Intellectual Property as a Determinant of Health.

• Author: Rutschman, Ana Santos

TABLE OF CONTENTS I. IP AND THE DETERMINANTS OF HEALTH: CURRENT PERSPECTIVES 414 A. The Framework for the Socioeconomic Determinants of Health 414 B. The Interface Between Intellectual Property and the Determinants of Health 418 II. ILLUSTRATING THE INFLUENCE OF IP IN HEALTH RISKS AND OUTCOMES 424 A. A Case Study on Pharmaceuticals: Preventing HPV Infection in the Twenty-First Century 424 B. A Case Study on Epidemic and Pandemic Preparedness: From Ebola to COVID-19 Vaccines and Treatments 432 C. A Case Study on AgTech: Genetically Modified Crops 440 III. TOWARDS A FRAMEWORK FOR THE IP DETERMINANTS OF HEALTH 444 A. The Existing IP Framework 444 B. Complementing the Toolkit of Determinants Of Health Through IP 448 IV. CONCLUSION 457 I. IP AND THE DETERMINANTS OF HEALTH: CURRENT PERSPECTIVES

1. The Framework for the Socioeconomic Determinants of Health

   Public health-oriented scholars, policymakers, and institutions have long recognized the existence of a series of nonclinical factors that affect the health of populations across the globe. Known as the determinants of health, these factors consist in a set of socioeconomic conditions that are likely to bear a significant impact on health risks and health outcomes.

   Work around the determinants of health is anchored in the idea that there are profound "inequalities in health" within populations in the same country. (1) Within the United States, for instance, different literatures have repeatedly documented disparities in morbidity and mortality rates depending on a range of nonclinical factors that ultimately have an impact on the quality of life and health outcomes associated with certain populations. (2) These factors include race, ethnicity, gender, state of residency (or even zip code within a city), (3) education,, class, (4) and income. (5) Similar studies have arrived at comparable conclusions within other countries in the Global North (6) and Global South. (7) Moreover, these disparities are also detected through comparisons between analogous populations in different countries or geographical regions. (8)

   An important characteristic of the global distribution of health disparities is that they have become systemically ingrained in economies of the Global South and the Global North alike. (9) But even though they are heterogenous in origin and kind, these inequalities have been found to share a common trait: they are "socially determined," in the sense that they emerge from complex decisionmaking processes. (10) The idea of social determination seeks to emphasize the fact that lack of access to vital goods and services, such as water or health care, is not merely attributable to the existence of infrastructural or technical shortcomings in the status quo. Rather, it is the product of a series of allocative decisions, often made by different actors and at different points in time, converging towards the ossification of structural inequalities and to the worsening of health outcomes within certain populations. (11)

   The concept of, and framework for, the determinants of health thus arose against this background, and current policy interventions relying on determinants frameworks embody this approach. The World Health Organization (WHO), which defines the social determinants of health as "the conditions in which people are born, grow, live, work and age," (12) further notes that these conditions "are shaped by the distribution of money, power, and resources at global, national, and local levels. The social determinants of health are mostly responsible for health inequities--the unfair and avoidable differences in health status seen within and between countries." (13)

   It is important to note that current definitions of determinants of health are not homogenous. Several institutions distinguish between social and economic determinants; the latter category includes factors like income levels and income distribution--which are often recognized as some of the most powerful predictors of health risks and outcomes. (14) Several other institutions, as well as commentators and policymakers, take a hybrid approach, speaking of socioeconomic determinants of health. (15) For instance, in addition to providing the most diffused definition of social determinants of health, (16) the WHO, in its framework for Health Impact Assessment methods, (17) describes determinants of health as encompassing both "the social and economic environment," and expands the concept to include "the physical environment," as well as a "person's individual characteristics and behaviors." (18)

   A number of other definitional approaches coexist. To give but one example, the U.S. Office of Disease Prevention and Health Promotion distinguishes between social and physical determinants of health. (19) The former group includes many conditions long recognized as social determinants, from access to healthcare services to quality of education and job training, as well as conditions recognized elsewhere as economic determinants (e.g., poverty levels). (20) Physical determinants include exposure to toxic substances, interaction with the built environment, and consequences of climate change. (21)

   The unifying thread in how existing definitions of determinants of health are populated is that they are generally conceptualized as conditions that are external to healthcare systems. (22) In this sense, a person's income, education, or exposure to harmful chemicals may contribute, directly or indirectly, to that person's interaction (or lack thereof) with a given healthcare system. These contributing factors, however, are nonclinical in nature, even if they might create the need for clinical interventions. Recent studies looking at premature death rates have underlined the relevance of nonclinical factors in health outcomes. Currently, only 10 percent of premature deaths in the United States are linked to issues arising in the context of clinical care; 30 percent of premature deaths are attributable to genetic factors; and 60 percent are attributable to social, environmental, and behavioral factors that fall under the general umbrella of socioeconomic determinants of health. (23)

   This Article uses the expression "socioeconomic determinants of health" in an expansive way, to include all types of nonclinical conditions that have been identified in the literature and in practice as bearing an impact on health risks and outcomes. Moreover, as detailed in the following Part, this Article seeks to articulate a connection between the canonical sets of determinants of health--as currently recognized in multiple literatures--and the impact of globally harmonized IP frameworks and norms.

2. The Interface Between Intellectual Property and the Determinants of Health

   The impact of IP regimes on discrete fields of health-related innovation has been studied by scholars in legal and nonlegal fields alike. Since the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) came into force in 1995, (24) commentators have noted a progressive but inexorable convergence of national and regional IP regimes towards higher levels of IP protection across the globe. (25) While this upwards harmonizing trend has been a general feature, (26) and not a specificity of the pharmaceutical and biotech domains, the TRIPs implementation battle over IP rights covering many of the technologies in these fields has been especially contentious. (27) As the ratcheting up of IP protection through tendentially harmonized regimes (28) has contributed to the divide between the Global North and South, (29) perhaps nowhere are escalating levels of patent protection as noticeable as in the field of health-related technological innovation. (30)

   Even under globalized and globalizing IP frameworks, there is room at the domestic level for the development of country-specific bodies of IP law and practices. With regard to pharmaceutical and biopharmaceutical technologies, lawmakers and law interpreters at the country level have experimented with different approaches, with varying degrees of success. India, for instance, availed itself of the transitional period granted by TRIPs. (31) Even when compelled to apply the patent floors mandated by the Agreement, it carved out a patentability regime for pharmaceutical innovations that is significantly less permissive of secondary patenting than most other countries. (32)

   However, the existence of strata of domestic patent law, lodged amidst tendentially overprotecting national and transnational IP regimes, is not enough to address the differentiated types of problems created by the (mis)application of current IP laws, norms, and philosophies to pharmaceutical and biopharmaceutical innovation. Part of the problem lies in the origins of contemporary IP. As Jerome Reichman and Rochelle Dreyfuss have put it, "[t]he domestic patent laws as currently practiced were largely formulated for the inventions of the Industrial Revolution, and these laws still reflect the technological premises and concepts of the creative sectors as they were then structured." (33) The foundational IP treaties, (34) whose ethos and many a provision were absorbed by TRIPs, (35) predate the pharmaceutical and biotech industries, and the TRIPs-induced race to ratchet up levels of protection has done little to account for the nuances of innovative processes in these fields, on the one hand, and for the very specific characteristics of the consumers of the emerging goods, on the other. As such, individualized contemporary IP regimes may be able to provide an ad hoc fix for a particular malfunction--as India did with regard to secondary patenting of pharmaceuticals (36)--through legislative, regulatory, or interpretive interventions. Nonetheless, they have proven incapable of tending to systemic problems rooted in modern embodiments of IP that render different types of drugs and biotech products unavailable to populations in need...