Comparing mental health and mental capacity law data across borders: Challenges and opportunities.

The island of Ireland is partitioned into Northern Ireland and the Republic of Ireland. In both jurisdictions, there have been important developments in mental health and mental capacity law, and associated policies and services. This includes an emphasis on developing more comprehensive approaches to collecting data on outcomes and so there is an opportunity to align these processes to enable comparison and shared learning across the border. This article explores: legal and policy developments; international approaches to mental health outcomes; and the type of data that would be helpful to collect to better understand the use of mental health and mental capacity laws. It is argued that an inclusive strategy to developing a comprehensive, integrated and aligned approach to collecting and analysing data would benefit citizens, policy makers and professionals.

What is the impact of intellectual property rules on access to medicines? A systematic review.

BACKGROUND: It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains 'flexibilities' designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions. METHODS: We searched Proquest, SCOPUS, Web of Science, PubMed, JSTOR, Westlaw and Lexis Nexis. Peer reviewed articles, government reports and other grey literature were included. Articles were eligible for inclusion if they were quantitative, in English, included a measure of cost, price, availability of or access to medicines, were about intellectual property or data exclusivity rules and published between January 1995 and October 2020. Ninety-one studies met our inclusion criteria. We systematically reviewed the studies' findings and evaluated their quality using a modified quality assessment template. RESULTS AND CONCLUSION: Five broad overarching themes and 11 subthemes were identified based on the articles' foci. They were: trade agreements (divided into EU FTAs and those that include the USA); use of TRIPS flexibilities (divided into compulsory licencing and parallel importation); patent expiry/generic entry/generic pathway (divided into comparative studies and single country studies); patent policies (also divided into comparative studies and single country studies) and TRIPS-plus rules (divided into data exclusivity, patent term extensions and secondary patenting). Most studies focused not on specific trade agreements, but on TRIPS-plus provisions, which can also be found within some trade agreements. The main finding of this review is that the stronger pharmaceutical monopolies created by TRIPs-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments. There is evidence that TRIPS flexibilities can facilitate access to medicines although their use is limited to date. There were few studies that included resource poor settings, signalling a need for greater research in such settings where the impact on access to medicines is likely to be more damaging.

Traversing TechSex: benefits and risks in digitally mediated sex and relationships.

BACKGROUND: Digital technologies play a significant role in people's sexual and intimate lives via smart phones, cameras, dating apps and social media. Although there is a large body of research on the potential risks posed by these technologies, research on benefits and pleasures is limited. METHODS: This study explored digital sexual practices, including perceptions of risks and benefits among a sample of Australian adults (n =445). Data were collected in 2020 via an online survey. Descriptive and bivariate analyses were undertaken to identify significant relationships between demographic variables and the use of technologies in relation to perceived risks and benefits. The mean age of participants was 42 years, over half were women (58.5%) and identified as heterosexual (61.1%). RESULTS: Findings reveal that use of digital media was common in participants' sex lives and relationships; 60.3% of participants had viewed pornography online, 34.9% had used dating apps, and 33.9% had sent sexual or naked self-images to another person. Over one in three reported positive outcomes from this: 38.2% felt emotionally connected to their partners due to online communication; 38.0% agreed that digital technologies facilitated closer connections;however, the majority of participants were aware of potential risks associated with online sexual engagement, particularly non-consensual exposure of their sexual or naked images, with women expressing greater concern. CONCLUSIONS: Policy, legal and educational responses should be based on holistic understanding of digital sexual engagement, acknowledging the ways in which technologies can support sexual relationships while also building people's knowledge and capacity to manage risks.

COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland.

Ireland has been a leader in the COVID-19 vaccine rollout in the EU, with almost 80% of the eligible population (aged over 5 years) fully vaccinated at the time of writing. The success of the vaccine rollout in this jurisdiction notwithstanding, the legal frameworks supporting the rollout had significant lacunas. Two aspects in particular highlighted a lack of legal preparedness: the inadequacy of the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks.

Mental health and capacity laws in Northern Ireland and the COVID-19 pandemic: Examining powers, procedures and protections under emergency legislation.

This article examines the changes made to mental health and capacity laws in Northern Ireland through temporary emergency legislation, known as the Coronavirus Act 2020. The purpose of the legislation was to respond to the emergency situation created by the COVID-19 pandemic, in particular the increase pressure placed on health services in the United Kingdom. An overview is provided of the government's rationale for the changes to Northern Ireland mental health and capacity laws, as well as exploring how they are likely to be operationalised in practice. Consideration is also given as to how such changes may impact upon existing human rights protections for persons assessed as lacking mental capacity. It is argued that it is important that regular parliamentary oversight is maintained in relation to the potential impact and consequences of such changes during the period they are in force. This should be done in order to assess whether they remain a necessary, proportionate and least restrictive response to the challenges faced in managing mental health and capacity issues in Northern Ireland during this public health emergency.

Gross Negligence Manslaughter in Healthcare: Time for a Restorative Justice Approach?

This article explores the merits of employing a restorative justice approach in cases of gross negligence manslaughter involving healthcare professionals, in line with the recent policy turn towards developing a just culture in addressing episodes of healthcare malpractice within the National Health Service in England. It is argued that redress for victims and rehabilitation of offenders should operate as key values, underpinning the adoption of a restorative justice approach in such cases. It would also be vital that a structured pathway was designed that established suitable protocols and safeguards for both victims and offenders taking account of problematic issues such as the informality of the process, power asymmetries between parties, and the context in which the offence took place. Taking all such matters into account, we propose that consideration be given to establishing a pilot involving the use of restorative justice in cases of gross negligence manslaughter involving healthcare professionals, which would be subject to judicial and stakeholder oversight to ensure transparency and accountability, which in turn could inform future policy options.

Not so new directions in the law of consent? Examining Montgomery v Lanarkshire Health Board.

This paper examines the UK Supreme Court decision in Montgomery v Lanarkshire Health Board, which deals with consent and information disclosure in medical treatment and care. It signaled a move away from a 'doctor knows best' approach to one that focuses on disclosing information to which particular patients would attach significance. Notwithstanding concerns about increased litigation and loss of professional autonomy, the reality is that the decision will make little difference to healthcare practice and consent in the UK. The Supreme Court has endorsed a view that most lawyers and doctors thought already prevailed, and it reflects the General Medical Council's guidance on the issue of consent in any case. Given recent healthcare scandals in the National Health Service (NHS), the Supreme Court's legal recognition of the importance of recognizing patient autonomy in disclosing risks about medical treatment and care is a welcome development.

Risky Bodies in the Plasma Bioeconomy: A Feminist Analysis.

In 2003 the UK National Blood Service introduced a policy of 'male donor preference' which involved women's plasma being discarded following blood collection. The policy was based on the view that data relating to the incidence of Transfusion-Related Acute Lung Injury (TRALI) was linked to transfusion with women's plasma. While appearing to treat female donors as equal to male donors, exclusion criteria operate after donation at the stage of processing blood, thus perpetuating myths of universality even though only certain 'extractions' from women are retained for use in transfusion. Many women in the UK receive a plasma-derived product called Anti-D immunoglobulin which is manufactured from pooled male plasma. This article examines ways in which gender has significance for understanding blood relations, and how the blood economy is gendered. In our study of relations between blood donors and recipients, we explore how gendered bodies are produced through the discursive and material practices within blood services. We examine both how donation policies and the manufacturing and use of blood products produces gendered blood relations.

Routine administration of Anti-D: the ethical case for offering pregnant women fetal RHD genotyping and a review of policy and practice.

BACKGROUND: Since its introduction in the 1960s Anti-D immunoglobulin (Anti-D Ig) has been highly successful in reducing the incidence of haemolytic disease of the fetus and newborn (HDFN) and achieving improvements to maternal and fetal health. It has protected women from other invasive interventions during pregnancy and prevented deaths and damage amongst newborns and is a technology which has been adopted worldwide. Currently about one third of pregnant women with the blood group Rhesus D (RhD) negative in the UK (approximately 40,000 women per year in England and Wales), receive antenatal Anti-D Ig in pregnancy when they do not require it because they are carrying a RhD negative fetus. Since 1997, a test using cell free fetal DNA (cffDNA) in maternal blood has been developed to identify the genotype of the fetus and can be used to predict the fetal RhD blood group. DISCUSSION: This paper considers whether it is ethically acceptable to continue administering antenatal Anti-D Ig to all RhD negative women when fetal RHD genotyping using maternal blood could identify those women who do not need this product. SUMMARY: The antenatal administration of Anti-D Ig to a third of RhD negative pregnant women who carry a RhD negative fetus and therefore do not need it raises important ethical issues. If fetal RHD genotyping using maternal blood was offered to all RhD negative pregnant women it would assist them to make an informed choice about whether or not to have antenatal Anti-D Ig.

Revaluing donor and recipient bodies in the globalised blood economy: transitions in public policy on blood safety in the United Kingdom.

The clinical use of blood has a long history, but its apparent stability belies the complexity of contemporary practices in this field. In this article, we explore how the production, supply and deployment of blood products are socially mediated, drawing on theoretical perspectives from recent work on 'tissue economies'. We highlight the ways in which safety threats in the form of infections that might be transmitted through blood and plasma impact on this tissue economy and how these have led to a revaluation of donor bodies and restructuring of blood economies. Specifically, we consider these themes in relation to the management of recent threats to blood safety in the United Kingdom. We show that the tension between securing the supply of blood and its products and ensuring its safety may give rise to ethical concerns and reshape relations between donor and recipient bodies.

Healthcare scandals in the NHS: crime and punishment.

The Francis Report into failures of care at Mid Staffordshire NHS Foundation Trust Hospital documented a series of 'shocking' systematic failings in healthcare that left patients routinely neglected, humiliated and in pain as the Trust focused on cutting costs and hitting government targets. At present, the criminal law in England plays a limited role in calling healthcare professionals to account for failures in care. Normally, only if a gross error leads to death will a doctor or nurse face the prospect of prosecution. Doctors and nurses caring for patients under the Mental Health Act 1983 and the Mental Capacity Act 2005 may however be prosecuted for wilful neglect of a patient. In the light of the Francis Report, this article considers whether the criminal offence of wilful neglect should be extended to a broader healthcare setting and not confined to mental healthcare.

Adding value? EU governance of organ donation and transplantation.

This article examines recent developments in EU governance of organ donation and transplantation, focusing on an analysis of the Commission's action plan and the proposed Directive. While the aims of the plan are laudable, a number of concerns remain with respect to the timetable for the plan and the adoption of the Directive, as well as the management of ethical and risk issues. In the final analysis, the added value of EU governance initiatives in the field is likely to be measured by the extent to which they successfully address the ongoing problem of organ shortage in Member States.