Solidarity in Health Research Regulation

New book chapter by Katharina Kieslich and Barbara Prainsack in The Cambridge Handbook of Health Research Regulation (2021).


This chapter explores the analytical and normative roles solidarity can play when designing health research regulation (HRR) regimes. It provides an introduction to the meanings and practical applications of solidarity, followed by a description of the role solidarity plays in HRR, especially in fostering practices of mutual support between patient organisations and between countries. We illustrate our argument in a case study of HRR, namely the European Union (EU) regulatory regime for research on rare diseases and orphan drugs. The current regime aims to decrease barriers to research on orphan drugs by creating, predominantly financial, incentives for research institutions to take on the perceived increased risks in this area. We show how the concept of solidarity can be used to reframe the purpose of regulation of research on orphan drugs from a market failure problem to a societal challenge in which the nature of barriers is not just financial. This has specific implications for the types of policy instruments chosen to address the problem. Solidarity can be used to highlight the political, social, economic and research value of supporting research on rare diseases and orphan drugs.


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Katharina Kieslich & Barbara Prainsack



The Cambridge Handbook of Health Research Regulation (2021, open access)

Edited by: Graeme Laurie, University of Edinburgh, Edward Dove, University of Edinburgh, Agomoni Ganguli-Mitra, University of Edinburgh, Catriona McMillan, University of Edinburgh, Emily Postan, University of Edinburgh, Nayha Sethi, University of Edinburgh, Annie Sorbie, University of Edinburgh

Publisher: Cambridge University Press