Surgical harm, consent, and English criminal law: When should ‘bad-apple’ surgeons be prosecuted?

This article examines the legal principles determining when surgical harm becomes a criminal matter. In England and Wales, and other common law jurisdictions, the criminal law has predominantly concerned itself with fatal medical misconduct via the offence of gross negligence manslaughter. The convictions of two surgeons in 2017 (Ian Paterson and Simon Bramhall), for offences against the person, suggests that police and prosecutors have, for the first time, become willing to prosecute surgeons for non-fatal surgical harm. Understanding when non-fatal surgical harm should be treated as a criminal matter is, however, a complex issue. The medical exception to the criminal law legitimizes consensual and reasonable surgical harm. Thus, the question of what is reasonable and what constitutes valid consent is key to determining the parameters of lawful surgery; however, the principles are perplexing and insofar as they may be agreed and understood, they are arguably unsatisfactory. After examining the cases involving serious surgical harm and analysing the doctrines applied, this article argues for a more patient-centred approach. The focus should be on the nature of the harm to the victim, the behaviour of the dangerous surgeon and whether a violation has occurred, rather than on traditional professional assessments, which are unduly deferential to the medical profession.

Gross negligence ‘medical’ manslaughter in Ireland: Legal context and clinician concerns

In recent years, the prospect of the criminal prosecution of medical practitioners for patient safety incidents resulting in fatality which occur in the course of clinical practice has caused heightened anxiety among medical practitioners, particularly in England and Wales, where a number of high-profile cases have raised public consciousness of this issue. The full impact of this landscape on individual practitioners and the delivery of healthcare has yet to be ascertained, although research suggests that medical practice has been impacted. Of particular interest is the phenomenon of defensive medicine which occurs where physicians adopt assurance and/or avoidance behaviours in an attempt to minimise the risk of medical negligence litigation and/or to avoid complaints to regulatory bodies. While defensive medicine is traditionally conceived of in a civil context, the possibility of criminal prosecution for patient safety incidents resulting in fatality may also result in alterations to medical practice. Drawing on the findings of an empirical study (a survey), this research sought to explore the impact, if any, of the threat of criminal prosecution on surgical practice in the Republic of Ireland, including a potential rise in defensive practice.

Should we criminalize a deliberate failure to obtain properly informed consent?

This paper takes the form of a polemic and thought experiment. The starting point is that, if medical law’s claims to place autonomy at the heart of the enterprise are to be taken seriously, then autonomy either needs to be considered a recoverable harm, or the most egregious infringements should be subject to the criminal law. This might particularly be the case where a doctor deliberately attempts to modify the patient’s decision by failing to disclose information that they know that the patient would find significant. The article considers medical law’s relationship with autonomy, before applying the criminal law – in the form of the analogous situation of defendants who deliberately fail to disclose HIV+ status to their sexual partners. What we find is a distinct difference in the way that autonomy is seen by medical and criminal law, although both are equally unsatisfactory.

The journey of research data: Accessing nordic health data for the purposes of developing an algorithm

This article traces the journey of Nordic health data requested for developing a healthcare algorithm. We focus on the legal requirements and highlight that differences in the legislation of Denmark, Norway and Iceland, and the interpretation thereof by responsible bodies, can pose a barrier for scientific researchers. In addition, non-legal institutional requirements or practices may hamper data access. First, despite some European harmonization, the mandate of research ethics committees and the data protection authorities vary in the three countries. Second, domestic institutions impose tailored requirements, sometimes only allowing domestic or affiliated researchers to access data sets. Third, the manner in which a dataset is collected, catalogued and stored has implications for data access. We make several recommendations for increasing transparency in Nordic data access, such as, increasing knowledge sharing regarding interpretation of General Data Protection Regulation (GDPR) criteria, adopting clearer regulations and pursuing greater citizen engagement in secondary use of health data.

‘Turning up the volume’: Increasing respect for the wishes and feelings of women with intellectual impairment in decisions about their reproductive rights in England and New Zealand

In 2004 a New Zealand Family Court Judge ordered that two extremely serious and irreversible interventions (termination of pregnancy and sterilization) be carried out on a 29-year-old woman, with mild to moderate intellectual disability, over her strenuous objection. Though her appeal was partially successful, an option which both respected her wishes and feelings and in all likelihood better promoted her best interests was not explored. A decade later, another Family Court judge held that it was in the best interests of a young woman with Down syndrome to be sterilized for contraceptive purposes, in spite of her indication that she might wish to have babies one day. The decisions were made under NZ’s adult guardianship legislation, into which courts have incorporated a best interests principle, which they have interpreted broadly. But, in contrast to the Mental Capacity Act 2005 (MCA), NZ’s statute lacks any requirement for decision-makers to take into account the wishes and feelings of the person with mental impairment. That requirement has been the catalyst for a more-empathetic, person-centric interpretation in English case law. Further reform to the MCA is advocated for, which would give formal primacy to P’s wishes and feelings through presumptions or special phrases, as well as requiring a reasoned justification for departing from them. The Convention on the Rights of Persons with Disabilities goes even further: the article 12 right to legal capacity requires respect for the ‘will and preferences’ of people with mental impairments and controversially, according to the UN Committee’s interpretation, requires the replacement of substitute decision-making regimes based on best interests with supported decision-making frameworks based on a person’s will and preferences.

Wrongful disturbance of reproductive planning: Is there a case for liability?

This article analyses claims involving parental allegations pertaining to the features their children were born with in violation of the express requests they made when they used reproductive procedures. This kind of claim, encouraged by the development of reproductive techniques and their associated procedures, has until now found little support in the courts. However, the increased level of precision of the scientific procedures used in reproduction, the amplified range of services provided by reproductive clinics, and the level of success they guarantee to service recipients might lead to a different judicial outcome. The author examines several court cases that involve incidents of this nature and suggests the conceptualization of a differentiated claim titled ‘wrongful disturbance of reproductive planning’.

What makes a parent in surrogacy cases? Reflections on the Fjölnisdóttir et al. v. Iceland decision of the European Court of Human Rights

The present commentary analyses and discusses the Fjölnisdóttir et al. v. Iceland decision of the European Court of Human Rights (ECtHR) of 18 May 2021. The case concerned an Icelandic couple who had been recognised as the legal parents of a child born by a surrogate mother in California. In contrast to most other surrogacy cases decided by the ECtHR, however, the child had no biological link to either of the intended parents. The ECtHR thus found that a ruling of the Supreme Court of Iceland which had rejected the recognition of the legal parenthood of the intended parents under Icelandic law had not violated Art. 8 of the European Convention on Human Rights, despite the fact that joint adoption by the intended parents was not possible in this case. The present commentary argues that this decision overexaggerates the importance of the biological link, creating injustices at the expense of the child concerned. In conclusion, the commentary calls for a more consistent and holistic framework to protect the best interests of the child and to prevent abuses of transnational commercial surrogacy.

Regulating patient safety during hospital discharges: Casting the Patient Safety Commissioner as the Representative of Order

This article examines the challenges in regulating patient safety during hospital discharges in England through the lens of liminality. Hospital discharges are internationally recognised as being a dangerous time for patients, and yet the role that regulators should play in addressing this has received little attention in any jurisdiction. Liminality’s spotlight on the in-between highlights how the discharge process can give rise to patient safety incidents that fall between regulator’s boundaries. Falling between boundaries results in a dearth of effective regulatory responses to address these incidents. By positioning the new role of Patient Safety Commissioner (PSC) as that of a ‘Representative of Order’, this article proposes a means by which this poorly regulated space could be navigated more successfully. This analysis suggests that the remit of the PSC role be expanded to include improving patient safety with regard to processes – not just medicines and medical devices. The full implications of this are also addressed.

Over-the-counter sales of antibiotics for human use in India: The challenges and opportunities for regulation

This article assesses the regulatory framework relating to over-the-counter (OTC) sales of antibiotics for human use in India. The OTC sale of antibiotics is recognised as a pathway for the emergence of antimicrobial resistance (AMR); a serious public health challenge in need of urgent regulatory responses. Analytically, this article identifies opportunities within existing laws in India and highlights gaps that need to be filled by modifying existing laws or developing new ones. Conceptually, it suggests a need to reflect on the limits of traditional, top-down, ‘command-and control’ regulation and to think about alternative approaches. The article therefore advocates for an approach to regulation that incorporates two elements. First, it argues for a broader concept of regulation that encompasses binding as well as non-binding regulatory instruments and initiatives aimed at influencing stakeholder behaviour (including soft regulation, economic incentives, information campaigns and uses of technology). Second, it makes the case for enhanced stakeholder participation in regulatory design. The article will be relevant for health policy and drug regulators in India and other low- and middle-income countries, as well as legal scholars, social scientists and others interested in the regulation of OTC sales of antibiotics for AMR containment.