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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]

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]

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]

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]

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]

Abstract The demographic development is a challenge for the European healthcare systems, and to meet these challenges it is crucial to develop efficient health preventive strategies to ensure that the population is, and stays fit as long as possible. However, along with demographic development, Europe is also facing a boom in lifestyle diseases which constitute an impediment for healthy ageing. Smoking and obesity are considered to be the major causes in this regard. Both internationally and nationally there has been a strong commitment to reduce smoking, and it seems that a combination of information, economic incentives and legal regulation have been successful. The article explores whether the same public health strategy could be useful fighting obesity, and discusses whether such public health measures are compliant from a human and patients' rights perspective. Special questions regarding public health initiatives targeting elderly patients will also be addressed. [ABSTRACT FROM AUTHOR]

The care for patients with dementia raises many legal (and ethical) issues. This article explores some of the more important topics, i.e. (early) diagnosis of the disease, the availability and provision of care, treatment and non treatment decisions, and medical research with dementia patients. [ABSTRACT FROM AUTHOR]

It has been recently adopted under Polish law that the determinant of death is both the brain death criterion, tantamount to the permanent and irreversible cessation of its function, and the equally valid circulatory criterion. This means that the determination of brain death is not indispensable to pronounce a person dead, because the irreversible cessation of circulation is sufficient in this respect. The purpose of this article is to present current developments in Polish law against the comparative, historical and medical background. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has severely disrupted non-coronavirus clinical trials. In the case of life-threatening diseases, such as cancer, this is particularly dangerous, as treatment cannot simply be stopped. In the EU, guidelines for the management of ongoing studies were issued; however, national coordination is still lacking. This article aims to raise awareness on the struggle of managing ongoing clinical trials in the EU during the pandemic. The goals are to bring attention, from a legal and regulatory point of view to the difficulties faced by those involved in clinical research, and to critically position the current hurdles against the backdrop of the existing legal and ethical framework. We investigated the EU guidance and the national approaches of all EU/EEA Member States, and critically discussed selected issues. We argue that the crisis may be an opportunity to foresee meaningful changes in the EU clinical trials framework post-COVID-19. [ABSTRACT FROM AUTHOR]

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

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

This work describes and assesses the implementation of the Cross-border Healthcare Directive in Spain. Although implementation has not yet taken place, the Government has already adopted a draft implementing regulation, on which this article is based. In addition, this article deals with a number of other rules that have been adopted in Spain, which are not strictly aimed at the implementation of the Directive but which are expected to facilitate its implementation and to help cement its effectiveness. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses various reports within the issue on topics including the European Union's (EU) directive on health care, patients' rights in Latvia and cross-border medical care in the Netherlands.

The article describes implementation of the Directive 2011/24/EU in the Czech Republic, its consequences with individual patient's rights and financing of healthcare for citizens of the European Union. [ABSTRACT FROM AUTHOR]

The right to healthcare applies regardless of a person's legal status. Prisoners have a right to a healthcare equivalent to the one in the community at large: access to medical care and preventive measures of good qualify and costs covered. States have a positive duty to provide for appropriate healthcare in prison, including harm reduction policies (for instance health screening, vaccination and needle exchange). Denial of access to appropriate health facilities to prisoners and other detainees is likely to result in bodily harm, unnecessary morbidity and avoidable death. Essential elements of the social right to care for the health of prisoners are protected through the positive obligations individual human rights impose on States (e.g., the right to life, the prohibition of torture, degrading treatment and punishment, the right to liberty and the right to private life). Health related human rights standards for prison healthcare have been formulated over worldwide and in Europe. The Council of Europe's Committee of Prevention of Torture monitors the situation of prisoners in Member States. Still, healthcare for prisoners falls short of what is required. Prison healthcare is an essential part of public health. A major involvement of the Minister of Health is indispensable. [ABSTRACT FROM AUTHOR]

Developments in European Union law have created rules favourable to cross-border patient movement. However, where national laws on patient rights differ, this may limit movement by creating confusion for patients and by reducing their confidence in seeking treatment abroad. This artide examines the extent to which English and French law recognize a patient right to information regarding treatment. In light of the differences between the two systems concerning both the form and the con:ent of the law, highlighted by recent developments in French law, the artide then considers whether the Patients' Rights Directive can provide a framework for coordination of national rules. [ABSTRACT FROM AUTHOR]

The second conference of the European Association of Health Law took place in the Royal College of Physicians in Edinburgh, Scotland on 15-16 October 2009. The event was generously sponsored by the British Academy and the AHRC/SCRIPT research centre based in the School of Law at the University of Edinburgh. The meeting was attended by 115 delegates from 26 countries and preceded by a public debate on assisted dying. This report gives an account of these events and the future direction of the work of the Association. [ABSTRACT FROM AUTHOR]

European countries share a number of fundamental values and ideas, but when it comes to the organisation of health care sectors and attitudes to basic patients' rights, there are also vast differences. Consequently, at the European level health law has to balance between the aspiration for uniformity and universal respect for fundamental rights on the one hand, and acceptance of national diversity on the other. The aim of the article is to characterise European health law in terms of both divergence and harmonisation, and to explore the tension between these two features in light of current trends and challenges. [ABSTRACT FROM AUTHOR]

Europe is facing a trend of demographic and social change that is likely to have a significant impact on our health systems in the coming decades. The primary concerns are related to the double challenge of population ageing and population decline. These changes will result in a shrinking workforce to handle the steadily increasing healthcare needs of the very old, who will constitute the fastest growing segment of the population. A number of strategies to meet this challenge are suggested and implemented, not least at the EU level. Adaptation of European health systems to the new situation also makes it necessary to revisit familiar medico-legal issues, in order to clarify and consolidate a number of already established patients' rights. [ABSTRACT FROM AUTHOR]

Current international legal instruments recognise the use of advance directives to carry on the will of the dementing research participant beyond the boundaries of her present legal capacity. Advance directives are gaining greater recognition in patient care than in medical research, where their legal status is still somewhat unclear. In particular, the three major international documents on medical research - the Council of Europe Convention on Biomedicine and Human Rights (ETS 164), its Additional Protocol on Biomedical Research (ETS 195), and Directive 2001/20/EC on Clinical Trials on Medicinal Products--give conflicting messages on the legal status of advance directives in medical research. This article examines the provisions in these documents and their national applications in Finland and the United Kingdom. [ABSTRACT FROM AUTHOR]

After the turbulent years 2002, 2003 and 2004 the Belgian health law seems to have reached calmer water. Indeed, after a quiet 2005, 2006 does not seem to have much to offer either. However, as will be shown in this article, this may be a wrong impression. There is a growing uneasiness with two important pieces of legislation that have been approved by Parliament in 2002: the act on euthanasia and the act on the rights of patients. This has resulted in debates and discussions that may finally lead to new legislation in the coming years. [ABSTRACT FROM AUTHOR]

The aim of this article is to have a close look at health legislation developments in Estonia, Latvia and Lithuania countries having a similar geographical, political and historical situation. This article is an attempt to analyze health legislation developments, bearing in mind some international obligations, constitutional provisions, court practice and the impact of reforms of health sector on the promotion of health legislation. Health legislation is a complex subject, covering a wide field of health law subjects. The main point, a right to health care, can be viewed from perspectives of social values and as a fundamental human right. The States' responsibilities are combined with individual rights. Patients' rights in all different aspects make up the core issue.

The focus and starting point of all objectives in guaranteeing patient and citizen rights is the involvement of patients and citizens in communication and decision-making processes at the level of individual relations and structural conditions in health care. Health care systems can be financed through insurance or taxes. The question of involvement arises in all systems. In the individual relationship the model for involvement is shared decision-making; involvement of citizens at the level of the health care system means to be heard, to give advice and/or to co-determine. The article refers to participation in this context. Rights guarantee involvement.

Describes the existing regulations in relation to patient's rights in Bulgaria. Right to choose doctors and health care establishments; Informed consent; Care and treatment; Confidentiality and privacy; Rights in case of transplantation and reproduction; Patients' obligations.

A number of international legal and ethical guidelines attempt to safeguard patients' rights in various health care areas. On the national level, health care legislation defines the rights of different patient groups more concretely in everyday practice. In general, the right to decide about one's own treatment — and to refuse treatment — is considered to be of the greatest importance. Several patient groups can, however, be treated involuntarily. In addition to minors, psychiatric patients in certain situations form a group of patients whose own will can be overridden in health care. In Finland also intoxicant abusers, the mentally retarded and patients suffering from certain communicable diseases can in special situations be taken into involuntary care. This article discusses the differences between the status and rights of involuntarily treated patients in different social and health care acts in Finland. Several paragraphs of the laws studied were identified that assign more rights to patients treated involuntarily under the Act on Social Work with Intoxicant Abusers and the Act on Special Care for the Retarded than to involuntary psychiatric patients. The practical implications of this article will be discussed. [ABSTRACT FROM AUTHOR]

Editorial. Discusses the conflict of freedom in research and patients' rights in genetic research. Minimal constraints associated with sample collection; Breech of private life; Protection of persons participating in genetic research studies.

Presents the response to the comments of Dr. Canellopoulou Bottis regarding the author's views on a medical patient's and relatives' right to privacy and the defense of ignorance and the right not to know. Agreement over the practice of information disclosure based on medical law without the benefit of medical ethics that reflect the fundamental values of society; Reiteration of the article's theme stressing the need for reflection on the appropriate legal response in light of medical problems due to genetics; Admittance on the failure of the law to effect its directives in all medical situations; Discussion of the duties to relatives in respect of genetic information.