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Dear STS Colleagues,

We are editing a handbook-style manuscript that explores issues at the intersection of pharma and society writ large. More details of the proposed handbook are below.

As a part of that process, we are inviting proposals of ~700 words that address one of the specific chapters (see below) or an alternative issue not currently covered in the book outline but that could fall within the books scope.

The deadline for chapter proposals is January 31st, 2024.

We as editors will notify authors of accepted chapter proposals by the end of February 2024, and commission first draft of chapters. A first draft of accepted chapters are to be submitted by authors at the end of July 2024. We anticipate a publication date of the entire completed handbook in early 2026 depending on the input and procedures of the publishing house. We are currently in negotiations with a renowned academic publisher to commission this manuscript.

For submissions and any questions please contact lead editor Conor Douglas (cd512@yorku.ca).

More information and details of the proposal below. Please attend to them in the preparation of your proposal.

We eagerly anticipate your submissions, thanks very much in advance.

Best regards, on behalf of the editorial team,

Dr Conor Douglas, York University (Toronto, Canada), cd512@yorku.ca Prof Susi Geiger, University College Dublin, susi.geiger@ucd.ie Dr Tineke Kleinhout-Vliek, Utrecht University, t.h.kleinhout-vliek@uu.nl

Prof Paul Martin, University of Sheffield, paul.martin@sheffield.ac.uk

Dr Sarah Wadmann, VIVE - Danish Center for Social Science Research, sawa@vive.dk

Proposal Summary

This Handbook intends to provide a comprehensive science and technology studies (STS) perspective to understanding dynamics at the intersection of the pharmaceutical and biotech sectors and society writ large. In doing so this volume deploys a socio-technical approach to understanding bio-pharmaceutical research, development and deployment / use. Our approach makes visible the political, economic, innovation, governance, production and consumption elements not conventionally understood in the science of pharma. Our position is that understanding pharma writ large requires attending to a broader set of issues (e.g. technological trajectories, intellectual property protections, industrial fragmentation and globalisation) and a wider set of actors (i.e. patient organisations, contract research organisations, public-private-partnerships, key opinion leaders, supra-national institutions) that we present here.

The STS approach driving this Handbook highlights three central themes. The first relates to the global dynamics of pharmaceutical research, development, production and use. The second theme is one of constructively critical engagement with the dominant model of pharmaceutical research, development and deployment (R,D&D), which often puts profits rather than health first. The third theme explored in the volume builds on the previous two by highlighting alternative models of innovation that respond to some of the challenges of the dominant and linear model.

These central themes will be explored through five sections structured along the lines of :

1) The development of pharmaceuticals and knowledge production,

2) Pharmaceutical manufacturing and infrastructures,

3) Market making and marketization of pharmaceuticals,

4) Regulation and governance pharmaceuticals,

5) The everyday use of pharmaceuticals: Prescription, diagnosis and (over)consumption

Section 1: Development of Pharmaceuticals & Knowledge Production (Section Editor: Paul Martin)

This section will focus on the production of knowledge about new medicines within the global pharmaceutical sector. In analysing the dominant model of innovation the chapters will provide a powerful critique of key arguments, underlying assumptions, and established models of innovation to explore the limitations of this paradigm. Examples from across the world will be used to illustrate how the development of new medicines can be done differently as a means of resisting the hegemony of Big Pharma and better serving the needs of both majority populations and marginalised groups.

Chapter 1.1. Some myths about pharmaceutical innovation The dominant model of pharmaceutical innovation within both industry and policy discourses is based on large companies discovering and developing new therapies, a process that is risky, expensive and time-consuming. The high rate of failure and massive expense of R&D provides a powerful justification for the high and rapidly increasing prices of new drugs. This chapter will critically examine a number of the key claims made by the industry about: a) the private sector being the main source of new medicines; b) the very high cost of developing a drug, estimated to be ~$2Bn; c) the effectiveness and efficiency of the current innovation model in creating drugs that meet health needs. In doing this it will question the industrys monopoly on drug development and its commitment to addressing global health needs.

Chapter 1.2. From bench to bedside and back again The translation of new scientific and clinical knowledge into novel therapeutics is one of the key challenges in contemporary biomedicine. The idea of translational research has become the central focus of policy efforts to valorise public investment in research and rests on successfully configuring the relationship between laboratory science, clinical investigation and industry. This chapter will critically unpack the notion of translation in the context of the creation of new medicines and explore the epistemic, institutional, and political processes at work, challenging the conventional linear model and suggesting how the relationship between these domains might be better understood.

Chapter 1.3. The datafication of the pharmaceutical sector: Promises and perils Massive new data infrastructures are being created across biomedical research and healthcare systems with the aim of improving care and enabling innovation. These are closely linked to the widespread introduction of whole genome sequencing. The pharmaceutical industry is both driving datafication and using it to establish new ways of developing drugs and diagnostics. At the heart of these efforts are the creation of new digital platforms and assets, which valorise administrative data, medical records and patient experience. This chapter will outline the dynamics of datafication in healthcare and biomedicine, and the strategies used by industrial actors to exploit these resources. It will explore both the possible benefits and risks for patient care, public health and wider society.

Chapter 1.4. The challenge of precision therapeutics A powerful imaginary of precision and personalised medicine is increasingly seen as the future of biomedicine with its emphasis on targeting disease sub-types and stratifying patient populations. At its heart is a fragmentation of traditional disease categories based on innovative diagnostic technologies and the development of therapies for niche markets. This stands in contrast to dominant industry business strategies based on blockbuster drugs for mass markets. The development of precision medicine is being led by new diagnostics (e.g. whole genome sequencing) and therapeutic modalities (e.g. gene therapy) targeting cancer and rare diseases. This chapter will chart the rise of precision therapeutics, the new infrastructures, practices and economies that are enabling them, and the implications for industry, healthcare and patients.

Chapter 1.5. How can policy influence pharmaceutical innovation to address market failure and promote public health? Despite massive investment in research and development by both the public and private sectors, there remain important areas of unmet need in global public health. These include tropical neglected diseases, rare diseases, AMR, the supply of affordable generic medicines and equal access to advanced therapies. Even where there are long-established treatments (e.g. insulin for diabetes) major problems with access remain in many countries. This chapter will explore how new policy initiatives might be used to reconfigure the relationship between the public and private sectors and steer private investment to better serve public health goals/missions. It will do this by drawing on examples from around the world, including global collaborative networks (e.g. DMDi) and novel purchasing processes (e.g. advanced purchase agreements for Covid vaccines).

Chapter 1.6. Social pharmaceutical innovation as an alternative framework for the development of new medicines The concept of social pharmaceutical innovation (SPIN) provides a powerful framework for thinking through how pharmaceutical knowledge might be produced to better serve public health needs. SPINs include patient and clinician-led initiatives to develop new medicines, often involving not for profit companies, academic centres and philanthropy. However, in attempting to create a new ecosystem for innovation SPINs face many economic, legal, regulatory and organisational challenges. This chapter will outline the promise of SPINs and the barriers that stand in their way. Drawing on examples based in countries across the world, it will suggest how new collaborative relationships, novel forms of governance, and the establishment of supportive institutions will be needed to make them flourish.

Section 2: Pharmaceutical Manufacturing & Infrastructures (Section Editor: Conor Douglas)

The manufacturing of pharmaceuticals is one area where large pharmaceutical companies have continued to play an active role, as opposed to acquiring early-stage research or prospective targets, contracting out clinical trials to CROs, etc. However, a number of large socio-technical trends are in the process of re-organizing manufacturing processes and throwing up new sets of challenges (see below). Manufacturing intersects with a number of other components of the pharmaceutical innovation system, and issues associated with research, development, deployment, access and use. The focus will remain on manufacturing while highlighting these key areas of overlap to other innovation processes. Based on these socio-technical trends, globalised political economies of medicines, and transformations in manufacturing processes, chapters here could be focussed as follows:

Chapter 2.1. Vaccine sovereignty (nationalism) and local manufacturing (in a post-pandemic world) This chapter will look to discuss the historical transitions and evolution of vaccine manufacturing. Once a state-led activity, vaccine manufacturing was eventually (neo) liberalised and captured by the private pharma and biotech sector. The recent COVID-19 pandemic has demanded new forms of vaccine research, development and manufacturing that feature novel forms of public and private partnerships, and purchasing agreements. At the same point in time, (early) challenges associated with the availability of the COVID-19 vaccine, and the pending threats of new communicable diseases, have pressured states to re-engage with vaccine production to insure the safety of their citizens. This chapter will explore these dynamics, relationships between public and private sectors, as well as continued availability issues in low and middle-income countries.

Chapter 2.2. Generics, manufacturing (and circulation) of off-patent drugs & biosimilars/next generation biologics (in India and China) This chapter will look to discuss the rise of the manufacturing of generics, both for the increasing number of off-patent drugs, but also for the production of biosimilars. Here the role of how intellectual property regimes constrain and/or facilitate genetic manufacturing will be explored. Associated with that are challenges related to the standardisation of biosimilars. Further, the global nature of production and subsequent circulation of generic drugs will also be addressed as the production of generics cannot be easily dissociated from availability and affordability issues, regulatory impacts especially in low and middle-income countries as it relates to both advanced products and essential medicines.

Chapter 2.3. Alternative manufacturing pathways for ATMPs While a significant number of cell and gene therapies are now on the market, or in clinical trials, they are often the most expensive treatments in the world. This chapter will look to discuss alternative approaches to manufacturing such advanced therapies in ways that are more sustainable to healthcare systems and treatment providers. In doing so, the chapter will tackle definitional questions facing these products (i.e. are they treatments, are they procedures, are they cell or gene based?), as well as explore socio-political issues emerging from some of these alternative pathways, which include: magistral preparation and pharmacist compounding, hospital exemptions & point of care / hospital manufacturing, charity-based not-for-profit manufacturing, and more. In doing so this chapter will seek to explore challenges associated with the scaling up of these often niche initiatives, as well as the emerging notion of a pharmaceutical commons.

Chapter 2.4: Biohacking, garage biology and fights for access citizen biology between activism and entrepreneurship This chapter will look to discuss the rise of citizen science and patient activism in alternative, informal, non-traditional forms of pharmaceutical manufacturing. Sometimes driven out of interest and curiosity, but in many other instances alternative forms of manufacturing are connected to access and availability challenges (e.g. manufacturing ones own insulin), and/or focused on neglected diseases for which there is limited commercial interest. These initiatives and collectives have taken manufacturing practices into their own hands to produce e.g. insulin, homebrewed antibiotics, genetically enhanced probiotic yoghourt, and making use of a range of rudimentary and advanced technologies like CRISPR-Cas9 gene editing. Referred to under many headings such as biohacking, garage biology, DIYbio, open-source drug discovery and more, this phenomenon challenges institutionalised forms of manufacturing. In doing so, it also challenges established notions of pharmacological expertise, and must negotiate biosafety and biosecurity regulatory issues.

Chapter 2.5. Planetary Pharma (industry side effects of manufacturing) This chapter will seek to discuss the environmental impact of pharmaceutical manufacturing. Not only will those impacts be detailed, critical analysis will also be given to initiatives seeking to green the industry. While pressures and opportunities are being placed in countries with large manufacturing sectors and large populations (e.g. India and China), risks and responsibilities are globally shared. Significant in discussions of environmental impacts of pharmaceutical manufacturing are issues associated with the disposal of pharmaceutical products (even defective ones at manufacturing stages), associated impacts with wastewater treatment, and the production of carbon in manufacturing processes. Associated with these environmental impacts is the rise of antibiotic resistance (which is being referred to as a silent pandemic and one of the primary targets of the current EU pharma policy reform proposal) resulting from the improper disposal of antibiotics.

Section 3: Market-Making and Marketisation of Pharmaceuticals (Section Editor: Susi Geiger)

This section takes a bifocal lens. First it zooms in on the evolution of pharmaceutical business models over the past four decades in what has been described as a move toward the financialization of the pharmaceutical industry and considering the market conditions that have both allowed for and been created through this process of pharmaceutical financialization. Importantly, this section then moves on to analyse the consequences of these changes in the pharmaceutical business model for states and patients access to medicines.

Chapter 3.1: The political economy of pharmaceutical markets - and its many failures This chapter will critically trace the financialisation of the pharmaceutical industry in the context of broader developments in regulation and policy, for instance, the 1995 TRIPS (the Agreement on Trade-Related Aspects of Intellectual Property Rights). What exactly changes when the main focus of pharmaceutical firms moves from a concern with research and development to assetization of a patent portfolio? What consequences does this move have on decisions over what drugs are being brought to market, where and at what price? Together with the section introduction, this chapter lays the foundation for a deeper understanding of the other processes traced in this section and elsewhere in the book, including pricing and the resistances that current value-based pricing practices have engendered.

Chapter 3.2: The contested pricing practices of pharmaceutical products How are pharmaceutical products priced? While the exact procedure in this highly complex, multi-actor process differs by jurisdiction, broad similarities can be ascertained. For one, the pharmaceutical industry has moved over the past two decades toward a value-based pricing system, which has created a great deal of controversy over the affordability of medications. As the section introduction has laid out, value-based pricing has also led - at least in Europe - to somewhat surprising coalitions of state buyers. This chapter will present the reader with the basics of pricing processes in pharmaceutical markets, explain who is typically involved, who holds the power, and how demands for greater transparency may or may not change this current state of play.

Chapter 3.3 The marketing of pharmaceuticals Beyond processes of market-making through pricing and market access strategies, the construction of pharmaceutical markets also involves very tangible activities of marketing. These include ghost-writing of research papers, channelling of data flows, influencing of key opinion leaders, and others. This chapter will provide an overview of these activities and some of the concerns that they create over the undue influence of pharmaceutical firms, both in relation to branded prescription drugs but also with regard to the marketing of generics and over-the-counter medicines.

Chapter 3.4: Patient organisations involvement in market access and pricing Following on from the previous chapter, this chapter seeks to explore what many consider an even more pernicious use of pharmas invisible hand: the funding, sponsorship and influencing of patient organisations. While many patient groups are vital in the research and development of new treatments (particularly in rare diseases), they are also vitally dependent on these types of sponsorship as their source of funding. Patient organisations may then also run the risk of losing credibility and/or of becoming mouthpieces of the pharmaceutical industry, for instance, when seeking reimbursement for high-priced medicines through government-directed protests. In the final count, this issue also refers to the markets that are missing - that is, that are left unserved by pharmaceutical companies.

Chapter 3.5: Global access: Voluntary mechanisms, market segmentation and tiered pricing While many of the issues in preceding chapters concern mechanisms in place in high-income countries, pharmaceutical firms market-making activities of course span the globe. They are often differentiated in terms of market entry, pricing and access programs depending on the level of income in a specific country and the potential market size. This chapter considers the global selection and entry strategies that pharmaceutical firms may pursue and analyses the interdependencies of markets within a global economy. Further, the chapter considers voluntary access mechanisms such as through the Medicines Patent Pool.

Chapter 3.6: The Pharmaceutical Commons: Alternative modes of pricing pharmaceuticals Directly following on from the chapter on global market access, this chapter zooms more deeply into alternative market access and pricing mechanisms. One of the proposals currently discussed, particularly after the catastrophic failure of global access to Covid-19 vaccines, is the construction of a (global) pharmaceutical commons as a radical alternative to existing pharmaceutical market structures. This chapter introduces several such proposals and evaluates their feasibility in the context of late-stage capitalist global structures.

Section 4: Regulation & Governance of Pharmaceuticals (Section Editor: Tineke Kleinhout-Vliek)

The pharmaceutical sphere is, sadly, one associated with scandals across the world. These include contested research practices, missing or skewed trial results, and severe side effects remaining unknown until too late. The pharmaceutical field is heavily institutionalised and regulated, for a large part in response to such scandals and accompanying public contestation. Virtually everywhere in the world, many different laws, policies and directives seek to safeguard the quality, safety, and efficacy of medicines, with a number of regulatory and governance bodies at national and international levels involved at different points in a pharmaceuticals life cycle. This section comprises chapters that engage with the practices and politics of regulation and governance. It explores the spaces that regulatory and governance institutions inhabit with other actors (i.e. including clinicians, patients, their representatives, and the public), which seek to affect decisions made. As a consequence of these dynamics chapters in this section will explore the following topics:

Chapter 4.1: The changing role of regulators Since the early 2000s, the USAs Food and Drug Administration (FDA) and other agencies such as the European Medicines Agency (EMA) have shifted their focus from gatekeepers to promoters of innovation, looking for ways to accelerate and streamline formal processes of market authorisation. This is driven by a number of factors including new assessment technologies, changing product profiles (e.g. orphan drugs), the devolution of clinical trials, and a greater emphasis on post-marketing surveillance. This chapter will explore the tensions raised by the changing role of regulatory agencies, the extent to which this represents deregulation and the implications for patient safety and public health.

Chapter 4.2: New routes to treatment: Accelerated access and conditional approval Formalised regulatory procedures where decision-making is fast-tracked and approvals become conditional are becoming commonplace. At the same time, HTA and reimbursement decisions increasingly rest on limited, often to-be-collected data. This demands new forms of post-marketing governance, including data standards (e.g. real-world evidence) and infrastructures. Historically, post-marketing data collection has been challenging, data that were collected often showed no benefit retrospectively, and disinvestment from established products has proved near impossible. This chapter charts the rise of new routes to market and the associated shifts in knowledge production and epistemologies.

Chapter 4.3: Patient and public engagement and changing epistemologies Regulatory and governance bodies are engaging more seriously with patients and in a more sustained manner. Public and Patient Involvement and Engagement or PPIE is high on policy agendas, and new data types include patient-reported outcomes and direct patient engagement in the form of patient testimonies or stories. Decision makers seek to take this patient input seriously without anecdotes driving decisions. Yet critical voices highlight patient mobilisation or even capture by industry. This chapter will engage with the role of patient-generated data and reported outcomes in facilitating or expediting decisions, and the tensions these generate.

Chapter 4.4: Judicialisation of pharmaceuticals This chapter will deal with the interaction of pharmaceutical governance and the law. This ranges from the work of antitrust and competition law in combating and preventing price-fixing, the transnational impact of organisations using the law to fight unfair pricing practices, or the local impact of the International Declaration of Human Rights where patients are citing the Right to Health to gain access to pharmaceuticals. It will engage with the questions where legality and legitimacy intersect when it comes to access to pharmaceuticals, how states and arms length bodies respond, and to what effects.

Chapter 4.5: Controlling falsified and substandard medicines Falsified and substandard medicines are products that have lowered or completely absent active pharmaceutical ingredients. These medicines are problematic in and of themselves, but are also connected to other widespread problems, such as medicine shortages, which provide incentives for falsifiers to fill the gap. Substandard medicines may be the result of wilful tampering but also negligence in manufacturing or storage. This chapter is to engage with the work of follow-up after medicine authorisation, including post-marketing surveillance, the work of inspectorates when it comes to quality and legislation on track-and-tracing medicines, raising questions on trust and potentially diverging conceptions of quality.

Chapter 4.6: Global harmonisation and differentiation This final chapter will engage with the processes, roles and effects of global regulations and harmonisations and current efforts at international policy reforms, including the Pandemic Accord and the reforms of EU pharmaceutical legislation proposed by the European Commission in 2023. It will trace the efforts of politicians, policymakers, and activists of different plumage in these processes and seek to elucidate the values (f.i. equity, solidarity, transparency) as co-produced in international policy processes, and what they come to mean in these contexts. It may also provide insights into the differential effects of policy harmonisation in particular national settings.

Section 5: The everyday use of pharmaceuticals: prescription, diagnostics and (over)consumption (Section Editor: Sarah Wadmann)

This section focuses on the everyday use of pharmaceuticals. In particular, it attends to the practical work undertaken by patients, relatives, clinicians and others to diagnose disease, prescribe and consume medicines, and what this implies for the distribution of treatment options. As socio-technical accomplishments, pharmaceuticals may work in a strictly technical sense, but their actual effects depend on how they are translated into specific contexts of use. What makes for a successful pharmaceutical innovation is not just a question of technical efficacy and safety; it depends on how it is embedded in and made workable through particular infrastructures. The section covers three core themes: 1) the politics of prescribing, 2) diagnostic practices of classification and, 3) pharmaceutical consumption, in particular the junction between use, misuse and non-use.

Chapter 5.1: Prescribing and deprescribing: Therapeutic practice at the nexus of expertise, power and regulatory oversight

Whether a slip of paper with handwritten instructions or a predefined category in an electronic record system, the prescription constitutes an obligatory point of passage for patients access to many pharmaceuticals. Prescribing is not merely a therapeutic action but also a practice shaped by negotiations of professional authority and legitimate expertise. This chapter speaks to the broad questions about what counts as appropriate use of pharmaceuticals, who gets to define what counts as appropriate use, and on which basis? Here this chapter charts and compares the history of prescription in select settings, and traces associated negotiations of professional authority and expertise.

Chapter 5.2: Reframing resistance: Mobilising around microbes and antimicrobial resistance

This chapter delves into a highly topical issue of global relevance, namely antimicrobial resistance. It explores how antibiotic prescription is enmeshed in and shaped by social meaning-making and material conditions that go well beyond the clinic. The chapter provides an overview of the ways in which antimicrobial resistance has been framed in public and policy debates, and explores how these framings interact and square with local meaning-making practices and practices of medicine use.

Chapter 5.3: Diagnostic stratification: Clinical decision-making in the era of precision medicine

While seemingly technical and mundane, classifications are powerful tools as they shape the epistemic space of what is thinkable, conceivable, and targetable and at the same time influence peoples access to healthcare. While social inquiry into diagnostic classifications has a long legacy, discussions about the delineation of disease have been revitalised by developments in precision medicine. This chapter recoups contemporary discussions about diagnostic classification in relation to precision medicine, and provides illustrative examples of the dilemmas that can arise when precision medicine enters clinical practice. It illustrates how new conceptions of disease and associated therapies become a site of negotiation among health professionals and in their interactions with government authorities, pharmaceutical companies and patient groups.

Chapter 5.4: Lay pharmacology revisited: Self-care at the fringe of biomedicine

While prescription practices are largely in the realm of professional expertise, the actual use of pharmaceuticals depends heavily on the behaviour, meaning-making and socio-economic circumstances of those who are to take the medications. Signalled by the notion of lay pharmacology, STS-scholars have observed how lay conceptions of disease and medicine are shaped by cultural repertoires and social relationships. This chapter provides an update and critique of social science discussion on lay pharmacology. In particular, it compares practices of self-care from diverse global settings and discusses implications for pharmaceutical consumption as self-care can take many forms that cannot be unambiguously categorised as either alternative or biomedical.

Chapter 5.5: Between use and abuse: What makes for an opioid crisis?

This chapter charts the terrain of pharmaceutical use and misuse and the porous boundaries diverting these practices. Taking the example of the current opioid crisis in the US and beyond, the chapter sheds light on the infrastructural arrangements that enable potent and potentially toxic remedies to circulate beyond the regulated realm of prescriptions. In doing so, it attends to the politics evoked in the negotiation of boundaries between consumption and overconsumption, therapy and enhancement, use and misuse.

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Conor Douglas

Associate Professor

Department of Science, Technology & Society, Faculty of Science

307 Bethune College |York University | 4700 Keele St. | Toronto ON, Canada M3J 1P3

Tel: 416.736.2100 extension 30104| cd512@yorku.ca | https://www.yorku.ca/science/profiles/faculty/conor-douglas/

Project Leader - Social Pharmaceutical Innovation: https://www.socialpharmaceuticalinnovation.org/

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