Petra Bárd

The case of biobank with the law: between a legal and scientific fiction

According to estimates more than 400 biobanks currently operate across Europe. The term ‘biobank’ indicates a specific field of genetic study that has quietly developed without any significant critical reflection across European societies. Although scientists now routinely use this phrase, the wider public is still confused when the word ‘bank’ is being connected with the collection of their biological samples. There is a striking lack of knowledge of this field. In the recent Eurobarometer survey it was demonstrated that even in 2010 two-thirds of the respondents had never even heard about biobanks. The term gives the impression that a systematic collection of biological samples can constitute a ‘bank’ of considerable financial worth, where the biological samples, which are insignificant in isolation but are valuable as a collection, can be preserved, analysed and put to ‘profitable use’. By studying the practices of the numerous already existing biobanks, the authors address the following questions: to what extent does the term ‘biobank’ reflect the normative concept of using biological samples for the purposes of biomedical research? Furthermore, is it in harmony with the so far agreed legal–ethical consensus in Europe or does it deliberately pull science to the territory of a new, ambiguous commercial field? In other words, do biobanks constitute a medico-legal fiction or are they substantively different from other biomedical research protocols on human tissues?

Mutual Recognition and Individual Rights: Did the Court Get it Right?

This article focuses on the case-law of the Court of Justice and the dialogue it conducted with national apex courts when seeking to reconcile the ‘free movement of judicial decisions’, as facilitated by mutual recognition, and individual rights in its interpretation of the Framework Decision on the European Arrest Warrant. The present analysis shall concentrate on the recent judgment in Aranyosi and Căldăraru. The article concludes that for the sake of legal certainty, more guidance should be provided under EU legislation to make sure that judicial cooperation does not lead to disproportionate intrusions on individual rights or even violations of absolute rights. This should be accompanied by a permanent mechanism for monitoring and addressing Member State compliance with democracy, the rule of law and fundamental rights. Ultimately, however, the courts will have to play a crucial role in carving out and applying fundamental rights exceptions. In providing guidance to national courts, the Court of Justice needs to further clarify that the application of mutual recognition and fundamental rights exceptions are not in conflict and show proper deference to the norms developed by the European Court of Human Rights and national (constitutional) courts.

Anonymity and Privacy in Biobanking

The present book chapter intends to provide a conceptual framework on the use and misuse of anonymity in biobank projects. The major point of departure is the comparative analysis of various functions of anonymity in the biomedical field. By applying this method, the authors also highlight differences between traditional and contemporary notions anonymity. The other aim of the chapter is to distinguish between the overlapping terms of confidentiality, anonymity, data protection, and privacy. While medical guidelines focus on the notion and technicalities of anonymisation, legal provisions are based on the pillars of data protection norms, such as the possibility of identification, and the attachment to the original goal of data processing. The difference between these approaches resulted in various forms of ambiguities in the practice of biobanks. In addition to offering a theoretical framework, the authors analyze numerous models for regulation, with examples mainly from the Central and Eastern European region. The overview of the functions of anonymity reveals also to what extent anonymity can be regarded as an efficient solution for the regulatory challenges. The authors sketch out the most influential regulatory positions and analyze them critically, using a multidisciplinary approach.

The Legal Regulation of Biobanks: National Report: Greece

This paper is an overview and analysis of the relevant Greek laws on data protection, and on genetic research.

Judicial independence as a precondition for mutual trust? The CJEU in Minister for Justice and Equality v. LM

This article discusses the relationship between judicial independence and intra-European Union (EU) cooperation in criminal matters based on the principle of mutual recognition. It focuses on the recent judgment by the Court of Justice of the EU in Case C-216/18 PPU Minister for Justice and Equality v. LM. In our view, a lack of judicial independence needs to be addressed primarily as a rule of law problem. This implies that executing judicial authorities should freeze judicial cooperation in the event should doubts arise as to respect for the rule of law in the issuing Member State. Such a measure should stay in place until the matter is resolved in accordance with the procedure provided for in Article 7 TEU or a permanent mechanism for monitoring and addressing Member State compliance with democracy, the rule of law and fundamental rights. The Court, however, constructed the case as a possible violation of the right to a fair trial, the essence of which includes the requirement that tribunals are independent and impartial. This latter aspect could be seen as a positive step forward in the sense that the judicial test developed in the Aranyosi case now includes rule of law considerations with regard to judicial independence. However, the practical hurdles imposed by the Court on the defence in terms of proving such violations and on judicial authorities to accept them in individual cases might amount to two steps back in upholding the rule of law within the EU.