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Press material Tuesday 13 June 2023

● Council of the EU   13/06/2023 16:35 | Press release | Council and European Parliament agree on rules to digitalise the visa procedure   Council negotiators and the European Parliament have provisionally agreed on rules to digitalise the visa procedure. The regulation introduces the possibility to apply for a visa online and replaces the current visa sticker with a digital visa. The goal of the proposal is twofold: to make the visa application procedure more efficient and to improve the security of the Schengen area. The agreement still needs to be approved by member states before the adoption process in the Council and the European Parliament can start. "The digital visa will make the application process easier for travellers, simplifies the administrative procedure and increases the security of the Schengen area by for example reducing the risk of falsification and theft of the visa sticker." Maria Malmer Stenergard, Swedish Minister for Migration The rules – when finally adopted – will create an EU visa application platform. With a few exceptions, applications for Schengen visas will be made through this platform, a single website, which will forward them to the relevant national visa systems. On this platform, visa applicants will be able to introduce all relevant data, upload electronic copies of their travel- and supporting documents, and pay their visa fees. They will also be notified of the decisions concerning their visa. In-person appearance at the consulate will in principle only be necessary for first-time applicants, persons whose biometric data are no longer valid and those with a new travel document. When a person intends to visit several Schengen countries, the platform will automatically determine which one of them is responsible for examining the application on the basis of the duration of stay. However, the applicant will also have the possibility to indicate whether the application needs to be processed by a specific member state according to the purpose of travel. Under the proposed new rules, visas will be issued in digital format, as a 2D barcode, cryptographically signed. This will reduce security risks related to counterfeit and stolen visa stickers. Background Recent migration and security challenges have significantly transformed the context of the EU’s visa policy. In addition, the COVID-19 pandemic considerably slowed down visa operations and created the need for more digital procedures. At the same time, technological developments provide new security features and opportunities to make procedures smoother and more effective, both for visa applicants and national authorities. In this context, the Commission submitted on 27 April 2022 a legislative proposal aimed at digitalising the visa procedure. EU visa policy (background information)

Press material Tuesday 13 June 2023

● Council of the EU   13/06/2023 16:28 | Press release | New Head of Mission appointed for EULEX Kosovo   The Council appointed today a new Head of Mission (HoM) for the EU Rule of Law Mission in Kosovo* (EULEX Kosovo). Mr Giovanni Pietro Barbano will replace Mr Lars-Gunnar Wigemark as HoM. Mr Barbano is a Major General in the Italian Carabinieri and the current Director of the Center of Excellence for Stability Police Units in Vicenza, Italy. His mandate as Head of EULEX Kosovo will run from 26 June 2023 until 14 June 2025. The decision to appoint Mr Barbano was taken by the EU member states in the Political and Security Committee (PSC). Furthermore, the Council recently extended the mandate of the mission until 14 June 2025 and in line with the latest strategic review of EULEX Kosovo, decided that, in addition to continuing to implement its tasks, the mission would assist the law enforcement authorities of Kosovo in developing their capacities to exchange information with regional and international counterparts in the field of legal assistance and cooperation in criminal matters. Background EULEX Kosovo was launched in 2008 as the largest civilian mission under the Common Security and Defence Policy of the European Union. EULEX’s overall mission is to assist the Kosovo authorities in establishing sustainable and independent rule of law institutions, with a focus on the police, judiciary and customs areas and through monitoring and operations pillars. Under EULEX’s current mandate, the mission undertakes monitoring activities and has limited executive functions, including as second tier security responder. EULEX continues to support the Specialist Chambers and Specialist Prosecutor’s Office in line with relevant Kosovo legislation. The mission works within the framework of UN Security Council Resolution 1244. * This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence Giovanni Pietro Barbano CV EULEX Kosovo website

Meetings Tuesday 13 June 2023

● Council of the EU   13/06/2023 15:49 | MEETING | Main results - Employment, Social Policy, Health and Consumer Affairs Council, 12-13 June 2023   EU health ministers met in Luxembourg where they adopted a recommendation on antimicrobial resistance and agreed on a general approach on the fee system for the European Medicines Agency. They also discussed ways to strengthen the pharmaceutical ecosystem and took stock of progress on other legislative files.

Meetings Tuesday 13 June 2023

● Council of the EU   13/06/2023 12:44 | MEETING | Supporting the future of Syria and the region - Brussels seventh Conference, 15 June 2023   Background note - Supporting the future of Syria and the region - Brussels seventh Conference, 15 June 2023

Press material Tuesday 13 June 2023

● Council of the EU   13/06/2023 10:51 | Press release | European Medicines Agency: Council agrees approach on a more modern and simplified fee structure   EU health ministers have set out the Council’s position on a regulation to modernise and simplify the structure of the fees payable to the European Medicines Agency (EMA) to better reflect the evolving demands and challenges it faces. The general approach approved today will enable the Council to start negotiations with the European Parliament. "The European Medicines Agency and national competent authorities play vital roles in protecting and promoting public and animal health. Today EU health ministers endorsed an approach that will enable this work to continue, supported by a fee system that is modern, straightforward and sufficiently flexible to adapt to future developments." Jakob Forssmed, Swedish Minister for Social Affairs and Public Health Aims of the new rules The proposed regulation aims to update the existing legislation governing fees charged by EMA. It will ensure that fees and remuneration are cost-based, flexible, and ensure adequate funding to guarantee the future sustainability of operations of the EMA while also providing sufficient support to member states’ national competent authorities (NCAs). The proposal also seeks to reduce the complexity of the current legal framework. Why does EMA’s fee structure need updating? EMA plays a crucial role in evaluating and supervising medicines, with the wider goal of benefitting human and animal health. In order to deliver on its mission, the agency needs a sound financial basis to support its operations, yet the existing fee structure is increasingly complex and no longer reflects the nature of the work and challenges involved. It is also necessary to remunerate the fundamental contribution of NCAs in a sustainable way. The position of the Council The Council’s general approach maintains the key elements of the Commission’s proposal, including the transition to a cost-based approach. Nevertheless, it fine-tunes the provisions for adjusting EMA’s fees and remuneration, ensuring that NCAs’ costs will be covered. The general approach also clarifies some of the measures relating to flexibility, which allow for further changes to be made to the fee system at a later date. Specifically, the Council has expanded the role of EMA’s management board updating the fees. Next steps Today’s general approach provides the upcoming Spanish presidency of the Council with a mandate to begin negotiations with the European Parliament, with a view to reaching a provisional agreement. Background EMA’s existing fee system has been in place for almost two decades, during which time it has become increasingly complex. A recent evaluation of the system identified five key issues, including misalignment of some of the fees with the underlying costs, a lack of remuneration for certain procedural activities, and discrepancies between relevant legal provisions. On 13 December 2022, the Commission published a proposal for a regulation revising the existing EMA fees system. The proposal has three objectives: to move from a flat-rate system to a cost-based system for EMA fees to ensure the sustainability of the European regulatory network formed by the EMA and National Competent Authorities (NCAs) to simplify existing legislation by merging the content of the two current EMA fee regulations for pharmacovigilance and non-pharmacovigilance fees into one single legal instrument Health ministers discussed the proposal and the Council’s position at the EPSCO Council on 14 March 2023. EU health policy (background information) Regulation on fees and charges payable to EMA – General approach

Press material Tuesday 13 June 2023

● Council of the EU   13/06/2023 10:44 | Press release | Tackling antimicrobial resistance: Council adopts recommendation   Today the Council has adopted a recommendation aimed at stepping up EU action to combat antimicrobial resistance (AMR) in the fields of human health, animal health and the environment. "We cannot afford to ignore the deadly threat that drug-resistant microorganisms pose to human health. Tackling antimicrobial resistance has been a key priority for the Swedish presidency and today’s recommendation provides EU countries with the tools to monitor and reduce antimicrobial consumption." Jakob Forssmed, Swedish Minister for Social Affairs and Public Health The recommendation employs a “One Health” approach to AMR, based on the fact that the health of humans, animals and the environment is intrinsically linked and that AMR can only be overcome through joint efforts taken across all three areas. Overall, the Council’s recommendation seeks to encourage the prudent use of antimicrobials such as antibiotics in human and animal health through a series of voluntary measures, with the aim of reducing the risk that microorganisms will become resistant to medical intervention. The proposed measures set out in the recommendation include: concrete targets to reduce antimicrobial use by 2030, including a 20% reduction in total human consumption of antibiotics and a 50% reduction in overall EU sales of antimicrobials used for farm animals and aquaculture strengthening of national action plans to help implement these targets and monitor the use of antibiotics at national level, including indicators to assess progress better surveillance of AMR and antimicrobial consumption (AMC) at all levels, including hospitals and long-term care facilities efforts to improve the health and welfare of food-producing animals to decrease the spread of infectious diseases in farming awareness raising among the public and professionals working in the human health and veterinary sectors, including training for health professionals and communication campaigns Background Antimicrobials are medicines that are used to prevent and treat infections in humans, animals and plants. They include antibiotics, antivirals, antifungals and antiparasitics. AMR occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to antimicrobials. As a result, antibiotics and other antimicrobial medicines are rendered ineffective and infections become increasingly difficult or even impossible to treat. AMR causes more than 35 000 deaths every year in the European Economic Area. If it continues to rise, it could lead to an estimated 10 million deaths globally each year, as well as having a severe impact on the world’s economy. The Commission published a proposal for a Council recommendation on AMR on 26 April 2023 as part of a package of measures aimed at reforming the EU’s pharmaceutical legislation. EU health policy (background information) Council recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach

Meetings Monday 12 June 2023

● Council of the EU   12/06/2023 18:17 | MEETING | Main results - Employment, Social Policy, Health and Consumer Affairs Council, 12-13 June 2023   On day one of the EPSCO Council in Luxembourg, EU employment and social affairs ministers agreed on the Council’s position for the directive on platform work. They also agreed the Council’s general approach on a directive establishing exposure limits for lead and diisocyanates in the workplace, and two directives setting out standards for equality bodies. Furthermore, they adopted a recommendation on strengthening social dialogue and approved conclusions on mainstreaming a gender equality perspective. Finally, they exchanged views on the European Semester and the directive on equal treatment.

13/06/2023 12:00 | Press release EU ministers discussed contribution of agriculture and forestry to growing bioeconomy and sustainable development On 11–13 June, EU ministers for agriculture gathered in Stockholm for an informal meeting on the potential of agriculture and forestry to contribute to a growing, resource-efficient bioeconomy and sustainable development.

13/06/2023 00:00 | Event

Informal meeting of agriculture ministers

On 11–13 June 2023, EU agriculture ministers will take part in an informal meeting in Stockholm, chaired by Minister for Rural Affairs Peter Kullgren. The theme of the meeting is the potential of agriculture to contribute to the green transition. This meeting provides an opportunity for the participants to learn about and see more of Swedish agriculture, research and innovation in an informal and relaxed setting. The programme includes a number of study visits, including the chance to see Swedish innovative agricultural solutions. Mr Kullgren will then host a dinner for the delegates that will showcase Swedish food and culture.