Section 5: Regulation and Governance

Health technologies—whether medical devices, drugs, or tissue-based therapeutics, such as stem cells—pose particular challenges in regard to their safety, efficacy, and long-term benefits and costs (and risks), both to patients and to the wider healthcare system. The four books in this section offer a detailed exploration of how health technologies are regulated. Governance points towards the ways in which such technologies and their producers are more, or less, accountable to those that use them, a process less to do with formal state regulation and more about process and practice within and between different social actors in scientific, clinical, and commercial domains. Faulkner (Medical technology into healthcare and society. A sociology of devices, innovation and governance. Basingstoke: Palgrave Macmillan, 2009) discusses the regulation of medical devices, which includes the mundane as well as the more sophisticated—for example, everything from ‘the bandage to the bioreactor’. Davis and Abraham (Unhealthy pharmaceutical regulation. Innovation, politics and promissory science. Basingstoke: Palgrave Macmillan, 2013) offer a detailed analysis of pharmaceutical drug regulation over the ‘neo-liberal era’ of the past 40 years, contrasting drug approval processes in the USA and EU. Webster (The global dynamics of regenerative medicine. A social science critique. Basingstoke: Palgrave Macmillan, 2013) examines the broad global ‘dynamics’ of regenerative medicine. Gottweis et al. (The global politics of human embryonic stem cell science. Regenerative medicine in transition. Basingstoke: Palgrave Macmillan, 2009) explore the relationship between emerging regulatory regimes and the global political economy of embryonic stem cells.