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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]

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]

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]

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]

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]

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]

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]

The article discusses the acknowledgement of the European Court of Justice for the essence sufficient and permanent access to high-quality hospital treatment. Topics discussed include the Treaty on the Functioning of the European Union in 2009, European Charter of Fundamental Rights in 2009, and the Standing Committee of European Doctors.

The Convention on Human Rights and Biomedicine, the first legally binding international instrument in the field of bioethics, was adopted in November 1996. In the present paper, following a brief overview of some of the Convention's provisions likely to conflict with national enactments already in effect, we shall attempt, on the basis of the materials available in the International Digest of Health Legislation, to analyse the positions adopted by the different states involved and to identify foreseeable conflicts, focusing on the following four issues: human genome; protection of the embryo; scientific research; and protection of live organ donors. [ABSTRACT FROM AUTHOR]

This paper examines the right to health care. Various expressions of this right may be distinguished. These include both individual rights and social rights which could be based upon international treaties and constitutional rights. They may be found in national health legislation and, in some cases, in jurisprudence. To analyze the consequences of limiting the right to health care, a framework for judicial review has been developed which encompasses these expressions of the right to health care. The framework was used to examine legal and health policy developments in three Western and two Eastern European countries. In Italy and the Netherlands the right to health care is protected constitutionally (but on differing legal bases) while the United Kingdom does not have a written constitution. In contrast, Hungary and Poland have for many years seen the state take responsible for the provision, administration and allocation of health care services and the right to health care was guaranteed theoretically but not in practice because of the lack of (financial) means. However, the Polish Constitution explicitly anticipates possible limitations of the right to health care. What all these countries have in common is a cost containment perspective where the future will bring even tighter limits on what resources patients may consume. Despite differences in legal structure between these countries, where they seem to converge is on the consequences of putting limitations on the right to health care. The courts in Italy, the Netherlands and the UK have formulated conditions drawn from the acceptance that this right has to be judged within the context of limited resources. It may be concluded that finding a compromise between the right to health care and cost containment policies could also be an issue, Eastern European countries will have to face in the future. [ABSTRACT FROM AUTHOR]

Personalised medicine, digital innovations, and neuro-technologies all offer significant potential benefit for human health and welfare, but also raise complex governance challenges. A variety of approaches have been adopted in the governance of innovative medicines and health technologies, including risk assessment, ethics and self-governance. Recently anticipatory or 'upstream' modes of governance have garnered favour. Anticipatory regulation demands a closer relationship between regulators and innovators, to shape the trajectories of the technology. In the EU context, responsible research and innovation has emerged as a key mechanism of governance. This is linked but distinct from a human rights governance which has the advantage of exerting both legal and moral force. What is needed in the healthcare context are governance models which ensure human rights considerations are taken into account from the earliest stages of innovation, to maximise the likelihood that developments are from the outset beneficial and oriented towards protecting ethical values. [ABSTRACT FROM AUTHOR]

There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues to be considered in the perspective of a possible legislative reform. [ABSTRACT FROM AUTHOR]

Due to its simplicity, low cost and accuracy, CRISPR-Cas9 has become a promising new technique in the field of gene editing. However, despite its virtues, it is not yet immune to scientific hazards and ethical legal concerns. These concerns have been used to justify opposition to genetic manipulation, and have led to some regulations to ban or impose a moratorium based on the precautionary principle. In Europe, regulation mostly comes from the European Union and the Council of Europe, both very cautious towards gene editing. In this article, two arguments on the future legal framework of CRISPR-Cas9 are made. The first is that continued research will contribute to more scientific accuracy; thus, the precautionary principle should promote regulated research to achieve this aim. The second is that most of the legal and ethical concerns surrounding CRISPR-Cas9 are based on unfounded prejudice emanating from a mystical understanding of the human genome. [ABSTRACT FROM AUTHOR]

As a result of the constantly increasing number of innovative but exceedingly high priced medicines, many Member States have implemented price-regulating mechanisms to ensure the financial viability of their healthcare systems. However, the European Court of Justice applies strict criteria to these measures - some of them have already been suspended for the purposes of the free movement of goods. The European Union (EU) allowed the development of an ever-stricter case law on one hand, without changing the legal frame on the other hand. Considering the importance and the binding nature of the Court's judgements, this leaves great uncertainty for national legislators about which measures to remedy the pricing problem are legally possible and which are not. In order to provide clarity, this article seeks to analyse the development of the case law and to define the legal scope for pharmaceutical pricing mechanisms in the EU. [ABSTRACT FROM AUTHOR]

In biobanking, collaboration and data sharing contribute to building genomic research capacity, and have the potential to further scientific advances that ultimately can result in advances in clinical care. However, in the absence of common applicable legal frameworks that enable collaboration, capacity building is hindered. With the applicability of the General Data Protection Regulation, the obstacles to data sharing which involve export of data from European Union Member States to third countries are expected to grow, rendering the collaboration between the EU and third countries even more challenging. This article examines how, if at all, data sharing in biobank research between the EU and third countries could be facilitated via the use of soft regulatory tools. It argues that although the existing soft tools might not in itself be suitable for meeting all the GDPR requirements, they could be the basis on which to raise the area-specific data protection bar globally. [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]

Sponsors of clinical trials have excluded pregnant women from trial participation mainly because of the fear of legal liability for foetal injury. Yet, to prevent untested treatments exposing foetuses generally to unwarranted risks, it is necessary that pregnant women are included in clinical trials. Despite sponsors' fears there are, however, major stumbling blocks for the child once born claiming compensation under English law. Neither the new EU Regulation 536/2014 on clinical trials nor tort law or statutory regulations have achieved a clear and fair avenue for the compensation of children injured in utero. There are also inadequacies with the voluntary pharmaceutical industry guidelines regarding such compensation. Greater clarity and fairness regarding tort and civil liability might encourage sponsors to conduct more trials in pregnant women and more pregnant women to volunteer taking part in research in the knowledge that their children will be compensated if they sustain injuries in utero. [ABSTRACT FROM AUTHOR]

In recent years the European Union (EU) has sought to develop a far-reaching policy regarding persons with disabilities. However, to date, EU non-discrimination legislation does not provide any clear legal definition of what constitutes a disability. The Court of Justice of the European Union (CJEU) has attempted to fill this gap and, in several decisions, has elaborated on the concept of disability and its meaning under EU law. The CJEU, with reference to the application of the Employment Equality Directive, has explained the notion of disability mainly by comparing and contrasting it to the concept of sickness. Against this background, this article critically discusses recent case law and attempts to highlight that, even though the Court has firmly embraced the social model of disability envisaged by the UN Convention on the Rights of Persons with Disabilities, the boundaries between the concepts of sickness and disability remain blurred. [ABSTRACT FROM AUTHOR]

This article aims at analysing how well the Advanced Therapy Medical Product Regulation (EC) No. 1394/2007 (ATMP Regulation) meets the needs of small and medium-sized enterprises (SMES), academia and public tissue establishments developing advanced therapy medical products (ATMPS). Benefits and shortcomings of the ATMP Regulation are identified, and possible amendments are proposed to accelerate the translation of research into advanced therapies and to facilitate the commercialisation of ATMPS whilst ensuring safety. It was set up as a lex specialis to ensure the free movement of ATMPS within the EU in order to facilitate their access to the internal market and to foster the competitiveness of European pharmaceutical companies, while guaranteeing the highest level protection of public health. Since the adoption of the ATMP Regulation in late 2008, only 5 ATMPS have been granted marketing authorisations thus far. Hence, there is a need to analyse whether the ATMP Regulation meets its objectives. [ABSTRACT FROM AUTHOR]

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 Commission has proposed a regulation 'on clinical trials on medicinal products for human use' to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We condude that the proposed regulation does not ensure a "high level of human health protection" — required by its legal basis in the TFEU — because it may force Member States concerned to accept a reporting Member States' approval of — in their estimation - an unethical clinical trial. [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]

Abstract In 2011, the Danish government announced that from June that year it would no longer cover the costs of medical interpreters for patients who had been living in Denmark for more than seven years. The Dutch Ministry of Health followed with an even more draconian approach; from 1 January 2012, the cost of translation and interpreting would no longer be covered by the state. These two announcements led to widespread concern about whether or not there is a legal foundation for interpreter provision in healthcare. This article considers United Nations treaties, conventions from the Council of Europe and European Union law. European Union member states have been slow to sign up to international agreements to protect the rights of migrant workers. The European Union itself has only recently moved into the area of discrimination and it is unclear if the Race Directive covers language. As a result, access to interpreters in healthcare, where it exists, is dependent on national anti-discrimination legislation or on positive action taken at national or local level rather than on European or international law. [ABSTRACT FROM AUTHOR]

Abstract The problem of ensuring the access of the elderly to healthcare has lately become increasingly important. The accessibility of affordable healthcare for the elderly largely depends on the design and performance of the healthcare system, the level of overall social protection that elderly people can enjoy, as well as on the availability of legislative guarantees and the opportunity to use them. Those drivers, alongside with the prospects of the European health system developments and their potential implications on the access of elderly people to affordable healthcare are discussed in this article. [ABSTRACT FROM AUTHOR]

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

The article focuses on the laws concerning organ transplantation and cross border medical care. All European Union (EU) member states now have specific legislation regarding the removal and the transplantation of organs, with few exceptions. In April 2009, the Committee on the Environment, Public Health and Food Safety of the European Parliament adopted a report which says that the proposed directive on cross border care by the EU shall not apply to organ transplantation.

In July 2009, the European Commission (DG Competition) published a Communication on the pharmaceutical sector. This inquiry was launched because there were some indications that competition in the pharmaceutical market in the European Union might not be working well. The report examines the reasons for the observed delay. This article analyses the outcomes from a critical standpoint, arguing in favour of enhanced 'soft law' accountability mechanisms in the pharmaceutical sector, defending conditional patenting and the introduction of a Community patent. [ABSTRACT FROM AUTHOR]

This article examines recent developments in EU governance of organ donation and transplantation, focusing on an analysis of the Commission's action plan and the proposed Directive. While the aims of the plan are laudable, a number of concerns remain with respect to the timetable for the plan and the adoption of the Directive, as well as the management of ethical and risk issues. In the final analysis, the added value of EU governance initiatives in the field is likely to be measured by the extent to which they successfully address the ongoing problem of organ shortage in Member States. [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]

The European Convention on Human Rights and Biomedicine of the Council of Europe provides in article 6 for special protection of persons who are not able to give free and informed consent to an intervention in the health field, e.g. minors. According to the second paragraph of this article it is up to domestic law to decide whether and under which conditions a minor is capable of taking autonomous decisions in the health field. In the present article an overview is given of the legal regulations in place regarding the position of minors in a health care setting in the EU Member States that have ratified the European Convention on Human Rights and Biomedicine namely Cyprus, Czech Republic, Denmark, Estonia, Greece, Hungary, Lithuania, Portugal, Slovakia, Slovenia and Spain. As the overview will show, the legal position of minor patients in a health care setting varies from country to country. This in view of the system they have opted for as well as the age and circumstances under which minors are allowed to take health care decisions autonomously. [ABSTRACT FROM AUTHOR]

The author analyzes article 3 of the European Convention on Human Rights. Though adequate facilities and moral or social support in the receiving country is considered by the Court, there is no international treaty to permit sick illegal residents on medical grounds. This deportation is considered illegal and violation of human rights by denying the right to health care, particularly for patients with HIV/AIDS which is a threat for the life of the patient.

Provides an overview of European developments and initiatives concerning the rights of patients to gain access to health care across the border. New cases before the European Court of Justice; Development of an adequate policy on patient mobility, which recognizes both the interest of patients and the need to protect the financing and infrastructure of health care and insurance systems; Commission proposal of reform of regulation 1408/71; Development of policy aimed at promoting collaboration between member states and those responsible for running health care systems.