There is an old legal saying that goes: "Always check the small print.” That's good advice to follow as we try to understand what will be the global impact of the billions of Euros promised on Monday (4 May) for a plan to develop and distribute a much-anticipated Covid-19 vaccine.
The “big print” in the headline looked encouraging. “World leaders pledge €7.4 billion to research Covid-19 vaccine" at Monday’s EU-convened virtual event. The words were also positive. Besides being spent on virus research, this sizable pot of money would “also be used to distribute any vaccine to poor countries on time and equitably."
At Monday’s pledging session, French President Emmanuel Macron said a vaccine must become a “global public good” and Boris Johnson called for “a truly global effort” because “it’s humanity against a virus.”
And we were told that GAVI (formerly known as the Global Alliance for Vaccines and Immunization) will be in charge of the distribution of this vaccine in poor countries of the Global South because this alliance holds “global leverage of the distribution and price of a vaccine”.
Yet, big puzzles remain. Is this vaccine really going to be treated as a so-called “public good” – say, like a lighthouse – rather than as a private commodity sold in the market? Will equity, global sharing and pooling of resources be the watch words of this campaign? And campaigners with the medicines access campaign of Doctors Without Borders/Médecins Sans Frontières (MSF) asked Green World: isn’t GAVI’s leveraging power rather overblown?
So there is much to ponder outside our own locked-down homes and our borders, especially in a week when we have learned that our own country has had more Covid-19 deaths than anywhere else in Europe.
The furious “race” to the patent office
Meanwhile we read elsewhere that as many as ninety research teams in a number of Western countries and China are engaged in a furious “race" – with pharmaceutical development, it is always a dog-eat-dog competition, never a collaborative effort – to get to the patent office first with their particular pharmaceutical specification and to file their solution to halt the worst global pandemic in over a century.
“First to patent” means you are firmly in the driving seat for two decades (or longer) and this is valuable because “pharmaceutical companies view Covid-19 as an once-in-a-lifetime business opportunity,” says an industry observer.
Another industry observer told me last week that while profits for this vaccine may not be “that spectacular” during the months of the initial/actual pandemic period, “the real money” will be made in the post-pandemic years when a patented Covid-19 vaccine may become an ongoing global public health staple. That is, if it can be afforded.
Larry Sanders, spokesperson on health issues for the Green Party of England and Wales, says that using the patent system for pharmaceuticals is “a complete rip off,” noting that governments spend most of the money in the development of new medicines.
“I fully support a free vaccine for the peoples of the world, anything less is morally bankrupt.” He added that his younger brother, Bernie Sanders, had taken the same stand in his campaign to become president of the US.
Given the frightening scale of the current crisis, the global South – and peoples everywhere who uphold essential fairness – have been promised, however, that this time drug development and distribution will be very different. This vaccine will be accessible.
In other words, fighting Covid-19 is not supposed to be like the H1N1 influenza pandemic of a decade ago when “developed countries placed large advance orders for 2009-H1N1 vaccine and bought virtually all the vaccine companies could manufacture.”
Nor, with GAVI in charge, is it supposed to be like the HIV-AIDS crisis when an antiretroviral treatment came onto the market in 1996 in the US and Europe at an annual cost of £6,500 per person, but then “it took until 2004, after millions of people had died from the illness, for India and South Africa to afford the treatment.”
There are worrying signs
Yet in 2020 (and beyond), it remains highly uncertain what type of vaccine distribution GAVI will be able to mount to save the lives of billions in the Global South because, well, “the small print” in the deal is not available yet. There are, however, worrying signs.
One important factor in GAVI’s success or failure will be determined by who owns the intellectual property rights, namely a state-protected patent monopoly, in any Covid-19 vaccine which, it should be noted, is not expected until 2021.
In the same Guardian news report, “EU officials said pharmaceutical companies that receive the funding [from this €7.4 billion fund] will not be required to forego their intellectual property rights of the new vaccines and treatments." So, despite Macron’s lofty words, it won’t be a public good at all.
That’s a “big print” message which very much worries veteran campaigners for access to affordable medicines.
“Without the sharing of [vaccine-related] technology and without the right to use that technology, it will just be business as usual and millions will have not get universal access at affordable prices”, lawyer and leading global medicines expert Ellen ‘t Hoen told Green World in a Zoom interview from France. She is in charge of the Medicines Law & Policy website that is providing perhaps the best ongoing briefings and background on the Covid-19 vaccine issue.
As Green World reported on 1 April, this monopoly stranglehold is also worrying the government of the small Central American country of Costa Rica and its young president Carlos Alvarado Quesada.
A model based on self-help, not charity
To ensure that a Covid-19 vaccine, when developed, will be available and accessibly-priced across the whole world and not just limited to richer countries with state-operated health care systems, Costa Rica has proposed that a patent pool be urgently created. (The idea of a medicines patent pool was developed by Unitaid, which is a hosted partnership of the World Health Organisation, and has come into the spotlight again.) Such a pool would be voluntary and include all life-saving treatments, diagnostics, and, most importantly, vaccines that could be used by all countries in this time of global emergency.
The Costa Rica proposal is based on a self-help and self-development model – and not a Western charity approach – and derived from bitter experience with the “let-us-take-care-of-you” approach.
Support for the Costa Rica proposal is growing. The UK House of Commons All Party Parliamentary Group on Vaccination for All is on board as is World Health Organisation director Dr Tedros Adhamom Ghenreyeusus and the government of The Netherlands.
Patent pool “not effective, not necessary”
But the private-public consortium which is also raising funds for research for a Covid-19 vaccine briskly disparages Alvarado’s plan.
The Costa Rica proposal is “not effective and not necessary”, Richard Wilder, general legal counsel of the Coalition for Epidemic Preparedness Innovations (CEPI) told Green World last week in an exclusive interview.
Wilder, who is also CEPI’s director of business development, said pharmaceutical companies, biotech firms and academic labs will refuse to share their vaccine technologies and scientific processes and there is “simply no time now” to do anything different than usual.
This then becomes a key question of the hour: is the need for a Covid-19 vaccine, its manufacture and its distribution now so great that “business as usual”, as Ellen ‘t Hoen puts it, is a non-starter? And will governments require patent holders to share?
An initial public airing of this conflict will come in about two weeks when Costa Rica’s proposal is set to be debated at a virtual World Health Assembly (WHA). In fact, Alvarado’s proposal will be the only item on its 18 May agenda.
The role of GAVI as vaccine distributor will also likely be under examination that same day. Created in 2000, GAVI is primarily funded by Bill Gates, the world’s second richest person, through the foundation he and his wife, Melinda, run. Gates is a key player in both CEPI and GAVI and Wilder, for example, formerly worked as associate general counsel for Intellectual Property Policy at Microsoft which, as is well known, Gates founded and owned.
GAVI, which has a long history of vaccine distribution, says it follows what is calls “a market-shaping model.” (There is, of course, a certain irony in promoting a narrative that lauds a supposed marketplace in monopolised commodities such as patented pharmaceuticals.) GAVI raises money from private donors and governments, makes bulk purchases of vaccines and immunisations from pharmaceutical companies, and then distributes them in the 58 poorest countries in the world, overwhelmingly in Africa.
On 29 April, for example, the UK Government announced it would be giving the equivalent of £330 million per year to GAVI for the 2021-25 five-year period.
Evaluating GAVI’s likely performance
But how do we assess the likely performance of GAVI in distributing a Covid-19 vaccine in the world’s poorest countries? We got the views of Kate Elder, senior vaccines policy advisor for MSF’s Access Campaign in a 45 minute video conference call to the United States.
Elder gave full credit to GAVI for some of its vaccine work with children in the Global South. She cited the case of pentavalent (or the 5-in-1 vaccine) in which GAVI had been able to reduce the cost of a vaccine dose significantly.
But she questioned how much market power GAVI will possess when it is confronted by the market share – that is, the 100 per cent share – possessed by a Big Pharma multinational owning a patented vaccine. “GAVI is going to have to work very, very hard to bring down prices” when (or if) there is only one seller in the market, Elder told Green World.
Elder also went through GAVI’s serious failings in not distributing a far cheaper version of a vaccine for the terrible childhood killer pneumonia that is not accessible, chiefly because of cost, to 55 million children. There is not the space here to summarise MSF’s case challenging GAVI’s complicit role in relation to the Big Pharma multinationals Pfizer and GlaxoSmithKline as presented in this 21 January 2020 MSF press release. In short, it is a shocker and shows what usually happens under the patent monopoly model for pharmaceuticals.
Elder says she is not certain whether GAVI will simply act again as a compliant buying agent for drug companies with a Covid-19 vaccine, adding there must be full transparency in all contracts. The “small print” problem raises its head again.
‘Covid-19 genocide’ of indigenous people
As mentioned above, GAVI’s remit only covers the 58 poorest countries in the world. That means Bolivia, the poorest country in South America, is too wealthy to make GAVI’s list. And we need to ask what will happen, for example, to the indigenous communities of the Amazon in neighbouring Brazil who are being threatened with “Covid-19 genocide” and where its far right president, Jair Bolsonaro, is making Donald Trump look like a public health Einstein.
An excellent report, titled ‘How will the Global South cope?’, in the New Statesman magazine for 24-30 April 2020 also provides a detailed expose of huge health system “gaps” in the underdeveloped world, to understate the matter. With a population of 11 million, South Sudan, for instance, has only four ventilators and 24 ICU beds for the whole country.
We can be sure of one thing. Drugs access campaigners such as Ellen 't Hoen and Kate Elder will someday uncover the small print of this Covid-19 vaccine deal. As Ellen told me last week, “this a pandemic. It is not a moment for profiteering, it is a time to show a spirit of solidarity.”
And we can be sure of another thing. More than one commentator will be asking, like this one, what does “returning to normal” mean and informing us of helpful facts such as “that the overall value of one human life is about US$9.5 million.”
Alan Story is a retired reader in Intellectual Property Law and a member of the Green Party in Sheffield.