'Pushing the boundaries': a dialogical account of the evolution of European case-law on access to welfare.

In the context of the 2004 Enlargement, several EU governments reformed their social legislation to restrict the access to benefits of job-seeking or inactive EU citizens. Many of these restrictions were in tension with the case-law of the European Court of Justice, but when it came to judge their compatibility with EU law, the ECJ was more lenient than many anticipated. This article analyses this shift in ECJ case-law by looking at the dialogue between the Court and national authorities against the backdrop of EU legislative reform. It demonstrates that Member States contributed to the evolution of case-law by 'pushing the boundaries' of EU law both domestically and before the Court. It shows in particular how closely the arguments presented before the Court by national judiciaries or governments correlate with the new interpretations adopted by the Court itself. This is illustrated with empirical evidence from the UK and Germany.

Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities.

Background: In 2014, the European Clinical Trials Regulation was drawn up by the European Commission to replace the Clinical Trials Directive. The new Regulation aims to solve the shortcomings revealed by the Directive, such as extensive timelines and high bureaucratic costs, while increasing standards for safety and transparency of clinical trials. Importantly, the Regulation also points at harmonizing procedures among European Member States. From January 31st, 2022, it will be possible to submit clinical studies through a new portal, namely the Clinical Trials Information System. Since not complying to the Regulation implies not participating in clinical trials, many European countries underwent changes in national documents and related procedures. In The Netherlands, the Site Suitability Declaration, a document necessary to ascertain the adequacy of a site to perform a trial, was reviewed. Methods: In our research, we investigated the status of the VGO implementation during a transition period among different stakeholders involved in the start-up process through a validated questionnaire and subsequent semi-structured interviews. Results: This project showed a slow-paced implementation, linked to communication and organizational challenges but also to a negative approach towards the change. Nevertheless, some stakeholders expressed constructive feedback as well, indicating the VGO as an upgrade. The latter was mainly achieved through establishing a trustful relationship with other stakeholders, undergoing additional adjustments, and having a positive mindset. Conclusions: This research pointed at a still too scarce collaboration between stakeholders, who should rather actively contribute to achieve the implementation goal.

'Social Citizenship' at the Street Level? EU Member State Administrations Setting a Firewall.

European integration, and especially the European Court of Justice, has challenged the national character of social rights; the latter have become increasingly transnational. This contribution examines the impact of the Court at the street level. It analyses how Member State administrations handle the social rights of mobile EU citizens in practice in case they are granted discretion. Therefore, a framework of shades of compliance is developed that captures Member State responses to EU law beyond the dichotomy of compliance and non-compliance. I argue that Member State administrations tend to make the access to social benefits difficult. Still, there may be differences in the shade of compliance on the ground. Surprisingly, these differences cannot be explained by the party-political environment but depend to a high degree on exposedness. The claim is empirically supported by a comparative study of Austrian welfare (and migration) administrations' practices.

Unrealized potential of drug repositioning in europe during COVID-19 and beyond: a physcian's perspective.

Drug repositioning is the scientific strategy of investigating existing drugs for additional clinical indications. The advantages of drug repositioning are that it benefits patients and that it adds new indications to existing drugs for lower costs compared to de novo drug development. Clinical research groups recognizing efficacy of these "old" drugs for a new indications often face an uphill struggle due to a lack of funding and support because of poor structural and regulatory support for clinical drug development. The current framework for drug repositioning allows "venture capital" companies to abuse loopholes in the legislation to gain long-term market authorization among with excessive high pricing. A new regulatory framework is needed to prevent abuse of the legislation and promote clinical investigator-driven drug repositioning. The COVID-19 pandemic has boosted funding and regulatory support for drug repositioning. The lessons learned from the COVID-19 pandemic should be implemented in a new clear blueprint for drug repositioning. This blueprint should guide clinicians through legislation for drug repositioning in the EU. This review summarizes the routes for registration and discusses the current state of drug repositioning in Europe.

Non-indigenous species refined national baseline inventories: A synthesis in the context of the European Union's Marine Strategy Framework Directive.

Refined baseline inventories of non-indigenous species (NIS) are set per European Union Member State (MS), in the context of the Marine Strategy Framework Directive (MSFD). The inventories are based on the initial assessment of the MSFD (2012) and the updated data of the European Alien Species Information Network, in collaboration with NIS experts appointed by the MSs. The analysis revealed that a large number of NIS was not reported from the initial assessments. Moreover, several NIS initially listed are currently considered as native in Europe or were proven to be historical misreportings. The refined baseline inventories constitute a milestone for the MSFD Descriptor 2 implementation, providing an improved basis for reporting new NIS introductions, facilitating the MSFD D2 assessment. In addition, the inventories can help MSs in the establishment of monitoring systems of targeted NIS, and foster cooperation on monitoring of NIS across or within shared marine subregions.

Main changes in European Clinical Trials Regulation (No 536/2014).

The new Regulation (EU) No. 536/2014 for clinical trials of medicinal products for human is part of a European regulatory framework in which the European Commission has wished to give a strong impetus to scientific research and industrial progress. It is a new regulation that fills a series of regulatory gaps in the Clinical Trials through the creation of a uniform framework for the authorization of clinical trials by all interested Member States with a single assessment of the results. The Regulation thus facilitates cross-border cooperation to make the clinical tests wider and encourage the development of special treatments, for example for rare diseases, but above all streamlines the rules on clinical trials across European Union (EU), introducing simplified rules for experimentation so-called 'low level of intervention', on which much has been discussed and still arouses concern, providing for authorized medicines or used off-label in the presence of scientific evidence published on efficacy and safety and to benefit from they will be mainly the pediatric and oncological therapeutic areas. The applications and any communication will be submitted paperlessly via a new electronic EU portal. The complex processing procedures and shorter time limits are to be stressed in comparison to the previously valid regulations. This is a major challenge for all stakeholders, but on the other hand it should contribute to the future role of the EU in the development of innovative medicines.

Personalising your health: an EU imperative.

In the fast-moving world of personalised medicine there are many issues and barriers-not least when it comes to getting novel drugs and treatments swiftly to where they are really needed. Slow bench-to-bedside rates do not help the 500 million potential patients across the EU's current 28 Member States, and the timings are affected by several elements during the development and licensing phases. As we all know, personalised medicine starts with the patient. It holds huge potential for improving the health of many patients and ensuring better outcomes for health systems' efficiency and transparency.

Risk-based methods for fish and terrestrial animal disease surveillance.

Over recent years there have been considerable methodological developments in the field of animal disease surveillance. The principles of risk analysis were conceptually applied to surveillance in order to further develop approaches and tools (scenario tree modelling) to design risk-based surveillance (RBS) programmes. In the terrestrial animal context, examples of risk-based surveillance have demonstrated the substantial potential for cost saving, and a similar benefit is expected also for aquatic animals. RBS approaches are currently largely absent for aquatic animal diseases. A major constraint in developing RBS designs in the aquatic context is the lack of published data to assist in the design of RBS: this applies to data on (i) the relative risk of farm sites becoming infected due to the presence or absence of a given risk factor; (ii) the sensitivity of diagnostic tests (specificity is often addressed by follow-up investigation and re-testing and therefore less of a concern); (iii) data on the variability of prevalence of infection for fish within a holding unit, between holding units and at farm level. Another constraint is that some of the most basic data for planning surveillance are missing, e.g. data on farm location and animal movements. In Europe, registration or authorisation of fish farms has only recently become a requirement under EU Directive 2006/88. Additionally, the definition of the epidemiological unit (at site or area level) in the context of aquaculture is a challenge due to the often high level of connectedness (mainly via water) of aquaculture facilities with the aquatic environment. This paper provides a review of the principles, methods and examples of RBS in terrestrial, farmed and wild animals. It discusses the special challenges associated with surveillance for aquatic animal diseases (e.g. accessibility of animals for inspection and sampling, complexity of rearing systems) and provides an overview of current developments relevant for the design of RBS for fish diseases. Suggestions are provided on how the current constraints to applying RBS to fish diseases can be overcome.