The Commission is today reporting on Croatia’s progress in meeting the necessary conditions to join the Schengen area. The European Commission considers that, based on the results of the Schengen evaluation process initiated in 2016, Croatia has taken the measures needed to ensure that the necessary conditions for the full application of the Schengen rules and standards are met. Croatia will need to continue working on the implementation of all ongoing actions, in particular its management of the external borders, to ensure that these conditions continue to be met. The Commission also today confirms that Croatia continues to fulfil the commitments, linked to the Schengen rules, that it undertook in the accession negotiations.
President Jean-Claude Juncker said: “I commend Croatia for its efforts and perseverance to meet all the necessary conditions to join Schengen. It is only through being united and standing together that we can ensure a stronger Schengen area. Sharing the achievement of Schengen must be our common objective. This is why I trust that Member States will take the right steps for Croatia to become a full Schengen member soon.”
Commissioner for Migration, Home Affairs and Citizenship Dimitris Avramopoulos said: “Schengen is one of the greatest and most tangible achievements of European integration. But its strength very much depends on its inclusiveness – now that Croatia has taken the measures to ensure that the necessary conditions are met, we must recognise this. Once it becomes a full Schengen member, it will contribute to further strengthening the Schengen area and ensure that the EU’s external borders are better protected.”
In his 2017 State of the Union Address, President Juncker expressed his unequivocal support for Croatia becoming a full Schengen member once all the necessary conditions were met. Today, the Commission is reporting on the positive result of a long process of evaluation and cooperation, which has seen Croatia steadily improve to meet those conditions.
Assessment of all Schengen criteria
Today’s Communication takes stock of the evaluations conducted between June 2016 and May 2019, which examined the application of Schengen rules and standards by Croatia in a number of areas. Whilst the Commission had already successfully evaluated and confirmed the full implementation of the Schengen rules in the areas of data protection, police cooperation, common visa policy, return, the Schengen Information System (SIS), firearms and judicial cooperation in criminal matters, today’s communication also confirms that Croatia has taken the necessary measures to ensure that the conditions for the application of Schengen rules in the field of external border management are met. Croatia will need to continue working to ensure the consistent implementation of all ongoing actions in this field.
Finally, the Commission is also reporting on the fulfilment of commitments undertaken by Croatia in its accession negotiations that are relevant for the Schengen rules. The commitments in particular concern the area of the judiciary and respect of fundamental rights. The Commission today confirms that Croatia continues to fulfil all of them.
The Commission invites the Council to discuss this communication with the aim of integrating Croatia into the Schengen area in line with the 2011 Act of Accession.
The Schengen area is the largest free-travel area in the world, currently including 22 EU countries (Austria, Belgium, Denmark, France, Finland, Germany, Greece, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia) as well as 4 associated non-EU countries (Norway, Iceland, Switzerland and Liechtenstein). It allows citizens to move freely between those countries without having to go through border checks, making it easier to travel, work and live across borders.
Countries wishing to join the Schengen area must undergo a series of Schengen evaluations to confirm whether they fulfil the conditions necessary for the application of the Schengen rules. These evaluations assess whether a country is able to take responsibility for controlling the external borders on behalf of the other Schengen States, efficiently cooperate with other law enforcement agencies in other Schengen states in order to maintain a high level of security once border controls are abolished, apply the Schengen rules such as control of external land, sea and air borders (airports), issuing of Schengen visas, return procedures, police cooperation and protection of personal data, and finally the need to connect to and the use of the Schengen Information System.
Once it is considered that all the necessary conditions for the application of all the relevant parts of the Schengen rules are met, it is for the Council, following consultation of the European Parliament, to take a final decision by unanimity.
Croatia declared its readiness to start the Schengen evaluation process in all relevant policy areas in March 2015. Today’s report takes stock of the progress made during this evaluation process in all relevant areas and confirms the continued fulfilment of commitments undertaken by Croatia during its accession negotiations to the EU.
Coronavirus: EU Strategy for the development and availability of therapeutics
The European Commission is today complementing the successful EU Vaccines Strategy with a strategy on COVID-19 therapeutics to support the development and availability of much-needed COVID-19 therapeutics, including for the treatment of ‘long COVID’. Today’s Strategy covers the full lifecycle of medicines: from research, development and manufacturing to procurement and deployment.
It is part of the strong European Health Union, in which all EU countries prepare and respond together to health crises and ensure the availability of affordable and innovative medical supplies – including the therapeutics needed to treat COVID-19.
The Strategy includes clear actions and targets, including authorising three new therapeutics to treat COVID-19 by October 2021 and possibly two more by end of the year. Concretely:
- Research, development and innovation
- Invest €90 million in population studies and clinical trials to establish links between risk factors and health outcomes to further inform public health policy and clinical management, including for long-COVID patients.
- Set up a ‘therapeutics innovation booster’ by July 2021 to support the most promising therapeutics from preclinical research to market authorisation. It will build on current initiatives and investments in therapeutic development, working in a close cooperation with the European Health Emergency Preparedness and Response Authority (HERA) preparatory action on mapping therapeutics. It will therefore ensure the coordination of all research projects on COVID-19 therapeutics, stimulating innovation and boosting therapeutic development.
- Access to and swift approval of clinical trials
- Invest €5 million under the EU4Health programme to generate better, high-quality safety data in clinical trials, which will help produce robust results in a timely manner.
- Provide EU countries with financial support of €2 million under the EU4Health 2021 work programme for expedited and coordinated assessments to facilitate approval of clinical trials.
- Explore how to support developers of therapeutics to build capacity to produce high-grade material for clinical trials.
- Scanning for candidate therapeutics
- Invest €5 million to map therapeutics and diagnostics to analyse development phases, production capacities and supply chains, including possible bottlenecks.
- Establish a broader portfolio of 10 potential COVID-19 therapeutics and identify five of the most promising ones by June 2021.
- Supply chains and delivery of medicines
- Fund a €40 million preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fab project, which in turn will become over time an important asset for the future the European Health Emergency Preparedness and Response Authority (HERA).
- Regulatory flexibility
- Authorise at least three new therapeutics by October and possibly two more by the end of the year and develop flexible regulatory approaches to speed up the assessment of promising and safe COVID-19 therapeutics.
- Start seven rolling reviews of promising therapeutics by end-2021, subject to research and development outcomes.
- Joint procurement and financing
- Launch new contracts for the purchase of authorised therapeutics by the end of the year.
- Secure faster access to medicines with shorter administrative deadlines.
- International cooperation to make medicines available to all
- Reinforce engagement for the therapeutics pillar of the Access to COVID-19 Tools Accelerator.
- Boost ‘OPEN’ initiative for international collaboration.
The Commission will draw up a portfolio of 10 potential COVID-19 therapeutics and by June 2021, identify the five most promising ones. It will organise matchmaking events for industrial actors involved in therapeutics to ensure enough production capacity and swift manufacturing. New authorisations, rolling reviews and joint procurement contracts will be up and running before the end of the year.
The therapeutics innovation booster, matchmaking events and preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fab project, will feed into the HERA, for which a proposal is due later in the year. The pilot project on access to health data will feed into the European Health Data Space proposal expected later this year.
Members of the College said:
Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “The situation in many intensive care units across the continent remains critical. We need to focus both on vaccines and therapeutics, as two powerful and complementary ways to combat COVID-19. But currently we have only one authorised medicine to treat COVID-19. By acting on better availability of medicines today, we are making sure patients receive the treatments they need while also preparing our future biomedical preparedness. A coordinated strategy on quick access to therapeutics will boost our strategic autonomy and contribute to a strong Health Union.”
Commissioner for Health and Food Safety, Stella Kyriakides, said: “Vaccinations save lives, but they cannot yet eradicate COVID-19. We need a strong push on treatments to limit the need for hospitalisation, speed up recovery times, and reduce mortality. Patients in Europe and across the world should have access to world-class COVID-19 medicines. This is why we have set a very clear goal: by October, we will develop and authorise three new effective COVID-19 therapeutics that can have the potential to change the course of the disease. We will do so by investing in research and innovation, the identification of new promising medicines, ramping up production capacity and supporting equitable access. Our Therapeutics Strategy is a strong European Health Union in action.”
Commissioner for Innovation, Research, Culture, Education and Youth, Mariya Gabriel, said: “By increasing vaccine availability across Europe, more and more Europeans are now protected against COVID-19. In the meantime, the development of innovative medicines to treat coronavirus patients remains a priority when it comes to saving lives. Research and innovation is the first step to finding effective and safe therapeutics, which is why we are proposing to establish a new COVID-19 ‘therapeutics innovation booster’ and will invest € 90 million in population studies and clinical trials.”
The Strategy on COVID-19 therapeutics complements the EU strategy for COVID-19 vaccines from June 2020 and builds on ongoing work by the European Medicines Agency and the Commission to support research, development, manufacturing and deployment of therapeutics.
The Strategy forms part of a strong European Health Union, using a coordinated EU approach to better protect the health of our citizens, equip the EU and its Member States to better prevent and address future pandemics, and improve the resilience of Europe’s health systems.
EU defence gets a boost as the European Defence Fund becomes a reality
Commission welcomes the adoption of the European Defence Fund (EDF), following the European Parliament’s approval. The EDF, with a budget of €7.9 billion, is the Commission’s flagship instrument to support defence cooperation in Europe. EDF will co-finance collaborative research and capability development projects amplifying national investment. It will also foster an innovative and competitive defence industrial base. In doing so, it will enhance Union’s technological sovereignty and therefore its open strategic autonomy.
Margrethe Vestager, Executive Vice-President for a Europe Fit for the Digital Age, said: “This is an important step for a stronger Europe. The Fund will play a key role to enable SMEs to participate in defence supply chains and widen cross-border industrial cooperation. Providing opportunities to companies all sizes helps achieving more innovative solutions, to foster an open internal market. So besides a stronger defence cooperation it contributes to our competitiveness.”
Thierry Breton, Commissioner for Internal Market, said: “Today marks a historic day for Europe. The idea of working together for promoting our Defence Union and for the security of EU citizens is now a tangible reality. In a global context where Europe needs to be stronger, more resilient and more autonomous in strategic areas, the European Defence Fund is a milestone and will significantly contribute to the security of EU citizens.”
A Fund to deepen EU defence industrial cooperation
Without substituting Member States’ efforts, the Fund will promote cooperation between companies of all sizes and research actors throughout the EU, in research and development of state-of-the-art and interoperable defence technology and equipment.
The Fund will support competitive and collaborative defence projects throughout the entire cycle of research and development, focusing on projects that have the potential to be game-changers for the armed forces of Member States. The Fund will foster innovation and incentivise the cross-border participation of SMEs. Projects will be defined based on defence capability priorities agreed by Member States within the framework of the Common Security and Defence Policy and particularly in the context of the Capability Development Plan. The projects will aim at contributing to the security and defence interests of the Union.
The EDF allows for the participation of European subsidiaries of third country companies and also for the cooperation with third country companies provided that their involvement ensure the security and defence interests of the EU, and meet the rigorous security conditions as set in the EDF Regulation.
A strong budget for ambitious and inclusive defence programmes
2021 constitutes the first year of the rollout of the new EDF, which will be operational for the period 2021-2027, in alignment with the Multiannual Financial Framework.
It will be endowed with a budget of €7,953,000,000 in current prices. This financial envelope will be divided into two pillars: €2,651,000,000 will be allocated to funding collaborative defence research to address emerging and future security threats and €5,302,000,000 to co-finance collaborative capability development projects.
Up to 4%-8% of the Fund budget is devoted to development or research for disruptive technologies (i.e. technologies that have the potential to create game-changing innovations). This budget represents an unprecedented opportunity to contribute to the development of a competitive and innovative European defence industry.
The complete establishment of the Fund both legally and financially will now allow the Programme Committee (PC), chaired by the Commission and composed of Member States representatives, to discuss priorities and confront topics with the aim to open calls for proposals in summer 2021. The Commission will directly manage the programme. The European Defence Agency (EDA) is invited to participate as observer and the European External Action Service (EEAS) will assist in the Committee.
The creation of a European Defence Fund was first announced in 2016. The Commission presented the first version of the European Defence Fund in June 2017, which has allowed defence cooperation at EU level to embark thanks to two pilot projects, the Preparatory Action on Defence Research (PADR) for 2017-2019 and the European Defence Industrial Development Programme (EDIDP) for 2019-2020.
The Fund is part of the priorities of the von der Leyen Commission for a ‘Stronger Europe in the World’.
A political agreement between the Member States and the European Parliament was found in December 2020 and today’s decision gives legislative effect to the EDF that will operate for the next 7 years.
Dual-use goods: what are they and why are new rules needed?
The EU is working on new export rules for so-called dual-use goods to prevent them being misused in human rights violations.
What are dual-use goods?
Dual-use products are goods designed for civilian use that in the wrong hands could be used to supress human rights or launch terrorist attacks. They can be anything from drones to chemicals.
Although these goods can improve people’s lives, they can be misused. Authoritarian regimes might use them to keep the population under control, while terrorist groups could use them to stage attacks.
Why are new rules needed?
To prevent dual-use goods being repurposed in ways that violate human rights , the EU wants to make sure strict export rules prevent them being sold to people or organisations wanting to misuse them.
The EU is currently working on an update of the existing rules to take into account recent technological developments, including new cyber surveillance tools, and beef up protection of human rights.
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