While US President Joe Biden’s administration announced its support for a waiver on patent protections for vaccines against the coronavirus disease (Covid-19), some experts are apprehensive about the impact on vaccine production in the near future. India and South Africa were the first to submit a proposal to the World Trade Organisation (WTO), suggesting a waiver for all members of the trade body on the implementation, application and enforcement of certain provisions of a 1995 intellectual property (IP) rights agreement in order to boost Covid-19 prevention, containment or treatment.
As the second wave of Covid-19 ravaged India’s healthcare infrastructure, calls to waive patent protections for vaccines gained momentum, with supporters arguing that the waiver could help the world come out of the pandemic much faster. After the US announced its support for the waiver, World Health Organisation (WHO) chief Tedros Adhanom Ghebreyesus termed the decision as a “monumental moment” in the fight against Covid-19.
But some experts believe that waiving intellectual property rights would have little effect given the technical complexity of manufacturing Covid-19 vaccines. In an opinion piece for the Washington Post, Rachel Silverman, a policy analyst with the Center for Global Development, said that the waiver won’t immediately boost vaccine supply to countries like India and Brazil, two of the worst-hit countries.
“It could even backfire, with companies using the move as an excuse to disengage from global access efforts,” Silverman wrote.
Silverman opined that most drugs are simple and easily analysable chemical compounds that can be produced with relative ease after reverse engineering by competent chemists. On the other hand, vaccines are complex biological products and “observing their contents is insufficient to allow for imitation,” she added.
While the European Union has shown willingness to discuss the proposal to waive intellectual property rights for Covid-19 vaccines, Germany has opposed any kind of waiver. A spokesperson for the German government said in a statement that the main factors in vaccine production are capacity and quality standards, and not patents. "The protection of the intellectual property is a source of innovation and must remain so in the future," she added.
WTO director-general Ngozi Okonjo-Iweala told the Post that even if the members of the trade body arrive at a consensus to waive the patent protections, production won’t scale up overnight. “It is very difficult to say now whether there is going to be a consensus, but I think they will be able to come to some pragmatic agreement that will give both sides the necessary comfort that they need,” she was quoted by the Post as saying.
Moderna Inc, the US-based pharmaceutical company which produced Covid-19 vaccines based on mRNA technology, said that rivals would face significant hurdles in scaling up manufacturing. During a post-earnings conference call, Moderna Chief Executive Stephane Bancel listed the barriers that other countries and companies would face from taking advantage of the waiver. Bancel noted that there is no mRNA manufacturing capacity in the world and companies won’t find people “who know how to make mRNA.”
“And then even if all those things were available, whoever wants to do mRNA vaccines will have to, you know, buy the machine, invent the manufacturing process, invent creation processes and ethical processes, and then they will have to go run a clinical trial, get the data, get the product approved and scale manufacturing. This doesn’t happen in six or 12 or 18 months,” he added.