Today, the Commission unveils its ideas and actions for a digital transformation that works for all, reflecting the best of Europe: open, fair, diverse, democratic and confident. It presents a European society powered by digital solutions that put people first, opens up new opportunities for businesses, and boosts the development of trustworthy technology to foster an open and democratic society and a vibrant and sustainable economy. Digital is a key enabler to fighting climate change and achieving the green transition. The European data strategy and the policy options to ensure the human-centric development of Artificial Intelligence (AI) presented today are the first steps towards achieving these goals.
The President of the Commission, Ursula von der Leyen, said: “Today we are presenting our ambition to shape Europe’s digital future. It covers everything from cybersecurity to critical infrastructures, digital education to skills, democracy to media. I want that digital Europe reflects the best of Europe – open, fair, diverse, democratic, and confident.”
Executive Vice-President for A Europe Fit for the Digital Age, Margrethe Vestager, said: “We want every citizen, every employee, every business to stand a fair chance to reap the benefits of digitalisation. Whether that means driving more safely or polluting less thanks to connected cars; or even saving lives with AI-driven medical imagery that allows doctors to detect diseases earlier than ever before.”
Commissioner for Internal Market,Thierry Breton, said: “Our society is generating a huge wave of industrial and public data, which will transform the way we produce, consume and live. I want European businesses and our many SMEs to access this data and create value for Europeans – including by developing Artificial Intelligence applications. Europe has everything it takes to lead the ‘big data’ race, and preserve its technological sovereignty, industrial leadership and economic competitiveness to the benefit of European consumers.”
Europe as a trusted digital leader
Digital technologies, if used with purpose, will benefit citizens and businesses in many ways. Over the next five years, the Commission will focus on three key objectives in digital:
· Technology that works for people;
· A fair and competitive economy; and
· An open, democratic and sustainable society.
Europe will build on its long history of technology, research, innovation and ingenuity, and on its strong protection of rights and fundamental values. New policies and frameworks will enable Europe to deploy cutting-edge digital technologies and strengthen its cybersecurity capacities. Europe will continue to preserve its open, democratic and sustainable society and digital tools can support these principles. It will develop and pursue its own path to become a globally competitive, value-based and inclusive digital economy and society, while continuing to be an open but rules-based market, and to work closely with its international partners.
Europe as a leader in trustworthy Artificial Intelligence
Europe has all it needs to become a world leader in Artificial Intelligence (AI) systems that can be safely used and applied. We have excellent research centres, secure digital systems and a robust position in robotics as well as competitive manufacturing and services sectors, spanning from automotive to energy, from healthcare to agriculture.
In its White Paper presented today, the Commission envisages a framework for trustworthy Artificial Intelligence, based on excellence and trust. In partnership with the private and the public sector, the aim is to mobilise resources along the entire value chain and to create the right incentives to accelerate deployment of AI, including by smaller and medium-sized enterprises. This includes working with Member States and the research community, to attract and keep talent. As AI systems can be complex and bear significant risks in certain contexts, building trust is essential. Clear rules need to address high-risk AI systems without putting too much burden on less risky ones. Strict EU rules for consumer protection, to address unfair commercial practices and to protect personal data and privacy, continue to apply.
For high-risk cases, such as in health, policing, or transport, AI systems should be transparent, traceable and guarantee human oversight. Authorities should be able to test and certify the data used by algorithms as they check cosmetics, cars or toys. Unbiased data is needed to train high-risk systems to perform properly, and to ensure respect of fundamental rights, in particular non-discrimination. While today, the use of facial recognition for remote biometric identification is generally prohibited and can only be used in exceptional, duly justified and proportionate cases, subject to safeguards and based of EU or national law, the Commission wants to launch a broad debate about which circumstances, if any, might justify such exceptions.
For lower risk AI applications, the Commission envisages a voluntary labelling scheme if they apply higher standards.
All AI applications are welcome in the European market as long as they comply with EU rules.
Europe as a leader in the data economy
The amount of data generated by businesses and public bodies is constantly growing. The next wave of industrial data will deeply transform the way we produce, consume and live. But most of its potential remains unfulfilled. Europe has everything it takes to become a leader in this new data economy: the strongest industrial base of the world, with SMEs being a vital part of the industrial fabric; the technologies; the skills; and now also a clear vision.
The objective of the European data strategy is to make sure the EU becomes a role model and a leader for a society empowered by data. For this, it aims at setting up a true European data space, a single market for data, to unlock unused data, allowing it to flow freely within the European Union and across sectors for the benefit of businesses, researchers and public administrations. Citizens, businesses and organisations should be empowered to make better decisions based on insights gleaned from non-personal data. That data should be available to all, whether public or private, start-up or giant.
To achieve this, the Commission will first propose to establish the right regulatory framework regarding data governance, access and reuse between businesses, between businesses and government, and within administrations. This entails creating incentives for data sharing, establishing practical, fair and clear rules on data access and use, which comply with European values and rights such as personal data protection, consumer protection and competition rules. It also means to make public sector data more widely available by opening up high-value datasets across the EU and allowing their reuse to innovate on top.
Second, the Commission aims at supporting the development of the technological systems and the next generation of infrastructures, which will enable the EU and all the actors to grasp the opportunities of the data economy. It will contribute to investments in European High Impact projects on European data spaces and trustworthy and energy efficient cloud infrastructures.
Finally, it will launch sectoral specific actions, to build European data spaces in for instance industrial manufacturing, the green deal, mobility or health.
The Commission will also work to further narrow the digital skills gap among Europeans, and explore how to give citizens better control over who can access their machine-generated data.
As set out in the strategy presented today, the Commission will present later this year a Digital Services Act and a European Democracy Action Plan, propose a review of the eIDAS regulation, and strengthen cybersecurity by developing a Joint Cyber Unit. Europe will also continue to build alliances with global partners, leveraging its regulatory power, capacity building, diplomacy and finance to promote the European digitalisation model.
The White Paper on Artificial Intelligence is now open for public consultation until 19 May 2020. The Commission is also gathering feedback on its data strategy. In light of the input received, the Commission will take further action to support the development of trustworthy AI and the data economy
Since 2014, the Commission has taken a number of steps to facilitate the development of a data-agile economy such as the Regulation on the free flow of non-personal data, the Cybersecurity Act, the Open Data Directive and the General Data Protection Regulation.
In 2018, the Commission presented for the first time an AI strategy, and agreed a coordinated plan with Member States. The framework for AI presented today also builds on the work carried out by the High-Level Expert Group on Artificial Intelligence, which presented their Ethics Guidelines on trustworthy AI in April 2019.
In her Political Guidelines, Commission President Ursula von der Leyen stressed the need to lead the transition to a healthy planet and a new digital world. In that context, she announced to kick-start the debate on human and ethical Artificial Intelligence and the use of big data to create wealth for societies and businesses during her first 100 days in office.
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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