Trade and technology
To produce vaccines, intellectual property rights may be waived. That’s counterproductive.
Published 07 June 2022
As the unsung hero of the Covid-19 pandemic, intellectual property (IP) has enabled dozens of collaborations all over the world, often between competitors. Weakened intellectual property rights (IPR) would undermine the private sector's incentive to invest in new technologies and treatments, leaving the world reliant on highly speculative alternative models of drug and vaccine development.
IPR’s role in vaccine development
Covid-19 vaccines have saved millions of lives during the pandemic. There are now 10 COVID-19 vaccines recommended by the World Health Organization for a disease that was unknown in December 2019. More than 60 vaccine candidates in late-stage clinical trials or pending regulatory review.
This innovation triumph has been matched in manufacturing. By December 2021, around 12 billion doses of vaccines had been manufactured, enough to vaccinate the world’s population. Currently, vaccine supply far exceeds the global distribution capacity. Africa’s first Covid-19 vaccine manufacturing plant in South Africa recently announced that it may close due to lack of demand.
The story is clear: new vaccines have made Covid-19 far less dangerous. Central to this success are the IP rights which have given companies ownership and rights over their inventions.
As the unsung hero of the pandemic, IP has enabled dozens of research collaborations and manufacturing partnerships all over the world, often between competitors. Rivals have shared proprietary compounds, platforms, and technologies to develop new vaccines and flood the market in record times.
Since June 2021, the number of vaccine manufacturing partnerships has risen from 93 to 357, and the collaboration ranges from end-to-end production to sourcing drug components. The common thread? The legal certainties that IPR provide, which allow companies, universities and governments to collaborate on research and development (R&D), often across borders and between commercial rivals. These certainties also help mobilise the capital required to build high-tech vaccine manufacturing capacity at the massive scale required to tackle a global pandemic.
Yet health NGOs and some governments argue that developing countries will get speedier access to new vaccines if IPR are suspended to enable manufacturers everywhere to produce them.
That argument drives a World Trade Organisation proposal to dismantle IP rights for Covid-19 vaccines, now in the final stages of negotiation at the Trade-Related Aspects of Intellectual Property Rights (TRIPS) council meeting. A final decision is due at the 12th WTO Ministerial Conference between 12 and 15 June.
Meanwhile, an equal push to weaken IP rights in a new treaty on Pandemic Preparedness is in its early stages at the World Health Organization, which gathered in May at the World Health Assembly in Geneva.
A new Joint Declaration supported by 25 think tanks from around the world argues that removing or weakening IP rights for pandemic vaccines and therapeutics would be highly counterproductive. It would undermine the incentive to invest in new technologies and treatments. IPR allow for risk-taking that brings rewards, such as the first mRNA vaccines that underpin global vaccination against Covid-19.
The highly speculative efforts into mRNA vaccines only paid off after decades of efforts. This critical technology now offers the potential for rapid solutions for future pandemics and other diseases, including malaria and a range of cancers.
Removing IPR in pandemic situations would also destroy the international manufacturing collaborations and partnerships essential to saving millions of lives in the current pandemic.
The active transfer of complex technology through teaching and physical presence by key personnel as part of these partnerships is protected by IP. Innovators can be confident that the sharing of valuable information is not risky commercially.
Unviable alternate models
If IPR are weakened now at the WTO or in any future treaty, few private sector companies would be willing to commit resources to pandemic vaccines and therapeutics. This would leave the world reliant on alternative open source or IP-free models of drug and vaccine development.
Such models were already available to researchers and governments at the beginning of the pandemic. Today, enough time has passed to make an initial assessment of their effectiveness. In summary, while a few examples have advanced towards market authorisation, their development has been too slow for a pandemic situation. This is largely due to open source or IP-free models struggling to attract the necessary funding to advance rapidly through clinical trials and establish large levels of manufacturing capacity.
Before a vaccine can be authorised for use, it must undergo three stages of clinical trials in volunteers, with the last stage involving many thousands of volunteers in multiple countries. These trials are essential to demonstrate the candidate vaccine is both safe and efficacious. Vaccine development can cost an estimated US$1.1 billion, accounting for failures.
One IP-free vaccine from the University of Helsinki managed successful pre-clinical trials. However, it was unable to secure funding for vital clinical trials in humans. Meanwhile, Corbevax, another patent-free vaccine developed by Texas Children’s Hospital, has been authorised for use in India. To date, there is no public data on its efficacy or clinical trials.
If successful, IP-free vaccines could prove useful additions to the pandemic preparedness arsenal. But these patent-free models face difficulties in marshalling the capital and expertise to rapidly scale-up global production. In other words, they would be unreliable if needed quickly in another pandemic.
Consider the complexity of scaling-up manufacturing of the mRNA vaccines that have underpinned global vaccination programmes. For its mRNA vaccine, Pfizer developed a 50,000-step manufacturing process, identifying and working with 86 different suppliers. The vaccine required 280 materials in total, 10 to 15 of which were novel. Innovation, refinement and investment allowed the company to cut the initial production time in half, enabling it to deliver more doses more quickly.
It’s difficult to imagine this kind of global, multi-stakeholder and ultimately capitalist endeavour happening so quickly in the absence of the legal certainties provided by IP rights. Particularly for manufacturing, the existence of IPR allows vaccine manufacturers to share valuable proprietary information with partners involved in smaller parts of the vaccine manufacturing chain, safe in the knowledge that it cannot be commercially exploited at a later date.
The way forward
Rather than limiting IPR in pandemic situations, governments should more sensibly focus on concrete measures that will genuinely speed up access to vaccines and therapeutics.
One is the need for greater global harmonisation of regulation. If every country were to carry out its own review of a vaccine, it would force the manufacturer to go through 190 different regulatory processes, according to Richard Hatchett, chief executive officer of the Coalition for Epidemic Preparedness Innovations. This issue is already recognised by the International Coalition of Medicine Regulatory Authorities (ICMRA), which is working towards greater international coherence in this area.
Meanwhile, various trade barriers have disrupted vaccine availability globally. Export restrictions imposed by India in April 2021 contributed to COVAX failing to deliver around 190 million doses on schedule by June 2021. This led to the massive delay of the pandemic response in low and middle-income countries. Governments should agree to a legally binding way to ensure that this does not happen again, preferably at the World Trade Organisation.
As WTO negotiators thrash out the final shape of an IP waiver, they should recognise that a zero IP world would be a backward step. It would discourage companies from making urgently needed refinements to existing vaccines to combat new Covid-19 variants and derail the dozens of vaccine-manufacturing partnerships, throwing global supply chains into chaos. It would put in jeopardy the billions of dollars currently being invested in upgrading manufacturing facilities and creating new ones.
With the precedent set at the WTO, few companies will want to invest in new vaccines when the next pandemic comes. Without the private sector, the world will be relying on highly speculative IP-free R&D models to research and mass produce vaccines in highly compressed timeframes. The experience with Covid-19 shows that in pandemics, IP works. The world should stick with it.
9. Park, Alice, and Aryn Baker. “Exclusive: Inside the Facilities Making the World’s Most Prevalent COVID-19 Vaccine.” Time, April 19, 2021. https://time.com/5955247/inside-biontech-vaccine-facility/. Neubert and Scheitz, “Exploring the Supply Chain of the Pfizer/BioNTech and Moderna COVID-19 Vaccines.”
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