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Richard W.M. Law and Kartina A. Choong

Abstract

Advances made in medical care mean that many critically ill patients with an acquired brain injury may survive with a disorder of consciousness. This may be in the form of a vegetative state (VS) or a minimally conscious state (MCS). Medically, there is a growing tendency to view these conditions as occupying the same clinical spectrum rather than be considered as discrete entities. In other words, their difference is now understood as one of degree rather than kind. However, is English law keeping pace with this development in medical knowledge? This article seeks to highlight the duality that exists in the legal decision-making process in England and Wales, and question the justifiability and sustainability of this dichotomous approach in the light of medicine’s current understanding on disorders of consciousness.

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Renaud Bouvet

Abstract

Increasing a soldier’s perception, action and survival abilities responds to an operational need justified by the evolution of the battlefield. The available or conceivable means are multiple, including invasive techniques involving the soldier’s mind and body. This field of intervention places the medical officer at the centre of the debate, as a guarantor of the soldier’s aptitude for combat, and as a possible actor of the soldier’s enhancement. The conditions of consent and medical necessity seem overwhelmed by the challenges of using a technique of enhancement in this context. Consent indeed appears necessary, but insufficient to justify its implementation, and the requirement of medical necessity seems obsolete, as the normal/pathological dichotomy that structures the medical thought is outdated, the goal being to reach a “supranormality”. Moreover, the decision-making process creates a tension concerning the articulation of the aim of medical practice with the operational objectives.

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Gauthier Chassang and Emmanuelle Rial-Sebbag

Abstract

Biobanks and health databases make an essential contribution to health-related research (‘5P medicine’: predictive/preventive/personalised/participatory/provable). Since 1947, the World Medical Association (WMA) has addressed important issues in medical practice and scientific research, adopting guidelines that are recognised as global ethical standards. In October 2016, the WMA’s 67th General Assembly, held in Taipei, Taiwan, adopted a new Declaration on the Ethical Considerations regarding Health Databases and Biobanks, revising the Declaration adopted by the 53rd WMA General Assembly in 2002. Considering the way health databases and biobanks are currently used in research, the new recommendations are designed to facilitate the responsible collection and storage of human samples and/or associated data, and the provision of these bioresources for scientific research aimed at benefitting patients and populations. We analyse the Declaration of Taipei’s scope and content, highlighting its innovative features compared with other recent European guidelines and the General Data Protection Regulation (GDPR).

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Ida Helene Asmussen and Katharina Eva Ó Cathaoir

Abstract

Developments within biotechnology are of a pace and complexity that challenge the predictability at the foundation of legislation, i.e. the possibility for politicians to foresee pitfalls and hazards, and design legislation accordingly. The lack of predictability is not only a challenge for the legislature, but also for the citizen, who is to consent to the new biotech services offered by the health authorities. How can one give informed consent to a measure, the consequences of which is hard to predict? Does the uncertainty and lack of predictability mean that paternalism has slipped back in as a ‘self-selected’ responsiveness to the rhetoric of the health regime? Recently, Denmark has taken another step in the direction of voiding autonomy of actual value by rendering genetic analysis contingent on agreeing that the resulting data may be stored in the recently established National Genome Centre, and reused for research unless the patient opts out.

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Gianluca Montanari Vergallo, Natale Mario di Luca and Simona Zaami

Abstract

Over the past decades, the number of effective and safe child vaccines available has increased. Yet, more and more parents have become concerned about vaccine safety. The authors address the following question: are vaccinations, especially in children, to be considered as mandatory treatment or should parents be entitled to choose whether to have their children vaccinated or not? In Europe, eleven countries have instituted mandates, whereas others have opted for mere recommendations and rely on information campaigns. Italy is one of those which have recently enacted legislation designed to broaden the scope of mandatory vaccinations. The paper’s authors argue that it is certainly hard to draw the line between individual and collective rights, yet it is incumbent upon state authorities to foster the common interest and the public good, which gives governments a right and an obligation to promote immunisation, at least until the safety threshold is reached.

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Santa Slokenberga

Abstract

In biobanking, collaboration and data sharing contribute to building genomic research capacity, and have the potential to further scientific advances that ultimately can result in advances in clinical care. However, in the absence of common applicable legal frameworks that enable collaboration, capacity building is hindered. With the applicability of the General Data Protection Regulation, the obstacles to data sharing which involve export of data from European Union Member States to third countries are expected to grow, rendering the collaboration between the EU and third countries even more challenging. This article examines how, if at all, data sharing in biobank research between the EU and third countries could be facilitated via the use of soft regulatory tools. It argues that although the existing soft tools might not in itself be suitable for meeting all the GDPR requirements, they could be the basis on which to raise the area-specific data protection bar globally.

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Herman Nys

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Liisa Nieminen

Abstract

This article combines two legal and ethical questions: a) the new Finnish method of citizens’ democratic participation (the citizens’ initiative), and b) the complex and controversial question of euthanasia. Both are currently pertinent questions in Finland. The citizens’ initiative institution is a success, especially for liberal people and human rights organisations in promoting issues which coalition governments are not ready to submit to the Parliament of Finland. The euthanasia question meets these requirements and the citizens’ initiative on euthanasia (KAA 2/2017) in principle has a good chance of succeeding in the Parliament, but the result is unpredictable. Many members of the Parliament have not yet decided their attitude to euthanasia, which is a more complicated issue than, say, same-sex marriage.