This chapter proposes an ex ante approach to tackling drug scarcity. Entities funding pandemic- and epidemic-related research should contractually require recipients to produce sufficient quantities of resulting medicines. The recipient would agree in the event of a future shortage to share its technology and know-how with a qualified third-party manufacturer, in exchange for compensation. Alternatively, funding entities could more broadly utilize dormant licenses, which activate in the event of a pandemic or epidemic, and which require rights holders to license out technology and know-how to alleviate shortages. Such provisions could go even further, integrating reasonable pricing assurances and ensuring access in low-income countries. By tying funding to such rights, governments and nongovernmental organizations could help reduce shortages, improve global access to medicines, and ultimately save lives.

As vaccines are complex technologies that interact with the human body, their development is overseen by regulators in the administrative state. Countries structure the review of pharmaceutical products according to domestic rules and institutional design. As such, vaccines are reviewed as biologic products by regulatory authorities at the domestic level, such as the Therapeutic Goods Administration in Australia or the Pharmaceutical and Medical Devices Agency in Japan. The national basis of vaccine regulation inevitably leads to country-specific processes and timelines and may in some cases lead to different decisions.

According to longstanding scientific consensus, vaccines are widely regarded as playing a fundamental role in public health. Therefore, one would reasonably expect that the dynamics of vaccine production and distribution would place a premium on incentivizing robust levels of investment in vaccine development, with the allocation of resulting vaccine occurring in ways that reflect public health priorities. Yet, that is often not the case. This book examines this disjunction from the viewpoint of the laws, policies, and other market-driven forces that shape the development and distribution of vaccines. Together, these mechanisms have long led to problems of under-investment in vaccine research and production, and inequitable allocation of limited vaccine supply in ways that recurrently disadvantage lower-income populations.

In previous chapters, the book considered instances of lacking access to vaccines, attributable to supra-competitive pricing or skewed allocation of limited doses. This chapter shifts the narrative toward emerging scenarios in which different types of barriers stand in the way of the ultimate goal of having robust vaccine distribution and uptake among all populations in need.

Although adopting a vaccine-centric viewpoint, the book has highlighted problems that are not exclusive to the field of vaccines. These issues affect the production and distribution of vaccines in particular ways, but also suggest the existence of broader, systemic flaws in the production and distribution of health goods – especially those that, albeit critically needed from a public health perspective, fare poorly under predominantly market-driven paradigms. The book concludes with a short reflection on how problems observed in the vaccine ecosystem feed into the larger backdrop of persistent shortcomings in the global public health system.

Pathogens and humans have coexisted for a long time. Studies suggest that, even before recorded history, nomadic populations are likely to have suffered from a plethora of diseases, such as malaria and perhaps yellow fever. The transition to a sedentary lifestyle anchored around small villages, and later on the establishment of large urban centers from Mesopotamia to the Indus Valley and what is modern-day China, paved the way for the increased spread and diversification of these pathogens. High population density, the comingling of humans and animals, and the proliferation of trade routes linking once-distant urban areas enabled viruses, bacteria, and other pathogens to propagate quickly and travel progressively farther. To this day, these dynamics set forth in antiquity continue to play out in similar ways in a world that has become more connected and densely populated.

So far, the book has explored different problems in the life cycle of a vaccine. First, it surveyed the pathways to bring new vaccines to market against a backdrop of lacking incentives to R&D, in spite of the recognized public health value of vaccines and the widespread use of intellectual property rights as an incentive to vaccine R&D. Second, it examined the allocative disparities that result from the commodification of vaccines, especially in situations of product scarcity, in which lower-income populations often face considerable hurdles in obtaining access to vaccines. This section examines possible solutions to alleviate these problems. It considers proposals that would take effect at the incentives level, by increasing funding for vaccine-related R&D work; proposals that would operate at transactional level, facilitating the transfer of vaccine technology through the use of patent pools and patent pledges; and proposals to expand and fine-tune the role of vaccine-dedicated public–private partnerships as instruments for the promotion of equitable access to vaccines by populations irrespective of their socioeconomic status.

A vaccine that overcomes scientific, funding, and R&D constraints and enters the market may still not become available to everybody who needs it. The public health goal of preventing or lessening disease through the administration of vaccines is not fulfilled at the point of market entrance. Rather, it requires that populations indicated for a particular vaccine are able to receive it. A separate dimension of investigating how well the vaccine innovation ecosystem functions is thus the problem of access to existing vaccines.

Given the strong public health, societal, and economic benefits associated with the availability and widespread use of vaccines, an ideal scenario would dictate that vaccines needed to prevent and mitigate public health crises be treated as R&D priorities. Both domestic and international innovation policies would prioritize their development, and there would be mechanisms in place to ensure an equitable distribution of these vaccines. In practice, that is not the case.