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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).

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.

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.

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.