Overview of Pharmaceutical Strategy for Europe (2020) and enlightenment to China's pharmaceutical field.

Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation.Copyright © 2022 by the Author(s).

Regulatory Aspects on AI and Pharmacovigilance for COVID-19

This chapter looks at current and perspective legislative and regulatory scenario, identifying rules governing the use of Artificial Intelligence in the health sector at European Union level with a focus on the impact of AI on pharmacovigilance activities. After some preliminary considerations on definitory issues, attention will be paid to the challenges posed by AI to pharmaceutical industry in developing medicinal products and monitoring their quality, safety and efficacy. The European strategy addressing the use of AI in pursuing a better health policy will then be outlined, followed by some caveat concerning ethical implications and protection of personal data. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

Analysis of the European Strategy for Hydrogen: A Comprehensive Review

This review focuses on analysing the strategy and aspirations of the European Union within the hydrogen sector. This aim is achieved through the examination of the European Parliament's hydrogen strategy, allowing for a study of actions and projects in hydrogen technologies. The Parliament's hydrogen strategy is the document that provides the guideline of how the EU intends to function in the hydrogen sector and manages to cover a wide range of topics, all of them significant to represent the entirety of the hydrogen sector. It touches on subjects such as hydrogen demand, infrastructure, research, and standards, among others. The review discusses also the aspect that the EU intends to be a leader in the hydrogen sector, including the large-scale industrialization of key elements such as electrolysers, and this purpose is corroborated by the large number of associations, strategies, plans, and projects that are being established and developed by the European Union. The most important conclusions to learn from this analysis are that hydrogen has many of the right characteristics to make it the key to decarbonisation, especially in hard-to-abate sectors, and that it is bound to be one of the main actors in the imminent green transition. Moreover, hydrogen seems to be having its breakthrough, and this field's development can have benefits not only from an environmental perspective but also from an economical one, enabling the way into the green transition and the fight against climate change.

The European Commission in Covid-19 vaccine cooperation: leadership vs coronationalism?

During the first weeks of the Covid-19 pandemic, European Union (EU) member states competed over scarce countermeasures. Regarding vaccines, a few member states launched exclusive joint endeavours, yet eventually, the EU centralised vaccine provisioning. The EU's external vaccine diplomacy proceeded almost inversely. After stepping into the breach in global health governance, European leadership faltered and global collaboration progressed more slowly. This article explores Europe's diverging trajectories in the regional and global provisioning of Covid-19 vaccines. Focussing on the European Commission's leadership, we investigate to what extent it promoted regional and international cooperation and with what success. We also explain which factors enabled and constrained Commission leadership. Employing a controlled comparison and process tracing, we find that Commission leadership was more extensive and impactful in regional than in global vaccine provisioning. Member state support was the main enabling condition. Without support, institutional capacity and resources were insufficient for impactful leadership. [ FROM AUTHOR] Copyright of Journal of European Public Policy is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

The European Commission and the COVID-19 pandemic: a pluri-institutional approach

According to a widely held view, the European Council decides how the EU should respond in times of crisis, since the European Council alone has the authority to lead. Other institutions, meanwhile, adopt at best a secondary role. An alternative perspective has emerged, however, which contends, first, that the European Council's influence on the EU's crisis response is variable and, second, that other EU institutions, in particular the European Commission, are able to shape EU action, including through interventions made independently of the European Council. This article builds on this alternative view to argue that the respective role played by the European Council and the European Commisson is contingent, first, on the policy area where a crisis strikes and second, on leadership or agency on the part of the Presidents of the two institutions. The dynamics of the EU's response to the COVID-19 pandemic support this view. Acting on its powers in public health and other affected areas, and with Commission President Ursula von der Leyen taking a highly pro-active approach to outbreak of the virus, the Commission intervened early, framed the pandemic as a crisis, and set and then expanded the EU's agenda. Although its decision-making role was important, the European Council largely followed the Commission's lead. [ FROM AUTHOR] Copyright of Journal of European Public Policy is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Crisis management performance and the European Union: the case of COVID-19

A seemingly continuous stream of crises in Europe has turned scholarly agendas towards assessment of the EU's management of crises. Those assessments vary widely, depending on the analytical focus and criteria used. This paper introduces three assessment criteria drawn from crisis research that pertain to the detection of a crisis, the mobilization of necessary resources, and the nature of the public debate about critical choices made in times of crisis. We relate these crisis management insights to long-standing debates in European integration theory to help link traditional crisis management assessments with EU-focused theorizing. The article offers a framework for assessment of the EU's performance as a crisis manager. We illustrate the utility of the framework with a brief application to the EU's response to Covid-19. We assess the EU's performance in positive terms: the Union acted quickly after a somewhat slow start and was very effective in mobilizing a variety of resources. At the same time, we note that major policy choices were made without a significant public debate about potential effects on the future character of the Union. [ FROM AUTHOR] Copyright of Journal of European Public Policy is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

The von der Leyen Commission: An Early Assessment

This chapter aims to situate the von der Leyen Commission historically and comparatively. As well as providing a provisional performance of the administration at mid-term, it assesses what the appointment and achivements of Ursula von der Leyen as a non-Spitzenkandidat demonstrates about the institutionalisation of presidentialised and personalised leadership of the Commission. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Understanding the European Green Deal: A narrative policy framework approach

The 2008 global financial crisis, climate change, and, ultimately, the COVID pandemic have once again challenged the European Union's (EU) capacity to find effective policy solutions to common problems. The article investigates how the novel policy narrative underpinning the European Green Deal (EGD), a new EU growth strategy aimed at transforming the EU into a fair and prosperous society with no net greenhouse gas emissions, has evolved into concrete policy commitments. By combining the theoretical insights of the narrative policy framework and the assumptions of constructivist approaches to the study of politics, we focus on the relevance of strategic narratives for the understanding of power dynamics related to the approval of the EGD' center piece—the European Climate Law. Our findings show how, by effectively using legitimacy arguments, the European Commission and the Parliament managed to secure a swift approval of the Regulation. © 2023 Policy Studies Organization.

The Role of School Teachers' and International Education Project Leaders' Digital Competence during Covid-19 Pandemic

This paper analyses the significance of digital competence in the light of the impact of the Covid-19 on formal and non-formal education settings. The Authors discuss the definition of digital competence, as provided by the European Commission, and quote key international research data on digital competence in education. Furthermore, based on research carried out by the Authors during the Covid-19 pandemic among school teachers familiar with digital technologies in learning, and international education project coordinators, the Authors claim that digital competence has become one of the most substantial elements in contemporary classroom and international education project management. © 2022 WMSCI.All rights reserved.

The von der Leyen Commission: An Early Assessment

This chapter aims to situate the von der Leyen Commission historically and comparatively. As well as providing a provisional performance of the administration at mid-term, it assesses what the appointment and achivements of Ursula von der Leyen as a non-Spitzenkandidat demonstrates about the institutionalisation of presidentialised and personalised leadership of the Commission. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Discourse, Antagonisms, and Identities during the COVID-19 Pandemic

This study utilizes theory from the Essex School of Ideology and Discourse Analysis (IDA) and investigates speeches and statements made by high-ranking European Union officials from the European Commission as well as policy documents. The inquiry reveals that antagonistic language was used to justify the tracking and tracing of civilians through the articulation of an empty “track and trace” signifier and the articulation of new identities premised on the vaccinated and non-vaccinated. Policy makers articulated new ideas surrounding a regime of truth and a common “people” while simultaneously negating opponents to pandemic policies by articulating floating signifiers, including xenophobia, disinformation, and populism. The exercise of power in health policies during the pandemic functioned according to logics similar to those employed in traditional political domains. © 2022 Centro de Estudos Sociais da Universidade de Coimbra. All rights reserved.

From the EHEA to the EEA: Renewed State-Making Ambitions in the Regional Governance of Education in Europe

The launch of the Bologna Process in 1999 supported by the European University Association was widely seen as an ambitious intergovernmental project to reshape national higher education institutions across Europe. Over time, however, the Bologna Process framework has not only been taken up in other parts of the world, but the European Commission has incorporated it into its European Higher Education Area, and most recently the creation of a European Education Area by 2025. In our chapter we explore the framing of this expanded agenda for the European Commission for education more generally in the face of rising national populisms across European, the new challenges posed by COVID-19 and institutional lockdowns, and the geo-strategic challenges to the East with the rise of China and its Belt and Road Initiative. We note the continuing dependence in techniques of governing such as mobility and ask about the ongoing challenges facing this state-making project. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Employment in the EU: post-industrial challenges and prospects

The work lives of many people everywhere are changing dynamically and will continue to be transformed in the coming years. Artificial intelligence and robotics are expected to create tens of millions of new jobs globally, while many jobs will re-form or even disappear. The dynamics of transformations observed in the labor market, namely the speed and breadth of the spread of diverse forms of employment, different from the standard one, in the European Union and many other countries around the world, including Russia, make the topic of this study especially relevant. The causes, scale and possible consequences of this phenomenon require the elaboration of theoret-ical aspects, conceptual apparatus, and monitoring on a permanent basis in the country and regional context. Most countries of the world are experiencing various socio-economic difficulties due to unbalanced structure of production and population, grow-ing precarization of employment, regional differences in living standards and quality of life, digital inequality, the negative impact of certain political decisions, objectively re-inforced by the COVID-19 pandemic and its consequences. Insecurity in the world of work challenges the fundamental principles of the European Social Model concerning job security and decent social protection through labor market segmentation and social polarization. The article analyzes the state and prospects of the European labor market and the efforts of EU authorities to adapt it to the postindustrial reality. © 2022, Institute of Europe Russian Academy of Sciences. All rights reserved.

EU Public Procurement Policy During Covid-19: A Turning Point for Legitimate EU Governance?

Public procurement is a policy area located between two contradictory tendencies. On the one hand, the European Commission strives for greater competition to widen procurement markets. On the other hand, the boosting of competition encounters resistance among the member states. This article investigates how these colliding tendencies played out during the initial stages of the Covid-19 crisis and, more specifically, how changes in the field of procurement affected legitimate governance in the EU. Based on institutionalist and EU governance theories, the study contributes to the literature with three principal findings. First, it demonstrates that the pandemic enabled exogenously driven changes in the field of public procurement with new policies and guidelines, while the EU’s overall aims in this field were upheld. Second, the study demonstrates that the Commission was the main driver of change and that it enhanced the harmonisation of procurement rules and supranational integration despite the crisis. Third, while these changes strengthened the role of supranational actors, the study demonstrates that the changes introduced allow member states increased flexibility when it comes to the implementation. In practice, however, this flexibility has the potential to undermine the EU’s initial aims, thereby jeopardising the EU’s legitimacy.

Overview of Pharmaceutical Strategy for Europe (2020) and enlightenment to China's pharmaceutical field

Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation. © 2022 by the Author(s).

Integration: Regenerating Europe’s Project beyond Covid-19

This chapter takes stock of the developments that occurred in the EU since Brexit and the explosion of the Covid-19 pandemic. It argues that although Brexit did not end European integration, the project still suffers from relevant institutional shortcomings that should be addressed in the framework of the newly established Conference on the Future of Europe. It also details how the EU took unprecedented steps to deal with the pandemic following the UK withdrawal. The chapter refers to the establishment of a massive recovery fund known as Next Generation EU (NGEU), which was designed to allow the European Commission to raise funds on the capital markets by issuing common bonds on behalf of the EU Member States. It examines the EU governance mechanisms during the pandemic and reflects on the constitutional opportunities to reform the EU going forward. © The Several Contributors 2021.

Ex Ante Governance in the European Union: Energy and climate policy as a ‘test run’ for the post-pandemic recovery

This paper asks what policy tools the European Commission used to push member states to align their national post-pandemic recovery preferences with its own preferences for the green (and digital) recovery. It claims that the Commission did not create new policy tool in response to the crisis, but utilised an existing one, previously successfully tested in climate and energy policy. This tool, ex ante governance, developed under the 2018 Governance Regulation, enabled the Commission to influence member states' national goals (defined in their National Energy and Climate Plans) before they were formally adopted. The Commission's main aim was to link the national targets with the 2030 climate and energy goals binding at the EU level. Ex ante governance helped the Commission achieve this linkage as it pushed member countries to commit to more ambitious national targets than they had originally intended. This enabled the EU27 to reach a commitment level that will support the 2030 climate and energy goals set at the EU level. This modus operandi contrasts with the previous ex post assessment process that was ineffective;the original rules on the Intergovernmental Agreements have revealed the limitations of this approach. Due to its success the Commission applied the ex ante governance model to the post-pandemic recovery, where it wanted to align member states' national preferences (presented in the National Recovery and Resilience Plans) with its green (and other) recovery objectives. Such a development indicates the emergence of a complex ex ante governance within the EU.

The added value of a European Reference Network on rare and complex connective tissue and musculoskeletal diseases: insights after the first 5 years of the ERN ReCONNET

In order to address the main challenges related to the rare diseases (RDs) the European Commission launched the European Reference Networks (ERNs), virtual networks involving healthcare providers (HCPs) across Europe. The mission of the ERNs is to tackle low prevalence and RDs that require highly specialised treatment and a concentration of knowledge and resources. In fact, ERNs offer the potential to give patients and healthcare professionals across the EU access to the best expertise and timely exchange of lifesaving knowledge, trying to make the knowledge travelling more than patients. For this reason, ERNs were established as concrete European infrastructures, and this is particularly crucial in the framework of rare and complex diseases in which no country alone has the whole knowledge and capacity to treat all types of patients. It has been five years since their kick-off launch in Vilnius in 2017. The 24 ERNs have been intensively working on different transversal areas, including patient management, education, clinical practice guidelines, patients' care pathways and many other fundamental topics. The present work is therefore aimed not only at reporting a summary of the main activities and milestones reached so far, but also at celebrating the first 5 years of the ERN on Rare and Complex Connective Tissue and Musculo-skeletal Diseases (ReCONNET), in which the members of the network built together one of the 24 infrastructures that are hopefully going to change the scenario of rare diseases across the EU.

The Politics of Competence in Global Health: The European Commission’s Global Response to the COVID-19 Pandemic

What was the European Commission’s (EC) global response to the COVID-19 pandemic and how did it use the crisis to claim competence in the area of global health? This article explores the EC’s global coronavirus response. In so doing, it suggests studying the crisis response in terms of how the EC struggled to be recognized as a competent player in the international community of states and institutions. In particular, the article shows how the EC utilized the crisis unleashed by the pandemic to engage in geopolitical positioning in relation to World Health Organization (WHO) funding and the vaccine race, and by using its financial clout to struggle for mastery as a global health actor. The article responds to the challenge of understanding differentiation in the broader field of European foreign, security and defence policies. By treating informal practices by the EC on the world stage in and of themselves, the article shows how the constant struggle for competence plays into the politics of European integration and considers its potential for being instantiated in formal transfers of competence in the area of global health. (This article is an output of the EUFLEX project, which has been funded by the Research Council of Norway (project number 287131). © 2021 Kluwer Law International BV, The Netherlands

Elevating the Standing of Vocational Education and Training in Romania

Initial vocational education and training (VET) has been intensely reformed in Romania. Elevating its status has been a recent concern, in the context of strong pressure from industry. However, it requires more than an ‘image makeover’ and the persuading of parents and young people. This analysis is based on a qualitative study, involving over 250 young people, and 100 teachers, employers and policymakers. The first part looks at the reforms since the fall of Communism. The second part highlights the work done to reshape the image of VET, based on the efforts of schools to fill the growing number of places, and attempts by companies to reframe perceptions of blue-collar jobs. The last part challenges the idea that the problem of VET is (mainly) one of image. The chapter discusses the mixed quality of education in VET, and questions the ambivalent role played by a range of short-term training programs. It also suggests that the dual system, despite strong policy endorsement, creates a small niche, but is not a structural remedy, as it does not commit towards social inclusion goals. The limitations of the campaigns that promote VET are also considered: the gendered nature of the ‘success stories’ and the failure to highlight the precarious nature of many employment options. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.