Vaccines as Technology: Innovations, Barriers, and the Public Health
By: Mary Quandt
Professor Ana Santos Rutschman, recently of SLU LAW and currently Professor of Law at Villanova University Charles Widger School of Law, returned to SLU as a Distinguished Speaker to discuss her new book, Vaccines as Technology: Innovations, Barriers, and the Public Health. Professor Rutschman wrote the book in conjunction with teaching a Vaccine Law and Policy Seminar class at SLU LAW during the 2021-22 school year. Her expertise in health law, intellectual property, innovation in the life sciences, and law and technology have made her a national and international expert on vaccine law and policy.
Quotidian yet complicated, vaccination is a world-changing technology that greatly reduces disease, disability, death, and inequity worldwide. As with any technology, vaccine development and production are subject to a variety of legal requirements, including those governing pharmaceuticals, patent law, intellectual property, marketing, and antitrust law.
“While vaccine development itself isn’t the work of the law, their effects certainly are,” Professor Rutschman explained. For example, law governing technology and innovation policy has a particular effect on vaccine markets and access to vaccines.
Vaccines are biologics, a diverse category of non-living organic materials developed for medical use. Some are easily conceived of, produced, and implemented; others are dramatically more complex. Many important vaccines — including COVID-19 vaccines — fall into the latter category. While some common drugs like painkillers have “biosimilars” (that is, easier or cheaper to produce alternatives), effective vaccines use a single, unique biologic material, making them complicated to bring to scale effectively. Furthermore, this means there are few options for “generic” competition, because there is only one pathway and it is often owned by a single company.
The vaccine market is made even smaller by the fact that vaccines are not like other essential goods: They are usually a quick, singular consumption of a small amount. Even more, the importance of these quick interactions is wildly underappreciated and the immense impact of vaccines on public health and the economy are undervalued.
Research and development (R&D) of vaccines are guided by legal frameworks governing technology and innovation policy. From a historic perspective, vaccine intellectual property filings did not take off until the 1980s. From the first vaccine patent filing in 1935 through the 1940s and 1950s — the “golden age of vaccine development,” which saw the introduction of vaccines for polio, MMR, and other common early childhood vaccines which were funded by national security interests — filings remained low. But after a landmark global treaty in the 1990s, patents exploded. The effects on the market are stark: The number of vaccine manufacturers peaked at 50+ companies in the first half of the 20th century and has decreased since then to fewer than 10 today. These few repeat players now control the capacity to exclude others from joining the market without patents of their own.
Until 2010, there were no federal pathways to regulate non-competition. Licensing and accessibility depended on the individual researcher, institute, or company that held the patent. For example, Jonas Salk famously ensured that the inactivated polio vaccine (IPV) he developed in the 1950s was widely licensed for large-scale, affordable production. In a 1955 interview, when asked who owned the patent for IPV, he replied: “Well, the people, I would say. There is no patent. Could you patent the sun?” In contrast, the COVID-19 vaccine and its variants have been subjected to ongoing legal conflicts as Pfizer, Moderna, and Johnson & Johnson argue over who owns the mRNA patent instead of making it widely available and affordable for a global audience.
Once a vaccine enters the market, it is also subject to legal frameworks that limit competition, affordability, and reproducibility. The basic vaccine standard is that it must be “safe” and “effective” as demonstrated through substantial evidence (42 U.S.C. § 262(a)). Under the COVID-19 pandemic, however, emergency use authorization 21 U.S.C. § 360bbb–3 created a new, lower threshold: Vaccine developers must show “it is reasonable to believe” that a vaccine “may be effective.”
Although vaccine producers are mainly in compliance with federal law, they do take advantage of legal loopholes. For example, Pfizer had an enrollment goal of 44,000 volunteers for its initial COVID-19 vaccine clinical trial. Generally, the distribution of participant race in clinical trials should reflect the current population make up. However, in Pfizer’s first trial, about 75% of participants were white; only 0.6% were Native American (compared to 1.3% in the general population). To keep up with a law requiring clinical trial participants to include minorities, the company stopped enrolling white people and only continued to enroll minorities over time. Even then, COVID-19 vaccine trials were more than 20% below diversity targets — which were lower than Dr. Fauci’s recommendation that trials “enroll minorities at levels at least double the percentages in the population” because of the disproportionate toll of COVID-19 in minority communities.
Legal frameworks regulating vaccines tend to protect intellectual property over global good; that is, the vaccine market hinges on their status as patented technology instead of the social good they bring. Accordingly, morally troubling practices can be entirely legal, such as the legal frameworks conditioning vaccine allocation. During pandemics, vaccine allocation is often first reserved for those countries that can pay into the development of the vaccine. In 2009, during the H1N1 pandemic (the first global flu in 40 years), projected global manufacturing capacity was 1-2 billion doses. However, the US alone reserved 600,000 doses — up to 60% of the global supply — through advance commitments, despite not representing 60% of the global need. COVID-19 was no different. By the end of 2021, global project capacity was 4-5 billion doses. Yet 32 high-income countries (E.U. countries, Canada, U.S., U.K., Australia, and Japan) captured more than 50% of the projected doses before they even came to market. These were certainly not the countries facing the highest public health costs of COVID-19.
Vaccines are vital technology. Their development and distribution are governed by laws controlling pharmaceuticals, intellectual property, marketing, patents, and medicine. Yet their basic purpose is the improvement of human health. Future vaccine scholarship and policymaking will hopefully move towards regulating vaccines not just for their transactional benefits, but also to increase accessibility and health equity.
Professor Rutschman’s lecture was given in person and via zoom on September 20, 2022 as part of the Health Law Distinguished Speaker Series hosted by the Center for Health Law Studies at SLU Law. Each academic year, the Center hosts leading scholars and practitioners who shape health law and policy. Students attend keynote lectures in the series and meet with speakers to discuss timely law and policy issues during small group discussions.