US pharmaceutical giant Gilead Sciences is under scrutiny for deals that activists say will restrict global access to remdesivir, an experimental antiviral drug that has shown promise in treating COVID-19.
The Foster City, California-based company has signed confidential licensing agreements with nine pharmaceutical manufacturers, including seven in India, that would prevent the generic version of the drug from being distributed in dozens of countries, including the U.S., which represent nearly half the world population.
Activists and civil society organizations say the licenses allow Gilead to control the global supply of its proprietary drug, even as the World Health Organization warns that the COVID-19 pandemic is entering a “dangerous new phase. “
Although the terms of the licenses have not been publicly disclosed, Gilead has said they allow a cheaper and more generic way of remdesivir to be distributed in 127 countries, including almost all the world’s poorest nations.
But the deals exclude countries with some of the worst coronavirus outbreaks, including the US, Brazil, Russia, Britain and Peru, leading to accusations that Gilead aims to sell only its most expensive and expensive version. Medication brand for middle-income and wealthy nations desperate for treatment.
“These bilateral licenses … are highly restrictive in their application,” said Brook Baker, a law professor at Northeastern University. “Gilead excluded these countries because they have commercial potential and because Gilead wants to reserve the right to avoid competition and to charge higher prices.”
Gilead did not respond to email requests for comment.
The company has faced criticism for setting remdesivir at $ 390 per vial for governments, or $ 2,340 per patient for a standard five-day course, and $ 520 for US insurance companies, or $ 3,120 for patient.
The company says prices are fair compared to the cost of a longer hospital stay. But critics contend that because Gilead received about $ 70 million in federal funds to develop the drug, prices are unfairly high.
Gilead Sciences Chief Executive Daniel O’Day speaks at a meeting with President Trump at the White House in March.
(Andrew Harnik / Associated Press)
One of the Indian companies that has negotiated a license with Gilead, Hetero Labs, said that its generic price will be priced at around $ 71 per vial. – it is still out of reach for many patients in the developing world. A study by Andrew Hill, a drug pricing specialist at the University of Liverpool, estimated that remdesevir could be obtained for just a few dollars per course of treatment.
Remdesivir, originally designed to treat Ebola, has been of great interest since the National Institutes of Health reported in April that the drug shortened the average recovery time of a COVID-19 patient by four days in a clinical trial. The Food and Drug Administration has approved the drug for emergency use.
With a COVID-19 vaccine believed to be months away, at best, medical experts have identified remdesivir as one of the few effective treatments for a pandemic that has claimed more than half a million lives. Dr. Anthony Fauci, who heads the National Institute of Allergy and Infectious Diseases, called the results of the clinical trial a “really very important” milestone.
This week, the United States government announced that it had purchased almost all of the 500,000 treatment courses that Gilead hopes to produce through September. That leaves Gilead’s licenses with nine generic drug manufacturers, including companies in Egypt and Pakistan, the best hope for patients in the rest of the world to access the drug.
India has the largest generic drug industry in the world and manufactures around 80% of the drugs sold in the developing world. The country gained a reputation as “the pharmacy of the poor” by reducing the cost of HIV treatment during the AIDS pandemic, thanks to strong competition among national drug manufacturers.
The experts said that by licensing a limited number of companies that are authorized to sell only in certain markets, Gilead would maintain control over the global price and marketing of the drug.
The licenses “are an attempt to contain competition by creating an oligopoly,” said KM Gopakumar, legal adviser to the Third World Network, an expert group that focuses on the pharmaceutical industry. “Gilead not only retains profitable markets like developed countries, but also eliminates the possible introduction of low-cost drugs into the US market.”
As the pandemic continues in poor countries in Asia and Africa, there is growing concern about ensuring an equitable supply of treatment. In March, 150 civil society organizations, including the medical charity Doctors Without Borders, wrote to Gilead expressing concern over the company’s attempts to restrict access to remdesivir.
“If remdesivir is deemed effective and approved, Gilead should not be allowed to enforce its patents or claim any other type of exclusivity on remdesivir,” the group wrote. “No company should take advantage of this pandemic.”
Activists also point to another aspect of the licenses: Gilead does not receive royalties, but only until another drug or vaccine is approved to treat or prevent COVID-19. Once that happens, although the size of the payments has not been disclosed, “it is clear that those royalties will add to the price of remdesivir,” said Baker, the law professor.
Arguing that private companies have too much control over access to drugs, a 2016 panel convened by the United Nations secretary-general recommended expanding public funding for research and clinical trials and removing monopoly rights on drugs. Health experts say a global treaty is needed, similar to the tobacco control framework adopted at the World Health Organization in 2003 that created universal standards that set out the dangers of tobacco and the rules that govern its production, sale, and taxes. .
But activists say the United States, backed by major pharmaceutical companies, has hindered such a treaty for the research and production of drugs and vaccines.
“Although there are many COVID drugs and vaccines in development, there is no guarantee that there will be equitable access,” said Gopakumar. “The best way to create a legally binding global treaty.”
Krishnan is a special correspondent.
