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Health Disparities and New Health Technologies – A Patients’ and Human Rights Perspective European Journal of Health Law Pub Date : 2021-04-05 Mette Hartlev
The human right to health requires that everyone should have equal opportunities to enjoy the highest attainable standard of health. In practice, this is hard to achieve, as health is shaped by social determinants. This article explores the impact personalized medicine and use of big data may have on health disparities. New health technologies offer a lot of hope for more individual and better health
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Anti-Epidemic Emergency Regimes under Polish Law in Comparative, Historical and Jurisprudential Perspective European Journal of Health Law Pub Date : 2021-03-29 Leszek Bosek
The SARS-CoV-2 crisis of 2020 triggered a number of unprecedented reactions of European states, in particular in the form of either constitutional emergency measures or statutory anti-epidemic emergency measures. Poland chose to deal with the crisis by delegating powers to the executive by ordinary legislative means and declared a nationwide state of epidemic emergency on 13 March 2020 and a week later
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Freedom of Scientific Research and Embryo Protection Under Italian and European Court of Human Rights’ Jurisprudence. Brief European Legislation Overview European Journal of Health Law Pub Date : 2021-01-25 Gianluca Montanari Vergallo
The paper addresses the issues of admissibility of human embryo research and the legal protection to be recognized, in light of the growing importance that scientific research has been gaining in the clinical and biomedical fields of embryonic stem cells for therapeutic purposes. As for human embryo experimentation, particularly on cryopreserved supernumerary embryos, European legislation varies, since
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The Rights of Elders in Ireland during COVID-19 European Journal of Health Law Pub Date : 2021-01-04 Katharina Ó Cathaoir, Ida Gundersby Rognlien
This article reflects on COVID-19 restrictions imposed on elders in Ireland through the lens of the right to private and family life (Article 8 ECHR), focusing on stay at home orders and recommendations advising elders to avoid social contact. Furthermore, we examine restrictions on visiting nursing homes given the high death toll in that setting. In our analysis, we zero in on the principles of foreseeability
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Antigone Betrayed? The European Court of Human Rights’ Decisions on Conscientious Objection to Abortion in the Cases of Grimmark v. Sweden and Steen v. Sweden European Journal of Health Law Pub Date : 2020-12-12 Irene Domenici
The article deals with the recent decisions of the European Court of Human Rights in the cases of two Swedish midwives who claimed a right to conscientious objection to abortion under Article 9 of the European Convention on Human Rights (ECHR). After giving an overview of the relevant previous case-law of the Court, I argue that the decisions of inadmissibility in the midwives’ cases are a step backwards
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The Determination of Death under Polish Law in Comparative, Historical and Medical Perspective European Journal of Health Law Pub Date : 2020-12-12 Leszek Bosek, Witold Borysiak
It has been recently adopted under Polish law that the determinant of death is both the brain death criterion, tantamount to the permanent and irreversible cessation of its function, and the equally valid circulatory criterion. This means that the determination of brain death is not indispensable to pronounce a person dead, because the irreversible cessation of circulation is sufficient in this respect
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Compulsory Vaccination and the Turkish Constitutional Court European Journal of Health Law Pub Date : 2020-10-21 Engin Yıldırım
As vaccine hesitancy is on the rise around the world, apex courts in some countries have confronted the difficult task of striking a fair balance between individual rights and the common good. Against this background, the article discusses the compulsory vaccination cases heard by the Turkish Constitutional Court (TCC). The TCC’s case law illustrates that any interference with bodily integrity must
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Conducting Non-COVID-19 Clinical Trials during the Pandemic: Can Today’s Learning Impact Framework Efficiency? European Journal of Health Law Pub Date : 2020-10-21 Teodora Lalova, Anastassia Negrouk, Angelique Deleersnijder, Peggy Valcke, Isabelle Huys
The COVID-19 pandemic has severely disrupted non-coronavirus clinical trials. In the case of life-threatening diseases, such as cancer, this is particularly dangerous, as treatment cannot simply be stopped. In the EU, guidelines for the management of ongoing studies were issued; however, national coordination is still lacking. This article aims to raise awareness on the struggle of managing ongoing
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The Underappreciated Role of Advance Directives: How the Pandemic Revitalises Advance Care Planning Actions European Journal of Health Law Pub Date : 2020-10-08 Hui Yun Chan
Covid-19 continues to alter our way of living and dying. Much attention has focused on how to resolve pressing issues surrounding resource allocation and competing public health ethics. While these are important discussions, the legal and ethical dilemmas of treatment decisions remain highly critical. The urgency to ensure that life and death affairs are in order is magnified due to the possibility
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View. The Dutch Critical Care Triage Guideline on Covid-19: Not Necessarily Discriminatory European Journal of Health Law Pub Date : 2020-09-21 André den Exter
Recently, the Dutch Medical Doctors Association (Federatie Medisch Specialisten en de Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst) drafted the ‘Covid-19 triage guideline ICU admission’ that has age cut-offs that deprioritise or exclude the elderly. Such an age limit for intensive care unit (ICU) admission in case of a national emergency seems discriminatory, and thus, is
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Is International Surrogacy the Lark’s Glimmer?: When Covid-19 Reveals the Legal Insecurity of Surrogacy Use European Journal of Health Law Pub Date : 2020-08-27 Gaëlle Deharo, Allane Madanamoothoo
If globalisation has led to a greater mobility of people specific issues have emerged with the current coronavirus pandemic. Consequently, extreme measures have been taken worldwide to flatten the curb of the virus. From lockdowns to several levels of isolation these measures have worked undoubtedly for some situations. Nonetheless, these same measures have sown chaos in other situations. One good
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Does Self-isolation Violate the Right to Liberty? An Analysis of the European Court of Human Rights’ Practice in Light of the Ukrainian Experience European Journal of Health Law Pub Date : 2020-08-13 Yana Litins’ka, Oleksandra Karpenko
COVID-19 became a stress-test for many legal systems because it required that a balance be found between rapid action to prevent the spread of the disease, and continued respect for human rights. Many states in Europe, including Ukraine, chose to enforce an obligation to self-isolate. In this article we review what the obligation to self-isolate entails in the case of Ukraine. We also analyse whether
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Medical Negligence Litigation and Apologies: An Empirical Examination European Journal of Health Law Pub Date : 2020-07-01 Mary-Elizabeth Tumelty
Research has evidenced the various aims of patient-plaintiffs and/or their families in medical negligence litigation, with emphasis frequently placed on the importance of an apology. Drawing on the findings of an empirical study conducted in Ireland, this article contributes to the discourse on apologies in medical negligence disputes. In particular, with reference to the findings of the research and
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Models of Governance for Innovation in Medicine and Health Research European Journal of Health Law Pub Date : 2020-06-15 Siobhán O’Sullivan
Personalised medicine, digital innovations, and neuro-technologies all offer significant potential benefit for human health and welfare, but also raise complex governance challenges. A variety of approaches have been adopted in the governance of innovative medicines and health technologies, including risk assessment, ethics and self-governance. Recently anticipatory or ‘upstream’ modes of governance
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Genetic Material and Sequence Data to Protect Global Health in the Light of Pandemic Outbreaks: Mapping the Legal Landscape under European and International Law European Journal of Health Law Pub Date : 2020-06-04 Claudia Seitz
The current pandemic outbreak of corona virus SARS-CoV-2 shows the need for comprehensive European cooperation in drug development and the importance of genetic material and sequence data in research concerning this unknown disease. As corona virus SARS-CoV-2 is spreading across Europe and worldwide, national authorities and the European Union (EU) institutions do their utmost to address the pandemic
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Exploring Solutions to Foster ATMP Development and Access to Patients in Europe European Journal of Health Law Pub Date : 2020-05-28 Vincenzo Salvatore
There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues
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Machine Learning Systems Applied to Health Data and System European Journal of Health Law Pub Date : 2020-05-19 Fedele Bonifazi, Elisabetta Volpe, Giuseppe Digregorio, Viviana Giannuzzi, Adriana Ceci
The use of machine learning (ML) in medicine is becoming increasingly fundamental to analyse complex problems by discovering associations among different types of information and to generate knowledge for medical decision support. Many regulatory and ethical issues should be considered. Some relevant EU provisions, such as the General Data Protection Regulation, are applicable. However, the regulatory
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Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance European Journal of Health Law Pub Date : 2020-05-18 Annagrazia Altavilla, Viviana Giannuzzi, Mariangela Lupo, Donato Bonifazi, Adriana Ceci
The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster
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High Price Medicines and Health Budgets: The Role Patients’ and Consumers’ Organisations Can Play European Journal of Health Law Pub Date : 2020-05-18 François Houÿez
Healthcare systems face challenges due to budget constraints, complex therapies, and new treatments for rare diseases. One of the most successful patient advocacy campaigns of all times was initiated by people living with HIV and AIDS in African countries. Facing industry giants, they won court cases allowing governments to ignore intellectual property rights when the price of a medicine was abnormally
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Introducing Key Elements Regarding Access to Personal Data for Scientific Research in the Perspective of Developing Innovative Medicines European Journal of Health Law Pub Date : 2020-05-18 Jean Herveg, Annagrazia Altavilla
This article aims at opening discussions and promoting future research about key elements that should be taken into account when considering new ways to organise access to personal data for scientific research in the perspective of developing innovative medicines. It provides an overview of these key elements: the different ways of accessing data, the theory of the essential facilities, the Regulation
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In dubio pro CPR? The Controversial Status of ‘Do Not Resuscitate’ Imprints on the Human Body – a Swiss Innovation European Journal of Health Law Pub Date : 2020-05-14 Melanie Levy
‘Do not resuscitate’ (DNR) imprints on the human body have recently appeared in medical practice. These non-standard DNR orders (e.g., tattoos, stamps, patches) convey the patient’s refusal of resuscitation efforts should he be incapable of doing so. The article focuses on such innovative tools to express one’s end-of-life wishes. Switzerland provides a unique example, as ‘No Cardio-Pulmonary Resuscitation’
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Health Technology Assessment (HTA) and Access Policies European Journal of Health Law Pub Date : 2020-05-07 Verena Stühlinger
For patients, innovations in healthcare can be both a great blessing (when saving people’s life or improving quality of life), as well as a curse (when only few people have access, e.g., because of high prices). Thus, when healthcare innovations are proven safe and ready for application, decision makers have to apply access policies and sometimes face difficult assessments. In this context, health
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Fighting Excessive Pharmaceutical Prices: Evaluating the Options European Journal of Health Law Pub Date : 2020-04-29 André den Exter
New treatment options for various cancer therapies appear to be extremely expensive and prices may increase further. The affordability and availability of life-saving medicines is therefore a key issue in the national health policies of all countries. International and European law grant several price-reducing options, including compulsory licensing. Still, countries are reluctant to apply for compulsory
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Deprivation of Liberty in Care. An ECHR and CRPD Approach and its Consequences for Belgium European Journal of Health Law Pub Date : 2020-04-16 Tim Opgenhaffen
This contribution examines deprivation of liberty in Belgian healthcare within the frameworks of the ECHR and CRPD. We develop and apply an ECHR-based framework to demonstrate that it is not the admissions to care facilities based on Belgium’s involuntary commitment law that give rise to the unjustified deprivation of liberty, but those based on representation regimes. This can be remedied by broadening
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Introducing ‘Health Vulnerability’. Towards a Human Right Claim for Innovative Orphan Drugs? European Journal of Health Law Pub Date : 2020-04-16 Éloïse Gennet
Although several European law instruments specifically promote the development of orphan medicines, rare disease patients still suffer from an excessive lack of access to orphan drugs. In order to base a claim for equity of access to research benefits, health vulnerability is introduced as a human rights-based public health concept. It represents a potentially valuable and powerful means in European
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New Technologies, New Challenges for Human Rights? The Work of the Council of Europe European Journal of Health Law Pub Date : 2020-04-16 Laurence Lwoff
Convergence of emerging technologies (e.g. biotechnologies, information and cognitive technologies) has opened new perspectives for progress with regard to human health. However, these technologies also open new possibilities for interventions on human beings, which may be more invasive, and possibly affect and modify individuals. Established practices in the field of biomedicine are also evolving
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How GDPR Enhances Transparency and Fosters Pseudonymisation in Academic Medical Research European Journal of Health Law Pub Date : 2020-03-04 G. Verhenneman, K. Claes, J.J. Derèze, P. Herijgers, C. Mathieu, F.E. Rademakers, R. Reyda, M. Vanautgaerden
The European General Data Protection Regulation (GDPR) has dotted the i’s and crossed the t’s in the context of academic medical research. One year into GDPR, it is clear that a change of mind and the uptake of new procedures is required. Research organisations have been looking at the possibility to establish a code-of-conduct, good practices and/or guidelines for researchers that translate GDPR’s
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Late Termination of Pregnancy in Belgium: Exploring Its Legality and Scope European Journal of Health Law Pub Date : 2020-03-04 Fien De Meyer
Termination of pregnancy when the foetus is considered viable remains a legal and ethical challenge for lawmakers and society. In Belgium, the lawfulness of late termination of pregnancy is contested by legal scholars up until today. Through statutory interpretation, this analysis demonstrates that this controversy is unwarranted and that termination of pregnancy for particularly severe and incurable
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Healthcare Resource Allocation and Priority-setting. A European Challenge European Journal of Health Law Pub Date : 2020-03-02 Caterina Di Costanzo
The right to health, as a right to healthcare, represents the most expensive social right in Europe, significantly affecting the total budget of the Member States, both in universal and insurance healthcare systems. No healthcare system provides unlimited healthcare resources to all its users. The resources available for healthcare are limited compared with demand, and all healthcare systems, regardless
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Strasbourg Medical Expulsion Rulings: Beyond the Deathbed Requirement European Journal of Health Law Pub Date : 2020-03-02 André den Exter
For decades, the European Court of Human Rights (ECtHR) has applied a restrictive interpretation on the Article 3 threshold in extradition cases. The removal of aliens from the contracting state is lawful unless the applicant faces an imminent risk of death (D v. the United Kingdom (St Kitts)). However, with the Paposhvili ruling the Court has lowered the deathbed requirement to a more favourable standard
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Teaching Health and Human Rights in a Globalised Classroom European Journal of Health Law Pub Date : 2019-12-16 Katharina Ó Cathaoir
This article outlines the importance of human rights in the health law curriculum. The author reflects on her experiences of teaching Health and Human Rights at the Faculty of Law, University of Copenhagen. Health and human rights, it is argued, can have important implications for students’ understanding of health and the role of law. Namely, it underscores the obligations of states and the rights
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The Right to Voluntary Termination of Pregnancy in Italy: Taking Stock Forty Years after the Enactment of Law no. 194/1978. Comparative Law-based Remarks European Journal of Health Law Pub Date : 2019-11-12 Gianluca Montanari Vergallo
Forty years after the enactment of Law no. 194/78 that governs voluntary interruption of pregnancy, Italy has been experiencing difficulties guaranteeing that patients gain access to abortion procedures in a timely fashion. Conscientious objection detracts considerably from the very effectiveness of the law, as pointed out by major European institutions as well. Hence, the network of family planning
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Gross Negligence Manslaughter and the Delivery of Healthcare: A Time for Change? European Journal of Health Law Pub Date : 2019-11-12 Jo Samanta, Ash Samanta
Manslaughter caused by gross negligence is a common law offence that has long existed in English jurisdiction. Although circumstances and context can be highly influential in determining the outcome of inadvertent errors, English law does not permit sufficient consideration of such issues. The recent and controversial case of R v. Bawa-Garba is used to illustrate some of the central issues that are
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Use of Force in Somatic Treatment of Adults in Denmark European Journal of Health Law Pub Date : 2019-10-04 Caroline Adolphsen
The article provides a critical analysis of the new Danish Act on Use of Force in Somatic Treatment of Adults with a Permanently Impaired Ability to Give Consent (FTAC, Act no. 655 of 8 June 2017), which covers adults unable to give an informed consent. The rules in the Act are included in the legal framework governing medical treatment with and without consent in Denmark, and the article draws on
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CRISPR-Cas9 and the Promise of a Better Future European Journal of Health Law Pub Date : 2019-10-04 Vera Lúcia Raposo
Due to its simplicity, low cost and accuracy, CRISPR-Cas9 has become a promising new technique in the field of gene editing. However, despite its virtues, it is not yet immune to scientific hazards and ethical legal concerns. These concerns have been used to justify opposition to genetic manipulation, and have led to some regulations to ban or impose a moratorium based on the precautionary principle
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Conflict between Children’s Autonomy and Protection in Healthcare. Comparative Study between Spanish and Belgian Law European Journal of Health Law Pub Date : 2019-10-04 Leyre Elizari Urtasun
This article addresses the autonomy of children and adolescents in healthcare decisions, focusing on those ones that might entail a risk to the child's life or health, especially when a medical intervention is refused. In these cases, a conflict between the recognition of the autonomy of the child and his or her protection arises, and various legal systems solve it in different ways. This study examines
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The Vexed Question of the Voluntary Patient European Journal of Health Law Pub Date : 2019-06-19 Hope Davidson
The current statutory framework in Ireland provides certain key safeguards for people who are admitted involuntarily for mental health treatment and care; the same legislation makes scant reference to the person who seeks treatment and care on a voluntary basis. This has led to concerns in relation to deprivation of liberty and to non-consensual medical treatment for these patients. This article seeks
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The Marco Cappato and Fabiano Antoniani (dj Fabo) Case Paves the Way for New Assisted Suicide Legislation in Italy: An Overview of Statutes from Several European Countries European Journal of Health Law Pub Date : 2019-06-19 Gianluca Montanari Vergallo
The article looks into the case involving Fabiano Antoniani, who, following a major road accident, was left tetraplegic. Marco Cappato drove him to a Swiss clinic where Mr. Antoniani took his own life by self-administration of lethal pentobarbital sodium. Cappato was put on trial, but the Italian Constitutional Court urged the Parliament to decriminalise assisted suicide in extremely serious cases
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Permission without Direction: Gross Negligence Manslaughter and Erasure following Bawa-Garba European Journal of Health Law Pub Date : 2019-06-19 Nathan Hodson
This article explores when a doctor convicted of gross negligence manslaughter would be erased from the medical register. The General Medical Council (GMC) sanctions guidance avoids directing the Medical Practitioners Tribunal (MPT) about erasure following gross negligence manslaughter and rulings at the High Court and Court of Appeal argue against any presumption of erasure after a doctor is convicted
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Doctor’s Criminal Liability and Medically Assisted Death – The Portuguese Case European Journal of Health Law Pub Date : 2019-06-19 Vera Lúcia Raposo
Recently, the Portuguese Parliament discussed four proposals aimed at allowing some forms of medically assisted death. However, all of them were rejected by the majority. Therefore, doctors who in some way accelerate a patient's death risk being convicted of the crime of homicide. Portuguese law provides some legal mechanisms that can exempt a doctor from criminal liability, such as causes excluding
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What Is Possible and What Is Not? The Development of a Legal Framework for Drug Pricing Mechanisms in the EU European Journal of Health Law Pub Date : 2019-04-24 Gisela Ernst
As a result of the constantly increasing number of innovative but exceedingly high priced medicines, many Member States have implemented price-regulating mechanisms to ensure the financial viability of their healthcare systems. However, the European Court of Justice applies strict criteria to these measures - some of them have already been suspended for the purposes of the free movement of goods. The
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Health Research, Consent and the GDPR Exemption European Journal of Health Law Pub Date : 2019-04-24 Mary Donnelly, Maeve McDonagh
This article analyses the balance which the GDPR strikes between two important social values: protecting personal health data and facilitating health research through the lens of the consent requirement and the research exemption. The article shows that the normative weight of the consent requirement differs depending on the context for the health research in question. This more substantive approach
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The Legal Framework for the Fight against Female Circumcision: From Cultural Indulgence to Human Rights Violations. The French Example European Journal of Health Law Pub Date : 2019-04-24 Catherine Le Bris
The harmful consequences of female circumcision for women's health have been demonstrated and are regularly recalled by the World Health Organisation. Whereas in the past, the cultural dimension of the practice was emphasised, which result in impunity or absence of guilt, it is now considered by the United Nations as a violation of human rights, especially of the right to health. In 2012, the General
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Medical Negligence, Systemic Deficiency, or Denial of Emergency Healthcare? Reflections on the European Court of Human Rights Grand Chamber Judgment in Lopes de Sousa Fernandes v. Portugal of 19 December 2017 and Previous Case-law European Journal of Health Law Pub Date : 2019-02-15 Julia Kapelańska-Pręgowska
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
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The Sale of ‘Liquid Gold’ in Ireland: Some Thoughts from Tort Law European Journal of Health Law Pub Date : 2019-02-15 Aoife Finnerty
At present, the sale of human milk in Ireland is completely unregulated. When the transaction concerns tainted breast milk and physical harm subsequently occurs, however, it may still be subject to the law of tort. By selling unsafe milk, a seller may be in breach of their statutory duty under the Liability for Defective Products Act, 1991 and their conduct may amount to negligence under the common
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Scientific Uncertainty in Courts. A France-Germany Comparative Perspective on Litigation surrounding Hepatitis B Vaccination European Journal of Health Law Pub Date : 2019-02-15 Alice Milon, Renaud Bouvet
Litigation concerning hepatitis B vaccination provides a good illustration of the difficulties courts encounter when deciding on compensation claims in which scientific uncertainty, whether real or perceived, is present. Despite the difference in approach to vaccination - an obligation in France and a recommendation in Germany -, their vaccine coverage is comparable, as are their regimes of compensation
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Disorders of Consciousness: Is a Dichotomous Legal Approach Justified? European Journal of Health Law Pub Date : 2018-12-26 Richard W.M. Law, 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
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From Privacy to Data Protection in the EU: Implications for Big Data Health Research European Journal of Health Law Pub Date : 2018-12-11 Menno Mostert, Annelien L. Bredenoord, Bart van der Slootb, Johannes J.M. van Delden
The right to privacy has usually been considered as the most prominent fundamental right to protect in data-intensive (Big Data) health research. Within the European Union (EU), however, the right to data protection is gaining relevance as a separate fundamental right that should in particular be protected by data protection law. This paper discusses three differences between these two fundamental
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Refusing Treatment Prior to Becoming Incapacitated: Supported Decision-making as an Approach in Advance Directives European Journal of Health Law Pub Date : 2018-12-11 Hui Yun Chan
Advance directives (ADs) provide people with the opportunity to express their wishes about treatment preferences prior to becoming incapacitated. While the normative logic behind ADs remain straightforward, as instruments of law they are not always effective because of questions about their validity and applicability. It is on this basis that this article attempts to resolve the legal intricacies on
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Can Maternal Spindle Transfer and Pronuclear Transfer Be Prohibited under EU Legislation? European Journal of Health Law Pub Date : 2018-12-11 Calum MacKellar
The question whether maternal spindle transfer (MST) and pronuclear transfer (PNT) can be prohibited under EU legislation was examined by the non-governmental organisation European Bioethics Research (EBR). It did so by submitting an official complaint to the EU Commission proposing that the UK Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 breached the prohibition on
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Please Smoke Your E-Cigarette Proportionally European Journal of Health Law Pub Date : 2018-12-11 Marco Inglese
Directive 2014/40/EU harmonises the manufacture, sales and presentation of tobacco and related products, notably, electronic cigarettes. As its predecessors, Directive 2014/40/EU has already been challenged on three occasions. This article will tackle the Pilbox case and assesses the impact of the principles of proportionality and subsidiarity on market harmonisation and health protection. It seeks
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Patients’ Rights, Medical Error and Harmonisation of Compensation Mechanisms in Europe European Journal of Health Law Pub Date : 2018-12-11 Kenneth Watson, Rob Kottenhagen
In 1999 the Institute of Medicine reported that most medical injuries relate to unavoidable human error in a context of system failure. Patient safety improves when healthcare providers facilitate blame-free reporting and organisational learning. This is at odds with fault-based civil liability law, which discourages a more open (doctor-patient) communication on medical injuries. The absence of a clear-cut
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The Primacy of the Patient’s Wishes in the Medical Decision-making Procedure Established by French Law European Journal of Health Law Pub Date : 2018-11-15 Renaud Bouvet
In its promotion of an autonomy model of decision-making in medical matters, French law, after making patients’ consent to medical procedures compulsory by case law then by legislation, established the primacy of the expression of patients’ wishes. Lawmakers followed the principle of shared medical decision-making and, for situations in which subjects are not fit to express their wishes, created mechanisms
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Data Protection and Biobanks in 2018 European Journal of Health Law Pub Date : 2018-11-15 Jean Herveg
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
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Biobanking between the EU and Third Countries — Can Data Sharing Be Facilitated via Soft Regulatory Tools? European Journal of Health Law Pub Date : 2018-11-15 Santa Slokenberga
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 clini ...
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Making Access to a Population of Bodies in the Name of Autonomy European Journal of Health Law Pub Date : 2018-11-15 Ida Helene Asmussen, Katharina Eva Ó Cathaoir
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
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A Duty to Recontact in the Context of Genetics: Futuristic or Realistic? European Journal of Health Law Pub Date : 2018-11-15 Corrette Ploem, Colin Mitchell, Wim van Harten, 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
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Legalisation of Euthanasia in Finland: Via a Citizens’ Initiative? European Journal of Health Law Pub Date : 2018-07-27 Liisa Nieminen
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
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Cases and Regulation of Advance Decisions in Germany European Journal of Health Law Pub Date : 2018-07-27 Marion Albers
The article clarifies principles, provisions and shortcomings of regulating advance decisions with a view to current regulatory approaches in Germany. The legal framework of instructional directives has been fundamentally amended in 2009. But recent cases illustrate some of the difficulties that arise and several decisions of the highest courts have reopened controversial discussions. The article argues
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From Legislative Shortcomings towards Better Human Rights Protection — Analysis of Legislation on the Emergency Medical Services in Finland and Estonia European Journal of Health Law Pub Date : 2018-07-27 Jenna Uusitalo
Emergency medical service ( EMS ) is designed, above all, to provide urgent treatment for patients with sudden life-threatening diseases or injuries. In wider context, however, EMS is a part of state’s constitutional obligation to guarantee adequate medical care. Therefore, this analysis of how EMS legislation has been drafted and implemented in practice can also be seen to reflect the state’s attitude
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