Countries around the globe are rolling out Covid-19 vaccinations after the United Kingdom became the first to start vaccinating its citizens in December last year.
Concerns have been raised, however, that rich nations are able to access a plentiful supply of vaccines while poor nations are not.
There have been many claims on social media that poor countries are being prevented from accessing vaccines because of patents held by drug manufacturers. It has also been claimed that removing patents would lead to fairer access.
Ferret Fact Service looked at this claim and found it Half True.
Patents are a type of intellectual property (IP). IP is defined by the World Intellectual Property Organization (WIPO) as “creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce”.
Protecting a person or organisation’s intellectual property falls into three main categories: copyright, trademarks and patents.
Patents protect inventions that, according to WIPO, “offer a new way of doing something, or a new technical solution to a problem”. Both products and processes can be patented.
In essence, copyright, trademarks and patents are a legal means of preventing anyone from stealing your ideas and making money from them at your expense.
Why are patents controversial when it comes to medicines?
Patents are generally granted for an initial period of 20 years and in some cases that can be extended. As a patent prevents anyone else from copying the product or process it relates to, pharmaceutical companies who hold patents on medicines can monopolise the market for a significant period of time.
This also means they can control the price at which their drugs are sold. There are those arguing that this leads to unnecessarily high prices, which may result in some drugs being unaffordable for those who need them.
In the case of life-saving medications, in particular, the fact that drug-development companies can control the market for so long is controversial, not least because those companies are generally highly profitable organisations.
When a patent expires, other pharmaceutical companies are free to manufacture identical drugs – known as generics – and these are almost always cheaper. That is, in part, because their product does not need to cover the cost of developing the drug and also because taking a drug off-patent leads to competition among suppliers.
Have any of the companies producing Covid-19 vaccines patented those drugs?
Talk about patents and coronavirus drugs has been doing the rounds since late last year, when India and South Africa suggested at a meeting of the World Trade Organization (WTO) that IP rights relating to coronavirus vaccinations be waived for a temporary period.
A decision on that suggestion, which was opposed by western powers including the US, EU and UK, was put on hold after failing to garner enough support. In its reasoning, the UK said it would be “an extreme measure to address an unproven problem”.
None of the vaccines have actually been patented yet. It usually takes years for a new drug to be granted a patent and work on the development of Covid-19 vaccinations did not begin until some point after December 2019, when the virus was first identified in China.
It is possible to expedite the process to as little as six months, but it is not apparent that any Covid-19 vaccine manufacturers have gone down that route.
While the drugs themselves have not been patented, some of the processes and technologies involved in creating them have. Those technologies will have been developed over time and will be used in the creation of a range of different drugs, not just the Covid-19 vaccines, which is why producers are resistant to giving them up.
Pfizer, which developed the first vaccine to be licensed in the UK alongside BioNTech, has refused to give up any of its IP rights. Last year its chief executive Albert Bourla said it was “radical” to suggest it should.
By enforcing any of their relevant patents, vaccine manufacturers would make it impossible for any other company to exactly replicate the production of their Covid-19 drugs.
Would removing those patents make it easier for poorer nations to access vaccines?
Not necessarily. It is true that removing all patents relating to the production of each of the vaccines could increase supply because it would mean any producer, anywhere in the world. could copy processes developed by the manufacturers.
However, Jason Jardine, a lawyer at IP law firm Knobbe Martens, says the cost of replicating pharma companies’ technologies and then scaling up production would likely make this prohibitively expensive in most cases. “Even if you have a lab that can copy someone else’s [technology], you still have to find a way to mass produce it,” he says.
But that does not mean it is impossible. Last year AstraZeneca, which has developed a vaccine alongside a team from the University of Oxford, signed a licensing agreement with the Serum Institute of India (SII) that will see the latter manufacture a billion doses of their vaccine for use in India and other low-income countries.
The agreement allows SII to make use of AztraZeneca/Oxford’s IP. Last year Oxford University Innovation chief operating officer Adam Stoten said the “default approach” would be to license its IP free of charge for the duration of the pandemic. It is not known whether SII is paying for its licensing agreement.
Similarly, Moderna, whose vaccine was approved for use in the UK at the beginning of January, announced last year that “while the pandemic continues” it will not enforce any patents “against those making vaccines intended to combat the pandemic”.
This month BioNTech started using a production facility run by French drugs company Sanofi, specifically to speed up production of the Covid drug it developed alongside Pfizer. Sanofi’s own attempts to develop a vaccine alongside GlaxoSmithKline suffered a setback at the end of last year.
Is anything else stopping poorer countries accessing vaccinations?
No country can begin rolling out a drug until it has received regulatory approval. In the UK, the Medicines and Healthcare products Regulatory Agency has expedited the process for approving coronavirus vaccines, but not all countries have the infrastructure in place to do that.
In December the WHO gave emergency validation to the Pfizer/BioNTech vaccine, in a process designed to “open the door for countries to expedite their own regulatory approval processes to import and administer the vaccine”.
Another problem is that richer countries have been quick to look after their own interests, pre-ordering large quantities of individual vaccines to roll-out as part of their own immunisation programmes. The UK Government, for example, pre-ordered 100 million doses of the Oxford/AstraZeneca drug months before it had received regulatory approval.
In partnership with the Global Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations, the WHO launched a scheme last year called Covax that will deliver vaccines to low-income nations. Covax is funded by wealthier nations, with the UK Government providing $734m and the US pledging $4bn.
Covax has agreed a number of deals with manufacturers, with rollout of the drugs expected to begin “in the first quarter of the year”.
Ferret Fact Service verdict: Half True
Cost is one factor that is preventing poorer nations from accessing Covid-19 vaccines, with the cost of developing patented technologies factored into the price of the drugs. Removing those patents would not necessarily lead to a slew of generic drugs being produced in or for poorer nations, though, because the cost of replicating the technology and scaling up production could be preventatively high. The coronavirus vaccines themselves have not been patented so there are no patents on those to remove.
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