July 05, 2020

As US Buys Entire Stock of Remdesivir, Countries Need to Break Gilead Patent

Prabir Purkayastha

THE US has bought up the entire stock of Remdesivir from Gilead, making it near impossible for this drug to be available anywhere else in the world. This has made all the more urgent that we break Gilead’s patent and issue compulsory license to Indian drug companies to manufacture the drug. The Indian Patent Act, 2005 in which the Left played a very important role, has clear provisions for compulsory licensing during a health emergency or an epidemic. Covid-19 is obviously both.

The US had over 50,000 new cases in the last 24 hours, about 25 per cent of all new cases worldwide, making it the global leader on how not to fight Covid-19 pandemic. Brazil and India are close behind, in the second and third place for new cases. After making America sick again, Trump is trying to compensate for his administration’s failure by buying Gilead’s production of next three months for the US, leaving nothing for rest of the world.

Remdesivir is the only drug that in drug trials has shown some benefit in fighting the virus infection. Dexamethasone, the only other drug that has shown efficacy in the disease, fights the inflammation, resulting from the SARS-CoV-2 infection, and not the infection itself. Remdesivir works by reducing the replication of the virus in the human body, and this helps in shortening the infection period of the patient by about 15-20 per cent. If the patient progresses to a more serious stage, needing oxygen support or ventilation, Remdesivir is of little help. Here, drugs like dexamethasone, which are anti-inflammatory, become important. 

But even if Remdesivir cuts down the infectious period, apart from benefitting the patients, it is also useful for society as it lowers the infectious period of the patient, and therefore less virus transmission.

We have been arguing in these columns that after the battle for access to cheap AIDS drugs, the next big battle would be fought over Covid-19 medicines and vaccines. In the World Health Assembly, the US was the only country that opposed the resolution that all medicines and vaccines should be put in a common patent pool, and accessible to all countries at reasonable costs. We now know the reason for the US opposition. It wants the control over medicines and vaccines for two reasons. One is to make the US citizens feel that Trump is looking after them by providing medicine, even if his administration has failed miserably in the fight against Covid-19 pandemic. The second, by controlling the medicine the rest of the world requires, Trump believes he can regain the sole global hegemon status of the US.

With this step, the US has also made clear its intention on vaccines as well. The US has backed a set five vaccines with a 13-billion dollar purse as a part of its Warp Speed programme. One company is Moderna, a US biotech company, one of the front runners in the vaccine trials. The other four entities backed by the US are: Astra Zenca-Oxford University, Johnson & Johnson; Merck; and Pfizer with BioNTech. If any of these vaccines succeed and others do not, be ready for a similar situation for vaccines as well. Fortunately for the world, there are a total of 17 such vaccines in the WHO’s list of clinical trials and another 132 that are in the pipeline.

So what can the rest of the world do? As the US and Donald Trump walk all over us in these pandemic times, do we have a response to the US steps, starting with Remdesivir?

Apart from the US buying up the entire stock of Remdesivir, the other issue is the price at which Gilead is selling this drug. For the US patients, the cost is $,3,000 (in Indian rupees, two and a half lakh rupees) for a course. For India, Gilead had licensed Cipla and Hetero, two Indian drug manufacturers to sell this drug at Rs 30,000 (or $400) for a full course. The Indian drug companies would essentially use the API, the key pharmaceutical compound, from Gilead and convert it to injectable phials for sale in the Indian market.

What is the actual cost of a course of Remdesivir? According to Indian industry sources, the active ingredient for a course should not cost more than Rs 100. If we add to that the cost of making it into a course of five injections, the total cost should not be more than Rs 300 or less than $ 5. Calculations by two authors from Institute for Clinical and Economic Review show that the price of Remdesivir for a full course of treatment in the US is less than $10, so the ball park figure of costs are in the range of $ 5-10. 

Why should a full course costing less than $10, be priced at $3,000, or 300 times its cost of production? At the “concessional” price of $400 for India, it is still 40 times the cost of its production. Gilead’s argument is that its medicines save hospital bills of around $12,000 and by charging only one-fourth of that, even if it is 300 times its cost of production, it is doing a big favour to the customers.

Remdesivir does not save lives, as we know from the results of the clinical trials. Otherwise, Gilead’s price would have factored a lifetime earnings saved by Remdesivir, and its price would probably have been even 10 times higher!

It is not clear that after the US has bought the entire stock of Gilead, will it have any API’s left for the rest of the world. Even if it does, the amounts are going to be completely insufficient for other countries.

So what should the world do? Fight a long battle it did during the AIDS epidemic? When the drugs cost around $12,000-15,000 for an annual course in the US and a concessional price of $4,000 for poorer countries? This battle was fought for 10 years, before it could be won in the WTO’s Doha Round in 2001. This was the Doha Declaration, where, it was finally accepted that in the case of a health emergency or an epidemic, any country had the right to issue compulsory license, within or even outside its borders, to produce the drug for its people. Indian generic drug manufacturer CIPLA could then supply the same drugs at $350 for a year’s course to a number of countries, which would otherwise have been completely bankrupted; or seen their AIDS patients dying in large numbers without medicines.

Remdesivir is a small chemical molecule and easy to manufacture. Any country with a minimal chemical infrastructure can produce this drug. An earlier version, which was also patented by Gilead but never manufactured, is known to be effective in cat coronavirus infections. Since Gilead never manufactured it, it is available only from fly by night operators, producing it in basement or garage workshops. This shows how easy it would be to produce Remdesivir, as it is only a minor tweak of the earlier patent. 

So why are other countries not starting the manufacture of Remdesivir? What are they waiting for? That Gilead and the US would behave better than they did under the AIDS epidemic? Are they afraid of the blackmail of the US and its allies for protecting patents? The threat of Super 301, which the US holds over many countries including India for daring to manufacture such generic drugs issuing compulsory licenses?

India figures prominently each year in the US Super 301 list, a list of countries that the US claims is infringing on the US patent laws. This has been repeated each year, earlier for its Patent Act not being in conformity with the US laws, and after 2012 for daring to issue a compulsory license to Natco for nexavar. Nexavar was a cancer drug which Bayer was selling for $65,000 a year’s course.

PM Modi, buckled under Trump’s threat and exported hydrochloroquine to the US even though it was under an export ban at that time. Will he be willing to stand up to the US on Remdesivir? Or will he tamely accept what Marjan Dekker, the CEO of Bayer had said after India issued the compulsory license on Nexavar, “We did not develop this medicine for Indians…We developed it for western patients who can afford it.” Will he tamely agree that Remdesivir be reserved for only US patients? Even if we have the capacity to produce it for our people? Or does his new trade war with China demand succumbing to the US on the Covid-19 front?