Appendix 2: The statutory duty of candour for care organisations across the UK

Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 sets out a duty of candour. It requires all health and social care providers registered with the Care Quality Commission (CQC) to be open and transparent with people using services, and their families, in relation to their treatment and care. The regulation also sets out specific actions that providers must take when a ‘notifiable safety incident’ occurs.  This includes informing people about the incident, providing reasonable support and providing truthful information and a timely apology. The CQC can prosecute for a breach of parts 20(2)a and 20(3) of this regulation.

The organisational duty of candour does not apply to individuals, but organisations providing health and care are expected to implement the duty throughout their organisation by making sure that staff understand the duty and are appropriately trained. The CQC provides guidance⁴⁵  for providers on meeting the duty of candour.

In April 2021 the Department of Health (Northern Ireland) launched a consultation on Duty of Candour Policy proposals and a ‘Being Open Framework’. 

The consultation outlined three policy proposals relating to a statutory duty of candour:

• A Statutory Individual Duty of Candour (IDC) with criminal sanctions, and a Statutory Organisational Duty with criminal sanctions;
• A Statutory IDC without criminal sanctions. Individuals would be sanctioned by their employer, regulator, and professional body, and a Statutory Organisational Duty with criminal sanctions; and
• A Statutory IDC without criminal sanctions, and separate criminal sanctions for withholding, destroying, or providing false or misleading information, and a Statutory Organisational Duty with criminal sanctions. 

The consultation followed recommendations for a statutory duty of candour made by the Inquiry into Hyponatraemia-Related Deaths, which reported in January 2018. This examined the circumstances relating to the deaths of five children in Northern Ireland hospitals. 

The Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 and The Duty of Candour Procedure (Scotland) Regulations 2018 set out an organisational duty of candour on health, care and social work services in Scotland. The duty came into effect on 1 April 2018.The overall purpose of the duty is to ensure that organisations are open, honest and supportive when there is an unexpected or unintended incident resulting in harm or death, as defined by the Act.

Organisations are required to follow a duty of candour procedure which includes notifying the person affected, apologising and offering a meeting to give an account of what happened.

The duty also requires the organisation to review each incident and consider the support available to those affected (this includes both those who deliver and receive care and support services).

Organisations are also required to publish an annual report on when the duty has been applied. This includes the number of incidents, how the organisation has implemented the duty and what learning and improvements have been put in place.

Alongside the legal requirements set by the Act, the Scottish Government has also published guidance⁴⁶  on the implementation of duty of candour for all organisations that provide health services, care services or social work services in Scotland.

The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 place a number of duties on responsible bodies providing NHS care. This includes a duty to be open when harm may have occurred:

‘where a concern is notified by a member of the staff of the responsible body, the responsible body must, where its initial investigation determines that there has been moderate or severe harm or death, advise the patient to whom the concern relates, or his or her representative, of the notification of the concern and involve the patient, or his or her representative, in the investigation of the concern’.

The Welsh Government’s Health and Care Standards Framework, includes a standard called ‘listening and learning from feedback’. In meeting this standard, the framework advises that ‘health services are open and honest with people when something goes wrong with their care and treatment’. The standards provide a framework for how services are organised, managed and delivered on a day-to-day basis.

On 1 June 2020, The Health and Social Care (Quality and Engagement) (Wales) Act became law. It is expected to come into force in spring 2023.

The Act will establish an organisational duty of candour on providers of NHS services, requiring them to be open and honest with patients and service users when things go wrong.

The legislation places a duty of candour on providers of NHS services (NHS bodies and primary care). The duty requires NHS providers to follow a process – to be set out in Regulations – when a service user suffers an adverse outcome which has or could result in unexpected or unintended harm that is more than minimal and the provision of health care was or may have been a factor.

The Act also requires NHS providers to report annually about when the duty has come into effect.

The Welsh Government intends to issue statutory guidance in relation to the duty of candour to support its implementation. In a Written Statement on 24 March 2021, the Welsh Government also stated its intentions to:

• review the Health and Care Standards (see above); and
• place a duty of candour on independent healthcare providers.