World leaders are struggling to agree on how to increase vaccine production amid the vast difference between vaccination rates in advanced and poorer countries.
There have been calls to the World Trade Organisation (WTO) to waive the intellectual property rights of vaccine manufacturers in order to boost production, and the US has shown its support. However, the opposition are insistent that there are other issues to address.
What is Intellectual Property?
Intellectual property refers to creations and innovations which are protected by patents, copyrights and trademarks. These prevent other parties copying such creations and allow the originator to reap the financial rewards from its sale and use.
Patents, in particular, give innovating firms protection through a short-term monopoly on their creation. This therefore provides a financial incentive to continue investment in research and development, as firms’ innovations will be protected from being copied – allowing the innovating firm to gain the full financial rewards of its work.
A waiver of intellectual property rights would allow others to copy the work of companies who have rolled out vaccines already, and thus vaccine production could start in countries elsewhere. This would increase the global rollout and could reduce the inequity of vaccine supply.
Support for a Waiver
Many developing countries argue that protecting patents provides an obstacle to increasing the production of vaccines and other products needed to tackle the pandemic. As BBC Global Trade Correspondent, Dharshini David, said: “nobody is protected until everyone’s protected.”
India, for example, is currently undergoing a vaccine shortage as despite the country’s own Serum Institute of India, the world’s largest vaccine maker, India has suffered major spikes in covid cases and deaths, with demand for the vaccine surging past the supply. The BBC has described India’s vaccine stocks as “nearly dried up” with only 124 million people with a single dose, out of the total population of 1.4 billion.
This shortage has been evident in many low and middle income countries, and as the WTO said in January: over 39 million vaccines had been given within 49 wealthier countries, while one poorer nation had received just 25 doses. WTO Chief, Dr. Ngozi Okonjo-Iweala, said it was “not acceptable” to leave poorer countries at the “end of the queue” for vaccines. In fact, South Africa’s President, Cyril Ramaphosa, strongly described the hoarding of vaccines and refusal to freely share vaccine-making blueprints, as “vaccine apartheid.”
The proposal for a waiver gained momentum after President Biden and the US gave its support, and US Trade Representative, Katherine Tai, explained that “extraordinary times call for extraordinary measures”. French President, Emmanuel Macron, changed his stance by now saying he is “absolutely in favour”, and European Commission President, Ursula von der Leyen, has said “the EU is also ready to discuss any proposals that address the crisis in an effective and pragmatic manner.”
Opposition Against a Waiver
However, Germany has expressed its opposition to the US-backed proposal, saying “the protection of intellectual property is a source of innovation and must remain so.” Companies invest heavily into research and development with the hope that their investment will be returned should they make a breakthrough, and the safe knowledge that their breakthrough will be patented. A waiver would diminish business confidence in future investment as a breakthrough may lack the complete protection of a patent, and the firm may lose out on the full financial benefits of their innovation if others were to copy.
Pharmaceutical companies have voiced their opposition to a waiver by iterating that patents are not the primary obstacle to the vaccine shortages in developing countries. The Head of the International Federation of Pharmaceutical Manufacturers & Associations, Thomas Ceuni, explained his concerns that a waiver could lead to a compromise in the “quality and safety of vaccines” that would ordinarily be ensured if companies were to handle the situation themselves. He went on to explain that trade barriers are preventing the flow of goods to other countries, thus “it is shortages and scarcity in the supply chains, which need to be addressed.
“None of this is addressed with the patent waiver.”
The German Government also stated that the waiver would have “significant implications for vaccine production as a whole” and the “limiting factors in the production of vaccines are the production capacities and the high-quality standards… not patents.” It seems therefore that the struggle with vaccines in low and middle income countries is due to the deficient economic development and resources of the country itself, rather than the secretive patent rights of the vaccines developed by companies. For example, BioNTech – the German Company which partnered with Pfizer – have said that developing the manufacturing process took a decade and validating production sites can take up to a year. In addition, the availability of the raw materials needed has also been an issue. Put nicely by Dharshini David: companies see a patent waiver as “akin to handing out a recipe without sharing the method or the ingredients.”
Alternatives to a Waiver
With opposition to a waiver insisting that their intellectual property rights are not the appropriate issue to address, alternatives have been considered.
The UK and EU have favoured a system of licensing whereby the “know-how” of vaccines is shared with chosen third parties, and this could even become compulsory. Some trade specialists have speculated that the US’ backing of the waiver proposal may result in manufacturers being more open to sharing expertise voluntarily. Indeed, Dr. Ngozi Okonjo-Iweala urges that “voluntary licencing… could save many more people” and this has been seen by the voluntarily sharing between Oxford-AstraZeneca and the Serum Institute of India.
On the other hand, the EU has also said the best short-term fix would be supply chain improvements and pushing richer countries to export more vaccines. The Covax scheme was set up last year in order to ensure that countries have fair access to vaccines, and that wealthier countries with a surplus of vaccines can donate them to poorer countries. More than 49 million vaccine doses have been delivered through Covax so far, however the global situation remains vastly uneven.
The Director-General of the World Health Organisation (WHO), Dr. Tedros Adhanom Ghebreyesus, has even accused the wealthier countries of “gobbling up” the vaccine supply, as in April only 0.3% of the vaccines administered around the world so far had gone to people in low-income countries. Moreover, around 20 million extra doses are needed by the end of June to make up the shortfall caused by the spiralling health crisis in India.
Although, vaccines are still coming through the Covax scheme, with Sweden pledging one million Astra-Zeneca doses in May, and the US company Moderna agreeing a deal with Covax for 500 million doses at its “lowest-tiered price”. However, the bulk of these will not be available until 2022.
It is perhaps not so straight-forward to balance protecting business rights which incentivise future innovation, and public policy of ensuring world health. However, the patent waiver would only be temporary, hence the opposition’s argument is not that a waiver will disrupt business rights, but that it will not address the real issues.
There are indeed developmental inequalities between countries which will hinder their roll-out of the vaccine. As BioNTech explained, it takes years to establish production even with the intellectual property rights waived. A waiver would therefore be a long-term strategy, allowing less developed countries to begin establishing manufacturers for the vaccine. Whereas the Covax scheme of donating vaccines is an effective short-term strategy, although this means some countries are reliant on this supply.
It may therefore be considered whether both strategies could be employed. Covax does provide for some of the shortfall experienced in less developed countries, however a phrase comes to mind: ‘give a man a fish and he eats for a day, teach a man to fish and he eats for a lifetime’.
Covax hopes to protect at least 20% of the population of the 92 countries signed up, however the WHO suggests that stopping COVID will require at least 70% of the global population to have immunity. It is therefore clear why the WTO is considering further measures such as a waiver of intellectual property rights.
It seems a large part of tackling the pandemic and vaccine inequity, is dependent on the goodwill of businesses, governments and people. Without the backing of other key nations, the waiver proposals may stall, but they nevertheless may pave the way for future policies. We must await the further discussions at the WTO for a consensus decision as to whether intellectual property rights will indeed be waived.