Patents are just one part of the vaccine puzzle. The key is the know-how about the actual manufacturing process.
In a sharp reversal of Washington’s previous stance, US President Joe Biden on Wednesday put his weight behind the idea of waiving intellectual property rights for Covid-19 vaccines. The European Union was quick to follow saying they were also ready to ‘consider’ patent waivers.
Developing nations led by India and South Africa have lobbied for months to get a waiver of the World Trade Organisation’s Trade Related Intellectual Property Rights (TRIPS), a global agreement that protects patents.
The inability of multinational firms to produce vaccine shots in large quantities threatens to derail a fragile recovery in rich nations as a second wave of contagious variants overwhelms healthcare systems in poor countries.
India, known as the “world’s pharmacy” because of the sheer number of drug companies it has, is struggling to save lives. More than 3,900 people are dying each day in the South Asian country, many of the fatalities due to the unavailability of oxygen.
“I believe we need the TRIPS waiver as well as tech transfer and support,” said Madhukar Pai, the Canada Chair in Epidemiology and Global Research.
“We need all countries to support the World Health Organisation’s COVID-19 Technology Access Pool (C-TAP), which is a commitment to share not only the IP, but also related knowledge and data related to COVID-19 health technologies,” he told TRT World.
C-TAP was established last year as a way for countries and companies to share knowledge and information on vaccines. But none of the western pharmaceuticals participated. Pfizer’s CEO Albert Bourla called it a “nonsense” idea.
Can sharing vaccine patents and know-how help save lives has become a paramount moot point and the debate has drawn in intellectuals and experts from across the political and geographical spectrum.
Bill Gates, the co-founder of Microsoft and celebrated philanthropist, who funds various global health initiatives, has been criticised for his opposition to putting the vaccine know-how in the public domain.
He agrees with western pharma companies in their assertion that sharing patents undermines innovation - even though Covid-19 vaccines have been developed on the back of technology funded by governments.
More than just patents
Just getting hands on the patents for vaccines won’t ramp up production overnight, industry people say.
Unlike small-molecule drugs such as an aspirin, vaccines are difficult to develop. There are no generic vaccines - each batch of a vaccine has to be exactly the same to trigger an immune response.
“Vaccine manufacturing is a very complicated process and a lot of know-how is required. Formal IP (intellectual property) is only a small part of it,” said Göran Conradson, the CEO of Ziccum, a Swedish medical tech start-up.
Ziccum is part of Developing Countries Vaccine Manufacturers Network (DCVMN), a foremost alliance that mostly represents companies from middle-income countries.
DCVMN supports the idea of sharing the vaccine know-how but is still unsure how to go about the transfer. “Exactly how this is done is open discussions on a case-to-case basis,” Conradson told TRT World.
Even before the pandemic struck last year, the global vaccine market was dominated by just a handful of big multinationals. GSK, Pfizer, Sanofi and Merck account for around 80 percent of vaccine sales by value.
As vaccine making technology has advanced, regulations have become more stringent. There are far more entry barriers for newer firms. In 1997, at least 55 countries were producing vaccines. By 2015, less than 20 countries had any kind of vaccine facility.
“You can’t give someone a patent filing and expect they can make a vaccine. Plus there are multiple holders of patents for a single product,” said Kristopher Howard, a vaccine consultant who advises governments, companies and NGOs, on how to transfer vaccine tech.
Pfizer’s vaccine has various components, some of which use technology patented by other companies. For instance, it’s vaccine relies on lipid nanoparticles, which take the virus-fighting ingredient from the syringe into our bloodstream. Acuitas Therapeutics, a biotechnology company, holds a patent for that.
“Also vaccines are so difficult to make because they use biological systems one way or another which are more difficult than small molecules,” Howard told TRT World. (Pfizer uses a process called biosynthesis to extracts DNA plasmids for its vaccine from E. coli bacteria)
Howard recently reposted a series of reports on LinkedIn that he has authored on the challenges of setting up vaccine-making facilities. His most recent article likened sharing vaccine know-how with a recipe of a 3-Michelin Star restaurant that can not be simply replicated.
“So the next time you are confronted with the concept of vaccine manufacturing know-how and want to wrap your head around the complexity involved, simply ask yourself, “why don’t more 3-Star restaurants franchise?” he wrote.
Patents are only the codified information. What actually happens during a tech transfer is on-site collaboration where engineers and scientists from a vaccine-making plant go to a new facility to train staff in weeks-long mentorship sessions.
Little will change if governments forcibly put Covid-19 patents in the public domain. To make it work, multinationals would have to share their expertise and processes they use to ensure quality control, which makes up for a large part of the vaccine manufacturing cycle.
The kind of technical issues that can prop up became evident from the disaster at Emergent BioSolutions plant in Baltimore, US. Emergent received more than $600 million from the US government to set up the facility as a contract manufacturer of vaccines.
But its staff mixed up the ingredients of J&J and AstraZeneca vaccines, spoiling 15 million doses and forcing a government intervention.
The challenges that lie ahead can be gauged from the case of Moderna, which in October last year made a public pledge of not enforcing patent infringement.
“Nobody has since come forward to take advantage,” said Evan O’Connell, a spokesman for GAVI, the vaccine alliance that aims to increase immunisation in poor countries.
GAVI along with WHO backs the COVAX, an initiative to ensure equitable distribution of vaccines. It’s also encouraging companies to share not just patents but knowledge. Delays in vaccines reaching the lower and middle income countries will only widen the gap, said O’Connell.
“This is bad news for those not able to access doses fast enough and it is bad news for countries that do have access, as it just means that the virus will continue to rage and mutate.”