The Burden of History: How Past Scandals Have Shaped the Future Governance of Human Tissue and Health Data’

A ubiquitous issue in medical law is how to strike the balance between affording individuals freedom and keeping communities safe. Legislators strive to do this by examining existing practices (constantly fluctuating due to evidence and experience) and anticipating future ones (notoriously difficult); it is a sophisticated exercise in the context of medicine because of the field’s proximity to science and innovation. The ingrained culture of self-regulation and professional ethos-based governance also obscures practices and emerging trends in a way that frustrates appropriate public debate and timely legislator intervention. This creates a trigger for explosive decompression of public opinion where practices are no longer socially acceptable (or, indeed, never were) and where emerging biomedical practices are poorly communicated or implemented. The resulting scandals create a social legacy which drives the political context of subsequent legislation. This chapter looks at two such events – the Alder Hey organ retention scandal and the care.data controversy – and analyses the legacy they created for the future regulation of the use of human tissues and data for biomedical research.