Health Minister Greg Hunt has reassured Australians they will not miss out on key coronavirus treatment remdesivir after the United States moved to buy up almost all of the drug's global supply until October.
Earlier this week, the Trump administration announced a deal with US manufacturer Gilead Science to secure 500,000 doses - over 90 per cent of the pharmaceutical company's production output for the next three months.
The United States remains one of the hardest-hit nations by the pandemic, with almost 2.7 million cases reported, which accounts for almost one quarter of total cases worldwide.
A spokesperson for Mr Hunt confirmed Gilead had donated a supply of the drug to Australia's national medical stockpile.
The size of the donation has not been confirmed but the government is confident it has enough doses to meet demand from coronavirus patients.
“The government welcomes the donation of remdesivir to the National Medical Stockpile from Gilead, which will be available for use in eligible patients prescribed by a medical practitioner,” the spokesperson said.
“Australia currently has sufficient supply of remdesivir to meet current patient needs on the basis of our expert medical advice.”
Initially developed as a drug to combat the Ebola virus, remdesivir received emergency approval by the American Federal Drugs Administration in May.
In Australia, remdesivir has not been approved by the Therapeutic Goods Administration but it has been recommended as a treatment for patients by the National COVID-19 Clinical Evidence Taskforce.
The investigational drug remdesivir has shown promise as a treatment for coronavirus sufferers. Source: Gilead Sciences
"[Therefore] it's a very unusual situation for Australia to get this sort of drug donation," Associate Professor Barbara Mintzes from the University of Sydney Pharmacy School told SBS News.
Gilead, which received taxpayer funding to develop the treatment, is pricing the drug at around $753 a vial, and a full treatment course, which lasts on average six vials, will run at over $3,400.
The firm has refused to release its patents on the drug, despite calls from civil society groups including Doctors Without Borders to do so.
Its latest supply deal with the United States has been criticised by public health experts, who have raised concerns it undermines the global effort to fight the virus and find a cure.
“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,” Professor Mintzes said.
“The US deal with Gilead and limits on which countries can be supplied under this licensing agreement leave countries such as Australia in the lurch.”
It may still be possible for Australians to import versions of the drug from overseas.
Gilead has announced arrangements with nine manufacturers outside the United States to produce and supply a version of the drug to 127 developing countries.
Two Indian pharmaceutical firms began production of remdesivir under licence in June, with the aim of making it available on the Indian market in July.
But the Indian government is yet to indicate if it will prohibit the export of those licensed drugs.
“This raises the possibility that patients or their families access remdesivir from India, as happened when highly active drugs against hepatitis C were available in India but not yet PBS listed in Australia,” UQ Professor David Paterson said.
Australia can also reinstate its option under commercial trade agreements to issue compulsory drug licences on public health grounds, which overrule Gilead’s intellectual property over the treatment.
That would allow Australia to manufacture its own doses or import low-cost versions of the drug from other countries.
“We don’t know for sure whether remdesivir will prove to be an important treatment for COVID-19 [but] If it does, given that the US is buying out Gilead’s supply, and also given the extremely high price as compared with costs of production, the obvious solution for Australia would be to also consider compulsory licensing,” Professor Mintzes said.
The drug is available for use in clinical trials and on compassionate grounds in three hospitals across Australia as part of a limited global access program.
Pharmaceutical firms in Egypt have been allowed to manufacture remdesivir under license. Source: EPA
While studies have found the drug shows promise, there is yet to be conclusive evidence it helps save the lives of coronavirus patients.
“Regardless of the availability of remdesivir, the only drug proven in clinical trials to lower mortality from COVID-19 is the generic steroid, dexamethasone,” Professor Paterson said.
“In Australia, dexamethasone is readily available and is inexpensive, making it the cornerstone of therapy for hospitalised patients with deterioration in their respiratory status.”
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