Background The egregious failings in patient safety at Mid Staffordshire NHS Foundation Trust between 2005 and 2009 identified by Sir Robert Francis QC in his public inquiry prompted him to recommend the introduction of a new criminal offence into English law in circumstances where a patient dies or is seriously harmed by a breach of fundamental standards. The authors evaluate whether, from the perspective of fairness and justice, a new criminal offence in this context is necessary and desirable.
Methods The authors considered the basic principles and functions of the criminal law and compared them with the principles and functions of the civil law. They then identify two primary tasks for the criminal law to perform in healthcare settings: (a) to establish primary duties to patients consisting of appropriately graded offences targeted at conduct that harms patients or unjustifiably poses risks to patients, and (b) to establish secondary duties to patients, consisting of offences aimed at punishing and deterring instances in which healthcare management and workers undermine the goals of regulation by lying or giving misleading information to regulatory officials or by obstructing their work. The authors focus on the first of these functions, identifying the scope of existing regulatory schemes that may give rise to criminal liability in English law when applied to healthcare contexts to identify whether a new criminal offence is needed.
Results A gap in the existing regime of criminal liability is identified, and it is this gap which a new criminal offence seeks to fill. The authors suggest how such an offence should be structured, drawing primarily upon foundational principles of criminal liability. It is suggested that a new general offence of wilfully neglecting or ill-treating a patient that can be committed by any healthcare organisation or worker (appropriately defined) is warranted.
Conclusions The criminal law has an important role to play in the healthcare context. Its central function is not primarily to deter and coerce people into complying with standards of behaviour deemed desirable. Rather, its central function lies in its symbolic and expressive significance, publicly proclaiming that the highly culpable mistreatment of others is wrongful and worthy of public censure and sanction.
- Patient safety
- criminal law
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Sir Robert Francis QC's public inquiry into egregious failings in patient safety at Mid Staffordshire National Health Service (NHS) Foundation Trust between 2005 and 20091 (which built upon his earlier independent inquiry into these alleged failings2) described the failings he observed as ‘the biggest scandal in NHS history’3 involving ‘appalling and unnecessary suffering of hundreds of people’.4 The Francis Report's many recommendations included the introduction into English law of a new criminal offence in circumstances where a patient dies or is seriously harmed by a breach of fundamental standards.5 The Report by the advisory group chaired by Don Berwick (the ‘Berwick Report’)6 broadly supported this proposal, refining the scope and content of the proposed offence in terms of the wilful neglect or ill-treatment of patients (see table 1 for a comparison of the Francis Report and Berwick Report proposals in relation to the criminal law).7 This article offers a legal perspective on whether a new offence is needed in this context, focusing primarily on whether it would be fair and just to do so. Our aim is to facilitate understanding of the proper role of the criminal law in supporting compliance with regulatory standards in the provision of healthcare, thereby clarifying and addressing various concerns and misconceptions about the criminal law that have arisen in recent debates.
The role of law in promoting compliance with regulatory standards
The healthcare sector is heavily populated with various bodies, agencies and institutions that have some responsibility for the provision and oversight of healthcare quality. Corresponding to this plethora of institutions is a formidably wide and varied range of standards, guidelines and other ‘norms’ of diverse legal status that apply to the provision of healthcare. Those operating during the period scrutinised by the Francis inquiry include, to name but a few, ethical norms of professional behaviour primarily enforced by professional associations such as the General Medical Council (GMC) and the Nursing and Midwifery Council, the criteria relied upon by the Healthcare Commission in its ‘Annual Health Check’ of NHS Trusts, and the standards of care that employers are under a legal duty to provide (on pain of criminal liability for failure) in order to ensure workplace safety arising under the Health and Safety at Work Act 1974 which the Health and Safety Executive (HSE) is responsible for enforcing.
Thus, it is important to bear in mind that the law is only one of a broad and varied range of instruments that may be employed for the purpose of encouraging and supporting compliance with regulatory standards. Although acts and omissions may properly be described as ‘unlawful’ if they involve either (or both) a violation of civil or criminal law standards, it is important to distinguish between them. While the civil law is concerned with ‘private’ wrongs, delineating the individual civil obligations we owe to one another (such as the duty to abide by a contract), the criminal law is concerned with ‘public’ wrongs arising from breach of obligations to victims that we also owe to the state (eg, to refrain from murder or theft). Civil liability is therefore primarily concerned to ensure reparation to the injured party arising from the breach of another's civil obligations. In the healthcare context, civil liability takes its most familiar form in the legal duty of care owed by healthcare professionals and workers to patients which may, if breached, give rise to a negligence action entitling the patient to recover financial compensation for his or her loss. While civil liability can help deter behaviour that may pose unjustified risks to others, and in enabling those harmed to recover compensation, its role is limited in several ways. First, it is necessary to establish that actual harm resulted from the violation and that it was caused by the substandard treatment. This may be difficult in healthcare contexts where patients are already suffering from serious medical conditions. Second, injured persons may be unwilling to institute legal proceedings, particularly given the emotional and financial costs associated with the civil litigation process. Third, because civil liability is essentially regarded as a private matter between individuals, there are no ‘public interest’ criteria that apply to any decision whether or not to initiate and maintain formal enforcement action.
The criminal law occupies a different and distinctive role. Unlike civil wrongs, criminal violations are regarded as wrongs done to the victim (if any) and to the public at large. Hence the creation of an unjustified risk of harm might be properly subject to criminal sanction (as with the offence of dangerous driving) even if it does not result in actual harm to any individual (thus obviating the need to prove a causal link between wrongdoing and harm done). Furthermore, criminal proceedings are normally initiated by public enforcement officials (typically, the police and the Crown Prosecution Service, working together) on behalf of the state. Criminal proceedings may, of course, end in a conviction, and result in punishment of the offender above and beyond any compensation awarded. It is the public and punitive character of the criminal law that makes its role unique and in particular need of justification.8–10 Because the punishment of offenders for the commission of a crime may lead to the imposition of some form of hard treatment entailing quite serious deprivations of liberty, as well as considerable public censure, reprobation and stigma, public prosecutors must be guided by the public interest when exercising their discretion to prosecute.11
It is common in regulatory contexts for both the criminal and civil law to operate concurrently, alongside other instruments and standards, all aimed at encouraging desired behaviours and outcomes. Indeed, ideas of ‘responsive regulation’ and ‘smart regulation’ which have received widespread support by regulatory policy-makers rest on a belief that to promote effective compliance, regulators should have at their disposal a wide and varied range of sanctions of increasing severity to which they can have recourse if less draconian attempts to elicit the desired behaviours prove ineffective.12 ,13 Where, as in the healthcare context, multiple regulatory systems are in operation, mechanisms will be needed to deal with overlap. For example, under current GMC Guidelines, a criminal conviction resulting in a custodial sentence does not automatically result in the suspension or termination of a doctor's license to practice. Rather, the matter must be referred to a GMC Fitness to Practice panel to consider whether the matter should be referred to an Interim Orders Panel to determine whether a doctor's registration should be restricted while allegations about that doctor's conduct are resolved.14 By contrast, a claim for damages based on alleged medical negligence may proceed concurrently with an investigation by a public enforcement official arising out of the same conduct in considering criminal prosecution.
The role of the criminal law in healthcare settings
In healthcare settings, the criminal law has two tasks to perform. First, it must establish primary duties to patients consisting of appropriately graded offences targeted at conduct that harms patients or unjustifiably poses risks of harm to patients, whether the fault lies with healthcare management or with frontline workers. Second, it must establish secondary duties to patients, consisting of offences aimed at punishing and deterring instances in which healthcare management and workers undermine the goals of regulation. The proposed offence of wilful neglect or ill-treatment of patients proposed by the Berwick Report and the Francis Report's proposed offence based on a breach of fundamental standards resulting in serious harm or death to a patient are directed towards the first of these tasks. We argue that a new offence based on the provision of manifestly substandard patient care is both necessary and justified, based on recognition that many patients in healthcare settings occupy positions of acute vulnerability akin to that of mentally incapacitated patients who are already entitled to legal protection from the criminal law against wilful neglect or ill-treatment. We also offer suggestions concerning how such an offence may best be defined.
In order to identify whether a new criminal offence is needed, the scope of existing schemes that can ground criminal liability in healthcare contexts must be considered, which we shall discuss first.
The offences that are likely in practice to be the most important ones at the top of the hierarchy of criminal wrongdoing in healthcare contexts are those involving gross negligence manslaughter. In circumstances where gross negligence in the provision of healthcare results in the death of a patient, any individual person may be criminally liable for the common law offence of manslaughter by gross negligence. This offence has been used to prosecute medical staff.15 It is committed where (a) the individual owed a duty of care not to cause the death of the patient, (b) a breach of the duty caused the death of the patient and (c) the breach of duty came about through gross negligence on the individual's part as to whether death might be caused by his or her act or omission. This offence applies mainly to individuals or very small companies, and is likely to be an inappropriate charge against the management body of a hospital, regional authority or Clinical Commissioning Group. In circumstances where senior managers of organisations have contributed to grossly negligent care resulting in the death of a patient, such organisations might then be criminally liable for corporate manslaughter arising under the Corporate Manslaughter and Corporate Homicide Act 2007.
Posing unacceptable risks of harm
The posing of risks of harm through unsafe working practices is governed by the Health and Safety at Work Act 1974. Accordingly, there is no need to create a specific offence of exposing patients to an unacceptable and continuing risk of harm.16 The offences and defences under the 1974 Act should not be modified in an attempt to make them ‘fit’ the healthcare context better as this would set an unwelcome precedent, opening the door to many other organisations asking to be treated in a similar ‘special’ way. The Francis Report's discussion of the role of the HSE in enforcing the 1974 Act demonstrates that problems concerning its application to the healthcare sector do not arise from the scope of the Act's offences. Rather, problems arise from the urgent need to ensure that the HSE is adequately resourced, and for much greater clarity and practical coordination concerning how the overlapping jurisdiction between the HSE and healthcare regulators will be handled.17
Neglect and ill-treatment of patients
The preceding discussion demonstrates that adequate criminal offences already exist that would apply, broadly speaking, (a) to the causing of patient deaths arising from gross negligence on the part of individual healthcare workers or healthcare organisations or (b) from organisational conduct that exposes patients to an unacceptable and continuing risk of harm (whether or not such risks actually materialise). In relation to non-fatal offences against patients, however, there is a significant gap in the law. There is no clear and simple hierarchy of harmful wrongdoing subject to criminal sanctions that are relatively general in scope and applicable to the healthcare sector. For example, any of the following criminal offences might apply to the causing of non-fatal harm in particular healthcare contexts including:
The common law offence of misconduct in a public office. This offence is committed when a public office holder's breach of duty manifests misconduct so bad as to amount to an abuse of the public's trust. It has been applied to prison service nurses (for acting corruptly)
The offence under section 44(2) Mental Capacity Act 2005 of ‘ill treatment or neglect of a person lacking mental capacity’
The offence under section 127 Mental Health Act 1983 for any hospital or independent care home (i) to ill-treat or wilfully to neglect a patient receiving treatment for a mental disorder as an inpatient in that hospital or home, or (ii) to ill-treat or wilfully to neglect, on the premises of which the hospital or home forms part, a patient who is receiving such treatment there as an outpatient
The offence of child cruelty under section 1 Children and Young Persons Act 1933. This offence is concerned with the conduct of a person ‘responsible’ for a child or young person and involves (among other things) wilfully ill-treating or neglecting a child or young person (or causing such a child or young person to be neglected or ill-treated) in a manner likely to cause the child or young person unnecessary suffering or injury to health
Some of the offences created under section 51 of the Private and Voluntary Healthcare (England) Regulations 2001, which set out more detailed requirements for the provision of treatment services to patients, such as regulation 15(b) which states that treatment provided to patients must reflect published research evidence and guidance issued by the appropriate professional and expert bodies as to good practice in treating the patient's condition
A number of offences created by the Heath and Social Care Act 2008 (Regulated Activities) Regulations 2010 for breach of the so-called ‘essential standards’ in healthcare, such as the requirement in regulation 14(a) that service users must be protected from the risks of inadequate nutrition and dehydration, including the provision of a choice of suitable and nutritious food and hydration in sufficient quantities to meet service users’ needs.
There is nothing systematic about the relationship between these offences, which were created at different times for different purposes. Others could be added to the list. It is noteworthy that the Crown Prosecution Service has said, in relation to the neglect of elderly patients, that:
in cases where the victim has not died, and does not have a loss of capacity under the Mental Capacity Act 2005 and is not being treated as a patient for the purposes of the Mental Health Act, prosecutors may find it difficult to identify an appropriate criminal offence.18
The Crown Prosecution Service rightly highlights the absence of any clear, general offence that applies to non-fatal harm caused by uncaring attitudes, ill-treatment, gross negligence or catastrophic management failure. Hence, under existing law, an anomalous situation may arise where two adults are receiving wholly wrong and harmful treatment in the same healthcare facility, but only one lacks capacity for the purposes of the Mental Capacity Act 2005. In such an example, there could be a prosecution for wilful ill-treatment only in relation to the patient lacking mental capacity. Yet many patients in ordinary hospitals, who do not lack capacity under the Mental Health Act 1983 or the Mental Capacity Act 2005, may nevertheless be vulnerable, too trusting to effectively make sound choices about treatment for themselves, and unwilling or unable to alert others when something is going wrong. They should be given a similar level of legal protection under the criminal as well as the civil law.
There are several ways of filling this gap. The Francis Report suggests drawing a line between causing ‘serious’ harm (appropriate for criminalisation), and lesser harms or risks (not to be criminalised).19 But this suggestion presents difficulties because there is no legal definition of ‘serious’ harm so that the issue is currently a matter for the jury and because a minor harm caused to a patient may develop (perhaps, through unforeseen medical complications weeks or months later) into a serious harm, at which point the possibility of criminal liability will open up when it was inapplicable at the earlier time, generating uncertainty. Hence a preferable approach is to focus the offence on the fault element: on the wilful neglect or ill-treatment involved in the conduct in question, leaving the nature and degree of harm caused thereby as a matter for sentence aggravation in appropriate cases. This approach is consistent with the general principle that criminal liability should in general not be used to punish mere carelessness or inadvertence. Hence it would be wrong to criminalise understandable or momentary errors, slips or instances of forgetfulness, even when they may lead to serious consequences. Rather, a serious kind or degree of fault must be shown. Accordingly, we support the introduction of a general offence on the following lines:
wilfully neglecting or ill-treating a patient, or wilfully causing a patient to be neglected or ill-treated.
This should be an offence that can be committed by any healthcare organisation or worker (appropriately defined). Such an offence clearly goes beyond the causing of injury. It may include neglect or ill-treatment stemming from (say) the tolerance of unsanitary conditions, persistent verbal abuse or intimidation, malevolent denial of visiting rights, or discharging sick patients before they are fit for discharge.
Offences committed through ‘wilful’ neglect or ill-treatment require proof of intention or knowledge as to the inadequacy of care or treatment, or a ‘couldn't care less’ attitude towards the inadequacy.20 They would be broadly based on similar existing specialised offences (referred to above), so that the interpretation and application of the offence could draw upon words and concepts already familiar to the courts. The offence could be committed by a health service organisation and/or an individual healthcare worker. The offence is more likely to be committed through knowledge or a ‘couldn't care less’ attitude, rather than intentionally. In the case of a health service organisation this might occur when, for example, reports of ill-treatment are ignored or suppressed, or where members of staff are discouraged from reporting such incidents. It should be triable in either the Magistrates’ or the Crown Court. For Crown Court trials, in our view a maximum sentence of 2 years’ imprisonment (an unlimited fine, in the case or organisations) is probably about right, although the Berwick Report rightly observed that the modern Parliamentary preference is for a 5-year maximum: in line with the maximum sentence available for wilful neglect of someone receiving treatment for mental disorder, under section 127(1) of the Mental Health Act 1983, and for wilful neglect of someone lacking (or reasonably believed to be lacking) capacity, under section 44 of the Mental Capacity Act 2005. A 5-year maximum may nonetheless seem excessive to many (including the authors). However, maximum sentences are almost never imposed in practice, and it is worth noting that 5 years’ imprisonment is also the maximum sentence available for the more general offence of assault occasioning actual bodily harm contrary to section 47 of the Offences Against the Person Act 1861.
How would it work in practice?
Our support for the introduction of a proposed new offence should not be interpreted as supporting a predominantly punitive approach to the promotion of quality in the provision of healthcare. Rather, we fully endorse the Berwick Report's emphasis on the need to cultivate a system of continual learning and improvement of patient care and explicitly eschew a fear-driven approach that is ‘toxic to both safety and improvement’.21 This is because the existence and operation of criminal liability within a regulatory regime need not be conducive to an environment in which those subject to the regime operate within a culture of fear and suspicion. The overwhelming evidence demonstrates that, in regulatory contexts, the criminal law is very rarely resorted to, used only when attempts to negotiate future compliance have failed or the suspected violation is of a very serious and highly blameworthy nature, thereby necessitating formal criminal prosecution in order to demonstrate publicly the wrongfulness of the conduct in question.22–25 Criminal liability for the wilful neglect or ill-treatment of patients lacking mental capacity or receiving treatment for a mental disorder in an independent hospital or care home has existed for some years. Yet we are not aware of any claims that this has generated a culture of fear in those contexts, or has led to the overzealous use of the criminal law or inhibited candour and cooperation between healthcare workers.
In other words, the criminal law's role in this context is not to play a frontline part in deterring and coercing people into complying with proper standards of behaviour. Rather, its central function applies only to the worst kinds of unacceptable ill-treatment. When it is used against such serious wrongdoers, the criminal law carries a uniquely symbolic and expressive significance that is lacking when less draconian regulatory instruments, or civil liability, are used. A criminal conviction amounts to a public proclamation that the conduct in question is seriously wrongful and worthy of condemnation and punishment, whether or not it leads directly to a substantial improvement in healthcare quality. In light of the appalling failures of care evidenced by the Francis Report, there is no doubt that the criminal law could properly have been invoked, not primarily because it will deter such failures of care in the future, but because it is the most powerful and important social institution through which we hold to account, and express public censure of, those who have mistreated others in a wholly unacceptable and highly culpable way.26 ,27
We are grateful to John Coggon and Roger Brownsword and the editors for comments on earlier drafts.
Files in this Data Supplement:
Collaborators Jeremy Horder.
Competing interests The authors received a fee for research expenses associated with the provision of independent advice to the Berwick review group on the safety of patients in England.
Provenance and peer review Not commissioned; externally peer reviewed.