
âThese extraordinary times and circumstances⊠call for extraordinary measures,â US trade representative Katherine Tai, as she surprised the world by throwing the countryâs backing behind a temporary waiver of intellectual property rights for covid-19 vaccines.
The turbo-charged an idea pushed by India, South Africa and many campaigners: that lifting the IP protections on covid-19 vaccines would boost supplies by allowing the vaccines to be made in greater numbers, in more countries.
Tedros Adhanom Ghebreyesus, director general at the World Health Organization (WHO),Ìę the US backing a âmonumental moment in the fight against #COVID-19â. The head of the European Commission, Ursula von der Leyen, said last week that the bloc is ready to discuss the proposal of vaccine patent waivers to see if it could improve production and distribution.
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It is far from guaranteed that a waiver will win the unanimous approval needed at the World Trade Organization (WTO) â which oversees IP â but there has already been strong opposition to the US move.
âIP rights werenât the practical problem to scaling up global vaccine production and waiving them isnât a simple solution to what is a wicked problem,â said the UK Bioindustry Association in a statement. The trade bodyâs members include Pfizer and AstraZeneca. Luciana Borio, former chief scientist at the US Food and Drug Administration, ÌęâSadly, this action wonât help get more vaccines available to the world.â
The response from companies reluctant to waive their IP should come as little surprise. A WHO-backed plan to scale up vaccine supplies, theÌę, was launched a year ago. Companies were encouraged to waive IP protections on more than just core products, such as the ingredients that help to deliver the vaccine into cells, as well as collaborate to give other firms the know-how to produce vaccines or treatments. It was .
There are two main arguments for why a waiver would make little difference to vaccine supplies. The first is it wouldnât disclose enough information for another firm to successfully make such a complex biological product,Ìę of Saint Louis University in Missouri and Julia Barnes-Weise of the think tank Global Health Innovation Alliance Accelerator in a newsletter produced by the Petrie-Flom Centre at Harvard Law School.
They explain that a patent provides the basic instructions for a specific component or process needed to produce a vaccine, but just like a culinary recipe, it doesnât cover any unwritten tips that are key to producing the final product.
Second, they write that there are âsimply not enoughâ manufacturing facilities and equipment, and raw materials.
Others agree it wouldnât be a silver bullet for countries today, such as crisis-stricken India, but argue it could help vaccine roll-outs globally in the longer term.
Ellen ât Hoen of research group Medicines Law & Policy in the Netherlands refutes the idea that there arenât enough facilities to make more vaccines. She says that several vaccine manufacturers have been trying to obtain IP rights so they can make covid-19 vaccines, including , the worldâs largest generic drug-maker. She acknowledges that a waiver wonât fix supply problems overnight. âBut what I hope a waiver will do is unleash a greater will to collaborate,â she says.
One senior scientist advising the UK government believes a waiver is unlikely to make an immediate difference to supplies, because of the time it takes to get manufacturing sites to a level that is quality assured, and because IP is only part of the equation. However, they see longer term positive consequences, including stimulating new manufacturing plants globally.
at Imperial College London agrees. âIt probably wonât result in manufacturing vaccines faster in the following months. If the IP waiver is maintained for the long run it might lead to producing more vaccines in more than a yearâs time.â
Some researchers prefer alternatives to a waiver, which resemble the WHOâs rejected C-TAP plan.
, also at Imperial, favours a licensing scheme with the original vaccine makers. âIt would avoid a lot of time with the licensee trying to reproduce the process from the basics of the patents, as well as trying to reverse engineer various aspects,â he says.
âAn IP waiver led by the US government may feel good and look good, but if it does not bear the right fruit, it will remain mere tokenism. If IP rights are waived, some countries may be able to manufacture vaccines, but quality assurance can be a nightmare,â says virologist Jacob John at Christian Medical College in Vellore, India. He would prefer a renewed effort to get vaccine makers to transfer technology to other companies.
If a waiver does come to pass â a process that could require months of talks at the WTO â any impact on vaccine supplies looks unlikely to materialise until the longer term. However, in the short term, the US governmentâs stance has made an obscure WHO project, C-TAP, in which manufacturers may have been able to set some of the terms for how they share their IP, look like a much more attractive prospect to vaccine manufacturers.
Article amended on 10 May 2021
This article has been updated to include information on the World Health Organizationâs C-TAP plan.
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