American pharmaceutical giant Gilead Sciences is under scrutiny for deals that, according to activists, will restrict global access to remdesivir, an experimental antiviral drug that has shown promise in the treatment of COVID-19.
The company, based in Foster City, California, has signed confidential licensing agreements with nine pharmaceutical manufacturers – including seven in India – that would prevent the distribution of the generic version of the drug in dozens of countries, including the United States, which represent almost half of the population. world.
Activists and civil society organizations say the licenses allow Gilead to control the global supply of its patented drug, even when the World Health Organization warns that the COVID-19 pandemic is entering a “new and dangerous phase”.
Although the terms of the licenses have not been made public, Gilead said they allow a cheaper and more generic way of remedying to be distributed in 127 countries, including almost all the poorest nations in the world.
But the deals exclude countries with some of the worst coronavirus outbreaks – including the United States, Brazil, Russia, Britain and Peru – leading to claims that Gilead intends to sell only its most expensive and most expensive version of the drug in income drugs medium and high. rich nations that are desperate for treatment.
“These bilateral licenses … are highly restrictive in their application,” said Brook Baker, a professor of law at Northeastern University. “Gilead excluded these countries because they have commercial potential and because Gilead wants to reserve the right to prevent competition and charge higher prices.”
Gilead did not respond to email requests for comment.
The company faced criticism for the price of remdesivir at $ 390 per bottle for governments – or $ 2,340 per patient for a standard five-day course – and $ 520 for American insurers, or $ 3,120 per patient.
The company says the prices are fair when compared to the cost of a longer stay. But critics say that since 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 negotiated a license with Gilead, Hetero Labs, said it would price its generic version at around $ 71 per bottle – still out of reach for many patients in developing countries. AN study conducted by Andrew Hill, a specialist in drug prices at the University of Liverpool, estimated that remdesevir could be done for just a few dollars per course of treatment.
Remdesivir, originally designed to treat Ebola, has been of intense interest since the National Institutes of Health reported in April that the drug reduced the average recovery time for a patient with COVID-19 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 killed more than half a million lives. Dr. Anthony Fauci, who heads the National Institute of Allergy and Infectious Diseases, classified the results of the clinical study as a “really very important” milestone.
This week, the U.S. government announced that it has purchased almost all of the 500,000 courses of treatment that Gilead hopes to produce by September. This 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 has earned a reputation as a “pharmacy of the poor” by reducing the cost of anti-HIV treatment during the AIDS pandemic, thanks to strong competition between manufacturers of home medicines.
Experts said that by granting licenses to a limited number of companies 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 advisor to Third World Network, a think tank focused on the pharmaceutical industry. “Gilead not only keeps markets profitable as developed countries do, but it also eliminates the potential introduction of low-cost drugs into the American market.”
As the pandemic continues to increase in poor countries in Asia and Africa, there is a growing concern to ensure an equitable supply of treatment. In March, 150 civil society organizations, including the medical charity Doctors Without Borders, wrote to Gilead expressing concern about the company’s attempts to restrict access when remitting.
“If remdesivir is found to be effective and approved, Gilead should not apply its patents or claim other types of exclusivity in relation to remdesivir,” the group wrote. “No company should profit from 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 this occurs, although the size of the payments has not been disclosed, “it is clear that these royalties will increase the price of remivorship,” said Baker, a law professor.
Arguing that private companies have a lot of control over access to medicines, a 2016 panel convened by the United Nations secretary-general recommended expanding public funding for research and clinical trials and eliminating monopoly rights on medicines. Health experts say a global treaty is needed, similar to the tobacco control framework adopted by the World Health Organization in 2003 that created universal standards that affirm the dangers of tobacco and rules that govern its production, sale and taxation.
But activists say the United States, backed by major pharmaceutical companies, has prevented this treaty for research and production of medicines and vaccines.
“While there are many drugs and COVID vaccines in development, there is no guarantee that there would be equitable access,” said Gopakumar. “The best way to create a global legally binding treaty.”
Krishnan is a special correspondent.