A call for evidence
Official concerns about the statutory duty of candour fitness for purpose were first raised in December 2023. This followed the announcement of a review of the duty in the then government’s response to the Hillsborough disaster report. This prompted the previous government to launch a consultation on the statutory duty that ran from 16 April 2024 to 29 May 2024 Duty of candour review - GOV.UK. This consultation was described as a ‘call for evidence’.
The purpose of DHSC’s review was to understand the extent to which the statutory duty of candour was being honoured, monitored and enforced. In launching the consultation, DHSC was at pains to emphasise that limited or non-compliance with the duty cannot be justified. Its aim was “to deliver recommendations for better meeting the policy objectives of the duty and which can be implemented at pace.” In other words, to tighten up the duty.
Background
To recap, the statutory duty of candour was introduced in the wake of the Mid Staffs scandal in 2014. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 The duty places a direct obligation upon all health and social care providers registered with CQC to be open and honest with patients, service users and their families when a notifiable safety incident occurs.
A notifiable safety incident is defined as one that:
- was unintended or unexpected
- occurred during the provision of an activity that CQC regulates
- in the reasonable opinion of a healthcare professional, has or might result in death or severe or moderate harm (including psychological) to the person receiving care
Once a provider knows that a notifiable safety incident has occurred, they must:
- notify the relevant person of the incident in person to say sorry, explain what is known, and any further enquiries to be made
- offer the person reasonable, practical and emotional support
- provide the person with written notes of the initial discussion and of the notification, details of further enquiries, their results and an apology. The organisation is also required to keep copies of all correspondence relating to the incident
This statutory duty is enforced by the CQC. If a provider is found to be non-compliant, the CQC can impose conditions on them, issue warning notices and fines, remove their registration, and bring criminal prosecutions without needing to first serve a warning notice. The statutory duty is distinct from the professional duty of candour, which places an obligation on health and care professionals – as individuals – to be open and honest with patients and service users when things go wrong. This is regulated by professional regulators such as the GMC, NMC and the GDC. The current review is not considering the professional duty but any changes to the statutory duty are likely to be reflected in the professional duty in due course.
Call for evidence findings
The current government published the findings of the call for evidence on 24 November 2024. Findings of the call for evidence on the statutory duty of candour - GOV.UK It decided to bring forward its publication of this report ahead of a final response because of three developments since the call for evidence was published.
First, the final report of the Infected Blood Inquiry (May 2024) included wider recommendations for the duty of candour to cover individuals in leadership positions in NHS organisations, and making them personally accountable for responding to concerns about patient safety. Secondly, in the King’s Speech in July 2024, the government committed to bring forward legislation to establish a Hillsborough Law ahead of the next anniversary of the Hillsborough disaster. This would establish a duty of candour on all public servants and officials, with criminal sanctions for the most serious breaches. Thirdly, the government very recently committed to the regulation of NHS managers in November 2024 and launched yet another public consultation to gather views from managers, regulators, patients, the public, healthcare staff and employing organisations on options and considerations for the regulation of NHS managers (see more on this below). The consultation includes questions on a professional duty of candour for NHS managers and on the existing statutory (organisational) duty of candour in respect of non-NHS managers[CM1] .
The report itself (based on 261 responses from various groups, including patients, families, caregivers, healthcare professionals, and healthcare providers) highlights some major concerns about the statutory duty of candour. Concerns include inconsistent understanding and application of the duty, inadequate training for staff, and cultural barriers within healthcare systems leading to the duty being treated as a ‘tick-box’ exercise and lacking compassion and meaningful engagement.
Only 40% of respondents thought the purpose of the duty was clear, while over half felt that healthcare staff lacked understanding of its requirements. Compliance was perceived to be inconsistent, with significant concerns about staff avoiding candour due to fear of blame, lack of senior management support, or unclear roles and thresholds. Patients and families were particularly critical, with many reporting poor communication and a lack of accountability from providers. Respondents also highlighted the need for more robust systems and senior-level accountability to improve monitoring and learning.
To address these issues, respondents recommended clearer guidance and improved training for healthcare professionals. There were also calls for stricter enforcement, including – importantly – introducing individual accountability for senior managers to improve compliance and promote a cultural shift towards greater transparency and openness, and away from fear of litigation or retribution.
What’s next in 2025?
There is little doubt that the statutory duty of candour will be significantly tightened in 2025. During the last 12, months we have seen repeated, high-profile examples of the damage caused to organisations by the absence of an open and transparent culture when things go wrong. The need for greater candour has been a recurrent theme in the Hillsborough Report, the final report of the Infected Blood Inquiry and the ongoing Thirlwall Inquiry into the Lucy Letby case.
Perhaps the clearest indication of direction of travel is the emphasis that’s now being placed on individual, as opposed to organisational, responsibility when it comes to candour. As Sir Rob Behrens, the former Parliamentary and Health Service Ombudsman, said when giving evidence recently to the Thirlwall Inquiry “[the statutory duty of candour] doesn't work because it doesn't apply to individuals, it applies to persons and that is interpreted as a public body."
The review of the duty of candour is undoubtedly part of a wider agenda to increase personal accountability for individual healthcare managers. Tellingly, the government has confirmed that it will consider both the responses to the manager regulation consultation (the findings will be published as soon as possible following closure of the consultation), and the call for evidence on the statutory duty of candour, as it continues to develop policy on candour in healthcare.
We will be closely monitoring developments at Altea to ensure our clients are kept fully informed of how any developments will impact them, their staff and their service users.
“The information contained in this article does not represent a complete analysis of the topics presented and is provided for information purposes only. It is not intended as legal advice and no responsibility can be accepted by Altea Insurance for any reliance placed upon it. Legal advice should always be obtained before applying any information to particular circumstances.”
