Why is waiving patents on COVID-19 research controversial?

The COVID-19 pandemic has had an intense global impact. Whilst it isn’t the first healthcare crisis to deeply affect multiple countries, it is the first to trigger such a rapid and successful global development programme of interventions and vaccines across the scientific community. As a result, university-industry collaboration has been thrust into the public domain. Major pharmaceutical companies working together and with academia, with support from governments and the wider ecosystem, have developed and deployed vaccine doses in record time. 

At face value, it might seem that the more open nature of some of the vaccine collaborations would be an ideal way forward for commercialising research from across the sciences, and there are calls around the world to waive patents on COVID-19 vaccines. However, the idea of waiving patents on Covid-19 vaccines and using non-exclusive licenses is not a simple solution, rather a tangled and seriously controversial debate.

How has COVID-19 changed research collaboration?

Over the last few months, we’ve spoken directly with thought-leaders from industry R&D, academia and research commercialisation in our Covid-19 webinar series and learnt about the many ways the pandemic has impacted how academia and industry collaborate. A key feature of the global response to the pandemic, especially across the scientific community, has been sharing of information and pooling of resources to drive rapid development of treatments and vaccines. We’ve heard examples of core business development groups being established between companies and academics to inform research and coordinate approaches. In one recent webinar (best practices for university-industry collaboration around COVID-19) panellists from universities in the USA and South Africa discussed the use of non-exclusive licences and open-source designs to help fast-track collaborations and provide life-saving interventions as quickly as possible.

The Oxford/AstraZeneca vaccine is probably the most famous example now of royalty-free licensing, with it’s pricing held at not-for-profit distribution. AstraZeneca holds a license to manufacture and distribute the University of Oxford’s vaccine and has committed to producing it at no profit for the duration of the pandemic, thus improving access to doses across the world as well as sharing their license so that manufacturing could begin at multiple sites. Although this may be the most well-known case, other universities around the world have independently taken similar approaches, not just to vaccines, but also to therapeutics and other interventions. What’s more, the research commercialisation community has been actively encouraging more accelerated approaches and humanitarian licensing to drive rapid and broad distribution of COVID-19 interventions.

So why isn’t waiving patents on Covid-19 vaccines a simple solution?

Although there have been calls for major vaccine makers to drop patents protecting COVID-19 vaccines in a move supported by the WHO, these have not been unanimous. Countries such as the US, China and Russia are backing the call for patent waivers to the World Trade Organisation, who enforce global IP rules. 

Waiving patents on Covid-19 vaccines would remove the rules that prevent them from being copied and manufactured by others, potentially reducing the costs of production. NGOs such as Oxfam and UNAIDS say it would be an opportunity to save lives across the world as the rollout of vaccines would be accelerated, and would allow equitable access to vaccines for all countries. Furthermore, it would provide open access to the ‘recipe’ for a vaccine and potentially stimulate collaboration between companies who would normally be competitors.

Whilst some countries are pushing for patents to be waived, there is still a sense of uncertainty over the idea. There is also a strong resistance being displayed by governments and pharmaceutical companies, as well as the academic and technology transfer community. Of course, this is frequently where the initial research into disease vaccines often begins, and here discussions around waiving patents on Covid-19 vaccines is akin to opening a can of worms.

The R&D and technology transfer professionals we spoke to in our recent webinars raised the issue of how we could guarantee the efficacy and safety of vaccines if the patent rules were waived. Open-source information as to how to manufacture a vaccine alone may not be adequate; it would need to be accompanied by the transfer of the skills and technical information from the personnel who developed the vaccine to ensure product quality. 

As many countries already face vaccine hesitancy from some of their population, uncertainty around the quality of the vaccine could generate further reluctance to be vaccinated, impacting our ability to overcome the spread of the virus. There may be other barriers to vaccine manufacturing, including access to raw materials and specialised equipment, that waiving the patent alone cannot overcome. Finally, the removal of profit incentives may discourage pharmaceutical companies from investing in disease research in the future.

The removal of patents on COVID-19 vaccines would certainly be an egalitarian and humanitarian approach to ending the pandemic, and at the time of writing the pace of vaccine rollout in higher-income countries is far outstripping vaccine delivery in poorer countries. In the June 2021 G7 summit, world leaders have promised to donate an extra 870 million vaccine doses, but this has been met with criticism as inadequate. According to the WHO, it will take 11 billion doses to bring the pandemic under control, at which point 70% of the world’s population would be vaccinated.

There is no easy or simple answer to the ongoing debate around waiving patents on Covid-19 vaccines. However, there are approaches that could buy time for the solution to be properly discussed by all parties, consequently achieving an outcome agreeable to all. This might include a combination of pharmaceutical manufacturers using low-income pricing models and other non-exclusive license variations, along with increases in vaccine donations from governments through initiatives such as COVAX. Like the pandemic itself, there is no ready-made solution and a clear path through will require a coordinated and cooperative effort from all parties.

Written by Ruth Kirk. Edited by Alex Stockham.

Copyrights reserved unless otherwise agreed – IN-PART Publishing Ltd., 2021: ‘Why is waiving patents on COVID-19 research controversial?’

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