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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 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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Malpractice lawsuits are a substantial concern in health systems with miscommunication, inadequate information, and unsuccessful patient involvement in decisionmaking seeming to be contributing factors. This paper draws attention to the explicit role of informed consent (IC) obtainment in actualized complaint cases and to what extent novel methods to exercise IC through means of shared decision-making (SDM) and supporting tools might be applicable. A national sample of cases from the Health Professionals Disciplinary Board in Denmark is reviewed and discussed together with international legal instruments and case law. It is confirmed that patients claim their right to participate in decision-making about healthcare options. In many situations SDM and accompanying tools would apply and possibly they could sometimes prevent IC duty breaches, assist documenting IC procedures, and help avert the need for litigation. [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 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]

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]