Intellectual Property Rights and Vaccine Production

By Mark Comer

The WHO recently criticised the “shocking” disparity in the global distribution of Covid-19 vaccines.  Twenty-seven countries in the EU and five other wealthy nations have secured approximately half of all Covid-19 vaccine doses (Mullard, 2020). The problem of inequal access to vaccines is apparent and numerous world leaders and former officials have pushed for a waiver of intellectual property (IP) rights in order to boost production of vaccines worldwide. The proposal to waive current World Trade Organisation (WTO) regulations has been divisive, but the WTO itself noted that maintenance of patents during a public health crisis would be difficult to justify (Zarcostas, 2021). Such a waiver would allow for production of cheaper, generic versions of currently licensed vaccines. Nonetheless, a minority of members of the WTO continue to resist efforts to waive intellectual property rights. Within the current proposal, efforts are also being made to include waivers for a variety of health technologies related to vaccine production as well as products such as ventilators or personal protective equipment. However, the prevailing view of the pharmaceutical industry is that waiving intellectual property rights for vaccines would not necessarily increase production in the short-term.

The most convincing argument for maintenance of intellectual property rights is that vaccine production is currently being held back by existing bottlenecks in raw materials, distribution, and production. Thus, a waiver would not address the rate-limiting steps in vaccine production. One should also note the especially challenging nature of vaccine production, the necessity for highly trained staff, specialist equipment and strict quality control. Failures in production could severely damage confidence in the vaccine. This is especially true for mRNA vaccines which due to their novelty reduces the availability of trained staff and necessary equipment. Expansion of the waiver to include the technologies necessary to produce, package, and store the vaccine would also likely be necessary for any increase in production. The United States also oppose this expansion of the waiver to include the necessary technologies as this approach is unlikely to have a meaningful impact on production. The challenge of vaccine production can be difficult to meet even in developed countries, the FDA last month was forced to temporarily halt vaccine production in Baltimore after several million doses failed quality control measures (Lovelace & Macias, 2021). 

There is an argument to be made that technology and knowledge sharing by pharmaceutical companies could have happened earlier in the development of the vaccines and thus increased the preparedness to manufacture more doses.  Though a study commissioned by the management consultancy firm McKinsey estimated that technology transfer for production of a vaccine could take anywhere from 18 to 30 months (Zarcostas, 2021).  It seems that the current issue of a production shortfall is predicated on historical unwillingness of the pharmaceutical industry to engage in sharing of technology and production “know-how” rather than existing IP rights.  Pharmaceutical companies have also pointed out that export restrictions on vaccine materials are contributing to supply shortages (Nawrat, 2021). The US Chamber of Commerce and the International Federation of Pharmaceuticals Manufacturers & Associations have both argued that the current focus on waiving IP protection is an unnecessary distraction from addressing existing issues with the supply chain and production bottlenecks (Zarcostas, 2021). Removal of IP protections seems to be a longer-term solution for the issue of limited vaccine supplies and not an immediate remedy due to the significant number of barriers to successful vaccine production.

In addition, the pharmaceutical industry claims that waiving of IP protections is unnecessary as it has already partnered with several developing countries to produce vaccines. The most prominent example for this is Oxford-AstraZeneca’s partnership with the Serum Institute of India. However, this also proves that technology and knowledge transfer may not be as difficult or time-consuming as prominent members of the industry claim. Moreover, the WHO has already established a regulatory framework for such knowledge sharing through C-TAP (COVID-19 Technology Access Pool) (Marris, 2021), although the pharmaceutical industry has failed to engage with it. The industry has also stressed the role of intellectual property rights in driving innovation (IFPMA, 2021), and that the wide variety of available vaccines was made possible by existing IP rights. Continued engagement of investors is also dependent on existing intellectual property rights, though the role of a profit-making incentive in development of life-saving medications is another ethical quandary in and of itself. It is also important to consider solutions to vaccine inequality that do not involve intellectual property. For example, it may be possible to address poor access to vaccines for developing nations through the COVAX initiative. The initiative set up by the WHO aimed to ensure equal access to vaccines through purchasing doses of licensed vaccines. Despite this, it has currently shipped only 71 million doses or approximately 3.5% of its target of 2 billion (by the end of 2021). The chronic underfunding of the COVAX initiative represents an opportunity for a solution for vaccine inequality that exists outside of changes to existing intellectual property rights. 

Perhaps unsurprisingly, the issue of intellectual property rights is not as clear cut as either the pharmaceutical industry or politicians claim. The current shortfall in vaccine doses is undoubtedly affected by supply and manufacturing bottlenecks but this ignores the significance of the pharmaceutical industry’s historical unwillingness to transfer knowledge and technology to developing countries at scale. The real issue lies within technology and knowledge transfer, rather than in legal or regulatory frameworks. In the long-term increased sharing of vaccine production technology and know-how will be key for future pandemic preparedness and for addressing emerging variants of Covid-19.

 References:

Mullard A. How COVID vaccines are being divvied up around the world. Nature. 2020 Nov 30.

Zarocostas J. What next for a COVID-19 intellectual property waiver?. The Lancet. 2021 May 22;397(10288):1871-2.

Lovelace B., Macias A. Covid vaccine: FDA finds poor conditions at Baltimore plant that ruined J&J doses [Internet]. [cited 2021 May 25]. Available from: https://www.cnbc.com/2021/04/21/fda-finds-poor-conditions-at-baltimore-plant-that-ruined-millions-of-doses-of-jj-covid-vaccine.html

Nawrat A. Exploring the Covid-19 vaccine IP waiver proposal at the WTO [Internet]. [cited 2021 May 25]. Available from: https://www.pharmaceutical-technology.com/features/wto-ip-waiver-proposal-covid19-vaccine/

Marris S. COVID-19: Experts call on UK to back intellectual property waiver on coronavirus vaccines | UK News | Sky News [Internet]. [cited 2021 May 25]. Available from: https://news.sky.com/story/covid-19-experts-call-on-uk-to-back-intellectual-property-waiver-on-coronavirus-vaccines-12302294

Pharma delivers COVID-19 solutions, but calls for the dilution of intellectual property rights are counterproductive – IFPMA [Internet]. [cited 2021 May 25]. Available from: https://www.ifpma.org/resource-centre/pharma-innovation-delivers-covid-19-solutions-beyond-expectations-but-calls-for-the-dilution-of-intellectual-property-rights-are-counteproductive/

Stevens P. Why waiving intellectual property rights for Covid vaccines is wrong [Internet]. [cited 2021 May 25]. Available from: https://www.telegraph.co.uk/business/2021/05/09/waiving-intellectual-property-rights-covid-vaccines-wrong/

COVAX explained | Gavi, the Vaccine Alliance [Internet]. [cited 2021 May 25]. Available from: https://www.gavi.org/vaccineswork/covax-explained

Coronavirus (COVID-19) Vaccinations – Statistics and Research – Our World in Data [Internet]. [cited 2021 May 25]. Available from: https://ourworldindata.org/covid-vaccinations

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