Vaccines as Technology: Innovation, Barriers and the Public Health (Introduction)

The fact that vaccines are subject to many of the same market forces that regulate other types of technology warrants examining the vaccine ecosystem through the lens of technology-centered law and policies. Many of the legal and policy frameworks applicable to vaccine research and development (R&D) and vaccine distribution were not created in the petri dishes of public health law and policy. Intellectual property as commonly understood today is largely a byproduct of the technological developments brought about by the Industrial Revolution, and was implemented with the overarching utilitarian purpose of promoting innovation – which in the case of the patent system focuses specifically on scientific and technical innovation. Vaccines and other health goods join the ranks of innovations that qualify for patent protection, even though they are used in ways that are fundamentally different from other types of technologies. Further back in time, contract law developed mechanisms to regulate the provision of goods. Unlike intellectual property, these early developments took place long before vaccines were created, as the Sumerians traded in cloth and the citizens of Ancient Rome transacted in glassware. Modern contractual mechanisms allow a country, or a restricted number of countries, to use contracts to exhaust the global supply of vaccines just as a wealthy Sumerian or Roman could appropriate all cloth or glassware. Yet, vaccines are markedly different from these commodities, and used for non-commodifiable purposes. Even the emergence of international law, which regulates relationships between sovereign or quasi-sovereign actors, has yet to find a way to limit the exclusionary effects that contracts and patents combine to produce in vaccine markets. The book therefore interrogates these legal frameworks and the policies they generate, and searches for solutions within existing laws to mitigate long-lasting inequalities in vaccine production and distribution. A second reason for the vaccines-as-technology approach adopted in the book relates to the nature of vaccines themselves: they are products of biotechnology, the engineering of a blend of living and non-living materials with the goal of creating a product that does not exist in nature. As such, they are especially complex forms of technology. As seen in chapters 1 and 3, modern vaccines consist of an amalgamation of technologies, from the substance that prompts the body to trigger an immune response (the antigen) to stabilizers, to the delivery mechanism. Moreover, vaccines are a subset of pharmaceutical products known as biologics, which are known for being especially hard to replicate. The particular technological characteristics of vaccines sets them apart from other goods – including several other health goods. This means that the process to bring a new vaccine to market is subject to different regulations than those applicable to most other goods, as seen in chapter 2. Their technological specificities also mean that some corrective interventions that are successful with regard to other technologies, and even other types of pharmaceutical products, might not work if a vaccine is at stake. For instance, if a less complex product is scarce, policymakers may direct competitors to make and distribute copies, even if the original manufacturer opposes the measure and refuses to collaborate. This policy may be successful if the product is a mask or structurally small drug, such as many of the drugs sold over the counter in pill format. But if scarcity involves a vaccine – as it did during the COVID-19 pandemic – the same measure might not be enough to overcome lack of cooperation from patent holders and to meet the heightened logistic standards required by vaccine manufacturing. A study of the specificities of vaccines as technologies is therefore necessary to inform innovation policy as applicable to vaccine R&D, manufacturing and distribution. A third reason for the book’s technology-centric approach is tied to the fact that the discovery, development and delivery of vaccines is becoming increasingly dependent on the application of technologies from fields that are not related to biotechnology or health. In providing a glimpse into the future of vaccines in chapter 6, the book describes emerging uses of 3D printing technology and artificial intelligence in different areas of vaccinology. The ways in which exogenous technologies help push the boundaries of vaccine R&D and distribution have been hailed as promising. At the same time, their use makes the vaccine ecosystem to some extent dependent on innovation policies set in connection with non-vaccine technologies. For instance, if early-stage research using artificial intelligence incorporates racial or socioeconomic biases – as it often does in a myriad of non-vaccine contexts – these biases are bound to affect the ultimate vaccine product, further tilting vaccine R&D and production in benefit of patients belonging to dominant racial and socioeconomic groups. By introducing and using this vaccines-as-technology framework, the book makes three main contributions. First, it draws attention to the intertwining laws, policies and other structures that determine and shape the development and distribution of vaccines. Second, the book shows that excessive reliance on market-driven forces – including but not limited to patent-centric modes of vaccine development – produces results that are largely antithetical to public health and systemically disadvantage lower-income populations, especially those located in the Global South. And third, operating within existing legal and policy tools, the book examines possible solutions to mitigate the most acute consequences of this reliance on markets instead of public health needs.