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The European healthcare sector is transforming toward patient-centred and value-based healthcare delivery. The European Health Data Space (EHDS) Regulation aims to unlock the potential of health data by establishing a single market for its primary and secondary use. This paper examines the legal challenges associated with the secondary use of health data within the EHDS and offers recommendations for improvement. Key issues include the compatibility between the EHDS and the General Data Protection Regulation (GDPR), barriers to cross-border data sharing, and intellectual property concerns. Resolving these challenges is essential for realising the full potential of health data and advancing healthcare research and innovation within the EU. [ABSTRACT FROM AUTHOR]

This paper focuses on the COVID-19 vaccines authorised for use in the European Union, and explores the mechanisms in place to control vaccine safety and to compensate injured patients, mainly in the context of European law. Based on these considerations, the paper concludes that the refusal by some potential vaccinees to take the vaccine based on safety concerns is ungrounded and an indication of unrealistic expectations, but that in order to build public trust proper compensation mechanisms should be in place. [ABSTRACT FROM AUTHOR]

The role of the Council of Europe (CoE) in tobacco control remains largely unexplored. This paper aims to fill this gap, focusing on the CoE's European Social Charter. Article 11 of the Charter protects the right to health, and adequate tobacco control measures are necessary to respect this article. This paper examines the potential and limits of the Collective Complaints procedure, one of the two monitoring mechanisms of the Charter, as a means to evaluate the compliance of national tobacco control measures with Article 11. It demonstrates that, so far, this mechanism has never been used in this way. However, although the Collective Complaints procedure presents several drawbacks, it should not be underestimated. Indeed, it possesses certain features, such as the collective nature of the complaint and the lack of the requirement of the exhaustion of domestic remedies, which might make it a particularly suitable tool for the abovementioned purpose. [ABSTRACT FROM AUTHOR]

The aim of this article is to assess whether Female Genital Cosmetic Surgery (FGCS), which refers to procedures which change the structure and appearance of healthy female genitalia for non-medical reasons, violates the Female Genital Mutilation Act 2003, in the light of CPS guidance issued in 2019 and literature regarding the motivations of women seeking FGCS and its effectiveness. The paper concludes that FGCS does , prima facie, constitute FGM and argues that the medical exception contained in the legislation should seldom be available – but based on CPS guidance, a criminal prosecution will rarely be in the public interest. The article ends by asserting that the distinction drawn in practice (if not in law) between the treatment of western and non-western women is problematic, not only because it is discriminatory, but because tolerating FGCS may serve to legitimise FGM and result in the circumvention of the FGM Act 2003. [ABSTRACT FROM AUTHOR]

The new EU Regulation on health technology assessment (HTAR) provides for joint clinical assessments (JCA) of health technologies at EU level. When Member States carry out health technology assessments (HTA) at the national level, they shall give due consideration to the results of a JCA and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether JCA results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as 'national HTA' and which requirements need to be fulfilled to trigger the obligations under Article 13 HTAR are discussed in more detail in this paper. [ABSTRACT FROM AUTHOR]

The WHO's management of the pandemic has drawn sharp criticism. It has been suggested that there is an urgent need for a reform providing more intrusive administrative powers. By contrast, this paper argues that the WHO needs sharing powers rather than intrusive powers. Given that the main international norms have arguably designated the WHO as a "non-authoritarian" authority aiming at the highest possible level of health for individuals, the paper suggests that sharing of administrative powers should be incentivised by involving all the relevant actors in the decision-making process, namely through the participation in proceedings of all actors involved in the decision-making, namely governments, national health authorities, and other non-state actors. [ABSTRACT FROM AUTHOR]

Due to the war against Ukraine, the European Union Temporary Protection Directive, establishing a new migration status of temporary protection, was activated for the first time. The substance of the minimum requirement for providing healthcare services in the Directive appears unclear but is supposed to correspond to human rights standards. This article analyses the standards established in the European Social Charter (revised), recognising several health-related rights. The paper clarifies the material scope of health-related rights and analyses to what extent the Charter applies to persons enjoying temporary protection. The application of health-related rights in the Charter varies depending on citizenship, whether refugee status was additionally sought, and whether a person is seen as a resident or regular worker. The study indicates ambiguity in the position of this group and how the European Social Rights Committee may include it in the scope of protection. [ABSTRACT FROM AUTHOR]

Over the past few years, some parents and clinicians in the UK have argued about decisions on the fate of critically-ill children, with the cases ending in protracted and emotionally-sapping legal disputes. The long-running legal conflicts have played out in the public eye, eliciting conflicting opinions. At the core of the disputes is whether parents or clinicians should determine the appropriate course of action. In the event of the disagreements, the domestic court intervenes guided by the 'best interests' principle. A corpus of scholarship, falling on either side of the debate, has captured the contradictions. Until recently, the discourse had focused on the common recourses to domestic courts and the European Court of Human Rights. However, in the recent case of incapacitated 12-year-old Archie Battersbee, his parents sought redress from the international human rights system through the Committee on the Rights of People with Disabilities to stop termination of his life support. The courts barred the involvement of the Committee on the basis that the UK had not incorporated the treaty which birthed the Committee. The case brought into sharp focus the relationship between international law and domestic law. First, this paper asserts that the weight (not) given to international law by the domestic courts was inconsistent with its treatment of international obligations in other cases. Secondly, the position that unincorporated treaties do not have legal effect in domestic proceedings is ambiguous. Finally, the treaty body appeared ill-suited to handle a case of a critically-ill child in the face of the impatient demands of local justice. [ABSTRACT FROM AUTHOR]

The key aim of this paper is to highlight the oft-under-represented narrative of how persons with disabilities (specifically, those with intellectual disabilities) may access the benefits that genome editing may offer. Firstly, this paper reflects on the critical need for a paradigm shift in how we view intellectual disabilities, and centering the rights of persons with disabilities to allow them to access the broad scope of their right to health under various international law instruments (including the complementary right to habilitation under Article 26 of the CRPD). Secondly, the paper evaluates the legal provisions in the CRPD and other international instruments relating to the rights of persons with intellectual disabilities, and their access to genome editing technologies. This analysis intends to demonstrate that human rights in disability discourse be complemented with emancipatory, participatory, and transformative research. Finally, the paper argues for a reinvigorated line of thinking that expands on the social model of disability: to align with inclusive, contemporary disability discourse that embodies greater responsibility and innovation in perpetuating better access to genome editing technologies for persons with intellectual disabilities. [ABSTRACT FROM AUTHOR]

Ireland has been a leader in the COVID-19 vaccine rollout in the EU, with almost 80% of the eligible population (aged over 5 years) fully vaccinated at the time of writing. The success of the vaccine rollout in this jurisdiction notwithstanding, the legal frameworks supporting the rollout had significant lacunas. Two aspects in particular highlighted a lack of legal preparedness: the inadequacy of the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks. [ABSTRACT FROM AUTHOR]

Abstract In 2007 the European Commission published a White Paper on a 'Strategy on nutrition, overweight and obesity', proposing measures to impede the current trend towards a steady gain in weight by Union citizens. In this article, these ideas are discussed critically in the light of the competences of the Union and from a public health law perspective, in order to scrutinise the effectiveness of the measures and to identify shortcomings in the White Paper. One focus of this article will be European food legislation, as food is one of the leading causes of people being overweight or obese. [ABSTRACT FROM AUTHOR]

Informed consent (IC), following the Supreme Court judgment in Montgomery v Lanarkshire Health Board , [2015] UKSC 11, constitutes a key patients' right. There is a vast literature exploring the significance of this right, while an analysis of the role that this has played in England during the COVID-19 vaccine distribution has been under-explored. Using England as a case study, this paper argues that IC has received limited protection in the COVID-19 vaccination context of the adult population, upholding at its best only a minimalistic approach where mere 'consent' has been safeguarded. It suggests that new approaches should be brainstormed so as to more properly safeguard IC in a Montgomery-compliant-approach , namely in a way that enhances patients' autonomy and medical partnership, and also to better prepare and respond to future pandemics. [ABSTRACT FROM AUTHOR]

The AI Act is based on, and at the same time aims to protect fundamental rights, implying their protection, while fulfilling the safety requirement prescribed by the AI Act within the whole lifecycle of AI systems. Based on a risk classification, the AI Act provides a set of requirements that each risk class must meet in order for AI to be legitimately offered on the EU market and be considered safe. However, despite their classification, some minimal risk AI systems may still be prone to cause risks to fundamental rights and user safety, and therefore require attention. In this paper we explore the assumption that despite the fact that the AI Act can find broad ex litteris coverage, the significance of this applicability is limited. [ABSTRACT FROM AUTHOR]

There is little consensus between European States regarding the legal treatment of surrogacy in general and of transnational commercial surrogacy in particular. Against this background, the jurisprudence of the European Court of Human Rights (ECtHR) in this matter is of particular significance since it provides some common ground for the legal treatment of transnational commercial surrogacy in Europe. For this reason, the present paper will outline the development of the jurisprudence of the ECtHR on transnational commercial surrogacy, giving particular attention to the Mennesson and Labassee decisions, the Paradiso / Campanelli case, and the 2019 Advisory Opinion. On this basis, it will conclude by underlining the importance of the best interests of the child principle in the jurisprudence of the ECtHR on transnational commercial surrogacy. [ABSTRACT FROM AUTHOR]

In the post-pandemic world, the ability of researchers to reuse, for the purposes of scientific research, data that had been collected by others and for different purposes has rightfully become a policy priority. At the same time, new technologies with tremendous capacity in data aggregation and computation open new horizons and possibilities for scientific research. It is in this context that the European Commission published in May 2022 its proposal for a sector-specific regulation aiming at establishing the legal landscape and governance mechanisms for the secondary use of health data within the European Union. The ambitious project is centred on administrative efficiency and aspires to unleash the potential of new technologies. However, the quest for efficiency usually comes with privacy compromises and power asymmetries and the case of the European Health Data Space Regulation is no different. This paper draws attention to some of these compromises and suggests specific amendments. [ABSTRACT FROM AUTHOR]

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 the European Court has granted member States a wide margin of appreciation. Some countries, including Italy, have strict legislation protecting embryos from the fertilisation stage, whereas others have taken permissive approaches, allowing experimentation until 14 days after fertilisation. Science, however, has shown that the 14-day limit can be moved. The author finds it necessary to achieve broad international consensus and shared regulations. Lawmakers, however, need to balance respect for the principle of life, represented by the embryo, against scientific needs, in order to devise sound regulations safeguarding both apparently conflicting fundamental values. [ABSTRACT FROM AUTHOR]

Sterilisation is one of the safest, most effective and most widely used method of family planning in the world. However, it is illegal and inaccessible in Poland. This paper argues that implications of the anti-sterilisation policy in Poland amount to a violation of human rights, especially the right to respect for private and family life and the right to equality. It also explores this question with regard to the right to health. In particular, the argument goes, the rights-based challenges to the criminal prohibition of sterilisation require a gender-sensitive perspective on contraceptive policy that recognises the intimate connection between reproductive choice and the status of women. Certain concerns associated with contraceptive sterilisation (e.g. fear of abuse or post-sterilisation regret) would be addressed more appropriately by less restrictive measures that respect rights of individuals and better respond to their needs — in particular a system of counselling, confining decisions about sterilisation to the doctor-patient level and basing them on free and informed choice. The paper concludes that sterilisation policy should be part of the comprehensive reproductive health policy built upon respect for human rights and principles of equality and public health, as opposed to the present Polish government's policy, which is ideologically driven and does not conform to international standards. [ABSTRACT FROM AUTHOR]

In this paper I have tried to identify and analyse some critical points that Regulation No. 526 of 2014 on clinical trials still presents. I have seen that in the face of a long gestation, the criticisms that have been made of the regulation have been various. If we think of the first criticism identified in the regulation, the so-called law shopping, we must affirm that the subject of experimentation is a very delicate matter since it has a direct and frontal impact on the guarantee of the right to health of European citizens and the use of law shopping does not provide adequate guarantees for the protection of the rights of those participating in a trial. Secondly, the marginalisation of the Ethics Committees whose role is decided at the level of the single national legal system does not ensure that components of independence and representation of the point of view of patients and their associations are guaranteed. This aspect is undoubtedly an important criticism of the regulation as the importance of the role played by the Ethics Committees in the assessment procedures for authorisation applications is not taken into fully consideration. Also, in this case, the economic need for simplification and speed of the evaluation procedure seem to prevail over the need to ensure a thorough and independent scientific and ethical review of authorisation applications. We believe that in the case of Regulation No. 536 of 2014, greater awareness of risks and opportunities will be achieved only by verifying in practice the possible distortions to which this legislation can lead. Only through serious monitoring and reporting of the effects of the regulation on the protection of patients' rights will it be possible to identify and indicate targeted changes to the rules contained therein and, of course, to adopt the consequent measures to reduce possible damages. In this sense, also on the basis of a possible and foreseeable future phase of gestation of Regulation No. 534 of 2014, we believe that in the European area, in the field of clinical trials but not exclusively, that trend, developed above all in the French context, of the "experimentation of laws" should be further cultivated. [ABSTRACT FROM AUTHOR]

This paper deals with a series of legal cases in Italy, Germany, and Austria, between September 2019 and December 2020, which ruled that laws prohibiting or restricting assistance in suicide were unconstitutional. There are similarities between these three cases, all of which are influenced by the practice of assisted suicide in Switzerland, but also differences, not least because of the antecedent legal contexts. Each case is based on flawed reasoning. They have in common an exaggerated account of autonomy or self-determination, insufficiently qualified by the duty to protect human life or by other ethical constraints. The Italian and Austrian Courts also appeal to the principle of equality and to a supposed analogy with refusal of life-sustaining treatments, both of which raise concerns in relation to further expansion of the provisions. In responding to these flawed judgements, legislators should favour proposals that prevent the normalisation of assisted and non-assisted suicide. [ABSTRACT FROM AUTHOR]

The present article deals with the Italian Electronic Health Record (hereinafter EHR), recently introduced by Act 221/2012, with a specific focus on personal data protection. Privacy issues--e.g., informed consent, data processing, patients' rights and minors' will--are discussed within the framework of recent e-Health legislation, national Data Protection Code, the related Data Protection Authority pronouncements and EU law. The paper is aimed at discussing the problems arising from a complex, fragmentary and sometimes uncertain legal framework on e-Health. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This paper explores the application of EU Competition Law to the exploitation of human genome editing technology. Holders of key patents in the sector have applied different methods for disseminating the technology, such as different forms of licensing agreement and patent pools. It is found that that the competition rules are ill-suited to assess some of the licensing arrangements applied, which give rise to legal uncertainty. Accordingly, holders of patents on human genome editing technology may be discouraged to apply efficient methods for disseminating the technology. This may delay or obstruct some of the benefits the technology is supposed to deliver to the market, maker actors and consumers. [ABSTRACT FROM AUTHOR]

There are ongoing concerns of social justice regarding inequalities in the distribution of access to potential genome editing technologies. Working within non-ideal theory, Colin Farrelly advances a justification for the use of patents to speed up the arrival of safe and effective interventions for all, including the socially disadvantaged. This paper argues that such success is less assured when one considers the actual functioning of patents and the practical implications of the patent system in the context of biotechnological innovations. I suggest that non-ideal theoretical approaches risk reverting back to a form of ideal theory if they simply refer to such real-world constraints — e.g. patents — but do not critically assess and fully examine how such constraints manifest themselves in practice. I highlight some considerations that would be important in order to develop and foster a more robust non-ideal approach to justice in biotechnological developments. [ABSTRACT FROM AUTHOR]

Both Artificial Intelligence ('AI') and genome editing are technologies that on their own promise to revolutionise healthcare. But their common application can facilitate progress in the field even more. Multiplied benefits go along with increased risks. In this article, I identify and analyse legal challenges associated with applying AI facilities in medicinal products based on somatic genome editing. These challenges are caused by several factors. First, the two technologies share the characteristics that create and facilitate common risks. Second, each of the technologies is subject to very complex regulatory frameworks. These frameworks are not substantially connected to control the safety and quality of the common product. The main argument of this paper is that the management of common risks is only possible through common procedures. I discover the gaps in the current legislation that prevent from establishing these common procedures and provide recommendations to fill them in. [ABSTRACT FROM AUTHOR]

With the technical possibility of genome editing, we have reached a new phase of transforming human beings and even altering our genetic legacy. Genome editing constitutes new responsibilities in many fields. Science and society have never been as dependent on each other as they are today. We must also learn from the past episodes of eugenics and we need to investigate fraudulent practices and cases of failure in scientific research that have often occurred due to merciless scientific competition, profit-seeking commercial interests, or individual pride. Genome editing raises numerous legal questions, such as: Would it be possible to make a legal difference between specific versions of gene editing? Who decides on what is considered a disease or an anomaly, a condition, or a variation? Which diseases are worth being corrected or treated and which ones are not? What kinds of social implications will gene editing bring about when it becomes widely available? Some normative distinctions have already been made in the case of gene therapy: separating somatic from germline interventions. But this distinction has not yet been analyzed in the light of the most recent editing practices. Genome editing also realigns the structure of ethical debates. It makes us rethink the concept of discrimination and scrutinize its cases in the field of assisted reproductive procedures. It revolutionizes the concept of medical treatment. It may increase or reduce inequalities based on health conditions. It may lead to numerous new rights in the field of genetics. Good genome editing practice can only be achieved through the close cooperation between the natural and social sciences. The present paper will endeavor to examine this new form of dialogue. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The Framework Convention for Tobacco Control (FCTC) is undoubtedly the most efficient international instrument for tobacco control. Article 8 FCTC shapes many smoke-free policies worldwide and in doing so it is usually associated with smoke-free regulation in enclosed public spaces. Our paper highlights that the FCTC contains a sound foundation for smoke-free policies that stretch beyond enclosed public places, such as open public spaces and (quasi-)private spaces. We demonstrate, in particular, that such wide smoke-free regulation, which is gaining momentum around the globe, is versatile and compatible with human rights standards. As such, these expanded smoke-free policies contribute to a wider culture of smoking denormalisation that scales up FCTC's aspiration for tobacco control and subsequently to a smoke-free global society. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Nanomedicine, the application of nanotechnology to healthcare offers numerous improvements to medical diagnosis, drug delivery, therapy and implants. The potential impact of nanomedicine is foreseen radically to change health care; however it also challenges existing perceptions, dynamics and standards relating to ethics, safety and governance. This paper introduces the emerging field of nanomedicine and then proceeds to detail the current regulatory framework and regulatory bodies in the European Union relating to medicinal products, medical devices, biologics and therapies. This is followed by a detailed analysis of two nanomedical applications in the context of regulatory challenges. The paper concludes with a discussion of the adequacy of the current regulatory regime in Europe and where problems are likely to arise as nanomedicine evolves. [ABSTRACT FROM AUTHOR]

All academics, perhaps with the exception of those who are hermits with independent private means, are concerned with questions of networking and research funding. The nature of academic life is to search out new ideas and revisit old ones, and to discuss these ideas with others. This requires networks of colleagues and funding to provide the basic resources of time and literature. This may be at the local level, but increasingly the expectation is that these activities should become more and more elaborate; our networks are now international, and our time and resources cost ever increasing amounts which, for many if not most academics, must be found outside the general budget of the home University. Our success as academics is measured, in increasing part, on our ability to show our networking and external funding credentials. There is a more resounding reason to pursue both networking and externally funded research: through such projects the experience of each individual can be increased such that the result is far greater than one could achieve alone. Networking and external funding are not ends in themselves, but they can and should be a great enhancement to academic life and contribution. None of this is news or a novel claim; it is simply today's environment. This paper considers some opportunities for how networking and externally funded research might help the EAHL to realise its aims in developing the discipline of health law. We, as authors, do not claim any special expertise in the area, and readers are quite justified in thinking “who are they to talk to us about what we clearly know much more about?” However, we were asked to start a discussion at the inaugural conference of the Association, and the thoughts that we present now were designed to do that. It is a discussion which will form one of the early activities of the Association. Here the paper is divided first issues concerning networking, and second those concerning research funding from sources external to one's home University. We draw upon our own experiences, and would be grateful to hear of better examples, and particularly about contradictory experiences. [ABSTRACT FROM AUTHOR]

Significant changes in the field of Azerbaijan's healthcare legislation came just at the time when the coronavirus (COVID-19) pandemic broke out in the world. The end of 2019 was supposed to lay the groundwork for the introduction of the country's long-awaited health insurance - a landmark change in terms of national healthcare transformation; although the Law 'On health insurance' was adopted in the 1990s, its implementation was per se frozen for many years due to various reasons. Therefore, the pandemic complicated the process even more. It also coincided with significant updates of the Law 'On human organs and tissues donation and transplantation', which comes into force in 2022, and legislation related to disability. Thus, this paper focuses on recent changes in healthcare legislation; analyses system of health insurance, updated transplantation and disability laws. It gives an overview of the developments that accompany the process of legislation transformation. [ABSTRACT FROM AUTHOR]

This paper will analyse the essential legal requirements of the European Convention on Human Rights which touch on the lives (and deaths) of people with mental disabilities. It will examine the procedural safeguards which must be followed when involuntarily detaining a person under mental health legislation; access to a court to test the lawfulness of detention; the requirement to be free from torture, inhuman or degrading treatment or punishment; the right to respect for private and family life, home and correspondence; and the right to life, including investigation after a death. The paper will discuss some of the factors which explain the relative scarcity of mental disability cases decided by the Strasbourg Court. In conclusion there will be an examination of the role of lawyers and other key players in mental disability, and how stakeholders can move forward to prompt much needed social reform. [ABSTRACT FROM AUTHOR]

With rapid scientific and technological advances, a new genetic era is emerging. However, these advances raise ethical and legal issues, particularly genetic discrimination, that may threaten advancing science in the absence of appropriate regulation. There is currently no concrete legislative position in this area at EU level, but rather a patchwork of diverging legislative approaches amongst Member States. Genetic discrimination has been singled out as an area of reform in Europe as evidenced, for example in EU Charter of Fundamental Rights, Article 21.1 prohibiting discrimination based on ‘genetic features.’ The United Nations Convention on the Rights of Persons with Disabilities also informs this debate and may spur legislative action. From a transatlantic perspective, the United States’ federal legislation (Genetic Information Non Discrimination Act) is noteworthy. Considering scientific and technological developments, the rights at stake and the various regulatory benchmarks, this paper explores the regulation of genetic information in the EU. [ABSTRACT FROM AUTHOR]

The right to health is recognised in human rights law and is also part of the catalogue of patients' rights. It imposes a duty on governments to put in place a system of health protection making it possible for individuals to enjoy the highest attainable standard of health. However, disease patterns are constantly changing, and more and more attention is being paid to so-called lifestyle diseases. Individuals may expose themselves to health threats due to personal choices like eating and smoking habits, and this raises the issue of the individual's obligation with regard to ill health. Hence, is there not only a right to health but also a duty to be healthy? Using obesity as an example, and based on a cross-disciplinary research project, the article analyses selected European and national public health policy papers to see how individual rights and duties are framed and to analyse the use of stigmatisation as a public-health strategy from a health and human rights perspective. [ABSTRACT FROM AUTHOR]

Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this article. This article analyses firstly the short term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonized medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g., the way in which hospitals are organized in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper will finally analyse also how health monitoring projects may change the traditional (non-) relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require to new legal rules. [ABSTRACT FROM AUTHOR]

The article discusses various papers published within the issue including "The development of health law as a way to change," and "Diversity and harmonisation, trends and challenges in European health law."

In R (Axon) v Secretary of State for Health the Gillick competence test was confirmed. Commitment to childhood autonomy and privacy rights caused renewed academic criticism of the 'refusal' cases. This paper considers the form any changes to the law may take, and the potential consequences for the rights of parents and young people. Silber J.'s contention that parental Article 8 rights cease when the child makes a competent decision is potentially problematic if applied to refusal cases, especially in the context of the distinction between competence to consent to treatment and to the disclosure of information. [ABSTRACT FROM AUTHOR]

The aim of this paper is to compare the different existing approaches to advance health care directives within the European context, and to explore the possibility of reaching a deeper consensus among countries on this subject. To this end, it first discusses the shortcomings of Article 9 of the Council of Europe's Biomedicine Convention. Second, it offers a comparative analysis of the legal status of advance directives in a number of European countries. Finally, it presents the conclusions of an international interdisciplinary workshop focused on this topic that was held in Zurich in June 2008. [ABSTRACT FROM AUTHOR]

This paper focuses on the legal implications in terms of duties and responsibilities for radiologists and radiologic technologists of independent pre-reading of mammograms by radiologic technologists, so patients could be discharged without being seen by a radiologist. Pre-reading could be effectuated when preconditions are met to perform reserved procedures by unauthorised professionals as stated in the Individual Health Care Professions (IHCP) Act. Furthermore, compliance with a protocol or code of conduct in combination with adequate training and supervision should be sufficient to disprove potential claims. For a wide implementation, pre-reading should be well-embedded in legal rules and should answer the professional standard of care. [ABSTRACT FROM AUTHOR]

Biomedical research and international collaborations in biomedical research become more and more important — economically and politically, making harmonised legislation for human research subject protection indispensible. The European Convention on Human Rights and Biomedicine is the first binding contract under international law to protect human rights in the field of biomedical research. Almost 10 years after its entry into force neither Germany nor Austria have signed or ratified the Convention. Research involving incapacitated adults is one of the key issues in this context. This paper analyses the Convention and other European, US and international legislation, focusing on research involving incapacitated adults in “non-therapeutic” trials. It shows that a ban of “non-therapeutic” research involving incapacitated adults leads to an unjust exclusion of this patient group, leading to uncertainty and disadvantages in medical treatment. [ABSTRACT FROM AUTHOR]

The article presents several court cases on European Court of Justice in Europe. Accordingly, the paper discusses the facts of the cases being presented. Moreover, the paper also provides the legal context of these cases as well as the preliminary ruling, the rulings of the European Court of Justice and its judgement.

The article presents several court cases in European Court of Human Rights in Europe. Accordingly, the paper discusses the facts of the cases being presented. It also discusses the law being imposed on these cases as well as its alleged violation on different articles of the convention. Moreover, the paper also offers a further discussion on the court's findings on the proceedings of the cases being presented.

In the era of an aging population and escalating healthcare costs, the futility debate has become the object of extended critical attention. The issue has divided experts in relevant fields into two camps. The proponents of medical futility defend the physician's exclusive right to determine the futility of treatment and decide whether treatment should be withheld or withdrawn. On the other hand, opponents believe that a discourse of power lies at the heart of the futility debate. They believe that medical futility was constructed, in part, as a means of enhancing the physician's domination in a context wherein medical authority was threatened. This paper presents some current approaches to the futility debate and highlights positions taken by physicians and bioethicists. It concludes that establishing an operational guideline, either at hospital or national level, is a critical requirement for resolving problems posed by futility. It suggests that policies should not be based on either excessive patient's autonomy or physician's paternalism. [ABSTRACT FROM AUTHOR]

This paper has three parts. In Part One, we argue that while biological samples and genetic information extracted from them are not (in terms of Directive 95/46/EC) personal data in and of themselves, each is capable of being personal data in appropriate contexts. In Part Two, we argue that if this is correct, then the requirement for sources of human biological samples to give informed consent for any use of their samples (which the European Court of Justice has maintained to be a fundamental principle of EC law but not one to be enforced via patent law) must be enforced by data protection law in the EU. Finally, in Part Three, we consider the implications of our position for the capacity of Directive 95/46/EC to adequately protect third party interests given the shared nature of genetic data. [ABSTRACT FROM AUTHOR]

As one of the first transition countries in Central and Southeast Europe, the Republic of Croatia, through comprehensive health service legislation, has made a significant step forward in aligning its standards in the protection of patients' right to those that exist in the developed western democracies. However, the legislation on patients' rights is still not having any significant effect on improving the position of patients in the health system. In this paper, the emphasis is on presenting the legal solutions from the recent Act on the Protection of Patients' Rights, including an analysis of the causes of the existing discrepancy between the legal standards and the actual position of patients in Croatia. [ABSTRACT FROM AUTHOR]

Directive 95/46/EC on the Protection of Individuals with regard to the Processing of Personal Data and on the Free Movement of Such Data has been transposed into national law and is now the Data Protection (Amendment) Act, 2003. The Directive and the transposing Act provide for new obligations to those processing data. The new obligation of primary concern is the necessity to obtain consent prior to the processing of data (Article 7, Directive 95/46/EC). This has caused much concern especially in relation to 'secondary data' or 'archived data'. There exist, what seem to be in the minds of the medical research community, two competing interests: (i) that of the need to obtain consent prior to processing data and (ii) the need to protect and foster medical research. At the same time as the introduction of the Act, other prior legislation, i.e. the Freedom of Information Act, 1997-2003, has encouraged candour within the doctor-patient relationship and the High Court in Ireland, in the case of Geoghegan v. Harris, has promulgated the 'reasonable-patient test' as being the correct law in relation to the disclosure of risks to patients. The court stated that doctors have a duty to disclose all material risks to patients. The case demonstrates an example of a move toward a more open medical relationship. An example of this rationale was also recently seen in the United Kingdom in the House of Lords decision in Chester v. Afshar. Within the medical research community in Ireland, the need to respect the autonomy of patients and research participants by providing information to such parties has also been observed (Sheikh A. A., 2000 and Irish Council for Bioethics, 2005). Disquiet has been expressed in Ireland and other jurisdictions by the medical research communities in relation to the exact working and meaning of the Directive and therefore the transposing Acts (Strobl et al). This may be due to the fact that, as observed by Beyleveld "The Directive makes no specific mention of medical research and, consequently, it contains no provisions for medical research as an explicitly delineated category." (Beyleveld D., 2004) This paper examines the Irish Act and discusses whether the concerns expressed are well-founded and if the Act is open to interpretation such that it would not hamper medical research and public health work. [ABSTRACT FROM AUTHOR]

The industrialization and internationalization of biomedical research is not without consequences on the regulation of research or, at least, on the interpretation of that regulation. As more research is done at the international level, the pharmaceutical industry and the research community are calling for a harmonized regulation to limit the administrative burden of controlling clinical trials and to fasten the R&D process. The purpose of this paper is to analyse briefly the role of the national laws in that process. Part I will outline the structure and the nature of the international regulation of research in a European perspective. Using the examples of research ethics committees (RECs), informed consent and the question of liability and liability insurance, Part II will analyze the importance of the national laws in the implementation of this international regulation. [ABSTRACT FROM AUTHOR]

The 1980s was a decade of protracted crisis within state socialism in Central and Eastern Europe, most manifestly in Poland. Poland became the trendsetter and model for change not only during the crisis of State socialism but also afterwards, during the pre-transition crisis and breakthrough from one system to another and the first period of democratic transition. Poland, therefore, experienced both the advantages and disadvantages of being a pioneer. This is for instance the case with the health care sector. This paper examines recent legislative changes in the Polish health care system. A descriptive analysis of the current legal framework identifies the main changes that have occurred since the dissolution of the socialist health system. Further research of, in particular, the new Health Insurance Act reveals several discrepancies with respect to its 'compatibility' with European Community law. Since adoption of the acquis communautaire is a prerequisite for accession, the author discusses a main acquis aspect related to social health insurance law, viz the implementation of Co-ordination Regulation 1408/71. [ABSTRACT FROM AUTHOR]