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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.

---END---





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 |
Conor Douglas


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