On 17 June, the European Commission presented a European strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. The EU Vaccines Strategy intends to ensure the production in Europe of qualitative, safe and efficacious vaccines, and to secure swift access to them for Member States and their populations. Moreover, the Strategy reflects the global solidarity effort and ensures equitable access to an affordable vaccine as early as possible.
Joint action at EU level is the surest, quickest and most efficient way of achieving these objectives. No Member State on its own has the capacity to secure the investment in developing and producing a sufficient number of vaccines. It is only through swift and unified action by the EU and its Member States that sufficient and speedy supplies of a safe and effective vaccine can be ensured. A common strategy allows better hedging of bets, sharing of risks and pooling investments to achieve economies of scale, scope and speed.
The Commission has signed two first contracts to allow the purchase of a vaccine, once proven safe and efficient, with AstraZeneca and Sanofi-GSK. Successful exploratory talks were concluded with Johnson & Johnson on 13 August, CureVac on 18 August, Moderna on 24 August and BioNTech on 9 September.*
Are all Member States represented in the Steering Committee and in the Negotiation Team?
All Member States have endorsed the approach set out by the Vaccines Strategy and signed up to an agreement for its implementation. As a result, all Member States are represented at the Steering Committee which discusses and reviews all aspects of the Advanced Purchase Agreement (APA) contracts before signature. The Committee appoints the members of the Joint Negotiation Team, which negotiates the APAs with the vaccines developers and reports to the Committee. All participants in these instances have been appointed by their Governments and have signed declarations of absence of conflict of interest and confidentiality.
What is the difference between concluding an Advanced Purchase Agreement (APA) and signing a contract with a pharmaceutical company?
Before an Advanced Purchase Agreement (APA) is negotiated, the Negotiation Team holds exploratory talks with the company to find out whether proceeding into detailed contractual negotiations is reasonable. If this is the case and a common understanding is reached on a terms sheet, a tender invitation is sent to the company, which then has to propose an offer.
An APA is concluded when both sides have finalised the contractual work. This is discussed and agreed with the Steering Committee. The conclusion of an APA requires the approval of the Commission.
If the APA provides for an obligation for the Member States to purchase vaccine doses (even if there might also be additional optional doses in the APA), Member States have 5 working days to notify if they wish to opt-out. The contract is only signed if at least four Member States are ready to be bound by it.
If the APA provides only for an option for Member States to purchase vaccine doses at a later date, the Commission can approve and sign the APA directly with the company concerned. Member States can decide later whether to exercise the option. It are the Member States that are responsible for purchasing the vaccines when they become available.
Will the Commission publish the contracts signed with pharmaceutical companies?
The focus for the Commission is the protection of public health and securing the best possible agreements with companies so that vaccines are affordable, safe and efficacious. Contracts are protected for confidentiality reasons, which is warranted by the highly competitive nature of this global market. This is in order to protect sensitive negotiations as well as business related information, such as financial information and development and production plans.
Disclosing sensitive business information would also undermine the tendering process and have potentially far-reaching consequences for the ability of the Commission to carry out its tasks as set out in the legal instruments that form the basis of the negotiations. All companies require that such sensitive business information remains confidential between the signatories of the contract. The Commission therefore has to respect the contracts it concludes with the companies.
Finally, the Commission is accountable towards the other European institutions and the European citizen. The Commission is acting in full compliance with all applicable rules regarding financial management, which can be subject to audit at a later stage.
LIABILITY & INDEMNIFICATION
Has the Commission made concessions on liability to the industry, in particular on indemnification for certain liabilities?
The Commission ensures that any agreement made to secure vaccines through the Vaccines Strategy will be fully compliant with EU law. The contracts the Commission is negotiating fully respect and protect citizens’ rights, in line with the Product Liability Directive.
In line with EU product liability rules, liability remains with the company. However, in order to compensate for potential risks taken by manufacturers due to the unusually shorter timespan for vaccines development, the APAs provide for Member States to indemnify the manufacturer for possible liabilities incurred only under specific conditions set out in the APAs.
The Commission has made clear throughout the implementation of the Vaccines strategy that it is not prepared to make compromises on the application of the existing rules that apply to bringing a pharmaceutical product into the market. These principles are equally valid for any indemnification clause the Commission negotiates.
Thus, the provisions on liability and indemnification do not alter in any way the regulatory burden of proof borne by the companies to demonstrate the safety and efficacy of their products. Any vaccine put on the market will have to meet the necessary safety requirements and undergo the independent scientific assessment by the European Medicines Agency as part of the EU market authorisation procedure.
The EU and Member States will continue taking all necessary measures to protect citizens, ensuring that:
- a strict, independent scientific assessment (looking at quality, safety and efficacy) must be carried out before a vaccine is approved;
- citizens’ rights remain fully protected;
- Member States are ready to financially cover certain of the companies risks to ensure that vaccines are actually available for EU citizens to protect public health.
How can a COVID-19 vaccine be developed and authorised within a 12-18 months timeframe when the normal process takes around 10 years? What are the roles of the European Medicines Agency (EMA) and the European Commission in this context and how can the process of marketing authorisation be speeded up in emergency situations?
We are currently in the middle of the most severe public health crisis in modern times. Finding a safe and effective vaccine will be a key element of the exit strategy from the pandemic. Europe and the world need to act swiftly and teams around the world are working with the ambition of delivering a successful vaccine within a timeframe of 12 -18 months. Delivering a successful vaccine within a compressed timeframe does however not mean compromising on safety, on the contrary, the safety and effectiveness of vaccines is non-negotiable and a fundamental requirement for any vaccine to reach the EU and other markets.
It is indeed true that vaccine development can take time and this is why we created our Vaccines Strategy to come together and work on all fronts, around the clock, with all Member States, global partners, researchers and scientists to develop a safe and efficacious vaccine in a short time frame. The often-quoted 10 year timeframe refers to the time from concept to authorisation, including gathering the necessary evidence through clinical trials. Reducing this timeline to 12-18 months means both accelerating development and manufacturing timelines as well as the marketing authorisation.
The regulatory processes will be flexible but will remain as rigorous as always. Together with the Member States and the European Medicines Agency, the Commission will use existing flexibilities in the EU’s regulatory framework to accelerate the authorisation and availability of successful vaccines against COVID-19, while maintaining the standards for vaccine quality, safety and efficacy.
Market authorisation process
The vaccine producers will decide if and when to submit an application for a marketing authorisation for a vaccine. The role of the EMA in this context is to carry out an independent scientific assessment of the application and submit its scientific opinion to the European Commission which is responsible for issuing a marketing authorisation that is valid for the entire EU. The marketing authorisation will only be granted if the benefit-risk balance is positive following an assessment of the quality, safety and efficacy of the product.
Variations to usual development plans are possible in the emergency context and developers can reduce timelines, for example, by conducting some studies in parallel, instead of carrying them out sequentially, and by using a variety of trial designs and endpoints to determine efficacy. Developers are advised to discuss development plans with regulators to clarify requirements for marketing approval.
Clinical trials for COVID-19 vaccines are being carried out more quickly than usual because the effort being put into their organisation and conduct has been significantly increased by the sponsors, researchers and regulators. The widespread nature of the pandemic means that large numbers of trial participants can be recruited in a relatively short time, without compromising the quality of the trials themselves.
The EU regulatory system is dedicating significant resources to supporting the rapid development and authorisation of safe, effective and high-quality COVID-19 vaccines. EMA’s pandemic Task Force (COVID-ETF), which brings together in one group the best scientific experts from the EU regulatory network, will work closely with EMA’s human medicines committee (CHMP) for optimal and fast coordination of activities related to the development, authorisation and safety monitoring of vaccines against COVID-19.
Can a vaccine be approved before completion of phase 3 of clinical trials?
A core objective of the Commission and the European Medicines Agency, through the EU Vaccines Strategy, is to ensure the quality, safety and efficacy of vaccines. As such, any vaccine can only be granted a marketing authorisation in the EU after a thorough evaluation. To recommend the authorisation of a vaccine, EMA needs to have sufficient information on its safety, efficacy and pharmaceutical quality. Marketing authorisation is only granted when the evidence shows that the benefits of the vaccine outweigh any risks.
In principle, large-scale Phase 3 efficacy trials involving thousands of participants are required to support the marketing authorisation of a COVID-19 vaccine. These trials should be designed to measure the vaccine’s efficacy in protecting against COVID-19 (efficacy endpoints) and its safety. This is because there are no known indicators (such as the levels of antibodies in the blood) that can predict protection and could be used instead of efficacy endpoints. In addition, we are currently in a situation where the virus is circulating, which makes it feasible to establish the efficacy of a vaccine in large-scale clinical trials.
The protocols of such clinical trials, including any plans for interim analyses, are subject to regulatory approval.
What does the scientific assessment by the European Medicines Agency consist of? What is the process of approval?
To obtain a marketing approval for a vaccine in the EU, a vaccine developer needs to submit the results of all testing/investigations to the medicines regulatory authorities in Europe as part of a ‘marketing authorisation’ application.
Applications for marketing authorisation submitted to EMA undergo a comprehensive, independent scientific assessment carried out by EMA’s expert scientific committees on human medicines and on safety (the “CHMP” and “PRAC”), made up of experts working in national medicines’ regulatory agencies. As for all medicines, EU legislation requires that the initial evaluations are carried out separately by two different assessment teams (led by a so-called Rapporteur and Co-Rapporteur) and reviewed by the Committee as a whole.
For COVID-19, EMA has put in place rapid review procedures to deliver assessments of applications quickly while ensuring robust scientific opinions. Key to this shortening of timescales are ‘rolling reviews’. In a public health emergency, EMA assesses data for promising medicines or vaccines as they become available. Through these rolling reviews, EMA can therefore start evaluating data while the development is still ongoing. When the medicine’s development is progressed enough for a marketing authorisation application, the formal assessment procedure can take place in a shorter than usual timeframe, because the data have already been scrutinised during the rolling review.
The CHMP, once it has concluded its scientific evaluation of the data and after assessing the quality, safety and efficacy of the medicinal product in question, makes a recommendation on whether the medicine should be given a marketing authorisation in the EU.
However, if comprehensive data would not be available at the time of the marketing authorisation application, the EU regulatory system is designed to potentially accommodate this situation by providing for a conditional authorisation system. This means that the initial (“conditional”) authorisation granted by the Commission is based on less comprehensive data than would normally be the case (nonetheless with a positive benefit-risk balance), and with obligations on the marketing authorisation holders for the data to be completed afterwards and to be submitted for assessment. Conditional marketing authorisations are closely monitored and are subject to annual review.
The European Commission takes a decision on whether or not to issue the marketing authorisation on the basis of the recommendation from the EMA. The decision-making timeframe will also be reduced by shortening the period for consulting Member States, and allowing translation of the documents into the full set of languages after the authorisation, rather than before.
What safety requirements need to be met?
In order to authorise any medicinal product, EMA needs to have and assess robust information on its safety, efficacy and pharmaceutical quality, with safety being of the utmost importance. The safety requirements for COVID-19 vaccines remain as high as for any other vaccine in the EU, the context of a pandemic will not change this.
Before a vaccine is approved for use, the main body of evidence for its safety and efficacy comes from the results of clinical trials, where participants are selected carefully and followed up under controlled conditions.
In addition, after authorisation, EU law requires that the safety of the vaccine – as is the requirement all medicinal products – will be monitored while in use. In addition to safety, the vaccine’s effectiveness should also be monitored. As part of such monitoring, studies are carried out after marketing. Some of these studies may be imposed on companies as part of the conditions for maintaining their marketing authorisation; other studies will be conducted by public authorities responsible for vaccination programmes.
The EU has a comprehensive safety monitoring (pharmacovigilance) system that allows measures to be put in place to minimise risk, to ensure reporting of suspected side effects, to detect any potential adverse effects, and introduce any necessary mitigating actions early.
Specifically for COVID-19 vaccines, EMA in close collaboration with the Commission, Member States, European and international partners, is establishing enhanced safety monitoring activities. These activities are aimed at making sure that any new information collected post-marketing will be identified and evaluated as quickly as possible, and appropriate regulatory actions are taken in a timely manner to protect patients and safeguard public health. These activities include the collection of exposure data, enhanced safety signal detection and management, enhanced transparency and setting a European infrastructure for vaccines monitoring, including multicentre observational studies on COVID-19 patients. Prompt and clear communication of the outcomes of these evaluations will be ensured.
ONCE A VACCINE IS AVAILABLE
What actually happens when the vaccine is available?
A vaccine will only become available after meeting the established safety requirements, having first undergone the robust scientific assessment by the European Medicines Agency and completed the EU market authorisation procedure.
The Member States will then be able to benefit from those doses by purchasing them, according to the APA concluded.
Where will the doses be stored?
Each Member State will decide on the best way to store the vaccines. The technical storage conditions are defined by each manufacturer based on specific requirements of each type of vaccine so as to ensure they quality.
Who will receive the first doses?
All Member States will have equal access to the available doses. The Member States will then decide whom they will offer the vaccines to among their population.
COVID-19 VACCINE GLOBAL ACCESS FACILITY (COVAX)
What is the Commission‘s involvement with COVAX?
The COVAX Facility, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world.
Supporting equal and global access to a safe and efficient vaccine for everyone in the world is a priority for the Commission. No region of the world is safe until we are all safe. That is why, on 31 August, the Commission’s expressed its interest to participate in COVAX. The 31 August announcement included a support of €400 million in guarantees for the COVAX Facility. The vaccines purchased in this context are for Low and Medium Income Countries.
The Commission and Member States joining the COVAX Facility reaffirm that they are supporting COVAX’s objectives and interest as a group, in order to make the EU Vaccines Strategy and the COVAX Facility complementary and thus mutually reinforcing.
The Commission and Member States are currently pursuing a joint approach for their participation in COVAX, and the 31 August expression of interest is part of this process. Talks are ongoing with Gavi and CEPI to reach an agreement in September on terms and conditions for the EU’s participation in the COVAX Facility. .
Will the Commission procure vaccines through the COVAX facility?
The Commission is only purchasing vaccines on behalf of EU Member States via the mechanism set up in the EU Vaccines Strategy and finances it through the Emergency Support Instrument (ESI). The Commission’s participation in COVAX supports a global effort to produce and distribute vaccines to all in need, in particular for low and middle income countries. The detailed terms and conditions for the EU’s and Member States’ participation and contribution is under discussion and will be worked out in the coming days and weeks.
Can Member States buy vaccines through COVAX?
Member States have committed, as part of the EU Vaccines Strategy, not to enter into parallel negotiations with the same vaccine manufacturers with which talks are on-going at EU level. This does not exclude the possibility to take part in negotiations with other vaccine companies through COVAX.
What will the guarantees be used for and why not give cash?
The Commission is providing financial guarantees backing COVAX negotiations on advanced purchase agreements of vaccines. These guarantees will enable COVAX to lower the risk and conclude advanced purchase agreements with a larger portfolio of vaccine producers.
Contracts under negotiation by COVAX require a strong financial backing which the EU guarantees will provide.
How does the Commission ensure complementarity between the EU Vaccines Strategy and COVAX?
The EU Vaccines Strategy goes hand in hand with the EU’s commitment to global solidarity. This applies at different levels: support to companies in their capacity expansion, advancing research and support development for the benefit of the world population. Investing upfront in the accelerated development and manufacturing of vaccines to the benefit of the rest of the world. By providing financial resources to the international institutions, such as WHO, CEPI, GAVI, the EU is also supporting access to vaccines for the whole world.
Manufacturers with whom the EU negotiates are also committed to supply future doses to other countries in the world, there is no exclusivity for delivery to Europe only and no export restriction.
What Europe is doing is making important and risky investments so that together with the regulatory authorisation procedures that we have in place, we accelerate the development of safe and efficacious vaccines, which will also be to the benefit of the rest of the world.
What we do in Europe is complementary and mutually reinforcing with our action for global solidarity. That is also why the Commission and the EU Member States have decided to join the COVAX facility.
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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