Around the world, governments fund critically important medical research and development using public money — including to develop a COVID-19 vaccine. Publicly funded research has led to dramatic healthcare innovations, but unfortunately, most countries rarely demand that the resulting health innovations be safeguarded for public health, or be made affordable and accessible to those who need them most.
8 December update:
What is MSF calling for?
Any vaccines, treatments or diagnostics for COVID-19 must be affordable, and available to all countries equally. Governments, pharmaceutical corporations, philanthropic organisations and research organisations developing medical tools should take all necessary measures to ensure that supply is allocated based on needs alone.
These measures include corporations committing now to sharing data, providing technical know-how to generic manufacturers to facilitate production as needed, and not enforcing intellectual property. Governments need to work in solidarity to meet not only their domestic needs but also support other countries to get access to medicines, diagnostics, and vaccines.
Why is MSF calling for equitable, affordable access to vaccines?
COVID-19 medical tools should not be a privilege for only the small number of people who can afford them, excluding millions of people worldwide. Pharmaceutical corporations should do the right thing and put people and public health before their profits.
“In our work around the world, MSF has witnessed too many people suffering and dying from diseases because of an absence of affordable medical tools. While we anxiously wait for an effective COVID-19 vaccine, let’s ensure that history does not repeat itself. We must rely on one another to do the right thing, and governments and civil society will have to hold each country to account. We can anticipate that global demand will outstrip supply capacity of future COVID-19 vaccines, certainly at the very beginning. While it’s encouraging that so many global leaders have claimed that future vaccines will be global public goods, there is a real concern that nationalist interests could lead to a scramble for who can buy them first.”
MSF also wants to see that the protection and treatment of frontline healthcare workers is prioritised, especially in low-income countries. This includes ensuring that these workers have access to any treatments for COVID-19, including pre-exposure and/or post-exposure prophylaxis
“Governments and Gavi must adhere to a transparent and objective global allocation system that at the very least prioritises access to vaccines for frontline healthcare workers and people at greatest risk of severe illness and death worldwide,” adds Wong.
What does MSF want to see from pharmaceuticals and governments?
MSF is urging governments to demand that pharmaceutical corporations commit to selling any potential future COVID-19 vaccines at cost. Several heads of state have already referred to future COVID-19 vaccines as ‘global public goods’ and ‘the people’s vaccine’. But the translation of these important political statements into concrete plans to purchase future COVID-19 vaccines is yet to be determined.
Kate Elder is the senior vaccines policy advisor for Médecins Sans Frontières' Access Campaign and spoke to Susie Ferguson on Radio New Zealand.
“Governments and Gavi need to demand that pharmaceutical corporations open the books so we can see how much potential COVID-19 vaccines will actually cost to produce. Everyone seems to agree that we can’t apply business-as-usual principles here, where the highest bidders get to protect their people from this disease first, while the rest of the world is left behind. Governments must ensure any future COVID-19 vaccines are sold at cost and universally accessible to all across the world.”
What is GAVI?
Created in 2000, Gavi is an international organisation – a global Vaccine Alliance, bringing together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world’s poorest countries.
What responsibility do governments have?
Governments have a responsibility to ensure that public funds are used for public good. This means that any funding put towards potential COVID-19 medicines, treatments and vaccines results in affordable and accessible products that can be mass distributed in an equitable manner.
“The drugs we buy are often underwritten by research and development funded by governments, universities and philanthropists. These same donors have pledged hundreds of millions of dollars into research and development of COVID-19 therapies and vaccines. It is critical that any investment of public funding, made available by taxpayer dollars, comes with strings attached, and results in a public good distributed based on need,” said Jennifer Tierney, Executive Director for MSF Australia.
What powers do governments have to override patents in emergencies?
Governments can and should be prepared to suspend and override patents during the COVID-19 pandemic to ensure availability, reduce prices and save more lives. The Australian government, for example, has the power to enact “Crown use” provisions which ensure that the needs of the Australian public are considered ahead of profit. Under these provisions, federal or state governments can negotiate to use intellectual property rights in line with public good. If negotiations fail, these provisions allow the governments to move ahead without the permission of the designer or patent owner.
How many COVID-19 vaccine candidates are there?
MSF is aware of more than 160 vaccine candidates which are currently under development; a handful of which are undergoing clinical trials. MSF is monitoring the progress of many of the ongoing trials, knowing that approval of a vaccine to prevent COVID-19 is likely at least 12-18 months away.
How do patents threaten access to drugs?
Patents and other forms of intellectual property give companies exclusive rights to make and sell a product with no fear of competition, leaving producers largely free to charge what they please – in other words, a monopoly.
Exclusive patent rights also threaten supply and availability, and encourage researchers to work in isolation from, and in competition with, one another, rather than collaboratively for a common goal like treating COVID-19. To ensure the public’s access to lifesaving medical tools during the COVID-19 pandemic, pharmaceutical corporations should give up their patents and monopolies. Health is not a commodity and medicines shouldn’t be a luxury.
What do we know from previous experiences with the pharmaceutical industry?
MSF’s experience with the pharmaceutical industry has shown that they consistently put profit over people. We’ve seen this in the fight to get fair and affordable pricing on drugs for pneumonia and tuberculosis. We’ve seen this with antiretroviral drugs for HIV; those drugs are so excessively priced that they are out of reach for people in low-income countries.
Using the example of pneumococcal conjugate vaccine (PCV), 25 per cent of the world’s countries still do not have access to this lifesaving vaccine, largely due to its high price. This is driven by the lack of competition in the market – until recently only Pfizer and GlaxoSmithKline made the vaccine. Middle-income countries spend up to two-thirds of theirvaccine budgets on this vaccine alone, placing a burden on these countries. We must learn from this and ensure COVID-19 vaccines are available to all at cost.
How much does it really cost to develop a drug?
While pharmaceutical corporations often say it costs US$2-3 billion to develop a new drug, other credible estimates are at least 10 times lower. A recent pricing study found that medicines to treat COVID-19 are not expensive to produce and could be priced such that anyone who needs treatment should be able to access it.
Don’t pharmaceuticals need to charge high prices to pay for innovation?
The pharma industry claims that high prices and patent-based monopolies are necessary to recoup the investments made in the research and development phase, and to finance future innovation. But increased patenting has not resulted in increased innovation for medical products and there is a fatal imbalance between the burden of disease and drug development.
The reality is that pharmaceutical companies choose to develop drugs based on the likely return that a product will offer through sales, meaning that there is a severe lack of investment in medical tools to meet the needs of people who can't afford them.
MSF experiences the consequences of this acutely: for example, the inadequate or non-existent treatments for neglected diseases such as Chagas disease and kala azar (visceral leishmaniasis); and the long, toxic and insufficiently effective treatments routinely used to treat drug-resistant tuberculosis.
What’s the story behind the drug ‘remdesivir’?
Remdesivir, manufactured by pharmaceutical corporation Gilead Sciences, is one of the antiviral drugs currently in clinical trials for the treatment of COVID-19. It has not been approved for any other indication anywhere in the world. Gilead already holds primary patents on remdesivir in more than 70 countries that may block generic production until 2031.
On 29 June 2020, the US Department of Human Health and Services announced that it had secured half a million treatment courses of remdesivir, including 100 per cent of Gilead’s production for July, and 90 per cent for August and September. The US announcement means that there is very little – or even no – supply for any other country, especially because Gilead’s negotiations with generic companies to produce the drug exclude nearly half the world’s population.
This nationalistic approach is problematic. Gilead Sciences relied on public research funding to develop remdesivir. Gilead could not have developed this drug without support from various governments, trial participants from different countries, and the participation of health organisations, including MSF. Nonetheless, earlier this year, Gilead attempted to use a special designation from the US Food and Drug Administration that would have given them an invincible monopoly for remdesivir for seven years in the US. Gilead has since dropped this attempt after strong lobbying and pressure from civil society and groups including MSF.
What is a GeneXpert?
The GeneXpert is a cartridge-based testing system produced by Cepheid, a US-based diagnostics manufacturer. In June 2020, Cepheid received approval for its Xpert Xpress SARS-CoV-2 test cartridge for testing for the novel coronavirus, from the World Health Organization’s emergency use program. The test is to be used on existing GeneXpert devices, of which there are over 23,000 machines worldwide, including 11,000 in low- and middle-income countries that are used mainly for testing for TB, HIV and other diseases.
Why do we think that Cepheid’s COVID-19 test is not affordably priced?
Cepheid announced that they would charge US$19.80 per test in low-income countries (similar to what they charge for the Xpert Ebola test), including in the world’s poorest countries where people live on less than two dollars per day. The price of this test for high-income countries is a minimum $35. Research by MSF and others shows that on Cepheid’s TB test (which uses a similar test cartridge) the cost of goods, including manufacturing, overhead and other expenses, for each cartridge is as low as $3. Therefore, each test, based on substantial volumes, could be sold with a profit of $5.
“As countries are struggling to deal with suspected COVID-19 cases, having an accurate rapid diagnostic test is essential for real-time management of people affected with the virus, in order to tackle this pandemic,” said Dr Greg Elder, Medical Coordinator for MSF's Access Campaign. “So many lives could be saved if corporations like Cepheid made their test available urgently and affordably in all countries.”
Why is the call to Cepheid so crucial?
Since WHO recommended GeneXpert MTB/RIF for initial testing for tuberculosis, thousands of these machines are currently in use in low- and middle-income countries. Using the existing GeneXpert systems for COVID-19 in these countries is essential for timely diagnosis and could fill a critical need provided it is available at the recommended affordable price of $5 per test.