David McNair, executive director for global policy at The ONE Campaign said: “This is a global crisis that crosses every border, with the threat of new, more virulent strains increasing the risk to us all. Either we beat the virus together or we don’t beat it at all, so we urge all parties to resolve these differences.”
Collaboration is required, he said, to massively increase the supply of vital vaccines and to help develop a truly global approach in tackling the virus, in all countries.
Brandon Locke, policy and advocacy manager at The ONE Campaign, told us the delays to vaccine supply to the EU and the bitter disputes that ensued were completely predictable. “There were a lot of manufacturing promises, and a lot of bilateral arrangements, but what we are seeing right now is the immediate repercussions of having very few licensing agreements and not maximizing production capacity. It is unfortunate, but I think it just goes to show why we need to look more towards scaling manufacturing instead of dividing up a very limited number of vaccines on the market.”
Such developments put the onus now very much on pharma companies to start sharing intellectual property (IP) and technology in terms of COVID-19 vaccines, tests and treatments, he argued.
South Africa and India have been calling on the WTO, which governs trade rules among its 164 member nations, to temporarily waive IP rights related to COVID-19 products and treatments. The aim is to be sure that that medicines, vaccines and other technologies needed to control the pandemic can be made available to all.
The WTO is again reviewing the proposal at its Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) meeting this week, on February 4, following on from earlier discussions, throughout last year, with the aim of participants eventually reaching consensus on the proposal.
“Initially, the meeting on Thursday was supposed to be a formal meeting, one which would have solidified positions with potentially then the general council vote to follow, but the status of the February 4 meeting was changed so that it would be just an informal one, to allow bilateral discussions to continue, before the countries agree their firm positions. The formal TRIPS Council meeting has been scheduled for mid-March, so they have sort of kicked the can down the road a little bit,” said Locke.
Disincentive to innovation
The pharmaceutical industry is opposed to any move to suspend IP rights.
Companies argue that they are already taking voluntary actions that make the temporary waiver of IP rights unnecessary. Moderna said it is not going to enforce its COVID-19-related patents against other companies while the pandemic continues, and that it is willing to license its IP for COVID-19 vaccines for the post-pandemic period.
Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, (IFPMA), in an Op-Ed article in the New York Times in December 2020, said it was unclear how suspending patent protections would ensure fair distribution. “But what is clear is that if successful, the effort would jeopardize future medical innovation, making us more vulnerable to other diseases.”
There is a lot of merit to the claim that IP is a driver of innovation, acknowledged Locke.
“But a lot of critics would say ‘well what kind of innovation are you referencing?’ There are thousands of redundant patents on very rare diseases that you only find in high income countries, whereas with [challenges] like malaria and tuberculosis and tropical diseases you don’t see that sort of innovation on that front, so I think there is an inherent problem in how IP drives certain types of innovation.
“But that is not really the question at hand, the question is whether suspending IP rights would impact or detract from innovation in the future and I think there are a lot of really clear examples of where exceptions were made for other emergency epidemic or pandemic situations and they did not inhibit innovation at all. You can look at the AIDS crisis where pharma companies were charging between US$10,000 and US$15,000 per patient for angiotensin receptor blockers (ARB) and then, eventually, we got the DOHA regulation, paragraph 6 where India, South Africa and Brazil were able to provide generic versions of the same drugs for much cheaper. It would be very difficult to make the argument that development had a depressing or negative effect on pharmaceutical innovation over the past 20 years.”
An IP framework is needed, certainly in the case of ensuring safety of medicines, he said.
“However, the reason we have emergency exceptions in the TRIPS agreement is essentially for that – for emergencies - which is what this pandemic is now. When you look at the amount of cost that is being hammered on the global economy and on people’s lives, there is no ethical, legal or rational reason not to be producing vaccines as cheaply and widely as possible.”
Some vaccine developers have been involved in technology transfer - the AstraZeneca agreement with India’s Serum Institute is an obvious example. Pfizer has not gone down that route to date.
“Pfizer is a much bigger company, with the global capacity to do things on its own. It took much less government money than any other vaccine manufacturer. It is one of the largest pharma companies so it can do that. But if you look at how long it took for BioNTech to transfer its technology to Pfizer and then how long it took for them to almost double the COVID-19 vaccine production capacity, it is quite impressive and shows how quickly these things can be done. Nobody was making mRNA vaccines prior to this. It just goes to show there is a lot of potential when the will is there,” commented Locke.
Aren't there issues with manufacturing capacity in low- and middle-income countries (LMICs), and thus wouldn’t sharing of IP or technology transfer likely have limited impact in those markets?
“Within the context of the TRIPS waiver, therapeutics and diagnostics are also covered and there is a lot of potential to immediately scale up small molecule drugs and testing regimes to combat the pandemic. In the context of vaccines, there is some manufacturing capacity potential in LMICs such as India and South Africa, etc. I think that technology transfer, what it takes to scale production of vaccines, is not without difficulty, but we have seen it happen in other circumstances. The argument that you shouldn’t take the first step because it doesn’t get you across the finish line is not a very good one for not doing so. You need to start with IP, the patents, etc. and, from there, you can move on to other developments such as technology transfer. They have to go hand in hand,” said Locke.
He believes the TRIPS waiver has a chance of going through.
“We have had the first crack in the ice, so to speak, as last week Italy told us it would support the waiver as part of its G20 presidency, which would be a massive boost of legitimacy and would put pressure on the European Commission to change its position.”
The ONE Campaign also wants wealthier countries to fund the Access to COVID-19 Tools (ACT) Accelerator to promote equitable access to vaccines, therapeutics, and diagnostics. That was set up by the World Health Organization (WHO) and its partners to scale up the mechanism required for delivery of those products but also to strengthen the global health system architecture, said Locke.
“It is a very solid, ambitious project, but there is still a funding gap of US$27bn. It sounds like a lot but the estimation of costs of unequal vaccine distribution in advanced countries alone is US$4.3-9 trillion. So when you look at the big picture, US$27bn is not that much money.”
And with the virus starting to mutate, other challenges are emerging, he added.
“If COVID-19 is allowed to continue in any part of the world, such as in South Africa or any country, you can have a strain that comes back to the US or the EU that is not containable with the vaccines we have on the market. It is in everybody’s interest to ensure equitable rollout of vaccines.
“So we are also calling on countries for fairer distribution of what already exists in terms of vaccine does. We know the EU has purchased 2.3bn doses, Canada has purchased 10 does per citizen, the most per capita of any country, and what we are trying to get countries to do is to start sharing doses proactively as vaccines get approved by regulators, say before 70% of the EU population is vaccinated, to start balancing out this inequity.”
Prohibiting or trying to discourage exports is sending the wrong signal that the EU is only concerned with its own citizens, said Locke.
But coronaviruses like COVID-19 are not going away. Scaling manufacturing is critical: “This is something we are going to have to deal with every year. We will need as many vaccines next year as we will this year. A long-term solution is needed, as opposed to countries not looking past their own nose.”
Urgent needs of low- and middle-income countries
The COVAX Facility of the ACT Accelerator has agreements to access 2 billion doses of WHO pre-qualified vaccines during 2021, but this represents only 20% of the vaccine needs of participating countries.
And, according to an article in The Lancet, written by the Lancet Commission on COVID-19 vaccines and therapeutics task force members, the ultracold chain requirements of mRNA COVID-19 vaccines are likely to be an insurmountable hurdle in LMICs, outside of major cities.
“COVID-19 vaccine delivery will require considerable investment of resources, health-care staff, and careful planning to avoid opportunity costs, including a disruption of routine health services and a decline in essential childhood vaccination coverage, which could result in outbreaks of measles and other vaccine-preventable diseases.”
Evaluating the urgent needs of LMICs in terms of vaccines and therapeutics to tackle the pandemic the authors said that strengthening those countries’ capacity to do clinical trials and promoting LMIC participation in research are also crucial.
“More LMICs need to participate in future vaccine trials and in testing the clinical effectiveness of different therapeutic agents to ensure that interventions and implementation are suitable for local contexts.”
Tracking the safety and effectiveness of different COVID-19 vaccines over time in various populations and settings will necessitate improvements in pharmacovigilance, continues the piece.
“Regulatory authorities in many LMICs need to be strengthened and could benefit from a program of national and international support, as well as regional cooperation and reliance mechanisms. As part of internationally coordinated actions, COVID-19 technologies should be transferred to LMIC-based manufacturers, accompanied by regulatory guidance. Efforts to boost local manufacturing capacity in LMICs will contribute to equity, global solidarity, and global health security.”