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Abstract

Over the past 20 years, plasma has become a medical treatment characterized as “liquid gold” to signal its lifesaving potential. Through a manufacturing process termed fractionation, plasma, collected through blood donation, is turned into Plasma Derived Medical Products (PDMPs). The World Health Organization (WHO) has underlined the importance of PDMPs for global health care, including a number of PDMPs on the WHO Model List of Essential Medicines. The process of collecting plasma from a donor, manufacturing plasma derived treatments, and distributing those treatments globally requires the coordination of multiple social actors operating in different social, political and economic contexts, but has received little attention in scholarly literature on public policy or the social sciences. This paper will introduce a set of analytic questions and concepts that can direct a sociology of plasma products. We build on the behavioral turn in the policy sciences to identify relevant policy questions emerging from this field and offer the analytic tools necessary to investigate how different social actors in this space make meaning of plasma. To do this, we will draw on key concepts in the sociology of health and illness.

Keywords

public policy plasma donation essential medicines blood systems sociology of health and illness

Over the past 20 years, plasma has become a medical treatment characterized as “liquid gold” to signal its lifesaving potential. Through a manufacturing process termed fractionation, plasma, collected through blood donation, is turned into plasma-derived medical products (PDMPs). The World Health Organization (WHO) has underlined the importance of PDMPs for global health care, including a number of PDMPs on the WHO Model List of Essential Medicines. The PDMP in highest demand is immunoglobulin (Ig), and its uses have expanded significantly in recent years for many indications, for immunodeficient patients, or as immunomodulatory therapy for people living with autoimmune and alloimmune disorders. The global Ig market size was valued at US$15.05 billion in 2022 and is projected to grow.¹ Moreover, Ig represents a significant health care cost for public systems.² Various jurisdictions globally have undertaken efforts to increase their ability to collect plasma for the use of PDMPs.

The process of collecting plasma from a donor, manufacturing plasma-derived treatments, and distributing those treatments globally thus requires the coordination of multiple social actors operating in different social, political, and economic contexts, but has received little attention in scholarly literature on public policy or the social sciences. A perspective that embeds people's choices and behaviors in a social context is necessary as these treatments gain prominence, have a meaningful impact on some patients’ lives, and represent a growing expense for health care systems. Policies that determine how to collect, distribute, fund, and disseminate these therapies globally must be examined to determine which actors shape policymaking in this field, under what conditions, and in whose interests.

This article introduces a set of analytic questions and concepts that can direct a sociology of plasma products. We build on the behavioral turn in the policy sciences to identify relevant policy questions emerging from this field and offer the analytic tools necessary to investigate how different social actors in this space make meaning of plasma. To do this, we draw on key concepts in the sociology of health and illness.

Background: The Global Market in Plasma-Derived Medical Products

Plasma is called “the gift of life” by organizations that ask you to give yours to potentially save someone else. As demand increases, so must plasma collection. When separated from the rest of our blood, plasma is light yellow; it is a liquid that takes nutrients, hormones, and proteins to the parts of the body that need it. It contains ingredients that can be manufactured into medicines—antibodies, clotting factors, and the proteins albumin and fibrinogen can treat everything from burns, shock, and trauma to autoimmune disorders, hemophilia and immunodeficiency disorders. Plasma is collected through a whole blood donation, or through apheresis, which separates plasma from other components of blood. It is typed and tested for infectious agents to meet quality standards, combined with thousands of plasma donations in a large holding tank, and then separate into fractions and individual proteins (i.e., fractionation). Then the proteins are removed, cleaned, retested, and packaged for use by clinicians and patients.

The process of collecting and transforming plasma into medicines involves multiple systems and social actors, but most scholarship on this subject has focused on one aspect at a time: the ethics of payment for plasma, the necessity for sufficiency, the cost-effectiveness of these products for health systems, and the clinical efficacy of the products. Very little work has mapped the various social actors in this system or addressed emergent policy issues as part of an interconnected whole despite significant economic, legal, and policy development in this arena.

Most of the world's plasma supply is collected by commercial manufacturers in the United States who pay donors. In other jurisdictions, payment is prohibited. The way that plasma is collected, manufactured, and distributed to recipients plays out differently by region in the complex provision of blood services. In some states there is legislation requiring voluntary nonremuneration as in Australia, the United Kingdom, and most of Canada. In others, plasma is exempted from that legislation, so the voluntary nonremuneration system works alongside private for-profit plasma collection by companies attached to the fractionation industry that pay donors, as in the United States and Germany. A few companies dominate this market: CSL-Behring (Australia), Grifols (Spain), Shire (United States), Octopharma AG (Switzerland), and Kendrion S.P.A. (Italy). CSL has most of the market share. It began as a state-supported manufacturer of vaccines, antivenoms, and PDMPs attached to Australia's blood system, then was privatized and was publicly listed and traded on the Australian Stock Exchange and became a worldwide commercial manufacturer. Additionally, there are some state-owned enterprises (e.g., Laboratoire Français de Biotechnologie in France) and nonprofit plasma manufacturing facilities (e.g., National Bioproducts Institute in South Africa).

Two international associations represent the plasma collection and fractionation organizations. The International Plasma and Fractionation Association (IFPA) is the umbrella association promoting the interest and activities of member organizations involved in the collection of human blood and plasma, and the manufacture and supply of medicines derived from human plasma (https://ipfa.nl/). This association supports a nonprofit business model where no financial gain flows from the donation to external or individual shareholders and aims to ensure greater global and national access to PDMPs based on a preference for voluntary nonremunerated blood donation. They also foster interactions with international patient organizations such as the World Federation of Haemophilia (WFH) and the International Patient's Organization for Primary Immunodeficiency (IPOPI). The Plasma Protein Therapeutics Association (PPTA) represents the private sector manufacturers of plasma-derived and recombinant analog therapies and collectors of source plasma used for fractionation. They advocate for access and affordability of therapies for patients, lobby regulatory agencies, and collaborate with patient advocacy organizations. These organizations work together and have both identified the need to increase plasma collection for Ig.

Several jurisdictions are struggling with how to meet sufficiency amid changing legislation regarding payment for plasma. In an effort to coordinate a response to these challenges and strengthen the resilience of plasma collection in the European Union, The European Blood Alliance spearheaded a recently completed the SUPPLY Project. Through an assessment of the entire plasma chain from donation to use, they aimed to enable a stable and adequate supply of PDMPs.³ In September 2023, the European Union approved the new substances of human origin (SoHO) rules, aiming to provide donors and patients a harmonized framework for donations while maintaining some limits on the supply side for therapies. It also concluded that donation should be based on the principle of voluntary unpaid donation.⁴ As the issues of plasma supply and sufficiency continue to be debated globally, crucial questions about how the various people in this system understand these issues and make decisions in relation to each other are underexplored.

At the same time, debates over the ethics, pragmatics and legality of payment become more pressing. COVID exacerbated the reliance on commercial supply as collections decreased⁵ and trade across countries was threatened.⁶ Jurisdictions like United Kingdom and Canada are making efforts to increase their domestic sufficiency when it comes to the supply of PDMPs by ramping up voluntary nonremuneration programs for plasma collection. The European Blood Alliance sees improving sustainability and resilience regarding PDMP availability as imperative given their responsibility to meet the needs of patients. The situation is different for low- and middle-income countries (LMICs), who do not have equal access to PDMPs and where patients do not receive adequate treatment.⁷ The WHO published guidance on increasing PDMPs for LMICs through fractionation of domestic plasma in 2021, and the issue of access remains a global problem.

Despite wide use of PDMPs, most people are not aware of what plasma is or what it does. This changed somewhat in 2020 when plasma derived from human beings with COVID-19, convalescent plasma, was investigated as a treatment for the virus. A number of trials were initiated internationally; while they did not demonstrate that convalescent plasma is an effective treatment for COVID-19,⁸ the trials raised the profile of plasma.

The plasma system involves many stakeholders operating together, from the international organizations representing plasma manufacturing associations, the manufacturers, the blood services and private operators that collect plasma, donors, recipients, and all of the clinical and regulatory interlocutors who facilitate evaluation and distribution. Given that this policy terrain spans jurisdictions and includes multilevel regulatory agencies and governments, a research program for a sociology of plasma products must attend to the multiple dimensions to policymaking involving risk, trust, public provision of health care, and regulation of medical products. Further, a behaviorally oriented research agenda^9,10 requires an understanding of the perceptions, decisions, and actions of various social actors in this policy field including plasma donors, recipients of plasma products, and clinicians who prescribe the products. Thus, our aim is to review relevant scholarly work on this topic, theorize the importance of the behavioral turn in policy sciences,^9,10 and present a set of analytic questions and concepts that can offer direction for a sociology of plasma products.

Relevant Scholarly Work

Existing scholarly work on plasma does, to some extent, address motivations of plasma donors, regulation and governance of plasma products, and recipients’ choice of treatments and treatment modalities. It does not address how social actors in this system interact with each other or explain how they exist in a broader context of the related social and political systems. We briefly review this work.

Plasma Donation

There is a growing literature on the knowledge, motivations, and experiences of donors that supply plasma-derived products in voluntary nonremunerated contexts; this literature indicates that plasma donors want to know more about how their donation has an impact on patients, as they are motivated by the knowledge that the blood operator is in need of plasma donation.^11–15 Work in Canada suggests plasma donors are motivated by an interest in contributing to the national plasma supply¹⁵ and that they are aware of and interested in issues such as payment and the engagement of the commercial sector in collection.¹⁶ A recent rapid review indicates that this literature focuses mostly on site-level factors related to blood collection agency engagement with donors, and individual-level factors to donation, and further research must examine broader social-level influences.¹⁷ This includes how individual characteristics and experiences influence willingness to donate plasma, and the social and cultural level factors, such as how social networks and community shape perceptions and experiences with donation.¹⁷

There is also literature in the field of bioethics about whether payment for plasma is morally objectionable.^18–21 From a sociological perspective, the question of morality is secondary to what informs different perspectives on donation, and what motivations and behaviors exist for both paid and unpaid plasma donation. Implicitly embedded in the ethical debate is a question of how people should value the material: as a gift given by the donor, free of remuneration; as a medicinal product to meet the needs of patients who require plasma-derived medications; as raw material for the profitable enterprise of plasma protein products; or as liquid gold. Those questions of how donation is understood, informed by the history of the blood service, the person's cultural and social milieu, and their economic stability are underexplored in the literature on what motivates people to donate plasma.

Regulation and Governance

The governance of the collection of plasma for fractionation has evolved on a separate and parallel path from governance of whole blood collection. Farrell's work^22–24 documents the history of regulating plasma products in the European Union and the relationship between risk, innovation, and the regulation of health technologies. Her work on politics, ethics, and law in risk governance involving multi-valued human biological materials indicates that risk has informed the governance of blood systems, and that risk is a sociocultural contract influenced by public perception.

When Farrell examined risk and innovation with this lens, she paid close attention to the for-profit plasma products industry, which has developed over the past fifty years amid the legacy of the HIV blood scandals. After these scandals there was an urgent need to improve quality and safety of plasma collection,²² which took the form of both industry self-regulation and more stringent regulatory oversight nationally and supranationally. Farrell argued that a regulatory regime has emerged to address the growing plasma industry, to offer confidence that the industry is producing a safe product. She offered an examination of how the law is involved in contextual relationships with ethics and politics in risk governance involving human biological materials.²²

Outside of this work in Europe, there is very little literature exploring the governance of distribution and use of PDMPs. Most of the policy discourse in this area has been focused on the concept of self-sufficiency, wherein the nation has adequate supply of safe blood products to meet patient need, and patients have access to blood products obtained from donors of national origin.^2,25–36 This concept comes from the World Health Assembly resolution SHA63.12 which directs the WHO to promote self-sufficiency in the supply of safe blood components through voluntary blood donations to prevent shortages and meet national transfusion requirements. While some fractionation plants were once incorporated into blood services, as governments detached themselves from public utilities and privatized public services through the 1990s, these companies started to operate on the global market.³⁷ Nonprofit companies then operated with “self-sufficiency” policies that incorporated protectionist provisions in national laws and entailed contracts between manufacturers, blood operators, and relevant government authorities.³⁷

In an influential commentary, Strengers and Klein described the global reliance on U.S. commercial plasma industry, and the potential threats to an imbalanced plasma supply.³⁸ They argued that plasma should be considered a strategic resource, which the European Union defines as “economically important raw materials which are subject to a higher risk of supply interruption,” to minimize the risk of shortages of plasma and essential PDMPs.³⁸ Elevating plasma to a strategic resource means giving it appropriate supervision, governance, control, and sustainable management.³⁸ Further, it means that potential shortages could become part of national political agendas where plasma becomes better secured for patients nationally. The concept of self-sufficiency has been influential, as blood services in Australia, Canada, the Netherlands and the United Kingdom have initiated a national plasma collection system for the purpose of security of supply. While promising, this approach is challenging for LMICs who do not have access to fractionation in the same way as high-income countries.³⁸ Strengers reiterated this argument for plasma as a strategic resource in 2023, particularly given the reduced supply of plasma from the United States following the COVID-19 pandemic, and the consequent impact on the global plasma supply as well as the sometimes-precarious political reliance on the United States to trade this resource.⁶

Strengers and Klein also advocated for moving from a market driven approach to plasma collection to a public health approach and clarified that these systems do not need to be mutually exclusive. They did not fully explain what a public health approach would entail, or how those systems would operate together, or which entities would potentially be more influential given their resources. These questions deserve attention. In a recent commentary in Transfusion Clinique et Biologique, Ythier took up some of Strengers and Klein's arguments, and advocated for the collection of plasma from nonprofit collection organizations, where if the costs are too high, they are publicly subsidized from the government budget to ensure the economic viability of the nonprofit collection and industrial production.³⁹

The Recipient

Ig products are administered by injection or by using intravenous therapy, necessitating the involvement of multiple health professionals including physicians, pharmacists, and nurses. The diffuse, increasing, and changing uses of Ig mean that recipients are often not aware that the product has come from a plasma donor. Further, there are different methods of preparation of Ig, and commercial products differ based on plasma pool size, steps to improve yields, and removal of contaminants. Jurisdictions have unique processes for evaluating the cost-effectiveness of different products and offering coverage or not, meaning that patients have differential access to these treatments depending on where they live. There is a nascent field of literature on the experiences of Ig recipients, mostly focused on patients’ need for more information about their diseases and treatments^40,41 Ig treatment satisfaction and burden of treatment^42–44 and preferences between subcutaneous Ig versus intravenous Ig.^44–50 This literature does not address the social relations of how the treatment has an impact on the patient's life, or how the recipient understands their role in a broader health care system and the connection to a donor. Farrell's work²² draws our attention to the role of social movements in the way that the tainted blood scandal was handled in the United Kingdom, and she documents what she calls “the rise of the recipient,” where recipients are becoming more organized about their knowledge of and access to therapies. There are indeed patient organizations that have begun to enter this policy space, representing illnesses treated by Ig. These organizations advocate for individuals with the illness, and in some cases are engaged in policy discussions about access to these products. We do not know of empirical work studying how patient advocacy groups operate in the realm of the plasma system, but our current scholarly work documents the experiences of Ig recipients embedded in health systems, and it indicates that they are engaged in patient advocacy through support groups, information panels, conferences, and bill hearings related to plasma and Ig issues.

In summary, there are emerging bodies of literature that offer insight into aspects of the complex system that produces PDMPs, which sheds light on the key issues that could be explored in a sociology of plasma products. There are gaps in this literature; for instance, while there is scholarship about the experiences of plasma donors, there is a need to explore why most people do not donate plasma—this could include research on systemic barriers to donation among underrepresented groups. While there is a solid foundation of literature on the governance of plasma, there is a need to study emerging efforts of blood operators, governments, and manufacturers to address the increased demand for plasma comparatively across jurisdictions. Finally, there is very little literature about the recipients of these products, or the clinicians engaged in prescribing or managing them through health systems internationally. To understand the complexity and the contours of this market, researchers must expand their scope to understand each of the actors in the system, their values, and behaviors as situated in social, political, and economic contexts, and the ways in which they are interrelated.

Toward a Sociology of Plasma Products

Given the gaps identified above, we seek to introduce a set of analytic questions and concepts that can identify and explore the social relations involved in the production and use of plasma products. Social relations are patterned human interactions that involve relationships between individuals and in groups that are organized informally or formally. The study of social relations involves how language, ideas, principles, and beliefs are created in the context of social existence as it is lived, including both its possibilities and its limitations.⁵¹ This approach situates individuals and institutions within the broader political and social context of discussions over universal health care, free market approaches to health care delivery, the social determinants of health, and the role of power and profit underlying these systems of thought.

We build on work by Farrell mapping the relationship between the blood collection agency, the donor, and the recipient, understanding how risk factors into public health decisions and the management of human biological materials.²² This includes work that examines how the production, supply, and deployment of blood is socially mediated and discusses how blood and plasma are made available to some patients and not always in sufficient quality or quantity.⁵² Questions about production, supply, and deployment of blood are bound up with a blood economy where the need to protect public health is balanced with industry, professional, public, and patient concerns—a dynamic that deserves further examination.⁵² We build on this work using sociological theory that attends to social actors as situated in a particular historical moment.

While we aim for this work to provide theoretical insight into a nascent field of study, we also aim to inform public policy on how best to meet the needs of patients who require PDMPs in an equitable way. Thus, we examine the behavioral turn in public policy, which draws on insights from sociology, anthropology, and cultural studies.

The Behavioral Turn in Public Policy

The field of policy studies has traditionally incorporated a philosophical assumption that human beings are rational self-interested actors existing in an ordered social setting. State actors and policymakers take measures to alter behavior of human beings in the direction they prefer, rewarding compliance and disciplining noncompliance.⁹ At the same time, literature in this field has grappled with the limitations of that approach, particularly given that their models often fail to predict people's actual behavior.⁹ The behavioral turn in public policy is a recognition that people's motivations are less utilitarian, focusing on public behavior in practice, and demonstrating how people's behaviors deviate from ideal-type models of rational behavior.⁹ Recently, there has been an effort to examine and rethink some of the fundamental tenets of behavioral policy.^9,10,53 This rethinking includes a recognition that behavioural policy studies relies mostly on the disciplines of economics and psychology, and tends to treat individuals as isolated from social and cultural context.⁵³ We see this recent theorizing as an opening for the role of social sciences like sociology and anthropology in policymaking.

These disciplines allow for more in-depth attention to how social actors interpret their own social and cultural milieu and behave within shifting historical, social, political and economic contexts. Leong and Howlett acknowledge that this kind of behaviorally informed policy knowledge comes with greater uncertainty about which policy measures should be undertaken and how.⁹ The value of a sociologically informed policy analysis is that it can address issues like motivation and compliance embedded in broader social issues, such as trust, solidarity, equity, and power. While this analysis makes the work more complex, even messy, we posit that attending to policymaking in this way is also more sensitive to how people behave in their everyday lives, and thus can point to policymaking that is holistic, meaningful, and ultimately more effective.

The theoretical and methodological tools employed in the sociology of health and illness allow for investigation of these nuanced experiences embedded in social systems. Particularly, qualitative work in this field can capture experiences of health and diseases as they are lived in a contemporary moment, illuminate the construction of medical beliefs, examine the regulatory, organizational and behavioral scripts underlying unfulfilled promises of health interventions, follow how money is spent and motivations attached to money, examine actors across space and time, and consider social mechanisms as part of causal explanations.⁵⁴ For instance, social science research has taken up these analytic questions when investigating organ donation,⁵⁵ cord blood banking,⁵⁶ and human tissue economies.^57,58 However, human-derived medications differ from cord blood, tissues, and organs because instead of being collected and then delivered to a recipient, they go through a commercial industry where they undergo a manufacturing process to become a different product. We suggest that this additional manufacturing and the related necessity of a third party requires expanding our theoretical scope to consider production, distribution, and consumption of these products that are shaped by political economies.⁵⁹ To move toward a sociology of plasma products, we point to the following areas of inquiry: examining the promise of plasma products, locating the recipient in a social and cultural context, engaging the donor as a social actor in the blood system, and considering the role of governance.

Examining the Promise of Plasma Products

A sociological approach can explain how an emerging area of health is socially and historically contingent. To understand the increasing demand for and use of Ig and to inform collective decision making in the public interest related to its optimal use, funding, and distribution, it is necessary to analyze the interplay among key actors: the companies that create these treatments and the regulatory regime that is in place to monitor their performance; the researchers who investigate uses of Ig, and the funding and infrastructure supporting this research; and the health technology assessment bodies who evaluate the value of these products in terms of cost-effectiveness. A sociological lens suggests the need to answer critical questions such as how Ig has come to be known as a lifesaving treatment, who has promoted the use of this treatment, and how appropriate use is constructed and valued. A recent scoping review of the current and future demand of Ig globally concluded that more research is needed on clinical or organizational strategies that could control demand.⁶⁰ Comparative work could address how evidence of different Ig products is assessed in different jurisdictions, by whom, and in what conditions given restraints on health systems. For example, Canada's Drug and Health Technology Agency provides health care decision makers with evidence to inform decisions about optimal use of drugs and medical devices and has advised health care providers on the appropriate use of Ig.⁶¹ Additionally, the provinces have developed their Ig utilization management programs that consult clinical guidelines, but conditions for which Ig is approved vary across the four Ig programs.⁶²

Locating the Recipient in a Social, Cultural Context

The sparse literature on patient experiences with Ig use does not address how the treatment impacts the patient's life (beyond the clinical response and location of treatment), work, gender roles, family dynamics, and mental health. There is a need to better serve Ig recipients by understanding how knowledge about Ig is developed and reproduced in the everyday experiences of its use and to make connections between these everyday experiences and the broader political landscape of the production and distribution of Ig. The “rise of the recipient” that Farrell²² identified deserves further exploration.

A sociological approach can generate understanding of how knowledge about the collection, production, and distribution of Ig develops among Ig recipients, their clinicians, and other social actors like patient organizations. Patient advocacy organizations suggest that sometimes Ig recipients encounter problems accessing products. In some cases, these patient groups are funded by the companies that manufacture Ig products and could be invested in their expanded use. At the same time, given that the uses of Ig are diffuse, involving multiple disease areas, and distributed by multiple clinicians with varying levels of knowledge and experience, patient organizations can be a source of information and assurance for these patients.

The role of clinicians in this space also deserves attention. The illnesses, like polyneuropathies and immunodeficiencies, for which Ig is indicated are rare and sometimes challenging to diagnose, thus creating difficulties in identifying Ig as a possible treatment. Conversely, Ig is sometimes used as a diagnostic tool, when a patient's collection of symptoms, without a formal diagnosis, are alleviated by treatment. The nascent literature examining clinical demand for Ig demonstrates the importance of study to investigate what drives increasing prescription volume, as well as what challenges exist for clinicians when making decisions about caring for patients who receive these treatments.^60,63

Further, the existing literature in this area neither addresses how the recipient understands their role in a broader health care system nor attends to the fact that recipients are positioned differently across space and time. This is particularly relevant given the systemic inequities in global access to this treatment.⁶⁴ A sociological perspective is also necessary to contend with structural global inequities among countries and the effects on access to therapies and health services. In LMICs the concerns from recipients are different given the serious problem of access to Ig.^38,64,65

Engaging the Donor as an Actor in the Blood System

Plasma must be extracted from humans, and thus its meaning is mediated by human interaction. The body of literature about what motivates plasma donors is growing; however, a sociology of donation is necessary to understand the social conditions that make donation possible for some and not others. The concept of altruism remains strong in the literature on donation in general, and it has carried over into plasma donation studies. But recently scholars have attempted to retheorize or reimagine that concept in relation to plasma^66,67 to consider the fact that motivations to donate are developed in the context of social relationships. Related to this point, donors are not the only relevant actors to consider when understanding the experience of donation, and what factors encourage recruitment and retention. For instance, work on the role of staff in the plasma center is also understudied.⁶⁸

Engaging the donor as an actor in the blood systemalso means attending to barriers to donation for people who do not necessarily donate—in countries like Canada, Australia, and the United Kingdom, this includes underserved racialized communities. Further research must also examine what factors attract non-whole blood donors to become plasma donors, focusing on broader, social level influences. This is also the case for some men who have sex with men, gay, bisexual, and queer men, and some Two Spirit, transgender, and non-binary individuals (MSM/2SGBTQ+), who have complex reactions to efforts to encourage plasma given the history of deferrals for these communities.⁶⁹

This work should also account for different models of donation. There is a gap in the literature on donor perceptions about payment by the commercial sector collecting plasma. Most blood collection agencies have evolved with a model of voluntary nonremuneration that is intimately tied to the concept that if blood is donated without compensation, it is altruistic, and thus donors will be more likely to make responsible choices when they disclose medically relevant information before donation. The belief, then, is that voluntary nonremuneration will protect the blood supply from disease. Empirical work on how donors understand the plasma system, and specifically the issue of compensation, indicates that donor's understandings of the plasma system are situated in broader issues related to trust in the blood service and health system, to different models of public health, and to economic considerations of how plasma is valued.^70,71 Further research in this area is required to consider the following: a) legislative changes about payment and remuneration and how they are shaped by political and economic contexts; b) the experiences of donors and staff in the commercial sector; c) the transparency of the commercial sector when it comes to sharing data about a public health resource; and d) demographic considerations about who wants to get paid, why, and how. In short, this matter is very limited to the dichotomy of altruism versus commercialism with very little empirical work to support policymaking.

Considering the Role of Governance

Another strength of the sociology of health and illness is the ability to reframe dominant perspectives. In other instances where sociologists have proposed a new pathway for conceptual frameworks about a given topic, such as a sociology of standards,⁷² the sociology of diagnosis,⁷³ or a sociology of donation,⁷⁴ they have offered new ways of thinking about the phenomenon. For instance, Timmermans and Epstein⁷² proposed thinking sociologically about standards and standardization by considering the history of standardization as a process, and standards as a defining aspect of modern life; they situated this effort within a rich body of social theory.⁷² Machin and colleagues⁷⁴ noted that donation has been investigated and framed using a body part or product, whereas a sociology of donation could take a systems-wide view to provide novel and contemporary insights into the field as a whole.⁷⁴ We propose that a similar undertaking could prove useful when considering the governance of PDMPs.

Farrell's work pointed to the lack of scholarly attention to the evolution of governance of plasma products in other jurisdictions, and the role of the international players (WHO, IFPA, PPTA; 23). Her attention to how political context has impacted regulatory governance of blood and plasma products was instructive.²³ Her analysis of policy frames (how issues or problems are perceived and implemented through governance in a policy sector), regulatory connection (ensuring regulation keeps pace with innovation), and regulatory legitimacy (garnering public trust among citizens, and ensuring the regulation is effective) in the European Union could be leveraged to understand how the plasma system has evolved globally, and how PDMPs are manufactured and distributed across jurisdictions.

Further scholarly attention to governance of plasma products could analyze how concepts such as “self-sufficiency,” “strategic resource,” and “market-driven” versus “public health” approaches to plasma collection are defined and used in a policy context. How have these concepts emerged historically, and how are they mobilized in different policy contexts? And further, to what extent do these concepts address the global inequity that exists in the distribution of PDMPs globally? The limited supply of PDMPs and their high cost mean that they are primarily accessible to high-income countries, which consume 70–80 percent of the global production of PDMPs.⁷⁵ Recent work has explored the challenges that have led to this situation, and what practical, systemic, and regulatory changes could be made to address the problem.^5,75 These challenges could be examined through the framework of the political economy of research and innovation, which attends to the production, distribution, and consumption of knowledge, and how these activities are shaped by political economies.⁵⁹ This approach could illuminate the strengths and weaknesses of existing governance frameworks, but also help to identify who they can serve, and whether there are alternative frameworks that can be pursued.

Examining production, distribution and consumption of knowledge means conducting in-depth research with knowledge producers—the scientists, regulators, manufacturers, and public health officials who make decisions about what constitutes a risk to the public, and how to mitigate harms. Qualitative researchers have been able to trace the subtle and unexpected ways in which financial incentives influence the behavior of all parties involved in scientific research, regulatory decisions, and health care. Understanding governance means paying attention to who makes decisions, in what conditions, with what assumptions. The behavioral turn in policymaking offers an opportunity to investigate the motivations of policymakers, regulators, and other social actors engaged in governance.

Conclusion

The behavioral turn in public policy, particularly one that acknowledges the role of sociology and rethinks how people make meaning in social situations is an opening for a research agenda considering the sociology of plasma products. Plasma products have limits both in the resources available to develop the product and in the supply of material from donors. There are numerous social actors in this space, each located in a particular social, political, cultural, and professional context. Our approach draws on a sociological tradition of understanding how individual social actors enter these systems that are already made, but also can have agency in how they participate within or challenges these systems. When applied to health sciences and technologies, this approach can surface tensions that are not immediately apparent in the dominant narratives of progress and innovation. Our approach can also identify areas in which these different social actors are very much aligned. The most significant area in which this is already clear is in the shared aim to meet the needs of patients who require these products to live. The European Union's SUPPLY Project recommendations for how to build a robust, safe and sustainable plasma strategy that ensures equitable patient access to medicine is instructive for nations around the world; it highlights the need for an improved understanding of Ig usage, the development of a structured and harmonized prioritization and management plan in times of shortages, and a need for linkages to other initiatives and export networks dedicated to the management of Ig supply.⁷⁶

Working toward a sociology of plasma products informed by the behavioral turn in public policy has real-world application. For instance, further research into how recipients access and experience these products can raise awareness of the importance of access to these treatments, and encourage voluntary nonremunerated plasma donation. The literature to date suggests that donors want to know how their donation makes a difference for the patient, recipients want to know how regulators are keeping them safe, blood operators, regulators, manufacturers and governments want a system that is safe and efficient, and manufacturers want to respond to a growing market for their products. These alignments are an opportunity for a cohesive system where the aim of meeting patient needs is achieved.

Footnotes

Author Contribution

Both authors contributed to all aspects of the manuscript.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

This work was funded by a grant from the Social Sciences and Humanities Research Council (SSHRC).

Social Sciences and Humanities Research Council of Canada, (grant number 435-2022-0187).

ORCID iD

Kelly Holloway

Author Biographies

Dr. Holloway is a medical sociologist with interdisciplinary training in health policy and political economy. Following her doctoral work in Sociology at York University, Dr. Holloway did two CIHR-funded postdoctoral fellowships at Dalhousie University and the University of Toronto. She is now Assistant Professor at the University of Toronto Institute of Health Policy, Management & Evaluation, and Scientist at Canadian Blood Services, where her work is focused on donor behaviors in a social and political context, and policies related to blood services.

Dr. Grundy is a registered nurse and an Assistant Professor with the Lawrence Bloomberg Faculty of Nursing at the University of Toronto. Dr. Grundy's work explores the interactions and intersections between the medically-related industry and publicly-funded health systems and the implications for delivery of healthcare, professional practice, and health policy. Dr. Grundy is Director of the WHO's Collaborating Center for Governance, Accountability, and Transparency in the Pharmaceutical Sector. Dr. Grundy is the author of Infiltrating healthcare, How marking works underground to influence nurses (2018, Johns Hopkins University Press).

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