Showing papers in "European Journal of Health Law in 2011"

Age Determination of Unaccompanied Asylum Seeking Minors in the European Union: A Health Law Perspective

Abstract: In the European Union, unaccompanied asylum seekers below 18 years of age are entitled to specific treatment. Age assessment practices to verify the age-statement by the asylum seeker differ between EU Member States. Medical methods in use raise questions about accuracy, reliability and safety. The medical, legal and ethical acceptability of invasive methods (notably X-rays) in particular is controversial. Human rights are at stake. The lack of common practices results in different levels of protection (discrimination). The absence of standardisation is an obstacle for the functioning of the Common European Asylum System. EU Best Practice Guidelines should remedy the situation; such guidelines should reflect the best interest of the child.

Access to health care for illegal immigrants: a specific organisation in France.

Abstract: Health care is a fundamental human right in Europe, and all Member States recognise everyone's right to the access to preventive healthcare and to receive medical care in the event of sickness or pregnancy. Nevertheless, this right is focused on citizens and the application to migrants, particularly undocumented migrants, varies widely in the EU. The French legislation is organized with a humanitarian approach. In this article, the authors present the French system of social protection, the "Couvernture medicale universelle" or CMU, which provides the same protection to asylum seekers and documented immigrants as to nationals, and the "Aide medicale d'etat" or AME, that is open to every person who does not fulfil the legal conditions to obtain the CMU, such as illegal immigrants. Created in 1995, recently access to the AME has been restricted. A claim of discrimination has been rejected by the Conseil d'Etat and 215,000 persons received the AME in 2009. The expenses incurred by the AME increased by 17% in 2010, and there is a debate in Parliament to limit care and to ask the recipient for a financial contribution.

Pushing the boundaries of lawful assisted dying in The Netherlands? Existential suffering and lay assistance.

Abstract: Two matters that have a significant presence in the contemporary Dutch assisted dying debate, are the nature of the suffering required for an assisted death to be lawful, and the issue of who can lawfully assist. This article explores whether the lawful medical assisted dying model is too restrictive in failing to recognise existential suffering, considering selected case studies involving such suffering and lay assisted death. It addresses the question whether The Netherlands would take a trip down a slippery slope if the lawful model of assisted death were extended to cases where individuals are 'tired of life'.

Market introduction of innovative high risk medical devices: towards a recast of the directive concerning medical devices.

Abstract: The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a "recast" of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA.

Consent Forms in Genomics: The Difference between Law and Practice

Abstract: Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant information and consent documentation in the future studies.

Provision of health services to irregular migrants with a special focus on children.

Abstract: All European countries are now facing a situation where a part of the population consists of migrants without a permit to stay or reside. These persons may have health problems, and the question then rises regarding health services to irregular migrants. Normally, welfare benefits are offered those with a relationship to the country concerned, as citizen, asylum seeker, tourist, etc. Irregular migrants are outside the society, and it could be suggested that they therefore should be denied health services. On the other hand, common European standards of humanity lay obligations on the States, for example, where situations are life-threatening. This contribution gives an overview of relevant legal instruments, both from the UN, Council of Europe and the European Union. Although there are many similarities, the instruments have their differences, and there may even be some tensions regarding the underlying values.

News & Views Ethical Standards For Clinical Trials Conducted In Third Countries: The New Strategy of the European Medicines Agency

Abstract: Clinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications Reference to the EMA Reflection paper is made

The way assisted suicide is legalised: balancing a medical framework against a demedicalised model.

Abstract: To date, in three European countries and three American states--i.e., The Netherlands, Luxemburg, Switzerland, and the states of Oregon, Washington and Montana--it is permitted by law for one person to assist in the suicide of another person. When comparing the legislations of these countries/states, it becomes apparent that The Netherlands, Luxemburg, Oregon, Washington and Montana have chosen a medical approach (the so-called medical model), whereas the Swiss legal framework for assisted suicide is clearly a non-medical one (the demedicalised model). The differences between these two models mainly concern two aspects: the requirement as to the capacity of the person providing assistance in suicide and the condition regarding the state of health of the person committing suicide. A closer view on the practice of assisted suicide in the depenalising countries shows that the differences are smaller than initially thought. Nevertheless, important distinctions still remain. When analysing which model is most preferable, it is concluded that an involvement of a physician is inevitable and necessary and that the requirement of a certain medical condition is needed to set a clear and objective limit.

News & Views As Easy as A, B and C: Will A, B and C v. Ireland Be Ireland’s Wake-up Call for Abortion Rights?

Abstract: This article examines the development of Ireland’s abortion policy from 1861 to the present day. It explores the reasoning for this policy as well as the inherent problems with this policy. It examines in detail the A, B and C v. Ireland judgement and its impact, (if any) on Irish abortion law. Finally, it discusses the margin of appreciation doctrine used by the European Court of Human Rights in deciding cases of a moral nature.

Saviour-sibling and the psychological, ethical and judicial issues that it creates: should English and French legislators close the Pandora's Box?

Abstract: Since the advent of test-tube babies, advances in the biomedical field have risen steadily. In parallel, the scientific body has never since ceased to debate the ethical issues that they arise. This is particularly the case regarding saviour-sibling. Saviour-sibling refers to a child who is conceived to cure an older brother or sister suffering from a serious family genetic disease. Therefore, it is meant to give birth to a child who will provide stem-cells taken from the umbilical cord or bone marrow afterwards, to treat an elder sick sibling. In England, this practice has been explicitly allowed by the new Human Fertilisation and Embryology Act 2008 under some strict conditions. In France, this practice, authorized by the Bioethics Law of August 2004 and confirmed by its decree of implementation published in the Official Journal on 23 December 2006, is also strictly regulated. This technique opens up new perspectives and enormous hope. Its legalisation is certainly justified by the suffering of the parents and to avoid that they travel to other States where it is permitted. However, it raises serious psychological ethical and judicial issues. Following an analysis of the English and French laws on saviour siblings, its controversial side will be highlighted, before concluding whether or not this new Pandora's box which is saviour-sibling, should be closed and other alternative methods encouraged.

Parents As Decision-Makers — Do the Attitudes of Norwegian Doctors Conform to Law?

Abstract: This article studies whether the attitudes of Norwegian doctors regarding surrogate decision power in end-of-life care conform to legal rules, particularly as they apply to the protection of children. The article is based on a hypothetical scenario concerning a critically ill child, believed to be dying, presented to 406 doctors. The study indicates that doctors may permit parental/surrogate decision-making to a greater extent than justified by law, sometimes in contravention of the child's best interests, which should be a fundamental guideline in all decisions that concern children. This article suggests a need to improve knowledge of doctors concerning parents'/surrogates' right to participate in life-or-death decisions. We conclude that Norway needs a precedent decision from the Supreme Court that confirms the right of judicial review of end-of-life decisions, and which applies the principle of the child's best interests as a fundamental guideline in the final decision.

Introduction of a national electronic patient record in The Netherlands: some legal issues.

Abstract: The electronic patient record (EPR) is a major technological development within the healthcare sector. Many hospitals across Europe already use institution-based electronic patient records, which allow not only for electronic exchange of patient data within the hospital, but potentially also for sharing medical data with external healthcare providers, involved in the patient's care, such as general practitioners or pharmacists. In this article, we discuss the attempt made by the Dutch government to introduce a nationwide electronic patient record (n-EPR). Describing and analyzing the new legislation that is currently being developed to establish the infrastructure for the n-EPR and the related legal issues, we conclude that the introduction of a n-EPR give rise to some substantial concerns. These vary from technical and quality issues such as the reliability of patient data and sufficient standardization and interoperability of the systems used, to issues in the field of data security and confidentiality. For a successful introduction of the n-EPR within the healthcare sector, a condicio sine qua non is that the related legislation provides sufficient safeguards and clarity with respect to the responsibilities and liabilities of its main users: the healthcare professionals.

"Braxton Hick's" or the birth of a new era? Tracing the development of Ireland's abortion laws in respect of European Court of Human Rights Jurisprudence.

Abstract: In Ireland, Article 40.3.3 degrees of Bunreacht na hEireann (the Irish Constitution) guarantees the right to life of the unborn child and the equal right to life of the mother. Abortion in Ireland is permissible only where there is a real and substantial risk to the mother's own life. Since Ireland became a signatory to the European Convention on Human Rights in 1950,2 there have been concerns that it could result in Ireland being compelled to introduce a right to abortion. This article commences with a review of the extant law on abortion in Ireland, tracing the Constitutional protection afforded to the unborn child. The article will discuss the impact of the European Court of Human Rights' jurisprudence in regard to access to abortion and to information on abortion services in Ireland in an effort to ascertain if it really has resulted in a radical change to Irish abortion laws. As such, it will also be necessary to examine the more recent decisions of the ECtHR such as Tysiac v. Poland, and A, B, and C v. Ireland, to determine both the approach of the ECtHR to access to abortion in general and also to consider if it has resulted in a liberalisation of abortion law in Ireland.

Access to advanced therapy medicinal products in the EU: where do we stand?

Abstract: The European Union has a public health strategy and will generally ensure in all its policies and activities a “high level of human health protection”. The new Regulation (EC) n o 1394/2007 on advanced therapy medicinal products (ATMP), stems from this global policy and aims to harmonise access to the ATMP market. A real will for the harmonisation is clearly expressed in legal texts and enforced in the implementable procedures and requirements. However, several barriers remain. On the one hand, the scope of the ATMP Regulation is limited. On the other hand, Member States benefit from a wide margin of action.

Concurrence between complaints procedures in the Dutch healthcare system.

Abstract: There are various ways in which complaints about healthcare providers’ performance can be handled in the Netherlands. In practice, situations occur relatively frequently in which one and the same treatment by a provider results in various different complaints procedures being instigated or, in other words, in concurrence between complaints procedures. Dutch periodicals published information on a total of 42 cases of concurrence between 1997 and 2007. Concurrence between complaints procedures prompts a series of questions about how it arises, its legal implications, the possible consequences for those involved and whether it has any added value. This article examines these various issues.

Use of the Dead Body in Healthcare and Medical Training: Mapping and Balancing the Legal Rights and Values

Abstract: By exploring the central legal principles and issues regarding usage of the dead body in healthcare and especially in medical training, this article aims at drawing some general conclusions on the legal status of the dead body and the protection of the deceased's integrity, dignity and autonomy The article demonstrates that the use of the cadaveric body for scientific and educational purposes involves a redrawing of the traditional boundaries between the decent and the indecent, making these acts acceptable that would otherwise be regarded as assaults on the sanctity of bodily boundaries This is made possible by the fact that the underlying principle of dignity is not perceived to be of an absolute nature when applicable to deceased persons

The new regulation of abortion in Spain.

Abstract: The enactment of Law 2/2010 on Sexual and Reproductive Health and on Voluntary Interruption of Pregnancy represents a radical change in the regulation of abortion in Spain. The law moves from the medical indication model that has been in place since 1985 (which established certain cases in which abortion was legal) towards a time-limit model that, with some exceptions, allows free abortion during the first 14 weeks of pregnancy. Along with the hot debate that this fundamental change has caused, other features of the law have also arisen as a source of conflict, including the regulation of the informed consent of underage women for having an abortion and the rules regarding the conscientious objection by healthcare professionals.

A Matter of Health? Legal Aspects of Private Umbilical Cord Blood Banking

Abstract: Private umbilical cord blood banking raises a question of special legal regulation. This practice promises the safe storage of biological material on the assumption that it may be useful, at a certain moment in future, for its own donor (or for a donor’s close family member) for curing serious blood diseases. Although currently the therapeutic value of umbilical cord blood is confirmed, there are strong scientific doubts and relevant controversies regarding its use in autologous transplantations. This fact produces conditions of legal uncertainty, since the benefit for those wanting to conclude contracts with private umbilical cord blood banks is not clear. The Greek example illustrates this situation of regulatory deficit well, which eventually creates a major problem, given the increasing number of private banks offering relevant services in the country.

A French hospital sentenced for unreasonable obstinacy.

Abstract: On 2 June 2009, the Nimes administrative court condemned the Hospital of Orange (France) for unreasonable obstinacy after neonatal resuscitation. On 14 December 2002, an apparently stillborn child was resuscitated after approximately 30 minutes of foetal distress. Cardiac activity was recovered, but the child has since suffered from severe disabilities. The court did not find any fault committed by the hospital regarding maternal care. However, the hospital was sentenced to compensate for the injuries caused by unreasonable obstinacy. According to the court, the medical team should have taken into account the harmful neurological consequences of prolonged foetal distress. The court did not condemn the act of resuscitation itself, but its excessive length. This court ruling serves as a basis for reflection regarding the limits by which unreasonable obstinacy should be set.

Monitoring quality in a federal state with shared powers in healthcare: the case of Belgium.

Abstract: The Belgian healthcare system consists of a complex of more or less autonomous groups of healthcare providers. It is the responsibility of the government to ensure that the fundamental right to qualitative healthcare is secured through the services they provide. In Belgium, the regulatory powers in healthcare are divided between the federal state and the three communities. Both levels, within their area of competence, monitor the quality of healthcare services. Unique to the Belgian healthcare system is that the government that providers are accountable to is not always the same as the government that is competent to set the criteria. The goal of this article is to provide an overview of the main mechanisms that are used by the federal government and the government of the Flemish community to monitor healthcare quality in hospitals. The Flemish community is Belgian's largest community (6.2 million inhabitants). The overview is followed by a critical analysis of the dual system of quality monitoring.

Disclosure of medical data to relatives after the patient's death: recent legal developments with respect to relatives' entitlements in the Netherlands

Abstract: In the Netherlands the physician is still bound to professional confidentiality after the patient's death. However, in the legal doctrine and in case law some exceptions have been recognized, especially for circumstances where the relatives have a legitimate interest in the inspection of medical records of the deceased. Today developments as regards the Dutch proposal to new legislation on patients' rights, notably the proposed insertion of a provision stipulating the conditions under which the relatives have a right of access to medical records of the deceased, give cause for renewed consideration of this issue related to legal protection after death. This article explores whether the proposed provision corresponds to the prevailing principles regarding disclosure of medical data after death. It is concluded that there is a need to reconsider the provision's wording or to adhere to self-regulation of the Royal Dutch Medical Association in order to strike an appropriate balance between the various interests concerned.

Intellectual disability, autonomy, and legal rights

Abstract: Andreas Dimopoulos’ book Issues in Human Rights Protection of Intellectually Disabled Persons1 provides a timely and thoughtful addition to the complex but vital debates on normatively sound, practically robust legal rights for adults with diminished or contested autonomy. It also offers health lawyers an opportunity to reflect on the nature of our work. What paradigms inform our critiques? Would the norms our works develop wrongly harm, ignore, or exclude rightful members of society? How representative is legal principle of guiding norms in social and professional practice? Should we seek abstract ethical principles to resolve imperfections in the law? Such questions come to the forefront when reading Dimopoulos’ book. In this review article, I explore his analysis, interrogating his critique and exposing areas where I would depart from his methods, findings, or conclusions. Dimopoulos’ work is impressive and engaging, and an important contribution on an issue that receives too little attention. My arguments are intended to add constructively to the dialogue of which his book forms a part. I give a detailed and evaluative presentation of his argument, and end with a short, more generally reflective discussion.

Preserving Life and Facilitating Death: What Role for Government after Haas v. Switzerland?

Abstract: In our 'rights society' we seek to vindicate and protect, through our legal and political institutions, those rights we view as fundamental to human flourishing However, changing social mores and limitations in our ability to relieve (or cope with) certain health conditions have resulted in unanticipated demands being placed on those rights; patients rely on them in seeking death, which is not normally associated with flourishing and which is largely antithetical to rights and health regimes aimed at promoting or preserving human life The recent European Court of Human Rights decision in Affaire Haas v Suisse demonstrates the challenge of relying on rights to achieve death Haas is the most recent case aimed at articulating the scope of individual autonomy and the duties of government in assisted dying scenarios Once again, the applicant has invoked rights to achieve 'a good death', and in doing so has called upon public authorities to take some action to assist him This paper considers Haas in the context of its predecessor European case, Pretty v United Kingdom, offering some observations about how they differ and why Haas had little chance of success, and was correctly decided