Medical Law Review

Future challenges for UK regulation of brain organoid research
Jackson E
One of this century's most dramatic scientific developments is the reprogramming of stem cells in order to create organoids, that is, self-organizing 3D models that mimic the structure and function of human organs. This article considers whether brain organoids in particular might raise any new questions for law, now or in the near future. If complex human brain organoids were to become capable of consciousness or sentience, the current regulation of human tissue research, which protects the interests of tissue donors, might need to be supplemented in order to protect the interests of the tissue itself. Human brain organoids can also be implanted into animal hosts, and if this were to result in animals with significantly enhanced cognitive abilities, additional protective measures might become necessary.
Unlocking the promise of UK health data: considering the case for a charitable GP data trust
Redhead CAB, Bowden C, Ainsworth J, Burns N, Cunningham J, Holm S and Devaney S
The UK National Health Service general practice (GP) patient data constitute a rich research resource, but collecting, managing, and sharing patient data present challenges. In May 2021, to address these challenges, substantial changes to the system for processing pseudonymized GP patient data in England were announced. As part of an opt-out process, patient consent to sharing GP data was deemed to have been given. However, when over a million people quickly acted to opt out of the new system, the process was paused, and an engagement exercise commenced, whose aim was to inform a re-designed programme addressing patient concerns. In this article, we present and discuss the findings of the General Practice Data Trust pilot study, which has investigated people's reasons for opting out of sharing their data, and, looking for practical solutions to their concerns, has discussed with participants the concept of a 'data trust' to manage the sharing of patient data. Making a conceptual argument for the use of the (relatively new) charitable incorporated organization as a governance model for a GP data trust, we demonstrate how this could address patients' concerns and represent a more attractive means of stewarding GP data for research and service planning purposes.
G v Human Fertilisation and Embryology Authority [2024] EWHC 2453 (FAM): two distinct routes to posthumous fertility treatment
Cherkassky L and Ottley E
Regulating algorithmic care in the European Union: evolving doctor-patient models through the Artificial Intelligence Act (AI-Act) and the liability directives
Solaiman B and Malik A
This article argues that the integration of artificial intelligence (AI) into healthcare, particularly under the European Union's Artificial Intelligence Act (AI-Act), poses significant implications for the doctor-patient relationship. While historically paternalistic, Western medicine now emphasises patient autonomy within a consumeristic paradigm, aided by technological advancements. However, hospitals worldwide are adopting AI more rapidly than before, potentially reshaping patient care dynamics. Three potential pathways emerge: enhanced patient autonomy, increased doctor control via AI, or disempowerment of both parties as decision-making shifts to private entities. This article contends that without addressing flaws in the AI-Act's risk-based approach, private entities could be empowered at the expense of patient autonomy. While proposed directives like the AI Liability Directive (AILD) and the revised Directive on Liability for Defective Products (revised PLD) aim to mitigate risks, they may not address the limitations of the AI-Act. Caution must be exercised in the future interpretation of the emerging regulatory architecture to protect patient autonomy and to preserve the central role of healthcare professionals in the care of their patients.
A reparatory account of health inequities
Thomson M
Colonialism has left biological and social legacies that damage health. The resulting racialized health inequities re-enact past harms and are a profound social injustice. In response, this article brings together reparatory justice and health equity. Understandings of reparatory justice have evolved from a focus on compensation for past wrongs to the need for a more sustained and expansive politics of repair. This seeks to recognize the history and legacies of harm while diminishing the likelihood that such harms are repeated. Addressing racialized health inequities in the UK, and working with this articulation of reparatory justice, this article argues for the repair of bodies that continue to be damaged by historically rooted harms. Social determinants of health research has long linked socio-economic inequalities to poor health outcomes, and promoting health equity by addressing these inequalities can be an important element of the work to repair the past. This response acknowledges the moral case for both reparatory justice and health equity, while potentially addressing problems faced by traditionally articulated reparatory claims. Finally, exploring law's role in addressing racialized health inequities can help us better understand how law is a determinant of health and its role in advancing health equity.
Harnessing deliberative regulation to address inequities in accessing healthcare services in England
Germain S and Veronesi G
System-level decisions around the commissioning and provision of healthcare services in England have contributed to barriers in accessing the National Health Service. In this article, we ask how to better regulate resource allocation to ensure greater equity in access to healthcare services. First, we focus on the Health and Care Act 2022, which, drawing on principles of deliberative regulation to address health inequalities, initiates a shift away from previous regulatory approaches towards a collaborative decision-making model. We then shed light on the systemic factors creating and maintaining access barriers by considering shortcomings in previous regulatory approaches. With these in mind, we consider whether deliberative regulation-providing communities with resources to create normative solutions to intrinsic issues-could help address these systemic challenges. To assess the potential of laws or policies to achieve greater equity in healthcare, we also introduce an evaluative framework based on deliberative principles. We apply this framework to a case study of an Integrated Care System to gauge the extent to which the Health and Care Act 2022 has indeed been effectively adopting a deliberative approach by intentionally engaging marginalized communities in decision-making and devising accountability mechanisms for the allocation of healthcare resources.
The two lives of the Mental Capacity Act: rethinking East-west binaries in comparative analysis
Chua H, Kong C and Dunn M
The Mental Capacity Act 2005 in England and Wales and Singapore's Mental Capacity Act 2008 (which substantially transplants provisions from the former statute) might appear to be twins on paper, but they have gone on to lead very different lives. In this article, we examine how two broadly identical laws have taken on divergent identities within their respective jurisdictions when implemented and interpreted in the courtroom. We reveal and analyse differences in parliamentary intent concerning at what stage a person's decision-making agency is putatively empowered; judicial development of central concepts; underlying socio-cultural commitments; and outline opportunities for bi-directional learning in mental capacity law across both jurisdictions.
Mental health and capacity laws in Northern Ireland: examining the position of children and young people
Farrell AM, Agnew E and Hann P
Mental health and capacity laws applicable to children and young people in Northern Ireland (NI) lack clarity and coherence, with significant gaps in service provision and safeguarding. Drawing on an examination of such laws, we argue that law reform is needed. In the short term, we suggest there is merit in publishing statutory guidance, such as a Code of Practice, to address both the issue of evolving capacity in children and to facilitate best practice in policy and practice. This modest reform in the short term should be accompanied by a firm political commitment to ensuring that NI's innovative fusion mental capacity legislation is fully brought into force in the medium term. Meanwhile, law reform should form part of a holistic approach on the part of NI's policy-makers towards improving mental healthcare provision for children and young people in line with a human rights-based approach. This would include the following: increased allocation of funding and resources to facilitate more timely access to suitable treatment and related services; enhancing participation in policy, judicial, and clinical decision-making that impacts their lives; and employing a range of executive accountability mechanisms to drive improvements in such provision over time.
Towards a rights-based approach for disabled women's access to abortion
Furgalska M and de Londras F
This article adds to the still limited scholarship on the impact of abortion laws and policies on people with disabilities and those with diminished capacity who seek abortion. We argue that neither the legal nor policy framework currently operating in England and Wales adequately incorporates and protects the rights of people with disabilities or those experiencing mental ill-health. Rather, the law and policy framework jeopardizes their reproductive agency. We argue that greater attention to and incorporation of standards contained within the UN Convention on the Rights of Persons with Disabilities (including the sources produced by its Committee) and implementation of guidelines produced by the World Health Organization would result in a rights-affirming framework that supports disabled women's reproductive agency, enhances their effective enjoyment of human rights, and supports them in accessing quality abortion care.
Addressing the consequences of the corporatization of reproductive medicine
Attinger SA, Jackson E, Karpin I, Kerridge I, Newson AJ, Stewart C, van de Wiel L and Lipworth W
In Australia and the UK, commercialization and corporatization of assisted reproductive technologies have created a marketplace of clinics, products, and services. While this has arguably increased choice for patients, 'choice', shaped by commercial imperatives may not mean better-quality care. At present, regulation of clinics (including clinic-corporations) and clinicians focuses on the doctor-patient dyad and the clinic-consumer dyad. Scant attention has been paid to the conflicts between the clinic-corporation's duty to its shareholders and investors, the medical profession's duty to the corporations within which they practice, and the obligations of both clinicians and corporations to patients and to health systems. Frameworks of regulation based in corporate governance and business ethics, such as stakeholder models and 'corporate social responsibility', have well-recognized limits and may not translate well into healthcare settings. This means that existing governance frameworks may not meet the needs of patients or health systems. We argue for the development of novel regulatory approaches that more explicitly characterize the obligations that both corporations and clinicians in corporate environments have to patients and to society, and that promote fulfilment of these obligations. We consider mechanisms for application in the multi-jurisdictional setting of Australia, and the single jurisdictional settings of the UK.
Guy's and St Thomas'-v-Knight [2021] EWHC 25: Dignity in English law
Weismann MJ
Donor conception, direct-to-consumer genetic testing, choices, and procedural justice: an argument for reform of the Human Fertilisation and Embryology Act 1990
Redhead CAB and Frith L
In this article, using theories of procedural justice and 'slow violence', we consider potential reform of the Human Fertilisation and Embryology Act 1990. Our theoretical discussion is underpinned by findings from the ConnecteDNA project, exploring how people affected by donor conception experience direct-to-consumer genetic testing (DTCGT). The negative impacts of DTCGT, especially shock discoveries about the circumstances of someone's conception in adulthood, are linked to donor anonymity, and how its continued protection is experienced as a barrier to the rights and agency of donor-conceived people. We focus on two key issues relating to the donor information access process set out in section 31ZA of the 1990 Act. The first is that it excludes certain cohorts of donor-conceived people, creating inequalities of access to donor information. The second is the impact of the use of DTCGT to search for that information. We discuss what a procedurally just process of law reform would look like, concluding that, whatever (prospective) approach to donor anonymity is taken, the donor information access process should be the same for all donor-conceived people. We thus argue that, even were the status quo to be maintained, reform of the donor information access process with retrospective effect would be required.
Anticipatory declarations in obstetric care: a relational and spatial examination of patient empowerment, institutional impacts and temporal challenges
Hulme AV
Seeking an anticipatory declaration from the Court of Protection (CoP) to manage a risk of future loss of capacity in pregnant people during labour and delivery appears to be occurring more frequently. This article examines a growing case sample of recent CoP judgments in which anticipatory declarations have been sought and adopts a combined relational and spatial approach to question whether these types of anticipatory declarations empower patient autonomous choice, and to illuminate the complex web of relational, spatial, and temporal factors that hold influence over the way in which mental capacity law operates. Viewing such processes from both a patient and institutional perspective offers useful insights into the law's normative workings, boundaries, and constraints, and ultimately points to conclusions on the (in)effectiveness of anticipatory declarations as a legal mechanism for dealing with the risk of a patient losing capacity in the future. Moreover, however, taking a broader, spatial view signals the challenges posed by these cases to mental capacity legislation itself. The justifiability of the binary construct of capacity/incapacity has been challenged by some writers in this field, and this article offers further reflection on the integrity of this binary through its discussion of anticipatory orders for pregnant people.
FemTech: empowering reproductive rights or FEM-TRAP for surveillance?
Hofmann D
The emergence of FemTech technologies promises to revolutionize women's health and reproductive rights but conceals an insidious trap of surveillance and control in the hands of private and state actors. This article examines the extent to which FemTech technologies, under the guise of empowerment, enable private actors to play a leading role in managing reproductive rights, replacing largely inactive States in this crucial function. The analysis shows how private FemTech companies are becoming critical players in implementing and defending these rights, often in response to the inaction or inadequacies of States. The article approaches the FemTech phenomenon from several angles, including the promises of empowerment, concerns about surveillance and control, and the ambivalent roles of private actors as implementers and defenders of reproductive rights. This structure makes it possible to offer a critical analysis of the legal, societal, and ethical implications of FemTech, highlighting the tensions between the promises of empowerment and the risks of surveillance and control.
The Delicate Balance Struck by the Abortion Services (Safe Access Zones) (Scotland) Act 2024
Ottley E
Editorial: Reproductive health, choice, and justice
Clough B, Fovargue S, Heywood R and Miola J
France's constitutional right to abortion: symbolism over substance
Tongue ZL
The short-lived verdict in Le Page v Center for Reproductive Medicine: why 'personhood' matters in the regulation of assisted reproductive technologies
Grant ER
Mediating disputes under the Mental Capacity Act 2005: relationships, participation, and best interests
Lindsey J and Danbury C
This article analyses the use of mediation to resolve mental capacity law disputes, including those that arise in the healthcare context. It draws on original empirical data, including interviews with lawyers and mediators, and analysis of a mediation scheme, to argue that mediation has the potential to be an effective method of resolution in mental capacity law. It highlights the relationship benefits of mediation while acknowledging the challenges of securing P's participation and best interests. The final section of the article considers how mediation can operate in one of the most challenging healthcare environments, the Intensive Care Unit. The article emphasizes that the challenges we see in mediation are not unique and exist across the spectrum of Court of Protection practice. Therefore, the article concludes that mediation may be used effectively but the jurisdiction would also benefit from a clearer regulatory framework in which it can operate.
Michael Holmes v Poeton Holdings Ltd [2023] EWCA Civ 1377: a necessary clarification for a non 'de minimis' discussion in causation
de Moraes Paisani Matthey Claudet P
A health-conformant reading of the GDPR's right not to be subject to automated decision-making
van Kolfschooten HB
As the use of Artificial Intelligence (AI) technologies in healthcare is expanding, patients in the European Union (EU) are increasingly subjected to automated medical decision-making. This development poses challenges to the protection of patients' rights. A specific patients' right not to be subject to automated medical decision-making is not considered part of the traditional portfolio of patients' rights. The EU AI Act also does not contain such a right. The General Data Protection Regulation (GDPR) does, however, provide for the right 'not to be subject to a decision based solely on automated processing' in Article 22. At the same time, this provision has been severely critiqued in legal scholarship because of its lack of practical effectiveness. However, in December 2023, the Court of Justice of the EU first provided an interpretation of this right in C-634/21 (SCHUFA)-although in the context of credit scoring. Against this background, this article provides a critical analysis of the application of Article 22 GDPR to the medical context. The objective is to evaluate whether Article 22 GDPR may provide patients with the right to refuse automated medical decision-making. It proposes a health-conformant reading to strengthen patients' rights in the EU.