By Anne Moore, Senior Lecturer in Biochemistry and Cell Biology, University College Cork
Covid-19 vaccines are key to ending the pandemic. From a humanitarian, moral and pragmatic perspective, the countries must unite to ensure fair and rapid access to these vaccines, worldwide. As political and health leaders have stressed: no one is safe until we are all safe.
But satisfying this need is complicated. Before the pandemic, the global demand for all vaccines was around 5.5 billion doses a year. We now need at least three times this for Covid-19 alone, with continued high-scale production likely to be needed in subsequent years.
Such a fast increase in vaccine production is unprecedented and expected obstacles need to be addressed. One particular idea gaining traction is that vaccine production is being limited by patents and other intellectual property (IP) rights – legal mechanisms that allow organisations to stop others (for a limited period) from making, using or selling their inventions without their permission – and that these should be waived. This, however, should not be a major priority.
Not the main barrier
South Africa and India have petitioned the World Trade Organization (WTO) to waive certain IP protections, for a limited time, that relate to products for preventing, containing or treating Covid-19. This would allow countries to produce Covid-related products, such as vaccines, for themselves, without fear of being punished for infringing the IP rights of the companies that developed them.
Various NGOs, former heads of state and Nobel laureates have declared their support. It’s claimed that waiving IP agreements “would expand global manufacturing capacity”, allowing production to ramp up “unhindered by industry monopolies that are driving the dire supply shortages blocking vaccine access”.
The WTO petition references suggestions that IP rights have limited the availability of personal protective equipment and the production of ventilators during the pandemic. However, little (if any) evidence has been presented that suggests IP protection is blocking Covid-19 vaccine manufacture.
Rather, technical and logistic issues are the biggest barriers currently standing in the way of increasing vaccine production and deployment. To boost vaccine availability right now, it would be better to address these.
One obstacle to increasing production is the supply of raw materials needed to make and deploy these vaccines. The almost instantaneous tripling of demand for specialised materials is placing huge pressure on many pharmaceutical and medical supply chains. This needs to be fixed, not just to help with the production of authorised Covid-19 vaccines, but also to ensure we don’t delay testing and approving vaccines still in development.
Empty glass vaccine vials
Second, transferring the manufacturing process from one facility to another always takes significant resources, as staff at the new site need to be trained in every aspect of production and quality assurance. On top of this, skills are also required in the clinical, legal, commercial and regulatory aspects. Expanding production capacity is thus not instantaneous, and certainly wouldn’t immediately happen just because IP protection has been waived.
Nevertheless, this technology transfer continues, with several Covid-19 vaccine manufacturers transferring their technology, under licence, to sub-contractors. An example is the licensing of the AstraZeneca vaccine to the Serum Institute of India. To get manufacturing going, the institute dedicated 1,000 staff to the project.
This raises a further point, which is that for technology transfer to work, countries must have specialised facilities and a skilled workforce capable of making vaccines. They also need robust regulatory authorities to audit and approve the safety of what’s produced.
Advocating for current and long-term commitments to increasing these skills around the world could be a more successful way of increasing the number of countries manufacturing vaccines in the long term, compared to waiving IP rights. Indeed, past efforts to increase worldwide manufacturing capacity and access for other medicines, such as those for drug-resistant tuberculosis, have taken this sort of broader approach and not focused solely on IP.
Likewise, if we are serious about improving access to Covid-19 vaccines, other issues need to be addressed. Pricing, as well as allocation and deployment mechanisms, such as Covax, must be optimised to allow equitable vaccine deployment.
IP remains useful
Love it or loathe it, IP also plays a central role in getting vaccines developed.
Given the emergency we’re in, companies that are normally competitors are working together to produce vaccines. Here, IP can facilitate cooperation; it’s clear which organisation owns what technology, meaning companies don’t have to worry about their ideas being taken when collaborating.
Plus, for academics who aim to translate their research into having real-world impact, there are few options other than to license their innovations to commercial entities who have the expertise and resources to bring the research into clinical use. The Covid-19 vaccine partnership between the University of Oxford and AstraZeneca is a successful example of this inter-dependency.
Such transactional agreements (and so developing health innovations from academic research) rely on IP and being able to give commercial partners exclusive access to knowledge. Enacting an IP waiver risks bringing levels of uncertainty across the vaccine field because, without the exclusive rights to a product, it’s less clear if developing it will lead to a return on investment.
This may put companies off working on vaccines. The vaccine space has only recently grown from being a very narrow field, comprising just a few companies at the start of the century, so the threat of losing developers is real. We need to have as many competitors in the field as possible to sustain diverse academic-commercial partnerships. This diversity has already helped create a range of Covid-19 vaccines.
Current IP regulations are not perfect, and this IP waiver discussion rightly forces an examination of current systems. However, waiving IP is unlikely to be a short-term solution to rapid vaccine manufacture and deployment and could lead to long-term obstacles for vaccine development.