Sofiya Bidochko: Covid-19 Vaccination
COVID-19 vaccines are crucial to saving lives, protecting healthcare systems, and ending the pandemic. They inject hope into the minds of fearful people—hopes of protection, survival, and eventual normalcy. However, these injections of hope have not been equally distributed across the world. Rather, the vaccine supply—severely limited by a lack of raw materials and manufacturing facilities—has been bought out by high-income countries that have supported vaccine development efforts and paid hundreds of millions of dollars.
In May of 2021, according to tweets from the UN Under-Secretary-General Melissa Fleming, more than 80% of the approximately 1.3 billion coronavirus vaccines administered worldwide were in high-income countries, leaving the other countries greatly unprotected. Countries such as the US and Israel—which have paid over a billion dollars combined—have had enough vaccine supply to fully vaccinate every citizen and offer boosters while developing nations still cannot offer each citizen their first dose. This discrepancy has caused the latter to face constant catastrophic surges of the virus, completely overwhelming healthcare systems. Additionally, it has global consequences, as highly unvaccinated nations are breeding grounds for worrying variants.
Patents on COVID-19 vaccines are a large barrier to vaccine production. With patent protection from a respective country, the vaccines have legal protection against copying and hence a monopoly for a limited time, usually 20 years. The guaranteed monopoly creates an incentive for the patent holder to take on the risk and financial demands of developing its product as the patent holder can charge high prices and reap the benefits of its investment during its monopoly period. Once the period of patent protection ends, other companies can enter the market and use the technology that was previously patent-protected.
In late 2020, a group of developing nations, led by India and South Africa, argued to the World Trade Organization that patents on COVID-19 vaccines should be waived so that other manufacturers local to their own countries could make the vaccine. These countries wanted local manufacturers to make the vaccine because there was not enough supply produced by Moderna and Pfizer and these countries weren’t going to receive the limited supply over countries such as the U.S. and Germany which paid billions to help with vaccine development.
The group requested a three-year waiver of IP protection for any COVID-19 related products. The waiver follows a belief that every country should have the right to make its vaccines during a pandemic while intellectual property restrictions impede vaccine production. Many western nations and pharmaceutical companies such as Moderna and Pfizer did not support this idea as they believe it will result in unregulated, poor quality vaccines from outside manufacturers due to the complexity of vaccine development technology. Eventually, President Biden announced support for waiving COVID-19 related patents but the majority of the European Union remains skeptical. The global debate of patent waiving remains largely unresolved.
Waiting twenty years for a patent to expire can be impractical in a pandemic. Hence, the country issuing the patent can intervene and issue a compulsory license to allow others to produce the product. The entity that is issued the compulsory license has to pay a royalty to the patent owner. While this sounds like a practical solution, the process of obtaining a compulsory license is very time-consuming which becomes a great challenge in urgent matters such as a pandemic. The licensing process is also complicated and bureaucratic. For example, the World Trade Organization limits compulsory licenses for only domestic production and use in Article 31 of The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Therefore, a country cannot issue a compulsory license to a company that isn’t domestic and the products cannot be exported to another country.
Due to the time-consuming bureaucratic process of obtaining a compulsory license and the fees associated with forced payments to the patent holder, developing countries argue that compulsory licensing still does not serve as an effective solution to vaccine monopolies and product shortages. They argue that it is best to completely waive the patents for a temporary period. Waiving patents would allow countries like Bangladesh, Denmark, and India to quickly manufacture and obtain COVID-19 vaccines.
Critics of patent waiving argue that relinquishing patents will be an ineffective solution to the production shortage. The patent will reveal the specific recipe of the vaccine, but other manufacturers will not be educated enough on the elaborate production process to know how to create it, especially vaccines with advanced mRNA technology. Prashant Yadav, a supply chain expert and senior fellow at the Center for Global Development, has stated that “In such a setting, imagining that someone will have staff who can create a new site or refurbish or reconfigure an existing site to make mRNA [vaccine] is highly, highly unlikely” (Garde et. al, 2021). He believes that the lack of raw materials and facilities for manufacturing doses is the biggest issue and suspending waivers will do little to solve these issues.
Adding complexity, the patent holder decides how much insider information to share when waiving a patent. This education gap in producing the vaccine can complicate production, in turn making patent waiving useless. Norman Baylor, former director of the Food and Drug Administration’s Office of Vaccines Research and Review, has stated that “There are currently no generic vaccines primarily because there are hundreds of process steps involved in the manufacturing of vaccines, and thousands of check points for testing to assure the quality and consistency of manufacturing. One may transfer the IP, but the transfer of skills is not that simple” (Garde et. al, 2021). Without knowing the necessary quality controls and protocol used by the original patent holders, the vaccines manufactured could be ineffective and possibly dangerous because of the substandard processes.
On the off chance that a patent holder wants to share its trade secrets or there is an extremely well-educated professional in vaccine development, creating appropriate factories is a long process. Some of the countries arguing for patent waivers would need to build completely new factories as they lack functional ones. While building time is surely long, BioNTech, the company that partnered with Pfizer for the development and production of the COVID-19 vaccine, has said that independent of building time, validating production sites can take up to a year. Hence, time is just as challenging with waived patents as it is with a compulsory license. Even if all these factors are accommodated, challenges would still persist in sourcing raw materials and manufacturing pipelines.
For the critics of patent waiving, the solution to inadequate vaccine supply is not a matter of intellectual property. Patent waiving will not fix the shortage of education, facilities, and raw materials necessary for vaccine production. Consequently, waiving patents can produce future issues of companies feeling discouraged from developing new products. If companies spend large amounts of time and money only for intellectual property protections to be waived in a public emergency, then they are disincentivized from doing so again in the future. Who then will develop the vaccines for future pandemics?
Given the range of problems associated with vaccine production through patent waiving, other solutions must be found to increase the number of shots in arms. One possible solution is for countries to incentivize companies that hold the patents to voluntarily license their product/technology. This means that the patent holder will allow the other entity to make the patent-protected product and sell it. Generally, compulsory licenses and patent waivers go against the desires of the patent holders as they want to maintain a monopoly on their unique product and earn more money, making it more likely that they will not release the secret insider information that is critical for development. However, if companies voluntarily choose to license, they are more likely to develop an effective relationship with the other entity. For example, AstraZeneca successfully licensed their vaccine to India’s Serum Institute, intending to supply one billion doses to low and middle-income countries, including India. On October 21st, 2021, India celebrated a milestone of administering 1 billion vaccines with about 90% of the doses coming from the Serum Institute licensing agreement with AstraZeneca (India Celebrates, 2021).
Moderna argues that a more effective way to increase production is to leave it in the hands of the patent holders. The company has refused to release its formulation process, believing the best way to increase vaccine supply is for their own company to increase production. Its cofounder Noubar Afeyan has said that Moderna will produce 3 billion vaccines in 2022, triple the number currently produced (Garde et. al, 2021). With this increased development, Moderna could supply enough vaccines. Of course, this option places the future of vaccine distribution in the hands of top pharma, entities focused on profit and sales. Despite this argument, the United Nations Health Agency continues to push Moderna to release its formulation process.
A third alternative is for wealthier countries to donate vaccine supply. For example, as of October 2021, the White House said that the U.S. has donated over 200 million doses to over 100 countries (Holland and Singh, 2021). However, one may argue that this solution will only perpetuate the problem. Wealthy nations will only donate vaccines once they have secured enough for themselves and the amounts they choose to donate are highly subjective. This issue is portrayed through the unfulfilled promises at the G7 summit in June 2021 where adequately supplied countries pledged to donate 1 billion vaccines. The majority of these pledges have not been fulfilled. Additionally, this donation plan does not solve the underlying issue of vaccine production.
While vaccine production is still widely debated, most can agree that there is not one simple solution. For example, plans with combined solutions are currently being developed by the European Union. The EU hopes that with a combination of supply chain improvements, compulsory licensing utilization, and increased vaccine donations from wealthier nations, patent waivers will be unnecessary.
Solutions like these are band-aids, and more deliberation should be given to a long-lasting solution that will solve the root of the problem. The underlying issue is that vaccine research, development, and manufacturing are too heavily concentrated in wealthy nations. Increasing vaccine supply is impossible if there are not enough manufacturers and experts across the world. By investing in a more robust global network of vaccine manufacturing and development, not only could this pandemic be ended, but the world would be more prepared for the future.
Sofiya Bidochko is a Sophomore at Yale University in Silliman College
Citations
Garde, D., Branswell, H., & Herper, M. (2021, May 6). Waiver of patent rights on Covid vaccines may be mostly symbolic, for now. STAT. Retrieved November 19, 2021, from https://www.statnews.com/2021/05/06/waiver-of-patent-rights-on-covid-19-vaccines-in-near-term-may-be-more-symbolic-than-substantive/.
Holland, S., & Singh, K. (2021, October 21). U.S. coronavirus vaccine donations reach 200 million doses ... U.S. News. Retrieved November 19, 2021, from https://www.usnews.com/news/top-news/articles/2021-10-21/us-coronavirus-vaccine-donations-reach-200-million-doses.
India celebrates 1 billion covid-19 vaccine doses with song and dance. The Straits Times. (2021, October 21). Retrieved November 19, 2021, from https://www.straitstimes.com/asia/south-asia/india-celebrates-1-billion-covid-19-vaccine-doses-with-song-film.