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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

‘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’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 ...

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

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

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

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

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