Legal Framework and Current Issues
This monograph provides a survey of adoption and assisted reproduction as alternative (non-coital) ways of establishing parent-child relationships in Germany.
On 19 December 2017 the Grand Chamber of the European Court of Human Rights (ECtHR) delivered a judgment in the Lopes de Sousa Fernandes v. Portugal case. The judgment may be described as one of the hard cases dealing with a healthcare context, as it aimed to clarify the scope of positive substantive state obligations under the European Convention on Human Rights and the conditions of international responsibility. This article explores the judgment against the wider background of the previous case-law of the Court. It focuses on the question of the classification of healthcare problems into three categories: medical negligence, systemic deficiency, and denial of emergency healthcare, and reflects upon their ratione materiae justiciability before the European Court of Human Rights.
Richard W.M. Law and Kartina A. Choong
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.
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.
Gianluca Montanari Vergallo, Natale Mario di Luca and Simona Zaami
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.
Data protection rules applies to biobanks’ activities to the extent that they fall under the scope of the General Data Protection Regulation, which is already susceptible to raising some difficult issues to solve. If subjected to it, biobanks’ activities will have to comply with the applicable substantive rules governing data processing, data subject’s rights, obligations of data controller and processor, without omitting the specific authorities and mechanisms ensuring data protection effectiveness.
Corrette Ploem, Colin Mitchell, Wim van Harten and Sjef Gevers
Medical genetic testing, ‘next generation sequencing’, is increasingly generating data that could become useful for patients after they have been discharged from care. If new information is discovered that links a disease to a specific mutation, do health professionals have a legal duty to recontact their patients? Apart from other concerns (such as respecting the patient’s right not to know), in many cases, this would require re-evaluation or re-analysis of the data. Taking such issues into account, we conclude that, at least at this point in time, it is not arguable that there is an unconditional duty of this kind. Health professionals should always do what can be reasonably expected from them to do justice to the patient’s right to information. When there is reason to believe that recontacting would be of significant clinical relevance for the patient, they should do so, unless efforts and costs involved would be disproportional.