Gilead blocks Brazil’s access to generic drugs



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In global competition For a treatment for the new coronavirus, one company took the initiative: the American multinational Gilead Sciences. On May 1, his drug Remdesivir, still in the testing phase, was approved for use against covid-19 in the United States (in emergencies only) and Japan (for patients with severe symptoms).

After obtaining the first such authorization in the world, the drug maker quickly licensed companies in India and Pakistan to produce generic versions of the drug and sell them to 127 countries. Brazil is not among them. Neither do its South American neighbors, with the exception of Guyana and Suriname.

A Remdesivir treatment costs around $ 4,500, Jorge Bermúdez, a researcher at Fiocruz and a former member of the United Nations Secretary-General’s High Panel on Access to Medicines, told me. In other words, at the current price, the ten injections used in severely covid-19 patients would cost more than R $ 26 thousand.

With more than 206 thousand confirmed cases of the disease, a health system on the brink of collapse and a quarter of the population living on less than R $ 420 per month, the consequence of the high value of the drug in Brazil is obvious. Although Remdesivir survives the testing phase and is established as the long-awaited treatment for covid-19, which killed more than 14,000 Brazilians, almost none of us will have access to it.

Brazil’s exclusion from the list of 127 countries chosen by Gilead to receive generic drugs, Bermúdez explained, is due to the fact that the products generated by these licenses are normally destined for low-, middle- and low-income countries. Brazil, which is just a few steps away from returning to the Hunger Map, is a middle-income country, according to the World Bank. Or rich, as Jair Bolsonaro already considered it.

However, Gilead did not take into account the income of the United States when the CEO of the pharmaceutical company, Daniel O’Day, announced that he would give 1.5 million doses of the drug for free to the richest country in the world, a donation equivalent to more than $ 675 million.

“Of course, this has to do with Gilead’s marketing in the United States, for having approved emergency use, but it is unfair to donate to one country while others are excluded,” Bermudez criticized. “With the collapse of the system and the lack of SUS funds, it would be a tragedy for Brazil to have to pay this amount [de US$ 4,5 mil por paciente]”

However, the most worrying thing is not the inability to buy Remdesivir. After all, it’s worth remembering that the drug may not be the official treatment for covid-19. The problem is that this same scenario can be repeated with any other medicine or vaccine that is approved in the fight against the new coronavirus. That is, if the Brazilian pharmaceutical companies and multinationals are victorious in the fight they are fighting to maintain their monopolies, even in the face of the thousands of lives that will be lost.

Right now, the greatest threat to monopolies, and the greatest hope for equal access to medicines, is a bill presented on April 2 at the Covid-19 External Commission of the Chamber of Deputies. It is intended to guarantee the issuance of compulsory and automatic licenses for any technology related to coronavirus, such as vaccines, diagnostic tests and drugs for treatment.

The justification is simple: in times of emergency, you need to act as quickly as possible. “We don’t live normally, when it is possible to stop and discuss and evaluate every possibility [de quebra de patente]Bermúdez summed up. “Any product with proven efficacy should have automatically recognized access for everyone during the pandemic.”

The bill is signed by 11 parliamentarians from across the political spectrum: there are party names as diverse as PT, PSL, PCdoB, DEM, and PSDB. However, the more than 40 days after his presentation in the special committee were not enough for the PL to reach the plenary. Even the requests sent to the city’s mayor, Rodrigo Maia, from the DEM in Rio de Janeiro, for urgent treatment were evaluated.

“What we feel in Congress is that [os deputados] they want to know how the industry is going to see this ”, explained Bermúdez. The responses came recently, with opposing positions from Interfarma, which represents multinational pharmaceutical companies, and FarmaBrasil, representative of the national sector.

“They say that this inhibits innovation, that there will be no more research or investment, that they will eliminate the plants in Brazil. It is what is always claimed when there is a compulsory license, ”said the researcher, noting that the project does not intend to change patent registration procedures in general. “Either it is discussed in such a way that people will value life and access, or they will prioritize the business interests behind monopolies and high prices.”

They complained, but they were

In our entire history, there is only one case of compulsory drug licensing. In 2007, the Lula government decided to break the patent of the German multinational Merck for antiretrovirals used in the treatment of HIV and AIDS. “[As farmacêuticas] They claimed the same at the time and are still here. “

Although there are no Brazilian medicines for covid-19 in the trial phase, Bermúdez believes that FarmaBrasil’s opposite position, which surprised him, may be explained by the interest of Brazilian pharmaceutical companies in maintaining good relations with multinationals that normally import technologies.

The investigator recalls that the president of the entity was one of the businessmen who accompanied Bolsonaro on a surprise trip to the Federal Supreme Court, to request the reopening of trade.

In addition to the resistance of the pharmaceutical companies, the short history and the process of breaking the patent are too slow for the moment in which we live, there is another reason why this path is not the best to take during the pandemic: the political situation. .

Approval of a patent infringement requires “an agreement within the government,” Bermúdez explained to me. In 2007, according to him, there was a “composition of people who understood the seriousness of the matter and issued the compulsory license”, something that, for him, will not happen under the Bolsonaro administration.

“Having a consensus between the ministries of Health, Agriculture and Foreign Affairs and the National Institute of Intellectual Property, at that time, I think it is impossible,” he said. “The interests are different. Agriculture wants to export chicken, export orange. Any action against a company, in this case, Gilead is a US company, which may have consequences in other areas, it will stop. ”

As with Gilead generics, what may turn out to be another light at the end of the tunnel for various countries may not reach Brazil. On March 23, the President of Costa Rica wrote to the World Health Organization, WHO, requesting the creation of a set of technologies related to the fight against the new coronavirus, accessible to all member countries, regardless of who has them. made up. But the final decision of who enters and who remains outside of that swimming pool – still under discussion – “depends on the relationship that the country has with the WHO by the government,” Bermúdez told me.

The same day that the Costa Rican president wrote to the WHO, Bolsonaro made a dismissive statement by the organization in an attempt to justify non-compliance with its recommendations. “People talk a lot about following WHO, right? Is the WHO President-Director a doctor? He is not a doctor, “he said. Ethiopian Tedros Adhanom, in fact, is not a doctor, but he has a doctorate in community health and a master’s degree in immunology from infectious diseases.

A month later, the president directly attacked WHO, questioning why he should follow an entity that he accused of encouraging masturbation and child homosexuality. Therefore, the inclusion of Brazil is far from being guaranteed.

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