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Explainer: rescEU and Humanitarian Aid under the new MFF

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Why is the Commission proposing to strengthen the EU Civil Protection Mechanism and rescEU?

The EU Civil Protection Mechanism is a crisis management structure that allows Member States and Participating States[1] to strengthen their cooperation in the field of civil protection, to improve prevention, preparedness and response to disasters. It is based on voluntary contributions of Member States, with the European Commission playing a key coordinating and co-financing role.

The need for a more flexible, faster and reactive system to respond to large-scale emergencies is one of the lessons learnt from the outbreak of the coronavirus pandemic.

The rapid spread of the virus exposed some limitations in the current crisis management framework. At times when Member States are hit by the same emergency simultaneously and unable to offer each other assistance, the EU is currently unable to help quickly enough to fill these critical gaps as it does not have its own assets and has to rely on voluntary support from Member States.

A reinforcement and upgrade of the EU Civil Protection Mechanism – as requested by the European Council in March 2020 – is therefore necessary to avoid situations where Member States are left alone during crises.

What is the main objective of the proposal?

The Commission’s proposes to allow the EU and its Member States to be better prepared for and able to react quickly and flexibly to crises, in particular those with a high-impact given the potential disruption to our economies and societies.

Under the Commission’s proposal, the EU will be able to;

  • directly procure an adequate safety net of rescEU capacities;
  • use its budget more flexibly to be able to prepare more effectively and react faster in times of exceptional needs
  • dispose of the logistical capacity to provide multi-purpose air services in case of emergencies and to ensure timely transport and delivery of assistance;

These strategic capacities will be supplementary to those of the EU Member States. They should be strategically pre-positioned in such a way as to ensure the most effective geographic coverage in response to an emergency.

In this way, a sufficient number of strategic assets will be available in order to support Member and Participating States in situations of large-scale emergencies and offer an effective EU-response.

What kinds of action will be financed under the proposal?

The upgraded EU Civil Protection Mechanism will equip the European Union with assets and logistical infrastructure that can cater for different types of emergencies, including those with a medical emergency dimension. This would allow the EU to:

  • Acquire, rent, lease and stockpile identified rescEU capacities;
  • Fully finance the development and the operational cost of all rescEU capacities as a strategic European reserve in case national capacities are overwhelmed;
  • Enhance the funding for national capacities deployed under the European Civil Protection Pool to increase their availability for deployment;
  • Ensure timely transport and delivery of requested assistance. This also includes internationally deployable experts, technical and scientific support for all types of disasters as well as specific medical equipment and personnel such as ‘flying medical experts’, nurses and epidemiologists.

Humanitarian Aid

How will EU humanitarian aid be enhanced under the new MFF?

The Commission proposes €14.8 billion for humanitarian aid, of which €5 billion come from the European Union Recovery Instrument to reinforce the humanitarian aid instrument.

The increased budget reflects the growing humanitarian needs in the most vulnerable parts of the world. The Humanitarian Aid Instrument will provide needs-based delivery of EU assistance to save and preserve lives, prevent and alleviate human suffering, and safeguard the integrity and dignity of populations affected by natural hazards or man-made crises.

A significantly enhanced Solidarity and Emergency Aid Reserve will reinforce EU action in response to all aspects of the health crisis, as well as other emergencies. Funds can be channelled to provide emergency support as and when needed through EU instruments such as humanitarian aid in cases where funding under dedicated programmes proves insufficient.

Why is the Commission proposing to increase humanitarian aid budget?

Humanitarian crises in the world are increasing: In 2020, nearly 168 million people will need humanitarian assistance and protection, a significant increase from 130 million people in 2018 (OCHA humanitarian needs overview 2020). The needs are stemming from the conflicts, global refugee crisis, worsening natural disasters due to climate change.

The coronavirus pandemic further increases already existing humanitarian needs. It has a major health, social and economic impact on societies around the globe, in particular on the poorest countries. It is estimated that up to 265 million people worldwide could be under severe threat of hunger by the end of 2020 due to the effects of the pandemic (OCHA humanitarian needs overview 2020). This requires strong reinforcements to the humanitarian aid budget to meet the growing needs.

The EU adapted its humanitarian response in light of the needs stemming from the coronavirus pandemic. However, the impact of the pandemic and the economic fall-out, are compounding existing needs, making it all the more important that the Union is equipped to demonstrate solidarity with the rest of the world.

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EU Politics

Coronavirus: EU Strategy for the development and availability of therapeutics

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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.

Next Steps

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.

Background

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.

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EU Politics

EU defence gets a boost as the European Defence Fund becomes a reality

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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.

Next Steps

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.

Background

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.

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EU Politics

Dual-use goods: what are they and why are new rules needed?

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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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