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The principle of conferral tames the EU competence to regulate research in a comprehensive manner, yet furthering research is one of its aspirations. Data protection, however, is an area within which the EU has legislated extensively. During the development of the General Data Protection Regulation (GDPR), an important issue to tackle was how to balance the ambitious EU aspirations and differing stakeholder interests, on the one hand, with limited competences in research regulation, on the other, and how to determine the extent to which data protection could be used as a means to further scientific research in the EU legal order. The outcome is the GDPR multifaceted research regime that sets forth EU policy and opens up for further regulations from the Member States as well as the EU. The research regime that the GDPR has created poses numerous questions. Key among these is, what are the implications of the operationalisation of Article 89 GDPR in biobanking? This chapter sets out some of the underlying tensions in the area and pins down key conceptual foundations for the book. It provides insights into the EU's interests in the area of biobanking and maps out central elements of the research regime that has been built within the GDPR. Thereafter, it analyses the key concepts used in the book, including biobank and biobanking, scientific research as undertaken under the GDPR, individual rights and public interest. Lastly, it shares some preliminary reflections as starting points for the analysis to come.

The principle of conferral tames the EU competence to regulate research in a comprehensive manner, yet furthering research is one of its aspirations. Data protection, however, is an area within which the EU has legislated extensively. During the development of the General Data Protection Regulation (GDPR), an important issue to tackle was how to balance the ambitious EU aspirations and differing stakeholder interests, on the one hand, with limited competences in research regulation, on the other, and how to determine the extent to which data protection could be used as a means to further scientific research in the EU legal order. The outcome is the GDPR multifaceted research regime that sets forth EU policy and opens up for further regulations from the Member States as well as the EU. The research regime that the GDPR has created poses numerous questions. Key among these is, what are the implications of the operationalisation of Article 89 GDPR in biobanking? This chapter sets out some of the underlying tensions in the area and pins down key conceptual foundations for the book. It provides insights into the EU's interests in the area of biobanking and maps out central elements of the research regime that has been built within the GDPR. Thereafter, it analyses the key concepts used in the book, including biobank and biobanking, scientific research as undertaken under the GDPR, individual rights and public interest. Lastly, it shares some preliminary reflections as starting points for the analysis to come.

Through the lens of legal pluralism and state sovereignty this research examines the competence and authority of the Council of Europe and the EU to handle the market aspects (technical performance and utility) as well as privacy (consent to a medical service and data protection requirements), and examines the obligations these two legal orders place on the Member States of the EU. This research traces the avenues for coexistence between the legal orders in relation to direct-to-consumer genetic testing, and examines how the coexistence of the Council of Europe and the EU is reflected in the legal framework that is relevant to the regulation of direct-to-consumer genetic testing

This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.

Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .

This open access book focuses on the discrepancies in biobank research regulations that are among the most significant hurdles to effective research collaboration. The General Data Protection Regulation (GDPR) has established stringent requirements for the processing of health and genetic data, while simultaneously allowing considerable multi-level exceptions for the purposes of scientific research. In addition to directly applicable exceptions, the GDPR places the regulatory responsibility for further defining how the Member States strike a balance between the individuals' rights and the public interest in research within their national legal orders. Since Member States' approaches to the trade-off between data subjects' rights on the one hand, and appropriate safeguards on the other, differ according to their ethical and legal traditions, their data protection requirements for research also differ considerably. This study takes a comprehensive approach to determine how the GDPR affects regulatory regimes on the use of personal data in biobanking research, with a particular focus on the balance between individuals' rights, public interest and scientific research. In this regard, it has two main goals: first, to scrutinize the GDPR research regime, its objective and constitutive elements, the impact it has on biobanking, and its role in a changing EU landscape post-Brexit; and second, to examine how various exceptions have been operationalized nationally, and what challenges and opportunities this diversification entails. The book not only captures the complexity GDPR creates for biobanking, but also sheds light on various approaches to tackling the corresponding challenges. It offers the first comprehensive analysis of GDPR for biobanking, and the most up-to-date overview of the national biobank regulatory frameworks in Europe.

The General Data Protection Regulation (GDPR) came into force in May 2018. The aspiration of providing for a high level of protection to individuals' personal data risked placing considerable constraints on scientific research, which was contrary to various research traditions across the EU. Therefore, along with the set of carefully outlined data subjects' rights, the GDPR provides for a two-level framework to enable derogations from these rights when scientific research is concerned. First, by directly invoking provisions of the GDPR on a condition that safeguards that must include 'technical and organisational measures' are in place and second, through the Member State law. Although these derogations are allowed in the name of scientific research, they can simultaneously be challenging in light of the ethical requirements and well-established standards in biobanking that have been set forth in various research-related soft legal tools, international treaties and other legal instruments. In this article, we review such soft legal tools, international treaties and other legal instruments that regulate the use of health research data. We report on the results of this review, and analyse the rights contained within the GDPR and Article 89 of the GDPR vis-à-vis these instruments. These instruments were also reviewed to provide guidance on possible safeguards that should be followed when implementing any derogations. To conclude, we will offer some commentary on limits of the derogations under the GDPR and appropriate safeguards to ensure compliance with standard ethical requirements.

EU Digital green certificates were initially envisaged as a joint EU initiative to facilitate free movement during the pandemic. However, many countries rapidly extended their use in different contexts at the national level, raising serious ethical and legal concerns and questions, in particular, on how to strike a right balance between the interests of the individual and the interests of society. The paper aims to explore the legal implications of using vaccination certificates at the national level, in particular by exploring and comparing practices in selected Nordic and Baltic countries. The article emphasises that, despite COVID-19 crises, the governments should protect fundamental rights and values and when deciding on new restrictions carefully assess their necessity and proportionality. National responses call for a new regulatory framework to ensure responsible use of digital technologies in public interests.

Key Points To effectively collaborate in biobanking and build capacity in low and middle-income countries, data transfer from European Union (EU) Member States to states in Africa is crucial. Although under the General Data Protection Regulation (GDPR) avenues for data transfer exist, the ones feasible for transcontinental data exchange for biobank research rely on EU enforcement which in essence means limited oversight possibilities and, consequently, considerable risks to the EU data subject's privacy. To ensure effective data protection for data subjects in biobanking, raising the data protection bar in data recipient countries is crucial. Although Kenya, Nigeria, South Africa, and Uganda have taken considerable steps towards developing data protection frameworks, only that of South Africa and Nigeria's Protection of Personal Information Bill seem to be such to meet the protection level set out by the GDPR. The legislative initiatives in Kenya and Uganda require revisions to ensure that protection of privacy is not undermined when data are being sent to these countries. Currently, considerable responsibility is placed in the hands of the legislatures in the countries of concern—and notably in Kenya, and Uganda—to set foundations for ending research and research integrity-harming practices. In Nigeria, these foundations are defined in the Protection of Personal Information Bill, but not adopted yet. South Africa, however, has taken a big step towards building routes for genuine biobank capacity-building in the country and collaboration in that regard. ; B3Africa

Despite the increasing availability of direct-to-consumer (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 article is part of the Topical Collection on Citizen's Health throughpublic-private Initiatives: Public health, Market and Ethical perspectives.

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.

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.