Biolyse is a small pharmaceutical manufacturer in Canada with a simple proposition: provide a recipe for a coronavirus vaccine, and it will produce 20m doses for nations in the global south. It has approached AstraZeneca and Johnson & Johnson, and even asked the Canadian government to help it with compulsory licensing – which would give it the authorisation to produce another company’s patented product for emergency use – but so far no one has taken up its offer.
When I reached him by phone this week, John Fulton, the vice-president of Biolyse, told me: “We’ve been passed over. We’ve got this production capacity and it’s not being put to use. If we had started this last year, we could have shipped millions of doses by now. This is supposed to be like a wartime effort, everyone in it together. But that doesn’t seem to be the case.”
The situation seems mind-bogglingly shortsighted. The world desperately needs coronavirus vaccines. About 430m doses have been produced so far this year, enough for about 215 million people. And of the doses already given, about half have gone to the richest 16% of the world’s population. Covax, the World Health Organization initiative to transfer vaccines to nations in need, has delivered just 38m doses. According to analysis by the Center for Global Development and the Economist, nations in the global south may not reach widespread vaccination until 2023.
The situation is dire, and we need more vaccines. At the moment, there is no worldwide joined-up effort to expand production. As incredible as it sounds, after all the public money that went into vaccine development, making and distributing them has been left entirely up to the market. Each company has its own – totally secret – recipes and supply chains, and they insist no other approach is possible.
But the Biolyse offer does suggest another way. They’re a chemotherapy drug manufacturer, certified to produce advanced biological compounds for injection. “We have the facilities and equipment, bioreactors, we have fill-and-finish capability. Depending on how much help we get with technology transfer, we could be ready in a few months,” explains Biolyse’s head of production Claude Mercure. “I don’t understand pharma’s stance on this. Everyone needs to make money, sure. But this is a very serious situation and there’s no reason to be this harsh,” he added.
Fulton says he has been in touch with other manufacturers who say they also have spare capacity – for instance, fellow Canadians Pnuvax and the Bangladeshi producer Incepta. He hopes to put together a consortium to strengthen their offer to industry.
Many governments and organisations back the idea of opening up production. India and South Africa have asked the WTO to suspend patent protections to allow other companies to produce existing vaccines and drugs – but they have been blocked by rich nations. Former world leaders and nobel laureates have called for suspending patents and coordinating production across the world – the kind of global effort that eliminated smallpox and polio in the 20th century. But so far their efforts have been unsuccessful.
This would mark a shift away from business as usual. The pharmaceutical industry has long relied on a very strict global intellectual property regime to ensure they are the sole suppliers of their most profitable drugs. For them, this is an existential issue that goes beyond the current crisis. The arguments against opening up the rights to make coronavirus vaccines are the same ones the industry has always used: that it would stifle innovation, and that transferring the knowhow to others would be too difficult or simply wouldn’t work.
But the coronavirus vaccines were created with huge amounts of public research. And generic drug manufacturers in developing nations have proven time and again that they can make large amounts of high-quality drugs, for a fraction of the price.
This system, where a company that holds the patent on a drug can monopolise its production, even in a global emergency, is a recent invention. During the second world war, the US government forced pharmaceutical companies to share recipes for antibiotics. In the worldwide campaign against smallpox, the WHO maintained a register manufacturing techniques and recipes, evaluating them and helping to share the technology globally. We collectively recognised that some things are more important than the legal protection of profit.
In fact, prior to the WTO and the proliferation of trade treaties, countries around the world regularly used “compulsory licensing” to make the pharmaceutical industry allow local manufacturers to produce drugs after paying a licence fee. This was so uncontroversial that Canada used to do it for anti-ulcer medications. Patents weren’t always sacrosanct. Biolyse is currently working with the non-profit Knowledge Economy International to exercise a little-used Canadian law allowing for compulsory licensing to let them to proceed. But progress has been slow.
It may seem like it’s a bit late in the crisis to try new approaches. But the truth is, for much of the world the pandemic hasn’t even hit its halfway point. The worldwide shortage in vaccines is likely to continue for years. Allowing big pharma to handle business as usual has worked out for just a rich few. There are people willing to work for the kind of worldwide approach we had in the past, we have to support their efforts.