There is no doubt that COVID-19 will have a substantial impact on access to biologics and biosimilar uptake, as well as on the related ethical, legal, and social dimensions of prioritization decisions. This holds especially true for Denmark and European markets, where governments are expected to cover most of the pharmaceutical needs of their citizens and where the crisis has been leading to an im

As the world rushes to identify safe and effective vaccines and therapeutics to counter the COVID-19 epidemic, attention is turning to the next step: manufacturing these products at enormous scale. To speed up the process, firms are even es-tablishing manufacturing capacity “at risk,” before products receive regulatory approval (1). Yet for at least some complex COVID-19 vaccines and biological th

There has been a rapid rise in papers modelling the impacts of autonomous vehicles. Drawing on a review of this literature, we analyse and discuss the messages conveyed by these studies from a policy-making perspective. An overview of the studies is provided to highlight the different policy frames. We consider the roles that modelling knowledge should have in policy-making in the context of unsta

Whether the E.U. Trade Secrets Directive sufficiently and appropriately covers cutting-edge complex technologies is of critical interest to policy-makers, scientists, and commercial developers alike. One such technology—adaptive immune receptor repertoire sequencing, or AIRR-seq—raises difficult questions concerning what information is and should be protected under the new Directive, and how to be

The EU Trade Secrets Directive (‘the Directive’) has standardized the national laws in EU member states for the protection of trade secrets. For the first time, a harmonised definition of what constitutes a ‘trade secret’ is established as well as common measures aimed at preventing the misappropriating of trade secrets and rules for procedures and sanctions.The adoption of the Directive reflects

The growing significance of trade secrets (TS) in today's society and business has unleashed an unprecedented boom in litigation, legislation, and in media and scholarly attention. Many factors contribute to this development, such as the rise of digitalization & artificial intelligence, increasing mobility, a changing intellectual property (IPR) landscape, the greater flexibility and applicabi

This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable EU regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the softwar

This chapter will map the ethical and legal challenges posed by artificial intelligence (AI) in health care and suggest directions for resolving them. Section 1 will briefly clarify what AI is and Section 2 will give an idea of the trends and strategies in the United States (U.S.) and Europe, thereby tailoring the discussion to the ethical and legal debate of AI-driven health care. This will be fo

In February, 2020, the European Commission published a white paper on artificial intelligence (AI) as well as an accompanying communication and report. The paper sets out policy options to facilitate a secure and trustworthy development of AI and considers health to be one of its most important areas of application. We illustrate that the European Commission's approach, as applied to medical AI, p

The study of (anti-)deuteron production in pp collisions has proven to be a powerful tool to investigate the formation mechanism of loosely bound states in high-energy hadronic collisions. In this paper the production of (anti-)deuterons is studied as a function of the charged particle multiplicity in inelastic pp collisions at s=13 TeV using the ALICE experiment. Thanks to the large number of acc

PURPOSE: We assessed the associations between population-based polygenic risk scores (PRS) for breast (BC) or epithelial ovarian cancer (EOC) with cancer risks for BRCA1 and BRCA2 pathogenic variant carriers. METHODS: Retrospective cohort data on 18,935 BRCA1 and 12,339 BRCA2 female pathogenic variant carriers of European ancestry were available. Three versions of a 313 single-nucleotide polymorph

This chapter aims to contribute to an understanding of the physical environment as an important part of the rehabilitation process for patients recovering from a stroke who rehabilitate at home. To further develop evidence-based care models for rehabilitation at home and incorporate person-environment dynamics, an understanding of how environmental factors relate to everyday life and recovering at

A search for a chargino-neutralino pair decaying via the 125 GeV Higgs boson into photons is presented. The study is based on the data collected between 2015 and 2018 with the ATLAS detector at the LHC, corresponding to an integrated luminosity of 139 fb−1 of pp collisions at a centre-of-mass energy of 13 TeV. No significant excess over the expected background is observed. Upper limits at 95% conf

Background: Infectious complications in ANCA associated vasculitis (AAV) are a major cause of morbidity and mortality. The aim of this study was to determine the incidence rates, predictors and outcome of severe infections in AAV. Methods: We conducted a population-based cohort study in Southern Sweden with 326 incident cases of AAV diagnosed between 1997 and 2016. Diagnosis of vasculitis was conf

The top anti-top quark production cross-section is measured in the lepton+jets channel using proton–proton collision data at a centre-of-mass energy of s=13 TeV collected with the ATLAS detector at the LHC. The dataset corresponds to an integrated luminosity of 139 fb−1. Events with exactly one charged lepton and four or more jets in the final state, with at least one jet containing b-hadrons, are