- US President Joe Biden threw his support behind waiving intellectual property (IP) rights for COVID-19 vaccines
- The move could potentially help end the pandemic sooner
- In theory, man's best arsenal against COVID-19, the "incredibly effective" mRNA shots, may soon be produced by "generics" drug makers
- But the move could prevent its biggest drug companies, such as Pfizer and Moderna, from scooping super profits from the mRNA vaccine
- A major part of research on mRNA vaccines over the last 30 years had been funded using US taxpayers' money
Pharmaceutical giants, aka "Big Pharma", are protected by undisclosed trade secrets and patents. An exclusive group of drug makers has ensured that rich countries can lay claim to most of their miracle drugs — while limiting the number of companies that can also produce the vital vaccines.
America follows an advanced system and strict laws to protect the intellectual property (IP) of its most innovative companies from copycats or knockoffs. But with COVID-19 vaccines, the US has made a sweeping policy U-turn by supporting a vaccine patent waiver proposal at the World Trade Organisation (WTO).
In effect, the move announced late on Wednesday (out on Twitter on Thursday), allows other pharma companies within and outside the US to make copies of the most advanced COVID-19 vaccines, notably the mRNA shots.
On May 5, 2021, US President Joe Biden threw his support behind waiving IP rights for COVID-19 vaccines, in a landmark decision. World leaders lauded the US move.
Biden's support for a waiver — a sharp reversal of the previous U.S. position — is historic. It was followed swiftly by a statement from his top WTO negotiator, Ambassador Katherine Tai.
The most well-known types are copyrights, patents, trademarks, and trade secrets.
US response to global health crisis
Ambassador Tai stated: “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures." Her statement came amid growing concerns that big outbreaks in India could allow the rise of vaccine-resistant strains of the deadly virus, undermining a global recovery.
President Biden and drugmakers had been facing demands from activists and global leaders to suspend IP rights cover for vaccines as pandemic-driven deaths and infections rise, even as the world faces the worst economic downturn in decades, triggered by a vicious cycle of lockdowns and infections.
Such a policy would waive the IP rights of vaccine makers to potentially enable companies in developing countries and others to manufacture their own versions of COVID-19 vaccines.
Countries suffering from a massive spike in new cases — including India and South Africa — have pushed for the waiver. In India, now facing a “COVID tsunami”, it was reported recently that less than 2% of the population had been vaccinated. New COVID cases are at record highs globally, as the pandemic rages unchecked in many poor and middle-income countries.
In effect, the US government is now saying that the intellectual property (IP) protection for the COVID vaccines — especially the mRNA shots developed by US researchers dubbed as “incredibly effective”, but not widely available — will now be “open-sourced”.
US taxpayers' money had been a big part of mRNA's success as a vaccine platform. For example, Moderna allied with the National Institutes of Health (NIH) and received a billion dollars from the US government’s "Operation Warp Speed". This allowed the company to speed up vaccine development. It's also a fact that basic research on mRNA had been bankrolled by government grants.
It's the first time this type of vaccine, with a proven efficacy upwards of 90%, has been authorised for use. The breakthrough technology has been under development since the late 1980s, and is also being geared up for use against other infectious diseases, as well as certain types of cancer.
Today, mRNA is the leading edge in man's fight against COVID. The US government has signed advance purchase agreements for hundreds of millions of mRNA shots with both Pfizer and Moderna, for a minimum of $19.50 per shot. Given the guaranteed revenues, the stock price of Pfizer and Moderna have spiked.
But the waiver, even if temporary, could mean super-profits expected by the companies behind it may no longer be realised. The flipside, however, could potentially end the pandemic sooner, instead of later.
It’s not the first time that it happened.
In 1921, soon after Federick Banting discovered that insulin could be used to treat diabetes, he sold the patent to the University of Toronto for about $1. (Banting later won a Nobel prize, as his discovery meant a life-saving drug could become widely available.)
With the IP waiver, “generic” or lower-priced mRNA shots could theoretically become more widely produced by a network of second-tier vaccine makers closer to where they’re needed, and where they could also be delivered much faster.
While Biden's move raises the "soft power” and do-gooder profile of America — the CEOs of its biggest pharmaceutical companies are not expected to take it sitting down.
mRNA ‘secret sauce’ will now be known?
Moreover, the move will, in theory, make the “secret sauce” to the revolutionary mRNA vaccine technology — such as how “lipoprotein nanoparticles” (LNPs) are used to deliver mRNA to target cells to boost immunity — known to other drug makers, who until now have no idea how it’s made using the Kariko-Weissman technique.
In declaring IP waivers for the COVID-19 vaccines and therapies, the Biden government has made a bold policy decision.
The US evaluation regime for new drugs is one of the most advanced and most trusted, due to the independence of its scientists as well as massive government support for research and development. Stringent rules also govern clinical trials of new drugs/vaccines, manufacturing and post-distribution.
It's not immediately known what part of the mRNA vaccines will be "open-sourced". Tesla, a US-based electric vehicle maker, has also open-sourced much of its car-making techniques, except the self-driving AI software.
It's not clear how the latest move of the Biden team would hasten the production and distribution of badly-needed COVID-19 vaccines, especially for the developing world, given the WTO process can be tedious. The intricacies of mRNA calls for tedious hard-core science, which calls for new skill sets and tools that disrupt traditional vaccine making. It's also unclear what part of it is protected by patents, and what part is not (and therefore remains a trade secret).
Ambassador Tai cautioned the WTO deliberations may"take time" but that the US would also continue to push for increased production and distribution of vaccines - and raw materials needed to make them - around the world.
Shares in vaccine makers Moderna Inc and Novavax Inc dropped several percent in regular trade, although Pfizer Inc stock fell only slightly.