WTO) for a temporary waiver of patents on all products that could be useful in curbing the COVID-19 pandemic.  Thus, laboratories around the world could have access to the technology and would be able to produce generic versions. This, in the opinion of the authors of the bill, would both reduce the cost of vaccines and increase global production. In addition to vaccines, tests, machines and possible treatments would also be included. If adopted, the waiver would be legally binding. Since then, hundreds of countries have started supporting the project. However, the richer countries resisted, insisting that the pandemic could not be a reason to break trade rules. Meanwhile, China and African governments have submitted a separate draft resolution to the World Health Organization (WHO) with proposed measures to strengthen technology transfer and domestic vaccine production. The initiative is at an impasse.

Recently, the government of US President Joe Biden announced support for the patent breach of vaccines against COVID-19 in the ongoing negotiations at the WTO. The announcement represents a historic and unexpected change in the position of the United States, a country traditionally protectionist in relation to intellectual property and engaged in defending the profits of private companies in the health sector, whether in Republican or Democratic governments, such as the current one. The reason for the change in position was the exceptional nature of the pandemic. European Commission (EU) President Ursula Von der Leyen said the European Union is ready to join the debate, and has received support from French President Emmanuel Macron. Russian President Vladimir Putin is also in favor of the suspension. Germany, the EUs biggest economic powerhouse and home to a large pharmaceutical sector, rejected the idea.

In Brazil, the Federal Senate approved on April 29 the patent break of vaccines against COVID-19. By 55 votes to 19, parliamentarians endorsed the compulsory license for pharmaceutical compounds. After approval by the Senate, the Brazilian government started to support the WTO negotiations on the measure. Until then, Brazil, which traditionally supported the breaking of patents for medications, was against the suspension in line with the stance adopted by the United States government during the administration of Donald Trump. In April, the Minister of Foreign Affairs, Carlos França, had already said that he did not consider the possibility of breaking patents as the most effective way to accelerate vaccination in the country. The Brazilian chancellor echoed remarks made by representatives of private laboratories, that the bottleneck is not in the patents themselves, but in the material limits of the production capacity of the vaccines. However, the minister informed that Brazil would analyze the new American position and affirmed that, if it were to serve the interests of the country, the government could change its opinion. The new position of the Brazilian government was announced on May 07 in a joint note from the Ministries of Foreign Affairs, Health, Economy and Science, Technology and Innovations. News published on Brazilian website Portal Uol, on May 27 states that By agreement with pharmaceutical companies, Brazil resists breaking vaccine patents. Sought by the press office of the Brazilian Society of Tropical Medicine (SBMT), the Ministry of Health informed, by e-mail, that it would not take a position on the issue.

Before the presidential sanction, the text, which has undergone changes, must undergo analysis and voting in the Chamber of Deputies, where it may have resistance. The breach of patents, seen as a way to speed up vaccination in Brazil, is provided for by the Brazilian industrial property law (9.279/1996), in international law, and in article 71 of the Brazilian Patent Law, in addition to having immediate authorized effect by decree 3.201/99, of the Presidency of the Republic. However, it divides opinions.

Dr. Carlos Gadelha, current coordinator of the Center for Strategic Studies at Fiocruz, points out that this movement that places the vaccine and products linked to COVID in the context of a pandemic as accessible to the population, without being restricted access by patents, is something favorable and that Fiocruz supports it. This position reflects a responsible and pragmatic vision of Fiocruz and at the same time follows its tradition of commitment to a vision of global cooperation, of globalization driven by solidarity cooperation and not only by commercial interests. “This international movement to subordinate the economic question to the question of life is welcome and Fiocruz supports the general action so that the right to property does not overlap with the right to life. This movement is almost a call for global cooperation in the context of a pandemic, the dimension of health as a public good prevails in relation to the economic dimension and individual property”, he highlights. Dr. Gadelha recalls that Fiocruz even anticipated this vision by making a more favorable agreement on a vaccine that showed high efficacy and that allows for large-scale production, under Brazilian conditions, such as, for example, adequate temperature for distribution throughout the national territory, which presents very favorable cost-effectiveness (produced at the lowest price in the country) and which enables universal access.

The director of the Butantan Institute, Dimas Covas, stated at the beginning that the breaking of vaccine patents at this time would represent an additional difficulty for Brazil. In a public hearing at the Temporary Commission of Covid-19 (CTCOVID-19), he also highlighted Brazils deficiency in the production of immunizers. Watch the video here. Searched countless times by the SBMT press office to talk about the breaking of patents, the Butantan Institute did not respond until the closing of this edition.

The National Health Surveillance Agency (Anvisa) is in favor of the bill that authorizes the breaking of patents because it understands that this is an unprecedented moment in humanity that requires exceptional measures. In a statement at COVIDs CPI, Anvisa president Antonio Barra Torres talks about the breach of a vaccine patent. “It is important that we always remember the forces that are mobilized in this case, because it is an undertaking in which 7 billion people all want the same product, and the manufacturers of that same product are few. Therefore, the defense of these patents, the defense of this right to, of course, with total justice, gain your profits is a very heavy defense. Now, in terms of humanists, if there is a possibility that a country can break a patent, produce and vaccinate its people, as a doctor and as a human being, I dont see why not. But I would like to make it clear that it is not a regulatory issue, so Anvisa has no manifestation in that sense, this is not a regulatory issue”, he testified. Watch the excerpt here. Sought numerous times by the SBMTs press office to talk about the breaking of patents, Anvisa did not respond until the closing of this edition.

What the suspension of COVID-19 vaccine patents would allow is not entirely clear, but pharmacists and analysts argue that relinquishing patent rights would not do much to get vaccines to developing countries more quickly. Thats because making them is much more complex than just following a recipe, requiring factories with specialized equipment, highly trained workers and strict quality control. There is also little capacity for factories available. In addition, many raw materials for making vaccines, along with bottles, caps and other components, are scarce, which will not change any time soon.

Patents – Every patent registered by an agency that regulates intellectual property has a maximum time of existence. In Brazil, this time is 20 years after the patent filing date or 10 years after the granting date. During the term of the patent, its holder will be able to economically exploit the asset, either by own production or by technology transfer. Although provided for by law, the first case of Compulsory License or patent breach was only used once in Brazil, in 2007, with the patent for the drug Efavirenz, used in the treatment of AIDS. In 2001, the Brazilian government announced that it would break the patent for another antiretroviral drug, Neflinavir. After the declaration, the laboratory offered more favorable conditions and Brazil stepped back.

Ready to produce vaccines

In a virtual meeting, held on May 25, a global network representing 42 unions from 27 countries launched a letter in defense of universal access to immunizations against COVID-19, tests, treatments, therapies and medicines to fight the pandemic. Pharmaceutical workers said they were ready to collaborate fully with the production of vaccines against COVID-19 aimed at accelerating immunization on a global scale. Shortly before the virtual meeting, IndustriALL leaders met with the director general of the WTO, Ngozi Okonjo-Iweala, to discuss the topic. The secretary general of IndustriALL Global Union, Valter Sanches, stressed that it is an emergency and only with solidarity will it be possible to take vaccines and treatment to all regions at the necessary speed. “IndustriALL pharmacists are willing to contribute, to reconvert production, to transfer technology and skills. We must remove barriers that prevent most of the world from receiving what is needed”, he said.