Enforcement of the duty Statutory duties of candour in relation to harm to patients
A statutory obligation should be imposed to observe a duty of candour: On healthcare providers who believe or suspect that treatment or care provided by it to a patient has caused death or serious injury to a patient to inform that patient or other duly authorised person as soon as is practicable of that fact and thereafter to provide such information and explanation as the patient reasonably may request; On registered medical practitioners and registered nurses and other registered professionals who believe or suspect that treatment or care provided to a patient by or on behalf of any healthcare provider by which they are employed has caused death or serious injury to the patient to report their belief or suspicion to their employer as soon as is reasonably practicable. The provision of information in compliance with this requirement should not of itself be evidence or an admission of any civil or criminal liability, but non-compliance with the statutory duty should entitle the patient to a remedy.
How was this assessed?
Response
Accepted in Part
Response
Accepted in PartThe government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) on 19 November 2013, responding to all 290 recommendations of the Francis Report. This followed an initial response "Patients First and Foremost" in March 2013. Key reforms included a new Chief Inspector of Hospitals, strengthened Care Quality Commission inspection regime, a statutory duty of candour, and the fit and proper person test for NHS directors. Volume 2 (Cm 8754) contains the government's detailed responses to each of the 290 recommendations. See: https://assets.publishing.service.gov.uk/media/5a7cd486ed915d63cc65d167/34658_Cm_8777_Vol_1_accessible.pdf
Published Evidence
Published assessments of implementation progress from inspectorates, select committees, official progress reports, and other sources. Check the source type badge to see whether each assessment is independent or government self-reported.
Over 1,400 Freedom to Speak Up Guardians across healthcare organisations in England. 38,000+ cases raised in 2024-25, cumulative total exceeds 142,000 since inception. However, NHS Staff Survey 2024 shows only 71.5% of staff feel secure raising concerns about unsafe practice (stagnant for years), and only 57% are confident their organisation would address concerns.
DHSC published findings of call for evidence on statutory duty of candour. 261 responses received. Key finding: 52% of respondents said CQC had not adequately enforced the duty. Many reported it had become a "tick-box exercise". Only 40% thought the purpose was clear and well understood. Final government response still pending.
Research published 2023 marking ten years since the Francis Report found mixed results. Structural and legislative changes largely delivered (duty of candour, FPPR, CQC overhaul, revalidation, Freedom to Speak Up Guardians). However, cultural change not fully embedded; understaffing, fear of speaking up, and poor complaint handling persist in parts of the NHS.
NMC Revalidation launched 1 April 2016 in direct response to Francis Report. All nurses and midwives must revalidate every three years. Replaced the Post-Registration Education and Practice system. Updated NMC Code published March 2015 strengthened requirements around candour and raising concerns.
NMC published updated Code of Professional Standards for nurses and midwives (March 2015). Standard 14 specifically requires nurses and midwives to be open and candid with all service users about all aspects of care, including when mistakes or harm have occurred.
Sir Robert Francis published Freedom to Speak Up Review on 11 February 2015 with 20 principles and actions. Led to: Freedom to Speak Up Guardians mandatory in all NHS trusts from October 2016; National Guardian's Office established January 2016.
Government published "Culture Change in the NHS" (Cm 9009) reporting progress on all 290 recommendations. Key achievements: 19 hospitals placed in special measures; those trusts recruited 109 additional doctors and 1,805 additional nurses; 129 board-level changes made; excess avoidable deaths fell by 450 in less than a year.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20: statutory duty of candour came into force for NHS trusts November 2014, extended to all CQC-registered providers April 2015. Requires providers to notify patients/families of notifiable safety incidents and apologise.
Government published "Hard Truths: The Journey to Putting Patients First" (Cm 8777) in two volumes. Vol 1 set out new actions; Vol 2 provided detailed response to each of the 290 recommendations. Approximately 204 of 290 recommendations were fully accepted.
GMC medical revalidation launched December 2012. All licensed doctors must demonstrate fitness to practise every five years through appraisal and evidence. Francis Report endorsed and recommended strengthening revalidation.