Providers of health and social care in England are under a statutory duty to be open and honest with patients who suffer harm when receiving care or treatment. This ‘duty of candour’ was introduced by regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and is one of 13 fundamental standards of care regulated by the Care Quality Commission (CQC). This was hailed as a landmark for openness in patient–professional relationships and as having the potential for enhancing a safety culture in healthcare. However, the decision to supplement existing ethical duties and policy initiatives encouraging openness with a statutory duty was contentious and encountered considerable medical resistance. This paper will trace the background to the legal duty, analyse its contents and consider its enforcement and potential obstacles to its effectiveness. Our analysis will foreground resistance based in practitioners’ and healthcare institutions’ fear of litigation and prosecution in the UK. However, opposition to candour emerged within the medical profession prior to the emergence of modern liability systems. This paper will argue that in order to create a culture of candour it is important to look beyond the more commonly identified professional concerns about litigation and understand these historical trends. In particular, we argue that a longer-term understanding of medical resistance to openness has important lessons for the likely effectiveness of the legal duty of candour.
User involvement in regulation: A qualitative study of service user involvement in Care Quality Commission inspections of health and social care providers in England