The United States government has bought almost all the next three months' anticipated production of remdesivir, possibly the best-performing drug in Covid-19 trials so far. The announcement leaves other nations with difficult choices on how to best treat their patients, but even in America, the price of treatment is creating controversy.
More than 160 drugs already approved for treating other conditions are currently under trial against Covid-19. Most have no reported results or evidence is contradictory. Arguably that is the case for remdesivir as well, though there is evidence it speeds up recovery of Covid-19, but it is the first drug where the standard of proof is sufficient to gain EU recommendation.
Global supplies of the drug are limited as it was originally designed as an anti-Ebola drug, and have almost entirely been used up in clinical trials. Gilead, the antiretroviral drug's owner, is producing more as fast as it can, but the American government has pre-bought all of July's production and 90 percent of the following two months, leaving a deficit for the rest of the world.
“The US arrangement to buy 500,000 doses of remdesivir from Gilead raises concerns not only about access in other countries, but also how to prevent profiteering from the COVID-19 pandemic and ensuring that patients who need treatment are able to access it,” said Dr Barbara Mintzes of the University of Sydney in a statement.
The Trump administration's "America first" attitude is raising concerns, not just about the current situation, but what may happen if a Covid-19 vaccine becomes available.
The UK's business minister Nadhim Zahawi said the US was undermining and "not helping" the global effort to fight the pandemic by buying up the world's current supply of one of the only drugs seen to be effective against Covid-19. He told The Telegraph the UK was working "responsibility so we actually deal with the pandemic in a way that helps all of the world," adding, "By attempting to compete we ultimately undermine all our strategies."
In a press briefing Monday, Director-General of the World Health Organization Dr Tedros Adhanom Ghebreyesus warned that not working together was allowing the virus to win. "Unless we address the problems we have already identified at the WHO – the lack of national unity, and the lack of global solidarity, and the divided world, which is actually helping the virus to spread – the worst is yet to come," Dr Tedros said.
Remdesivir was designed by Gilead as an anti-Ebola drug and its patent has a long way to run. Contrary to some reports, it proved reasonably successful, nearly halving the death rate from Ebola, but another drug released at the same time performed slightly better, and thus cornered the market. That meant that when Covid-19 arrived remdesivir was not widely available.
Nations without access now have to choose between giving patients less proven drugs, or breaking Gilead's patent and producing the drug elsewhere. The latter is certainly an option, with India and Bangladesh routinely producing generic versions of drugs still under patent because they don't recognize the patent there. Mintzes noted the Netherlands is currently considering such a move, known as compulsory licensing, which overrides the intellectual property rights of the company. However, many nations have historically avoided the conflict that would come from abandoning international agreements and importing such drugs.
Gilead is charging $390 per vial of remdesivir; a six-day treatment will cost $3,200. Under a licensing agreement, Gilead has approved manufacturers in Africa and Asia selling the drug at much lower prices, but only to a specified list of low and middle-income countries, leaving wealthy nations (and some others) stranded.
Campaigners for cheaper drugs are incensed at the price Gilead is charging, given the cost of manufacturing is estimated at less than $1 a vial. On the other hand, while drug manufacturing is frequently cheap, research and development costs are enormous, with companies paying up to a billion dollars for the clinical trials to prove their drug works. Gilead argues it needs to recoup those costs, and make sufficient profit to balance all the drugs that fail.
Other experts have noted the case brings long-standing tensions into focus. The case “Reflects the global nature of the medicines industry and the many factors that impact on timely and affordable access to essential medicines,” said the University of Sydney's Professor Andrew McLachlan.
The situation also demonstrates how one nation's failure to control Covid-19 affects everyone else. If American infection rates had fallen like those of comparable nations, there might be enough doses to go round.