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Commission joins the COVID-19 Vaccine Global Access Facility (COVAX)

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Today, the European Commission has confirmed its interest to participate in the COVAX Facility for equitable access to affordable COVID-19 vaccines everywhere, for everyone who needs them. As part of a Team Europe effort, the Commission is today also announcing a contribution of €400 million in guarantees to support COVAX and its objectives in the context of the Coronavirus Global Response.

Ursula von der Leyen, President of the European Commission, said: “Global collaboration is the only way to overcome a global pandemic. Under the Coronavirus Global Response and the Global Goal Unite campaign, we have seen the world come together as one. Almost €16 billion have been pledged so far and the most talented researchers and organisations are pooling their efforts to deliver vaccines, tests and treatments, which will be our universal, common good. Today, the Commission is announcing a €400 million contribution to COVAX for working together in purchasing future vaccines to the benefit of low and middle income countries. I’m confident this will bring us closer to our goal: beating this virus, together.”

Stella Kyriakides, Commissioner for Health and Food Safety, said: “It is only by working together globally, in solidarity, that we can defeat the coronavirus. We need an inclusive international approach and as we are showing today, Team Europe – European Commission and EU Member States – is committed to ensuring the success of the COVAX Facility and facilitating access to a vaccine in an equitable manner for all people across the world.” 

Jutta Urpilainen, Commissioner for International partnerships, said: “Only by securing equitable access to a COVID-19 vaccine across the world will we end the pandemic and ensure a sustainable recovery; working with our partner countries is crucial so that we can build back better and healthier.

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.

As part of a EU joint engagement (Commission, Member States and European financial institutions, notably EIB) to mobilise resources for the Coronavirus Global Response, the Commission intends to mobilise up to €400 million in guarantees to support COVAX and its underlying objectives as part of a Team Europe effort. The detailed terms and conditions for the EU’s participation and contribution will be worked out in the coming days and weeks. Team Europe is ready to put its expertise and resources at work within COVAX to accelerate and scale-up development and manufacturing of a global supply of vaccines for citizens across the world, in poor and rich countries.

The EU’s participation in COVAX will be complementary to the ongoing EU negotiations with vaccine companies that aim at scaling up manufacturing capacity of vaccine producers, contributing to global efforts.

Background:

The European Commission is committed to ensuring that everyone who needs a vaccine gets it, anywhere in the world and not only at home. No one will be safe until everyone is safe. This is why it immediately responded to the WHO’s call for action and has raised almost €16 billion since 4 May 2020 under the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery.

As a milestone under the Coronavirus Global Response, the global action for universal access to affordable coronavirus vaccination, treatment and testing, The Global Goal: Unite for our Future campaign was launched by NGO Global Citizen on 28 May under the patronage of President Ursula von der Leyen.  

On 4 May, the Commission also proposed a cooperation framework to align global efforts and accelerate progress in developing coronavirus vaccines, therapeutics and diagnostics and strengthening health systems: the Access to COVID-19 Tools (ACT)-Accelerator.

Three partnerships, based on the three priorities of the Coronavirus Global Response, are at its core. They gather industry, research, foundations, regulators and international organisations to work together on all steps needed to deliver new tools and solutions, from research to manufacturing and deployment.

COVAX is the vaccines pillar of the ACT-Accelerator, a global collaboration to accelerate the development, production, and equitable access for all countries across the world to COVID-19 tests, treatments, and vaccines.

Co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, COVAX was launched at the end of April 2020 at an event co-hosted by the Director-General of the World Health Organization, the President of France, the President of the European Commission, and the Bill and Melinda Gates Foundation. Since then, the EU has been actively engaged with Gavi, CEPI and other participant countries in the setting up of COVAX governance and financial tools. The final terms of the EU’s participation following today’s expression of interest still need to be defined.

The COVAX Facility aims to purchase 2 billion doses by the end of 2021, by negotiating with a diversified portfolio of vaccine suppliers covering different scientific technologies, time delivery and prices. The COVAX Facility is an insurance mechanism which will reduce risk for manufacturers, concerned about investing without assured demand, and for countries, concerned about failing to secure access to a viable vaccine.

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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 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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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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