{"title":"Implications for COVID-19 vaccination following the European Court of Human Right’s decision in Vavřička and oths v Czech","authors":"A. Alekseenko","doi":"10.1177/09685332221078417","DOIUrl":"https://doi.org/10.1177/09685332221078417","url":null,"abstract":"Mass vaccination in the fight against the global pandemic of COVID-19 brings new questions to the ‘old’ issue of mandatory vaccination. The intention to restrict access to some spheres of life on the basis of an individual’s vaccination status provides fertile soil for potential violations of fundamental subjective rights, such as the right to bodily integrity and the interest not to be subject to medical intervention without consent, the right to a private life, and the right to engage fully within society without unjust discrimination. The potential implications of mandated or necessary vaccination for individual rights have not been fully explored, but the recent decision from the European Court of Human Rights in the case of Vavřička and others v. The Czech Republic (2021) gives us a sense of the Court’s approach to the question, given that the hearing (and subsequent decision) took place at the height of the pandemic. In this commentary, the judgement and the dissenting opinion will be analysed and compared from the perspective of the different understanding of the doctrine of proportionality. It will be argued that the approach, wherein the nature of the considered right is becoming the central question, corresponds more adequately with the aims of the Convention. Consequently, it can be suggested that in considering how to regulate vaccination against coronavirus, it is necessary to reframe the analysis in order to ensure that States remain true to the underlying ethos of the Convention to protect individual rights against State interference.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"22 1","pages":"75 - 89"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41486259","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":"Exploring remedies for defective artificial intelligence aids in clinical decision-making in post-Brexit England and Wales","authors":"Helen Smith, K. Fotheringham","doi":"10.1177/09685332221076124","DOIUrl":"https://doi.org/10.1177/09685332221076124","url":null,"abstract":"Artificially intelligent systems (AISs) are in development to aid the clinicians and patients of the United Kingdom’s National Health Service. We assess the statutory requirements for product liability claims against producers of defective AISs in clinical use and set out the criteria for bringing a successful claim against a producer to the courts of England and Wales. We argue that the mismatch between product liability and safety regulation leaves patients, and consumers more generally, without an adequate remedy for the consequences of AIS defects. We also discuss the intertwinement of the consumer Protection Act 1987 and the Medical Devices Regulations 2002. Recent developments such as United Kingdom’s withdrawal from the European Union and the updated Medicines and Medical Devices Act 2021 are discussed. In addition, we offer novel discussion regarding the tort of ‘breach of statutory duty’ as provided for by the Medicines and Medical Devices Act 2021.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"22 1","pages":"33 - 51"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45222951","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":"Criminal responsibility for medical injury: A helpful or harmful mechanism for patient safety?","authors":"M. Tumelty","doi":"10.1177/09685332211064806","DOIUrl":"https://doi.org/10.1177/09685332211064806","url":null,"abstract":"This special issue of Medical Law International stems from an interdisciplinary workshop which took place in November 2019, titled ‘Criminal responsibility for medical error – a helpful or harmful mechanism for delivering patient safety’. The event was funded by the Irish Research Council’s New Foundations Scheme, and held at the School of Law, University College Cork, to address growing concern around the use of the criminal law to regulate healthcare practices and to consider the implications, if any, for patient safety. The papers included in this special issue are revised versions of selected papers presented at this workshop. As editor of this issue, I am grateful to all those who participated in the workshop and to the Irish Research Council, for making this knowledge exchange possible. I would also like to sincerely thank the anonymous reviewers of the papers included in this special issue. This special issue, Criminal responsibility for medical injury: a helpful or harmful mechanism for patient safety? seeks to investigate some of the core challenges posed by the increasing interactions of the criminal law with the practice of medicine. The rise in criminal investigations and prosecutions of medical practitioners arguably reflects changing societal attitudes to the profession,1 and while the desire for accountability is understandable and important, it is argued that criminal sanction is only ‘helpful’ where it is morally appropriate and improves patient safety. It is positively harmful where it does little to improve patient safety and to ensure the delivery of safe healthcare, but rather is experienced as punitive in nature and criminalises physicians for incidents of human error.2 The authors of this collection of papers, Ash Samanta and Jo Samanta,","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"289 - 292"},"PeriodicalIF":0.0,"publicationDate":"2021-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43326438","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":"Surgical harm, consent, and English criminal law: When should ‘bad-apple’ surgeons be prosecuted?","authors":"Alexandra Mullock","doi":"10.1177/09685332211057004","DOIUrl":"https://doi.org/10.1177/09685332211057004","url":null,"abstract":"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.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"343 - 368"},"PeriodicalIF":0.0,"publicationDate":"2021-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46295165","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":"Gross negligence ‘medical’ manslaughter in Ireland: Legal context and clinician concerns","authors":"M. Tumelty, E. Spain","doi":"10.1177/09685332211057008","DOIUrl":"https://doi.org/10.1177/09685332211057008","url":null,"abstract":"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.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"321 - 342"},"PeriodicalIF":0.0,"publicationDate":"2021-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48563275","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":"Should we criminalize a deliberate failure to obtain properly informed consent?","authors":"Clark Hobson, J. Miola","doi":"10.1177/09685332211060265","DOIUrl":"https://doi.org/10.1177/09685332211060265","url":null,"abstract":"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.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"369 - 392"},"PeriodicalIF":0.0,"publicationDate":"2021-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65244014","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 journey of research data: Accessing nordic health data for the purposes of developing an algorithm","authors":"K. Cathaoir, H. D. Gunnarsdóttir, M. Hartlev","doi":"10.1177/09685332211046179","DOIUrl":"https://doi.org/10.1177/09685332211046179","url":null,"abstract":"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.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"22 1","pages":"52 - 74"},"PeriodicalIF":0.0,"publicationDate":"2021-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48330932","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":"What makes a parent in surrogacy cases? Reflections on the Fjölnisdóttir et al. v. Iceland decision of the European Court of Human Rights","authors":"Julian W. März","doi":"10.1177/09685332211043499","DOIUrl":"https://doi.org/10.1177/09685332211043499","url":null,"abstract":"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 exaggerates 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.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"272 - 285"},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45373115","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":"Wrongful disturbance of reproductive planning: Is there a case for liability?","authors":"V. Raposo","doi":"10.1177/09685332211034995","DOIUrl":"https://doi.org/10.1177/09685332211034995","url":null,"abstract":"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’.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"220 - 242"},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43191593","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":"‘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","authors":"J. Manning","doi":"10.1177/09685332211044730","DOIUrl":"https://doi.org/10.1177/09685332211044730","url":null,"abstract":"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.","PeriodicalId":39602,"journal":{"name":"Medical Law International","volume":"21 1","pages":"243 - 271"},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42275400","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}