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Remdesivir: US purchase of world stocks sparks new “hunger games,” warn observers

BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m2661 (Published 03 July 2020) Cite this as: BMJ 2020;370:m2661
  1. Jacqui Wise
  1. London

With the US’s nationalistic hoarding, Jacqui Wise looks at the implications for vaccines and more effective treatments for covid-19

The US has bought up almost all the world’s supply of the antiviral drug remdesivir in a move that has important implications for access to medicines in the event of a more effective treatment or a vaccine against covid-19 becoming available.

The first 140 000 doses of remdesivir for covid-19 were supplied to drug trials around the world and have now been used up. The US has now bought more than 500 000 doses, which is all of Gilead’s production for July and 90% of that for August and September.1

“President Trump has struck an amazing deal to ensure Americans have access to the first authorised therapeutic for covid-19,” said the US health and human services secretary, Alex Azar.

Priti Krishtel, cofounder of the organisation I-Mak, which campaigns to increase access to drugs, told The BMJ that the move was just the beginning of the new “hunger games.”

She said, “It signals that in the not so distant future all countries are going to be pitted against each other to get access to treatments and vaccines. High income countries and populations are poised to prevail at the direct expense of the poorest ones.

“Governments should not fall into this nationalism trap. If companies can’t meet supply to meet global needs, governments absolutely should be overriding patents to any future treatments or vaccines to allow production by other suppliers. Anything less will result in countless deaths worldwide.”

Ellen ’t Hoen, a Dutch lawyer and head of Medicines Law and Policy, a group of experts who work to ensure the availability of effective, safe, and affordable drugs for all, agreed. She told The BMJ, “I am not surprised by the move. It is an extension of the Trump administration’s America First approach. It is similar to its attempts to get first access to Sanofi’s covid-19 vaccine candidate. This is the new world where there is hand to hand combat over potential products and vaccines.”

Unjustified price

Gilead has set a price for governments of developed countries of £390 (€430; $440) for a vial of remdesivir, with a five day treatment course using six vials equating to £2340 per patient. In the US the price for private insurance companies will be $520 for a vial, or $3120 per treatment course. The company’s chairman, Daniel O’Day, said that the price was set well below the value the drug provides, so as to ensure broad and equitable access at a time of urgent global need.

However, ’t Hoen commented, “The high price cannot be justified when you look at the cost of production of the drug, estimated to be less than a dollar a day, and the fact that the development of the covid-19 indication was largely carried out by the government.”

Approval of remdesivir in the US and Europe was based on preliminary data published in the New England Journal of Medicine.2 This trial showed that remdesivir reduced the median time to recovery from 15 days to 11 days when compared with placebo. This effect was not seen in patients with mild to moderate disease: time to recovery was five days in both the remdesivir group and the placebo group.

The trial was carried out by the US National Institute of Allergy and Infectious Diseases, and the advocacy organisation Public Citizen estimates that taxpayers contributed at least $70.5m to the drug’s development.3

“A lot of vaccines and drugs for covid-19 have benefited from public investment. Governments should make sure if they fund research they do so with strings attached to ensure fair pricing and global access,” said ’t Hoen.

“Marginal advantage”

Yannis Natsis, policy manager for universal access and affordable medicines at the European Public Health Alliance, told The BMJ, “These kinds of headlines fuel the competition and race between governments to secure access to a drug that appears to be of only marginal advantage. It pushes up the price that governments are prepared to pay.”

Gilead, like other drug companies, is in talks with the European Commission and several European governments over its products. Natsis, who is also a board member of the European Medicines Agency, said, “The pharmaceutical industry is knocking on open doors at the moment and there is an astonishing lack of public scrutiny. We risk a much more dangerous and expensive repetition of the Tamiflu fiasco.” In the mid 2000s governments all over the world spent billions of pounds on stockpiling the antiviral drugs oseltamivir (Tamiflu) and zanamivir (Relenza), but a BMJ campaign for the release of clinical trial data on Tamiflu (bmj.com/tamiflu) eventually showed that the drug had little effect in managing or preventing flu.

Jonathan Van-Tam, England’s deputy chief medical officer, told a parliamentary hearing that the UK has adequate supplies of remdesivir for emergency use, although he warned of potential difficulties securing future supplies. He said that brand new drugs to treat covid-19 were likely to be in “relatively short supply in the first instance” in comparison with existing generic ones such as dexamethasone.

Gilead has said that it is doing everything it can to accelerate manufacturing timelines and increase quantities of remdesivir to meet the growing demand around the world.

Compulsory licences

To tackle the shortage of remdesivir, developed countries could issue compulsory licences to access generic versions. This is a provision in patent law and contained in article 31 of the international Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), whereby governments can decide to grant others the right to use the patent without consent of the patent holder. In the UK this is called crown use. Compulsory licensing is rare these days in high income countries but happened often during the HIV pandemic.

Gilead has licence agreements with manufacturers in India, Egypt, and Pakistan for the supply of remdesivir to 127 low and middle income countries, but that does not serve developed nations or countries outside these agreements. A Bangladeshi firm also produces a generic version of the drug but without a licence from Gilead, which it does not need as Bangladesh is classified as a least developed country

“Whether developed countries issue compulsory licenses depends on whether they think the drug is important or not,” said ’t Hoen. “But considering there are so few treatment options for serious covid cases, many health systems may want to have access.”

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