Priority 5 - Promoting our European Way of Life

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Security Union

Judicial cooperation

Fundamental rights

Consumer Protection

Migration

European Commission Work Programme 2024

Prevent and Fight Migrant Smuggling

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Proposal: On the 28th of November 2023, the European Commission published a Proposal for a Regulation on enhancing police cooperation in relation to the prevention, detection and investigation of migrant smuggling and trafficking in human beings, and on enhancing Europol’s support to preventing and combating such crimes and amending Regulation (EU) 2016/794 (press release).

Problem: Migrant smuggling has reached new heights, driven by increasing demand due to various global crises like economic recessions, environmental emergencies, conflicts, and demographic pressures in third countries. In 2022, around 331,000 irregular entries were detected at the EU's external borders, the highest level since 2016, which was a 66 per cent increase compared to the previous year. The activity of smuggling networks, mostly organized criminal groups, has also grown substantially, making profits ranging between EUR 4.7-6 billion annually. This criminal activity has resulted in significant loss of life, particularly at sea, emphasizing the urgency for a strong response to reduce irregular migration.

Objective: The Proposal aims to reinforce Europol’s role in combating migrant smuggling and trafficking in human beings. This involves particularly strengthening the European Centre Against Migrant Smuggling. Moreover, the Proposal seeks to enhance the prevention, detection, and investigation of migrant smuggling and human trafficking by strengthening inter-agency cooperation, information sharing and coordination on countering smuggling and trafficking.

Subject Matter: The Proposal introduces several key measures: (1) Strengthening inter-agency cooperation: To improve coordination and information exchange on countering migrant smuggling and human trafficking, the European Centre Against Migrant Smuggling at Europol will include Europol staff, seconded national experts, and liaison officers from member states’ Eurojust and the European Border and Coast Guard Agency. This setup aims to ensure regular information exchange and operational cooperation. (2) Enhancing strategic analysis and coordination: The Proposal addresses the need for improved strategic analysis and coordination at the EU level by defining specific tasks for the European Centre Against Migrant Smuggling. These tasks include monitoring trends in migrant smuggling, providing annual reports, strategic analyses, threat assessments, and updates on migratory routes, and investigative and operational actions. The Centre will convene meetings at least twice a year with representatives from each member state, Eurojust, the European Border and Coast Guard Agency, EMPACT, and the Commission to ensure effective coordination. (3) Improving information sharing: Member states are obligated to share information, including biometrics, on migrant smuggling and human trafficking with Europol. This includes establishing direct connections to Europol’s Secure Information Exchange Network Application (SIENA). (4) Reinforcing member states' resources: The Proposal suggests that member states designate specialised services to combat migrant smuggling and human trafficking, ensure adequate resourcing of these services, connect them to SIENA, and make the European Centre Against Migrant Smuggling act as a network of these specialised services. (5) Enhancing Europol’s operational support: The Proposal aims to codify and develop the concept of operational task forces and introduce Europol deployments for operational support. These tools will provide coordination, analytical, operational, technical, and forensic support upon request from member states or by the Europol Executive Director. A pool of experts will be created, available for deployment by Europol, and obligations for member states to effectively implement these tools will be set. Third countries may also participate in operational task forces, and Europol deployments can take place in third countries.

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Proposal: On the 28th of November 2023, the European Commission published a Proposal for a Directive laying down minimum rules to prevent and counter the facilitation of unauthorised entry, transit and stay in the Union, and replacing Council Directive 2002/90/EC and Council Framework Decision 2022/946 (press release).

Problem: The exploitation of vulnerable individuals by criminal networks using various routes (land, sea, and air) to facilitate irregular migration has led to increased risks and profits. In recent years, there has been a marked increase in irregular entries at the EU's external borders, driven by global crises such as economic recessions, environmental emergencies, conflicts, and demographic pressures in third countries. The extensive involvement of smuggling networks in these activities, often organised in criminal groups, highlights the urgent need for an effective response, particularly given the substantial profits generated by these networks and the high human cost since 2014.

Objective: The main objective is to modernise the EU criminal law framework, which was initially adopted in 2002, to clearly define and effectively sanction the facilitation of unauthorised entry, transit, and stay in the EU. Moreover, the Directive seeks to ensure effective investigation, prosecution, and sanctioning of organised criminal networks responsible for migrant smuggling. In addition, it aims to create clarity and legal certainty by distinguishing between the criminalisation of facilitation of irregular migration and humanitarian assistance.

Subject Matter: The Directive includes a precise and detailed definition of the criminal offences to counter activities that endanger human life and disrespect human dignity for financial gain. Specifically, assistance of unauthorised entry, transit, or stay in the Union constitutes a criminal offence when linked to financial or material benefit, or when highly likely to cause serious harm to third-country nationals or any other person, even without financial or material benefit. The levels of penalties should reflect the higher social concern regarding more serious and harmful conducts, thus demanding more severe criminal penalties for aggravated offences. This includes offences committed within the framework of a criminal organisation, causing serious harm or endangering life, use of serious violence, victimising vulnerable individuals like unaccompanied minors, or causing death. Furthermore, the Directive calls for penalties to be effective, dissuasive, and proportionatewith a maximum term of imprisonment of at least three years for regular offences, ten years for aggravated offences, and fifteen years for offences causing death. Minimum levels for the maximum term of imprisonment are set for natural persons, and there are provisions for accessory measures in criminal proceedings. The Directive also addresses the liability of legal persons, ensuring that they can be held accountable for criminal offences committed for their benefit by individuals in leading positions or due to lack of supervision or control. Other significant provisions include establishing aggravating and mitigating circumstances in relation to the criminal offences, setting limitation periods for these offences, and defining jurisdiction rules to effectively counter cross-border criminal activities, including crimes committed outside a member state’s territory. The Directive also stresses the importance of preventive measures, such as public awareness campaigns, research, and education programmes, to reduce the commission of these offences. In terms of resources and enforcement, the Directive mandates that member states ensure national authorities have sufficient staff, financial, technical, and technological resources, and specialised training for effective implementation. It also highlights the need for effective and proportionate investigative tools, aligned with the principle of proportionality and respect for fundamental rights, to prosecute these criminal offences. Lastly, the Directive emphasises data collection and statistics, requiring member states to collect, publish, and transmit relevant statistical data to the Commission for assessing and developing evidence-based policies at the EU level.

A Joint European Degree

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Non-legislative, Q2 2024.

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Non-legislative, Articles 165 and 166 TFEU, Q2 2024.

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Non-legislative, Articles 165 and 166 TFEU, Q2 2024

European Commission Work Programme 2023

Mental Health

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Non-legislative Act: On the 7th of June 2023, the European Commission published a Communication on a comprehensive approach to mental health (press release).

Problem: Mental health is a result of the interweaving of the personal with the external, meaning that our community, our economy, our environment and global affairs all influence the way we think and feel. Events of recent history (the COVID-19 pandemic, war, inflation, the triple planetary crisis), have been detrimental to psychological health. Suicide now claims second place as the leading cause of death among the youth. Urgent action is needed to improve the situation.

Objective: In accordance with the European Pillar of Social rights, affordable, preventive and curative mental health should be made a public policy goal. A comprehensive approach to mental health includes biological and psychological effects and their connection to family, security, work, school, digital spaces etc. The objective of this communication is to improve mental health and remove obstacles to good psychological wellbeing at all capacities of living.

Subject Matter: Working together with the WHO, a budged of 11 million has been allocated to the promotion of mental health across all policies within the EU4Health programme. To address suicide rates and depression within the EU, a budget of 6 million has been assigned to developing preventive policies. This Communication urges member states to use digital tools to their advantage, to facilitate access to information, treatment, support, and care. The Commission largely targets two groups: children and youth, as well as migrants. The importance of mental health for children has been framed, amongst other things, in relation to social media and online platforms. To improve mental strength globally, these platforms should make greater efforts in creating a healthy virtual environment and assessing their influence over impressionable groups. Furthermore, bullying and other detriments will be studied to develop a prevention toolkit to counter children’s poor psychological health. For migrants, especially Ukrainian refugees, the focus is on developing coping strategies and resources to help with the aftermath of displacement. Additionally, the protection of victims of crime and discrimination, be it a cause of gender or sexuality, is to be stressed in policy implementation. Special attention shall be allocated to the inclusion of at-risk-groups in the program operative including senior citizens, inhabitants of rural areas, the unhoused, people of the Roma community, people with chronic illnesses (especially cancer), people with disabilities and people post-partum. As discussed in the Communication, a big part of overcoming social challenges that lead to poor mental health is overcoming stigma. Furthermore, the Commission has selected mental health at work as a point of concern. Projects identified in promoting mental health (including research and awareness campaigns, capacity building, and direct support from qualified bodies) are to be funded with 1.23 billion of EU support. Moreover, monitoring and evaluation systems for supervision and impact assessment are to be set up. Maintaining that mental wellbeing is an integral part of general health, the Commission urges member states to cooperate in a precautionary approach to aid those suffering from challenges to their psychological welfare in the EU and beyond. With democratic and European values at the forefront, this Communication strengthens the foundations of the European Health Union in prioritizing help and social reintegration.

Legal Migration

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Non-legislative Act: On the 15th of November 2023, the European Commission published a Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Skills and Talent Mobility (press release).

Problem: Employers are increasingly facing challenges in finding suitable workers, exacerbating the competitive and innovative capacity of the EU economy. This issue is further intensified by Europe's ageing demographic, highlighting the urgent need for effective measures to bolster the workforce and address skills gaps in critical areas such as healthcare, Information and Communications Technology, and sectors pivotal to the green and digital transitions.

Objective: The general aim of the Communication is to make the European Union more attractive to global talent and to simplify international recruitment pocesses. It seeks to address the aforementioned labour and skills shortages by facilitating the mobility of talent, especially from non-EU countries, and improving the recognition and validation of professional qualifications gained in third countries. Furthermore, it aims to enhance intra-EU mobility and foster cooperation with partner countries for mutual benefit, thereby contributing to the overall competitiveness and innovation capacity of the EU.

Subject Matter: The Communication addresses labour and skills shortages in the EU by advancing strategies to attract global talent and facilitate workforce mobility. Key to this strategy is the creation of the EU Talent Pool, a centralised platform that simplifies the recruitment process, making it easier for EU employers to connect with skilled workers from non-EU countries. This platform focuses on occupations that are critical to Europe's green and digital transitions. Another major aspect is the simplification of the process for recognising professional qualifications from third countries. The Commission encourages member states to streamline these procedures, reducing administrative burdens and enabling faster employment and education access for third-country nationals. Additionally, the Communication emphasises the importance of Talent Partnerships with third countries. These bilateral agreements focus on skill development, qualification recognition, and legal migration, aiming to provide mutual benefits and prevent brain drain while promoting skill and knowledge transfer. The document also proposes enhancing learning mobility within the EU and with third countries. This initiative aims to attract talented students and professionals to the EU for education and skill development, thereby increasing the EU's attractiveness as a hub for education and employment. Furthermore, the Communication underscores the necessity for strategic use of skills intelligence. This involves developing advanced methods to monitor and respond to labour market needs and skill shortages. It includes the proposition for member states to improve transparency in qualification recognition, potentially through the development of interoperable databases and an EU-level tool for comparability statements for third-country qualifications.

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Non-legislative Act: On the 15th of November 2023, the European Commission published a Commission Recommendation on the recognition of qualifications of third-country nationals (press release).

Problem: The labour force shortage limits the EU's ability to adapt to changes in work production, communication across economies, and labour markets. Employers across the EU consistently face difficulties in finding workers with the required skills. The shortage spans all industrial ecosystems in many member states, with rising vacancies in high, medium, and low-skilled jobs. These shortages pose a significant challenge to the EU's aspirations to remain a global leader and to meet ambitious climate and energy targets.

Objective: The Recommendation seeks to facilitate the integration of third-country nationals into the EU labour market in response to the Union's economic and societal needs. The document outlines a comprehensive approach, recommending member states to simplify and expedite recognition procedures and adopt a 'whole-of-government' approach. The overall goal is to streamline the process for third-country nationals to contribute effectively to the EU labour market, thereby addressing the skill gaps and fostering sustainable economic growth.

Subject Matter: The document emphasizes the need for member states to streamline and expedite the recognition processes for third-country nationals. The ‘whole-of-government’ approach, integrating various sectors such as education, employment, and migration to create a cohesive system. This includes upskilling and reskilling, improving labour market activation, promoting internal mobility within the Union, and making the EU more attractive to skilled third-country nationals. The document advocates for reducing administrative barriers and adopting a 'skills first' approach, which prioritises the full range of an individual's skills and experiences, rather than focusing solely on formal qualifications. An important aspect of the recommendations is the establishment of bilateral Talent Partnerships with third countries. These partnerships aim to create mutual benefits, focusing on skill development, qualification recognition, and facilitating legal migration pathways. The document also highlights the role of learning mobility, with an emphasis on attracting talented third-country students and professionals to the EU for skills development. This includes fostering learning opportunities within the EU and encouraging cooperation with third countries. The goal is to enhance the EU's overall attractiveness as a destination for education and employment. To support the integration of third-country nationals, the recommendations call for improved transparency in the recognition processes for qualifications obtained in third countries. This includes encouraging member states to develop interoperable databases on recognition processes and exploring the feasibility of an EU-level tool for generating statements of comparability for specific third-country qualifications.

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Proposal: On the 15th of November 2023, the European Commission published a Proposal for a Regulation of the European Parliament and of the Council establishing an EU Talent Pool (press release).

Problem: EU employers are facing acute and structural labour and skills shortages in many professions. Even though the EU addresses the shortages through activating the inactive EU population, reskilling the existing workforce, improving working conditions and facilitating intra-EU mobility, due to the growing labour market needs, labour migration must be included. International job matching is often ineffective. Additionally, uncertainty about the accuracy and qualities of qualifications from the side of the employer from within the EU and the feeling of exploitation or unfair recruitment from the side of the employee from a third country might deter skilled workers.

Objective: Attracting talent from outside the EU contributes to tackle existing and future labour shortages. Incentivising potential economic migrants can further contribute to reducing irregular migration pressure. The Pact on Migration and Asylum recognises the need to develop an EU Talent Pool. This Talent Pool aims at partially addressing the challenges by facilitating matching of job vacancies of employers. It is a voluntary tool for interested member states, open to low, medium and highly skilled jobseekers that work in shortage occupations. It would become a tool to support the implementation of Talent Partnerships.

Subject Matter: The Commission proposes to develop an EU Talent Pool targeted to address labour market needs in key occupations only. It entails the development of an online platform that presents information on recruitment, immigration and recognition procedures in the member states. Firstly, the Talent Pool would be a voluntary system that allows member states to facilitate measures aimed at making the recruitment process easier and faster while maintaining their national tools. This preferred Option (Option 2) would use legislative action to implement the Talent Pool, which will ensure appropriate safeguards protecting transparency and accountability on fundamental right, in particular with regard to personal data. Secondly, the EU Talent Pool will consist of an EU Talent Pool Secretariat, EU Talent Pool Steering Group and EU Talent Pool National Contact Points. Throughout the implementation phase, the Commission will organise regular meetings with participating member states via the EU Talent Pool Steering Group to discuss and clarify any issues that may arise. By 2031 and every five years after, the Commission will present a report evaluating the implementation, functioning and impact of the EU Talent Pool. In particular, data will be gathered on 1) the number and type of profiles of jobseekers registered, 2) the number and type of job vacancies registered, 3) the number of visits on the platform, 4) the number of job placements facilitated, 5) the number of “EU Talent Partnerships passes” (certifying and validating skills) and 6) the number and type of placements facilitated via the Talent partnerships. The EU Talent Pool Secretariat monitors the performance of the platform. Thirdly, immigration procedures can be facilitated if the member states wish to put them in place to allow for a faster recruitment. This includes the obtention of visas and residence permits for work purposes and the exemption from the principle of preference for Union citizens for job vacancies transferred to the Talent Pool platform.

Visa policy

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Proposal: On the 18th of October 2023, the European Commission published a Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2018/1806 as regards the revision of the suspension mechanism (press release).

Problem: While in general Visa-free travel is beneficial for the EU and its partners around the globe, bringing advantages for citizens and strengthening relations with partners, promoting exchanges, Visa-free travel can also be the source of significant migration and security challenges. Through overstays by visa-free travellers or through asylum applications lodged in by nationals from visa-free third countries with low recognition rates, visa-free travel can result in increased irregular migration. Insufficient visa alignment can even lead to visa-free countries turning into a transit hub for irregular entry to the EU.

Objective: Regulation (EU) 2018/1806 provides the possibility of suspending the exemption from visa requirements temporarily. With increasing challenges resulting from irregular migration, and threats to the security of the EU, the suspension mechanism established in Regulation (EU) 2018/1806 as a safeguard against the abuse of visa-free travel needs to be improved. So far, the suspension mechanism was triggered twice.

Subject Matter: Currently, the suspension mechanism can be triggered in the event of: A substantial increase in the number of nationals of the third country concerned refused entry or found to be staying in the EU’s territory without the right to do so, or a substantial increase of asylum applications of thirds countries for which the recognition rate is low. Further, a decrease of cooperation on readmission, an increased risk or threat to the internal security of member states (in particular a substantial increase in criminal offences) can lead to a suspension. If the visa exemption was obtained because of visa liberalisation dialogue, the non-compliance with specific requirements can trigger the mechanism. The suspension procedure consists of an initial duration of nine months decided by a Commission implementing act. Should the circumstances persist, the suspension is prolonged by an additional 18 months. Where no solution is found, the Commission can propose the permanent termination of the visa exemption by ordinary legislative procedure. The Commission has to inform the European Parliament and the Council immediately of such notification. With the new Proposal, especially Article 8 will be adapted and extended. The suspension mechanism may be triggered by a notification of any member state to the Commission or on the basis of the Commission’s own analysis. Reference periods have to cover at least two months, allowing considering longer periods of persistent problems. Grounds for suspension now further include the operation of an investor citizenship scheme, the non-alignment of the visa policy of a third country where there is a risk of substantial increase in the number of third-country nationals (particularly because of geographic proximity). The significant threat of internal security now specifically addresses hybrid threats. The duration of temporary suspension is increased to 12 months and the second phase is raised from 18 to 24 months. In either phase, the suspension may be lifted as soon as the circumstances that led to the suspension are remedied. With Article 8e an urgency procedure is introduced, allowing the Commission to suspend a visa exemption through an immediately applicable implementing act. This procedure will be used in particular to prevent a mass influx of third-country nationals arriving irregularly from a third country that is visa-free or to prevent a serious damage to the public policy or international security.

Follow-up Initiatives under the New Pact on Migration and Asylum

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Non-legislative Act: On the 18th of October, the European Commission published an EU Action Plan for the Eastern Mediterranean and the Atlantic route (press release).

Problem: Irregular arrivals via the Eastern Mediterranean route increase steadily, with a rise of 113 per cent in 2022 compared to 2021. Member states are exposed to increased migratory pressure and smugglers further exploit certain routes. Until now, the EU-Turkey Statement was the only framework for cooperation along the route.

Objective: The Action Plan seeks to complement actions under way through other EU Action Plans addressing the Western Balkans, the Central Mediterranean route and the Western Mediterranean and Atlantic routes. With this Action Plan consistency in the overall whole-of-route approach is ensured. The EU-Turkey Statement of 2016 will remain the main framework for cooperation along the Eastern Mediterranean route.

Subject Matter: This Action Plan seeks to (1) Prevent irregular departures, combatting migrant smuggling and trafficking in human beings, (2) Strengthen border management, (3) Enhance return and readmission cooperation, and (4) Ensure efficient migration management, improve asylum procedures and support sufficient reception capacity. Cooperation with Türkiye is inevitable to achieve the goals laid out. (1) In order to combat irregular departures, root causes will be addressed by strengthening comprehensive engagement with relevant countries of origin and transit in both Asia and Africa. Vocational training, skills development and more measures are offered to support displaced and vulnerable populations. Programmes like the Global Action addressing Trafficking in Persons and the Smuggling of Migrants and the PROTECT programme are supported in their implementation, all while Partnership projects with countries of Asia and Africa are rolled out. Possibilities to post liaison officers at key airports are explored to strengthen operational cooperation. Cooperation with Türkiye and the International Migration Cooperation Centre in Istanbul continues while cooperation between EUROPOL, Frontex and EUROJUST are enhanced. Additionally, efforts to offer safe and legal avenues to protection with sustained resettlement efforts and the creation of legal migration including mobility operations continue. (2) The strategic policy for European Integrated Border Management lays out priorities and guidelines to address challenges at the EU’s external borders. In this context border management capacities at the border to Türkiye will be supported, for example, through 220 million euro to increase the Surveillance Capacity at the border with Iran. Regional cooperation is fostered while border management and control is reinforced and improved by ensuring efficient border procedures with adequate infrastructure and equipment, including trained staff. (3) Frontex and the commission strengthen national operational and infrastructural capacities, providing expertise and support to Cyprus, Greece and Bulgaria. Diplomatic outreach toward third countries of origin and transit are coordinated with concrete steps to improve readmission under the framework of Article 25a of the Visa Code. (4) To enhance asylum and reception capacities and procedures, an efficient, effective and future-proof migration management system at national level needs to be established to provide a coordinated response to migration challenges. Member states will be supported to be able to provide adequate reception capacities for children and adults, responding to the needs of vulnerable persons. Furthermore, member states will be supported to improve their national asylum and reception systems through technical and operational assistance by the EUAA, all while ensuring sufficient national resources are devoted to migration management. To enhance flexibility and streamlining processes in relocation transfers, the implementation of the Voluntary Solidarity Mechanism (VSM) is accelerated.

Resilient Schengen Area

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 Legislative, incl. impact assessment, Articles 77(2)(b) and (d) TFEU, Q3 2023.

Combatting Child Sexual Abuse

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Proposal: On the 6th of February 2024, the European Commission published a Proposal for a Directive on combating the sexual abuse and sexual exploitation of children and child sexual abuse material and replacing Council Framework Decision 2004/68/JHA (recast) (press release).

Problem: The rise of child sexual abuse and exploitation, particularly online, has significantly challenged the EU's current legal frameworks. Technological advancements have not only increased children's online presence but have also provided perpetrators with sophisticated means to conceal their identities and illegal activities. This development has led to an exponential growth in the online sharing of child sexual abuse material and has created new forms of abuse that current legislation struggles to address effectively. Moreover, discrepancies in member states' legal frameworks regarding investigation, prosecution, and victim support have hindered a unified, effective response across the EU.

Objective: The recast Directive aims to comprehensively update and strengthen the EU's approach to combating child sexual abuse and exploitation. By recognising the evolving technological landscape, it seeks to ensure that all forms of child sexual abuse and exploitation, including those facilitated by new technologies, are adequately criminalised. The Directive intends to harmonise national rules on investigation and prosecution, taking into account recent technological developments, thereby enhancing the effectiveness of the fight against these crimes.

Subject Matter: One of the cornerstone aspects of the recast Directive is the expansion and clarification of the definitions related to offences, ensuring they encompass the broad spectrum of abuse facilitated by modern technology. This includes updating the definition of child sexual abuse material to cover not only traditional forms of content, but also materials created or disseminated through the use of advanced technologies, such as deepfakes and virtual reality. Furthermore, the Directive recognises the necessity of criminalising the solicitation of children for sexual purposes in an online environment, acknowledging the shift towards digital platforms for the initiation of such exploitative interactions. Moreover, the Directive introduces specific provisions to enhance the investigation and prosecution of offences, recognising the unique challenges posed by the digital sphere. It mandates member states to ensure that their investigative bodies are equipped with the necessary tools and expertise to tackle crimes facilitated by the internet, including the capability to conduct undercover operations online. Additionally, the Directive calls for improved cooperation and coordination at both the national and EU levels to ensure a more effective response to cross-border cases of child sexual abuse and exploitation. The protection and support of victims are central to the proposed changes, with the Directive advocating for measures that minimise secondary victimisation and provide comprehensive assistance. This includes ensuring that medical examinations of child victims are conducted with sensitivity and by trained professionals, as well as strengthening the right to compensation for victims, taking into account the impact of online dissemination of abuse materials. Preventative measures also form a crucial part of the proposed changes, with the Directive emphasising the importance of education and awareness-raising initiatives aimed at both children and adults. It advocates for the development of programmes that address the root causes of abuse and exploitation, promoting safe online practices and empowering children to protect themselves.

Cybersecurity

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Non-legislative Act: On the 18th of April 2023, the European Commission published a Communication on Closing the cybersecurity talent gap to boost the EU’s competitiveness, growth and resilience ('The Cybersecurity Skills Academy') (press release).

Problem: There are significant cybersecurity skills shortage and gaps within the European Union. Cybersecurity is integral to the security of citizens, businesses, and member states, as well as the EU's political stability, democratic stability, and societal and economic prosperity. The cybersecurity threat landscape has evolved dramatically, with an increase in cyberattacks targeting military and civilian critical infrastructure. The EU faces threats from advanced technologies such as AI and bots, with ransomware attacks causing substantial financial and reputational damage. These incidents have targeted public administration, governments, and European institutions, with sectors like finance and health being consistently attacked.

Objective: In response to these challenges the Commission is introducing the Cybersecurity Skills Academy. This initiative aims to create a single point of entry and synergies for cybersecurity education, training offers, and funding opportunities. It is designed to support the development of cybersecurity skills, scaling up stakeholder initiatives to impact the labour market, including in the defence sector. The Academy will focus on training cybersecurity professionals and will align its activities with common goals and key performance indicators for greater impact.

Subject Matter: The Academy's implementation will be based on four pillars: fostering knowledge generation through education and training, ensuring better channelling and visibility of available funding opportunities, calling stakeholders to action, and defining indicators to monitor the market's evolution and assess the effectiveness of actions. The Academy is expected to address the visibility and synergies of training and certification, benefiting various sectors that require similar expertise. The Proposal also emphasises the need for cooperation between academia, training providers, and industry to design and deliver cybersecurity training addressing in-demand skills. It aims to attract younger generations to cybersecurity careers and integrate cybersecurity into education and training programmes. Support for the development of micro-credentials, vocational education, and training programmes will be continued, with a focus on fostering greater cooperation across Europe. To facilitate national-level cooperation and foster synergies between the public and private sectors, member states are encouraged to explore setting up Cyber Campuses. These campuses will serve as poles of excellence at the national level for the cybersecurity community, with the Academy aiding in their networking and coordination. The Academy's governance structure will likely take the form of a European digital infrastructure consortium, allowing member states to work jointly on closing the cybersecurity skills gap and closely cooperate with the Commission, ENISA, and the European Cybersecurity Competence Centre.

Learning Mobility

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Proposal: On the 15th of November 2023, the European Commission published a Proposal for a Council Recommendation ‘Europe on the Move’ – learning mobility opportunities for everyone (press release)

Problem: The central problem addressed by the proposal is the need to enhance access to quality education and facilitate the movement of learners between different countries' education systems. The proposal acknowledges that organising learning mobility is a key driver for improving the quality of education and training offered by institutions. This need arises from the recognition that learning mobility significantly benefits personal, educational, and professional development, as well as civic engagement and social inclusion.

Objective: This initiative aims to break down barriers to learning and transition the culture of education towards lifelong learning that enriches individuals and societies. This is underpinned by the recognition that learning mobility is a pivotal element in personal, educational, and professional development. The proposal intends to create more inclusive and accessible learning mobility opportunities for people of all ages and backgrounds. This includes expanding the scope of mobility beyond intra-EU to international levels, thus enhancing the EU's position as an attractive destination for global talent in education and training.

Subject Matter: A central aspect of the proposal is the expansion of learning mobility opportunities to include a wider array of participants. This expansion encompasses not only young people but also learners of all ages, educators, and staff, embracing a more inclusive approach. It acknowledges that certain groups, particularly those with fewer opportunities due to economic, social, cultural, geographical, or health-related reasons, face significant barriers in accessing these opportunities. The proposal sets ambitious targets to ensure that these groups are not left behind. The proposal sets specific targets to be achieved by 2030: at least 25 per cent of higher education graduates should have a learning mobility experience; at least 15 per cent of vocational education and training learners should benefit from learning mobility abroad; and at least 20 per cent of all learners benefiting from learning mobility abroad should be people with fewer opportunities. The proposal also focuses on enhancing the recognition of qualifications and learning outcomes obtained through mobility experiences. This is crucial for facilitating the integration of learners into the EU labour market and for ensuring that the skills and competencies acquired through mobility are valued and utilised effectively. Furthermore, the document proposes to strengthen cooperation with key third countries, promoting the EU as an attractive destination for talent and enhancing the recognition of third-country qualifications.

Prevention Package

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Non-legislative, Q1 2021.

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Proposal: On the 31st of January 2024, the European Commission published a Proposal for a Council Recommendation on vaccine-preventable cancers (press release).

Problem: There is an increasing burden of cancer cases and deaths across the EU, particularly those caused by Human papillomaviruses (HPV) and Hepatitis B virus (HBV). These infections, leading to cancers such as cervical, liver, and other types, represent a significant public health challenge. Moreover, the COVID-19 pandemic exacerbated issues by disrupting routine vaccination programs and spreading misinformation, further impacting vaccine uptake and confidence.

Objective: By enhancing and expanding routine vaccination against HPV and HBV to prevent associated cancers the EU strives to support its member states. The Recommendation would improve vaccination coverage rates, address public health challenges, and align with the United Nation’s Sustainable Development Goals. Furthermore, it aims to bolster the resilience of health systems by promoting vaccination as a key preventive measure against vaccine-preventable cancers, thereby improving public health outcomes.

Subject Matter: The Recommendation underscores the importance of public health education campaigns aimed at dispelling myths and increasing awareness about the benefits of vaccination, which is critical in overcoming vaccine hesitancy. A key component of the proposed strategy involves integrating vaccination efforts into broader national cancer prevention and health strategies, ensuring that vaccination programs are accessible and tailored to meet the needs of diverse populations. This includes targeting at-risk groups and ensuring that vaccinations are affordable and readily available to all segments of the population. Furthermore, the Recommendation suggests establishing robust monitoring and evaluation frameworks to track vaccination rates, identify barriers to vaccine uptake, and assess the impact of vaccination programs on reducing the incidence of HPV and HBV related cancers. This data-driven approach will enable continuous improvement of strategies and interventions over time. International cooperation is also emphasized as crucial for tackling global health challenges associated with vaccine-preventable diseases. The Recommendation advocates for the EU to play a leading role in global health initiatives, promoting vaccination, and sharing knowledge and resources with countries outside the EU to help reduce the global burden of HPV and HBV related cancers. In summary, the Recommendation proposes a multifaceted strategy aimed at enhancing vaccination coverage across the EU through improved coordination, public education, integration into national health strategies, robust monitoring, and international cooperation.

European Commission Work Programme 2022

Follow-up protecting Health: Fighting the COVID-19-Pandemic

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Non-legislative Act: On the 27th of April 2022 the European Commission published a Communication on COVID-19 -Sustaining EU Preparedness and Response: Looking ahead (press release).

Problem: Based on experiences from the past two years, it is safe to say that the summer months are likely to see lower COVID-19 pandemic incidence rates, thus creating a window to prepare for possible future pandemic surges. In order to fully use the opportunity to prepare for future emergencies, EU to collectively act in a fast manner to adequately manage the pandemic in the coming months, moving from emergency to a more sustainable mode. Therefore, member states are invited to take actions before the autumn, building on the successful EU-wide coordination for health preparedness and response, specifically with regard to the likeliness of new SARS-CoV-2 variants.

Objective: The Commission’s primarily goal is to protect public health while keeping society and economy open and resilient. To achieve the following, member states are advised to use this period to strengthen their surveillance, healthcare systems, and overall pandemic preparedness. Meanwhile, researchers and vaccine manufacturers are to prioritise the development of universal, variant-proof vaccines that offer longer term protection against infection. Furthermore, the development of COVID-19 therapeutics, particularly targeted for immunocompromised patients who are over-represented in intensive care units, and the continued need for improving access to COVID-19 vaccines and therapeutics globally are areas highlighted in the Communication. As shown previously, COVID-19 vaccines have had a positive impact on the resilience of EU’s society, therefore, the focus should be on increasing the roll-out of booster doses, especially for the most vulnerable groups. Preparedness by member states such as in reintroducing mask-wearing, ventilation and physical distancing is key to effectively slow down the spread of COVID-19. Lastly, promoting trust-worthy content, identifying and responding to information gaps as well as engaging in countering information manipulation are highly encouraged.

Subject Matter: Member states shall consider increasing vaccination coverage rates among younger children ahead of the 2022-2023 school year. Efforts are needed to combat vaccine hesitancy as well as to encourage the uptake of booster doses by all eligible adults, starting from three months after the primary course. The Commission encourages member states to integrate year-round surveillance systems for acute respiratory illnesses that are sustainable, representative and based on common criteria for case identification and testing strategies in the EU as well as connect general practitioners, hospitals, laboratories. Additionally, they shall continue to collect and share with the ECDC reliable and timely data from integrated surveillance systems as well as from population-based surveillance systems to monitor COVID-19 hospitalisations and deaths. In order to reduce misinformation surrounding COVID-19, it is crucial to ensure a continued, consistent and repeated messaging by monitoring of the information environment and trends to react and share accordingly. Finally, the Commission itself will continue supporting additional preparedness measures under the Union Civil Protection Mechanism further developing its rescEU strategic reserve of medical equipment.

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Legislative procedure completed: On June 13th 2022, the European Parliament and the Council agreed on the extension of the EU Digital Covid Certificate by one year. Thus, the respective Regulation is to be extended by one year until 30 June 2023 (press release). 
Travel across the EU will remain accessible to persons in possession of the EU Digital Covid Certificate for another year, thus until June 30th 2023. Depending on further evolution of the epidemiological situation, by 31 December 2022, the Commission will publish a report on the EU Digital COVID Certificate, which may be accompanied by a proposal to shorten the period of application of the Regulation.

Proposal: On the 3rd of February 2022 the European Commission published a Proposal for a Regulation amending Regulation (EU) 2021/953 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic (press release).

Problem: The infamous COVID-19 pandemic did not only pose a threat to health systems across the European Union, but further lead to public health measures taken by member states seeking to protect individuals’ health as well as the capacity of their healthcare systems. In order to deter the reintroduction of border controls between member states as well as facilitate safe free movement during the COVID-19 pandemic, the EU Digital COVID Certificate framework has been established for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates. In the light of current developments related to new SARS-CoV-2 variants of concern, the Commission proposes extending the validity of the EU Digital Covid Certificate by another 12 months, acknowledging that it shall be lifted as soon as the epidemiological situation allows.

Objective: Primarily the proposal aims to adapt to current conditions in relation to the COVID-19 pandemic, extending by 12 months the application of Regulation (EU) 2021/953, which lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. Continuing the operations and maintenance of the Regulation already adopted by the Council and the European Parliament in June 2021 is to allow member states to waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery.

Subject Matter: The definition of SARS-CoV-2 tests shall be broadened to include antigenic assays performed in a laboratory setting and not only rapid antigen tests that give results in less than 30 minutes. An explicit clarification that vaccination certificates is to contain the number of doses administered to the holder, regardless of the member state in which they have been administered, shall contribute to the accurate reflection of the overall number of doses administered. It will further be ensured that EU Digital COVID Certificates can be issued to persons participating in clinical trials for COVID-19 vaccines, and that such certificates may be accepted by other member states in order to waive restrictions to free movement. The Health Security Committee, ECDC or EMA may be asked by the Commission to issue guidance on the acceptance of COVID-19 vaccines undergoing clinical trials.

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Proposal: On the 3rd of February 2022 the European Commission published a Proposal for a Regulation amending Regulation (EU) 2021/954 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) regarding third-country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic amending Regulation (EU) 2021/954 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) with regard to third-country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic (Press release) .

Problem: Third-country nationals legally residing or legally staying in an EU member state may travel freely within the territories of the other member states, provided that they fulfil certain conditions. Some of the restrictions adopted by the member states as a measure to limit the spread of COVID-19 have had an impact on the exercise of that right. In order to facilitate free movement for third country nationals with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery during the pandemic, the EU Digital COVID Certificate framework has been extended to third country who are entitled to travel to other member states in accordance with EU law. Considering the emergence of new SARS-CoV-2 variants of concern, it is necessary to ensure that the EU Digital COVID Certificates are applicable beyond the already defined date of 30 June 2022.

Objective: Offering additional open-source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate, as it is also possible to connect third countries the certificates of which are made interoperable by means of conversion shall facilitate free movement for third country nationals during the pandemic. Similar to the Proposal to amend the EU Digital COVID Certificate for EU citizens, the following aims to adapt to current conditions in relation to the COVID-19 pandemic, extending the application of Regulation (EU) 2021/953, which lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. Continuing the operations and maintenance of the Regulation already adopted by the Council and the European Parliament in June 2021 is to allow member states to waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery.

Subject Matter: The regulations around the recognition of SARS-CoV-2 tests and the validity of COVID digital certificates are equivalent to the subject matter of the proposed regulation on a framework for the issuance, verification and recognition of interoperable certificates attesting to COVID-19 vaccination and testing and recovery from COVID-19 infection.

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Non-legislative Act: On the 2nd of September 2022 the European Commission published a Communication on EU response to COVID-19: preparing for autumn and winter 2023 (press release).

Problem: In light of the COVID-19 summer wave, driven by Omicron BA.4 and BA.5, it has become evident that the pandemic is far from over. Case numbers remain high among people aged 65 years and over, with consequent increases in hospitalisation rates and intensive care unit (ICU) admissions in this age group. Moreover, as it has been the case in previous years, there is a possibility that the EU will be confronted with another COVID-19 wave this autumn and winter. The circulation of other respiratory viruses, including influenza, as usual in the winter season is also likely to put a strain on health systems. Furthermore, repercussions from long-COVID, as well as the impact of the pandemic on mental health amount to additional challenges to the already overburdened national healthcare systems and their workforce across the EU.

Objective: Member states are encouraged to put the necessary integrated strategies and measures in place to help avoid a surge of COVID-19 this autumn and winter, and to put in place the necessary structures that allow an adequate response to future outbreaks in a sustained manner. Across the Union, the coordination of preparedness efforts ahead of the next wave and further rollout of vaccination programmes is needed. The Commission most importantly aims to act now in order to limit the expected pressure on healthcare systems, the disruption of the economies and challenges for the society. Specific objectives include but are not limited to: Developing COVID-19 vaccines and making them available for this autumn and winter, as well as rolling out an optimised COVID-19 vaccination strategy. Creating integrated surveillance systems shall monitor different diseases like influenza, COVID-19, and other respiratory virus infections in the EU. Commitment and community engagement when adapting measures such as working from home or limiting the size of mass gatherings will be accompanied by continued efforts to facilitate free movement in the EU during the COVID-19 pandemic, both for people and goods.

Subject Matter: For EU’s member states it is crucial to continue national COVID-19 vaccination strategies using the currently available vaccines to reduce hospitalisations, severe disease and death. Additionally, closing vaccination coverage gaps among eligible individuals, including eligible children and adolescents according to national vaccination schedules to prevent crises within health systems. Thus, developing national vaccination programmes outlining which vaccines should be used for which population groups can be helpful. The Commission expects the implementation and, if possible, coordinated effective communication through initiatives and strategies to promote the uptake of additional vaccine doses and the completion of the primary series by those who have not yet done so. With the help of integrated surveillance systems, data from previous years shall help determine country-specific thresholds of epidemic severity, taking into account the different levels of severe disease and available healthcare capacity.

European Care Strategy

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Non-legislative Act: On the 7th of September 2022, the European Commission published a Communication on the European care strategy (press corner).

Problem: The COVID-19 pandemic disclosed structural gaps within the care systems, highlighting the importance of having robust formal care services to ensure continuity of care. Not only is there a need to improve the resilience of EU’s care systems, but also their availability since high-quality care services are still, for many people, neither accessible nor affordable. Specifically, people with disabilities are confronted with insufficient care services, support for families and personal assistance. Additionally, inadequate care services disproportionately impact women, obstructing their work-life balance and options to take on paid work.

Objective: The European care strategy works to improve standards for both carers and care receivers. In order to do so, it aims to increase the access to care services, as well as raise working conditions and create a work-life balance for carers. The increase of the availability of care services shall be accompanied by the improvement of their quality and affordability. Additionally, it is crucial for EU’s member states to improve access to and the quality of early childhood education and care. The revision of the Barcelona targets, proposed by the Commission, aims to enhance the participation of children at risk of poverty or social exclusion as well as increase the time-intensity of participation in early childhood education and care. Furthermore, due to increasing demand for care, the sector needs not only to retain staff but also to attract more workers with the right skills. Thus, better working conditions and wages, supported by strong social dialogue, education and training, shall be pursued. Having reliable and comparable data on participation in early childhood education and care, e.g. with a breakdown by specific groups or age categories can better monitor the progress and ensure evidence-based policy making.

Subject Matter: Two specific Council Recommendations have been proposed to provide policy frameworks for reforms and investments at national, regional and local levels. The Communication itself, sets out further supportive actions at European level and calls for action at national level. Member states shall introduce a legal entitlement to early childhood education and care, taking into account the availability and length of adequately paid family leave. They shall further work on improving working conditions for staff in early childhood education and care, while taking measures to improve the work-life balance for parents and close the gender care gap. The Commission will support member states in their individual efforts to design and implement reforms in the area of early childhood education and care via the European Education Area Strategic Framework and the Technical Support Instrument. Furthermore, utilising the upcoming Horizon Europe partnership ‘Transforming health and care systems’, the Commission will enhance assessment and transferability of good practices and create a community-building and exchange forum. Member states are advised to foster effective social dialogue and to conclude collective agreements for the care sector with the objective of providing care workers with fair working conditions and adequate wages. Consequently, the Commission will launch an awareness raising campaign on the new rights granted by the Work-Life Balance Directive and cover the unequal sharing of unpaid care work in its upcoming communication campaign on combating gender stereotypes.

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Non-legislative Act: On the 7th of September 2022, the Commission put forward a Proposal for a Council Recommendation on the Revision of the Barcelona targets on early childhood, education and care (ECEC) (press release).

Problem: The Barcelona objectives, initially established in 2002, have on average been reached at EU level. Nonetheless, some member states are significantly lagging behind, and differences persist in particular for children from lower income households. Additionally, a gender employment gap persists to exist, limiting the possibility for women to participate in and allocate time to paid work. The COVID-19 pandemic has further increased gender inequalities in unpaid care, reinforced traditional gender roles and impeded with the modest progress in gender equality achieved previously.

Objective: The main purpose of the Proposal is to expand the scope of relevant aspects for reaching the Barcelona targets such as, but not limited to accessibility, affordability, and quality. In doing so, this Recommendation invites member states to contribute more holistically by increasing their contribution in ECEC. In turn, this should encourage women’s participation in the labour market. With specific regards to the affected children, their social and cognitive development should improve, especially for children in vulnerable situations or from disadvantaged backgrounds. This proposal further aims to tend to the needs of both parents and children with the hope of persuading interest in such services. Parents in member states will meaningfully engage with paid work, as participation in ECEC takes into account the time-intensity of childcare. In this way, families, especially those with young children, will be at lower risk of poverty or social exclusion.

Subject Matter: As a legal instrument, the Proposal signals the Member States’ commitment to the objectives and measures described in the aforementioned Recommendation. It further provides a strong basis for cooperation at European level in this area, while fully respecting the competence of the Member States. Essentially, Member States will freely decide, according to their national circumstances, how they can make the best use of the Council Recommendation. In the course of the European Semester, the Commission plans on monitoring the implementation of the Barcelona targets, particularly in relation to women’s labour-market participation and gender equality. Furthermore, the assessment of the participation by all children in ECEC (number of hours attended per week) is to be included. Differences will be recorded between the participation of children from different groups, including children at risk of poverty or social exclusion and, where feasible, children with disabilities, with a migrant background, Roma children and other relevant groups, taking into account the age of the children and specific national features. The Commission’s Annual Report on Gender Equality and the Gender Equality Strategy Monitoring Portal shall monitor the implementation of the Recommendation. Additionally, member states are invited to develop and improve data collection on the participation of children in ECEC including with reference to children in vulnerable situations or from disadvantaged groups.

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Legislative procedure completed: On the 8th of December 2022, the European Council adopted and published a Recommendation on access to affordable high-quality long-term care. Improve access to affordable and quality long-term care for all people who need it. It also focuses on improving working conditions, access to training and generally strengthening the resilience of long-term care systems to future challenges.

Proposal: On the 7th of September 2022, the European Commission published a Proposal for a Council Recommendation on access to affordable high-quality long-term care (press release).

Problem: In the upcoming years, the already high demand for long-term care will be further increased while EU’s working-age population will continue to decrease as a result of demographic ageing. As women who have traditionally carried out most of the informal care burden are increasingly employed more and retiring later, there is less informal carers. Along with an increased labour demand across different economic sectors, this risks further reducing the supply of formal carers due to them moving to more attractive sectors. Other issues include care system differences in terms of their design and maturity across the Union, as well as the lack of adequate social protection that represents significant barriers to accessing long-term care.

Objective: The Proposal predominantly aims to support member states in their efforts to improve access to affordable high-quality long-term care by providing guidelines on the direction of reforms. These shall address the shared challenges of affordability, availability, quality, and the care workforce, as well as ensure sound policy governance in long-term care. Cooperation on Union-level with regards to long-term care shall strive for upward convergence. Specific objectives identified by the member states include: Guaranteed access for all to adequate health and long-term care and assurance that such care does not lead to poverty and financial dependency. The promotion of quality in health and long-term care shall be accompanied by the adaption of care to the changing needs and preferences of society and individuals. It is crucial to ensure that adequate and high-quality health and long-term care remains affordable and sustainable, by promoting healthy and active lifestyles, good human resources for the care sector and a rational use of resources.

Subject Matter: Member states are called to improve the adequacy of their social protection for long-term care, so that long-term care is timely, comprehensive, and affordable to those who need it. They shall increase the offer of long-term care services, while making sure that there is a balanced mix of services in all care settings, including by developing and/or improving home care. It is crucial to establish a quality framework for long-term care guided by the quality principles set out in the annex to the recommendation and include an appropriate quality assurance mechanism. The Commission shall support the implementation of this recommendation, including by mobilising EU funding, monitoring progress in the context of the European Semester and with the Social Protection Committee and the Employment Committee. A new framework of indicators for monitoring will be established in order to facilitate mutual exchanges. The Council shall be reported on the progress within 5 years of the adoption.

Protecting Health

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Legislative procedure completed: On the 14th of December 2023, the Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC was adopted (press release). The Regulation further increases the safety and quality of substances of human origin (SoHO). New measures will fill regulatory aps, facilitate cross-border circulation and promote greater cooperation between national authorities. A SoHO Coodingation Board (SCB) is established to support member states in the implementation of the Regulation. The Regulation widens the scope of EU rules to cover all SoHOs like breast milk (except solid organs), improves donor and recipient protection, and requires the registration of all enteties carrying out activities affecting the safety and quality of SoHO.

Proposal: On the 14th of July 2022, the European Commission published a Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (press release).

Problem: The current legislation contains outdated technical rules, which fail to fully protect patients from avoidable risks. Additionally, blood, tissues, and cells (BTC) donors, including children born from donated eggs, sperm, or embryos (offspring), are exposed to avoidable risks due to these outdated rules. Moreover, member states have divergent approaches to the oversight of BTC, which impedes cross-border exchanges of these materials. Consequently, the full potential of BTC processed or used in new ways is not fully realised for patients, and there is a vulnerability to interruptions in the EU supply of BTC.

Objective: The Proposal aims to set high standards of quality and safety for Substances of Human Origin (SoHO), blood, and blood derivatives, as required by Article 168(4) point (a) of the Treaty on the Functioning of the European Union (TFEU). The overarching goal is to ensure a high level of health protection for EU citizens by ensuring they have access to safe and effective BTC. Recognising that new technologies and risks will continue to emerge, the Proposal seeks to implement a future-proof, crisis-resistant, and agile framework capable of accommodating new risks and trends. It also aims to continue providing appropriate safety and quality requirements while exploring areas for improving the efficiency of the legislation and simplifying its implementation for all stakeholders.

Subject Matter: A significant component of the Proposal is the introduction of a series of common measures to address legal gaps in the BTC framework. These measures aim to strengthen oversight, facilitate innovation, and manage the supply of SoHOs, especially in times of crisis. To support the implementation of these measures, guidelines from expert bodies will be developed. Additionally, an advisory mechanism for SoHOs is proposed, though no changes in the delineation of the borderline with legal frameworks for pharmaceuticals or medical devices are suggested. The Proposal also addresses the issue of voluntary unpaid donation of BTC. It recognises that the current approach has not been adequate in protecting EU patients from shortages or sudden supply disruptions. Therefore, the Proposal introduces measures to ensure safety and quality for patients treated with SoHO therapies, protect donors and offspring, harmonise oversight practices among member states, develop safe and effective innovative SoHO therapies, and improve the resilience of the sector to mitigate the risk of shortages. The Regulation aims to establish more harmonised measures for member states and organisations involved in the collection, testing, processing, distribution, and application of SoHOs. This harmonisation addresses the insufficient minimum harmonisation previously identified as a key reason for reduced trust between member states, resulting in reduced cross-border exchange and sub-optimal access for patients to SoHOs. Furthermore, the Proposal plans to establish a central digital platform, the EU SoHO Platform, which will facilitate the monitoring of several indicators, providing continuous information and data. This platform is crucial for monitoring the progress towards achieving the objectives of the new Regulation.

Advance Passenger Information

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Proposal: On the 13th of December 2023, the European Commission published a Proposal for a Regulation on the collection and transfer of advance passenger information (API) for enhancing and facilitating external border controls, amending Regulation (EU) 2019/817 and Regulation (EU) 2018/1726, and repealing Council Directive 2004/82/EC (press release).

Problem: Due to an increased use of air travel in recent decades, efficient management of passenger flows at airports is necessary. However, current legislation on the collection and transmission of Advance Passenger Information (API) exhibits certain gaps and weaknesses, which affect the efficiency and effectiveness of border checks.

Objective: Therefore, the two proposals within the legislative package aim to strengthen the API framework by closing gaps and inconsistencies between member states in the collection and use of API. Simultaneously, external border management and the fight against illegal immigration shall also be improved.

Subject Matter: The proposal focuses on the effectiveness and efficiency of border controls at the external borders of the Union. It contains precise rules on the collection of API data and their transmission to competent border authorities. Specific attention is also given to the routers of the corresponding data. Through this harmonised framework, airlines shall be able to systematically request API data without being confronted with diverging requirements depending on the member state.

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Proposal: On the 13th of December 2022, the European Commission published a Proposal for a Regulation on the collection and transfer of advance passenger information for the prevention, detection, investigation and prosecution of terrorist offences and serious crime, and amending Regulation (EU) 2019/818 (press release).

Problem: Union airports are frequently used in the context of serious and organised crime. Against this background, information on air passengers has an important role to play in law enforcement as well as in the fight against terrorism. The PNR Directive, which was adopted in 2016, already stipulates that airlines transfer commercially collected Passenger Name Record (PNR) to competent border authorities. However, the Directive does not require airlines to collect data that exceeds the normal course of business. Advance Passenger Information (API) data, which in combination with PNR data allows for particularly effective law enforcement, is therefore not collected and transferred in its entirety, under the current legislation.

Objective: Thus, the Regulation aims to close this gap by establishing more effective rules on the collection and transfer of API data in combination with PNR data. This should increase the effectiveness of the fight against serious crime and terrorism in the EU. The proposal is part of a package that aims to close gaps and inconsistencies between member states in the collection and use of API data.

Subject Matter: The Regulation contains instructions for the collection and transmission of API data by airlines to routers. As mentioned above, airlines will thus be obliged to transfer complete API data to Passenger Information Units via the router. In this context, specific provisions on protocols, processing and deletion of personal data will be adopted. Other provisions concern rules for routers and possible sanctions against airlines for non-compliance with the Regulation.

Reciprocal Access to Security-Related Information

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Legislative, incl. impact assessment, Q4 2022.

Cancer Screening

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Non-legislative Act: On the 20th of September 2022, the European Commission published a Proposal for a Council Recommendation on strengthening prevention through early detection: A new EU approach on cancer screening and replacing Council Recommendation 2003/878/EC (Press release).

Problem: The Council Recommendation 2003/878/EC that encourages member states to implement population-based, quality-assured screening programmes has been instrumental in improving cancer screening and ensuring that the vast majority of people in the target age ranges have access to organised screening. Nonetheless, a 2017 implementation report highlighted ongoing challenges and needs, most importantly that the current Recommendation is not based on the latest evidence.

Objective: The optimised Recommendation shall support cancer screening through the whole pathway of cancer care as part of a new Union approach to cancer prevention under Europe’s Beating Cancer Plan. Developing a new EU-supported Cancer Screening Scheme shall ensure that, by 2025, 90 per cent of the EU population who qualify for breast, cervical and colorectal cancer screenings are offered screening. To do so, the breast, cervical and colorectal cancer screening recommendations are to be updated. Cancer screening programmes shall be extended to include lung and prostate cancer, as well as to gastric cancer in those countries or regions with the highest gastric cancer incidence and death rates. The regular systematic monitoring of screening programmes discover disparities via the European cancer information system and the Cancer Inequalities Registry. Data on cancer screening shall be shared across the Union, including through the planned European Health Data Space.

Subject Matter: EU’s member states are advised to offer evidence-based and person-centered cancer screening, taking into account the basic principles of safety, ethics, public engagement and equity. Screening programmes need to be accessible in accordance with European guidelines with quality assurance, where they exist, through a stepwise approach to take account of available human and financial resources. A systematic call/recall system and quality assurance at all appropriate levels, together with an effective and appropriate diagnostic and treatment and aftercare service shall follow evidence-based guidelines. In order to report the results to the public and the personnel providing the screening, the process of and outcome of organised cancer screening shall be monitored regularly. Cooperation between the member states and the exchange of best practices as regards cancer screening is highly encouraged by the Commission.

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Legislative Act: On the 29th of June 2022, the European Commission published a Delegated Directive on amending Directive 2014/40/EU of the European Parliament and of the Council as regards the withdrawal of certain exemptions in respect of heated tobacco products (press release).

Problem: The already existing Directive 2014/40/EU1 prohibits the market placing of tobacco products with a characterising flavour or containing flavourings in any of their components or having certain technical features. Under Article 7(12) of the Directive however, all tobacco products other than cigarettes and roll-your-own tobacco are exempted from these prohibitions.

Objective: The aim of the Delegated Directive is to extend the prohibition of the market placing of tobacco products with a characterising flavour or containing flavourings in any of their components or having certain technical features (which already exists for cigarettes and roll-your-own tobacco) to heated tobacco products and to remove the member states’ possibility to grant exemptions for these products from the labelling requirements. Such measures shall contribute to a high level of health protection, for young people in particular.

Subject Matter: The Commission shall adopt delegated acts to withdraw the exemption. Member states shall adopt and publish, 8 months after entry into force at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

Education Package

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Non-legislative Act: On January 18th, the European Commission published a Communication on a European strategy for universities (press release).

Problem: In light of major challenges, the higher education sector has an essential role to play in Europe’s post-pandemic recovery and in shaping sustainable and resilient societies and economies. Several areas of concern are in crucial need of revision in order to allow universities to embark on a process of rethinking and renewing themselves. Transnational cooperation as well as the funding of universities are insufficient. Moreover, a persistent gender gap remains in some fields of study and research and in decision-making positions at universities. Foreign interference in higher education institutions is increasingly threatening the fundamental academic and democratic values that the EU’s universities strive for.

Objective: The Communication highlights the necessity to support and enable universities to adapt to changing conditions, to thrive and to contribute to Europe’s resilience and recovery. Specifically, there are four joint key objectives to be inaugurated by mid-2024. Initiatives that promote transnational cooperation such was the case with Erasmus+ and Horizon Europe shall be implemented. To do so, adequate financial support is pivotal. Higher education and research shall focus on ensuring 1) quality and relevance for future-proof skills, 2) diversity and inclusion 3) democratic practices, fundamental rights and academic values and freedom of scientific research. Universities shall be empowered as actors of change in the twin green and digital transitions by supporting their full engagement in unfolding green and digital transitions. Through deeper international cooperation within Europe and beyond, EU’s universities shall become more competitive on the global scene. Lastly, higher education systems in partner countries that work in line with European values are to be assisted.

Subject Matter: In cooperation with the stakeholders and the member states, the Commission aspires to expand to 60 European Universities with more than 500 universities as well establish a legal statute for alliances of universities by mid-2024. A unique European Student Identifier available to all mobile students in 2022 and to all students in universities in Europe by mid-2024 will be deployed as part of the European Student Card initiative. Member states are encouraged to maximise the impact of EU interventions, by seeking further synergies with national financing, notably in the context of European Universities and develop adequate funding mechanisms for universities. Interdisciplinary approaches, including through institutional accreditation, academic assessment, reward and professional development are to be facilitated, while national support schemes are to be developed. It is further crucial to enable the access to higher education of refugees and individuals seeking asylum, including the establishment and scaling of complementary pathways for refugee students and the related support. Additionally, the Commission will support member states’ efforts through peer learning and sharing best practices in promoting whole-institutional approaches to sustainability, climate and environmental literacy. Finally, in cooperation with the stakeholders and EU’s member states, the Commission will set-up a data-focused European Higher Education Sector Observatory in 2023 and promote synergies between the European Education Area, the European Research Area and the European Higher Education Area in a fit-for-purpose and flexible manner.

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Legislative procedure completed: On the 05th April 2022, the European Council adopted and published a Recommendation on facilitating effective European cooperation in higher education.

Proposal: On the 18th of January 2022, the European Commission published a Recommendation for a Council Recommendation on building bridges for effective European higher education cooperation (press release).

Problem: A number of challenges impede the delivery of joint transnational educational activities and programmes at all levels. Such difficulties are linked to incompatible requirements preventing the award of joint degrees as well as the lack of a legal statute for alliances of higher education institutions preventing them to efficiently pool resources, share infrastructure or transfer technology.

Objective: The central aim of the Recommendation is to allow all higher education institutions in Europe, their learners, staff, and researchers to benefit from an optimised transnational cooperation. To do so, EU’s institutions as well as the member states need to join forces in an attempt to make the European higher education sector stronger and consolidate its global attractiveness and competitiveness. More transnational cooperation can help harness the potential of all available resources, engaging different types of higher education institutions with complementary education and research capacities, and strengths. Alliances of higher education institutions shall obtain a legal statute in order for them to pool resources, capacities and their strengths. Lastly, building transnational bridges at an institutional level can accelerate higher education institutions’ transformation across all their missions of education, research, innovation, and service to society, helping tackle European and global challenges.

Subject Matter: EU’s member states are advised to support higher education institutions to test the feasibility of setting-up a legal statute for alliances of higher education institutions. They shall promote the delivery at national level of a joint European degree, making it easier for higher education institutions engaged in transnational cooperation to provide joint programmes and award joint degrees. With a joint European degree, the value of transnational experiences in the higher education qualification the students obtain shall be recognised. Additionally, the generalised use of the European Student Card initiative made available to all mobile students by mid-2024 across all higher education institutions in Europe, will facilitate mobility at all levels. At the same time, it is crucial to protect institutional autonomy while setting up common governance arrangements for deeper transnational cooperation. Thus, universities shall be allowed to take independent decisions on internal governance, financial, staffing and academic matters. Furthermore, the Commission support the member states and higher education institutions to pilot the use of existing European instruments as a step with a view to developing by mid-2024 of a legal statute for alliances of higher education institutions. The Commission’s assistance in the roll-out of the European Student Card initiative shall help reduce the administrative burden of managing students and staff mobility and exchanges embedded within transnational partnerships of higher education institutions. The programmes made in the member states action plans for the implementation of this Recommendation, shall be evaluated by the Commission.

Migration and Asylum Initiatives in the Light of the Ukraine War

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Legislative procedure completed: The European Ministers of the Interior voted on the 3rd of March 2022 in favour of adopting the proposal of the 2nd March, thus deciding in favour of activating the Temporary Protection Directive (press release).
Invoking Temporary Protection, the EU aims to offer quick and effective assistance in European countries to people fleeing the Russian invasion of Ukraine
The Directive will ensure the immediate protection and rights of those eligible, reduce pressure on national asylum systems, enhance solidarity and responsibility sharing, and lastly, secure further support from EU agencies such as Frontex, the European Union Asylum Agency and Europol.

Proposal: On the 2nd of March 2022 the European Commission published a Proposal for a Council Implementing Decision establishing the existence of a mass influx of displaced persons from Ukraine within the meaning of Article 5 of Council Directive 2001/55/EC of 20 July 2001, and having the effect of introducing temporary protection (Press release).

Problem: The unprovoked and unjustified Russian military Invasion of Ukraine on 24 February 2022 in violation of international law and the principles of the UN Charter, has already had and will continue to have an impact on EU’s external borders, increasing migratory pressure resulting from the many thousands of persons seeking protection in EU member states. Depending on how the conflict evolves, the EU is likely to host a significant number of persons, with a possible figure of between 2.5 million and 6.5 million persons. Thus, the Commission seeks to establish the existence of a mass influx of displaced Ukrainians and other third-country nationals and stateless persons legally residing in Ukraine at the time of the conflict.

Objective: This proposal primarily creates a legal basis in order to activate the application of the Temporary Protection Directive outlining the main elements, including a description of the specific groups of persons to whom the temporary protection should apply and the date on which the temporary protection will take effect. Temporary protection within the Union shall quickly allow displaced persons to enjoy harmonised rights that offer an adequate level of protection, including a residence permit, the possibility to engage in employed or self-employed activities, access to suitable accommodation, the necessary social welfare assistance, medical or other assistance, and means of subsistence. It shall further limit the need for these displaced persons to immediately seek international protection and overwhelm the asylum systems of the member states, by reducing formalities to a minimum because of the urgency of the situation. Lastly, member states shall be assisted to manage the influx of displaced persons in a controlled and effective way with full respect for fundamental rights and international obligations.

Subject Matter: Persons with the right to enjoy temporary protection include Ukrainian nationals residing in Ukraine who are displaced as of 24 February 2022 following the military invasion by Russian armed forces on that date, third-country nationals or stateless persons legally residing in Ukraine who are unable to return to their region of origin in safe and durable conditions because of the situation prevailing in that country, as well as family members of the two categories of people. The Commission shall coordinate cooperation and exchange of information among member states in relation to monitoring the reception capacities and identifying any need for additional support. The situation shall be kept under constant monitoring by the Commission, in cooperation with the member states, the European Border and Coast Guard Agency (Frontex), the European Union Asylum Agency and the European Union Agency for Law Enforcement Cooperation (Europol). Finally, the European Border and Coast Guard Agency (Frontex), the European Asylum Agency (EUAA) and Europol shall provide operational support to the member states who requested their assistance to help them cope with the situation, including for the purposes of applying this implementing Decision.

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Non-legislative Act: On the 2nd of March 2022 the European Commission published a Communication providing operational guidelines for external border management to facilitate border crossings at the EU-Ukraine borders (Press release) .

Problem: In the light of the Russian military invasion of Ukraine on 24 February 2022, the European Union is facing a situation characterised by a mass influx of Ukrainians and other third country nationals residing in Ukraine at the time of the conflict. Rising waiting times at EU’s border crossing points as well as constant queues and congestions are calling for optimised contingency measures.

Objective: Operational guidelines are to assist the member states bordering Ukraine in the current situation at the external borders of the EU. Focusing on the measures available to the member states shall ensure the effective and efficient management of the crossing of persons fleeing Ukraine through the borders with Poland, Slovakia, Hungary and Romania. The guidelines shall additionally allow member states to avoid congestions at and around their borders, while maintaining a high level of security for the entire Schengen area. In particular, the guidance provides a comprehensive overview of facilitation measures concerning border controls which are available under the Schengen rules, while still ensuring the necessary level of border checks. Member states concerned are recommended to take advantage of support by European Border and Coast Guard Agency (Frontex) in all activities carried out by the border guards at the borders. In this respect, Frontex is to give priority treatment to all the requests of the member states concerned to the EUROSUR fusion services, in particular for providing regular monitoring with tailor made imagery services, including satellite imagery, covering the adjacent pre-frontier areas of Ukraine to assess the situation and providing tailored multipurpose aerial surveillance service. The Commission further strongly encourages member states with a common border with Ukraine to request support from Europol.

Subject Matter: Measures include the simplification of border controls for certain categories of persons, including vulnerable persons, such as children, and other categories, such as transport workers that find themselves in Ukraine while carrying out their services. Border controls shall be organised outside of border crossing points while special arrangements for crossing the borders by rescue services, police, fire brigades and border guards, seafarers regardless of their nationality shall be provided. In order to ensure access and return of organisations providing humanitarian aid to people in the Ukrainian territory, the establishment of emergency support lanes is essential. Outside the scope of the Schengen rules, the waiving of customs duties and measures to facilitate the entry of pet animals travelling with their owners from Ukraine are also planned.

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Non-legislative Act: On the 21st of March 2022 the European Commission published a Communication on Operational guidelines for the implementation of Council implementing Decision 2022/382 establishing the existence of a mass influx of displaced persons from Ukraine within the meaning of Article 5 of Directive 2001/55/EC, and having the effect of introducing temporary protection (Press release).

Problem: Following the introduction of the Temporary Protection Directive, several member states expressed their uncertainty concerning its implementation, therefore, identifying a number of issues on which it finds it useful to provide guidance, the Commission has established implementation guidelines concerning the scope (persons covered/not covered by the Council Decision, family members) and the appropriate way to handle children, as well as the persons’ right to move freely between member states, registration and provision of information.

Objective: A Solidarity Platform has been set up by the Commission with a view to harmonise the operational response among member states, helping collect information and examine the needs identified. The mobilisation of relevant EU instruments shall coordinate the matching of offers for solidarity with the needs identified and coordinate the transfer of persons on a general level between member states and, where appropriate, to third countries, in cooperation with EU agencies and other relevant actors. The overall objective of the presented guidelines is to assist EU’s member states in applying the Temporary Protection Directive, notably considering that it provides guidelines for external border management to facilitate border crossings specifically at the EU-Ukraine borders.

Subject Matter: As a living document, the guidelines will have to be updated regularly based on new questions received from member states, to reflect the situation on the ground and take due account of member states’ evolving needs; thus, these guidelines may be followed by more specific recommendations on particular topics. The Commission further intends to update the dedicated webpage regularly on information for people fleeing the war in Ukraine, with any additional guidance that might be required by the member states. Moreover, the Commission has been and will continue working closely with the European External Action Service, relevant EU agencies and member states under the framework of the Migration Preparedness and Crisis Blueprint Network to establish an overview of the level of preparedness for a potential crisis.

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Non-legislative Act: On the 23rd of March 2022 the European Commission published a Communication welcoming those fleeing war in Ukraine: Readying Europe to meet the needs (press release).

Problem: Given that the Russian invasion of Ukraine has led to an unprecedented scale and speed of arrivals, mainly women and children, the Commission sets out a perspective on actions inside the EU that will support those who are fleeing the country. Establishing the Temporary Protection Directive was the first step towards offering quick and effective assistance and a clear legal status to the arrivals, while the challenge now is to give life to those rights in practice.

Objective: The Communication addresses primarily the experiences children have been exposed to, highlighting the need for particular protection, care and psychological support. Meeting the immediate reception and protection needs of the arrivals as well as helping regain a sense of stability is key for averting the potential risks of abuse and trafficking. As part of the Temporary Protection Directive, the member states shall provide access to the rights that include accommodation, education, healthcare and access to jobs. It is further necessary to offer refugees a safe heaven in Europe, specifically protecting minors and providing them access to education. Healthcare serviced as well as the job market are to be, in addition to housing and accommodation, facilitated for the new arrivals. The Union plans to assist the solidarity among private individuals, public authorities and the civil society by introducing fast and flexible solutions to help mobilise financial support to member states hosting those fleeing war against Ukraine.

Subject Matter: Using resources and expertise across the EU through the Solidarity Platform, the Commission will mobilise key networks to support member states. Moreover, it will help member states use EU funds quickly and flexibly, so that tailor-made funding can flow rapidly to support their efforts, key organisations and civil society to make the rights granted through temporary protection a reality. Lastly, it shall put in place dedicated structures so that member states of both first entry and of destination, and other key service providers, can deploy the best available tools as quickly as possible.

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Legislative procedure completed: The Council voted on 4th of April 2022 in favor of using cohesion funds for refugees in Europe (CARE) as well as extending the implementation period of the three home affairs funds 2014-2020 (CARE) by one year (press release).
The decision on CARE allows member states to use remaining funds from the Cohesion Fund for the 2014-2020 programming period to provide emergency assistance to people seeking protection in the EU due to the Russian invasion of Ukraine. Among other things, investments in education, employment, housing, health and childcare services will be financed. In addition, some of the money will go towards providing basic material assistance, such as food and clothing. The new rules will help the member states to cope with the current challenges in migration, but also in border management.

Proposal: On the 8th of March 2022 the European Commission published a Proposal for a Regulation amending Regulation (EU) No 1303/2013 and Regulation (EU) No 223/2014 as regards Cohesion’s Action for Refugees in Europe (CARE) (press release).

Problem: In response to the invasion of Ukraine by the Russian Federation and the resultant impact on the European Union and several of its eastern regions in particular as well as the extended impact of the COVID-19 pandemic on the EU as a whole, the proposal clarifies the range of support that can be provided to member states and regions to enable them to address this extraordinary situation and to prevent their ongoing work to build a resilient recovery from the COVID-19 pandemic being put at risk.

Objective: The Commission primarily aims to provide exceptional and targeted changes to the overall 2014-2020 legal framework established for the European Structural and Investment Funds and for the Fund for the European Aid to the Most Deprived (FEAD). Specific measures are to be set out for the FEAD, in particular taking into account the urgent need to provide basic material assistance to those persons affected by the military aggression by Russia. In order to appropriately address the migratory challenges, it is necessary to allow for retroactive eligibility to the start date of that aggression for concerned operations. Furthermore, flexibility in the support between ERDF and ESF shall be increased for such operations so that available funding in programmes can be used quickly. Member states shall be allowed to amend certain elements of programmes supported by the FEAD without requiring approval by the Commission. Lastly, support from the Funds is to be mobilised to alleviate the burden on national budgets.

Subject Matter: Member states and regions shall continue benefitting from a 100 per cent EU co-financing rate for the accounting year 2021-2022, and this by way of notification to the Commission. Arrangements as well as additional flexibility between ERDF and ESF specifically for operations addressing the migratory challenges as a result of the military aggression by Russia, are to be introduced for the budgetary execution of additional payments resulting from the application of the 100 per cent co-financing rate. Member states shall have the flexibility to amend programmes supported by the FEAD and this by way of notification to the Commission and also with a retroactive start date of eligibility of support set at 24 February 2022.

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Legislative procedure completed: On October 4th 2022, the European Parliament adopted the Proposal for a Regulation to improve cohesion policy - Flexible Assistance to Territories (FAST - CARE) - to address the consequences of Russian aggression (parliament statement). In the wake of Russian aggression against Ukraine, the EU has decided to provide targeted measures to Member States to meet the needs of people fleeing the war in Ukraine, while continuing to support the recovery of European regions.

Proposal: On June 29th, the European Commission published a Proposal for a Regulation on Upgrading Cohesion policy - Flexible Assistance to territories (FAST - CARE) - to address the consequences of Russian aggression (press release).

Problem: The Russian invasion of Ukraine has resulted in heightened geopolitical instability and the disruption to the world economy. Additionally, the sudden inflow of people fleeing the Russian aggression, currently 5.6 million people in the Union, member states have been trying to address their humanitarian needs. The Commission has already introduced several proposals to increase flexibility in cohesion funding, helping member states to provide emergency support and access to services. Nonetheless, stakeholders from civil society, local and regional authorities as well as the member states have addressed the Commission and raised specific difficulties that have been encountered.

Objective: An additional set of measures shall further increase the flexibility of the cohesion policy to address the consequences of the war, and provide liquidity amounting to 3.5 billion euro. FAST-CARE measures will provide member states with easier and faster access to funding in order to address the needs of people fleeing the war in Ukraine, while continuing to support the recovery of Europe’s regions. The Flexible Assistance to Territories (FAST - CARE) will complement the CARE measures. Legislative proposals shall broaden the flexibility under cohesion policy and provide additional pre-financing. Non-legislative measures on the other hand, are meant to optimise the effective use of the funds and address the emerging needs.

Subject Matter: Some of the proposed legislative measures include: additional pre-financing, amounting for 3.5 billion euro, that are to be paid in 2022 and a co-financing rate of up to 100 per cent for priorities promoting the socio-economic integration of third country nationals under 2014-2020 programmes, with the increased rate also being available under 2021-2027 programmes, until mid-2024 with a possibility to review. For projects addressing migratory challenges, member states will be able to declare expenditure for reimbursement while further measures shall enable the continuation of support to uncompleted operations, such as the risk of delays due to price increases, and the shortage of input materials. Updating the guidelines on closure of the 2014-2020 programmes will be part of the non-legislative measures proposed by the Commission. This will bring substantial additional flexibilities benefiting to unfinished projects, by: (1) extending the administrative deadlines for their completion from national resources; (2) reducing the size of such projects which may still be included in the final accounts; and (3) by increasing the corresponding share of expenditure, compared to the total expenditure decided for the concerned programmes.

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Legislative procedure completed: On the 19th of April 2022, the Council Recommendation on the conversion of hryvnia banknotes into the currency of host Member States for the benefit of displaced persons from Ukraine was adopted. Member states have to establish national schemes facilitating the conversion of hryvnia banknotes up to a maximum of 10 000 hyrvnias per person without charges, if displaced people are entitled to temporary protection. The scheme schould be in place for a minimum of three months.

Proposal: On the 1st of April 2022 the European Commission adopted a Proposal for a Council Recommendation on the conversion of hryvnia banknotes into the currency of host Member States for the benefit of persons fleeing the war in Ukraine (press release).

Problem: Since the beginning of the unprecedented act of aggression by Russia, around four million people have arrived from Ukraine in the EU, many of them having urgent liquidity needs to cover essential expenses. Due to the suspension of the exchange of hryvnia banknotes into foreign cash, those that have arrived in the Union face difficulties in converting hryvnia banknotes into the currency of their host member state.

Objective: As part of the Union’s response to people fleeing as a result of the Russian military invasion of Ukraine, the Commission aims to facilitate the exchange of hryvnia banknotes into host member state currency in order to support displaced persons from Ukraine in meeting their needs, in particular as they travel across the Union. A coordinated approach among the member states regarding national schemes is to grant the displaced persons from Ukraine the same conditions for converting hryvnia banknotes into local currency independently of the member state that hosts them.

Subject Matter: The Commission recommends member states to establish national schemes to facilitate the conversion of hryvnia banknotes into the national currency. It is mandatory for each displaced person to present evidence of being entitled to temporary protection in order to be able to convert their hryvnias banknotes into the currency of the member state. Maximum limits for the conversion per person, which is to be free of charge, shall be at or below 10 000 hryvnias. During the duration of the scheme that amounts to a minimum of three months, the applicable exchange rate shall be the official exchange rate as published by the National Bank of Ukraine. Additionally, member states shall strive to make the best use of a network of participating credit institutions for the implementation of the scheme, as well as consider to agree with participating credit institutions on how to record and check the identity of each displaced person that utilises the scheme.

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Legislative procedure completed: On the 12th of April 2022, Regulation (EU) 2022/613 amending Regulations (EU) No 1303/2013 and (EU) No 223/2014 as regards increased pre-financing from REACT-EU resources and the establishment of a unit cost was adopted. For the implementation of operations addressing migratory challenges resulting from the military aggression by the Russian Federation, member states may include in the expenditure declared in payment applications a unit cost linked to the basic needs and support of persons granted temporary protection or other adequate protection under national law. In addition to the initial pre-financing, the Commission shall pay 4 per cent of the REACT-EU resources allocated to programmes for the year 2021 as additional initial pre-financing in 2022. For programmes in member states which have had a level of arrivals of persons from Ukraine greater than 1 per cent of their national population between 24 February 2022 and 23 March 2022, that percentage shall be increased to 34 per cent.

Proposal: On the 23rd of March 2022 the European Commission published a Proposal for a Regulation amending Regulation (EU) No 1303/2013 and Regulation (EU) No 223/2014 as regards increased pre-financing from REACT-EU resources (Press release).

Problem: In response to the immediate additional budgetary pressures stemming from the management of massive arrivals of persons fleeing Ukraine that the member states are facing, this proposal provides for exceptional and targeted changes to the 2014-2020 legal framework established for the European Structural and Investment Funds and for the Fund for the European Aid to the Most Deprived (FEAD).

Objective: The purpose of this Proposal is to mobilise support from the Funds for all member states in order to alleviate the burden on national budgets as a temporary and exceptional measure and without prejudice to the rules that should apply under regular circumstances, to increase the amount of pre-financing that is paid out under REACT-EU. A higher share of these increased pre-financing resources shall be allocated to those member states which are confronted with the largest arrivals of persons fleeing Ukraine, either as transit countries or as countries of final destination.

Subject Matter: As additional unitial pre-financing in 2022, the Commission shall pay 4% of the REACT-EU resources allocated to programmes for the year 2021. For programmes in member states which have had a level of arrivals of persons from Ukraine greater than 1% of their national population between 24 February 2022 and 23 March 2022, that percentage shall be increased to 34%. Member states shall report on the use made of this additional initial pre-financing to address the migratory challenges faced as a result of the military aggression by the Russian Federation and its contribution to the recovery of the economy.

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Non-legislative Act: On the 27th of April 2022 the European Commission published a Communication on attracting skills and talent to the EU (press release).

Problem: In order to support the EU's green and digital transformation and to help rebuild the labour market after the setbacks caused by the COVID-19-pandemic, the Commission considers it crucial to encourage Member States to use their EU membership as an advantage to attract talent and different types of skills that can contribute to the dynamism of the EU economy. Legal migration not only benefits immigrants, but also promotes cooperation between countries of origin and destination and also helps to strengthen the cohesion and resilience of European societies.

Objective: Advocating legal migration requires legislative, operational and future-oriented policy measures that can adequately address some of the most important challenges that the EU is facing in attracting skills and talent, in the short and long-term. Moreover, as a result of the Russian military aggression against Ukraine, it is necessary to adjust EU’s labour market to successfully integrate the working age people arriving in the EU from Ukraine. Structural shortages in tourism, hospitality, IT, health, and logistics sectors in addition to the increase in unfilled job vacancies shall be contested by the stimulation of legal migration, which in turn can strengthen European cooperation with countries of origin and transit, including with the aim to reduce irregular migration. More effective legal routes for migrants as well as a shared competence between the European Union and its member states are encouraged. In addition, in order to address the growing labour market needs, linked to demographic trends and shortages, the EU needs to withstand occupational shortages in specific sectors and regions by attracting talent from around the world.

Subject Matter: Simplified procedures for the admission of workers of various skill levels to the EU, and the mobility within the EU of workers from non-EU countries that are already in the EU, as well as the improvement of their rights and their protection from labour exploitation will be the result of the recasting of the Long-Term Residents Directive and the Single Permit Directive. Talent Partnerships with key partner countries shall address the challenge of international matching by developing a comprehensive policy framework and financial support to engage key partner countries strategically in all areas of migration management, including effective return and readmission, as well as the prevention of irregular departures. By mid-2023, the Commission aims to formally launch the EU Talent Pool and its web portal that will be an EU-wide pool of candidates from non-EU countries, which will be selected on the basis of specific skills levels, criteria and migration requirements, following a screening of candidates’ credentials. In the third quarter of 2022, the Commission shall organise a high-level conference, which will launch the new EU platform on labour migration and further pave the way towards a sustainable EU legal migration policy.

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Non-legislative Act: On the 5th of April 2022 the European Commission published a Recommendation on the recognition of qualifications for people fleeing Russia’s invasion of Ukraine (press release).

Problem: The unprecedented inflow of people fleeing from the war in Ukraine not only requires immediate support to provide shelter, humanitarian aid and access to healthcare, but also specific action to ensure that people are smoothly integrated into the host countries and have access to education, housing, and jobs. On the basis of previous experiences, non-EU nationals, and in particular refugees, often have to take jobs below their qualification level. Therefore, providing a simple and rapid recognition mechanism is needed to ensure that people enjoying temporary protection can work in jobs for which they are qualified.

Objective: The Commission primarily seeks to establish an efficient, rapid and well-functioning system of recognition of their professional qualifications in order to facilitate the recognition of qualifications acquired in non-EU countries and increasing their comparability with EU qualifications. Reducing formalities for the recognition of professional qualifications shall ensure that procedures for recognising foreign qualifications are quick, fair, transparent, and affordable. Encouraging the integration of people under the temporary protection mechanism shall lead to the better use of their skills, benefiting both the individual and the host community. It further provides relevant experience and skills to people during their period of temporary protection, which adds value to their qualifications when returning to their home country.

Subject Matter: Member states are encouraged to speed up the recognition process by putting in place fast-track procedures for handling applications of professionals enjoying temporary protection. Ensuring that only essential documents are required as well as accepting other forms of proof than original documents (e.g. digital copies) shall facilitate the procedure. To reduce and eliminate costs, such as application fess in addition to demanding certified translations is to benefit the refugees. Additionally, member states are advised to take the decision to impose any compensation measure as soon as possible, and not take longer than a month after an applicant’s request for recognition. Digital tools such as the FRAUDOC - Guidelines on Diploma Mills and Document Fraud for Credential Evaluators shall help member states in cases of doubt about the authenticity of the qualification verification. Finally, the Commission recommends that, if possible, a recognition decision made in one member states shall be accepted EU-wide.

Follow-up Initiatives under the New Pact on Migration and Asylum

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Non-legislative Act: On the 21st of November 2022, the European Commission published an Action Plan for the Central Mediterranean (press release).

Problem: The increase in illegal immigration to the European Union highlights the need for sustainable and structural European solutions to common challenges based on the comprehensive approach set out in the New Pact on Migration and Asylum, including new measures on the external dimension of migration. The Western Balkan route in particular has seen a sharp increase in migratory movements. On the central Mediterranean route, over 90 000 migrants and refugees arrived in 2022, mainly from Libya and Tunisia, and originating mainly from Egypt, Tunisia and Bangladesh. This represents an increase of over 50 per cent compared to 2021, with most of these arrivals reaching the European Union after dangerous journeys and search and rescue operations at sea.

Objective: The Commission presents three main objectives that need to be achieved in order to provide adequate assistance to all persons in distress at sea until they are safely disembarked, regardless of the circumstances that brought people into such a situation. This includes better cooperation with partner countries and international organisations, a more coordinated approach to search and rescue, and enhanced implementation of the voluntary solidarity mechanism and the joint roadmap. It is crucial to promote cooperation and solidarity between member states, as well as coordination between all relevant actors and stakeholders, in order to prevent fatalities at sea, maintain the safety of shipping and find sustainable solutions to the current challenges.

Subject Matter: There is a list of 20 specific actions to be taken. Before the end of the year, the Team Europe initiative will be launched on the Central Mediterranean Route, providing new opportunities for coordination with partner countries and relevant UN agencies. Operational coordination of external action on migration will be improved through MOCADEM and EMWP, while the capacity of countries of exit, notably Libya, Tunisia and Egypt, will be strengthened. A new regional programme will be developed and implemented to combat migrant smuggling and human trafficking in North Africa. In addition, the trilateral EU/AU/UN Task Force on Libya will be strengthened to promote the use of humanitarian corridors from Libya to the EU and to intensify voluntary humanitarian returns from Libya to countries of origin or safe destination. The negotiation and conclusion of the working arrangement between Frontex and the EU Border Assistance Mission in Libya (EUBAM) and Frontex's cooperation with EUCAP Sahel Niger are also highlighted. This cooperation will also be consolidated with Niger. During 2023, the implementation of the EUAA-Egypt roadmap for international protection assistance will be accelerated. Diplomatic efforts with third countries to which irregular migrants are to be returned require coordination. In this context, it is necessary to quickly launch targeted return operations with the support of Frontex. The implementation of the Regional Development and Protection Programme in North Africa and Niger should be a priority alongside the accelerated activation of the talent partnerships with Tunisia, Egypt, and Bangladesh. EU member states need to strengthen their cooperation and coordination with Frontex, UNHCR and IOM. At the global level, further discussions within the International Maritime Organisation may be crucial. The Solidarity Platform should revise the standard operating procedures for resettlement and additionally match the proposed projects and financial contributions in order to start implementing the alternative solidarity measures through projects that match the identified activities and needs. Finally, it is recommended that the EUAA prioritise supporting member states in the rapid implementation of the voluntary solidarity mechanism through its instruments and operational plans.

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Non-legislative Act: On the 8th December of 2022, the European Commission published an Action Plan on the Western Balkans (press release).

Problem: The central problem addressed in the Action Plan is the significant increase in irregular border crossings along the Western Balkan routes into the European Union. Between January and November 2022, almost 130,000 such crossings were reported, which is three times higher than the same period in the previous year. These crossings result from two intersecting flows: visa-free arrivals in the Western Balkans travelling onwards to the EU, and migrants passing through the region irregularly after following the Eastern Mediterranean route. The increase in irregular migration poses challenges to border management, public safety, and the maintenance of an effective asylum system.

Objective: The Action Plan aims to strengthen the partnership with the Western Balkans in light of their EU accession perspective and their continued efforts to align with the EU acquis. It identifies 20 operational measures to build on the progress achieved, focusing on strengthening border management, ensuring swift asylum procedures, taking action against migrant smuggling, fostering readmission cooperation and return, and aligning visa policies. The overall goal is to develop a unified and comprehensive approach that effectively manages migration, enhances security at the EU's external borders, and maintains the integrity of the EU asylum system.

Subject Matter: A key measure in the Action Plan is strengthening border management along the Western Balkan routes. This involves reinforcing Frontex joint operations and deployments along the EU's external borders with Western Balkan partners, based on existing Frontex Status Agreements. The EU is also committed to launching and concluding negotiations of the Frontex Status Agreements with Albania, Montenegro, Serbia, and Bosnia and Herzegovina, in line with the new legal framework. The provision of border management and surveillance equipment, training, and a budget of EUR 40 million focused on Montenegro, Bosnia and Herzegovina, Serbia, and Kosovo are also integral to this approach. The Action Plan emphasises ensuring swift asylum procedures and supporting reception capacity across the EU and Western Balkans. This involves continuing support to Western Balkan partners in strengthening and accelerating their asylum and registration procedures, including through the implementation of the EUAA Joint Roadmaps. The EU commits to enhancing the management of reception capacity, building on the model of the pilot IPA programme for the multi-purpose reception centre at Lipa, and developing contingency planning for the winter season. Fighting migrant smuggling is another crucial aspect of the Action Plan. The EUROPOL Operational Task Force, established to tackle migrant smuggling at the border between Serbia and Hungary, is a significant step in this direction. The Action Plan calls for the extension of similar Task Forces at other borders and enhancing the participation of all Western Balkan partners in the EMPACT cycle 2022-2025 and its Operational Action Plan to fight criminal networks involved in migrant smuggling. Enhancing readmission cooperation and returns is also a focus of the Action Plan. The EU is increasing its action to step up returns from Western Balkan partners, expanding ongoing pilot programmes financed with IPA funds, and strengthening the operational capacities of the Western Balkan partners to carry out returns. This includes deploying return specialists, sharing knowledge and expertise on the return process, and facilitating cooperation with countries of origin. Finally, achieving the alignment of visa policy with the EU is addressed in the Action Plan. It calls for the swift alignment of visa policy with the EU by reinstating and effectively implementing visa requirements for third countries in line with EU visa policy. The EU continues to monitor operational developments and legislative actions by Western Balkan partners, including actions towards visa alignment, ensuring continuous monitoring and assessment of the action of the partners in the region towards visa alignment.

Follow-up to Fostering Europe’s Security

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Legislative procedure completed: On the 23rd of January 2024, the Proposal for a Directive amending Directive 2011/36/EU on preventing and combating trafficking in human beings and protecting its victims was adopted (press release). The new agreement introduces more robust regulations to combat human trafficking. It equips law enforcement and judicial bodies with enhanced tools to investigate and prosecute, especially concerning exploitation occurring online. These regulations extend to emerging forms of exploitation, such as forced surrogacy, illegal adoption, and forced marriage. Additionally, crimes facilitated through digital platforms will incur heavier penalties. The rules mandate formal referral mechanisms for victim support and criminalize the use of services provided by trafficking victims. Member States will need to formulate National Action Plans and designate National Anti-Trafficking Coordinators. Furthermore, an EU-wide annual data collection on trafficking cases will be mandatory. These changes aim to address the evolving challenges in trafficking and exploitation effectively.

Proposal: On the 19th of December 2022, the European Commission published a Proposal for a Directive amending Directive 2011/36/EU on preventing and combating trafficking in human beings and protecting its victims (press release).

Problem: Human trafficking for purposes other than sexual and labour exploitation has become more prominent over time. Advances in technology allow traffickers to recruit, advertise and exploit their victims remotely and to distribute exploitative material online. These same technological means make it more difficult to detect the crime, identify the perpetrators and trace the money used to commit the crimes and the profits made from the crimes. Although there is currently a regime of sanctions against legal persons, it does not sufficiently meet the objectives of the Anti-Trafficking Directive. Recent studies have shown that the demand for sexual services, cheap labour and products continues. In addition, a large proportion of trafficking cases go unreported. This is one of the factors preventing a comprehensive understanding of the extent of trafficking in the EU.

Objective: The Commission attempts to address the challenges posed by the increasing digitalisation of trafficking in human beings and to improve the criminal justice response to technology-enabled crimes. To this end, it is crucial to update the reference to tracing, freezing, managing and confiscating proceeds by explicitly referring to EU legislation on these issues. It shall be ensures that all member states establish national referral mechanisms through legislative or administrative provisions in order to streamline the functioning of relevant national bodies and to achieve further harmonisation of their structures and practices in referring victims to appropriate assistance and support systems. Offences against trafficking in human beings will be addressed by two different mandatory regimes, one for standard offences and one for serious offences. This would require member states to collect and report data on trafficking in human beings to the Commission on an annual basis.

Subject Matter: The Directive expects member states to take the necessary measures to ensure that a responsible legal person is subject to criminal or non-criminal fines and, where appropriate, sanctions, such as exclusion from entitlement to public benefits, aid, or subsidies and the temporary or permanent closure of establishments used for committing the offence. Member states shall take the necessary measures to ensure that their competent authorities have the power to trace, freeze, manage and seize the proceeds of crime and instrumentalities used to commit crime. The effectiveness of their systems for combating crime will be reviewed on the basis of statistical data. Member states shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than one year after its entry into force. They shall forthwith communicate to the Commission the text of those provisions.

European Commission Work Programme 2021

Follow-up protecting Health: Fighting the COVID-19-Pandemic

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Legislative procedure completed: On the 15th of June 2021 the Regulation on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic entered into force. Previously, on the 21st of May 2021, the Council and the European Parliament had reached a provisional political agreement (Press release). 
The Regulation will enter into force on 1 July 2021, with a phasing-in period of six weeks for the issuance of certificates for those member states that need additional time. The EU Digital COVID Certificate will be available, free of charge, in a digital and paper-based format, containing a digitally signed QR code. It will cover vaccination, test and recovery information, allowing member states to refrain from imposing additional travel restrictions on the holders of an EU Digital COVID Certificate. The Commission will also mobilise €100 million to support Member States in providing affordable tests.

Problem: In the light of the Covid-19 pandemic, the right to free movement within and outside of the member states has been severely restricted over the last two years. The Regulation lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. It further facilitates the progressive and coordinated lifting of restrictions imposed in accordance with the Union law by member states in order to limit the spread of SARS-CoV-2.

Objective: The COVID certificate will enable EU citizens to exercise their right to free movement during the COVID-19 pandemic. As a uniform attestation of vaccination, testing and/or the recovery status of the holder, it shall be valid in all of the member states, free of charge and accessible to all EU citizens.

Subject Matter: The vaccination certificate will contain information on the identification of the holder, the administered vaccine and its number of doses. Further metadata such as the certificate issuer and/or a unique certificate identifier will also be added. Similar to the vaccination certificate, the test certificate will hold identification information on the citizen, the test performed as well as metadata as insurance. Information about the holder and the certificate metadata, as well as information about previous SARS-CoV-2 infections following a positive test (also applies to rapid test) will be included in the recovery certificate.
After the official adoption of the proposed Regulation, it is expected to enter into force on 1st of July 2021. The Regulation is to apply for a period of 12 months from the date of entry, while a six-week phase-in period is intended to make it easier for member states to comply with the requirements of the Regulation. Hitherto, it is possible for member states to issue certificates that are not yet in compliance with this Regulation. Four months after the date of application, the Commission has to submit a report to the European Parliament and the Council. No later than three months before the end of the application, a second report on the lessons learned from the application, including its impact on the facilitation of free movement and data protection, taking into account the evolution of the epidemiological situation of the pandemic will be published by the Commission.

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Legislative procedure completed: On the 26th of March 2021, the Regulation establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 entered into force (press release).
As a response to the COVID-19 pandemic, the EU4Health Programme was adopted to reinforce crisis preparedness in the EU and contribute to building stronger, more resilient and more accessible health systems. Specifically, the EU4Health programme provides a budget of 5.3 billion euro during the 2021-27 period. The fund will be invested in four health areas to improve and foster health, protect people, allow access to medicinal products, medical devices and crisis-relevant products and strengthen health systems in EU’s member states.

Proposal: On 28 May 2020, the European Commission published a Proposal for a Regulation establishing a Programme of Union action in the field of health ("EU4Health Programme") for the period 2021-2027 and repealing Regulation (EU) No 282/2014.

Problem: The COVID-19 pandemic, which is one of the biggest challenges the world has been faced with, highlighted EU’s deficiencies in effective decision-making. Particularly due to the member states’ tendencies to act alone, the Commission demands the prioritization and coordination of the health systems within all member states in order to provide a state of the art health care, prepared to deal with unforeseeable health threats in line with the International Health Regulations (IHR).

Objective: The current Programme shall complement actions previously taken by the member states for the improvement of people’s health throughout the Union as well as ensure a high level of human health protection in all Union policies and activities. The promotion of health in the Union is essential for reducing the burden of communicable and non-communicable diseases. Further, reducing health inequalities, promoting healthy lifestyles and enabling access to healthcare are some of the objectives. The Regulation aims to protect Union citizens from serious cross-border threats to health and ensure the responsiveness and coordination of member states' health systems. Additionally, the availability, accessibility and affordability of medicines, medical devices and crisis-related products within the EU should be improved, contributing to the development of better health systems, their resilience and resource efficiency.

Subject Matter: The Commission will strengthen the capability of the Union for prevention, preparedness and response to serious cross-border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, and data gathering and surveillance. Ensuring the availability of reserves of medical, healthcare and support staff in case of a crisis in addition to supporting actions to ensure appropriate availability, accessibility and affordability of crisis relevant products and other necessary health supplies have been planned. By supporting digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models and universal health coverage can enhance the effectiveness, accessibility, sustainability and resilience of health systems. Further, the EU aims to foster the prudent and efficient use of medicines, by encouraging a more environmentally friendly production and disposal of medicines and medical devices. The development, implementation and enforcement of Union health legislation as well as the deployment of high-quality, comparable and reliable data in order to underpin policy making and monitoring, and further promote the use of health impact assessments of relevant policies have been highlighted. Member states shall be reinforced to work in coordination with each other, particularly on the basis of their health systems, including in the implementation of high-impact prevention practices, and the scaling up networking through the European Reference Networks and other transnational networks. Lastly, EU will be globally contributing to international and global health initiatives.

European biomedical Research and Development

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Legislative, incl. impact assessment, Q4 2021.

European Health Data Space

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Legislative procedure completed: On the 15th of March 2024, the Proposal for a Regulation on the European Health Data Space was adopted (press release). The Proposal aims to prioritize citizens' control over their healthcare data and facilitate its use for research and public health purposes. The agreement reached by co-legislators establishes clear rules for accessing and utilizing health data across the EU, ensuring compliance with high data protection standards. Through the European Health Data Space, citizens will have seamless access to their health records, while healthcare professionals can access patient data for treatment, and research efforts can leverage data securely for innovation and public health initiatives.

Proposal: On the 3rd of May 2022, the European Commission published a Proposal for a Regulation on the European Health Data Space (press release).

Problem: When it comes to exercising the rights over their electronic health data, including accessing and transmitting their electronic health data nationally and cross-borders, natural persons face several difficulties. Although provisions of Regulation (EU) 2016/679 ensure the rights of natural persons over their data, including health data, are safeguarded, the uneven implementation and interpretation of the GDPR by member states creates legal uncertainties, resulting in barriers to secondary use of electronic health data. This results in difficulties for natural persons to benefit from innovative treatments, while policy-makers, due to barriers impeding access to necessary electronic health data, are not able to react effectively to a health crisis. Additionally, given different standards and limited interoperability, manufacturers of digital health products and providers of digital health services operating in one member state face barriers and additional costs when entering another one. Finally, in light of the COVID-19 pandemic, the necessity of ensuring timely access to personal electronic health data for health threats preparedness and response, as well as for treatment has been emphasised.

Objective: The Regulation aims to establish rules governing the European Health Data Space in order to protect natural persons’ access and control over their own health data. It is further crucial to improve the functioning of the single market for the development and use of innovative health products and services based on health data. Moreover, ensuring that researchers, innovators, policy-makers and regulators make the most of the available health data for their work, while preserving trust and security has been highlighted. Specific objectives aspire to empower natural persons through increased digital access to and control of their health data and support their free movement. Setting requirements specific to electronic health record (EHR) systems and obligations shall ensure that EHR systems placed on the market are interoperable, secure and respect the rights of natural persons regarding their health data. Lastly, a consistent and efficient framework for the secondary use of natural persons’ health data for research, innovation, policy-making, official statistics, patient safety or regulatory activities is envisaged.

Subject Matter: With this Regulation, the European Health Data Space (‘EHDS’) is established. Rules, common standards and practices, infrastructures and a governance framework for the primary and secondary use of electronic health data are provided in the document in order to better protect the rights of natural persons in relation to the availability and control of their electronic health data. Presented rules address the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union. Additional rules and mechanisms will support the secondary use of electronic health data. A mandatory cross-border infrastructure is established, enabling the primary use of electronic health data across the Union. This Regulation specifically applies to manufacturers and suppliers of EHR systems and wellness applications placed on the market; controllers and processors established in the Union processing electronic health data of Union citizens and third-country nationals legally residing in the territories of member states; and to data users to whom electronic health data are made available by data holders in the Union.

Follow-up Initiatives under the New Pact on Migration and Asylum

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Non-legislative Act: On the 29th of September 2021, the EU Commission published a Communication about a renewed EU action plan against migrant smuggling (Press release).

Problem: The rise of migrant smuggling, particularly the instrumentalisation of migration for political purposes, demands a new strategy from the EU as well as the member states in order to protect EU’s external borders, reduce human trafficking, and protect the fundamental rights of the people concerned.

Objective: With the 2021-2025 Action Plan, the Commission aims to build on the successes of the first EU Action Plan (2015-2020) in order to obstruct current smuggling strategies. In addition to the transition of smuggling networks from ‘low risk, high return’ into ‘high risk, low return’ that was established by the first action plan, better regulations of migration are required. Several priorities were presented by the Commission for tackling migrant smuggling, these include: reinforced cooperation with partner countries and international organisations, implementing the legal frameworks and sanctioning smugglers active within and outside the EU, preventing exploitation and ensuring the protection of migrants, reinforcing cooperation and supporting the work of law enforcement and the judiciary to respond to new challenges, and improving the knowledge on smugglers’ modi operandi.

Subject Matter: Operational partnerships with third countries along migratory routes and international organisations such as UNODC and Interpol will be shaped through operational, legal, diplomatic and financial tools. This will enable the Commission to better enforce the Anti-trafficking Directive and the Residence Permit Directive. After the report on the implementation of the Facilitators package in 2023, further action will be considered. In the first half of 2022, the Commission plans to propose a complete digitalisation of the visa procedure jointly with finalising the negotiations on the Screening Regulation and adopting the Eurodac Regulation as a matter of priority. Additionally, it calls on Frontex to further reinforce its capacity to monitor designated maritime areas and identify suspicious vessels, and in cooperation with Europol and Eurojust, to further support partner countries to identify digital smuggling. Ultimately, the development of new technologies, including that of artificial intelligence, and regular reports on migrant smuggling by Frontex and Europol, can help deter human trafficking.

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Non-legislative Act: On the 27th of April 2021 the EU Commission published a Communication regarding an EU Strategy on voluntarily return and reintegration (Press release).

Problem: Being part of the European Commission's New Pact on Migration and Asylum, a common EU approach for returns is an essential component of a comprehensive and integrated migration management system. Considering however that only about a third of the people ordered to leave the EU effectively do so, the Commission is committed to implement a new strategy to enforce the return and reintegration of migrants.

Objective: The Communication advocates for the voluntary return of migrants as well as improved and effective reintegration measures in the countries of return. A humane, effective and sustainable return of irregular migrants is key to promoting trust in the system, making it more credible and efficient. Through a common and ambitious reintegration policy, the EU intents to help overcome the socio-economic and psychosocial difficulties migrants face when returning to their community, thus making their return more sustainable. Future prospects for the returnee and their local community will be fostered by reinforcing the cooperation between national and local authorities, host communities and the civil society. Reintegration can in turn lead to new partnerships and promote more comprehensive development strategies in partner countries. The Commission aims to assist the member states to a more consistent and coordinated approach, fully exploiting the potential of voluntary return and reintegration as well as establishing closer links with development initiatives and national strategies in partner countries. Overall, the strategy aspires to increase the effectiveness and sustainability of the common EU return system for the benefit of returnees, the EU and partner countries.

Subject Matter: In order to implement this strategy, the Commission, in cooperation with the Council and the European Parliament, will work on concluding negotiations on the various elements of the new package including but not limited to the Eurodac Regulation. The commission requires Frontex to carry out more return operations and to take over the activities of the European Return and Reintegration Network by mid-2022. It further recommends a cooperation between member states and Frontex in the areas of voluntary return and the first steps towards reintegration. The close partnership between the Commission and the High Representative in the partner countries concerned is intended to ensure coordination between all participants. The Return Coordinator and the High Level Network for Return shall be responsible for ensuring that member states' actions in the field of voluntary return and reintegration are coherent and coordinated. Moreover, with the support of Frontex information tools at EU level, such as the List of Return and Reintegration Assistance Inventory, should be optimized. To foster ownership of reintegration by partner countries, the Commission, together with all stakeholders, will collaborate with authorities and local communities of those countries in planning and implementing reintegration programmes. The Commission will support the strengthening of third countries’ capacity to provide voluntary return and reintegration services. Finally, the Commission will further support research on voluntary return and take into account the objectives of this strategy in member states' multiannual programmes under the Asylum, Migration and Integration Fund.

Schengen Package

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Non-legislative Act: On the 2nd of July 2021 the EU Commission published a Communication regarding a strategy towards a fully functioning and resilient Schengen area (Press Release).

Problem: A series of crises and challenges in the last decade, including the 2015 "refugee crisis" and the persistent terrorist threat on European soil, have led to internal border controls being reintroduced in a number of member states, undermining the core idea of the Schengen area. Furthermore, faced with the Covid pandemic, more member states were prompted to reintroduce internal border controls, jeopardising the proper functioning of the Single Market. Given that the Schengen area is one of the biggest achievements of European integration and has a fundamental role in the European Union’s construction, the Commission developed a strategy optimizing the functioning of the Schengen area.

Objective: The Commission aims to strengthen the three key pillars of the Schengen area, i.e. effective external border management, measures to compensate for the absence of controls at internal borders and robust governance, for new challenges ahead. Accordingly, new measures are needed to protect the integrity of the Schengen area and further improve its functioning. In order to guarantee freedom, security and justice, the EU is required to take effective action particularly in the areas of security, police and judicial cooperation as well as migration. Through the operational cooperation and information exchange between police and judicial authorities in criminal matters as well as measures in the fields of visa and return policy, the effective exercise of the fundamental freedoms within the European Union will be ensured. Additionally, increased political dialogue, better monitoring, enforcement of the Schengen legal framework and a strong governance system equipped to deal with future Schengen-wide challenges, can compensate for the absence of controls at internal borders as well as foster trust between member states.

Subject matter: The Commission will present several proposals for regulations in the areas of border management and visa procedures in the period of 2021 and 2023. A guidance on the systematic checks against relevant databases at entry and exit of the Schengen area, as well as model provisions on the exchange of information on situational awareness to be used in bilateral and multilateral agreements with third countries, will also be provided. Other proposals, such as the legislative proposal for an EU Police Cooperation Code, have also been planned. In the light of global digitalisation, the use of technologies as alternative to border controls is to be examined and the Handbook on the European Arrest Warrant is to be modernised. Moreover, the Commission will present a proposal for a Regulation to revise the Schengen Evaluation and Monitoring Mechanism. Organising Schengen Forums and annual "State of Schengen Reports", the Commission will evaluate previous activities and possibly optimise them with new measures. By presenting a Communication on the lessons learned from the Covid pandemic, the EU will be able to codify new guidelines and recommendations in the Practical Handbook for Border Guards. The proposal for a regulation amending the Schengen Borders Code and the establishment of an emergency plan for better crisis management are also foreseen

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Proposal: On the 2nd of June 2021 the EU Commission published a Proposal for a Council Regulation on the establishment and operation of an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing Regulation (EU) No 1053/2013 (Press release) .

Problem: In the light of new challenges such as the instability in Europe’s neighbourhood and beyond, the 2015 refugee crisis and its consequences, the persistent terrorist threat and the COVID-19 pandemic, the EU's Schengen area has been put under sustained pressure. A new Schengen Strategy tackling the vulnerability around the European borders is needed in order to adequately promote the significant social and economic benefits that were once established by the ‘Schengen Agreement’.

Objective: The Proposal aims to ensure a strengthened and a more resilient Schengen area that does not have internal border controls, while also optimising the governance and surveillance structures. Through the revision of the Schengen evaluation and monitoring mechanism, the absence of controls at internal borders will be compensated, the free movement facilitated and a high level of security and justice ensured. In doing so, the mechanism may promote mutual trust between member states. This, in turn, should contribute to an improved performance within the Schengen area as well as tackle current challenges faced by the EU. The new Mechanism should carry out impartial and objective evaluations that are able to identify deficiencies in the application of the legislation in practice and ensure that those deficiencies are swiftly addressed. Following an evaluation programme from 2015-2019, significant weaknesses in the Mechanism that were identified - including the excessively long duration of the evaluation process (10-12 months) and the time needed by Member States to implement the recommendations (two years)- will be addressed by the new evaluation and monitoring mechanism.

Subject Matter: The Commission shall establish annual and multiannual evaluation programmes, the drafting of questionnaires, the setting of schedules of visits, the conducting of visits, the drafting of evaluation reports and recommendations as well as ensure the follow-up and monitoring activities. Through the cooperation between the Commission and the member states the implementation of the new Regulation can be optimised. The evaluation and monitoring mechanism will be carried out with the contribution of the relevant Union bodies, offices and agencies in accordance with their respective mandates. Additionally, member states are required to grant full and unimpeded access to all areas, premises and documents to which access has been requested, including national and internal guidelines and instructions, also classified ones. The implementation of the Regulation will be further facilitated though expertise, risk analysis, reports and other relevant information provided by Frontex and Europol.

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Proposal: On the 14th of December 2021 the EU Commission published a Proposal for a Regulation amending Regulation (EU) 2016/399 on a Union Code on the rules governing the movement of persons across borders (Press release).

Problem: In the light of numerous crises such as the persistent terrorist threat following a spate of attacks on European soil and the prevailing Covid-19 pandemic, member states have been quick to reintroduce internal border controls, jeopardising the proper functioning of the Single Market. An amendment to the Regulation on ‘Schengen Borders Code’ is proposed with the idea to strengthen EU’s capacity to respond in a uniform manner to major public health threats, to threats resulting from instrumentalisation of migrants as well as to terrorism threats.

Objective: The Proposal aims to establish a uniform application of measures at the external borders in case of a threat to public health by adopting a binding instrument that would set out temporary travel restrictions at the external borders in such circumstances. Further the instrumentalisation of migrants at external borders asks for a unified response as well as a coherent approach when taking measures needed to manage the arrival of persons being instrumentalised by a third country in a humane, orderly and dignified manner. In order to ensure that internal border controls remain a measure of last resort, the proposal clarifies and expands the list of elements that must be assessed by a member state when taking the decision on temporary reintroduction of border controls. Likewise, it supports the creation of a contingency planning for Schengen in the situation of a threat affecting a majority of member states at the same time. To limit the negative impact of the temporary reintroduction of border checks at internal borders, safeguards and mitigating measures should be applied in addition to alternative measures to address the identified threats instead of internal border controls.

Subject Matter: Amending the Regulation (EU) No 2016/399, definitions for certain concepts such as ‘border surveillance’ and ‘instrumentalisation of migrants’ have been added in order to assure the perception uniformity of the member states. Border surveillance has further been added to the Regulation with the objective to detect and prevent unauthorised border crossings, to counter cross-border criminality and to take measures against persons who have crossed the border illegally. Restriction on travel to the EU shall be applied to situations where the European Centre for Disease Prevention and Control or the Commission identify the existence in one or more third countries of an infectious disease with epidemic potential. The absence of border control at internal borders shall not affect the exercise of police or other public powers by the competent authorities of the member states in their territory, including in their internal border areas, as conferred on them under national law, insofar as the exercise of those powers does not have an effect equivalent to border checks. The temporary reintroduction of internal border controls will be limited to specific parts of internal borders that are at risk of a serious threat to public policy or internal security. The criteria allowing the reintroduction or prolongation of internal border controls are set out by the Commission and include the scope of the perceived threat, the absence of other measures as well as further relevant data detailing the events that constitute a serious threat to its public policy or internal security.

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Legislative procedure completed: On the 13th of June 2023, the European Parliament and the Council reached a provisional agreement on the digitalisation of Schengen visa applications (press release). Through the establishment of an EU online Visa application platform, the visa sticker and application will now be digitalised.

Proposal: On the 27th of April 2022 the European Commission published a Proposal for a Regulation amending Regulations (EC) No 767/2008, (EC) No 810/2009 and (EU) 2017/2226 of the European Parliament and of the Council, Council Regulations (EC) No 1683/95, (EC) No 333/2002, (EC) No 693/2003 and (EC) No 694/2003 and Convention implementing the Schengen Agreement, as regards the digitalisation of the visa procedure (press release).

Problem: Considering that the EU common visa policy is an essential element in ensuring the security and proper functioning of the external borders of the Schengen area, reforms within the system are needed in order to resolve the difficulties related to the visa application process. Lengthy process and accumulating costs for consulates to manage, process and archive (and eventually destroy) paper documents, a paper-based process that is neither threat nor risk-proof, a physical visa sticker that is prone to falsification as well as the payment of additional fees for travel (to the nearest consulate or visa application centre) or when applying through an external service provider, are some of issues identified by the Commission. Additionally, the current fragmentation in terms of national practices for managing the application process negatively affects the functioning of the EU Visa policy applied and the perception of the European Union as a single geographical entity.

Objective: The Commission primarily aspires to promote the digitalisation of public services, including the EU visa policy, making Europe fit for the digital age. Moreover, in order to contribute to a secure, safe and resilient EU and to make the EU a more attractive destination for travellers, enhancing its perception as a single geographical entity a common visa policy is pursued. Specific objectives include the modernization, simplification and harmonizing of the visa application process for member states and TCNs, the risk reducing of (identity) fraud, forgery, and facilitation of the verification process at the border through digitalisation as well as the creation of a single EU Visa application platform and the implementation of a digital visa instead of a visa sticker.

Subject Matter: Member states shall separately establish management and control systems for their programmes as well as ensure the quality and the reliability of the monitoring system and of data on indicators, in accordance with the Common Provision Regulation (CPR). Additionally, they shall send each year an assurance package, which includes the annual accounts, the management declaration and the audit authority's opinions on the accounts, the management, and control system and the legality and regularity of the expenditure declared in the annual accounts. Under the CPR as part of the Integrated Border Management Fund, the instrument for financial support for border management and visa will be managed. The Directorate-General for Migration and Home Affairs (DG HOME) will continue to apply its Anti-Fraud Strategy in line with the Commission's Anti-Fraud Strategy (CAFS) in order to ensure inter alia that its internal anti-fraud related controls are fully aligned with the CAFS and that its fraud risk management approach is geared to identify fraud risk areas and adequate responses.

Follow-up to the EU Security Strategy

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Non-legislative Act: On the 14th of April 2021 the EU Commission published a Communication regarding an EU Strategy to tackle Organised Crime (Press release).

Problem: Due to its complex nature, organised crime poses a significant threat to European citizens, business, state institutions, and to the economy. Although national measures currently applied by the member states are crucial to combat crime, a common Union strategy can better address the challenges of organised crime given that it is operating cross-border and online, across all areas of crime in a networked environment, using the newest technologies, and threatening EU’s security as a whole.

Objective: By promoting cooperation between law enforcement and judicial authorities within the member states, the exchange and timely access of information needs to be facilitated. Multidisciplinary and multiagency operational cooperation globally, particularly in areas with no internal border controls such as freedom, security and justice, should contribute to the dismantling of global criminal networks as well as their transport routes. The Communication highlights the need to tackle organised crime structures, thus not only investigate low level criminals, but also weaken the entire network or rather 'the criminal ecosystem'. Reinforcing asset recovery measures is necessary in order to prevent money laundering, the promotion of financial investigations and the penetration of profits from organised crime into the economy and society. In light of the current digitization trend, the EU plans on upgrading its law enforcement and justice departments with new technologies.

Subject Matter: The Commission will initiate four new proposals, including the launch of a platform for cooperation between Joint Investigation Teams. The cooperation with various stakeholders to optimise the European Multidisciplinary Platform against Criminal Threats (EMPACT) and new measures to combat international crime are meant to be generatred between 2021 and 2025. The financial resources needed to combat organized crime are to be increased through the Internal Security Fund for the period 2021-2027. In 2022, an EU anti-counterfeiting toolkit will be established setting out principles for joint action, cooperation and data sharing among law enforcement authorities, right holders and intermediaries. In the same year, a further action plan against trafficking of cultural goods will be encouraged. Through the revision of Confiscation Directive and the Council Decision on Asset Recovery Offices as well as the assessment of existing EU anti-corruption rules, the Commission intends to strengthen its crime prevention network. Additionally, the EU is determined to cooperate and exchange information on the link between corruption and organised crime including through Europol. By cooperating with member states new measures will be evaluated to address lawful and targeted access by law enforcement authorities to encrypted information in the context of criminal investigations. Similarly, the involvement of member states in the Digital Exchange of Electronic Evidence (e-EDES) system will optimise the fight against crime, particularly on the ‘Darknet’, thus it is essential for the EU to develop a common surveillance tool.

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Proposal: On the 11th of May 2022 the European Commission published a Proposal for a Regulation laying down rules to prevent and combat child sexual abuse (press release).

Problem: In order to ensure the protection of children both offline and online, detection and reporting of as well as the support to victims of child sexual abuse are crucial. Considering that at least one in five children falls victim to sexual violence during childhood, the EU is currently still failing to protect children, with the online dimension representing a particular challenge. While member states have started preparing and adopting national rules to fight against online child sexual abuse, uniform Union rules on the detection, reporting, and removal of online child sexual abuse are necessary to adequately protect the children.

Objective: The Proposal primarily aims to guarantee children’s fundamental rights to care and to protection of their well-being, mental health and best interest, and support the general public interest to effectively prevent, investigate and prosecute the perpetration of the serious crime of child sexual abuse. Establishing a clear and harmonised legal framework on preventing and combating online child sexual abuse shall allow legal certainty to providers as to their responsibilities to assess and mitigate risks and, where necessary, to detect, report and remove such abuse on their services in a manner consistent with the fundamental rights laid down in the Charter and as general principles of EU law. A European Centre shall be developed in order to prevent and counter child sexual abuse (‘the EU Centre’) to facilitate and support implementation of this Regulation and thus help remove obstacles to the internal market, especially in connection to the obligations of providers under this Regulation to detect online child sexual abuse, report it and remove child sexual abuse material.

Subject Matter: The EU Center shall create, maintain and operate databases of indicators of online child sexual abuse that providers will be required to use to comply with the detection obligations. The EU Centre shall carry out certain complementary tasks, such as assisting competent national authorities in the performance of their tasks under this Regulation and providing support to victims in connection to the providers’ obligations. Additionally, it shall use its central position to facilitate cooperation and the exchange of information and expertise, including for the purposes of evidence-based policy-making and prevention between all parties involved. The monitoring of the implementation of the regulation shall be in jurisdiction of the EU Centre (along with service providers and Coordinating Authorities) that shall collect and analyse data relevant for measuring the effectiveness of the detection, reporting, and removal obligations. The data collected by the EU Centre shall be made available to the Coordinating Authorities and to the Commission. To help ensure that the database is prepared by the entry of this Regulation, the Commission has already made funding available to member states.

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Nicht-legislativer Akt: Am 9. Dezember 2020 hat die Europäische Kommission eine Mitteilung über eine EU-Agenda für Terrorismusbekämpfung: antizipieren, verhindern, schützen und reagieren veröffentlicht (Pressemitteilung).

Problem: Die dschihadistische Bedrohung durch oder inspiriert von Daesh, al-Qaeda und deren Verbündeten besteht weiterhin, und die Bedrohung durch gewalttätige Rechts- und Linksextremisten nimmt zu. Zudem hat sich die Art der Anschläge verändert. Angesichts des länderübergreifenden Charakters solcher Gewalttaten drängt die Kommission auf Maßnahmen auf EU-Ebene auf der Grundlage einer verstärkten Zusammenarbeit zwischen den Mitgliedstaaten und den EU-Institutionen.

Ziele: Das Hauptziel der Mitteilung besteht darin, die pluralistische Gesellschaft der EU, ihre gemeinsamen Werte und die europäische Lebensart zu bewahren, indem den Bürgern ermöglicht wird, sich in ihren eigenen Häusern und Straßen sowie im Internet sicher zu fühlen. Daher ist es wichtig, sich auf Bedrohungen durch neue und aufkommende Technologien vorzubereiten, wie z.B. die böswillige Nutzung von Drohnen, künstlicher Intelligenz und chemischem, biologischem, radiologischem und nuklearem Material. Die Union wird ihre kollektive Arbeit verstärken müssen, insbesondere um der Anziehungskraft extremistischer Ideologien entgegenzuwirken und die von Terroristen anvisierten öffentlichen Räume besser zu schützen. Außerdem müssen die Strafverfolgungs- und Justizbehörden in der Lage sein, das Recht sowohl im Offline- als auch im Online-Umfeld durchzusetzen.
Zu den spezifischen Zielen gehören die Antizipation bestehender und neu entstehender Bedrohungen, die Verhinderung von Anschlägen, der wirksame Schutz der Europäer und schließlich eine angemessene Reaktion auf solche Anschläge. Es ist von entscheidender Bedeutung, Radikalisierung und extremistische Ideologien anzugehen und besser zu bekämpfen, bevor sie Wurzeln schlagen. Die Optimierung kritischer Infrastrukturen sowie die Zusammenarbeit mit Europol und Eurojust können Schutz bieten und zusätzlich den richtigen Rechtsrahmen schaffen, um die Täter vor Gericht zu bringen und zu gewährleisten, dass die Opfer die Unterstützung und den Schutz erhalten, den sie benötigen.

Gegenstand: Risikobewertung und Peer-Review-Aktivitäten sowie die Finanzierung der EU-Sicherheitsforschung werden die Fähigkeit der EU zur Früherkennung stärken. Die Kommission wird einen Rechtsakt über digitale Dienste vorschlagen und in Zusammenarbeit mit Europol Leitlinien für die Umsetzung des EU-Krisenprotokolls bereitstellen. Die Mitgliedstaaten sollen dabei unterstützt werden, eine strategische Kommunikation zu entwickeln und die Verbreitung von Gegen- und Alternativnarrativen zu verstärken. Darüber hinaus müssen sie Lücken und Unzulänglichkeiten bei der Umsetzung der einschlägigen Rechtsvorschriften zügig beseitigen und an den Außengrenzen systematische Kontrollen aller Reisenden anhand einschlägiger Datenbanken sicherstellen. Die Schaffung eines Netzes von Finanzermittlern für die Terrorismusbekämpfung wird die grenzüberschreitenden Finanzermittlungen verbessern. Die Aushandlung internationaler Abkommen mit den Ländern der südlichen Nachbarschaft über den Austausch personenbezogener Daten mit Europol und die Stärkung der Zusammenarbeit mit den westlichen Balkanländern im Bereich der Schusswaffen können die europäische Sicherheit weiter erhöhen.

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Proposal: On the 25th of May 2022, the European Commission published a Proposal for a Directive on asset recovery and confiscation (press release).

Problem: Currently, organised crime is one of the highest threats to the European Union’s security. Nevertheless, asset recovery systems in member states are not well-equipped to deal effectively with the complexity of criminal organisations. National authorities have limited ability to quickly locate, identify and freeze assets. Inefficient management of frozen assets means that they lose value before a decision is made to confiscate them, and existing confiscation tools do not cover all high-revenue criminal markets and are not adapted to the complexities of structures and methods of criminal organisations.

Objective: The capabilities of competent authorities shall be strengthened to facilitate the identification as well as the freezing and manage of assets. Furthermore, it is crucial to strengthen and expand confiscation capacities to cover all relevant criminal activities of organised crime groups. This Directive aims to improve cooperation between all authorities involved in asset recovery. Finally, there is a need for a more strategic approach to asset forfeiture through a stronger commitment of these authorities to achieve common goals in this area.

Subject Matter: In order to facilitate the effective implementation of Union restrictive measures in all member states, the proposed Directive contains provisions to enable the swift tracing and identification of property held or controlled by persons or entities subject to such measures, including through cooperation with third countries. The proposed rules allow for a streamlined framework for tracing and identifying, freezing, confiscating and managing assets in criminal proceedings. This Directive also lays down rules to facilitate the effective implementation of Union restrictive measures and the subsequent confiscation of related assets where this is necessary for the prevention, detection, or investigation of criminal offences related to breaches of Union restrictive measures. Offences include participation in a criminal organisation, terrorism, trafficking in human beings, sexual exploitation of children and child pornography, trafficking in narcotics and psychotropic substances, and corruption. This provision sets out the specific tasks of asset recovery offices, including the exchange of information with other asset recovery offices in other member states, including in relation to the prevention, detection and investigation of violations of Union restrictive measures. It also entrusts the asset recovery offices with the task of tracing and identifying assets of persons and entities subject to Union restrictive measures. In this context, the offices will also be empowered to take emergency measures to temporarily freeze the assets in question. Each member state shall designate at least one asset management unit for the management of frozen and confiscated assets. These offices shall ensure the efficient management of frozen and confiscated assets either by directly managing frozen and confiscated assets or by providing support and expertise to other competent authorities responsible for managing frozen and confiscated assets. They shall also assist authorities responsible for the management of frozen and confiscated assets with pre-seizure planning and cooperate with other competent authorities responsible for tracing and identifying, freezing and confiscating assets in accordance with this Directive. Finally, cooperation between asset recovery offices and other competent authorities responsible for the management of frozen and confiscated assets in cross-border cases is encouraged.

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Proposal: On the 8th of December 2021 the EU Commission published a Proposal for a Council Recommendation on operational police cooperation (Press release) .

Problem: Taking advantage of the natural delineations of individual law enforcement jurisdictions, criminals have been operating across member states unabated, stimulating unauthorised movements of irregular migrants and evolving into an increasingly complex security threat. In the light of the tragic events in the Channel, the Commission deems it necessary to opt for a strong police cooperation between the member states, improving the use of police checks, procedures allowing for simplified readmission between the states as well as the application of bilateral agreements in that context.

Objective: The main objective of the Commission's proposal is to establish a Police Cooperation Code with the objective of streamlining, enhancing, developing, modernising and facilitating law enforcement cooperation between relevant national agencies as a way to support member states in their fight against organised crime and terrorism. In compliance with existing EU legislation, and building on best practice in bilateral or multilateral cooperation agreements between member states, police officers should carry out targeted joint operations, better monitor criminals, as well as be able to apprehend criminals in pursuits across national territories. Furthermore, remote access by police officers to their own databases during operating in other member states, as well as the use of secure communications that also function in a cross-border context, will be made possible. Broadening the role of existing Police Customs Cooperation Centres, joint police stations that are capable of not only exchanging information, but of planning, supporting and coordinating joint patrols and other joint operations based on shared risk analysis, should be constituted.

Subject Matter: To achieve the objectives, a coordination platform is to be established in cooperation with the Commission and Europol. In addition, member states should allow for the conduct of cross-border hot pursuits into their territory across land, sea, river, lake and air borders as well as collect statistics that their competent law enforcement authorities conducted and report those statistics annually to the European Parliament, the Council and the Commission. In the area of surveillance, the Commission encourages member states to allow the conduct of cross-border surveillance into their territory in relation to persons suspected of having committed or participated in one or more of criminal offences, but also to persons that can lead to the identification or the tracing of such suspects. It further advocates for the facilitation of the pooling of material, including through short or long-term loans based on jointly agreed procedures. Joint cross-border operations to counter migrant smuggling and human trafficking can be achieved by expanding the current tasks of member states’ existing Police and Customs Cooperation Centres through carrying out, supporting, and coordinating joint operations in intra-EU border areas as well as producing joint analysis of cross-border crimes specific to their intra-EU border area.

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Legislative procedure completed: On the 10th of May 2023, Directive (EU) 2023/977 on the exchange of information between the law enforcement authorities of Member States and repealing Council Framework Decision 2006/960/JHA was adopted (press release). With the Directive in place, Single Points of Contact (SPoC) are established in each member states, responsible mor managing requests and information. Depending on the request and the accessibility oft he information, time limits that do not exceed seven calendar days are set.

Proposal: On the 8th of December the EU Commission published a Proposal for a Directive on information exchange between law enforcement authorities of member states, repealing Council Framework Decision 2006/960/JHA (Press release) .

Problem: With the growing mobility within the Schengen area, a series of crises and challenges preventing and fighting criminal threats have led several member states to reintroduce internal border controls. The combined introduction of police checks and cooperation with regard to information exchange and communication is said to have the potential to yield the same results in controlling secondary movements as temporary internal border controls, while being less intrusive of the free movement of persons, goods and services. Protecting a fully functioning and resilient Schengen area is of utmost importance for the Commission.

Objective: Protecting a fully functioning and resilient Schengen area is of utmost importance for the Commission. It is necessary to make the organizational and procedural aspects of the exchange of information between law enforcement authorities in the EU more effective and efficient. A Union-wide Police Cooperation Code will be streamlining, enhancing, developing, modernising and facilitating law enforcement cooperation between relevant national agencies, supporting member states in their fight against organised crime and terrorism. Establishing common minimum standards for information exchange in areas of composition, structures, responsibilities, staffing and technical capabilities is encouraged as a way to ensure the efficiency of Single Points of Contact. With the lack of common practice in the use of existing communication channel(s) to exchange information within the EU in mind, a further objective of this proposal is to remedy the proliferation of communication channels used for law enforcement information exchange between member states while reinforcing Europol’s role as the EU criminal information hub for offences falling within its mandate.

Subject Matter: Common rules for the exchange of information between the law enforcement authorities of the member states where necessary concern requests for information submitted to the Single Points of Contact established or designated by the states. On the content of such requests, mandatory time limits for providing the requested information, reasons for refusals of such requests and the channel of communication to be used in connection to such requests are settled. Further, member states are encouraged to follow specific regulations on the establishment, tasks, composition and capabilities of the Single Point of Contact, including on the deployment of a single electronic Case Management System for the fulfilment of its tasks. While the Commission advocates for information exchange for the purpose of preventing, detecting or investigating criminal offences, it respectively discourages exchanges of information that are specifically regulated by other acts of Union law. Ultimately, the Directive establishes rules on the own-initiative provision of relevant information to Single Points of Contact or to the law enforcement authorities of other member states, in particular the situations and the manner in which such information is to be provided as well as the channel of communication to be used for all exchanges of information.

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Legislative procedure completed: On the 20th of November 2023, a political agreement was reached between the European Parliament and the Council on the Regulation on automated data exchange for police cooperation (Prüm II) (press release). The existing Prüm framework is now to be significantly improved by adding facial images and police records as well as by centralising data flows. This is intended to close information gaps and boost prevention, detection and investigation of criminal offences in the EU. To enter into force the agreement now needs to be formally adopted by the Council and the Parliament.

Proposal: On the 8th of December the EU Commission published a Proposal for a Regulation on automated data exchange for police cooperation (“Prüm II”), amending Council Decisions 2008/615/JHA and 2008/616/JHA and Regulations (EU) 2018/1726, 2019/817 and 2019/818 of the European Parliament and of the Council (Press release) .

Problem: While the EU has already provided law enforcement with a range of tools to facilitate the exchange of information, which have proven crucial in uncovering criminal activities and networks, there are still information gaps when it comes to the cross-border cooperation of law enforcement. Considering that certain data is stored separately in various national IT systems as well as in large-scale IT systems at the Union level, the communication between such systems needs to be optimized, enabling the exchange of data between law enforcement authorities in a timely manner. Therefore the Council invited the Commission to consider revising the Prüm Decisions with regards to the necessary technical and legal requirements.

Objective: Contributing to the internal security of the European Union, the general objective of the proposal is to improve, streamline and facilitate the exchange of information for the purpose of the prevention, detection and investigation of criminal and terrorist offences between member states’ law enforcement authorities as well as with Europol. The Commission explicitly aims to provide a technical solution for efficient automated exchange of data between law enforcement authorities to make them aware of relevant data that is available in the national database of another member state. Ensuring that more relevant data from national databases as well as from Europol’s databases is available to all competent law enforcement authorities in other member states is key to guaranteeing EU citizens’ security. Lastly, the specific policy objective of this proposal is to provide law enforcement authorities with efficient access to the actual data corresponding to a ‘hit’ that is available in the national database of another member state.

Subject Matter: Building on the existing Prüm framework, Prüm II is to reinforce and modernize the framework as well as allow the interoperability with other EU information systems. The following will enable the usage of all the relevant data that is available for law enforcement authorities in a member state by law enforcement authorities in other member states. With the creation of a new architecture, the exchange of data between member states is being facilitated, while a high level of protection of fundamental rights is ensured. Eu-LISA and Europol shall ensure that procedures are in place to monitor the development and the functioning of the router with regard to the technical output, cost-effectiveness, security and quality of service. No later than one year after the adoption of the proposed Regulation, and every year thereafter during the development phase of the router, eu-LISA shall submit a report to the European Parliament and to the Council on the state of the development of the router. No later than one year after adoption of the proposed Regulation, and every year thereafter during the development phase of EPRIS, Europol shall submit a report to the European Parliament and to the Council on the state of preparation for the implementation of this Regulation and on the state of the development of EPRIS. Two years after the start of operations of the router and every two years thereafter, eu-LISA shall submit to the European Parliament, to the Council and to the Commission a report on the technical functioning of the router while three years after the start of operations of all elements of the proposed Regulation and every four years thereafter, the Commission shall produce an overall evaluation of Prüm II. The Commission, then, shall transmit the evaluation report to the European Parliament, the Council, the European Data Protection Supervisor and the European Agency for Fundamental Rights.

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Legislative procedure completed: On the 14th of March 2024, the Proposal for a Regulation on import, export and transit measures for firearms, their essential components and ammunition, implementing Article 10 of the United Nations’ Protocol against the illicit manufacturing of and trafficking in firearms, their parts and components and ammunition, supplementing the United Nations Convention against Transnational Organised Crime (UN Firearms Protocol) (recast) was adopted (press release). The new EU regulations aim to curb firearms trafficking, a key facilitator of terrorism and organized crime, while simplifying the legal trade of firearms for legitimate purposes like hunting and sport shooting. These regulations include the establishment of a streamlined electronic licensing system, stricter checks on firearms components, and improved transparency through annual reports, all geared towards enhancing security and preventing illicit firearm movements within the EU. By harmonizing procedures and enforcing stricter standards, the regulations seek to mitigate the risk of firearms falling into the wrong hands and ensure responsible firearm ownership across member states.

Proposal: On the 27th of October 2022, the European Commission published a Proposal for a Regulation on import, export and transit measures for firearms, their essential components and ammunition, implementing Article 10 of the United Nations’ Protocol against the illicit manufacturing of and trafficking in firearms, their parts and components and ammunition, supplementing the United Nations Convention against Transnational Organised Crime (UN Firearms Protocol) (recast) (press release).

Problem: Illicit flows of firearms significantly facilitate serious and organised crime, including terrorism, by enabling violent actions to achieve criminal objectives, support illicit businesses, and protect these from competition. Furthermore, these illicit firearms exacerbate issues in other areas of organised crime, such as drug and human trafficking. It's estimated that in 2017, around 35 million illicit firearms were in civilian hands within the EU, constituting 56 per cent of the total estimated firearms, with illicit firearms outnumbering legally-held firearms in 12 EU member states. The current EU rules on the import, export, and transit of firearms, have shown gaps in effectively curbing the illicit trafficking of firearms, necessitating a more robust regulatory intervention.

Objective: The Proposal aims to significantly enhance the EU's regulatory framework on the import, export, and transit of firearms, their essential components, and ammunition, to combat and prevent their illicit trafficking more effectively. By introducing coordinated controls between member states and ensuring the traceability of firearms, it seeks to improve the detection of illicit firearms, components, and ammunition, and limit the import of semi-finished firearms and essential components to arms dealers and brokers only. Furthermore, it aims to clarify the roles of licensing authorities and bolster cooperation between law enforcement and licensing authorities in both import and export processes, thus enhancing the overall safety and security of the EU and its citizens by mitigating the risks associated with the illicit trafficking of firearms.

Subject Matter:  At the heart of the Proposal is the introduction of stringent requirements for the import, export, and transit of firearms and their components. The Regulation mandates that all firearms, including deactivated ones, must be properly marked and accompanied by deactivation certificates, as per EU standards, before being released into free circulation. This measure ensures that firearms are traceable and that their movement can be monitored effectively, thus reducing the risk of illicit trafficking. Moreover, the Proposal places restrictions on the import of semi-finished firearms and essential components, limiting such activities to licensed arms dealers and brokers. This is a significant step towards preventing the manufacture of untraceable "ghost guns" by individuals, which pose a considerable challenge to law enforcement agencies. Correspondingly, the regulation introduces checks on the criminal records of applicants for import authorisations through the European Criminal Records Information System (ECRIS) and mandates verification against the Schengen Information System to ensure that the imported firearms are not registered as lost, stolen, or sought for seizure. The Proposal also addresses the need for enhanced administrative cooperation and information exchange between competent authorities at both the national and EU levels. By establishing an electronic licensing system interconnected with the EU Single Window Environment for Customs, the regulation facilitates the swift and secure sharing of information related to the import and export of firearms. This digitalisation of procedures not only streamlines the administrative processes but also significantly reduces the administrative burden on economic operators, thereby promoting compliance and facilitating lawful trade. Another pivotal aspect of the proposal is the introduction of specific provisions for transit requirements, ensuring that firearms and their components originating from non-EU countries and destined for another non-EU country are subject to express authorisation by customs and competent authorities.

Follow-up to the European Education Area and the updated Skills Agenda

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Non-legislative Act: On the 10th of December 2021, the European Commission published a Proposal for a Council Recommendation on a European approach to micro-credentials for lifelong learning and employability (press release).

Problem: Today, people need to constantly update their knowledge, skills, and competences to bridge the gap between their education and training and the demands of a rapidly changing labour market. In addition, the COVID-19 pandemic has led to a rapid increase in demand for short, tailor-made learning opportunities. This demand for new forms of learning resulted in an increase in interest in 'micro-credentials' that certify the outcomes of these small learning experiences. However, the lack of a common definition of micro-credentials causes concerns about their value, quality, recognition, transparency as well as portability between and within education and training sectors, portability on the labour market and portability across countries.

Objective: The main aim is to expand learning opportunities for all and facilitate more flexible learning pathways throughout life, as well as to promote the right to timely and tailored support to improve prospects for employment or self-employment. Specific objectives presented in the proposal are: allowing people to acquire the knowledge, skills and competences they need to thrive in a changing labour market and society. They shall benefit fully from both a socially fair recovery from COVID-19 and just transitions to the green and digital economy. Providers of micro-credentials need more support to enhance the flexibility of the learning offer in order to empower people to forge personalised learning and career pathways. Inclusiveness and equal opportunities will be fostered, contributing to the achievement of resilience, social fairness and prosperity for all, in a context of demographic change and throughout all phases of economic cycles.

Subject Matter: Member states are invited to apply a common EU definition, standards, and basic principles for the design, issuance, and transferability of micro-credentials. They should develop the micro-credential ecosystem and use the potential of micro-credentials to support lifelong learning and employability. The ongoing and emerging development of micro-credentials should be facilitated in formal learning environments. Therefore, member states need to support higher education institutions to explore the role of micro-credentials by developing an attractive, inclusive and learner-centred range of lifelong learning activities, including through the activities of the European Higher Education Alliances. In addition, the ongoing and emerging development of micro-skills in non-formal and informal learning environments will be supported, including by promoting the provision and design of micro-skills through the allocation of public funds. The Commission will develop and adapt existing Union tools and services to support development of micro-credentials by all types of providers. This Recommendation shall be implemented by the member states as soon as possible. Finally, they will have to submit a plan setting out the corresponding measures to be taken at national level to support the achievement of the objectives of the Recommendation by 2025.

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Proposal: On the 10th of December 2021, the European Commission published a Proposal for a Council Recommendation on individual learning accounts (press release).

Problem: As previous initiatives have proven insufficient to substantially increase adult participation in continuing education and to close the gaps in support for access to continuing education, a completely new approach to lifelong learning is needed. Although the situation varies between member states, they all face similar challenges: Individuals do not receive sufficient financial support for continuing education, including for overcoming barriers to continuing education, and there is a lack of motivation to take up continuing education. For individuals, these problems lead to a higher risk of unemployment, lower wages and lower job satisfaction. In turn, companies face lower productivity. This results in lower GDP and lower resilience of the economy as a whole.

Objective: This Recommendation aims to support member states' efforts to enable more adults to engage in further learning in order to increase participation rates and reduce skills gaps. In doing so, it contributes to the EU's goal of promoting a highly competitive social market economy aiming at full-employment and social progress. All working-age adults should have access to continuing education, including for career transitions and regardless of their employment or occupational status, and be given more incentives and motivation to continue learning. Member states need to set up individual learning accounts to enable individuals to participate in training relevant to the labour market, and to establish a framework including guidance and validation opportunities to encourage the effective take-up of such training.

Subject Matter: Adequate annual provision must be accumulated for each individual learning account and used over a period of time to provide more extensive training. Member states must provide additional individual training entitlements for the accounts of those most in need of training or retraining. In addition, employers are encouraged to provide additional individual training entitlements for the individual learning accounts of their employees and others working in their industrial value chain. The availability and accessibility of career guidance services and validation opportunities, in person or online, must be ensured for each individual learning account holder, free of charge or through the use of their individual training entitlements. Furthermore, it is crucial that member states monitor and evaluate the functioning of individual learning accounts and the related framework and make adjustments where necessary in order to achieve the objective of this Recommendation in the most efficient way. Finally, the Commission shall evaluate the implementation of this Recommendation, in cooperation with the member states and after consulting the social partners and relevant stakeholders, and report to the Council within five years of its adoption.

EU Strategy on Combating Antisemitism

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Non-legislative Act: On the 5th of October 2021 the EU Commission published a Communication regarding an EU Strategy on Combating Antisemitism and Fostering Jewish Life (Press release) .

Problem: The Jewish community in Europe has continuously become a victim of harassment and discrimination. In the past decade, there has been a rise in antisemitism within the Member States, leading to several instances of hate speech, hate crimes, attacks on Jewish people, their properties, and institutions. Given that core European values such as the rule of law and respect for human rights are being disregarded through antisemitism, the Commission developed a strategy combatting hateful crimes and discrimination against the Jews.

Objective: The Communication demands a new strategy in the timeframe of 2021-2030 for combating all forms of antisemitism including but not limited to antisemitic incitement, hate crime and discrimination in all policy areas as well as in everyday life. In the course of promoting Jewish life in the EU and as part of the new Security Union strategy, extremism directed against Jews should be countered. Freedom of religion and belief are some of the areas in which the Jewish minority faces disadvantages and therefore needs a clear protection strategy. Optimizing education, research and remembrance, particularly with regard to the history of antisemitism in Europe, including the Holocaust, can further promote equality.

Subject Matter: The Commission will foster an annual civil society forum on combating antisemitism, where stakeholders and representatives of the Jewish community will identify measures required against discrimination. The mobilization of EU funds should be directed towards funding programs such as the Citizens, Equality, Rights and Values (CERV) programme, which aims to promote the fundamental rights of all people. National strategies for combatting antisemitism of respective member states will be encouraged and further evaluated by the Commission in 2023. Promoting organizations and projects that report on antiemetic hate speech both online and in everyday life, while integrating support services for victims of antisemitic hate crimes are also covered by the Communication. By 2022, new standards will be set for national equality bodies, and the member states will be supported in implementing the reforms. The IHRA definition will be used as a guideline as part of a zero-tolerance approach to antisemitic incidents within institutions. Further training of selected staff on the detection of antisemitism in the workplace has been planned. Additionally, the IHRA definition of Holocaust denial and falsification/trivialization for educational and awareness-raising purposes should be stimulated and transmitted to the general population through social media campaigns. The Program “Horizon Europe” encourages the financing of research and innovation activities with the aim of understanding current radicalization trends and presenting ways of effective prevention. Intercultural and interreligious dialogue will be implemented in order to maintain the cultural heritage, while the digitization of archives and testimonies of the Holocaust and the creation of a European research centre on modern antisemitism, Jewish life and culture can also contribute to the protection of Jews in the EU.

European Commission Work Programme 2020

Protecting Health: Fighting the COVID-19-Pandemic

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Non-legislative Act: On the 11th of November 2020, the European Commission presented a Communication and three legislative proposals (see below) to strengthen the EU’s health security framework and European medical and scientific institutions. (Press release)

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Legislative procedure completed: On June 23, 2022, the European Parliament and the Council reached an agreement on the Regulation regarding serious cross-border threats to health (press release).
With a stronger and more comprehensive legal framework, the EU shall be better equipped to react rapidly and trigger the implementation of preparedness and response measures to cross-border threats to health across the Union. Joint action on preparedness, surveillance, risk assessment, as well as early warning and response will increase EU’s and its member states’ capacities to do accurate risk assessments and take targeted response actions, including joint procurement of medical countermeasures, such as vaccines and therapeutics.

Proposal: On the 11th of November 2020 the European Commission published a Proposal for a Regulation on serious cross-border threats to health and repealing Decision No 1082/2013/EU (Press release).

Problem: During the fight against the COVID-19 pandemic, it has become evident that EU’s mechanisms for managing health threats suffer from general shortcomings that require a more structured Union-level approach when dealing with any future health crises. Providing a limited legal framework, the current system has not ensured an optimal response, therefore, a stronger and more comprehensive legal framework within which the Union can react rapidly and trigger the implementation of preparedness and response measures to cross-border threats to health across the EU, is being proposed. With a more consistent and coordinated approach the EU shall prepare for and manage any health crises to come.

Objective: The Commission’s proposal is primarily aims to strengthen preparedness capacities through the development of an EU health crisis and pandemic preparedness plan as well as to lay down requirements for the plans at regional and national level. This is to ensure the functionality of the health care system even under crisis conditions. Further objectives include enhanced surveillance, monitoring and accuracy of risk assessments at EU level by establishing rules for the surveillance of novel pathogens based on common EU case definitions in case of emergencies, and for the reporting of health systems and other relevant data for the management of cross-border threats. Member states are advised to cooperate in specific areas; therefore, the Commission advocates the establishment of new EU networks operated by the European Centre for Disease Prevention and Control (ECDC). Enhancing capacities for all-hazard risk assessment by the relevant agencies (ECDC, the European Medicines Agency) and risk assessment coordination where more agencies are concerned by establishing rules on the recognition of emergency situations, and activating new Union emergency mechanisms for the management of health crisis are further suggested.

Subject Matter: The development of an EU health crisis and pandemic preparedness plan shall lay down requirements for the plans at national level and be coupled with a comprehensive and transparent framework for reporting and auditing. This Regulation shall apply to public health measures including but not limited to communicable diseases, biotoxins, threats of chemical origin, threats of environmental or climate origin as well as threats of unknown origin. Establishing a Health Security Committee composed of representatives of the member states will enable coordinated action for the implementation of this Regulation as well as the preparedness and response planning of the member states. The Commission, in cooperation with member states and the relevant Union agencies, shall establish a Union health crisis and pandemic plan to promote effective and coordinated response to cross-border health threats at Union level. Coordination within the HSC will ensure the monitoring, early warning and assessment of, and response to serious cross-border threats to health. This early warning system will be supported by improved data collection tools and artificial intelligence. While a common European approach is pursued, member states shall regardless retain the right to introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Regulation.

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Legislative procedure completed: On the 25th of January 2022, the European Parliament and the Council reached an agreement on the role of the European Medicines Agency in crisis management and response (press release). With a now more active role, the Agency can strengthen EU cooperation in health crises by alleviating dangers to the supply of medication, providing scientific advice, organizing clinical trials, etc.

Proposal: On the 11th of November 2020 the European Commission published a Proposal for a Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Press release) .

Problem: In the light of the COVID-19 pandemic, the Union’s ability to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development showed itself to be limited, resulting in ad hoc solutions for the risk containment of shortages of medicines and medical devices such as ventilators, surgical masks and COVID-19 test kits. Given that the European Medicines Agency did not always have access to sufficient health data to formulate coordinated recommendations across the Union, a clear framework in preparation for and during public health emergencies and other major events should be established in order to enhance the Union's capacity to react quickly, efficiently, and in a coordinated manner to such emergencies.

Objective: The proposal aims to ensure a high level of human health protection by strengthening the Union’s ability to manage and respond to public health emergencies, which have an impact on medicinal products and medical devices. The smooth functioning of the internal market for such products during public health emergencies is key to provide efficient care within the Union. Monitoring and mitigating potential and actual shortages of medicinal products and medical devices considered as critical will adequately address a given public health emergency and/or other major events which may have a serious impact on public health. A timely development of high quality, safe and efficacious medicinal products with a particular focus on addressing a given public health emergency as well as ensuring the smooth functioning of expert panels for the assessment of some high-risk medical devices are on the objective. Lastly, the proposal seeks to ensure inter-Agency cooperation during health emergencies, most notably with the European Centre for Disease Prevention and Control (ECDC).

Subject Matter: New rules will be introduced for the Agency to provide advice on medicinal products. Such advice shall cover both medicinal products under development, those used under national compassionate use programmes, and those already authorised for a different indication but with the potential to also treat, prevent or diagnose the disease in question. A well-managed and sustainable structure shall coordinate the expert panels on medical devices, which will be involved in the assessment of specific high-risk medical devices and device types relevant for health crisis management and provide scientific advice essential in crisis preparedness and crisis management. To achieve the following, the Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency. Where the Agency considers that an actual or imminent major event needs to be addressed, it is necessary to inform the Commission and the member states thereof that in turn may request the assistance of the Medicines Steering Group to address the major event.

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Legislative procedure completed: On the 23rd of November 2022, the European Parliament and the Council reached an agreement on the Proposal for stablishing a European centre for disease prevention and control (press release). With the COVID-19 pandemic bringing to light the importance of healthcare and emergency response, the EU is making efforts to address relevant critical issues particularly regarding monitoring and the availability of expertise.

Proposal: On the 11th of November 2020 the European Commission published a Proposal for a Regulation amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control (Press release) .

Problem: As a result of the COVID-19 pandemic, shortcomings within the EU mechanism when managing health threats were revealed, which call for a more structured Union-level approach that specifically builds on the European value of solidarity. Reinforcing the mandate of the European Centre for Disease Prevention and Control (‘the Centre’) addressing surveillance, preparedness, early warning, and response under a strengthened EU health security framework is necessary to ensure consistency with other Union instruments as well as to ensure that the Centre fully complies with the ‘common approach’ for decentralised agencies.

Objective: With the aim to reinforce the capacities of the Centre in order to support preparedness, surveillance, risk assessment, and early warning and response to face future cross-border health threats, the Commission encourages the ECDC to assess and communicate current and emerging threats to human health from communicable diseases and provide recommendations for response at EU and national level. The ECDC shall provide timely information to the Commission, the member states, EU bodies and agencies as well as international organisations active within the field of public health, including risk assessments. Scientific and technical expertise will be provided to the member states and the Commission in the field of preparedness and response planning, including training. Coordinating data collection, validation, analysis and dissemination of data at EU level and thus establishing a robust European surveillance system for communicable diseases in the frame of the European Health Data Space is a key objective. The ECDC shall operate dedicated networks in the field of communicable diseases and substances of human origin, as well as host an EU Health Task Force to constantly support countries with preparedness strengthening and quickly intervene in a health crisis. All of the above shall improve international collaboration and the gathering of regional/national intelligence.

Subject Matter: Crucial areas of the proposal address situational awareness by the rapid digitalisation of integrated surveillance systems. Member states shall be better prepared to develop prevention and response plans against future epidemics and stronger capacities for integrated rapid epidemic and outbreak response, while reinforced measures shall control epidemics and outbreaks overall. It is necessary to expand the capacities to mobilise and deploy the EU Health Task Force in order to assist EU’s member states, as well as build key competences to monitor and assess health systems capacity for diagnosis, prevention and treatment of specific communicable diseases and patient safety. The Centre will be tasked with coordinating a new network of Union reference laboratories for public health and a new network of national services supporting transfusion, transplantation and medically assisted reproduction in order to build up the key competences for health protection within member states. Expanding work on the prevention of communicable diseases and specific health issues as well as reinforcing the contribution to the EU’s international cooperation and development and EU commitment to global health security preparedness are further encouraged by the Commission.

Fostering Skills, Education and Inclusion

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Non-legislative Act: On the 1st of July 2020 the EU Commission published a Communication on European Skills Agenda for sustainable competitiveness, social fairness, and resilience (Press release) .

Problem: Demographic changes in addition to green and digital transitions are transforming the work environment by creating new job opportunities as well as dissolving older ones. Thus, the European Union is required to draw on all of its talents and diversity introducing an unparalleled shift in skill sets along with amending the complications attributed to the accelerated digital transition that became apparent during the COVID-19 pandemic.

Objective: The Commission preeminently aspires to face the challenges posed by demographic changes and to push forward the twin transition building a more sustainable, resilient, and fairer Europe for the next generation. It further aims to pursue its leadership towards global recovery from the pandemic through a paradigm-shift on skills. Some of the key objectives are the reinforcement of sustainable competitiveness advocating for lifelong learning in order to work more effectively and take advantage of advanced technologies as well as the guarantee of social fairness. For workers in retail, transport, social or sanitation services, teachers, and trainers, resilience is essential specifically in the light of the constant strain due to the pandemic. Granting all Europeans access to attractive, innovative and inclusive learning programmes in addition to skilling them for suitable jobs are the guiding principles of the Communication.

Subject Matter: Establishing a pact for skills that brings together all stakeholders, private and public, should enforce the up- and reskilling of Europe’s workforce enabling people to participate in the twin transitions. The foundation for up- and reskilling lies on the modernisation of the information available on skills needs. Further, vocational education and training are to be optimised with the view to equipping young people and adults with the skills to thrive in the labour market and supporting the green and digital transitions, including transversal skills, ensuring inclusiveness and equal opportunities, and establishing European VET as a global reference point for skills development. Through individual learning accounts existing gaps in the access to training for working age adults shall be closed. Additionally, once individuals have a certificate proving their skills, they need to be able to communicate them when applying for a job or further learning. Therefore, a Union-wide platform will be established as a way to support people manage their careers in a fast-changing labour market. Meeting the budgetary requirements, demands a considerable mobilisation of private and public investment in skills resulting in an estimated additional investment of EUR 48 billion annually.

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Non-legislative Act: On the 30th of September 2020 the European Commission published a Communication on achieving the European Education Area by 2025 (Press release) .

Problem: Setting the foundation for personal fulfilment, employability, and active and responsible citizenship, qualitative and inclusive education, training and lifelong learning play an essential role in the recovery package that counters the effects of the COVID-19 pandemic. The EU Commission deems it necessary to prevent the health crisis from becoming a structural barrier to learning and skills development impacting on young people’s employment prospects, earnings, as well as equality and inclusion for the whole of the society.

Objective: Six pillars make up the dimensions of the European Education Area. A quality education shall provide young people with the knowledge, skills and attitudes to thrive in life and to cope with potential challenges. Inclusion and gender equality shall help reduce inequalities linked to socio-economic status. Considering that students from rural areas as well as those with a migrant background are negatively influenced in their educational opportunities, the Communication highlights the need to decouple educational attainment and achievement from social, economic and cultural status, to ensure that education and training systems boost the abilities of every individual and enable upward social mobility. In the light of current demographic and technological changes, facilitating the attainment of digital skills is crucial for job search in all sectors. To ensure a highly competent, enthusiastic and committed professional workforce, it is essential to overcome teacher shortages. Further, closer and deeper cooperation between higher education institutions is recommended with the idea to enable learners to move more easily between education systems in different countries thereby developing a pan-European talent pool, including in cutting-edge scientific disciplines and technologies such as artificial intelligence, cybersecurity and high-performance computing. Lastly, promoting EU’s soft power, particularly through spreading its messages and fundamental values, shall be warranted by Union’s exchange programmes.

Subject Matter: The Commission will support member states in the identification of effective policy reforms that support better achievement in basic skills, specifically those concerning curriculum and assessment, as well as the capacity of institutions and staff to be innovative and develop their learning approaches. The Commission will further support the cooperation between European stakeholder organisations, teachers associations and teacher education providers to work together and provide input to policy recommendations on innovative and multi-disciplinary teaching and learning approaches. Additionally, education stakeholders and member states representatives shall stimulate peer learning and the development of a European perspective in education while also building on democratic education environments free from bullying, harmful speech and disinformation. The Commission will support member states in the implementation of the European quality framework for high quality early childhood education and care systems, as well as propose dedicated working streams in the European Education Area enabling framework to develop policy guidance on gender equality in education and training. By 2021 the Commission will establish a European Innovative Teaching Award to recognise the work of teachers (and their schools) who make an exceptional contribution to the profession, in addition to launching the Erasmus Teacher Academies within the new Erasmus Programme in 2021 to create networks of teacher education institutions and teacher associations. Finally, the Council is invited to organise regular joint discussions between the Education, Youth, Culture and Sport Council and other Council configurations to help take a whole of government approach to education and training, and to strengthen the contribution of education and training to the EU political priorities, while support work on education within the European Semester.

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Non-legislative Act: On the 24th of November 2020 the European Commission published a Communication on an action plan on Integration and Inclusion 2021-2027 (Press release) .

Problem: Considering that migrants and EU citizens with a migrant background play a key role in the European economy and society, specifically giving a helping hand during the COIVD-19 pandemic as workers in essential services, doctors and nurses. Being among those groups most exposed to the pandemic, it is a moral duty in line with the EU’s fundamental values to promote integration and inclusion. Fully integrating migrants into the labour market can further be of economic importance as shown by recent research, generating large economic gains, including fiscal profits, contributions to national pension schemes and national welfare in general.

Objective: Key principles of the Integration and Inclusion action plan include the guarantee that all policies are accessible to and work for everyone, including migrants and EU citizens with migrant background. This means adapting and transforming mainstream policies to the needs of a diverse society, consider the specific challenges and needs of different groups. This action plan aims to take into account the combination of personal characteristics, such as gender, racial or ethnic origin, religion or belief, sexual orientation and disability that can represent specific challenges for migrants.

Subject Matter: Participation and achievement in education shall be promoted by targeted support for teachers to develop competences when dealing with cultural, religious and linguistic diversity in classrooms under the Erasmus Teacher Academies, as well as by targeted training for youth workers to acquire the skills specifically required for supporting integration of young migrants. Cooperation between national authorities in charge of integration and national centres for the recognition of qualifications shall be fostered. Promoting exchanges between member states on providing complementary/bridging courses for migrants in addition to providing information on recognition practices and on skills and qualifications for migrants using the full potential of the Europass portal is encouraged. Making full use of EU funding, in particular the European Social Fund Plus, the Asylum and Migration Fund and the European Regional Development Fund in order to support programmes and measures related to education, skills and language training is needed at national and regional level. The Commission will work with social and economic partners to promote a multi-stakeholder approach to labour market integration through the European Partnership for Integration as well as support employers through exchanges and peer-to-peer learning, building on the Employers together for integration initiative.

A New Pact on Migration and Asylum

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Non-legislative Act: On the 23rd of September 2020 the European Commission proposed a new Pact on Migration and Asylum with the preeminent objective to establish improved and faster procedures throughout the asylum and migration system. In order to restore the trust between member states and respectively strengthen the balance between responsibility and solidarity when dealing with migration at EU-level, the Commission highlights the need for a predictable and reliable migration management system (Press release).

To achieve the following, five regulation proposals have been issues: A new Proposal for a Screening Regulation, a Proposal to revise the Asylum Procedures Regulation, an amended Proposal for the Revision of the ‘Eurodac’ Regulation, a new Proposal for a Regulation on Asylum and Migration Management and a new Proposal to deal with crisis situations and cases of force majeure.

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Legislative procedure completed: On the 20th of December 2023, the Proposal for a Regulation introducing a screening of third country nationals at the external borders and amending Regulations (EC) No 767/2008, (EU) 2017/2226, (EU) 2018/1240 and (EU) 2019/817 was adopted (press release). The revised screening regulations will be applicable to individuals who do not meet the criteria for entry into an EU member state, those caught entering the EU irregularly away from official border checkpoints, or disembarking after a search and rescue operation, as well as those seeking international protection at a border crossing. Each EU country can conduct screenings at suitable locations of their choice, ideally situated at or near external borders, and possibly in other areas within the country. Only third-country nationals found within the EU and who have entered a member state's territory without authorization through an external border will be subject to screening. Screenings, which can take up to seven days, involve identity confirmation or verification, collecting Eurodac biometric data, and initial assessments of health and vulnerability. Moreover, security verifications will be conducted by accessing various relevant databases, including the Schengen Information System, the Entry/Exit System, ETIAS, and the ECRIS-TCN system. During the screening, third-country nationals must be accessible for these checks and may be detained to ensure compliance. They are entitled to emergency medical care and necessary treatments if they are sick. Protecting the welfare of children, especially unaccompanied minors, is of utmost importance in the screening process. An appointed representative will assist unaccompanied minors, and even without representation, they retain the right to seek international protection. MEPs have established a robust, independent mechanism in each member state to safeguard the fundamental rights of individuals undergoing screening.

Proposal: On the 23rd of September 2020 the EU Commission published a Proposal for a Regulation introducing a screening of third country nationals at the external borders and amending Regulations (EC) No 767/2008, (EU) 2017/2226, (EU) 2018/1240 and (EU) 2019/817 (Press release) .

Problem: The migration of third-country nationals with international protection needs has been recently overpowered by migration flows of mixed arrivals of persons challenging migration management at the EU level. When identifying those in need of international protection or deciding on effective returns, a common framework bringing together policies in the areas of asylum, migration, return, external border protection, fight against migrants’ smuggling and relations with key third countries reflecting a whole of government approach is needed.

Objective: The key objective of the proposal is to improve the identification process at the external borders of the EU so that the identity as well as any health and security risks of new arrivals are swiftly established. In this manner all third-country nationals who are present at the external border without fulfilling entry conditions or after disembarkation following a search and rescue operation will be referred towards the appropriate procedure. The uniformity of rules and policies is required to increase the security withing the Schengen area, and further clarify entry requirements for future arrivals. The proposed screening not only establishes transparency in the process of regular migration, it also creates an EU framework for the screening of third-country nationals who entered the territory of the member states without authorisation and who are apprehended within their territories. With an independent monitoring mechanism by the member states in relation to the screening, the fundamental rights of the persons concerned should be protected. Frontex as well as the European Union Agency for Asylum shall accompany and support the competent authorities in all their tasks related to the screening.

Subject Matter: The screening is to be applied at the external borders of the member states to all third-country nationals who have crossed the external border in an unauthorised manner, to those who have applied for international protection during border checks without fulfilling entry conditions, as well as those disembarked after a search and rescue operation, before they are referred to the appropriate procedure. Identifying all third-country nationals by verifying their identity against relevant databases shall ensure that the arrivals do not pose a threat to internal security. Health checks entailed by the screening will help recognise persons vulnerable and in the need of health care as well the ones posing a threat to public health. The screening shall also be carried out within the territory of the member states where there is no indication that third-country nationals have been subject to controls at external borders.

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Legislative procedure completed: On the 20th of December 2023, the Proposal for a Regulation establishing a common procedure for international protection in the Union and repealing Directive 2013/32/EU was adopted (press release). The updated regulations aim to streamline the process of assessing asylum applications, setting a six-month target for initial decisions and reducing the time for examining clearly unfounded or inadmissible claims. Quicker asylum procedures at borders, lasting up to 12 weeks, will be implemented near EU external borders or transit zones. Asylum seekers with denied claims are expected to be repatriated within 12 weeks. Individuals posing a threat to national security or public order, those providing false identity or nationality information, and applicants from countries with an asylum recognition rate below 20 per cent will immediately undergo border asylum procedures following screening. MEPs have ensured that asylum seekers receive complimentary legal advice during all administrative stages. Additionally, unaccompanied minors are exempt from border procedures, barring security concerns, and it's not anticipated that families with children will be prioritized for these procedures. These families are also to be provided with suitable accommodation. Should appropriate conditions for families with children not be met, the Commission can advise suspending border procedures. The EU's capacity for border procedures will initially be set at 30,000 reception places, with member states responsible for implementing these procedures on their territory. The Commission will set an annual cap for each country on the number of applications to be processed under border procedures. This capacity will be progressively increased over three years post-enactment. To avoid overcrowding, when capacity is maximized, applicants will be transferred to the standard asylum procedure. The Commission must define this “adequate capacity” within two months of the rules taking effect, and member states have six months to adhere to this directive. MEPs have introduced provisions to ensure the fair application of the country of first asylum and safe third country concepts. These can only be used when the applicant doesn't present valid objections and must have a reasonable connection to a safe third country. Protection in the first asylum country should include permission to stay, access to basic resources, healthcare, and education. While member states will initially use national safe country lists, the aim is to eventually develop a unified EU list of safe third countries and countries of origin.

Proposal: On the 23rd of September 2020 the EU Commission published a Proposal for a Regulation establishing a common procedure for international protection in the Union and repealing Directive 2013/32/EU (Press release) .

Problem: The continued arrival of irregular migrants has outlined structural challenges which put member states' asylum, reception and return systems under strain, resulting in an increased administrative burden and delays in granting protection for those in genuine need of protection. Establishing a European framework that can manage the interdependence between member states’ policies and decisions, bringing together policies in the areas of asylum, migration, return, external border protection and relations with key third countries, will promote mutual trust among member states as well as provide better management of migration within the member states.

Objective: A common asylum procedure, which replaces the various divergent procedures in the member states and is applicable to all applications made, is to ensure an effective and high-quality decision-making process. The proposal puts in place simpler, clearer and shorter procedures and combines those with adequate procedural safeguards and tools to respond to abuses of asylum procedures. Preventing unauthorised movements shall enable more efficient use of resources improving the rights of applicants, allow those in need of international protection to receive it faster and ensure the swift return of rejected applicants without a right to stay in the Union. The increased pressure resulting from arrivals of migrants with low chances of receiving protection needs is to be countered through new migration management tools, including more harmonized procedures at the external border. The purpose of the joint asylum and return border procedure is to quickly assess abusive asylum requests or asylum requests made at the external border by applicants coming from third countries with a low recognition rate in order to swiftly return those without a right to stay in the Union.

Subject Matter: A pre-entry phase is established consisting of a screening and a border procedure for asylum and return during which migrants will be registered and screened so that their identity, health, and security risks can be gathered. Migrants will then be referred to the appropriate procedure, meaning they will either be given asylum, refused of entry and/or directed to return. In addition, it will be determined whether an asylum application should be assessed without authorizing the applicant’s entry into the member state’s territory in an asylum border procedure or in a normal asylum procedure. Where an asylum border procedure used, determines that the individual is not in need of protection, a return border procedure will follow.

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Legislative procedure completed: On the 20th of December 2023, the mended Proposal for a Regulation on the establishment of 'Eurodac' for the comparison of biometric data for the effective application of Regulation (EU) XXX/XXX [Regulation on Asylum and Migration Management] and of Regulation (EU) XXX/XXX [Resettlement Regulation], for identifying an illegally staying third-country national or stateless person and on requests for the comparison with Eurodac data by member states' law enforcement authorities and Europol for law enforcement purposes and amending Regulations (EU) 2018/1240 and (EU) 2019/818 was adopted (press release). The updated Eurodac Regulation will enhance data collection on asylum seekers and irregular migrants found within EU member states. This will be achieved by adding facial recognition to the existing fingerprinting system and collecting additional details like names, surnames, nationalities, and dates and places of birth. Information regarding decisions to deport, return, or relocate individuals will also be included. The age at which children's data can be collected will be reduced from 14 to 6 years. Lowering the data collection age aims to facilitate the identification of unaccompanied minors who may leave care institutions or social services, and track those separated from their families and later located in another member state. In terms of security concerns, authorities will have the capacity to note in the system if an individual poses an internal security threat. This applies only if the person exhibits violent behavior, is unlawfully armed, has connections to terrorism or terrorist groups, or is implicated in crimes relevant to the European arrest warrant. Additional categories will be incorporated into the system. This includes recording those who have been disembarked in an EU member state following search and rescue operations, which will be used for statistical purposes to more accurately reflect migration patterns into the EU. Statistical data will be improved through cross-referencing and anonymization, enhancing interoperability between Eurodac and other justice and home affairs systems like the Visa Information System, ETIAS, and the Entry/Exit System. These enhancements are intended to provide valuable information to policymakers for better identification of irregular migrants and asylum seekers.

Proposal: On the 23rd of September 2020 the European Commission published an amended Proposal for a Regulation on the establishment of 'Eurodac' for the comparison of biometric data for the effective application of Regulation (EU) XXX/XXX [Regulation on Asylum and Migration Management] and of Regulation (EU) XXX/XXX [Resettlement Regulation], for identifying an illegally staying third-country national or stateless person and on requests for the comparison with Eurodac data by member states' law enforcement authorities and Europol for law enforcement purposes and amending Regulations (EU) 2018/1240 and (EU) 2019/818 (Press release) .

Problem: The insufficiency of the current migration management within EU’s member states that struggles with regulating asylum and return procedures, calls for an optimised strategy that provides a clear and consistent link between specific individuals and the procedures they are subjected to in order to better assist with the control of irregular migration and the detection of unauthorised movements.

Objective: The Commission primarily aims to transfer Eurodac into a common European database to support EU policies on asylum, resettlement, and irregular migration. To do so, in addition to ensuring consistency with the proposal for a Screening Regulation, applications of the various measures and rules foreseen in the proposal for a new Regulation on Asylum and Migration Management shall be supported. Gathering more accurate and complete data will improve policy making in relation to the assistance of irregular migration and the detection of unauthorised movements. With the objective to support the identification of appropriate policy solutions as well as to provide additional support to national authorities dealing with asylum applicants whose application has already been rejected in another member state, data from various databases shall be incorporated in the Eurodac data.

Subject Matter: In the database in addition to counting the applications, the number of applicants shall be regulated. Cross-system statistics using data from Eurodac, Entry/Exit System (EES), ETIAS and the Visa Information System (VIS) will offer the necessary background information for assessing such phenomena and for the appropriate policy response. Persons disembarked following a search and rescue (SAR) operation are now to be examined under a new category. A new field will be created where member states can indicate when an application has been rejected, thus reinforce the link with return procedures and provide additional support to national authorities dealing with an applicant for international protection whose application has been rejected in another member. It is further necessary to illustrate whether voluntary return and reintegration assistance has been granted as well as whether a person could pose a threat to internal security. Information on the state of visa applications along with all the other amendments shall be in full consistency with the proposal for a Regulation on Asylum and Migration as well as the Screening Regulation.

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Legislative procedure completed: On the 20th of December 2023, the Proposal for a Regulation on asylum and migration management and amending Council Directive (EC) 2003/109 and the proposed Regulation (EU) XXX/XXX [Asylum and Migration Fund] was adopted (press release). Under the newly agreed legislation, every EU member state is required to assist other EU countries experiencing significant migratory pressure, identified as "benefitting member states." These are nations where the influx of asylum seekers is so substantial that it places disproportionate demands compared to the broader EU context, necessitating immediate solidarity actions. Each year, a solidarity pool will be formed, with all EU countries contributing either through relocations (transferring an asylum applicant or a person granted international protection from a benefitted state to a contributing one) or financial contributions. The contribution of each member state is determined by considering both its population size (50 per cent) and GDP (50 per cent). Member states have the discretion to choose the nature of their contribution or a mix of both. Member states under migratory pressure can notify the Council and the Commission if they intend to use the pool and may request a reduction of their solidarity contributions. The regulation sets a minimum of 30,000 applicants for relocations and a financial contribution of 600 million euro. If there's a shortfall in relocation pledges, a benefitted member state can ask other countries to take on the responsibility of processing international protection applications instead of providing relocations. Special attention is given to countries frequently conducting Search and Rescue (SAR) operations at their borders. When assessing migratory pressure, SAR activities are considered, and a portion of the solidarity measures from the pool is allocated for such member states. Asylum applicants don't have the option to choose which member state is responsible for processing their application or their relocation destination. In determining individuals for relocation and their potential assignment to member states, vulnerabilities, including those of unaccompanied minors and SAR cases, are considered. Financial contributions are aimed at supporting migration, reception, and asylum actions within the EU. These funds can also assist actions in non-EU countries that directly impact migration flows towards the EU, enhancing their asylum, reception, and migration systems, including voluntary return and reintegration programs. The agreed-upon rules incorporate additional criteria to ascertain which member state is accountable for processing international protection applications, known as Dublin rules.

Proposal: On the 23rd of September 2020 the European Commission published a Proposal for a Regulation on asylum and migration management and amending Council Directive (EC) 2003/109 and the proposed Regulation (EU) XXX/XXX [Asylum and Migration Fund] (Press release) .

Problem: In the light of the fight against migrant smuggling aligned with the lack of an effective solidarity mechanism and efficient rules on responsibility, the EU requires a common framework that can manage the interdependence between Member States’ policies and decisions as well as the ever-changing realities of migration, which have meant increased complexity and an intensified need for coordination. A new solidarity mechanism that is flexible and responsive in design to adjust to the different situations presented by the different migratory challenges faced by the member states is to replace the current Dublin Regulation and reform the Common European Asylum System (CEAS).

Objective: With the clear objective to build mutual trust between member states in addition to ensuring the consistency of the EU approach on asylum, migration management, external border protection and relations with relevant third countries, the Commission aspires to achieve a stronger, more sustainable, and tangible expression of the principle of solidarity and fair sharing of responsibility. Particularly it sees the need to establish a common framework that contributes to the comprehensive approach to asylum and migration management based on the principles of integrated policy-making and of solidarity. The new solidarity mechanism shall assist member states with effective measures, such as relocation or return sponsorship, for them to effectively manage migration in practice where they are faced with migratory pressure. Enhancing the system’s capacity to determine efficiently a single member state responsible for examining an application for international protection will limit the cessation of responsibility clauses as well as the possibilities for shift of responsibility between member states, shortening the time limits for sending requests and receiving replies. Quicker access to the procedures for granting international protection in addition to discouraging abuses and preventing unauthorised movements of the applicants within the EU are to be attained by the following.

Subject Matter: On the basis of a comprehensive approach mutually-beneficial partnerships and close cooperation with relevant third countries as well as Union institutions and bodies, member states and international organisations shall be pursued. The Union and member states shall further ensure coherence of asylum and migration management policies, including both the internal and external components of those policies. The Commission shall adopt a European Asylum and Migration Management Strategy setting out the strategic approach to managing asylum and migration at Union level and on the implementation of asylum and migration management policies in accordance with the principles set out. Additionally, Migration Management Report adopted by the Commission, shall evaluate each year the migratory situation and the preparedness of the Union and the Member States. Monitoring and providing information on the migratory situation through regular situational reports based on good quality data and information provided by member states, the European Border, Europol, the Fundamental Rights Agency, etc., the Commission will assess the effects of the following proposal.

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Legislative procedure completed: On the 20th of December 2023, Proposal for a Regulation addressing situations of crisis and force majeure in the field of migration and asylum was adopted (press release). The provisional agreement must be formally adopted by Parliament and the Council before it can become law. The newly agreed provisional rules by Parliament and Council negotiators are designed to be activated during extraordinary circumstances involving large-scale arrivals of third-country nationals or stateless persons by land, sea, or air, including those disembarked following search and rescue operations. A crisis is defined as a situation where a member state's asylum, reception, child protection, or return systems become non-functional, potentially severely impacting the overall EU asylum system. These rules are also applicable in instances where a third country or hostile non-state entity actively promotes or assists the movement of third-country nationals and stateless persons towards the EU's external borders or a specific member state with the intention of destabilizing it. However, humanitarian aid operations are not regarded as instrumentalisation if they do not aim to destabilize the EU or any member state. In terms of decision-making and solidarity measures, the affected member state must submit a reasoned request to the Commission in a crisis. The Commission will then evaluate the situation within two weeks and decide on the existence of a crisis. It will also propose solidarity measures and possible derogations to the Council, along with a recommendation identifying groups entitled to prima facie protection. Under the new regulations, a reliable and continuous system of solidarity is established, requiring all member states to assist the affected member state. To address a specific crisis, a member state may suggest relocation of asylum seekers, financial contributions, or other measures to the Commission. 12 years could be exempt from the border procedure in instrumentalisation scenarios.

Proposal: On the 23rd of September 2020 the European Commission published a Proposal for a Regulation addressing situations of crisis and force majeure in the field of migration and asylum (Press release) .

Problem: As a way to avoid ad hoc responses to crises in relation to migration, an instrument ensuring that the Union has at its disposal specific rules that can address the exceptional situation of crisis in an effective manner, complementing the compulsory solidarity mechanism and the procedures that normally would apply, is needed. Although cooperation among member states as well as at EU level has been increasing, member states’ asylum, reception and return systems remain largely not harmonised. Thus, creating inefficiencies and not providing the same fair treatment to asylum seekers throughout Europe, incentivising therefore the movement of large numbers of migrants across Europe to seek better conditions and prospects for their stay.

Objective: With regard to the 2015 refugee crisis, the Commission introduces appropriate procedural rules and derogations as well as a rapid triggering of solidarity to the benefit of one or more member states to respond to crisis situations that put under significant strain even well prepared and functioning asylum and migration management systems. EU’s member states that are under pressure or risk of pressure are provided with a new approach to solidarity that not only includes a specific process to address the specificities of disembarkations following search and rescue (SAR) operations, but also increases the overall efficiency and coherence of the asylum and migration management systems to better prepare for situations of crisis in the field of migration and asylum. In addition to the operational and technical support the European Union Agency for Asylum can provide in case the member state’s asylum or reception systems are subject to disproportionate pressure, new measures proposed in the following are to be implemented in order to widen the scope for relocation and reinforce the possibility for member states to provide assistance to each other in carrying out returns, in the form of return sponsorship.

Subject Matter: The modified return sponsorship optimises the previously established policy for situations of crisis and allows the transfer of irregular migrants to the territory of the sponsoring member state if the person concerned does not return or is not removed within four months. Moreover, the extension of the scope of application of the border procedure to third-country nationals and stateless persons whose EU-wide first instance recognition rate is 75% or lower as well as the extension of the duration or the examination of an application of international protection under the border procedure by an additional eight weeks shall be enabled. Member states shall be allowed to derogate from certain provisions on the border procedure to carry out return as set out in the proposed Asylum Procedures Regulation and in the Return Directive, in order to facilitate the enforcement of such procedures in situations of crisis, when specific adjustments are needed to allow the competent authorities under strain to exercise their tasks diligently and cope with significant workload. For this purpose, the proposal extends the maximum duration of the border procedure for carrying out return by an additional period of eight weeks and introduces new specific and well-targeted cases, additional to the ones set in the proposal for a recast Return Directive, in which the existence of a risk of absconding in individual cases can be presumed, unless proven otherwise. Lastly, this proposal provides for an extension of the timeframe for the implementation of the obligation to relocate or undertake return sponsorship when a member state is in a situation of force majeure.

Fostering Europe’s Security

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Non-legislative Act: On the 24th of July 2020 the European Commission published a Communication on the EU Security Union Strategy (Press release) .

Problem: The COVID-19 crisis highlighted the need to guarantee security both in physical and digital environments as well as the importance of open strategic autonomy for EU’s supply chains in terms of critical products, services, infrastructures, and technologies. It has reinforced the need to engage every sector and every individual in a common effort to ensure that the EU is more prepared and resilient, particularly considering that the security of one member state is the security of all. With a constantly changing world, threats such as climate change, demographic trends, and political instability within and beyond the borders of the EU demand for a security union that acts as a management system, working within and outside its borders to contribute to global stability.

Objective: The Security Union shall contribute to building capabilities and capacities for early detection, prevention, and rapid response to crises through an integrated and coordinated approach, both globally and through sector-specific initiatives. Careful threat and risk assessment should be applied to target EU’s efforts to define and apply the right rules as well as develop reliable strategic intelligence as a basis for EU security policies. With a more intense cooperation between member states, involving law enforcement, judicial and other public authorities, in addition to partnerships within EU institutions and agencies, the understanding and exchange for common solutions shall be enhanced. Cooperation with the private sector is also key, particularly given that the industry owns an important part of the digital and non-digital infrastructure central to fighting crime and terrorism effectively.

Subject Matter: Key actions include the revision of the Network Information Systems Directive as well as an initiative on the operational resilience of the financial sector. A European Cybersecurity Strategy shall be accompanied by the creation of a Joint Cyber Unit that develops common rules on information security and cybersecurity for EU institutions, bodies, and Agencies. It is further necessary to ensure the implementation of the cybercrime legislation and additionally establish a Strategy for a more effective fight against child sexual abuse by initiating proposals on the detection and removal of child sexual abuse material. The Union is in need of a Counter-Terrorism Agenda that optimizes anti-radicalisation actions within the EU. Enhanced cooperation with key third countries and international organisations against terrorism should be on the agenda in order to tackle organized crime such as trafficking in human beings. EU Agenda on Drugs and Action Plan 2021-2025 shall, in addition to an assessment of the European Monitoring Centre for Drugs and Drug Addiction, be accompanied by a 2020-2025 EU Action Plan on Firearms trafficking. Lastly, strengthening Europol’s mandate shall be complemented by the increased cooperation between the EU and Interpol that will allow an EU-wide framework to negotiate with key third countries on sharing of information.

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Legislative procedure completed: On the 8th of June 2022, the European Parliament and the Council reached an agreement on strengthening the Europol Mandate (press release). The Decision prioritizes the protection of personal data as well as any other sensitive information in all legal processes.

Proposal: On the 9th of December 2020 the European Commission published a Proposal for a Regulation on amending Regulation (EU) 2016/794, as regards Europol’s cooperation with private parties, the processing of personal data by Europol in support of criminal investigations, and Europol’s role on research and innovation.

Problem: Evolving and increasingly complex security threats exploit the advantages that the digital transformation, new technologies, globalisation and mobility bring about, including the interconnectivity and blurring of the boundaries between the physical and digital world. Europol’s expertise, while it has previously supported member states in their fight against threats spread across borders that cut across a variety of crimes, the change of the threat environment calls for a different kind of approach that affectively addresses current challenges faced by EU’s member states.

Objective: This proposal primarily aims to strengthen the mandate of Europol within the mission and tasks of the agency, while specific objectives include enabling Europol to cooperate effectively with private parties, addressing lack of effective cooperation between private parties and law enforcement authorities to counter the use of cross-border services, such as communication, banking, or transport services, by criminals. Effectively supporting member states and their investigations with the analysis of large and complex datasets will address the big data challenge for law enforcement authorities. Research and innovation within member states shall be improved through their cooperation with Europol, while strengthening Europol’s cooperation with third countries in specific situations and on a case-by-case basis will help preventing and countering crimes falling within the scope of Europol’s objectives. Strengthening Europol’s cooperation with the European Public Prosecutor’s Office (EPPO) in addition to strengthening the data protection framework applicable to Europol as well as the parliamentary oversight and accountability of Europol shall be implemented.

Subject Matter: Europol must send each year to the Commission, the European Parliament and the Council a Single Programming Document containing multi-annual and annual work programmes and resources programming. Within the document objectives, expected results and performance indicators will be presented in order to monitor the achievement of the objectives and their results. Europol must also submit a Consolidated Annual Activity Report to the management board, the Commission, the European Parliament as well as the Council. To regularly monitor the provision of information by the member states, Europol will also report annually to the Commission, European Parliament, the Council and national parliaments on the information provided by each member state as concerns the information Europol needs to fulfil its objectives, including information relating to forms of crime in the prevention or combating of which is considered a priority by the Union.

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Legislative procedure completed: On the 14th of December 2022, the European Parliament and the Council reached an agreement on the resilience of critical infrastructure (press release). The Directive will monitor, assess and tackle threats to strengthen the resilience of critical entities especially for issues concerning energy, water and sanitation.

Proposal: On the 16th of December 2020, the European Commission published a Proposal for a Directive on the resilience of critical entities (press release).

Problem: The framework on critical infrastructure protection does not adequately address the current challenges. In light of an increased interconnection among infrastructures, networks and operators delivering essential services across the internal market, the current approach shall switch from protecting specific assets towards reinforcing the resilience of the critical entities that operate them. Compared to 2008, when the European Critical Infrastructure (ECI) Directive was adopted, the risk landscape is more complex and involves natural hazards, state-sponsored hybrid actions, terrorism, insider threats, pandemics, and accidents. Additionally, there are new challenges for operators in integrating new technologies such as 5G and unmanned vehicles into operations and at the same time addressing the vulnerabilities that such technologies could potentially create. These technologies and other trends make operators increasingly reliant on one another, thus a disruption affecting the service provision by one operator in one sector has the potential to generate cascading effects on service provision in other sectors, and also potentially in other member states or across the entire Union.

Objective: Primarily, the Directive aims to enhance the resilience of these operators (referred here as ‘critical entities’) against a range of natural and man-made, intentional or unintentional risks. Specific objectives include the transparency of risks and interdependencies faced by critical entities, as well as the means to address them and the assurance that all relevant entities are designated as ‘critical entities’ by member states authorities. It is further crucial to include the full spectrum of resilience activities in public policies and operational practice. Capacities shall be strengthened and cooperation between stakeholders improved.

Subject Matter: A strategy on the resilience of critical entities is to be developed by the member states. They shall additionally conduct national risk assessments and identify which operators are ‘critical entities’ on the basis of the outcomes of the risk assessment and specific criteria. This Directive provides obligations for member states to take certain measures aimed at ensuring the provision in the internal market of services essential for the maintenance of vital societal functions or economic activities. Moreover, obligations for critical entities are laid down aimed at enhancing their resilience and improving their ability to provide those services in the internal market. Rules on supervision and enforcement of critical entities, and specific oversight of critical entities considered to be of particular European significance are also provided.

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Non-legislative Act: On the 14th of April 2021, the European Commission published a Communication on the EU Strategy on Combatting Trafficking in Human Beings 2021- 2025 (press release).

Problem: The crime of human beings, often perpetrated by organised crime networks, is not only a gross violation of human rights but also imposes significant social and economic costs. Despite progress in combating this crime, trafficking continues to be a major concern, with prevalent exploitation of women and children for sexual and labour purposes. The problem is compounded by the digital era, where traffickers have adapted to online platforms for recruitment and exploitation, making detection and response more challenging.

Objective: The Communication aims to combat trafficking in human beings more effectively by identifying and halting trafficking early on, transforming it from a low-risk, high-return crime to a high-risk, low-return one. It proposes concrete actions respecting fundamental rights, focusing on prosecuting criminals, protecting and assisting victims to rebuild their lives, and addressing the specific aspects of human trafficking. This strategy integrates with the broader EU Strategy to Tackle Organised Crime 2021-2025, responding to the unique challenges posed by trafficking in human beings.

Subject Matter: The strategy proposes a multifaceted approach, focusing on the prevention of trafficking, protection of victims, and prosecution of perpetrators. One of the main areas of focus is the enhancement of legal frameworks and policies to combat human trafficking more effectively. This includes the evaluation and potential revision of the EU Anti-trafficking Directive, ensuring its relevancy and effectiveness in the current social and technological landscape. The strategy also underscores the need for member states to fully implement the Directive, harmonising their approach to combat trafficking and provide comprehensive protection to victims. Furthermore, the strategy addresses the need for enhanced cross-border, regional, and international cooperation. This includes the development and sharing of knowledge and information and the interoperability of information systems to make enforcement and judicial authorities more equipped to tackle traffickers. The strategy acknowledges the role of digital platforms in trafficking and proposes engaging with internet and technology companies to reduce their use for recruitment and exploitation of victims. In terms of protecting and empowering victims, especially women and children, the strategy proposes measures to improve the identification, assistance, and support of victims. This includes gender-sensitive and child-rights based training for professionals, the development of guidelines and toolkits, and the establishment of a European referral mechanism. Special attention is given to non-EU citizens who are victims of trafficking, with considerations for issuing residence permits and reflection periods, ensuring they receive appropriate assistance and protection. The strategy also highlights the importance of tackling the demand that fosters trafficking. It suggests assessing the possibility of modifying provisions in the Anti-Trafficking directive related to criminalising the use of services from trafficked victims. Moreover, it emphasises the need for awareness-raising campaigns and encouraging the private sector to incorporate anti-trafficking objectives in their policies, particularly in managing global supply chains. At the international level, the strategy outlines the need for robust cooperation with countries of origin, transit, and destination of trafficking victims. It emphasises the utilisation of EU’s external policy instruments, cooperation tools, and funding to share information on trafficking-related crimes and disrupt criminal networks.

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Non-legislative Act: On the 24th of July 2020 the European Commission published a Communication on an EU strategy for a more effective fight against child sexual abuse (Press release) .

Problem: The COVID-19 pandemic has substantially exacerbated child abuse online and offline by enabling unsupervised entry to online communities, as well as reinforcing abuse against children who live with their abusers. Becoming the largest host of child sexual abuse material globally, there has been an increase in reports of online sexual child abuse concerning the EU. The introduction of end-to-end encryption has further impaired the fight against child abuse, facilitating the access to secure channels for perpetrators where they can hide their actions from law enforcement. The Commission, therefore, deems it necessary to introduce possible solutions that could allow companies to detect and report child sexual abuse in end-to-end encrypted electronic communications.

Objective: The submitted strategy preeminently attempts to provide an effective response, at EU level, to the fight against child sexual abuse by developing a comprehensive response to these crimes, both in their online and offline form. Eight initiatives are to be implemented in order to develop the right legal framework, strengthen the law enforcement response and catalyse a coordinated multi-stakeholder action in relation to prevention, investigation and assistance to victims. Improving the protection of children globally through multi-stakeholder cooperation, establishing a European centre to prevent and counter child sexual abuse as well as strengthening law enforcement efforts at national and EU level are some of the objectives.

Subject Matter: The implementation of the Child Sexual Abuse Directive (2011/93/EU) that has been adopted in 2011 shall be finalised. In a first stage, the necessary legislation will be proposed to ensure that providers of electronic communications services can continue their current voluntary practices to detect in their systems child sexual abuse after December 2020. This will be followed by a different legislation that shall tackle child sexual abuse online effectively, including by requiring relevant online services providers to detect known child sexual abuse material and require them to report that material to public authorities. By the end of 2020, the Commission will launch an extensive study to identify legislative gaps, best practices and priority actions in the fight against child sexual abuse both online and offline. Europol is instructed to set up an Innovation Hub and Lab. With the funding of the Commission, the development of national capacities shall be facilitated in order to keep up with technological developments and ensure an effective response of law enforcement against these crimes. The Commission will start immediately to prepare a prevention network at EU level to facilitate the exchange of best practices and support member states in putting in place usable, rigorously evaluated and effective prevention measures to decrease the prevalence of child sexual abuse in the EU. A study launched by the Commission shall work towards the creation of a European centre to prevent and counter child sexual abuse to enable a comprehensive and effective EU response against child sexual abuse online and offline. Lastly, the Commission will continue contributing to increase global standards for the protection of children against sexual abuse by promoting multi-stakeholder cooperation through the WePROTECT Global Alliance, and through dedicated funding.

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Non-legislative Act: On the 24th of July 2020 the European Commission published a Communication on 2020-2025 EU action plan on firearms trafficking (Press release) .

Problem: Increasing the risk of terrorist attacks and organised crime, illicit trafficking, distribution and use of firearms remain a high threat, specifically considering that the sale of deactivated, reactivated and converted firearms has increased, partially due to their more easily accessibility online. The need to increase the flow of information and intelligence between the EU and the Western Balkans, according to Europol the main supplying regions of trafficking to the EU, calls for further intra-EU and international law enforcement cooperation, particularly since national legal frameworks and definitions remain divergent, impeding joint approaches and facilitating the exploitation for criminals.

Objective: The EU action plan of firearms trafficking prioritises the implementation of the Firearms Directive, ensuring that its corresponding delegated and implementing acts are correctly transposed and effectively enforced by all member states. A better intelligence picture shall be established through systematically delivering information to and consulting the Schengen Information System on lost and stolen firearms, as well as sold weapons which are prone to easy conversion into firearms. The Commission urges member states and south-east Europe partners to complete the establishment of fully staffed and trained Firearms Focal Points in each jurisdiction, as recommended by the Best practice guidance of national experts. Cooperation between the EU and non-EU partners, particularly with countries in North Africa and the Middle East, need to be stepped up in line with the priorities set out in the 2018 EU Strategy against illicit Firearms, Small Arms & Light Weapons and their Ammunition. Additionally, as part of this Action Plan, the Commission proposes specific detailed actions and governance for south-east Europe to be taken forward in close cooperation with the High Representative and in consultation with partners.

Subject Matter: Harmonising the legal environment, modernising the administrative structure and facilitating capacity building in addition to increasing stockpile security and stockpile reduction shall be enforced in south-east Europe. Law enforcement activities are to be optimised by the facilitation of operational cooperation, exchange of information, and cooperation on ballistic analysis. The Commission commits to deepen its engagement with south-east Europe partners and allocate dedicated financial resources to bring them up to the required standards. In line with the following, it intends to mobilise and earmark available means of the Internal Security Fund and the Instrument for Pre-accession Assistance to meet the most urgent challenges. Together with the High Representative, the Commission will convene a steering committee of key implementing partners and donors including Member State representatives, the European External Action Service, relevant United Nations Agencies (UNDP and UNODC) and NATO. In addition, at the level of the regional law enforcement agencies, the multitude of existing bodies is to be streamlined.

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Non-legislative Act: On the 24th of July 2020 the European Commission published a Communication on an EU Agenda and Action Plan on Drugs 2021-2025 (Press release).

Problem: Considering that significant economic damage can be attributed to drug use and more generally, an indirect negative impact that the drug market has through links with wider criminal activities, the disruption of the legal economy, violence in communities, damage to the environment, and by acting as a significant driver for corruption that can undermine good governance, the Commission deems it necessary to establish a robust new EU Agenda on Drugs. Drug availability remains high in the EU with the public having access to a wide variety of high-purity and high-potency drugs, calling for a national, EU and international level of strategy.

Objective: The introduction of the new Agenda and Action Plan on Drugs aims to protect citizens through better coordinated measures that will have a substantive and measurable impact on the security and health issues arising from drug use and the operations of the drug market. It further addresses the direct and indirect consequences arising from this problem including links to violence and other forms of serious crime, related health and societal problems, environmental damage, while raising public and policy awareness on these issues. As the threats and security challenges evolve, internal and external security are increasingly interconnected, therefore, protecting EU citizens from drug-related challenges requires coherence and close cooperation, where appropriate, between the objectives of the EU Agenda on Drugs and the EU’s external action. Building upon science led, evidence-based responses and fostering innovation, efforts are needed in research to identify priorities, achieve synergies and coordination as well as disseminate findings effectively. Intensifying such efforts to develop, adopt and use new technologies is to better monitoring, analysis and response in relation to trends and threats in the illegal drug markets.

Subject Matter: Disrupting major high-risk drug-related organised crime groups operating in, originating in or targeting the EU member states shall enhance the security within the Union. Here it is necessary to increase international cooperation with third countries or regions as well as EU agencies. Increased detection of illicit wholesale trafficking of drugs and drug precursors at EU points of entry and exit shall particularly focus on the smuggling of drugs in and out of the EU by using established trade channels. Effective monitoring of logistical and digital channels exploited for medium and small-volume drug distribution is planned in addition to increasing seizures of illicit substances smuggled through these channels in close cooperation with the private sector. It is further highlighted that dismantling drug production and processing, preventing the diversion and trafficking of drug precursors for illicit drug production, and eradicating illegal cultivation can reduce health and safety risks as well as environmental damage. For prevention and awareness raising, it is crucial to prevent the uptake of drugs, enhance crime prevention, and raise awareness of the adverse effects of drugs on citizens and communities. The efficiency of risk and harm reduction interventions shall be increased in order to protect the health of drug users and the public. Lastly, developing a balanced and comprehensive approach to the use of drugs in prisons by reducing demand and restricting supply is to disrupt the channels that supply drugs and other illegal objects.

Protecting Health

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Non-legislative Act: On the 3rd of February 2021 the European Commission published a Communication on Europe's Beating Cancer Plan (Press release) .

Problem: While the EU has previously introduced action on tobacco control and protection from hazardous substances that have positively impacted the fight against cancer, there has not been a European action plan that explicitly targets the leading cause of death in the EU. Considering that research and innovation, such as mRNA technologies, alongside digital technologies, have dramatically advanced the understanding for cancer initiation and progression, prevention and diagnosis, there is a need of an optimised as well as a Union-wide strategy that mobilises the collective power of the EU to drive change to the benefit of its citizens. Therefore, the Cancer Plan contains concrete, ambitious actions that will support, coordinate, and complement member states’ efforts to reduce the suffering caused by cancer.

Objective: Prevention, early detection, diagnosis, and treatment as well as the quality of life of cancer patients and survivors build the four pillars of EU’s Beating Cancer Plan. In the Communication, the Commission highlights the need to focus on research and innovation, tap into the potential that digitalisation and new technologies offer, and mobilise financial instruments to support individual member states. Through a Union-wide cooperation, essential expertise and resources will be shared, supporting countries, regions and cities with less knowledge and capacity. It will further help researchers to exchange findings between small and large member states, enabling access to crucial health data on the potential causes of cancer and promising treatments for it. Medical staff and hospitals will be able to tap into a wealth of shared information. Ultimately, it will ensure that all patients across the EU can benefit from better care and treatment.

Subject Matter: Within the Joint Research Center a new Knowledge Centre on Cancer is to be launched in 2021, helping in the coordination of scientific and technical cancer-related initiatives at EU level as well as diffusing best practice implementation and issuing guidelines to support new actions under the Cancer Plan. With a European Cancer Imaging Initiative, the sharing of anonymised images will be made accessible to a wide range of stakeholders across the ecosystem of hospitals, researchers and innovators. Europe’s Beating Cancer Plan will financially support member states’ efforts to extend routine vaccination against human papillomaviruses. Further, actions include the creation of a ‘Tobacco-Free Generation’ by reviewing the Tobacco Products and the Tobacco Taxation Directives and the legal framework on cross-border purchases of tobacco, as well as the revision of EU’s legislation on alcohol taxation and cross-border purchases of alcohol products. Reducing harmful alcohol consumption through support to capacity-building and best practice while also reducing young people’s exposure to online marketing and advertising of alcohol products shall be implemented. Optimising the EU Cancer Screening Scheme and the European Cancer Information System to enable, monitor and assess cancer screening is programmed starting in 2021. To ensure that children have access to rapid and optimal detection, diagnosis, treatment and care, the ‘Helping Children with Cancer Initiative’ shall be launched in addition to a Cancer Inequalities Registry to map trends in key cancer data identifying inequalities between member states and regions.

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Non-legislative Act: On the 25th of November 2020 the European Commission published a Communication on a Pharmaceutical Strategy for Europe (Press release) .

Problem: Safe, effective and affordable medicines are essential for the proper functioning of EU’s healthcare systems. Although new medicines, vaccines and treatments have helped to tackle some leading causes of disease and life-threatening illnesses, not all patients can benefit from modern innovations, because medicines are either unaffordable or unavailable. Thus, the Commission deems it necessary to ensure that it has a strong, fair competitive and green industry that delivers for patients, and which draws on the potential of the digital transformation of health and care, driven by technological advances in fields such as artificial intelligence and computational modelling.

Objective: Well-functioning international supply chains in addition to a well performing single market for pharmaceuticals, through an approach that covers the entire lifecycle of pharmaceutical products, from production to distribution, consumption and disposal, is proposed by the communication. While boosting the sector’s global competitiveness, the quality and safety of medicines shall be established. The cooperation between authorities in the member states and the European Economic Area within the European medicines regulatory network shall ensure that patients have access to high-quality, effective and safe medicines. Building on common values of universal access to good quality care, equity and solidarity, the competitiveness and innovative capacity of the EU’s pharmaceutical industry is to be supported. Respectively, the EU will develop an open strategic autonomy and ensure robust supply chains, including in times of crisis.

Subject Matter: Promoting investment and coordinating research, development, manufacturing, deployment as well as the use for novel antibiotics is to be insinuated by the new EU Health Emergency Response Authority. The revision of the legislation on medicines for children and rare diseases with the objective to improve the therapeutic landscape and address unmet through more tailored incentives is planned for 2022. Joint meetings of existing committees of regulators, health technology assessment (HTA) bodies and payers, involving key actors in the development, authorisation and access to medicines is necessary for a lifecycle approach and improved availability and affordability. Based on mutual learning and best-practice exchange on pricing, payment and procurement policies, the affordability and cost-effectiveness of medicines and health system’s sustainability shall be improved. Skills investment shall be prioritised in order to support the availability of a skilled workforce and its adaptability through the NextGenerationEU, and within the new Recovery and Resilience Facility and through commitments under the pact for skills. Enhancing dialogue among regulatory and other relevant authorities in the area of medicines and medical devices will increase cooperation on evidence generation within their respective fields. The support collaborative projects bringing together stakeholders to take forward the use of high-performance computing and artificial intelligence in combination with EU health data for pharmaceutical innovation. Other actions include cooperation with the EMA and the network of national regulators, promoting regulatory convergence as well as ensuring access to safe, effective high-quality and affordable medicinal products globally.

ZEI Related Publications

A European Way of Life?!

Liska Wittenberg

In: Robert Stüwe / Liska Wittenberg (Hrsg.): ZEI Future of Europe Observer, Von der Leyen: Europe’s New Deal Despite Corona?, Bd. 8 Nr. 1 April 2020, p. 12-13.

Diese Ausgabe des ZEI Future of Europe Observer bildet den Auftakt für das neu ausgerichtete Forschungsprojekt des ZEI zu den jährlichen Arbeitsprogrammen der Europäischen Kommission. Das ZEI-Projekt baut auf der bisherigen Arbeit des ZEI zur Juncker-Kommission auf. Zur Veranschaulichung des Stands einzelner Gesetzesmaßnahmen der EU soll die ZEI-Monitor-Ampel dienen. Im vorliegenden Heft analysieren unsere Research Fellows die sechs politischen Prioritäten der von der Leyen-Kommission und werfen einen Blick auf die anstehenden Aufgaben.

Identität und Weltfähigkeit. Sichtweisen aus einem unruhigen Europa.

Ludger Kühnhardt

Baden‐Baden: Nomos, 2020, Schriften des Zentrum für Europäische Integrationsforschung, Band 80, 744 Seiten, ISBN 978‐3‐8487‐6303‐0.

Die Zusammenhänge zwischen Fragen der Identität und der vielschichtigen globalen Transformation waren, weit über Europa hinaus, selten so  offenkundig wie im zweiten Jahrzehnt des 21. Jahrhunderts. Die Suche nach Identitätsklärungen stand – und steht auch weiterhin – im Kern der multiplen europäischen Krisenphänomene. Gleichzeitig war – und ist – die Europäische Union mit der Aufgabe konfrontiert, strategisch sprechen und handeln zu lernen hinsichtlich ihrer Rolle in der Welt. In der Rückschau zeigt sich, wieder einmal, dass und wie Krisen Auslöser einer vertieften und weiterführenden Reflexion über die politische Bedeutung und Zielrichtung der Europäischen Union und der Integrationsidee selbst waren. Professor Ludger Kühnhardt, Direktor am Zentrum für Europäische Integrationsforschung (ZEI) der  Universität Bonn ordnet in diesem Band seine Standpunkte, Sichtweisen und Stellungnahmen aus dem Jahrzehnt 2010 bis 2020.

The Juncker Commission: "Towards a New Policy on Migration"

Liska Wittenberg

In: Robert Stüwe / Thomas Panayotopoulos (eds.): The Juncker Commission. Politicizing EU Policies (Schriften des Zentrum für Europäische Integrationsforschung, Vol. 79), Nomos, Baden-Baden 2020, p. 169-181.

Das primäre Erkenntnisinteresse des Buches besteht darin, Strategien der Europäischen Kommission beim Umgang mit dem Phänomen der Politisierung in der EU‐Gesetzgebung zu erforschen. In einer Fallstudie zur Amtszeit von Präsident Jean‐Claude Juncker analysieren die Autoren des Sammelbandes, wie die EU‐Kommission zwischen 2014 und 2019 bestimmte politische Schwerpunkte gesetzt hat, um ihre Agenda voranzutreiben. Gegenstand der Analyse sind die zehn politischen Prioritäten der Juncker‐Kommission aus den jährlichen Arbeitsprogrammen seit 2014. Ausgangspunkt der Studie ist das von Juncker proklamierte Selbstverständnis als „politischer Kommission“. Die Bewertung der „Politisierung“ integrationspolitischer Vorhaben fällt dabei ambivalent aus: Auf der einen Seite hat die Juncker Kommission politisierte Themen gezielt aufgegriffen und als Gelegenheiten zur politischen Führung sowie zur Schärfung des eigenen institutionellen Profils genutzt. Auf der anderen Seite sah sich die EU‐Kommission zuweilen gezwungen, bei Krisen und Kontroversen Schadensbegrenzung zu betreiben.

Europe´s Migration Policy Towards the Mediterranean. The Need of Reconstruction of Policy-Making

Marvin Andrew Cuschieri

 ZEI Discussion Paper C 168 / 2007

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