Sense and Admissibility: Cross-Border EPPO Investigations and Evidence

AimsDecisions made in the ‘best interests’ of the infant as vulnerable members of our society deserve the highest levels of protection. How decisions are made where medical research in infants...

This research addresses the legal challenges posed by the implementation of digital twin technology in public health. Digital twins are advanced computational models which aim to replicate human organ functions and biological processes. Their goal is to enable the simulation of the entire human body and to personalize the outputs with individual patient’s health data. Digital twin technology promises to bridge gap between personalized medicine and precision public health. This research is based on a comprehensive review of the current European and Swiss legal frameworks for medical devices and data protection that apply to digital twin technology. Within these frameworks, digital twins are in a grey area, as they are only considered as medical device software when applied to individuals. They also incorporate artificial intelligence, machine learning, and data analytics, which are already a source of legal concern in a healthcare setting, but their effective use in public health raises additional issues. Preliminary findings suggest significant shortcomings in the legal frameworks regarding data privacy, and the potential for increased surveillance by health insurance systems, which could lead to human rights violations. The public health application of digital twins would require global data analysis of sensitive personal information, raising further questions about the secure storage, transmission, and processing of this data. The study concludes that current legal frameworks must be future proofed to manage the complexities introduced by digital twins in public health. In particular, it suggests that regulatory oversight of medical devices needs to be significantly improved in order to safely harness the potential of digital twin technologies for public health. Finally, the new European Union health data space and the forthcoming EU AI act will also play important roles in the implementation of digital twin technologies. Key messages • Applying digital twin technology in public health faces considerable challenges, particularly the issues around data privacy, potential discrimination, and increased surveillance. • We need to adapt and strengthen existing legal frameworks to effectively manage the complexities introduced by digital twins, ensuring that these technologies can be safely used for public health.

The growing popularity and rapid rise of unmanned aerial vehicles (drones) across various industries raises myriad legal, ethical and safety concerns that require a comprehensive yet pragmatic legal framework for effective governance. South Africa, with its sophisticated legal infrastructure and rapidly advancing technologies, offers an ideal context for scrutinising and comparing legal frameworks governing drone operations. This note examines the diverse applications of drones in various sectors, including private, commercial, recreational and military applications, in a context of rapid advancement in drone technology driven by artificial intelligence. The integration of drones into South African airspace brings to the fore unique challenges, including safety, security, privacy and airspace management. Existing regulations may not adequately accommodate such emerging issues in the near future. Therefore, a comprehensive re-evaluation of existing regulations is necessary if the regulatory framework is to remain relevant and effective, while accommodating rapid expansion in the country. The note’s key objective is to enhance the current drone legal framework. It comprehensively examines the regulatory framework governing the operation of drones in South Africa, and focuses on deficiencies in the current legal framework, offering valuable recommendations to tailor and refine it so as to yield comprehensive regulations that effectively govern the operation of drones in South Africa. By shedding light on the strengths and weaknesses of the existing legal framework governing drones in South Africa, as well as the law in China, Japan, the United States of America (US) and Australia, the authors endeavour to provide insights that can inform policymakers, jurists, legal professionals and stakeholders on best-practice methods to shape an environment that fosters an integration of governance and management regulatory frameworks, for the safe operation of drones, into the fabric of an evolving modern society.

Why do people often fail to enforce existing claims? What role do innovative, non-lawyer legal tech service providers play in access to justice? Does the current legal framework do justice to this role? And what follow-up questions does this raise for the work and regulation of the legal profession? The author addresses these and other questions in his interdisciplinary study: First, the reasons for the lack of claims enforcement are examined from a legal sociology and behavioural economics perspective before the current (constitutional) legal framework is evaluated on the basis of a comprehensive analysis of the novel business model. The work culminates in guidelines for a necessary reform. The work was awarded the Ernst Zander Prize 2024 by the Institute of Corporate Management (ifu) and the Dr Klaus Marquardt Prize by the Society of Friends of Ruhr-Universität Bochum e. V. (GdF).

Cases involving patients such as Mrs Yvonne Watts, who travelled from the UK to France for a hip replacement to avoid a ‘waiting list’ in the UK, relying on rights in European Union (EU) law, attract high levels of media attention. While the vast majority of patients are either unwilling or unable to travel across borders to receive health care, it is clear that some patients are seeking health care abroad. Although data on patient mobility within the EU are significantly limited, nevertheless, a relatively steady, small but not insignificant number of patients are moving across borders within the EU to receive health care. This paper considers the current legal framework on the rights in EU law of those patients who seek health care in another Member State. As the right to seek private health care abroad is (largely) non-contentious, and has been a well-established feature of EU law since at least the mid 1980s, the focus of this paper is on publicly or quasi-publicly funded health care.

Cases involving patients such as Mrs Yvonne Watts, who travelled from the UK to France for a hip replacement to avoid a ‘waiting list’ in the UK, relying on rights in European Union (EU) law, attract high levels of media attention. While the vast majority of patients are either unwilling or unable to travel across borders to receive health care, it is clear that some patients are seeking health care abroad. Although data on patient mobility within the EU are significantly limited, nevertheless, a relatively steady, small but not insignificant number of patients are moving across borders within the EU to receive health care. This paper considers the current legal framework on the rights in EU law of those patients who seek health care in another Member State. As the right to seek private health care abroad is (largely) non-contentious, and has been a well-established feature of EU law since at least the mid 1980s, the focus of this paper is on publicly or quasi-publicly funded health care.

Globally, electronic commercial transactions have been rising at a rapid rate. In the context of South Africa, this upward trend is associated with the high rates of mobile technology penetration evinced by using mobile devices like laptops, cell phones, smartphones, tablets, and other emerging electronic tools. Given that the laws and policy framework regulating e-commerce transactions is relatively new and at a developmental stage in the country, there are gaps regarding the regulation of commercial transactions as they relate to consumer protection in the online environment. Some matters have arisen and still emerging because of the outpacing of technological developments with the existing commercial laws. This disparity in technological innovations and the subsisting legal framework tends to affect the modern consumer who prefers to utilise technology to access goods and services and conclude contracts electronically. This study explored the challenges in online contract formation and the extent to which consumers are protected in the e-commerce environment. A qualitative research approach was adopted in this study, by utilising a desktop review of the existing policies and legal instruments on electronic transactions, namely, case law, international instruments, and national laws (the Electronic Communications and Transactions Act 24 of 2002). The study critically examined the mechanisms in the current legal and regulatory framework that facilitate the conclusion of electronic contracts. It also analysed the current international and national legal framework to appraise the adequacy of the subsisting legislation in protecting the rights of consumers who engage in online transactions. Findings from the study revealed that despite the mechanisms put in place by the current South African legal framework, more still needs to be done to ensure legal certainty to consumers, who are the weaker party in e-commerce transactions. The study recommended strengthening consumer protection in the e-commerce environment. Keywords: Online Contract, Consumers, Online Transactions, Consumer Protection, E-Commerce.

The outbreak and the rapid spread of global COVID-19 pandemic have put significant strains on the institutions. The need to adapt to “new normal” and contain the rapid spread of disease, while maintaining a functional society, resulted with introduction of numerous new legal mechanisms and adaptation of the existing ones. However, it seems that one area of law remains on the fringes: the regulation of wills. Even before the start of the pandemic many authors often pointed to the fact that the current legal framework does not follow modern technological developments, but no significant attempts were made to overhaul the inheritance law. Also, once the pandemic started in its full, there were no references to introduction of extraordinary mechanisms or new legal solutions to overcome the potential difficulties in forming wills. Comparative analysis yielded no better results: although some countries (such as Austria) recently completely overhauled their regulation of inheritance law, it seems that no attempts were made to introduce new types of wills or new methods of drafting wills into their regulations. Furthermore, following the spread of the pandemic, increasing number of potential testators find themselves unable to use traditional methods of drafting wills as they, or the authorized persons tasked with assistance and creation of wills, remain isolated from one another due to various reasons (lock-downs, isolation in case of experiencing symptoms, etc.). Having in mind these circumstances, it is necessary to ascertain whether there is a genuine need to introduce new types of wills into existing legal framework, or to adapt the current legal framework by facilitating the communication between citizens and the institutions. Also, it is necessary to analyze whether the interpretation of the existing legal framework enables the introduction of certain facilitating mechanisms. In order to reach these goals and clarify the possibilities within the current legal framework, interpretative and comparative method are used.

Use and development of rivers takes place within a complex legal framework that guides the actions of interested parties holding conflicting values. One of the major components of this legal framework is state water allocation law. This law takes several forms among the states, but its basic function is to establish rules for water use by assigning property rights in water. Another component of the legal framework for river use addresses the public access issue. The primary focus here is establishment of the boundary between the exclusive rights of landowners and the rights of the general public to use the surface and underlying beds of waterways. A third component consists of governmental controls over water use and development. These controls restrict the exercise of private property rights in the resource. From an initial focus of protecting the public right of navigation, this law has expanded to include protection of water quality and a variety of other environmental values. The current legal framework provides a relatively sound basis for balancing competing values and interests, but problems exist. For example, the division of water management responsibilities between the federal and state levels of government sometimes results in conflict, and existing procedures for managing conflict related to proposals for water transfer do not appear to be adequate. Therefore, the current framework will not remain static; it must continue to evolve in order to operate more effectively and to incorporate future increases in knowledge and the associated changes in values and management needs.

This analysis tests whether the quantitative requirements of the law (Basel and Committee of European Securities Regulators) regarding the Value at Risk (VaR) framework may lead to inaccurate and procyclical VaR estimations. We apply two of the most popular VaR models, the Historical (HVaR) and the Exponential Weighted Moving Average (EWMA VaR) models, to a wide sample of 13 European Indices during the period 2002-2019. The empirical evidence confirms our assumptions that the legal framework in many cases leads to inaccurate and procyclical VaR estimations. Moreover, we show that the limitation on the required data inputs does not really contribute to a more stable financial environment. Further, we show that the current framework does not examine the procyclicality issue. The evidence in this study shows that the current legal framework needs some reforms: (a) the guideline on the minimum number of data inputs for the VaR estimations should be removed, taking provided that the accuracy of the applied VaR model is often evaluated, and (b) the current backtesting procedure does not examine whether VaR estimations are representative of the financial conditions. An additional backtesting procedure at a lower that the 99% confidence level could resolve this issue.

Although international trade and climate change regimes are two different fields of international law, they are closely interrelated. In particular, certain domestic environmental policies adopted by States may run afoul of WTO law, thereby having adverse effects on free trade. It has been claimed by critics that non-discrimination principles and subsidies regulations of WTO law constrain its Members’ ability to take certain unilateral actions aimed at climate change mitigation. According to other commentators, despite the existence of potential conflicts between UNFCCC and WTO regime, there are still synergies which can be developed to bring a greater coherence, and WTO’s multilateral framework can serve as a vehicle to facilitate targets of the Paris Agreement. This paper argues that although sustainable development is recognized by WTO regime and it leaves some scope for climate change actions, its current legal framework does not provide sufficient space for member’s regulatory autonomy in order to take national regulatory policiesAlthough international trade and climate change regimes are two different fields of international law, they are closely interrelated. In particular, certain domestic environmental policies adopted by States may run afoul of WTO law, thereby having adverse effects on free trade. It has been claimed by critics that non-discrimination principles and subsidies regulations of WTO law constrain its Members’ ability to take certain unilateral actions aimed at climate change mitigation. According to other commentators, despite the existence of potential conflicts between UNFCCC and WTO regime, there are still synergies which can be developed to bring a greater coherence, and WTO’s multilateral framework can serve as a vehicle to facilitate targets of the Paris Agreement. This paper argues that although sustainable development is recognized by WTO regime and it leaves some scope for climate change actions, its current legal framework does not provide sufficient space for member’s regulatory autonomy in order to take national regulatory policies

Assessing inclusiveness for indigenous communities in mineral rights allocation in Ghana

Back in 2015, two hackers hacked a Jeep Cherokee, wirelessly gaining access to the controls of the vehicle through the vehicle’s entertainment system. The hackers slowed the vehicle down on a highway. Remarkably, this did not result in accidents. This did, however, illustrate the already existing cybersecurity risks of vehicles and their threat to road safety, thereby making legislators aware of these dangers. Recently, several legislative steps were made to improve the cybersecurity in vehicles. As cybersecurity enters the realm of road safety, it is necessary to identify the key principles for cybersecurity in vehicles. The current legal framework is discussed in light of these principles, identifying gaps in the current legal framework for cybersecurity in vehicles. As this contribution argues, the focus of the current legislative measures focuses predominantly on the ‘first line of defence’. These measures aim to prevent unauthorised access to the vehicle’s systems, but fail to identify the steps necessary to limit the damage that can be done if this first line of defence is breached and unauthorised access is gained. Moreover, other identified cybersecurity principles are not adequately ensured. In addition, the fragmentation of the current legal framework in itself gives rise to concerns.

Initial Coin Offerings in Europe – The Current Legal Framework and its Consequences for Investors and Issuers

Rights and coercion in municipal services for persons with co-occurring severe mental illness and substance use disorders - experiences with legal framework, in light of human rights. Aims: Persons with co-occurring severe mental illness and substance use disorders can have a considerable need for municipal health and care services but can be difficult to reach with such services. In Norway, there are known perceived ambiguities and obscurities in the legal framework for such services. This study aims to further examine these legal issues in a Norwegian context, by examining what challenges service providers experience in the practice of the current legal framework in this field. Design: The data consists of 13 qualitative interviews with strategically selected service providers from Norwegian municipalities and county governors' offices. The interviews were analyzed through systematic text condensation. Results: The participants reflections resulted in three especially salient perceived challenges in the practice of the current legal framework in this field: 'being dependent upon extra efforts that exceed the legal minimum requirements', 'lacking a legal basis and tools' and 'a complex and composite legal framework'. Conclusions: When seen in light of human rights, the three identified challenges in legal framework should be considered more closely both from a research perspective and from a policy making perspective. It should be investigated further whether human rights oblige the state beyond setting forth minimum requirements, how different human rights impact one another, especially with a view to service providers' rights v. service recipients' rights, and lastly if it is feasible to simplify or clarify the current legal framework to ensure adherence to the law and to promote equal practice among service providers.