Navigating Cross-Border Challenges In Biobanking: Analysing Eu Legislation, ECJ Case Law, and the Role of Private International Law

Abstract

Biobanks, as repositories for biological samples and associated data, play a pivotal role in advancing biomedical research and enabling personalized medicine on a global scale. However, the cross-border operation of biobanks faces intricate legal challenges arising from diverse regulatory frameworks across jurisdictions. This article offers a comprehensive analysis of the complexities surrounding cross-border biobanking within the European Union (EU), focusing on EU legislation and the notable legal precedents set by the European Court of Justice (ECJ). Additionally, it examines the efficacy of utilizing Private International Law mechanisms to navigate the legal intricacies inherent in biobanking activities. The initial section scrutinizes existing EU legislation governing biobanks, identifying potential areas of conflict and disparity stemming from variations in laws among member states. Particular attention is given to data protection, informed consent, and the transportation of biological samples. Subsequently, the study delves into significant ECJ rulings pertaining to biobanking and data sharing, emphasizing the legal principles established by the court in the context of cross-border biobanking. The third section explores the importance of Private International Law instruments in addressing the challenges posed by EU legislation and case law. It investigates the application of choice of law, jurisdiction, and recognition and enforcement of judgments to resolve conflicts between biobanks operating in different legal jurisdictions. Moreover, the study highlights the potential of international conventions and treaties in promoting harmonization within cross-border biobanking practices. By illuminating how legal theories and frameworks can facilitate efficient cross-border biobanking collaborations, this article offers valuable insights for policymakers, legal professionals, and biobank administrators. It provides recommendations to enhance international cooperation within the intricate legal landscapes of biotechnology and intellectual property. Leveraging Private International Law enables the pursuit of harmonized biobanking practices, thus propelling significant advancements in scientific knowledge and medical discoveries.