Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from IVDD 98/79/EC (
) to IVDR 2017/746
. Without amendments and ...contingency plans, implementation of the IVDR in May 2022 will lead the healthcare sector into uncharted waters due to unpreparedness of the EU regulatory infrastructure. Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests. Finally, it also may discourage manufacturers and academia from developing specialty tests, thereby hampering innovation in medical diagnostic care. We hereby inform laboratory professionals about the imminent diagnostic collapse using testimonies from representative stakeholders of the diagnostic supply chain and from academia developing innovative in-house tests in domains of unmet clinical needs. Steps taken by the EFLM Task Force on European Regulatory Affairs, under the umbrella of the Biomedical Alliance in Europe, will be highlighted, as well as the search for solutions through dialogue with the European Commission. Although we recognize that the IVDR promotes positive goals such as increased clinical evidence, surveillance, and transparency, we need to ensure that the capabilities of the diagnostic sector are not damaged by infrastructural unpreparedness, while at the same time being forced to submit to a growing bureaucratic and unsupportive structure that will not support its “
”.
The Maltese “passports for sale” (Golden Passports) was big news a year or two ago but has now disappeared below the radar of public attention. Yet, the mills of justice might grind slowly, but grind ...they do. The case brought by the Commission against Malta is scheduled to be heard by the CJEU sometime later this year. So, Malta offers passports for sale. Quelle Horreur! I hear you sniffing with disgust and indignation. They sell their citizenship, and hoopla – automatically these new citizens, ipso facto and ipso jure are European Citizens enjoying all the rights and duties which attach to such.
The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory ...processes as quickly as possible. The United States and the European Union approach these challenges in different ways. Whereas the United States has always relied on a strictly centralized process through 1 agency, the Food and Drug Administration (FDA), the European Commission synchronized the regulations of 28 different countries as they combined to create the European Union. The FDA historically developed as a consumer protection agency, whereas the regulations from the European Commission arose out of a need to harmonize inter-state commercial interests while preserving national "autonomy." Thus, whereas the FDA has the advantages of centralization and common rules, the European Union regulates medical drug and device approvals through a network of centralized and decentralized agencies throughout its member states. This study explores some of the similarities and differences in European and U.S. regulation of drugs and devices, and discusses challenges facing each.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
By now it has become clear that Poland is not willing to discharge the definitive judicial penalties of over EUR 600 million which the European Court of Justice (ECJ) has ordered it to pay for ...failing to observe coercive interim measures. When the Commission announced it would proceed to set off the outstanding amounts against money due to Poland from the EU budget, the Polish government vowed to fight the recovery ‘with all legal means’. Recently, Poland has put its money where its mouth is. It has brought four cases before the General Court to challenge the recovery. These actions have thus far evaded closer scrutiny in the legal blogosphere. However, they contain a significant challenge to the EU’s powers to enforce judicial penalties against Member States, namely as regards recovery by offsetting. As the cases raise issues which may have repercussions beyond these proceedings, this post casts a closer look at Poland’s applications and analyses their potential broader significance.
The European Commission has recently launched a proposal for a Directive to promote repair. In this paper we critically analyse the drafting process in order to understand the resulting policy ...options. We consider that although the ambition of the Directive was low from the beginning given the limited policy options, it became even worse during the consultation period. The selection of barriers to repair was limited, and manufacturers pushed for a narrow and closed form of Right-to-Repair (R2R) that transferred all control over the potentially emerging repair market to them. Some information measures were proposed so as to increase transparency, potentially increasing the administrative burden on independent repairers, along with measures to encourage repair when under legal guarantee. This Directive fails to promote repair or help independent repairers overcome access barriers, nor does it allow member states to go beyond the limits imposed in the Directive itself.
The European Commission of the Danube (ECD) 1856–1939 published an impressive number of maps, the most important being included in four atlases. However, despite previous efforts, until 1870, no ...precise map of the Danube Delta based on a unitary triangulation survey has been published. This article examines the mapping effort to recreate the triangulation network containing all the 110 points, based on the distances specified in the 1874 atlas, landmarks discovered during fieldwork and other reference layers used for georeferencing the 1870, 1886 and 1902 maps. Moreover, it offers supplementary information about ECD's vision of the liquid territories and their central feature: water and its representation on cartographic material. In our explanation, we explore the differences between various cartographic products and other sources of information used by the European Commission of the Danube to update its navigation charts. By reproducing these mapping efforts, we highlight the technical challenges for accurately mapping the Danube Delta's everchanging territory. Furthermore, by carrying out the work on digitising and indexing available cartographic material and validating them for accuracy we deliver an enhanced resource that can provide a new understanding for these maps, given their political and economic message. Finally, in this article we offer some reflections on the possible propaganda role the atlases may have played, as the accurate map building role of the ECD does not only assert technical mastery, but also makes a statement of control over the mapped territory.
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•A reconstruction of the oldest triangulation network made by the European Commission of the Danube (ECD)•A revision of the ECD atlases published at the end of the XIX century•Triangulation as a technology used to rationalise the liquid territories•The map as a manifestation of the sovereign state's authority
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
2024 will see numerous elections, including the European Parliament Elections in June. The Digital Services Act (DSA) obliges Big Tech to assess and mitigate systemic risks for “electoral processes”. ...The Commission published Draft Guidelines on the mitigation of systemic risks for electoral processes and sought feedback from all relevant stakeholders. While the protection of election integrity is a laudable aim, the Guidelines as proposed would not rebuild but further erode citizen trust in the digital environment and democratic processes. The recommendations are too vague, too broad and too lenient as regards the suggested cooperation between Big Tech, civil society and public authorities.
Over the past two decades, "active aging" has emerged in Europe as the foremost policy response to the challenges of population aging. This article examines the concept of active aging and how it ...differs from that of "successful aging." In particular, it shows how active aging presents a more holistic, life course-oriented approach than successful aging. We provide a critical perspective on active aging too by, first, tracing its emergence in Europe and then showing how, in practice, it has been dominated by a narrow economic or productivist perspective that prioritizes the extension of working life. It has also been gender blind. Nonetheless, it is argued that an active aging approach has the potential to enable countries to respond successfully to the challenges of population aging because of its comprehensive focus and emphasis on societal as well as individual responsibility. Finally, we set out the basic principles that need to be followed if the full potential of active aging is to be achieved.
There is growing understanding that the environment plays an important role both in the transmission of antibiotic resistant pathogens and in their evolution. Accordingly, researchers and ...stakeholders world-wide seek to further explore the mechanisms and drivers involved, quantify risks and identify suitable interventions. There is a clear value in establishing research needs and coordinating efforts within and across nations in order to best tackle this global challenge. At an international workshop in late September 2017, scientists from 14 countries with expertise on the environmental dimensions of antibiotic resistance gathered to define critical knowledge gaps. Four key areas were identified where research is urgently needed: 1) the relative contributions of different sources of antibiotics and antibiotic resistant bacteria into the environment; 2) the role of the environment, and particularly anthropogenic inputs, in the evolution of resistance; 3) the overall human and animal health impacts caused by exposure to environmental resistant bacteria; and 4) the efficacy and feasibility of different technological, social, economic and behavioral interventions to mitigate environmental antibiotic resistance.11The recommendations from the workshop have also been communicated in a separate report published on the website of the JPIAMR (www.jpiamr.org).
•The environment plays important roles in the development of antibiotic resistance.•Critical knowledge gaps and research needs in this area were identified.•These include aspects on evolution, transmission and interventions.•The analysis provided may be useful for guiding future research efforts.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Culture-led urban regeneration projects can be an answer for tackling current depopulation challenges in specific regions due to aging and outward migration. Existing literature stresses the ...importance of citizen involvement in culture-led projects for successful urban regeneration. However, traditional top-down business approaches, including the dominance of external accountability, often limit our ability to hear local citizens' voices. Therefore, comprehensive reporting on practices of citizen participation may bring value to future culture-led regeneration projects. In this viewpoint paper, we investigate the case of the European Capitals of Culture and analyze their own evaluation reports understand to what extent and how citizen participation is described in evaluation reports of culture-led regeneration projects. We use an established framework to classify citizen participation by the degree of citizens' right to decide and exercise power in decision-making. We demonstrate that smaller cities that need urban regeneration tend to mobilize cultural initiatives as an arena for citizen engagement. Although we do not find evidence of citizen participation in larger ECoC cities, their participation is still essential for local value creation. We finalize our viewpoint with policy recommendations that can be relevant globally for initiatives that aim at urban regeneration.
•Creation of local value is essential for initiatives aimed at urban regeneration•Smaller cities mobilize cultural initiatives as an arena for citizen engagement•Larger cities do not report on citizen participation in cultural megaprojects•Recommendations on practices and challenges of citizen involvement are of value
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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