Today’s Communication sets out the Commission’s proposals to strengthen the EU accession process. It aims to make the enlargement process more credible, predictable, dynamic and subject to stronger political steering. This will reinvigorate the accession process and make it more effective, enhancing credibility and trust on both sides.
What is new in these proposals? How did the enlargement methodology change?
The revised enlargement methodology builds on four main principles
Candidate countries need to deliver on the reforms they promised, and EU needs to deliver when they do.
Stronger political steer:
Engaging with the candidates at top level through regular summits and ministerial meetings.
Member States will be involved more strongly and have better opportunities to monitor and review the process.
A more dynamic process:
Clustering chapters will allow for more thorough political discussions on thematic areas and to identify opportunities for early alignment and integration into EU policies.
The cluster on fundamentals (rule of law, economic criteria and public administration reform) will take a central role and sufficient progress will need to be achieved before other clusters can be opened.
Predictability for both sides:
Defining more clearly the conditions for candidate countries. Providing them with clear incentives if key reforms successfully implemented – closer integration of the country with the European Union.
Clear incentives: supporting solid and accelerated economic development and tangible benefits for citizens in order to provide the environment that allows for the substantial reforms needed, e.g. increased investment opportunities, work for accelerated integration and “phasing-in” to individual EU policies, the EU markets and EU programmes, while ensuring a level playing field and strengthened regional integration.
More decisive measures sanctioning any serious or prolonged stagnation or even backsliding: from slowing down negotiations, to adjusting funding and withdrawing benefits of closer integration.
Is the Commission changing its enlargement policy?
The conditions to join the EU are set out in the Treaty on European Union and by the Copenhagen criteria, which are very clear, and do not change. The proposals will improve the process and make it more comprehensive.
Previous enlargement countries did not have to fulfil all these conditions. You are moving the goalposts and delaying the accession process.
No, the revised methodology is based on the same, well-established criteria to join the EU. These were defined already in 1993 at the European Council in Copenhagen: need to have stable institutions guaranteeing democracy, the rule of law, human rights and respect for and protection of minorities; a functioning market economy and the capacity to cope with competition and market forces in the EU; the ability to take on and implement effectively the obligations of membership.
In the case of the Western Balkans, additional conditions for membership were set out in the ‘Stabilisation and Association Process’, mostly relating to regional cooperation and good neighbourly relations.
There are no shortcuts to membership. It is true that the accession process today is more demanding than in the past. But this is because the process has been made more rigorous to help the countries tackle the more difficult challenges they face in their reform efforts.
How do you asses the progress of enlargement countries?
Each year the Commission adopts its “Enlargement package” – which includes a Communication on enlargement (setting out the way forward and taking stock of the situation in the enlargement countries) and individual country Reports. In the Reports, the Commission presents its detailed assessment of the state of play in each candidate country and potential candidate, what has been achieved over the last year, and set out guidelines on reform priorities. The assessments are based on the Commission’s regular monitoring of the situation in the countries, input from the EU Delegations on the ground and from a variety of other sources, including: contributions from the EU Member States, European Parliament reports, contributions from the governments of the countries, and information from various international and non-governmental organisations.
How does the EU support reforms in the enlargement countries?
The EU helps the countries that wish to become members with political, financial and technical support. This makes it easier for them to make progress in meeting the well-established requirements of membership, in particular implementing far-reaching reforms and aligning with EU rules and regulations.
The European Union provides the countries with financial support through the Instrument for Pre-accession Assistance. From 2014-2020, the EU dedicated EUR 11.7 billion for this purpose, with continued funding foreseen for 2021-2027. The EU and the national authorities decide on the areas where to invest the funds.
The Commission and Member States also support the enlargement countries’ public administrations with technical assistance to align, apply and enforce EU legislation as well as facilitating the sharing of EU best practices. This is done inter alia through TAIEX / Twinning workshops, expert missions and study visits.
What does the revised methodology mean for the fundamentals, in particular the rule of law?
We propose a balanced approach, which will lead to a more dynamic and more credible process, while putting an even stronger focus on the core role of fundamental reforms essential for the EU path. Rule of law will become even more central in the accession negotiations, for example through anti-corruption work being main-streamed in relevant chapters. There will be a stronger focus on the fundamentals of functioning of democratic institutions, public administration reform and supporting economic reforms. Progress on the fundamental reforms will determine the overall pace of negotiations.
Will public administration reform now be part of the accession negotiations as a chapter? What does this mean in practice?
The Commission’s proposal reconfirms the central role that public administration reform plays among the fundamentals of the enlargement process. These fundamentals will become even more central in the accession negotiations. Negotiations in the area of fundamentals will be opened first and closed last and progress on the fundamentals will determine the overall pace of negotiations. In this sense, public administration reform will be on an equal footing with the other fundamentals.
Will the new methodology be applied only to North Macedonia and Albania, or also Serbia and Montenegro?
The new methodology will be formalised into the negotiating frameworks for North Macedonia and Albania .
Many of the proposals could also be attractive for Serbia and Montenegro, as they can contribute to making the process more dynamic, predictable and credible for them as well. Serbia and Montenegro will be able to opt in if they wish. The negotiating frameworks already in place for Montenegro and Serbia would however not need to be changed.
The fact that a revised methodology will be the basis for the new negotiating frameworks will it mean there will be a two-speed process for accession: easier for the ones already negotiating and more difficult for Albania and North Macedonia?
The accession process is equally difficult for any candidate, but in different ways, since challenges differ. Negotiating frameworks are never identical. They take into account the context of each candidate and spell out the way negotiations are conducted. The speed of progress towards accession to the EU does not depend on the negotiations frameworks but on the political will of the country to implement the necessary reforms so the country meets the EU’s accession criteria. The conditions to join the EU are the same for all countries and the speed depends on the time they take to meet the criteria.
But by proposing today adjustments to the methodology we aim at better supporting their reform process: through the clustering of chapters, clearer criteria, and stronger political steer, our objective is to help the countries to move faster on reforms.
What about Bosnia and Herzegovina and Kosovo? What does this mean for them?
The EU has repeatedly confirmed its unequivocal support to the European perspective of the Western Balkans. The Stabilisation and Association Process remains the common framework of relations with the two.
In its conclusions of December 2019, the Council welcomed the Commission’s Opinion on Bosnia and Herzegovina’s application to EU membership. The Council urged executive and legislative bodies at all levels of government to start addressing the key priorities identified in the opinion, in line with the legitimate aspirations of the citizens of Bosnia and Herzegovina to advance towards the European Union.
The EU has welcomed the appointment of the new Government in Bosnia and Herzegovina and is ready to work with the authorities on the implementation of the 14 priorities identified, paving the way towards the candidate status.
For Kosovo, it is important that the new government resumes work on reforms, including the implementation of the Stabilisation and Association Agreement and building on the European Reform Agenda, to deliver tangible results for citizens.
The Commission looks forward to working with the new Government in Kosovo and to assisting in its European Reform Agenda, focusing on strengthening the rule of law, public administration and the economy. Is it also important that Kosovo abolishes the tariffs and renews its engagement in regional initiatives and cooperation.
What are the next steps now?
The Commission hopes the Member States will endorse the proposal, in parallel with the opening of accession negotiations with North Macedonia and Albania, ahead of the European Union-Western Balkans Summit in Zagreb on 6-7 May, for which the Commission will also put forward an economic and investment development plan for the Western Balkans region. If the Council takes a positive decision in this sense, it will task the Commission with presenting draft negotiating frameworks with the two countries. These will further spell out the proposals set out in the revised methodology.
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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