Suchergebnisse

The features of the coronavirus disease 2019 (COVID-19) pandemic demand a new form of contact tracing performed by digital means: digital contact tracing. However, this mechanism raises several issues in light of relevant European regulations, particularly in terms of personal data protection and privacy. The challenge is to have a digital contact tracing model that efficiently and speedily alerts people to potential infection, so they can get tested and isolated as necessary, but that also complies with European legal standards. This paper will address two main issues. First, it will analyse digital contract tracing and its different features from the perspective of data protection and privacy, seemingly the main concern in this domain. Secondly, the paper will analyse the loopholes and benefits of digital contact tracing in the European context, focusing on the tension between privacy, individual liberties and public health to address its legitimacy.

In the Novartis Farma SpA case (Case C-29/17), the Court of Justice of the European Union (CJEU) held that the decision of a Member State (Italy) to reimburse a drug used off-label (Avastin), and for that purpose submitted to repacking procedures, is not in violation of European law, even if there is a duly approved therapeutic alternative (Lucentis) on the market and the procedure is solely to reduce health care expenditures. This was not the CJEU's first ruling on off-label drug use. The novelty of the Novartis Farma SpA case is the economic element attached to the assessment of off-label prescriptions, even though the Court failed to consider this essential feature of the case. This paper analyses the Court's ruling in light of two main principles of European pharmaceutical law: the imposition of marketing authorization for drugs used in the European market; and the predominance of public health concerns over economic considerations. The paper concludes that the Court failed to identify a major issue in the Italian policy – the reimbursement of off-label drug used when there is a properly approved therapeutic alternative on the market – at the risk of undermining the entire European pharmaceutical framework and endangering public health.