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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 Swedish response to the Corona-crisis has been relatively moderate compared to most other countries. Sweden did not opt for a total lockdown, did not close elementary schools, day cares, bars, restaurants, movie theaters, and other places of business. Public gatherings of up to 50 people are still allowed until further notice. Sweden’s intra EU borders remain open – in contrast to its neighbor

Companies and healthcare providers are developing and implementing new applications of medical artificial intelligence (MAI), including the AI sub-type of medical machine learning (MML). MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, incl

Cloud-based technologies, big data, statistical signal processing algorithms, and Artificial Intelligence (AI) technologies are expected to play an increasingly important role in themedical field. Big data and AI-technologies rely on the cloud for data storage as well as for computational power and thus need effective and robust legal frameworks for international data transfer. Because of inconsis

In this two-part paper, influences from environmental factors on lightning in a convective storm are assessed with a model. In Part I, an electrical component is described and applied in the Aerosol-Cloud model (AC). AC treats many types of secondary (e.g., breakup in ice-ice collisions, raindrop-freezing fragmentation, rime splintering) and primary (heterogeneous, homogeneous freezing) ice initia

Over twenty years after the Universal Declaration on the Human Genome and Human Rights alerted the international community of the need to prevent discriminatory use of genetic information, it still remains a pervasive issue. Legal efforts to address genetic discrimination (GD) solely at the national level are unlikely to resolve a problem that now transcends national frontiers. People should have