On 1 April 2016 the Health (Tobacco, Nicotine etc and Care) (Scotland) Act 2016 received Royal Assent. The Act will come into force on 1 April 2018.

The Act introduces a new duty of candour procedure as well as new offences of ill-treatment and wilful neglect in the health, care and social work services.

The duty of candour

The duty requires organisations to follow a procedure set out in the Act and the Duty of Candour Procedure (Scotland) Regulations 2018 in the event that there is an unexpected or unintended incident resulting in death or harm.

The procedure includes notifying the person affected, providing an apology and offering a meeting. An apology is defined as "a statement of sorrow or regret". Furthermore, it demands a review of the incident, the offer of training and support to those involved and an annual report on implementation of the procedure.

Ill-treatment and wilful neglect

The new offences apply to organisations, directors, supervisors, employees and volunteers. However, the terms 'ill-treatment' and 'wilful neglect' are not defined. Without clear definitions the application of these offences is open to interpretation by the courts. An individual convicted can face up to five years imprisonment or a fine (or both). Where an organisation is convicted in addition to a fine the court may order the organisation to remedy its actions and/or publicise the facts surrounding the offence.

What will be the impact?

The new provisions are striking for two principal reasons in the medical sphere: (1) the tension between the duty of candour and the new offences, and (2) the ongoing debate surrounding the conviction of doctors.

There is an obvious tension here. The duty of candour is intended to complement the Scottish Government's drive towards a 'no blame culture'. However, it seems obvious that the new offences cut against that. Not only do these offences require blame but their mere existence will surely impact on the success of the duty of candour. Being faced with a potential prosecution will not encourage doctors to engage with the duty of candour process.

The timing of these new offences is also particularly topical in light of the ongoing debates surrounding the prosecution of Dr Bawa-Garba in England, and her subsequent striking off. Dr Bawa-Garba was convicted of gross negligence manslaughter in respect of a patient. In Scotland there is no such offence and while there is an equivalent offence, involuntary culpable homicide, there have been no successful prosecutions of a doctor. The mens rea – the state of mind necessary to be guilty of the offence – of culpable homicide lacks clear definition which perhaps explains why there have been no such prosecutions in the medical context. However, the lack of clarity in these new offences may work against the medical profession: the hurdle of establishing ill-treatment or wilful neglect seems inevitably lower than culpable homicide.

Consequently, while these new provisions seek to promote no blame on the one hand, they tend to suggest rather a lot of blame on the other.