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This article traces the journey of Nordic health data requested for developing a healthcare algorithm. We focus on the legal requirements and highlight that differences in the legislation of Denmark, Norway and Iceland, and the interpretation thereof by responsible bodies, can pose a barrier for scientific researchers. In addition, non-legal institutional requirements or practices may hamper data access. First, despite some European harmonization, the mandate of research ethics committees and the data protection authorities vary in the three countries. Second, domestic institutions impose tailored requirements, sometimes only allowing domestic or affiliated researchers to access data sets. Third, the manner in which a dataset is collected, catalogued and stored has implications for data access. We make several recommendations for increasing transparency in Nordic data access, such as, increasing knowledge sharing regarding interpretation of General Data Protection Regulation (GDPR) criteria, adopting clearer regulations and pursuing greater citizen engagement in secondary use of health data.

The human right to health requires that everyone should have equal opportunities to enjoy the highest attainable standard of health. In practice, this is hard to achieve, as health is shaped by social determinants. This article explores the impact personalized medicine and use of big data may have on health disparities. New health technologies offer a lot of hope for more individual and better health promotion and care, which potentially could be beneficial for the most deprived. However, there are also concerns that not all population groups will profit equally from this new population-based medicine, and that new digital health technologies will maintain – or even reinforce – existing health disparities. This article suggests using insights from poverty studies combined with a patients’ and human rights-based approach to ensure that the most deprived are not left behind in the application of new health technologies.

This chapter discusses how the legal and ethical aspects of gene technology are both a national concern for European states and a European concern addressed by both the Council of Europe (CoE) and the European Union (EU). The CoE has been engaged in bioethical issues since the beginning of the 1980s and has adopted a number of recommendations and resolutions concerned with developments in biomedical science and technologies. Most notable is the adoption of the CoE Convention on Human Rights and Biomedicine (Oviedo Convention) in 1997, which focuses on a number of selected human rights aspects of developments in biomedicine. The Convention includes a number of general legal principles applying to medical interventions on human beings, including informed consent and the right to privacy. The chapter then assesses informed consent and genetic counselling, as well as specific issues related to genetic testing of adults, children, fetuses, and embryos. It also considers genetic research, direct-to-consumer genetic testing, genetic discrimination, gene therapy, and the protection of genetic information.

This chapter provides an overview of the relationship between genetics and the law. Advances in genetics and genomics have created both hopes and concerns and raise a number of legal issues in both the United States and Europe. To understand the legal issues in genetics, it is helpful to have some understanding of the different types of genetic analysis that can be used and for which purposes. In virtually all these contexts, the doctrine of informed consent is important. While the law in the United States and Europe does not generally require non-directiveness, the legal doctrine of informed consent applies in all jurisdictions, imposing on physicians and genetic counselors the legal obligation to disclose material information that could influence a patient's decisions about genetic testing. The other ethical and legal issues that arise with genetic or genomic analysis differ depending on the purpose, context, and technology used. These legal issues concern the methods of regulating genetic tests offered in the clinical setting and through the “direct-to-consumer” online genetic testing industry; genetic discrimination; the scope of privacy protections of genetic information; and the regulation of human gene therapy, gene therapy research, and germline modifications.

This chapter seeks to provide an insight into how the regulatory discretion the GDPR has left to the Member States has been used. It reviews the biobank regulatory environment; whether and how derogations under Article 89(2) GDPR are enabled; the legal basis for scientifc research and role of consent in biobanking post-GDPR; the balance between individual rights and public interest in national law; and fnally, the GDPR’s impact and future possibilities for biobanking. While in exercising their national self-determination the Member States have some possibility to tailor data protection requirements corresponding to their values and aspirations, it risks coming with implications, jeopardizing collaborative research. At this point, it could be argued that Research Ethics Committees (RECs) may have a considerable role to play in navigating the gap between the legal and ethical requirements in both a national as well as a cross-border context.

Denmark offers very good opportunities for biobank research. There is a vast number of well-structured and comprehensive collections of biological material, which in combination with a ‘research generous’ legislation provides an excellent environment for biobank research. However, both the Danish biobank landscape and the regulatory environment is rather complex. In contrast to a number of other countries, there is no specific biobank act in Denmark. Instead, various regulatory regimes interact, which makes it challenging to navigate in the legal landscape. It is also rather non-transparent for the individuals, from whom samples have been collected, what samples are used for, and how they can influence the use of samples for research. With the GDPR and the Danish Data Protection Act it seems that research participants’ rights have been slightly weakened in Danish law. However, it is argued, that the GDPR has the potential to ensure more awareness of research participants right against the societal and scientific interest in research.

Despite the increasing availability of direct-to-c onsumer (DTC)genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients' rights. This study has not received any funding, but has benefited from interactions within the COST Action IS1303 'Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives', supported by COST (European Cooperation in Science and Technology) (http://www.cost.eu).

As members of the Nordic family of welfare states, both Norway and Denmark are characterised by universal access to health care. Legislation and individual rights have increasingly been used as tools to promote and protect patients' equal access to health care services. At the same time both countries are struggling with increasing health care expenditures, waiting lists and a demand to prioritise health care resources in light of new and expensive treatment options. This calls for political space to adjust prioritisation policies and procedures. The article analyses the regulation of access to hospital care in Norway and Denmark, from a law and politics perspective. We explore similarities and differences between the two countries with respect to the objectives of the regulation and formulation of the right to hospital care, and how the interplay between law and politics – and juridification and politicisation – is expressed and managed in the regulation. We conclude that even though there are differences between the two countries in the extent of juridification, the regulation in both countries still leaves room for continued political governance of issues related to the prior itisation of health care services.

BACKGROUND Despite strong indications of a high prevalence of weight-related stigmatization in individuals with obesity, limited attention has been given to the role of weight discrimination in examining the stigma obesity. Studies, up to date, rely on a limited basis of data sets and additional studies are needed to confirm the findings of previous studies. In particular, data for Europe are lacking, and are needed in light of a recent ruling of the European Court of Justice that addressed weight-based discrimination. METHODS The data were derived from a large representative telephone survey in Germany (n=3003). The dependent variable, weight-based discrimination, was assessed with a one-item question. The lifetime prevalence of weight discrimination across different sociodemographic variables was determined. Logistic regression models were used to assess the association of independent and dependent variables. A sub-group analysis was conducted analyzing all participants with a body mass index ⩾25 kg m(-)(2). RESULTS The overall prevalence of weight-based discrimination was 7.3%. Large differences, however, were observed regarding weight status. In normal weight and overweight participants the prevalence was 5.6%, but this number doubled in participants with obesity class I (10.2%), and quadrupled in participants with obesity class II (18.7%) and underweight (19.7%). In participants with obesity class III, every third participant reported accounts of weight-based discrimination (38%). In regression models, after adjustment, the associations of weight status and female gender (odds ratio: 2.59, P

Background: In assigning responsibility for obesity prevention a distinction may be drawn between who is responsible for the rise in obesity prevalence (‘backward-looking responsibility’), and who is responsible for reducing it (‘forward-looking responsibility’). Methods: We study how the two aspects of responsibility figure in the obesity policies of WHO (European Region), the EU and the Department of Health (England). Results: Responsibility for the emergence and reduction of obesity is assigned to both individuals and other actors to different degrees in the policies, combining an individual and a systemic view. The policies assign backward-looking responsibility to individuals, the social environment, the authorities and businesses. When it comes to forward-looking responsibility, individuals are expected to play a central role in reducing and preventing obesity, but other actors are also urged to act. WHO assigns to individuals the lowest degree of backward- and forward-looking responsibility, and the Department of Health (England) assigns them the highest degree of responsibility. Discussion: Differences in the assignment of backward- and above all forward-looking responsibility could be explained to some extent by the different roles of the three authorities making the plans. WHO is a UN agency with health as its goal, the EU is a liberal economic union with optimization of the internal European market as an important task, and England, as an independent sovereign country, has its own economic responsibilities.

Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patients differently than samples collected from research participants, particularly with respect to autonomy. Importantly, biobanks established for future unspecified research are not subject to research ethics review. Biobank-based research has gained more prominence on the national level recently, and the potential for a less fragmented and more consistent regulatory approach may emerge from this attention.

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.

In 2013, the American Medical Association (AMA) decided to recognize obesity as a disease. One of the main arguments presented in favor of this was broadly 'utilitarian': the disease label would, it was claimed, provide more benefits than harms and thereby serve the general good. Several individuals and groups have argued that this reasoning is just as powerful in the European context. Drawing mainly on a review of relevant social science research, we discuss the validity of this argument. Our conclusion is that in a Western European welfare state, defining obesity as a disease will not on balance serve the general good, and that it is therefore more appropriate to continue to treat obesity as a risk factor. The main reasons presented in favor of this conclusion are: It is debatable whether a disease label would lead to better access to care and preventive measures and provide better legal protection in Europe. Medicalization and overtreatment are possible negative effects of a disease label. There is no evidence to support the claim that declaring obesity a disease would reduce discrimination or stigmatization. In fact, the contrary is more likely, since a disease label would categorically define the obese body as deviant.

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.

The Danish Patients’ Rights Act from 1998 was the first comprehensive piece of legislation addressing the basic legal values and principles governing the relation between patient and the health care services. Since the adoption of the Act there has been continuous legislative activity in the field, and the objective of the article is to discuss how recent developments in Danish patients’ rights legislation shall be interpreted in terms of balancing interests of patients towards interests of society and the health care professions.

The five Nordic countries — Denmark, Finland, Iceland, Norway and Sweden — share a considerable part of their cultural and historical heritage. They have collaborated closely in their development of legislation during most of the 20th century and are also all traditional welfare states, but nevertheless demonstrate a surprising degree of variety in the area of health law. The Nordic Network for Research in Biomedical Law was founded in 2006, with the aim to promote intra-disciplinary collaboration and stimulate comparative Nordic research in this field of law. Exchange of information on recent legal developments has been a recurrent point on the agenda at the Network meetings.

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.

In this article, the author explores the nature of confidentiality in the doctor-patient relationship and discusses the extent to which patient's rights to confidentiality, privacy and autonomy are balanced by a professional interest in good care and the organizational interest in administrative efficiency.

This anthology aims to provide Nordic perspectives on the young and evolving field of health law – or biomedical law – by reflecting on issues that have been explored within the activities of the Nordic Network for Research in Biomedical Law. In the emergence of this fairly new legal discipline, it has become very clear that the Nordic region forms a part of Europe that has been strongly influenced by both hard and soft law initiatives from the European Union and the Council of Europe, but also that Nordic identity, culture, and collaboration clearly remain an important factor in the legal development of this particular region.

Stem cell biobanks can be understood as repositories of stem cells and stem cell lines including the data associated with the biological material. Such biobanks have widely differing extents, characters and purposes. Some are very large and serve broad-spectrum purposes. Others are smaller and have more distinct aims. Some are public, others are commercial. Altogether the area of stem cell banks is highly complex, which implies a regulatory challenge for legislators. This paper aims at clarifying how stem cell banks are regulated in international law with a special focus on the balancing of interests of different stakeholders. Tissue donors may have various interests in regards to stored stem cell samples, especially an interest in self-determination and privacy protection. These interests must be balanced against the interests of other actors, not least those patients who can benefit from the development of new treatment but also the interest of society at large in development of new knowledge. New issue arises in situations where stem cell research is moved from the laboratory to the clinic. The change of purposes associated with the translation of research into clinical practise gives rise to special regulatory concerns and challenges, especially in regards to tissue donor’s right to self-determination. The paper concludes that the international regulation only to a limited extent refer explicitly to how the transition from laboratory research to stem cell treatment should be dealt with, and that there is a need for clarification in international law of how to tackle this challenge.

The five Nordic countries--Denmark, Finland, Iceland, Norway and Sweden--share a considerable part of their cultural and historical heritage. They have collaborated closely in their development of legislation during most of the 20th century and are also all traditional welfare states, but nevertheless demonstrate a surprising degree of variety in the area of health law. The Nordic Network for Research in Biomedical Law was founded in 2006, with the aim to promote intra-disciplinary collaboration and stimulate comparative Nordic research in this field of law. Exchange of information on recent legal developments has been a recurrent point on the agenda at the Network meetings.

Danish health law does not explicitly consider the participation of patients in clinical training of medical students. This causes uncertainty with regards to patients' rights and to the obligations of the hospital and the medical student. In this paper, we evaluate the legal aspects as regards information, consent and privacy in situations where patients are involved in the training of medical students. We conclude that it is necessary to elucidate the legal aspects and develop legal and practical guidelines for these situations.

ResumeL’objectif de cet article est d’examiner le role des principes ethiques par rapport a la reglementation de la biotechnologie dans le domaine des plantes. L’exemple de la reglementation danoise est utilise pour montrer les difficultes a transformer des principes ethiques en droit. Au Danemark il y a eu le soutien du gouvernement pour la mise au point d’un cadre ethique pour l’utilisation de la biotechnologie dans le domaine de l’alimentation et des plantes. Cependant, il semble toujours que les principes ethiques ont du mal a se faire admettre dans la reglementation juridique. Ceci s’expliquerait partiellement par une tension entre le droit administratif traditionnel qui se preoccupe des droits individuels, y compris des droits a la propriete, et le droit environnemental qui est fonde sur des principes ethiques se preoccupant davantage des interet communs.

With the aim of understanding current problematizations of embryonic stem cell patenting this article rehearses the history of social entitlements related to reproductive material derived from women seeking care in institutions for reproductive health in Denmark. Our interest lies in the emergence of commercial exchange of material derived from embryos. Such exchange is characterized by contestation of the status of the embryo: is it a person or a commodity? To understand the modus operandi of the exchanges, we first explore how the concepts of personhood and morality, of commodity and ownership tend to be related in the ideal type of capitalist exchange. Historical context then helps us understand the contingency of exchange systems. Historically Danish women have had much less influence on the dissemination of material derived from them than they do today. However, today their entitlements have also found their limits, in particular with respect to commercial transactions. We claim that, ironically, material derived from institutionally mediated reproduction gains unprecedented personhood from confrontation with a capitalist exchange form which potentially designates it as a mere commodity.