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European Commission - Questions and answers

Questions and answers: the Coronavirus Global response Brussels, 28 May 2020 The Coronavirus Global Response builds on the commitment made by G20 leaders on 26 March to present a united front against the pandemic. With this in mind, on 24 April, the World Health Organization (WHO) and an initial group of health actors launched a global collaboration for the accelerated development, production and equitable global Access to COVID-19 Tools – the ACT Accelerator. Together, they issued a call to action. The European Commission responded to this call by joining forces with global partners to host a pledging event – the Coronavirus Global Response Initiative – as of 4 May 2020. The pledging event was co-convened by the European Union, Canada, France, Germany, Italy (also incoming G20 presidency), Japan, the Kingdom of Saudi Arabia (also holding the G20 presidency), Norway, Spain and the United Kingdom. More than 40 countries, United Nations bodies and philanthropies made a pledge towards the research and development of coronavirus solutions at this global event – with €7.4 billion equivalent to $8 billion – raised that day. The European Commission committed €1 billion in grants and €400 million in guarantees on loans through reprioritisation of Horizon 2020 (€1 billion), RescEU (€80 million), the Emergency Support Instrument (€150 million). Raising €7.4 billion was an extraordinary achievement but it will not be enough to ensure the distribution of coronavirus health technologies worldwide, as this involves significant costs in terms of production, procurement and distribution. This is why, on 4 May, President von der Leyen invited people to continue joining the Coronavirus Global Response, “in a global mobilisation of hope and resolve.” More information is available on the website: europa.eu/global-response.

How much money has been raised so far? The Coronavirus Global Response has so far raised €9.8 billion. The full list of donors and breakdown of donations are available here. The European Investment Bank has pledged €2 billion, including €141 million pledged on 4 May. 66% of the total amount – €6.5 billion – was pledged by Team Europe, i.e. EU and Member States, the Commission, members of the EEA and the European Investment Bank. €2.3 billion (23.5%) were allocated to vaccines, €814 million to therapeutics (8%), and €242 million (2.5%) to diagnostics. Furthermore, donors decided to pay special attention to strengthening of health systems with €4.3 billion (45.5% of the pledges). The remaining amount of €2.1 billion (21.5%) includes un-earmarked pledges, unallocated pledges, or pledges allocated to other coronavirus projects, including for humanitarian assistance, emergencies, or coronavirus national research programmes (€700 million). The following distribution summarises the amounts allocated to global health organisations: Approximately €1.1 billion through the Coalition for Epidemic Preparedness Innovation (CEPI), for vaccine development and deployment. Around €488 million through Gavi, the Vaccine Alliance. This amount excludes the general announcements that will take place during the Global Vaccines Summit on 4 June. Almost €257 million through the COVID-19 Therapeutics Accelerator, initiative intended to enhance treatment development and deployment. Over €60 million through the Foundation for Innovative New Diagnostics (FIND), for diagnostics development and deployment €2.6 billion through the World Health Organization (WHO), for health systems strengthening. €15.7 million through the Global Fund to Fight AIDS, Tuberculosis and Malaria. At least €700 million for national COVID-19 research project. The prioritisation of health systems strengthening by donors reflects a reality: in many countries, unequipped health systems represent the major bottleneck for accessing health innovations and preventing new outbreaks. There is a strong complementary between strengthening health systems and ensuring the effective deployment of vaccines, therapeutics and diagnostics. The vaccine, therapeutics and diagnostics partnerships will fully benefit from these complementarities.

What are the next steps? The outcome of the 4 May pledging event shows the willingness and capacity of the world to join forces and pool resources to overcome the pandemic. It bodes well for the unprecedented international collaboration and resources needed for production, procurement and distribution of vaccines, treatments and tests. The magnitude of the task requires the mobilisation of citizens globally. During the next four weeks, Global Citizen will lead the “Global Goal: Unite for our Future” campaign, with the European Commission as patron and Bloomberg Philanthropies, the Bill & Melinda Gates Foundation and the Wellcome Trust] as partners. Coronavirus Global Response partner countries – France, Germany, Canada, Spain, Belgium, Austria, Morocco, South Africa, Mexico, Norway, South Africa, Saudi Arabia, Italy, New Zealand and the United Kingdom – as well as the European Investment Bank are supporting this campaign. More are expected to join. The World Health Organisation is also a key partner and supporter in this endeavour. President von der Leyen will chair the “Global Goal: Unite for Our Future” Summit on 27 June. Global artists including Adam Lambert, Chloe x Halle, Chris Rock, , Dionne Warwick, Femi Kuti, Fher of Maná, Hugh Jackman, Idris & Sabrina Elba, J Balvin, Justin Bieber, Lady Gaga, Lang Lang, Miley Cyrus, Padma Lakshmi, Rachel Brosnahan and Shakirahave announced that they would help rally citizens to the cause, so they can in turn take action and reach out to world leaders. In doing so, the campaign will add momentum to organisations such as CEPI, Gavi, the vaccine alliance, the Therapeutics Accelerator, UNITAID, FIND and the Global Fund. These groups are leading efforts to develop and make available tests, treatments and vaccines for frontline health workers and those most vulnerable to the virus around the world. The Global Vaccine Summit organised by Gavi, the Vaccine Alliance on 4 June will be another important milestone in strengthening the health systems and immunisation capacities of the world's poorest countries, which will be instrumental in reaching the objectives of the Coronavirus Global Response. In addition, the Commission encourages people to donate towards the COVID-19 Solidarity Response Fund at WHO.

What is the ACT-accelerator global response framework? The universal and affordable access to COVID-19 Tools (ACT) was the main objective of the 24 April call to action from the global health partners. For this, significant funding is needed as well as a collaborative framework with a clarity of purpose and structure, to align global efforts and ensure that the money donated by countries is put to good use. Based on discussions with governmental and non-governmental partners, the European Commission has proposed a collaborative framework for the ACT-accelerator global response, as a coordination structure to steer and oversee progress made globally in accelerating work on the following three priorities: the development of vaccines, therapeutics and diagnostics with universal access, underpinned by strengthening of health systems needed for realising these priorities. Its three main missions are: Coordination through an agreed division of work at global level with light coordination; Resource mobilisation to fill the gaps in funding and manufacturing and identify opportunities Distribution for equitable and affordable access globally. The structure will be in place for two years (renewable). It will capitalise on the expertise of existing institutions and partners and not establish any no new structures or institutions.

Who is taking part in the ACT-accelerator global response framework? The core of the framework is the three partnerships based on each of the three priorities. They work as autonomously as possible, with a transversal work stream on health systems strengthening in relation to the coronavirus. Three partnerships on vaccines, therapeutics and diagnostics are in the process of defining their strategy, resources needs and accountability rules. A group of governmental and private non-profit partners is being convened to facilitate the work of the vaccine, therapeutics and diagnostics partnerships and ensure coherence across the partnerships, report to donors and global fora on progress and advocate for additional resources needed and solutions. Coronavirus Global Response partner countries will be part of the Facilitating Group. The private non- profit partners will be organisations with global reach and a track record in working for global public goods, such as the Bill & Melinda Gates Foundation, the Wellcome Trust and the World Economic Forum. The ACT-Accelerator framework will report to the global community on: Progress made in the three priorities i.e. vaccines, therapeutics and diagnostics as well as work on strengthening health systems for coronavirus; Identification of additional resources needed in the future; Envisaged action to raise such resources (through pledging or otherwise).

How will the three partnerships work? Each partnership will have two co-convenors, empowered and resourced to animate a partnership with all relevant actors (public sector, industry, research, funders, regulators, international organisations). Each of the three partnerships aligns the actions of the actors involved, in a whole-value-chain approach (from research to delivery and universal access). Together, they develop the agenda and co-implement the work needed. For vaccines, the co-convenor for the partnership will be CEPI, jointly with Gavi, the Vaccine Alliance, for vaccine deployment. For therapeutics, the co-convenor will be the COVID-19 Therapeutics Accelerator, a new Joint Venture by the Gates Foundation and the Wellcome Trust, jointly with UNITAID. For diagnostics, the co-convenor will be FIND (Foundation for Innovative New Diagnostics) jointly with the Global Fund A transversal work stream, across the three partnerships, deals with supporting health systems in order to cope with coronavirus, in which the WHO will play a prominent role. The WHO will also lead the work on product allocation across the 3 partnerships.

Who will have ownership of the products produced with funding from the initiative? For publicly funded research, there should be open access to results, i.e. data, knowledge and to intellectual property to the extent needed to ensure global deployment and access. Funding will benefit organisations that strive to ensure that the products will be available, accessible and affordable across the world, especially in the most vulnerable countries. Business partners will in principle not be required to forgo their intellectual property, but funding pledged will be accompanied by commitments from donors in support of global access and fair deployment of new diagnostics, treatment and vaccines against coronavirus.

Where are the main needs in the areas of vaccines, therapeutics and diagnostics? In these three areas, research and development (validation for tests) are most urgent, but underfinancing exists mainly on manufacturing, procurement and deployment. The current situation is as follows: Vaccines are difficult to develop and the outcome of research is uncertain. Currently, there are more than 100 vaccines in development, and around 10 have entered into clinical trials. Once a vaccine is available, the challenge will be to produce it in the extremely high quantities needed and required, as well as to ensure that it is available and accessible for all countries, including low and medium-income countries.WHO keeps track of all candidate vaccines at https://www.who.int/who-documents-detail/draft-landscape-of-covid-19-candidate-vaccines. Therapeutics: So far, more than 40 developers of potential treatments for coronavirus have contacted the European Medicines Agency (EMA) and the Member States for scientific advice. Most of the treatments proposed are medicines currently authorised for other diseases. Clinical trials are currently ongoing to determine their efficacy for the treatment of coronavirus patients. Once new therapies are identified, they will need to be produced, manufactured and procured at global scale. This will require significant funding. Diagnostics (Tests): Several types of tests, for different purposes, are currently in use. Some are used to detect infection and others to detect if the person has been infected by the virus. The latter still have be validated in terms of performance and produced on a large scale. The challenge is the procurement and deployment of tests, including equipment to analyse the results when applicable, as well as the link with effective and well-resourced testing strategies.

What is the estimated timeline for delivery on the three strands? Given the current crisis, there is no time to lose. Funds will be allocated as quickly as possible. While a number of solutions are already being investigated, R&D, manufacturing and deployment are all time-consuming, resource-intensive steps. This is why it is crucial to coordinate efforts at international level, to identify as quickly as possible the most promising solutions while accelerating their development.

What is the link to the replenishment of Gavi, the Vaccine Alliance? To face this crisis, developing countries need strong defences. The deployment of coronavirus vaccines will be next to impossible if we allow immunisation programmes to collapse. These health systems provide the core infrastructure needed to distribute them - the supply chains, the cold chain equipment, the trained health care workers, disease surveillance and community outreach. Support to lower income countries, as part of our global response, is essential to ensure our global health security and to avoid future pandemics. Given this global need, pledges are also welcomed to Gavi's replenishment, in order to contribute to raising at least US$7.4bn for its next five-year period. The EU and the co-hosts of the pledging initiative are strong supporters of Gavi and its role in the global coronavirus pandemic response. A Gavi replenishment summit takes place on 4 June 2020 in .

Will the fruits of the initiative only benefit countries that participate? No, the objective of this pledging event is to speed up innovations and ensure access for all, irrespective of the geographical origin of funds. Pandemics can only be effectively controlled when solutions are deployed globally. The initiative aims to rally significant financial contributions to develop diagnostics, treatments and vaccines and secure a high-level political commitment to ensure equitable access to diagnostics, treatments and vaccines to make sure no one is left behind.

For more information Coronavirus Global Response website

QANDA/20/958

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