Research

Alternative access schemes for pharmaceuticals: bypassing scrutiny?

Wellcome Research Fellowship in Humanities and Social Science

(Awarded 2020; started 2023)

High prices of new medicines have led most European countries to set up some kind of health technology assessment (HTA): evidence-based processes that evaluate whether a drug’s benefits outweigh its costs, before it receives public funding. Yet, increasingly, expensive new medicines bypass this scrutiny. Instead, they enter health systems through alternative access schemes: diverse provisions that provide patients with access to treatment that are not routinely funded – for example the English Cancer Drugs Fund or individual patient funding requests. As a result, some drugs, including notably expensive cancer medicines, are prescribed even though they never demonstrated their “value for money” in HTA, reaching up to 5% of pharmaceutical budgets in some countries.

Despite evidence of their growing significance, there is little systematic research on alternative access schemes. This project seeks to understand why alternative access schemes emerged, how decisions in these schemes are made, and what the policy implications are for patients and public finances. It systematises knowledge of this emerging phenomenon by providing an overview of alternative access schemes in Europe and a detailed analysis of their political economy in selected health systems. It will contribute to debates on affordability of new medicines. 


Shadow expertise: the role of alternative expert advisory groups during the COVID-19 pandemic

Borysiewicz Biomedical Sciences Fellowship Programme

(2021)

This research project examines a highly topical and theoretically under-defined phenomenon: the emergence of alternative expert advisory groups during the COVID-19 pandemic.

As the new public health threat of COVID-19 became apparent in February-March 2020, governments around the world drew on experts to define the most appropriate policy response to protect population health as well as key economic and social activity. In addition to formal advisory groups convened by governments, experts in some countries formed alternative groups to offer their advice on various aspects of the COVID-19 crisis.

The project investigates the role of these alternative expert groups in managing the COVID-19 pandemic in March-November 2020 in the United Kingdom and the Czech Republic. It focuses on the interaction of alternative expert groups with governments, politicians and civil servants, as well as with other experts, notably those in official government structures. It studies the activities of alternative expert groups as well as the resources that are available to them.

Theoretically, the project builds on Peter M. Haas’ framework of conceptualizing expert groups as epistemic communities: networks of experts united by their scientific knowledge and a common policy enterprise. The emergence of alternative expert groups allows us to address one of the important gaps in the literature on epistemic communities, which too often focuses on a dyadic relationship between policymakers and a single expert group and ignores other actors.


COVID-19 diagnostic tests in international perspective

(2020)

(see details here)

PI: Dr Stuart Hogarth

Capacity for diagnostic testing is one of the key issues facing policymakers in the current pandemic.

A team at the Department of Sociology, University of Cambridge, led by Dr Stuart Hogarth, has recently been awarded two grants to examine issues of testing for COVID-19.

Dr Hogarth will run a rapid survey of diagnostic manufacturers within the University of Cambridge funded project “CamCovDx – mapping the COVID-19 diagnostics industry and analysing regulatory responses to the current crisis”. CamCovDx aims at providing policymakers with comprehensive and up-to-date information about industrial capacity for the production of COVID-19 diagnostics, and at surveying and evaluating the emerging regulatory responses to the current crisis across the globe.

In addition, as co-investigators on the UKRI-funded project “Covid-19 international comparative research and rapid knowledge exchange hub on diagnostic testing systems”, led by Prof Michael Hopkins (University of Sussex), Dr Hogarth and Dr Olga Löblová will study the role of transnational actors including WHO, EU, large diagnostics companies, and charities in developing testing strategies during the COVID-19 pandemic. National responses to COVID-19 develop within systems of multi-level governance in which transnational actors such as the WHO play a critical role. How nation-states interact with transnational actors may be an important factor in determining national policy and impact on the scale of the global crisis.


CancerScreen 

(2017-2021)

(see project website)

Screening for cancer in the post-genomic era: diagnostic innovation and biomedicalisation in comparative perspective

PI: Dr Stuart Hogarth, Lecturer in Sociology of Science and Technology at the University of Cambridge. 

Overview

How do new diagnostic tests find their way into practice? What are the relative roles of industry and the public sector in the discovery, development and adoption of new biological markers of disease (i.e., biomarkers)? There is now an extensive body of interdisciplinary research on the political economy of pharmaceutical innovation, and the role of drug firms as corporate “engines of medicalisation”, but we know relatively little about the part played by diagnostics firms in bringing new technologies into routine clinical practice, or their impact on the creation of new disease categories. Building on previous research by the PI and collaborators, the aim of this project is to address this empirical gap and provide a new conceptual framework for understanding the changing dynamics of diagnostic innovation.

Running from April 2017 until September 2021, the project is funded by the European Research Council, under the Horizon 2020 Excellent Science programme (grant agreement No 716689).