EXPERT REACTION: US buys almost all global stock of COVID-19 drug remdesivir
Opinion piece/editorial: This work is based on the opinions of the author(s)/institution.
The US administration has bought almost all stock of the drug remdesivir for the next three months. The drug, produced by American pharmaceutical company Gilead, is one of only two drugs so far shown to help in the treatment of COVID-19. The Trump administration recently announced it has now bought more than 500,000 doses, which is all of Gilead's production for July and 90 per cent of August and September, leaving little for the rest of the world. Australian experts respond.
Organisation/s: Australian Science Media Centre, The University of Sydney, The University of Queensland, Australian Catholic University, The University of Melbourne, La Trobe University
These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.
Dr Deborah Gleeson is a Senior Lecturer in the School of Psychology and Public Health at La Trobe University whose main research area is trade policy and access to pharmaceuticals
The outrageous move by the US government to buy up almost the entire supply of remdesivir for the next three months throws the problems with the current model for funding development of pharmaceuticals into stark relief.
Under this model, patents are granted to incentivise investment in research and development. They provide a time-limited monopoly, when no one else can make or sell the product. While a drug is under patent, companies can set high prices, while keeping competitors out of the market. This presents obvious problems in a public health emergency, where rapid access to large supplies of affordable products is needed.
Gilead Sciences has priced remdesivir at $US 2340 for a 5-day course of treatment for developed countries. This is for a drug that is likely to cost less than $1 per day to produce. Gilead could make billions of dollars in profit during the pandemic, while preventing others from manufacturing the drug on the scale needed to meet global demand. Gilead’s actions show that pharmaceutical companies can’t be trusted to act ethically, and governments need to attach conditions to their funding for research and development to ensure that drugs and vaccines for COVID-19 are shared equitably.
Associate Professor Barbara Mintzes is from the Charles Perkins Centre and Sydney Pharmacy School at the University of Sydney specialising in the study of pharmaceutical policy
If remdesivir does prove effective in treating COVID-19, the drug would be needed not only in the US, but globally, including in Australia.
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.
Gilead announced its global price for remdesivir on June 29 as US $390 per vial. The Guardian reports that the cost will be US$3,200 for a six-day treatment, or AUD$4,607. The cost of production of remdesivir has been estimated to be less than US$1 per-day or US $6 (AUD$ 8.64) for a six-day course of treatment.
Gilead has licensing agreements with manufacturers in Egypt, India and Pakistan to supply remdesivir to 127 low to middle-income countries. 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: unable to access remdesivir from Gilead at a high price - as the US is doing - and unable to access it at a low price from generic manufacturers, as lower income countries can.
The solution? Under international trade agreements in a public health emergency, governments can issue compulsory licenses to bypass patent protection and either produce a drug themselves or buy the drug from generic manufacturers. The Netherlands is currently considering an amendment to its patent law to allow compulsory licensing of remdesivir: https://medicineslawandpolicy.org/2020/06/remdesivir-developed-country-price-announced/.
Currently, we don’t know for sure whether remdesivir will prove to be an important treatment for COVID-19. 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.
Remdesivir has shown early promise in clinical trials as a treatment for COVID-19 patients and it is not surprising that the Unites States government has purchased virtually all available stocks of the drug for the next three months, given the 2.5 million confirmed cases of COVID-19 in the USA. Viral transmission continues to climb in the USA and therefore the government is under immense pressure to address the situation.
Australia is comparatively in a much better place in terms of controlling SARS-CoV-2 transmission, and while remdesivir is under patent to Gilead, a pharmaceutical company does have both a moral and financial interest to increase production to meet demand. This will not be openly obvious to the general public but expect senior management at Gilead to be considering (or have considered) the use of contract manufacturers in other countries to produce remdesivir (under licence) to the parent company and subject to approval of the regulator. The Therapeutic Goods Administration (TGA) is Australia’s regulator for all pharmaceuticals sold in Australia.
Once Gilead have secured the required legal and regulatory paperwork to allow for manufacture at other locations the supply of remdesivir will become more widespread.
Supply of pharmaceuticals for use is governed by the regulator in each country the drug is marketed. In the USA all drugs are governed by the Food and Drug Administration (FDA) and supply of remdesivir was requested under an emergency use authorisation (EUA) on the 1st of May. Remdesivir does not appear to have formal approval from the FDA as an approved drug.
Drugs approved by the FDA are not automatically approved for use by other regulators (e.g. Therapeutic Goods Administration (TGA) in Australia). Stockpiling an unapproved drug does mean it will be made available to the public. The pharmaceutical company Gilead is undoubtably addressing these regulatory requirements to allow supply both in the US and other locations.
Two Indian companies, CIPLA and HeteroPharma, commenced production of remdesivir in June after signing a deal with Gilead in May. The intention from both companies was to make the drug available in India in July through both Indian government and open market channels. It is not clear if the Indian government has prohibited the export of the drug from India. 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.
Regardless of the availability of remdesivir, the only drug proven in clinical trials to lower mortality from COVID-19 is the generic steroid, dexamethasone. In Australia, dexamethasone is readily available and is inexpensive, making it the cornerstone of therapy for hospitalised patients with deterioration in their respiratory status.
What is not yet studied is whether the combination of an antiviral (such as remdesivir) and an immunomodulator (such as dexamethasone) provide more effective treatment than either drug alone.
Treatment with antiviral drug remdesivir for 10 days can improve the time to recovery (but not significantly reduce the risk of death) in people hospitalised with COVID-19. News today that the US plans to secure almost all of the global supply of remdesivir is concerning but reflects the global nature of the medicines industry and the many factors that impact on timely and affordable access to essential medicines.
The COVID-19 pandemic has lead to innovation and agility in health systems but also focused a spotlight on other unresolved tensions around equity of access to healthcare. The WHO holds that equitable access to medicines is a human right, but the challenges of national sovereignty, commercial interests and political posturing place pressure on the rights of communities around the world.
The Australian National Medicines Policy supports a “responsible and viable” medicines industry and recognises their essential role to bring new medicines to market. Unfortunately this “responsibility” is not shared round the world, especially in many developed countries.
The US government’s purchase of all available stocks of remdesivir from Gilead is unusual. Pharmaceutical companies generally make their products available internationally, subject to government approvals.
The number of cases of COVID-19 in the US is rising daily and hospitalisation of seriously ill patients is also likely to rise. Remdesivir is the only available antiviral option shown to reduce the duration of illness but is only available in limited quantities. The US government has clearly decided that their citizens should get exclusive access to remdesivir until sufficient amounts of the drug can be manufactured for international markets.
It is a pity that there could not be international cooperation between governments and industry to scale up production of remdesivir for international use. It is worth noting that such cooperation occurred in the 1940s for the scaled-up production of the newly discovered antibiotic, penicillin. Cooperation between companies and government laboratories in the UK and US under the guidance of their respective governments saw a massive scale up of penicillin production to treat wounded soldiers from World War II. That sort of cooperation seems to have been forgotten in this current crisis.
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