COUNCIL OF THE EUROPEAN UNION,update

 

25/09/2023 | Article Highlights of the agenda of the informal ministerial meeting on general affairs and cohesion policy On 28-29 September, the informal ministerial meeting on general affairs and cohesion policy will take place in Murcia to discuss issues such as the enlargement of the EU.

Press material Monday 25 September 2023

● Council of the EU   25/09/2023 17:21 | Press release | European Medicines Agency: Council and Parliament strike deal on a sustainable and flexible fee system   The presidency of the Council and European Parliament negotiators reached a provisional agreement on a regulation to modernise and simplify the structure of fees payable to the European Medicines Agency (EMA). The agreement still needs to be confirmed by both institutions before going through the formal adoption procedure. "Today’s agreement marks the transition to a sustainable, simpler and more flexible fee system for the European Medicines Agency. In order to ensure safety and high-quality medicines in the Union market, it is of paramount importance to ensure adequate funding for the agency and national competent authorities to deliver a top-class regulatory system." José Manuel Miñones Conde, Spanish Acting Minister of Health Facts and figures on the EMA’s fees The EMA charges a fee for processing applications from companies that wish to launch a medicine on the market, as well as for other tasks, such as monitoring the safety of medicines (pharmacovigilance). For 2023, fees and charges accounted for around 89% of the agency’s budget. The agency also pays national authorities for the scientific evaluation of applications. In 2023, it is estimated that €163 million will be paid to the national medicines regulatory agencies from the agency’s budget. Why does the EMA’s fee structure need updating? The EMA plays a crucial role in protecting and promoting human and animal health by evaluating and monitoring medicines. In order to deliver on its mission, the agency needs a sound financial basis to support its operations. However, the existing fee structure is increasingly complex and no longer reflects the nature of the work and the challenges involved. Key elements of the provisional agreement The provisionally agreed text stipulates that fees charged by the EMA should be cost-based. The text provides for a simplification of the current legal framework by establishing a single legal instrument for all fees (pharmacovigilance and marketing authorisations). It also provides for a more sustainable and flexible fee system, which will ensure both adequate funding for the EMA and sufficient support for national competent authorities in their tasks. To this end, three changes were introduced in the initial proposal: adjustment of certain fees to reflect inflation rates, including medicines for human use, and a smaller increase for veterinary products increase of fees for scientific advice and procedures regarding generic medicines, in order to put EMA on a sustainable financial footing increase in remuneration allocated to national competent authorities in order to cover the full costs of the work that they do for EMA and to ensure that they have the necessary qualified staff to do so The provisionally agreed text also contains changes to the monitoring and revision of fees. The aim is to increase the flexibility of the system and make it adaptable to future needs. In particular, the amendments are designed to expand the role of EMA’s management board, covering such areas as the updating of fees or adapting these to changing circumstances. Background The 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 a series of key issues. These included the misalignment of some of the fees with the underlying costs, a lack of sufficient costing for certain procedural activities, the overall complexity and lack of flexibility of the system, and discrepancies between relevant legal provisions. On 13 December 2022, the Commission published a proposal for a regulation revising the existing EMA fee system. The proposal has three objectives: to move from a flat-rate to a cost-based fee system to ensure the sustainability of the European regulatory network formed by the EMA and national competent authorities 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 Next steps Today’s provisional agreement must now be endorsed by the Council and the Parliament. It will then be formally adopted by both institutions. Negotiations between the two co-legislators were launched on 5 September and are concluded with today’s agreement. Key measures in health policy (background information)

Meetings Monday 25 September 2023

● Council of the EU   25/09/2023 17:20 | MEETING | Main results - Competitiveness Council (Internal market and industry), 25 September 2023   Ministers responsible for the internal market and industry met in Brussels to adopt a Council position on the Euro 7 regulation on motor vehicles emissions and on the review of the EU legislation on design protection.

Press material Monday 25 September 2023

● Council of the EU   25/09/2023 11:21 | Press release | Euro 7: Council adopts position on emissions from cars, vans, buses and trucks   The Council has today adopted its position (‘general approach’) on the proposed regulation for the type-approval of motor vehicles and engines, and of systems, components and separate technical units intended for such vehicles, with respect to their emissions and battery durability, better known as Euro 7. The new regulation, which for the first time covers cars, vans and heavy-duty vehicles in a single legal act, aims to set more adequate rules for vehicle emissions and to further lower air pollutant emissions from road transport. "Europe is known across the globe for producing low-emission and top-quality cars. We want to continue pursuing the goal of improving air quality. Our position is to continue the path of leading the mobility of the future and adopting realistic emissions levels for the vehicles of the next decade while helping our industry make the definitive leap towards clean cars in 2035. The Spanish presidency has been sensitive to the different demands and requests of the member states and we believe that, with this proposal, we achieved broad support, a balance in the investment costs of the manufacturing brands and we improve the environmental benefits derived from the regulation." Héctor Gómez Hernández, acting minister for industry, trade and tourism The Council position strikes a balance between stringent requirements for vehicle emissions and additional investments for the industry, at a moment when European car manufacturers are undergoing a transformation towards the production of zero-emission cars. The general approach keeps the existing emission limits and test conditions for light-duty vehicles. In the case of heavy-duty vehicles, emission limits are lower and test conditions slightly adjusted. Euro 7 also contains a special provision on urban buses to ensure coherence with the newly proposed 2030 zero-emissions target for these vehicles. New elements covered by Euro 7 Euro 7 sets limits for non-exhaust emissions such as particles from brakes and tyres. It additionally covers minimum performance requirements for battery durability in electric cars, and imposes stricter vehicle lifetime requirements. The regulation also provides for the use of advanced technologies and emission-monitoring tools. Council’s mandate The Council suggests a number of pragmatic changes to the Commission proposal while also keeping in mind environmental and health objectives. Among other things: the Council position keeps existing test conditions and emissions limits (as established in Euro 6) for M1 and N1 vehicles (private passenger cars and vans) in the case of M2 and M3 vehicles (buses and coaches), and N2 and N3 vehicles (heavy commercial vehicles), emission limits are lower and test conditions slightly adjusted, in comparison with Euro 6/VI the Council text strengthens the alignment of brake particle emission limits and tyre abrasion rate limits with international standards adopted by the United Nations Economic Commission for Europe it takes into account the newly proposed 2030 zero-CO2 emissions target for urban buses it also sets clear deadlines for the adoption of implementing acts (by the Commission) in order to provide economic operators with clarity and legal certainty

Press material Monday 25 September 2023

● Council of the EU   25/09/2023 10:17 | Press release | Intellectual property: Council adopts two positions on designs protection legislation   The Council has today adopted its positions ('general approaches') on the proposed revision of the designs legislation package: the directive on the legal protection of designs and the regulation on community designs. Updating the 20-year-old designs legislation, the new texts aim at facilitating the protection of industrial designs and adapting EU law in this area to the challenges of a digital and 3D-printing worlds. "Good design protection is essential for the competitiveness of our industry. The new rules will help boost the creativity of our designers and our companies in a faster and more reliable way, adapted to the challenges of the digital age, fighting against counterfeits." Héctor Gómez Hernández, Spanish acting minister for industry, trade and tourism Designs protection in the digital era An industrial design constitutes the external appearance of a product. The visual appeal created by a design is one of the key factors influencing a consumer’s choice in preferring one product over another. Good design constitutes an important competitive advantage for producers and increases the value of the product. Consequently, designs need to be protected against copies or imitations. The proposed directive and regulation update current legislation, which dates from 1998 and 2002 respectively, and will make easier the procedure to register designs at EU level and will further harmonise the procedures between European and national systems. The directive also introduces new rules to protect designs that can be reproduced with 3D printing. Most importantly, the revision aims at further harmonising the design protection for component spare parts used for the repair of complex products (e.g. car body parts). This step will liberalise the spare parts market, thereby delivering lower prices for consumers. This ‘repair clause’ is conceived only for future designs, but it will, however, maintain the protection of existing designs for a period of ten years. The Council's mandate The Council supports the main objectives of the package (i.e. it keeps the concept of the ‘repair clause’ as proposed by the Commission), but introduces several improvements including: an update of the definition of ‘design’ and ‘product’ to make them fit for the digital age and for future technological developments. For instance, ‘digital’ is replaced by ‘non-physical’ a simplification of the requirements to represent the design, so that even if, at the date of the request, some documents are missing, the design can still be registered on that date, provided that the representation of the design is clear enough the introduction of flexibility for designers to be able to defer the time of publication of their design to a maximum of 30 months, with the possibility for member states to give the option to the holders of the design rights to stop the deferment at their request (and not at the end of the deferment period) a clarification of the rules to declare design rights invalid, with the possibility for member states to provide for an administrative procedure of appeal, so that parties do not need to go to court the assurance that the fees for national-only protection should continue to be cheaper than European ones the possibility to cumulate the protection of designs and copyright, including national copyright laws a transposition period of 36 months (instead of 24) to give more time to member states to take the necessary measures to apply the new legislation Next steps The general approach agreed today formalises the Council's negotiating position. It provides the Council presidency with a mandate for negotiations with the European Parliament, which will start as soon as the Parliament adopts its position. Background Design-intensive industries represent almost 16% of GDP and 14% of all jobs in the Union. On 10 November 2020, the Council called the Commission to present proposals to modernise the EU design protection systems, which was almost 20 years old. On 28 November 2022, the Commission published a package of measures with two proposals: a Regulation amending Council Regulation (EC) No 6/2002 on Community designs and a Directive on the legal protection of designs (recast of Directive 98/71/EC). General approach directive on the legal protection of designs (recast) General approach on regulation amending Council Regulation (EC) No 6/2002 on Community designs and repealing Commission Regulation (EC) No 2246/2002 Commission’s proposal on Community Designs regulation

Press material Monday 25 September 2023

● Council of the EU   25/09/2023 10:16 | Press release | European Peace Facility: Council adopts an assistance measure in support of Beninese Armed Forces   The Council today adopted an assistance measure under the European Peace Facility worth €11.75 million to support the Beninese Armed Forces. It will, in particular, focus on supporting the Operation Mirador deployed in the northern parts of Benin since 2022. Through this assistance measure, the EU will provide intelligence, surveillance and reconnaissance (ISR) aircraft and Unmanned Air Systems, including spare parts and maintenance training, in full respect of relevant international law, in particular international human rights law and international humanitarian law. Background and next steps The European Peace Facility was established in March 2021 to finance all Common Foreign and Security Policy (CFSP) actions in military and defence areas, with the aim of preventing conflict, preserving peace and strengthening international security and stability. In particular, the European Peace Facility allows the EU to finance actions designed to strengthen the capacities of third states and regional and international organisations as regards military and defence matters. European Peace Facility, policy page EU cooperation on security and defence (background information) Infographic - European Peace Facility 22/09/2023 | Article EU ministers sign the Barcelona Declaration to promote social and territorial cohesion through transportEU Transport Ministers have concluded the informal ministerial meeting on Transport held in Barcelona with the signing of the Barcelona Declaration, a commitment to accessible, affordable and equitable mobility to promote social and territorial cohesion. PRESS MATERIAL Friday 22 September 2023 ● Council of the EU 22/09/2023 | Press release | Presidency press release - Informal meeting of European ministers of transport, Barcelona, 21-22 September 2023 EU transport ministers have concluded the informal ministerial meeting on transport held in Barcelona with the signing of the Barcelona Declaration, a commitment to accessible, affordable and equitable mobility to promote social and territorial cohesion. Read the presidency press release in EN, FR and ES.

Press material Friday 22 September 2023

● European Council   22/09/2023 18:30 | Press release | The European Council establishes the composition of the European Parliament   The European Council adopted a decision on the composition of the European Parliament today. The decision sets out the number of representatives in each member state to be elected to the European Parliament for the 2024-2029 parliamentary term. The decision sets the number of European Parliament seats at 720 in view of the demographic changes in EU member states. Additional seats have been allocated to: Belgium (+1), Denmark (+1), Ireland (+1), Spain (+2), France (+2), Latvia (+1), Netherlands (+2), Austria (+1), Poland (+1), Slovenia (+1), Slovakia (+1), Finland (+1). In its decision, the European Council invited the budgetary authority and the Commission to ensure that the increase in the number of seats foreseen by this Decision is budgetary neutral within Section 1 of the general budget of the Union. Background According to the Treaty on European Union, the number of Members of the European Parliament cannot exceed seven hundred and fifty (750), plus the President (+1). It provides for representation to be degressively proportional, with a minimum threshold of six (6) members per member state, and with no member state allocated more than ninety-six (96) seats. Today's decision will enable member states to enact the necessary domestic measures for organising the elections to the European Parliament for the 2024-2029 parliamentary term. Numbers of Members per member state 2024-2029 Belgium 22 Bulgaria 17 Czech Republic 21 Denmark 15 Germany 96 Estonia 7 Ireland 14 Greece 21 Spain 61 France 81 Croatia 12 Italy 76 Cyprus 6 Latvia 9 Lithuania 11 Luxembourg 6 Hungary 21 Malta 6 Netherlands 31 Austria 20 Poland 53 Portugal 21 Romania 33 Slovenia 9 Slovakia 15 Finland 15 Sweden 21 TOTAL 720 The text of the decision will be made available at a later stage.

Press material Friday 22 September 2023

● General Secretariat   22/09/2023 17:35 | Press release | Forward look: 25 September - 8 October 2023   Overview of the main topics and events at the Council of EU and European Council for the coming fortnight. Competitiveness Council (Internal market and industry), 25 September 2023 Ministers responsible for the internal market and industry will meet in Brussels on Monday the 25th of September with the aim of adopting Council general approaches on Euro7 and on the two legal texts of the EU legislation on design protection review. Ministers will also hold a policy debate on the role of competitiveness checks in the formulation of legislative proposals. Read more Justice and Home Affairs Council (Home Affairs), 28 September 2023 The Council will receive an update about ongoing legislative discussions to modernise EU asylum legislation and ministers will exchange views about the external dimension of migration. EU ministers and ministers from 14 Latin American countries will discuss cooperation in the fight against drug trafficking and transnational organised crime. Read more Meeting of the European Political Community, Granada, 5 October 2023 The third meeting of the European Political Community will bring together leaders from across the continent in Granada, Spain. Building on the work of the previous meetings of the European Political Community, the leaders will discuss how to make Europe more resilient, prosperous and geostrategic. Read more Informal meeting of heads of state or government, Granada, 6 October 2023 EU leaders will launch discussions on the EU priorities for the years ahead to prepare the EU’s Strategic Agenda and will take stock of past work. Read more Other events Informal meeting of culture ministers, 25-26 September 2023 Informal meeting of the General Affairs Council, 27-28 September 2023 Informal meeting of ministers responsible for cohesion policy, 29 September 2023 Indicative calendar of meetings under the Spanish presidency (1 July - 31 December 2023)

Press material Friday 22 September 2023

● Council of the EU   22/09/2023 15:00 | Press release | Taxation: The EU Code of Conduct Group on business taxation commemorates its 25th anniversary   For 25 years, the EU has continued to promote fair tax competition and address harmful tax practices, both within the EU and worldwide. On the occasion of the informal meeting of the High-Level Working Party on Tax Questions held in Madrid on 21 and 22 September, the Spanish presidency of the Council of the European Union organised a session to commemorate the work the Code of Conduct Group (business taxation). The group was established in 1998 to assess tax measures that may fall within the scope of the Code of Conduct: a political, intergovernmental commitment by member states to identify and assess – based on a number of criteria – tax measures that could be harmful to the tax bases of other member states and the European economy. The group works under the political guidance of EU finance ministers (ECOFIN). It also cooperates with third-country jurisdictions to promote and strengthen tax good governance and carries out work leading to the regular revision of the EU list of non-cooperative tax jurisdictions. The current chair of the EU Code of Conduct Group, Ms María José Garde, together with the former chairs of the group, reflected on the group’s achievements, the lessons learned during this productive period and the impact of 25 years of the Code of Conduct Group’s activity in the EU and globally. The panellists also exchanged views with the current members of the group and with delegates from the member states and the Commission on the future work of the group and on global challenges. Background The Code of Conduct is a political commitment of an intergovernmental nature. The Council’s Code of Conduct Group consists of high-level taxation experts from the member states. Assisted by the Council secretariat, the group is responsible for monitoring possible harmful tax measures in the EU member states. The Commission provides technical support to the group. The group’s work also has an international dimension, wherein it aims to promote effective changes with regard to worldwide tax good governance through cooperation. The Code of Conduct Group carries out the technical work, screening and assessment which leads to regular revision by the Council of the EU list of non-cooperative jurisdictions for tax purposes. This EU list is revised regularly following an in-depth review of the implementation of commitments made by all third-country jurisdictions that are part of the process. In this context, the group and its chair are conducting political dialogues with some 90 jurisdictions worldwide. Code of Conduct Group (Business Taxation) (background information) EU list of non-cooperative jurisdictions (background information)

Meetings Friday 22 September 2023

● Council of the EU   22/09/2023 10:17 | MEETING | Background brief - Competitiveness Council (Internal market and industry) of 25 September 2023   Background brief - Competitiveness Council (Internal market and industry) of 25 September 2023