{"title":"Regulating patient safety during hospital discharges: Casting the Patient Safety Commissioner as the Representative of Order","authors":"V. L. Moore","doi":"10.1177/09685332211023531","DOIUrl":"https://doi.org/10.1177/09685332211023531","url":null,"abstract":"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.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"195 - 219"},"PeriodicalIF":0.0,"publicationDate":"2021-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/09685332211023531","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43149140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Over-the-counter sales of antibiotics for human use in India: The challenges and opportunities for regulation","authors":"G. Porter, A. Kotwani, L. Bhullar, Jyoti Joshi","doi":"10.1177/09685332211020786","DOIUrl":"https://doi.org/10.1177/09685332211020786","url":null,"abstract":"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.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"147 - 173"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/09685332211020786","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45375498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fae Garland, Michael Thomson, Mitchell Travis, Joshua Warburton
{"title":"Management of ‘disorders of sex development’/intersex variations in children: Results from a freedom of information exercise","authors":"Fae Garland, Michael Thomson, Mitchell Travis, Joshua Warburton","doi":"10.1177/09685332211003636","DOIUrl":"https://doi.org/10.1177/09685332211003636","url":null,"abstract":"Non-therapeutic medical interventions on the bodies of children born with disorders of sex development (DSD)/intersex variations have been subject to increasing critical scrutiny. In response to recent criticism directed at the United Kingdom, and early moves to consider reform, we report on a freedom of information exercise that sought to evaluate whether National Health Service England is meeting international standards on optimal clinical management of DSD/intersex variations. The study explored what medical protocols are being followed to help inform potential reform, particularly with regard to non-therapeutic surgery. While the exercise revealed limited examples of promising practice, current protocols in the majority of Trusts appear unlikely to meet the complex needs of these children. We identify areas where significant improvement is needed, including data management, consistency in guideline use, composition of multidisciplinary teams and addressing disciplinary hierarchies within teams. These concerns sharpen criticisms of the lack of recognition of children’s rights in this context.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"116 - 146"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/09685332211003636","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42182932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pathogenic viruses as a global commons: The shared responsibility of pandemics","authors":"Tessa Sze-Myn Teo","doi":"10.1177/09685332211013392","DOIUrl":"https://doi.org/10.1177/09685332211013392","url":null,"abstract":"In light of the Covid-19 pandemic, the international community’s approach towards pathogenic viruses needs to be re-evaluated. This commentary notes that attempts to justify viral sovereignty, either under treaties or general principles of sovereignty, are flawed. Instead, viruses share more similarities with global commons and should be treated as such. More specifically, viruses should be regarded as the shared responsibility of international society, given that all countries are responsible for the continued spread of their diseases and all stand to benefit from their eradication.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"101 - 115"},"PeriodicalIF":0.0,"publicationDate":"2021-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/09685332211013392","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45828655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Legal Forms of Application of Artificial Intelligence in Medicine","authors":"V. Laptev","doi":"10.18572/1813-1239-2021-2-8-13","DOIUrl":"https://doi.org/10.18572/1813-1239-2021-2-8-13","url":null,"abstract":"Empirical researches of use of artificial intelligence on diagnostics, forecasting and operational assistance in medical activity demonstrates its high efficiency. The advantages of artificial intelligence in decision-making speed and learning ability have prompted mankind to develop these technologies and introduce them into everyday life. This article defines the legal forms of artificial intelligence. Issues of legal personality of participants in medical relations are studied. Possible approaches to the legal regulation of artificial intelligence activities are proposed, as well as on the application of legal liability to the liable person.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79134722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The ECtHR’s first advisory opinion: Implications for cross-border surrogacy involving male intended parents","authors":"L. Bracken","doi":"10.1177/09685332211002592","DOIUrl":"https://doi.org/10.1177/09685332211002592","url":null,"abstract":"This article examines the content and scope of the European Court of Human Rights’s first advisory opinion as regards the practice of cross-border surrogacy in Europe. While the advisory opinion concerns the recognition of the legal parentage of an intended mother, this article considers whether the reasoning could be applied to male couples who avail of surrogacy. It is argued that the non-genetically related intended father in the male couple is in a directly comparable position to the non-genetically related intended mother in the opposite-sex couple for the purpose of legal parentage following surrogacy.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"3 - 18"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/09685332211002592","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43230518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"National Immunization Technical Advisory Groups (NITAGs): A schema for evaluating and comparing foundation instruments and NITAG operations","authors":"S. Harmon, D. Faour, N. MacDonald","doi":"10.1177/09685332211002594","DOIUrl":"https://doi.org/10.1177/09685332211002594","url":null,"abstract":"The individual and community health benefits of vaccination have received significant attention and are now well understood. However, much less is known about immunization as a regulated space, its principles and standards and its institutions and instruments. In 2011, the World Health Organization (WHO) recommended that National Immunization Technical Advisory Groups (NITAGs) be established in each member country. NITAGSs are envisioned as independent, multidisciplinary expert groups within the national immunization framework, tasked with providing evidence-based evaluations and recommendations to governmental decision-makers about specific vaccines, vaccine-dosing, vaccine program development and immunization policy and practice more generally. As of 2020, 171 WHO countries have formed NITAGs. The widespread formation of NITAGs has highlighted an absence of sustained scholarship around immunization as a policy area subject to law, and it has given rise to many governance and operational questions. In 2017, for example, representatives of the Global NITAG Network (GNN) agreed that there is insufficient understanding of the impact of law on the functioning of NITAGs. Similarly, the Strategic Advisory Group of Experts on Immunization called for research into the variety of ways in which legislation and regulation have been used to promote immunization at a national level and to achieve different ends in relation to immunization and NITAG functioning. In answer to this call, the NITAG Environmental Scan (Project) was initiated. Drawing on scholarship around good governance, this article offers a comprehensive common assessment schema for critically and systematically approaching questions about NITAG governance and operation, applying that schema to the foundation instrument of the Côte d’Ivoire’s NITAG. It also reports on how well the schema is engaged by the NITAG foundation instruments in other GNN countries.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"69 - 98"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/09685332211002594","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41471177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joseph T F Roberts, Victoria Moore, Muireann Quigley
{"title":"Prescribing unapproved medical devices? The case of DIY artificial pancreas systems.","authors":"Joseph T F Roberts, Victoria Moore, Muireann Quigley","doi":"10.1177/0968533221997510","DOIUrl":"https://doi.org/10.1177/0968533221997510","url":null,"abstract":"<p><p>In response to slow progress regarding technological innovations to manage type 1 diabetes, some patients have created unregulated do-it-yourself artificial pancreas systems (DIY APS). Yet both in the United Kingdom (UK) and internationally, there is an almost complete lack of specific guidance - legal, regulatory, or ethical - for clinicians caring for DIY APS users. Uncertainty regarding their professional obligations has led to them being cautious about discussing DIY APS with patients, let alone recommending or prescribing them. In this article, we argue that this approach threatens to undermine trust and transparency. Analysing the professional guidance from the UK regulator - the General Medical Council - we demonstrate that nothing within it ought to be interpreted as precluding clinicians from initiating discussions about DIY APS. Moreover, in some circumstances, it may require that clinicians do so. We also argue that the guidance does not preclude clinicians from prescribing such unapproved medical devices.</p>","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"42-68"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/0968533221997510","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38958044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"‘Our legal responsibility…to intervene on behalf of the child’: Recognising public responsibilities for the medical treatment of children","authors":"J. Bridgeman","doi":"10.1177/0968533221993507","DOIUrl":"https://doi.org/10.1177/0968533221993507","url":null,"abstract":"This article argues for recognition of public responsibilities to protect the welfare of children with respect to decisions affecting their health and medical treatment. As the quote in the title of this article, from David Plank, the Director of Social Services responsible for bringing the case of Baby Alexandra before the courts, identifies, early cases concerning children’s medical treatment were brought by local authorities to determine responsibilities to protect the welfare of children. In cases such as Re B (1981), Re J (1990) and Re W (1992), the court was asked not only to determine the child’s best interests but also to clarify the duties of the local authority, Trust, court and child’s parents to the child. The respective duties established apply to all involved in cases brought before the courts on the question of a child’s future medical treatment, whether or not the child is in the care of the state. Recent cases concerning the medical treatment of seriously ill children have involved claims of parental authority to determine the care of their child. To the contrary, this article argues that court involvement is required when parents are disagreed with the child’s treating doctors over the child’s medical treatment because of public as well as parental and professional responsibilities for the welfare of all children.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"19 - 41"},"PeriodicalIF":0.0,"publicationDate":"2021-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/0968533221993507","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44760964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Death caused by negligent medical care: Reconsidering the role of gross negligence manslaughter in the aftermath of Bawa-Garba","authors":"A. Samanta, J. Samanta","doi":"10.1177/0968533221992838","DOIUrl":"https://doi.org/10.1177/0968533221992838","url":null,"abstract":"Gross negligence manslaughter is a well-established common law offence in English jurisdiction. Nevertheless, it remains a troubled area of law. Academic commentators, as well as the Law Commission, have frequently called for reform. We explore this offence through the prism of medical manslaughter and argue that the offence is insufficiently nuanced in certain situations of death caused by gross negligence. This applies particularly to complex professional circumstances where a coalescence of inter-linking factors may converge with disastrous results for the parties concerned. Using the clinical care model as an exemplar, we argue that relentless focus on the offender can result in a disproportionately high level of blame being foisted on an individual. On the basis of decision theory, we suggest that insufficient regard may be given to confounding contextual matters. Failure to address underlying systemic factors may impede wider patient safety initiatives such as professional medical candour and strategies designed for institutional improvements directed at broader societal benefit. We offer an alternative approach based upon principles of fair attribution of blame and transparency. A new statutory offence is suggested for a fault-based standard that is set by law that gives greater prominence to contextual matters. We argue for wider disposal options that include ancillary court orders for rectification of systems failures and more proactive engagement of the coronial process.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"293 - 320"},"PeriodicalIF":0.0,"publicationDate":"2021-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/0968533221992838","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42508150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}