Medical Law International
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Published By Sage Publications

2047-9441, 0968-5332
Updated Tuesday, 21 September 2021

2021 ◽  
pp. 096853322110461
Katharina Ó Cathaoir ◽  
Hrefna Dögg Gunnarsdóttir ◽  
Mette Hartlev

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.

2021 ◽  
pp. 096853322110447
Joanna M Manning

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.

2021 ◽  
pp. 096853322110349
Vera Lúcia Raposo

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’.

2021 ◽  
pp. 096853322110434
Julian W März

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.

2021 ◽  
pp. 096853322110235
Victoria L. Moore

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.

2021 ◽  
Vol 21 (2) ◽  
pp. 147-173
Gerard Porter ◽  
Anita Kotwani ◽  
Lovleen Bhullar ◽  
Jyoti Joshi

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.

2021 ◽  
Vol 21 (2) ◽  
pp. 116-146
Fae Garland ◽  
Michael Thomson ◽  
Mitchell Travis ◽  
Joshua Warburton

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.

2021 ◽  
pp. 096853322110133
Tessa Sze-Myn Teo

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.

2021 ◽  
pp. 096853322199751
Joseph TF Roberts ◽  
Victoria Moore ◽  
Muireann Quigley

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.

2021 ◽  
pp. 096853322110025
Lydia Bracken

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.

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