Vaccine inequality resurrects discussion of patent infringement

There is no doubt that mass vaccination is the most efficient way to control the pandemic, just look at the drop in hospitalization and mortality among those immunized. This success, however, helps to make the ethical dilemma created by the vaccinal inequality verified between countries greater.

In the immunization ranking, the 52 poorest countries, where 20% of the world’s population live, applied the same amount of doses as the sum of the trio Japan, France and Canada, responsible for 2.9% of the planet’s inhabitants. How to reconcile this difference with the motto “no one is safe unless everyone is safe”, adopted by the World Health Organization in the face of the pandemic?

The Covax Facility, a global initiative led by WHO to encourage the donation of immunization agents to poor countries, did not work. Only a quarter of the nearly 2 billion vaccine doses promised by the consortium for 2021 were donated to countries with low vaccination rates.

This mismatch led more than a hundred countries to join an international campaign, led by India and South Africa, in defense of the infringement of patents on immunizing agents. The group starts from the premise that, once access to vaccine technologies is freed, other countries could enter the production and boost global vaccination.

The dispute, which takes place within the scope of the World Trade Organization, has the surprising support of the US and the resistance of the European Union. Brazil was the first developing country to go against the proposal.

There is no consensus on the effectiveness of the measure, however. In general, complex products such as vaccines are not described in a single patent because each new discovery is registered separately and a single product can be covered by hundreds of associated patents.

“It’s true that it would be a lot of bureaucracy [para quebrar], but the pandemic will not end quickly. The world needs to take action to get vaccines where they need them quickly,” argues Ehsan Masood, professor of international science policy at Imperial College London.

Masood is also head of the editorial department at Nature, one of the most prestigious scientific journals in the world, which in May this year publicly took a stand in favor of breaking patents on Covid-19.

Nancy Jecker, professor of bioethics at the University of Washington School of Medicine, endorses the choir.

“[A quebra de uma única patente] it is not a self-sufficient or miraculous solution, but it is the first step. The Covid-19 pandemic won’t be the last the world will face, and we really need to share industrial production capacity more broadly,” says Jecker.

In the opposite position, the professor of economics Antônio Buainain, from Unicamp, claims that breaking the patent is a merely bureaucratic measure, with no immediate impact on production. “It gives the right to use that information to produce, but it is necessary to know the processes, have the capacity and excellence for that.”

The difficulty is perfectly illustrated in the case of the messenger RNA vaccine produced by Moderna. In October 2020, the American pharmaceutical company announced that, driven by the “obligation to make available its resources to end the pandemic as soon as possible”, it would not restrict the patents of the immunizing agent while the pandemic lasts.

This, however, does not mean that Moderna will completely share the recipe for the production of its vaccine, but rather that it does not intend to prosecute those who build technologies essentially identical to its own.

To try to take advantage of the opportunity, the WHO provided funding of US$ 100 million to the Afrigen Biologics laboratory, in South Africa, to try to produce the Moderna vaccine by reverse engineering, a method in which an identical copy is sought from the study of each. part of the model.

There is another barrier in the process of spreading manufacturing worldwide, points out former Health Minister José Gomes Temporão: the complexity of the production of RNA vaccines. Without pharmaceutical expertise, “few countries would dominate this technology platform.”

Temporão, who is a researcher at Fiocruz, defends the figure of compulsory licensing, the same mechanism that Brazil adopted during its tenure at the Ministry of Health (2007-2011) to produce an antiretroviral used in the treatment of HIV/AIDS.

Although in Brazil the expressions are used interchangeably, compulsory licensing is different from breaking the intellectual property guaranteed by the patent.

The break (or suspension) has a global impact and releases the patent to all companies with production capacity. Compulsory licensing, on the other hand, takes place within a nation or a group of nations and requires a much slower process.

Despite considering the Brazilian experience to be successful, the former minister recalls that the complexity of vaccines requires greater industrial and technological capacity than the manufacture of traditional medicines. The country or eventually authorized laboratory would need to have a team that masters the technique, as well as money to pay for the costly phase 3 clinical trials again.

For Temporão, these difficulties could be overcome with the project by senator Paulo Paim (PT-RS), approved in April this year, which allows Brazil to compulsorily license vaccines and other health technologies in a disaster situation (such as a pandemic).

By the approved project, the company that owns the patent was obliged to transfer know-how and supply the inputs used in the licensed products.

Upon enacting the law, President Bolsonaro vetoed the passage and announced that compulsory licensing will only be used if any company holding the patent refuses or fails to meet the country’s needs. Temporão says that the president “relativized a project that could be successful”.

On the other side of the counter, the president of the Research Pharmaceutical Industry Association (Interfarma), Elizabeth de Carvalhaes, analyzes that the president’s vetoes were very lucid and demanded “a lot of work from all of us”.

According to Carvalhaes, Interfarma believes that compulsory licensing would be an innocuous measure and would not bring a short-term solution, as the technology transfer process is extremely complex and slow, and the inputs to produce are often scarce and spread across different regions of the world.