Jo Samanta and Ash Samanta

Abstract

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 pertinent to the debate. We examine some of the key considerations that mitigate against punishment alone from being the optimal response to death caused by gross negligence during healthcare delivery. Instead we suggest that a broader focus on patient safety and the public interest is called for to ensure safe systems of work by enhancing organisational accountability and the promotion of professional and institutional duty of candour. We conclude by offering positive proposals for change.

Gianluca Montanari Vergallo

Abstract

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 and counselling centres needs to be expanded and supported; such institutions, in fact, may go a long way in ensuring that women make the best, informed decisions. The author has set out to deal with those issues by means of a comparative analysis. He believes that Italian lawmakers ought to follow in the footsteps of other European countries in order to balance the rights of objecting gynaecologists against those of women who choose to have an abortion, despite the relatively small number of doctors willing to carry out the procedure.

Leyre Elizari Urtasun

Abstract

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 this issue from a comparative perspective between Belgian and Spanish laws, taking into account that the latter was rewritten in 2015 to leave out all underage patients’ decisions that could constitute a risk for their life or health.

Vera Lúcia Raposo

Abstract

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. In Europe, regulation mostly comes from the European Union and the Council of Europe, both very cautious towards gene editing. In this article, two arguments on the future legal framework of CRISPR-Cas9 are made. The first is that continued research will contribute to more scientific accuracy; thus, the precautionary principle should promote regulated research to achieve this aim. The second is that most of the legal and ethical concerns surrounding CRISPR-Cas9 are based on unfounded prejudice emanating from a mystical understanding of the human genome.

Caroline Adolphsen

Abstract

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 international human rights in connection with the subject matter. The aim of the article is also to highlight the grey areas that still exist despite the new rules and to provide legal argumentation for solutions to the issues that can arise in these legal grey areas.

Vera Lúcia Raposo

Abstract

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 the conduct’s wrongfulness, and causes excluding the doctor’s culpability. Other elements to take into consideration are a proper interpretation of homicide crimes, thereby excluding conducts without the intent to kill; the relevance of patient consent; and the rejection of medical futility. This article explains how a doctor may not be held criminally accountable for medically assisted death, even in restrictive jurisdictions such as the Portuguese one.

Gianluca Montanari Vergallo

Abstract

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. From a comparison with other European countries, approaches range from restrictive (banning both active euthanasia and assisted suicide), to entirely permissive. An intermediate approach only entails a ban on active euthanasia. It would be desirable to uniformise the diverse national statutes on a European level, which would make it possible for everyone to receive assistance towards ending their suffering, with limitations to incurable cases to be medically verified, and at the end of a path designed to ensure that patient freedom of choice is upheld at all time.

Nathan Hodson

Abstract

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 of gross negligence manslaughter. The Court of Appeal in Bawa-Garba ruled that the sanctions guidance should not be taken to guide the MPT towards erasure after “serious harm to others either deliberately or through incompetence”, but merely permits erasure in those circumstances. This approach is consistent with the rest of the sanctions guidance which allows the MPT wide discretion and defends that MPT’s case-by- case approach. This promotes decision-making behind closed doors, diminishes the Sanctions Guidance, and makes it difficult to predict when a doctor will be erased after gross negligence manslaughter.

Hope Davidson

Abstract

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 to examine the development of the law in relation to voluntary patients in Ireland and to assess in light of recent developments where Ireland now stands in terms of protecting the right of the voluntary patient to liberty.

Mary Donnelly and Maeve McDonagh

Abstract

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 to consent is reflected in the research exemption which allows for a more nuanced balancing of interests. However, because the GDPR articulates the exemption at an abstract and principled level, in practice the balance is struck at Member State level. Thus, the GDPR increases difficulties for EU cross-border health projects and impedes the policy goal of creating a harmonised regulatory framework for health research. The article argues that in order to address this problem, the European Data Protection Board should provide specific guidance on the operation of consent in health research.

Catherine Le Bris

Abstract

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 Assembly asked States for a total ban on the practice. Despite the consensus on the punishability of female circumcision, its enforcement diverges, in particular in Western Europe. France is considered as a model in this area, that’s why this study focuses on it. Yet, under French law, there is no special legislation criminalising the practice: female circumcision is punishable on grounds of mutilation. However, the French success is not complete: the prevention of such acts could be improved.

Gisela Ernst

Abstract

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 European Union (EU) allowed the development of an ever-stricter case law on one hand, without changing the legal frame on the other hand. Considering the importance and the binding nature of the Court’s judgements, this leaves great uncertainty for national legislators about which measures to remedy the pricing problem are legally possible and which are not. In order to provide clarity, this article seeks to analyse the development of the case law and to define the legal scope for pharmaceutical pricing mechanisms in the EU.

Julia Kapelańska-Pręgowska

Abstract

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.

Aoife Finnerty

Abstract

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 law.

Alice Milon and Renaud Bouvet

Abstract

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 for damage attributed to vaccination, whether on the basis of producer liability or national solidarity. Confronted with scientific uncertainty, German and French courts choose to make use of presumptions to establish legal causality that is not contingent on scientific causality. German and French case law diverge however, with regard to their relationship to scientific criteria of causality, the volume of court cases, and consideration of claims, highlighting what seems to be a distinctive situation in France.

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.

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.

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.

Jean Herveg

Abstract

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

Abstract

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.

Edited by Anne-Marie Duguet and Emmanuelle Rial-Sebbag

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.

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).

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.

Marion Albers

Abstract

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 that both the making and the implementation of advance directives involve decisions made under conditions of uncertainty. Regulations must be and are already quite complex. Even so, problems are predictable if advance decisions are not embedded in a broader context of advance care planning.

Jenna Uusitalo

Abstract

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 towards the protection of human rights. A comparison between legal provisions on EMS in Finland and Estonia has been performed in order to illustrate these differentiations. Essentially, the article argues that Estonian EMS legislation seems to contribute more significantly to human rights protection, whereas Finland is more economically oriented in its attitude. However, both jurisdictions also contain some advantageous provisions, which could enhance the quality and improve the recognition of human rights in other states as well.

Aisling de Paor

Abstract

With developments in the field of genetics, new technologies such as genetic testing are fast emerging. Although offering unparalleled opportunities, these developments raise many ethical, legal and other issues. One challenge relates to the duty of confidentiality and disclosure obligations on doctors. Considering the familial nature of genetic information, doctors will increasingly have access to predictive health information, about individuals and individuals’ relatives. This article examines whether disclosure obligations on doctors should be expanded to encompass an obligation to disclose genetic risk to family members, and whether the exceptions to the duty of confidentiality should recognise genetic risk as potential harm. With recognition of the competing rights, the article considers the implications of recent case law in the United Kingdom, indicating a willingness to extend the duty of disclosure. This article argues that there is a case to be made for expanding disclosure obligations on doctors in certain circumstances.

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.

Giovanni Comandè and Giulia Schneider

Abstract

Health data are the most special of the ‘special categories’ of data under Art. 9 of the General Data Protection Regulation (GDPR). The same Art. 9 GDPR prohibits, with broad exceptions, the processing of ‘data concerning health’. Our thesis is that, through data mining technologies, health data have progressively undergone a process of distancing from the healthcare sphere as far as the generation, the processing and the uses are concerned. The case study aims thus to test the endurance of the ‘special category’ of health data in the face of data mining technologies and the never-ending lifecycles of health data they feed. At a more general level of analysis, the case of health data shows that data mining techniques challenge core data protection notions, such as the distinction between sensitive and non-sensitive personal data, requiring a shift in terms of systemic perspectives that the GDPR only partly addresses.

Gianluca Montanari Vergallo, Enrico Marinelli, Natale Mario di Luca and Simona Zaami

Abstract

Medically assisted fertilization techniques give rise to a wide array of issues, such as the rights to secrecy, partial anonymity or to the full disclosure of information about the donors’ identities. The authors espouse the right of donor-conceived children to know their biological origins, and delve into opposing views, either in favour of the gamete donors’ right to anonymity or against it. Be that as it may, the right to know one’s biological origins has been gaining a foothold as part of the broader right to personal identity. The latter is in fact codified and upheld in numerous international treaties and conventions as a fundamental human right. The authors expound upon the Italian legislation, which is designed to enforce total donor anonymity. Against that backdrop, the authors weigh the suitability of further regulating access to sensitive, identifying information about the procreation methods involved in each case.

Cinzia Piciocchi

Abstract

This article addresses the interactions between medicalisation and juridification and their impact on the concepts of health and illness. Juridification, de-juridification, medicalisation and de-medicalisation are defined in many different ways and it is particularly interesting to see how they affect each other, impinging on individual freedom and contributing to shaping the definition of health and illness and their public understanding. Juridification and medicalisation are particularly affected by the shifting perceptions of the public and private interests at stake, even if the identification of the public or private interest is not an easy task, especially when ethically controversial issues come into play. Nevertheless, the private/public interest analysis is a crucial issue in the understanding of the interactions between these two concepts and in the identification of the boundary lines between them, giving an important key to the understanding of their influence on the rights and liberties at stake.

Annagrazia Altavilla

Abstract

European Union (eu) action in the pharmaceutical sector has always had the dual objective of safeguarding public health by providing Europe with safe and effective medicines, while stimulating research, boosting innovation, and supporting the competitiveness of industry. To face major health, economic and scientific challenges, a series of measures have been adopted. Specific legal frameworks have been set up to improve patient safety by reducing the infiltration of counterfeit medicines into the supply chain, to increase the safety of medicines by modernising the pharmacovigilance system, as well as improving patient access by requiring high-quality health and medicine information. This article provides an overview of the new eu strategy aimed at increasing the safety and involvement of European patients, as well as the competitiveness of pharmaceutical industry in accordance with the principle of transparency. The analysis is carried out from a patients’ perspective addressing some paediatric specifications.

Elisavet Athanasia Alexiadou

Abstract

Roma, the largest and oldest ethnic group in Europe, systematically encounter difficulties in healthcare settings, while they are often exposed to high levels of poverty and social exclusion, adversely affecting their health and well-being. In light of this disturbing situation, this paper sets out to examine Roma access to healthcare in Europe from a human rights perspective. This will be followed by an assessment of the status of the Roma right to health (care) within a particular national reality (resource constraints and rising health inequalities). In fact, this case study tends to serve as a piece of discussion about issues relating to Roma access to healthcare, many of which exist (to some extent) in every country across Europe. Finally, practical recommendations are proposed as a way for remedying human rights abuses against Roma in healthcare settings and ultimately, for effectively realizing the Roma right to health (care).

Athanasios Panagiotou

Abstract

Despite the proposals to jettison fault/negligence as the fundamental criterion of imputation of medical liability, it remains at the core of most legal systems. At European level, the rise of cross-border healthcare has brought the issue of redress for medical malpractice and the need to enhance quality of care through the adoption of quality and safety standards to the fore. Furthermore, the necessity of best available external evidence to inform approaches to individual patient care is gradually acknowledged. In addition, clinical guidelines become an increasingly familiar part of clinical practice. Hence, the debate on their usefulness in medical malpractice cases has attracted significant scholarly attention. Despite their superficial attractiveness, clinical guidelines present core problems, which currently make them unsuitable as a determinant of the standard of care. The article concludes that, unless these issues are resolved, the usefulness of clinical guidelines in medical liability will be debatable.

Remigius N. Nwabueze

Abstract

Hughes and Stuart’s shocking and unexpected deaths from the transplant treatments they received at Cardiff’s University Hospital of Wales could, in Lord Denning’s terminology, be described as ‘a most extraordinary chapter of accidents’. As Hughes and Stuart’s transplant treatments were based on expanded criteria donor kidneys, their deaths underscore not only the perennial problem of organ shortage in England and Wales which necessitates the clinical use of ‘high risk’ organs; but also, their deaths invite a re-examination of some of the ethical and legal issues involved in transplantation with expanded criteria donor organs. Being incomparable in calamity and rarity, the Welsh transplant incident is bound to raise novel issues of first impression in negligence, issues that this essay attempts to identify and analyse.

Mary Donnelly

This article examines the legislative frameworks for advance healthcare planning in England & Wales (the Mental Capacity Act 2005) and in Ireland (the Assisted Decision-Making (Capacity) Act 2015), undertaking a comparative analysis of each measure, with particular focus on the detail of the approaches taken. It is only through this kind of detailed focus that the normative choices made by legislation can fully be understood and evaluated. The article argues that, in several respects, possibly because the drafters were able to reflect lessons learned from other jurisdictions, the Assisted Decision-Making (Capacity) Act 2015 provides a more rounded and complete form of advance healthcare planning than that provided by the Mental Capacity Act. This is on the basis that it provides more protection for patient choice; better potential for delivery on the choices made; and a more appropriate balance between formalities and enforceability.

Andrea Boggio

Since 2004, the regulation of assisted reproduction in Italy has undergone substantial reform as an effect of key judicial intervention. Limitations on embryo production, screening and transfer, the prohibition against engaging in preimplantation genetic diagnosis (pgd) and embryo selection, and the ban on gamete donation have all been removed by courts. In this article, I discuss how judicial intervention has improved the ability of Italian couples to access assisted reproduction technologies (arts), and how the expansion of reproductive rights is, however, still incomplete. In particular, I discuss the challenges in implementing the liberalisation of gamete donation, and identify the practical, political and cultural reasons for limited access to gamete donation. I also discuss the future of the prohibitions and restrictions that still exist in Law 40/2004.

Gabriella Berki

The language barrier and the lack of reliable information were identified as major practical obstacles of European patient mobility. Patients are highly concerned about the ability to communicate with their doctors when obtaining healthcare in a country where they do not speak the local language, as well as they find it complicated to gather all the necessary information about an unfamiliar healthcare system or about their cross-border healthcare entitlements conferred on them by the Union legislation. In a multilingual and patient-friendly European Union these issues must be tackled in order to ensure effective healthcare and to enforce patients’ right to cross-border healthcare. This article investigates the current legal tools within the European Union on language gap in patient-provider communication and access to information on cross-border healthcare entitlements. Moreover, it offers some possible solutions for the future.

Neil Maddox

This article examines the relationship between the existence of control rights and property in separated human biomaterials. Much of the theory as to what constitutes property is examined and it is contended that Article 22 of the Convention on Human Rights and Biomedicine does not presuppose property in such materials. An analysis is undertaken of the case-law relating to control and property in sperm and embryos from the uk, Australia and the us and the shortcomings of utilising the property paradigm in these disputes are highlighted.

Geneviève Michaux

European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

Calum MacKellar

Abstract

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 the modification of a person’s germ line genetic identity of the eu Clinical Trials Directive 2001/20/EC and the new Regulation eu 536/2014. A discussion then took place, during 2016, between ebr and the eu Commission whether mst and pnt principally involved a ‘medicinal product’ in which case the eu Clinical Trials Directive 2001/20/EC and Regulation eu 536/2014 would be applicable or whether the procedures just involved a medical procedure in which case the Tissue and Cells Directive 2004/23/EC was applicable which did not include any prohibition on the intentional modification of a person’s germline.

Menno Mostert, Annelien L. Bredenoord, Bart van der Slootb and Johannes J.M. van Delden

Abstract

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 rights, which are relevant to data-intensive health research. Firstly, the rights based on the right to data protection are of a less context-sensitive nature and easier to enforce. Secondly, the positive obligation to protect personal data requires a more proactive approach by the eu and its Member States. Finally, it guarantees a more comprehensive system of personal data protection. In conclusion, we argue that a comprehensive system of data protection, including research-specific safeguards, is essential to compensate for the loss of individual control in data-intensive health research.

Kenneth Watson and Rob Kottenhagen

Abstract

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 definition of ‘medical error’ complicates litigation and hence swift, appropriate patient compensation. No-fault systems perform better in this respect. A dual track liability system for medical malpractice is challenging to implement and operate, yet may be the only option for Pan-European harmonisation of medical liability.

Marco Inglese

Abstract

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 to demonstrate that, contrary to the old-fashioned stream of case law on this subject, the battlefield has been shifted from the scope of Art. 114 tfeu to the impact of general principles of eu law. It then assesses how health protection increasingly permeates internal market legislations, leading to a sort of ‘paternalistic’ harmonisation. Finally, it argues that after two decades of disputes concerning tobacco products, the Court of Justice of the European Union (cjeu) has successfully ended litigations on Directive 2014/40/eu, holding that its compliance with the principles of proportionality and subsidiarity is beyond doubt.

Hui Yun Chan

Abstract

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 ads refusing treatment prior to becoming incapacitated. The author advances a thesis in support of a modification of an approach known as supported decision-making to facilitate people in making ads. This approach pre-empts most of the doubts about an ad’s validity. The argument is founded on the presumption that an ad made using the supported decision-making approach provides a higher degree of assurance about the circumstances surrounding the making of ads, rendering it more likely to be binding on healthcare professionals.

Vicki Paskalia

Abstract

In March 2011, a new Directive was adopted by the European Parliament and the Council of the European Union: Directive 2011/24, on the application of patients’ rights in cross-border healthcare, the primary purpose of which has been to facilitate access to healthcare across national borders. Healthcare safety and the availability of legal remedies in cases of harm are important parameters of quality healthcare and important patients’ rights in modern healthcare systems, and they are therefore important issues in a context of cross-border patient mobility. The aim of this article is to shed some light on the provisions of the Healthcare Directive in relation to the issue of legal remedies in cases of harm. It is argued that the current legal state should be considered unsatisfactory, problematic and in need of more clarity and even harmonisation.

Sara Gerke and Shaun D. Pattinson

Abstract

Over the last 15 years, there has been a steady increase in the development of orphan medicinal products (omps). This raises an important question: What impact does the eu marketing authorisation of an omp have on related research? This article establishes that the key orphan incentive, namely the 10‑year market exclusivity provision laid down in Article 8 of the eu Regulation on omps (Regulation 141/2000), has a huge potential impact on related research. It is argued that this provision can make it too difficult for researchers/sponsors to attain marketing approval for closely related products. This article advances two proposals to address this problem. First, it argues for new principles for assessing similarity, so as to clarify and narrow the ambit of market exclusivity. Secondly, it argues for improved conditions for a demonstration of ‘clinical superiority’ for similar omps.

Lena Wahlberg and Johannes Persson

Abstract

In Swedish law, the notion of ‘science and proven experience’ (in Swedish, vetenskap och beprövad erfarenhet) defines the gold standard for public decision-making and practice, especially in medicine. The notion is notoriously vague but nevertheless plays an important role in the distribution of rights and duties of patients and healthcare workers. For example, failure to provide care in accordance with this standard can lead to penal responsibility. The notion also helps to define Swedish patients’ right to reimbursement for cross-border healthcare. From a legal point of view, the notion is especially intriguing because it appears to import medical standards into the legal conceptual apparatus. The purpose of this article is to explore the mechanisms of this and kindred ‘importing notions’ by investigating the role that the notion of science and proven experience plays in Swedish law and in the transfer of information between the legal and medical fields.

Piet Calcoen and Wynand P.M.M. van de Ven

Abstract

Recent European Court of Justice (ecj) case law has highlighted apparent inconsistencies in ecj rulings on the regulation of voluntary additional health insurance. In 2013, the ecj upheld Belgian regulations limiting the operation of the free market by restricting increases in premium rates of additional health insurance contracts. By contrast, in 2012, an ecj ruling required Slovenia to repeal such restrictive legislation and not to hinder the operation of the free market. The objective of this article is to feed the discussion on the question whether and under what conditions free-market-driven additional health insurance in the European Union might be acceptable. We conclude that, provided that basic health insurance effectively covers all essential healthcare (essential healthcare services being broadly defined), additional health insurance could be regulated in the same way as all other non-life insurance.

Ruth Horn

Abstract

This article explores factors that impede the implementation of advance directives to refuse treatment (ads) in three European countries: England, Germany and France. Taking into account socio-cultural and legal aspects, the article shows the extent, to which the law can, and does, influence physicians’ decisions to implement ads. The findings presented are based on qualitative interviews exploring physicians’ sense of duty to respect ads and the reasons given for failing to implement the law. It will be argued that this depends on: 1) how strictly the legal status of ads is defined, and 2) whether the law actually addresses the reasons why physicians may hesitate to implement ads (e.g. uncertainty about validity, importance of patient preferences). The article emphasises the importance of doctor-patient communication and shows how the implementation of ads could be improved by making discussions about treatment preferences a legal requirement.

Paul Quinn

Abstract

Personal health data is essential to many forms of scientific research. Such data may come from a large variety of sources including electronic health records (ehrs), datasets used for previous research and from data linked to biobanks. European data protection law recognises that in addition to using consent as a legal basis for the processing of personal health data for scientific research, such data may be used without consent where it is in the ‘public interest’. Despite the existence of such a legal option, ethics bodies in a number of states have shown reticence to utilise it, often pushing researchers into either obtaining consent or anonymising the data in question. Whilst the latter option may be appealing from a legal point of view, if carried out properly, the result may be that the research value of the data is reduced or even destroyed.

Clemens M. Rieder

Abstract

The national welfare state, so it seems, has come under attack by European integration. This article focuses on one facet of the welfare state, that is, healthcare and on one specific dimension, that is, cross-border movement of patients. The institution which has played a pivotal role in the development of the framework regulating the migration of patients is the European Court of Justice (ecj). The Court’s activity in this sensitive area has not remained without critics. This was even more so since the Court invoked Treaty (primary) law which not only has made it difficult to overturn case law but also has left the legislator with very little room for manoeuvre in relation to any future (secondary) eu law. What is therefore of special interest in terms of legitimacy is the legal reasoning by which the Court has made its contribution to the development of this framework. This article is a re-appraisal of the legal development in this field.

Katherine Wade*

Abstract

It is important that clinical research with children is encouraged so that they are not exposed to the dangers of extrapolation from adult treatments. Clinical trials with investigational medicinal products (imps) are an important part of improving medical care for children. Both the 2001 Clinical Trials Directive and the 2014 Regulation recognise the need for such research, including the need for non-therapeutic trials with imps. However, it is also recognised that a balance must be struck between permitting tailored medical care for children as a group on the one hand, and protecting individual trial participants from harm on the other. A central issue in striking this balance relates to defining the threshold of risk which should be permitted in such research. This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with imps and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the us.

Nadezhda Purtova

Abstract

eHealth Platform as a Service (‘PaaS’) is an innovative way to build mHealth apps out of cloud-based generic components. Having examined the current and future regimes of safety and performance, this article concludes that the ‘selling features’ of the PaaS (outsourced creation and maintenance of cloud-based parts for easy mHealth-building) undermine legal compliance, and the reform will not change this significantly. Although no safety and performance requirements apply yet to consumer eHealth, the medical apps are regulated. Their manufacturers must ensure the final apps are safe, while not being in control of the parts composing the apps. Generic components not meant for a specific medical device and their providers are not subject to safety and performance requirements. Market will likely push PaaS providers to offer mHealth manufacturers tools to ensure and control safety and performance when medical apps are concerned. I foresee no such incentives for consumer mHealth.

Dawid Sześciło

Abstract

A welfare state crisis resulting from austerity policies creates risks to healthcare systems throughout Europe. It escalates the pressure to reduce State responsibilities and weakens the guarantees of accessibility and quality of health services. One of the most effective barriers to this tendency might be a strong constitutional standard of the right to health. This article reviews the constitutional acts of 28 European Union Member States in order to explore the scope of protection of the right to health, with a special focus on the various aspects of equity of access to healthcare. It also shows the absence of a universal European standard of the constitutional regulation of this matter, and describe major differences relating to formulation, level of protection guaranteed, and the material scope of regulation. In conclusion, a hypothesis is proposed on the potential role of constitutional guarantees in preventing the deterioration of accessibility of health services.

Clayton Ó Néill

Abstract

This article considers the degree to which the religious beliefs of Jehovah’s Witnesses are given consideration in European and English courts. Adults’ refusal of blood transfusions is examined within the context of European human rights jurisprudence. A focus is also placed on the position of Jehovah’s Witness children who refuse blood transfusions in the specific context of English medical law due to the prevalence of related case law in this jurisdiction. It is argued that the European Court of Human Rights has given appropriate protection to the will-rights of competent adult Jehovah’s Witnesses who refuse blood transfusions. The position of children is somewhat different, and it is suggested that the courts should give greater consideration to the rights of competent children to manifest their religious beliefs.

Perihan Elif Ekmekci

Abstract

Cross-border healthcare and patient mobility across European Union Member States has been on the agenda of eu Commission for the last decade. Directive 2011/24/eu on the application of patients’ rights in cross-border healthcare went into force in 2013. The Directive mainly addresses the responsibilities of Member States in cross-border healthcare, regulates reimbursement procedure, and coordinates European reference networks and health technology assessment in the eu. The Directive has direct and indirect implications on Turkish health system. In this article, first an overview of Directive 2011/24/eu is addressed with special attention to its relation to patient rights and other eu legislations. Then, Turkish citizens’ position in the scope of eu legislation on patient rights is considered. Finally, the ethical implications of the Directive, conceptualisation of cross-border patient mobility, and Turkey’s particular position among other candidate countries regarding cross-border healthcare is discussed.