EUROPEAN COMMISSION Brussels, 28.10.2020 COM(2020) 687 final COMMUNICATION FROM THE COMMISSION on additional COVID-19 response measures



1.Introduction More than eight months have passed since the World Health Organisation recognised COVID-19 as a major public health emergency needing a global effort. Europe has adapted to an unprecedented situation and has led the global response. As our Union confronts a resurgence of cases, Member States are better prepared and coordinated than they were in the early months of the pandemic. We have more knowledge of how to combat the spread of the coronavirus, and how to do it in a way that limits the damage to our daily lives. However, citizens, families and communities across Europe continue to face an unprecedented risk to their health and well-being, while uncertainty undermines our societies and economies. Recent weeks have seen an alarming spread of the virus across Europe, and new measures have had to be applied. With health systems again under pressure, more needs to be done to control and overcome the situation, protecting lives and livelihoods, and promoting European solidarity. Whilst cooperation between Member States has improved since the start of the pandemic, it remains essential if we are to tackle effectively the threats we face. Unilateral and uncoordinated action undermines the impact of the EU’s response and the confidence of citizens. The relaxation of applied measures during the summer months was not always accompanied by steps to build up sufficient response capacity. This means that urgent steps are needed now at both national and EU level: stronger measures now can pay human and economic dividends in the coming months. The Commission has worked ceaselessly to support national efforts since the onset of the pandemic. The measures it has introduced have, amongst others, helped keep essential goods and services flowing, supported national healthcare systems which found themselves under pressure, supported the economy, facilitated free movement of people and crossing of borders and boosted preparedness. Work with EU agencies has helped the EU to build its operational response too. Work to combat the virus and to sustain the economy goes hand in hand, addressing citizens’ understandable anxieties and ‘fatigue’. It is essential to maintain and reinforce efforts until reliable treatments and/or vaccines are widely available and taken up. In October, the European Council underlined the need for more cooperation: “to continue the overall coordination effort based on the best available science, notably regarding quarantine regulations, cross-border contact tracing, testing strategies, the joint assessment of testing methods, the mutual recognition of tests, and the temporary restriction on non-essential travel into the EU”. This mirrors a strong wish amongst citizens for a strong EU role. This Communication sets out next steps in key areas to reinforce the EU’s response. 2.The next phase in EU Response Measures 2.1.Ensuring the flow of information to allow informed decision-making Citizens, policy-makers, and businesses depend on the information they have to inform their decisions: ensuring the quality and timeliness of that data is therefore crucial. Up to date, accurate, comprehensive and comparable epidemiological data is essential to know the status of the spread of the coronavirus at regional and national level. Provision of both numerical and qualitative information on testing, contact tracing and public health surveillance is crucial in the next months. The sharing of data on the EU COVID-19 Data Platform needs to become the norm: at present only five Member States are using this to share information. A new enhanced surveillance portal will act as an online entry point for all key activities. The European Centre for Disease Prevention and Control (ECDC) is pivotal as the central point for the data flow and needs to have the information required. Its surveillance of the situation should rest on data compiled according to common EU definitions, to have a better ability to detect early signals, and to support more accurate risk assessments and responses. Next month, the Commission will make proposals to improve the longer-term health security framework at EU level, but in the meantime, Member States must step up their sharing of data on a common basis, and ensure a strengthened and integrated surveillance system across the EU. This should extend beyond data relating to the pandemic itself, to areas such as data on the economic situation and on health systems (hospital beds availability and medicines shortages). Knowledge-sharing on the impact of different treatments is also critical to both the effectiveness and the efficiency of response. The Commission, in close cooperation with the ECDC, should facilitate discussion among epidemiologists and other experts at EU level to coordinate national approaches and exchange best practices. The use of existing networks or the creation of a new platform will be explored. This will allow for a better use of tools to target EU support where it is most needed. For example, accurate mapping of intensive care bed availability would help in the transfer of patients or medical teams between Member States, which can be supported through a €220 million mobility action already in place. Next steps: ·Member States should provide all relevant data to the ECDC and the Commission using common criteria. ·An upgraded ECDC online portal to bring together all key data by April 2021. 2.2. Effective and rapid testing

Testing – in conjunction with contact tracing and effective isolation practices - is one of the main tools available to slow down the spread of the coronavirus. Accurate and widespread testing allows for public health decisions to be taken on the best basis; rapid testing allows the minimum interruption in the essential work of staff in hospitals or care homes and for swift action to be taken in epicentres such as universities. It can also facilitate travel in certain circumstances. The Commission has been encouraging the development of reliable tests, national testing strategies and rapid antigen tests. The current shortfalls in the testing capacity in the face of a resurgence of infection show that further swift action is indispensable. There are two types of tests now developed for COVID-19. The category of “Reverse Transcriptase - Polymerase Chain Reaction” tests are considered as “gold standard” for their accuracy, but they take time and use various reagents that can be subject to demand constraints. Rapid antigen tests are a new generation of faster and cheaper COVID-19 tests, allowing for a test result in often less than 30 minutes. These are starting to reach the market and Member States are increasingly exploring their wider use. They offer the possibility for rapid, inexpensive and early detection of the most infectious cases, but are recognised as substantially less sensitive. This points to the need for careful strategies for their use: they can be particularly beneficial in scenarios such as suspected outbreaks of COVID-19 in remote settings or to help investigate outbreaks investigations in residential facilities such as care homes, or when there is widespread community transmission. The Commission is today adopting a Commission Recommendation on COVID-19 testing strategies, including the use of rapid antigen tests to promote effective testing. The Recommendation sets out key elements to be considered for national, regional or local testing strategies: the scope of COVID-19 testing strategies, groups to be prioritised in case of capacity problems, and key points linked to testing capacities and resources. The EU should monitor these national strategies shared by Member States to allow mutual learning and to identify gaps, on the basis of timely, accurate and comparable data at national, regional and local levels. The Recommendation should also accelerate the selection and deployment of rapid and reliable antigen tests. As a first step, the Commission is now mobilising €100 million under the Emergency Support Instrument to directly purchase rapid antigen tests and deliver them to the Member States, based on clear criteria reflecting defined needs at national level and stringent quality criteria. In parallel, the Commission is also launching a joint procurement to enable a second stream of access for Member States to these promising tests. Testing plays an important role in facilitating free movement in the EU. Some Member States are applying prior testing requirements which depend on the ability of other Member States to undertake such tests. Travellers unable to obtain them, for example because there are no testing capacities foreseen for asymptomatic travellers in the Member State of departure, should be offered to undergo a test after arrival. The mutual recognition of tests, of either type, is essential. If negative COVID-19 tests are to be required or recommended for any activity, this relies on the availability of such tests and the need for all tests meeting agreed minimum and sufficient standards to be accepted as valid. Absence of such mutual recognition could in particular become a serious hurdle if Member States require or recommend testing prior to travel (cf. section 2.6 below). As set out in the Council Recommendation on a coordinated approach to the restriction of free movement, Member States should enhance cooperation on different aspects related to testing, including verification of test certificates, taking into account research and advice of epidemiological experts as well as best practices. Cross-border cooperation on testing (e.g. on laboratory processing) would be one way to alleviate capacity shortfalls until these are remedied. Next steps: ·The Commission is mobilising €100 million from the Emergency Support Instrument to directly purchase rapid antigen tests and distribute them as soon as possible to Member States, based on a defined allocation strategy. ·The Commission will launch a joint procurement to make rapid antigen tests available and calls on all Member States to participate. ·National strategies on testing to be submitted by mid-November and an analysis completed by end of November. 2.3. Making full use of contact tracing apps Contact tracing is one of the most critical tools to prevent the spread of the virus and break transmission chains. But as infection rates increase, manual contact tracing operations become more difficult. Contact tracing and warning apps can make a real difference by using digital technology to send warnings more quickly. These apps alert users if they have been in proximity for a defined period to a person who reports a positive test for COVID-19: while ensuring full compliance with data protection and privacy rules. An EU toolbox has supported the development of many national apps, now launched in 19 Member States and downloaded by 50 million Europeans. This is a good start but much more is needed if the apps are to play a major role in controlling the spread of the coronavirus. All Member States should have an app in place, and there should be a new communication effort at EU and national level to promote uptake of these apps. At Member States’ request, the Commission has also recently launched a solution for linking national apps across the EU through a ‘European Federation Gateway Service’. Three national apps (Germany, Ireland, and Italy) are now linked through this service with five more Member States expected to connect in the coming days. This means that, for example, someone with the German app can receive a warning if they have had contact with someone who reported a positive test for COVID-19 via the Italian app. A further 16 Member States plan to join by the end of November. The Commission stands ready to assist Member States in any way possible to develop and roll out national contact tracing apps, and to interconnect them via the Gateway. Next steps: ·The Commission will support Member States to develop national tracing apps and connect them to the European Federation Gateway Service. ·All Member States should set up effective and compatible apps to allow an EU-wide system. 2.4. Effective vaccination The development and procurement of an effective vaccine is essential to bringing an end to the crisis. Under the EU Strategy on COVID-19 vaccines, the Commission is negotiating and concluding Advance Purchase Agreements (APAs) with vaccine producers so as to secure access to promising vaccine candidates at the earliest possible opportunity once proven safe and effective, and on the best possible terms. Contracts with upfront payments of €1.02 billion have been signed so far, with exploratory talks concluded with three companies involving a further €1.45bn in upfront payments. There is no guarantee that any given vaccine candidate will succeed. A broad portfolio of vaccine producers is therefore needed. The portfolio will be kept under constant review as the development of vaccines evolves. This will also require additional funding from Member States under the Emergency Support Instrument. In addition, a network is being set up to support smaller developers of promising vaccines. The EU has also led the global effort to provide fair and equitable access to vaccines and facilitate their deployment worldwide, as global public goods, via the COVAX facility. Vaccines do not save lives in themselves - vaccination does. Having a vaccine available is not enough. It also needs to be distributed and deployed to maximum effect. On 15 October 2020, the Commission set out the key steps that Member States need to take in order to prepare. This includes getting ready all the equipment and infrastructure to undertake the immunisation, and define clear priority groups to be the first to benefit. Member States were called on to establish national vaccination strategies to ensure full readiness and the approach to be taken as vaccination is rolled out to all. This work needs to be taken forward and operationalised as much as possible in a coordinated manner. The Commission will put in place a common reporting framework so that Member States can work together and learn from each other. The European Centre for Disease Prevention will compile a first overview of national vaccination plans by the end of October 2020, to allow lessons to be drawn and experience to be shared. A “test day” will be organised as an exercise to allow plans for strategy and deployment to be stress-tested. Citizens also need to know that vaccines are safe. This requires robust data, strong controls, and full transparency. In addition to the robust authorisation process before use, it calls for continuous observation as the vaccines are rolled out, with a real-time assessment of the impact of the vaccines once mass vaccination begins. As well as the pre-deployment authorisation by the European Medicines Agency, the Commission will support a platform for post-authorisation studies monitoring the safety, effectiveness, and impact of vaccination.

As work on the development and deployment of vaccines develops, other issues are likely to emerge which may require a degree of EU-level coordination and cooperation between Member States, such as the use of proof of vaccination to be provided to citizens. Next steps: ·Conclusions from first overview of national vaccination plans in November. ·Platform to be set up as part of strategy to monitor effectiveness of vaccine strategies as they are rolled out. 2.5. Effective communication to citizens Effective communication is a critical element of any public health crisis response. The success or failure of pandemic response largely depends on community engagement, individual behaviour and adherence to public health recommendations. It is therefore imperative that there is a sustained communication effort to keep citizens up to date on epidemiological developments as well as possible restrictive measures, which need to be consistent and clear in order to foster compliance among citizens. This is particularly important against a backdrop of the false and misleading information that continues to circulate, as well as to address the risk of “pandemic fatigue” and an increasing unwillingness to respect precautions such as physical distancing and reduced social interactions. Every effort should be made to ensure that targeted communication reaches segments of the population that are most vulnerable and those most likely to spread the disease through social interaction. It needs to be clear, consistent and up-to date. Special attention needs to be paid to social media monitoring and response. Vaccination is a specific area where public authorities need to step up their actions to tackle misinformation as a main cause of hesitancy, and coordinate on disinformation response. Next Steps: • All Member States should relaunch communication campaigns adapted to the current situation. 2.6.Securing essential supplies Since the start of the outbreak, the EU has supported manufacturers to ensure availability of the essential medicines and medical equipment needed in the fight against COVID-19. This has included joint procurement and strategic medical stockpiling to build up key supplies. The large Joint Procurement framework contracts provide support to the preparedness work by Member States. In case of emergency needs, reflecting European solidarity, under both the rescEU reserve of medical equipment and the Emergency Support Instrument, equipment such as ventilators and masks as well as therapeutics, such as Remdesivir, have been delivered to the Member States with most acute needs. Efficient distribution inside an open Single Market makes a major contribution to the effective delivery of supplies essential to the medical response. The Commission will remain vigilant and react quickly to disproportionate unilateral restrictions on these or any other types of goods, which undermine the collective effort. Open Joint procurements (where participating Member States and countries can place orders) ITEMS AVAILABLE SINCE VOLUME (OVER 12 MONTHS) BUDGET CEILING GLOVES AND COVERALLS April (gloves) May (coveralls) Several million €97 million EYE AND RESPIRATORY PROTECTION April 20 million goggles 12 million face shields 37 million FFP2 masks 26 million FFP3 masks 301 million surgical masks €1,4 billion VENTILATORS April 110,000 units €1,4 billion LABORATORY EQUIPMENT May 30 different lots €192 million MEDICINES USED IN INTENSIVE CARE UNITS October (contracts are being signed) 21 medicines in

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over 103 million vials €543 million REMDESIVIR (VEKLURY) October Over 500,000 treatment courses €3,4 billion As well as for tests (see above), a new Joint Procurement is also under way for medical equipment for vaccination (vaccine carriers, waste containers, injecting devices, disinfectants, personal protective equipment and anaesthetics). The EU has supported projects for the industrial repurposing of production capacities to meet urgently increased needs across Member States. Member States are invited to monitor the production capacity for essential medical supplies and map flexible production possibilities on their territory. In parallel, the EU led international efforts – in the G20 and bilaterally – to keep critical supply chains open and undisrupted. The next step will be for the EU to promote the “trade and health” initiative in the World Trade Organisation to bring new actions and commitments on keeping healthcare goods moving across borders. One step taken was to support the market by reducing the burden of customs duties and value added tax (VAT). The Commission authorised requests from Member States to suspend temporarily customs duties and VAT on the import of medical equipment from non-EU countries. It defined an indicative list of goods, such as personal protective equipment, testing kits, ventilators and key medicines. This will now be extended to April 2021. There is also room to further adapt the VAT framework to ensure that COVID-19 vaccines and tests become more affordable for health services and citizens. The Commission is therefore proposing to temporarily adapt the rules to apply a reduced rate or exemptions of VAT in respect of COVID-19 testing kits, and to allow Member States to grant a zero rate in respect of COVID-19 vaccines.

Next steps: ·Take forward the new joint procurement for vaccination equipment. ·Suspension of customs duties and VAT on imported medical equipment to the end of April 2021. ·The Commission call on the Council to swiftly adopt the proposal on exemptions for testing kits and vaccines. 2.7 Facilitating safe travel Free movement within the EU and the border-free Schengen area are key achievements of European integration. At the worst periods of the first wave of the pandemic, many national governments and local authorities applied travel restrictions at the local or regional levels, and reintroduced internal borders controls inside the EU, with only essential travel permitted. As the situation improved, controls on free movement inside and between Member States were lifted and most Member States opened their borders to non-essential travel. The improved coordination since then of measures linked to people moving around the EU further reduces any need for border controls. Any remaining COVID-19 related internal border control measures should therefore also be lifted. Most Member States have nevertheless required travellers from other Member States to undergo quarantine or testing before or upon entry into their territory, with requirements modulated according to the epidemiological situation. While such restrictions can be justified in the interests of public health, they must be proportionate and must not discriminate between citizens of different Member States, either de jure or de facto. In addition, a patchwork of different rules developed, with restrictions varying both in terms of which regions are covered and what measures are required upon entry (such as length of quarantine or the role of testing). This confusing situation was harmful to both the European economy and to citizens’ exercise of their right to freedom of movement. For this reason, the Commission made proposals for a more coordinated approach. The Council has adopted a Recommendation setting out a number of important steps towards clarity and consistency in defining regions according to their risk level. The ECDC has also started publishing the common map that should serve as the basis for Member States’ risk assessments. Member States should now implement these arrangements to give citizens and businesses clarity and predictability and the EU should continue to work on bringing the nature and extent of measures closer through a common approach. As the epidemiological situation deteriorates, it will be crucial to maintain safe travel for professional and imperative family reasons. It is important to ensure a consistent implementation of the list of essential travellers exempted from quarantine requirements. This has important economic as well as personal implications, and we must allow our economy to continue functioning even as restrictions on non-essential movement are tightened to slow the spread of COVID-19. The Commission will continue to monitor the situation carefully. A testing protocol for travellers The European Union Aviation Safety Agency and the European Centre for Disease Prevention and Control are working together on guidelines on testing which could be used by public health authorities, airlines and airports to help the safe arrival of passengers. This work is now being brought together in an EU Health Safety testing protocol, with the full involvement of national authorities. This would mean that common rules could be applied whenever testing is used, covering areas such as the timing of tests (both ahead of departure or upon arrival), proof of tests taken in another Member State, target groups, and the resources and infrastructure needed at airports, which could be extended to other potential locations. Regard should at all times be had to the overriding criterion of proportionality. Consistent quarantine rules The development of testing strategies, based on validated technologies and available capacities, should also inform an EU policy on quarantine. At present, there is a wide variety of measures applied, as Member States assess the different impacts on health, restrictions on freedom and likely compliance. For example, some quarantine measures are implemented on a voluntary basis, others are mandatory; some take testing into account in the process; and the duration of isolation and quarantine likewise varies from 7 to 14 days. The Commission has tasked the European Centre for Disease Prevention and Control to provide scientific guidance on quarantines, with a view to working with Member States on a common and proportionate European approach. A Common Passenger Locator Form Passenger Locator Forms help Member States undertake risk assessment of arrivals and enable contact tracing. The Council has agreed to work towards a common digital European Passenger Locator Form which would help both the swift processing of the information and improve data exchange between Member States. Work has been under way since July to develop this approach so that a common system can be put in place. Full respect for data protection requirements is needed. Each EU Member State would have access only to their national data, and personal data exchange for contact tracing would occur through existing channels. A pilot next month will allow Member States to prepare for its use and pave the way to launch the EU Passenger Locator Form in December. Re-open EU Planning and making a trip in Europe is becoming more complex by the day and citizens need clear information to minimise risks and costs. To provide timely and accurate information on health measures and travel restrictions in all Member States, the Commission launched the ‘Re-open EU’ online tool in mid-June. Nearly 7 million visitors have used the service since its launch. Once Member States provide a full information flow to the ECDC, it will become the one-stop-shop for information about the state of health measures and travel possibilities inside the EU. Tools like Re-open EU are crucial in terms of helping citizens make informed decisions to travel while keeping safe and healthy, and in supporting the economy. Tourism makes up some 10% of EU GDP, and is as high as some 25% in some Member States. A mobile Re-open EU app is being developed and will be launched in the coming weeks. The impact is of course lessened when information arrives late or is incomplete, such as failing to reflect regional differences in the measures in place. In order to maximise the benefits of this tool and make sure that information is accurate and up-to-date, the Commission calls on Member States to: ·Provide timely and frequent updates of health and travel measures, when measures change and prior to announcement. ·Provide complete and accurate information. ·Provide regional information, where possible and relevant. Guidance on essential travel from outside the EU