BIG PHARMA
Big pharma’s antidote to the COVID-19 waiver: is it a viable alternative?
As governments debate whether to waive COVID-19 vaccine patents, pharma companies have posed an alternative plan to help increase the vaccine rollout, Alex Baldwin finds.
In May, a consortium of pharmaceutical companies came together to pitch a new plan to help provide more equitable access to COVID-19 vaccines.
In the ‘five steps’ plan PhRMA, ABPI, BIO, EFPIA, ICBA, IFPMA and Vaccines Europe pledged to: step up dose sharing, continue to optimise production, call out trade barriers to be eliminated, support country readiness and drive further innovation.
The plan mainly focuses on pharmaceutical companies scaling up their efforts through the COVID-19 Vaccines Global Access (COVAX) scheme. It also commits to ‘calling out’ trade barriers to be eliminated, and aims to work with governments and suppliers to ensure countries can increase their vaccination efforts.
“Manufacturers, governments, and non-governmental organisations must work together to take urgent steps to further address this inequity. Immediate action must focus on stepping up responsible dose sharing and maximising production without compromising quality or safety,” the consortium said in a press release.
This commitment was revealed shortly after the US government announced that it would be backing the proposed COVID-19 IP waiver, currently pending before the World Trade Organization (WTO).
The waiver, first presented to the WTO by South Africa and India, calls for certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement to be waived for IP related to COVID-19 treatments, diagnostics and vaccines.
This hot-button topic has divided the public, but many IP lawyers and vaccine makers fail to see that waiving IP provisions will lead to more vaccines for developing countries, with some viewing it as a potential attack on the IP system as a whole.
Vaccine gap
As it stands, insufficient production and unequal distribution of COVID-19 vaccines are the key inhibitors for lower-middle and lower-income countries in the global south, who are still suffering greatly from the pandemic.
Initiatives such as COVAX were set up as a voluntary donation drive that promised two billion vaccines to those most affected countries. By July 2021, only 95 million doses had been administered.
Additionally, and less well known, the World Health Organization’s (WHO) Covid technology access pool (C-TAP) was launched in May 2020 to help the sharing of technologies to combat the virus.
This is the context in which the waiver proposal was made by India and South Africa. The idea was opposed by many lawyers—not just those who represent pharma companies. But there is a movement of IP scholars who claim that the waiver will greatly benefit those in need.
“The experience of the last year tells us that left to the status quo neither the market, nor voluntary action, will solve the problem of insufficient production,” said Luke McDonagh, assistant professor of law at the London School of Economics, and an advocate for the waiver.
”It is simply not the case that the market—and the patent system—was left to its own devices and we got the vaccines as a result.”
Luke McDonagh, London School of Economics
Perhaps the most common complaint of the waiver is the fear that, once COVID-19 vaccine IP is waived, it will set a dangerous precedent for the state to overrule IP rights, but McDonagh says that increased government intervention is necessary to address the pandemic.
“A lot of the success of the vaccines is down to this coordinating state intervention and huge public funding of vaccines, several of which are based on patented technologies developed at public institutions.
“It is simply not the case that the market—and the patent system—was left to its own devices and we got the vaccines as a result,” McDonagh adds.
For its supporters, waiving vaccine IP rights does not preclude the need for collaboration, more skilled persons, and increased development, but helps make these activities simpler.
Fifa Rahman, non-governmental organisation representative on the WHO Access to COVID-19 Tools Accelerator and module assistant for the School of Law at the University of Leeds explains: “Waiving TRIPS provisions is the first step in providing more vaccines, and it needs to come alongside tech sharing, facility space, etc. A waiver would ensure that manufacturers would not be able to block the production of these vaccines or access to the raw materials.”
A radical proposal
Those opposed to the waiver worry that relinquishing COVID-19-related IP rights will set a precedent for other IP rights to be waived further down the line.
“It is a radical, never before seen waiver,” said former director of the US Patent and Trademark Office Andrei Iancu, in the LSPN Connect webinar “IP Rights During a Pandemic”. Iancu raised a common critique of the waiver: its proponents have failed to give evidence that waiving these provisions will result in more vaccines going to the least developed countries.
This is the position that PhRMA takes, with a spokesperson telling LSIPR: “As countless experts have pointed out, waiving IP will further complicate efforts to get vaccines to people around the world, address emerging variants and save lives.
“The biopharmaceutical industry will continue to work with all stakeholders on the real solutions that will help get shots in arms as quickly as possible, such as dose sharing and optimising production.”
As it stands, the waiver is a hard sell for many but if certain provisions of the waiver were altered, it could benefit generics manufacturers, says Roger Kuan, partner at Haynes and Boone.
”Waiving IP will further complicate efforts to get vaccines to people around the world, address emerging variants and save lives.”
PhRMA spokesperson
“As long as the waiver is limited to just three years, as it currently stands, it’s unlikely that it will do any significant long-term damage to IP protection for treatments moving forward,” Kuan says.
“This calculus would change if the TRIPS waiver was extended out past three years as that could incentivise governments, companies or private investors to commit the capital necessary to start new ‘generics’ therapeutics manufacturing plants to compete with branded therapeutics manufacturers.”
The five steps alternative
The five steps have been generally welcomed by IP lawyers, who see it as a safer alternative that will result in tangible increases in vaccine distribution without sacrificing crucial rights that have been a cornerstone of private property protection.
The importance of IP was a key driver in the plan. A PhRMA spokesperson told LSIPR: “IP protections enabled biopharmaceutical research companies to move quickly and effectively to research, develop, manufacture and deliver treatments and vaccines to combat COVID-19.
“IP protections are facilitating partners to more easily share technology and information to find new ways to fight the virus and scale-up manufacturing.”
Chad Landmon, partner and chair of the IP group at Axinn, Veltrop & Harkrider believes the plan could have a “demonstrable impact” on increasing vaccine supply for people in developing countries.
“Increased cooperation among sophisticated pharmaceutical companies and voluntary agreements to share technology will have much more of an impact on increasing vaccine supply than simply waiving IP rights,” says Landmon.
If the pharmaceutical companies stayed true to their pledges, the impact could be measurable.
If the pharmaceutical companies are fully committed to the cause, then “it has the potential to result in more vaccine doses being made available to people in developing countries than the TRIPS waiver”, agrees Kuan.
“Until now, we have seen the best results in tackling the pandemic from joint action by governments and private companies. But as it stands, many lower-income countries lack the leverage to effectively combat the virus.
“The pledges made by pharmaceutical companies are welcome, but if things fail to change drastically, more governments and even more in the IP space might lean towards temporarily waiving vaccine IP rights.”
Voluntary action by pharma companies remains the “preferable solution” because it will be better at boosting production, says McDonagh.
“But in the absence of sufficient involvement in C-TAP or the South Africa mRNA hub, the mandate and leverage provided by the waiver is a necessity,” he adds.
Images, from top: Shutterstock / Gorlov-KV, Cryptographer, Kritthaneth, Prostock-studio
