Source: EURLEX
Language: en
Format: md

![european flag](./../../../images/eclogo.jpg)EUROPEAN COMMISSION

Brussels, 15.7.2020

COM(2020) 318 final

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

Short-term EU health preparedness for COVID-19 outbreaks

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

Short-term EU health preparedness for COVID-19 outbreaks

I.INTRODUCTION

The COVID-19 pandemic, which has brought about one of the worst crises in recent history, requires continuous vigilance and coordinated action.

Though many unknowns remain, significant knowledge is being acquired on the disease itself, its transmission, prevention and treatment. Member States, supported by the Commission and EU Agencies, are increasing their testing capacity, improving surveillance and strengthening health system capacity, for instance through an increase in intensive care unit beds or reinforced medical countermeasures. The EU and its Member States have introduced measures to mitigate social and economic impacts, such as maintaining the functioning of the internal market, supporting the transport and tourism sector, protecting employment and supporting medical care services for vulnerable groups. Member States are increasingly coordinating their response. Public health measures have helped stabilise the situation and bring the number of new infections to a level manageable by health systems. This has allowed the progressive lifting of many restrictions imposed over the last months and the resumption of most activities.

Yet, the virus still circulates in the across the world. Regional outbreaks across the EU and a growing number of daily new cases across the globe reinforce the fact that the pandemic will only end once under control everywhere. Infectious diseases such as COVID-19 often come in waves and new, localised outbreaks are appearing across Europe and other continents.

Learning the lessons of the earlier stages of the pandemic, Europe must use this period of lower transmission rates to reinforce its preparedness and coordinated response capacity to counter further outbreaks of COVID-19. Time is of the essence to ensure that science-based measures are in place and have been stress tested to guarantee adequate implementation.

This Communication aims at ensuring the EU’s short-term health preparedness in case of further COVID-19 outbreaks in Europe. It draws particular attention to the need to reduce the burden of the 2020/2021 seasonal flu, so to mitigate the additional strain on health systems should this coincide with a further outbreak of COVID-19. For each domain, this Communication draws on the main lessons learned, positive and negative, and outlines key measures to be taken in the coming months. This will require strong coordination and exchange of information in and between Member States and communities as well as commitment to implement these measures, which are a national competence. Going forward, agreement on common approaches on health measures will continue to be sought within the Health Security Committee
[1](#footnote1)
 (HSC) as well as in other fora such as the Integrated Political Crisis Response (IPCR).

Experience has shown that coordinating actions with neighbours and at EU level is vital. Containment and management of any new outbreaks will also require continued cooperation and support to EU’s immediate neighbourhood and beyond. Therefore, where appropriate and feasible, the Commission will associate the Western Balkans, the Neighbourhood countries and other partner countries with the actions proposed in this document.

II.Enhancing preparedness – lessons learned and short-term actions

1.Testing, contact tracing and public health surveillance
[2](#footnote2)

Sufficient testing capacity is an essential aspect for preparedness and response to COVID-19
[3](#footnote3)
. Without adequate testing, there is no early detection of potentially infectious individuals and no visibility on infection rates and transmission within communities. It is a prerequisite to adequate contact tracing.

However, over the past few months, Europe has been suffering from shortages of tests and testing materials, trained laboratory personnel and for some supplies of laboratory equipment, while the EU is one of the largest producers of some of this equipment. Moreover, testing policies and methodologies have greatly differed across countries and national contact tracing capacities were often overwhelmed as large-scale community transmission occurred
[4](#footnote4)
.

|  |
| --- |
| Localised outbreaks - local & national response    After several weeks into the lifting of very restrictive measures, we now observe a resurgence of reported cases in several Member States, with a number of localised outbreaks in specific settings and community transmission still reported in most EU/EEA countries. The recent outbreaks are illustrating that local outbreaks must be immediately contained to avoid larger community transmission. In order to do so, immediately scaled testing and tracing should be implemented in the concerned area. Local mitigation measures, such as isolation, should then be enacted.    The necessary capacity should be deployed immediately and can be sourced both at the local and national level. The importance of local capacity and local knowledge must be recognised to ensure a tailored and specific response. Segmenting specific activities that require local knowledge for optimal efficiency, such as contact tracing, and those that can be developed without specific local knowledge, such as the provision of mobile labs or the technical running of RT-PCR tests, will be pivotal in best responding to these outbreaks. Such an approach will require coordination and information sharing between the local and national authorities.  . |

Finally, as containment measures are being gradually lifted
[5](#footnote5)
, testing, contact tracing and public health surveillance are required, as they enable the control of localised outbreaks. Their rapid scalability is crucial to keep up with a possible progression in the pandemic and to avoid having to reinstate strict confinement measures. These activities must also be specifically tailored for vulnerable groups and in settings with high density and limited ability to physically distance. A key step in preparedness is therefore the systematic identification of vulnerable locations and populations in all Member States.

a)Testing

Laboratory capacities for testing COVID-19 infection have increased
[6](#footnote6)
, combined with developments in point of care testing, 3D printing of testing equipment and new testing methods. The Commission has launched a joint procurement with Member States, with a ceiling budget of over €350,000,000 for laboratory supplies.
[7](#footnote7)
 Increased laboratory capacity, trained staff and innovation needs to be in place across all Member States to ensure a system that allows fast scalability, robust results and localised deployment response.

Now that Member States have increased their testing capacity in line with the ECDC guidance, they have to make sure that they can quickly increase testing coverage to mildly symptomatic patients and people who have been in contact with positive cases.
[8](#footnote8)
 It is also important that Member States continue to monitor the volume of tests performed and their results over time. Testing must also be able to be rapidly deployed through decentralised strategies to help control localised clusters. Finally, Member States should ensure that the expansion of testing capacity for COVID-19 does not come at the expense of other surveillance programmes (e.g. for influenza).

b)Contact Tracing

The coupling of standard contact tracing approaches with interoperable mobile applications (‘apps’) can reinforce the ability to stop new chains of transmission and prevent spread to the community
[9](#footnote9)
 while maintaining the data protection principles as outlined in relevant legislation
[10](#footnote10)
. Ten Member States have already launched apps for contact tracing and warning. Eleven more intend to launch an app in the near future. Following the adoption of the Recommendation
[11](#footnote11)
 on technology and data to combat and exit from the COVID-19 crisis, EU solutions and a common toolbox
[12](#footnote12)
 were developed to facilitate the interoperability of national apps
[13](#footnote13)
 while safeguarding privacy and data protection.
[14](#footnote14)
 Interoperability among all national apps should be a reality, so that travellers and workers can continue to move confidently across EU borders. The Commission has amended
[15](#footnote15)
 today the eHealth Network Implementing Decision 2019/1765/EU in order to provide the modalities for operating a secure IT infrastructure which supports the interoperability of contact tracing and warning apps across the EU. The Early Warning and Response System (EWRS) ensures secure and effective sharing of information between Member States’ health authorities. Moreover, preparedness measures
[16](#footnote16)
 at the points of entry
[17](#footnote17)
 into the EU, such as international airports, ports, international railway stations or land border crossings need to be implemented and can further support contact-tracing efforts, again helping to ensure the freedom of movement across the EU.

c)Surveillance

Public health surveillance should take place based on the following parameters: Intensity and geographical spread; Viral strain changes through molecular typing
[18](#footnote18)
; Nosocomial outbreaks
[19](#footnote19)
; Changes in risk groups including links to environmental exposure; Respiratory disease syndromes; Age specific population immunity; situation in residential care institutions; or the impact on healthcare systems.

This must enable the detection of hot spots at an early stage. Member States must therefore share standardised and timely epidemiological data at subnational level, including hospitalisation data and intensive care occupancy. The accumulation of such data, including through digital epidemiology relying on social media analysis, helps tracking the pandemic and allows for accurate modelling of the disease’s spread.

|  |  |
| --- | --- |
| Action area: Testing, contact tracing and public health surveillance | |
|  | Timeline |
| ØRun scenario-based national stress tests for contact tracing systems, testing capacities and testing deployment (Member States)  As localised outbreaks are being identified and are likely going forward, these stress tests should be performed at local levels, based on specific scenarios, such as superspreader events, outbreaks in targeted sectors such as slaughterhouses, educational settings and residential homes that could later be expanded to other areas of activity. Lessons learned and best practices to be shared post exercise. | July to September |
| Testing | |
| ØEnsure availability of necessary testing capacity through demand planning and R&D (Member States & European Commission)  This will facilitate the ability to increase capacity, if required. | Ongoing |
| ØVia the HSC, EU level agreement for aligned testing strategies and methodologies (European Commission & Member States)  Agreement sought in the HSC via a written declaration. | July to September |
| Contact Tracing | |
| ØComplete the implementation of interoperable contact tracing apps (Member States, European Commission & ECDC)  Follow-up to Guidelines for Member States for interoperability and development of appropriate solutions for cross-border interoperability of apps; Continuous development of EWRS to facilitate information sharing. | July to September |
| ØDevelopment of EU mechanisms for common digitalised Passenger Location Forms for relevant transport sectors (e.g. Joint Action EU Healthy Gateways with the support of the European Union Aviation Safety Agency- EASA) | Ongoing |
| Public health surveillance | |
| ØGuidance for specific outbreak investigations, e.g. in nosocomial settings, potential ‘superspreading’ events (e.g. mass gatherings), and other special occupation settings (ECDC)  This serves to help improve the understanding and surveillance of the epidemiological dynamics. | August |
| ØSampling campaign in waste waters, assessment of results and connection to epidemiologic data (European Commission & Member States)  This aims to track the presence of the virus in urban wastewaters. [20](#footnote20) | Ongoing |
| ØReinforce the population-based sentinel primary care and hospital surveillance system (ECDC & Member States)  ECDC will work with Member States to advise on best practices to help reinforce existing systems that support surveillance at national level. | July to September |
| ØTechnical assistance for the design, conduct and analysis of results from seroprevalence studies [21](#footnote21)  to promote comparability at EU level (ECDC, European Commission & Member States) | July to September |
| ØEnsure EU-wide sharing of clinical, epidemiological, virological data through the EU COVID-19 data sharing platform (European Commission, ECDC & Member States) | Ongoing |
| ØCreation of an EU level register for the prevention and reduction of epidemiological risks, including environmental health determinants (European Commission)  This will be complementary to other platforms and ensure open access and interoperability of data platforms that contain COVID-19 data. | October |

2.Medical countermeasures: smooth functioning of the single market and access to personal protective equipment, medicines and medical devices

The COVID -19 crisis negatively affected trade with third countries, free movement of goods within the EU, and the smooth functioning of the single market. In particular, access to personal protective equipment, medicines and medical devices was a major shortfall across the EU in the early days of the pandemic. As the crisis deepened, global supply chains could not cope with the increased demand. Disruption of production in the then most affected locations occurred. The introduction of export bans by national and third countries’ authorities, as well as problems with international transport of goods, bottlenecks in conformity assessment, as well as the prevalence of not compliant, unsafe and fake products, exacerbated shortages. It became clear that a global race for supplies has come at a high price for products which in some cases lacked in quality. Coordinated solidarity at EU level via the Union Civil Protection Mechanism (UCPM) was also hampered or delayed, given that all countries faced the same type of shortages at the same time 
[22](#footnote22)
. Moreover, the commercial cargo market was disrupted and access to transport options became uncertain.

A range of measures were introduced to overcome these challenges. They included industry conversions, monitoring of shortages with the European Medicines Agency, supporting industry initiatives to optimise production and supply of essential medicines
[23](#footnote23)
, export authorisations
[24](#footnote24)
 and engagement with third party countries as well as freely available standards
[25](#footnote25)
. In addition, the Commission launched joint procurements
[26](#footnote26)
, constituted strategic stockpiles (rescEU), increased cooperation and controls of market surveillance and safety authorities to ensure that only safe protective equipment were offered in the Single Market and new guidance on community coverings was asked to the European Committee for Standardisation (CEN)
[27](#footnote27)
.

Furthermore, the Commission adopted guidelines on export restrictions
[28](#footnote28)
 and on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak
[29](#footnote29)
, and actively worked towards lifting national export restrictions and other obstacles to the free movement of medical equipment and medicinal products. The Commission also adopted a decision
[30](#footnote30)
 authorising Member States affected by the coronavirus pandemic to temporarily suspend customs duties and VAT on protective equipment, testing kits or medical devices such as ventilators. This has made the medical equipment that doctors, nurses and patients desperately need more accessible.

To ensure the free flow of goods within the EU, the Commission actively worked towards lifting national export restrictions. The Single Market Enforcement Task Force (SMET) started meeting with the immediate aim to address restrictions to the free movement of goods, including medical supplies.

Protecting the integrity of the single market, as one of our main assets towards recovery, remains one of the Commission’s priorities. Unjustified obstacles to the free movement of goods, in particular medical equipment and medicines, will continue to be actively challenged by the Commission, using all tools available, including infringement procedures.

The Commission recalls the obligation of Member States to notify draft national technical regulations before they are actually adopted in order for the Commission and other Member States to react. Should the need arise, such as the sudden proliferation of barriers as witnessed during the COVID-19 crisis, SMET should be used as an urgency mechanism to coordinate an appropriate response.

Experience gained from the implementation of the Emergency Support Instrument (ESI) “mobility package”
[31](#footnote31)
, may serve as a basis for developing a coordinated EU response to possible future reductions in global and regional cargo transport capacity.

The Commission also put in place a clearinghouse mechanism, the Clearing House for medical equipment used for COVID-19 (CCH), which serves as a platform for exchange and assessment with Member States on demand and supply of key COVID-19 medical countermeasures, as well as monitoring and helping to improve EU industry capacity.
[32](#footnote32)
 An online information collection platform on supply and demand was created to facilitate the match-making of supply and demand between Member States expressing needs and companies offering medical equipment. Despite some improvements, there are no indications that shortages of medical equipment have been fully resolved. The ECDC and the Joint Research Centre (JRC), are supporting forecasting and modelling.

However, more is needed to prepare for possible future surges in cases. Member States are invited to urgently establish a clear overview on their needs for medical supplies, national production capacities and stockpiles of essential equipment. Procurement activities at the EU level are ongoing to ensure the availability of Personal Protective Equipment, ventilators, laboratory equipment and critical ICU medicines (see annex), as well as access to therapeutics when they will receive market authorisations from the European Medical Agency, and support to the production and deployment of potential successful vaccines. Large EU procurement framework contracts provide support to the preparedness work for Member States. Member States are encouraged to make use of the possibilities to buy medical equipment under the current contracts. It will also be important to ensure that measures are in place to ensure that adequate Personal Protective Equipment reaches the critical social support care sector which provides essential services for older persons and persons with disabilities.

Member States are also invited to map out possibilities for flexible production capacity and conversion of production on their territory. The Commission stands ready to support Member States in industrial reconversion and the establishment of plans for flexible production capacity.

Moreover, research and innovation is geared towards the development of medical countermeasures and providing the evidence base for development and creation of needed common standards for essential products (e.g. diagnostics tests, health data, product approvals, joint public procurement of innovation, and development of clinical guidelines). This needs to be maintained and coordinated and can also be supported by ensuring that relevant European research organisations remain operational in the case of further outbreaks.

As highlighted by the Commission’s EU Strategy for COVID-19 vaccines of 17 June 2020, a permanent solution to the current crisis will most likely be brought about by the development and deployment of an effective and safe vaccine against the virus. In this regard, the European Commission is currently negotiating with vaccine producers on behalf of Member States with a view to agree Advance Purchase Agreements. This will be instrumental in returning economic and social life to normality across Europe and the world.

 

|  |  |
| --- | --- |
| Action area: supply of personal protective equipment, medicines and medical devices | |
|  | Timeline |
| ØPreserve free movement of goods, and in particular of essential medical supplies within the EU (Member States & European Commission) [33](#footnote33) | Ongoing |
| ØImplementation of the EU vaccines strategy (ESI – European Commission & Member States)  The Commission will enter into agreements with individual vaccine producers on behalf of the Member States, with the right to buy vaccines ensured by Advance Purchase Agreements. | Ongoing |
| ØEstablish overview on needs for medical supplies, national production capacities and stockpiles of essential equipment, map flexible production capacities/ conversion possibilities (Member States) | July to September |
| ØOrganise an exchange of best practices among Member States on repurposing, adaptation and ramp-up of production lines to the production of medical supplies (European Commission) | September/October |
| ØEnsure access to COVID-19 therapeutics currently in clinical trials via supply agreements with pharmaceutical companies (European Commission) | July to September |
| ØSupport an EU coordinated approach for the planning and implementation of large-scale COVID-19 clinical trials in Europe (European Commission & Member States) | Ongoing |
| ØExchange between the Commission and Member States on national procurement processes and bottlenecks (Member States & European Commission) | Ongoing |
| ØSupport equitable access and deployment of needed medical countermeasures:  -Ongoing contracts under joint procurements (PPE, ventilators, laboratory equipment, ICU medicines) (Member states)  -New Joint Procurements (European Commission) [34](#footnote34)    -Emergency Commission procurements for Member States (ESI) [35](#footnote35)  -Strategic EU stockpiles (rescEU) [36](#footnote36)  and deployment plans covering the Union  -Transport of medical supplies into the EU (ESI) | Ongoing |
| ØMonitor access, availability and risks of shortages of medical countermeasures and their key ingredients and components (European Commission, European Medicines Agency & Member States)  ØIncrease capacity and speed up certification and conformity assessment of products to be placed on the market while ensuring safety, accuracy and conformity with EU standards (Member States) | Ongoing |
| ØMember States to make full use of existing instruments such as the Joint Procurement Agreement to purchase and stockpile essential medical equipment, and ensure coordinated national stockpiling initiatives (Member States) | July to September |
| ØCustoms and market surveillance authorities to ensure that only compliant medical and personal protective equipment reach the EU market (joint actions with Member States) | Ongoing |
| ØGuidance on re-usable medical and personal protective equipment (ECDC) | July |

3.Healthcare surge capacity

The Covid-19 pandemic has strongly impacted healthcare workers that have been caring for Covid-19 patients, often under high levels of stress for sustained periods of time. They are not only vulnerable to contagion due to their heightened exposure to the virus, but also often needed to work in the context of shortages of appropriate personal protective equipment. Shortages of intensive care unit capacities and specialised healthcare workers to treat COVID-19 patients were also widespread. In most of the EU, national solutions to the shortage of intensive care unit beds proved to be feasible. However, one of the key lessons learned was that, whilst physical infrastructure could be expanded, the most pressing need became the availability of healthcare staff that were competent within intensive care units. In some instances, health care service reservists and medical students were called in and, where needed, rapid training was provided. The Commission also supported a European clinicians’ network allowing healthcare professionals to exchange information and improve their management of COVID-19 patients. However, this reallocation of resources sometimes came at the expense of provision of care for patients with other conditions.

|  |
| --- |
| Cross-border support: healthcare personnel and transfer of patients    During the first outbreak in Europe, certain areas were significantly more affected than others. In some cases, the local capacities were overwhelmed, which was aided by European cross-border support via the sending of specialised healthcare personnel as well as the transfer of COVID-19 patients. For example, co-financed under the EU’s UCPM, Romania and Norway dispatched doctors and nurses to Northern Italy, and in terms of patients, 6 Member States were involved in cross-border transfers of COVID-19 patients.    Based on preliminary initial lessons learned, national strategies should be in place to maximise health systems’ ability to cope. However, in certain instances, support from neighbouring and EU Member States is indeed essential. As such, the Commission has bolstered the solidarity mechanisms by allocating dedicated ESI funding and implementing specific mechanisms to support cross-border transfer of patients and transport of medical teams. |

Maintaining rapid access to surge public health capacities without neglecting other areas of healthcare is essential.
[37](#footnote37)
 Moreover, it is also essential to ensure that, in critical shortage situations, the prioritisation (or “triage”) of healthcare provision is done on the basis of guidance strictly based on medical criteria. Finally, based on experience of the transfer of patients across borders and the need for supplementary healthcare worker capacity when national levels are overwhelmed
[38](#footnote38)
, the Commission has already activated financial support through the Emergency Support Instrument for the transport of medical personnel and patients between Member States. In addition, the UCPM coordinates the deployment of emergency medical teams and equipment to requesting countries.

|  |  |
| --- | --- |
| Action area: healthcare surge capacity | |
|  | Timeline |
| ØFinance and organise the transport of medical personnel and teams into the EU and between Member States and transfer of patients between Member States and to third countries (ESI – European Commission) | Ongoing |
| ØGuidelines for optimisation of hospital space, including de-isolation and discharge of patients clinically healed but still COVID-19 positive (ECDC) | July |
| ØOnline European network of clinicians and development of training modules on COVID-19 for health professionals (including via a virtual academy) in partnership with European federations, such as the European Society of Intensive Care Medicine (Member States, ECDC, European Commission)  This includes practical trainings and information, such as the donning and doffing of personal protective equipment and may extend to intensive care training modules. | Ongoing |

4.Non-pharmaceutical countermeasures

A number of non-pharmaceutical countermeasures, such as restriction of movement, social distancing, use of facemasks in public areas and border controls, were implemented across Member States and third countries
[39](#footnote39)
. These measures have often been necessary to slow down the spread of the virus and have saved tens of thousands of lives, but they have come at a high social and economic cost. Restriction of movement and measures such as closure of public spaces caused disruptive and unprecedented negative social and economic consequences on societies (e.g. access to their workplace for cross-border workers, family separation, access to education and childcare, standstill and disruption in a number of economic sectors and social effects like isolation) and economies of the EU by disrupting the functioning of the single market. They have also negatively affected the single market for goods, restricting their free movement and disturbing supply chains all over the EU and beyond. They also had serious consequences for the freedom of movement inside the EU and the functioning and integrity of the Schengen area. Moreover, the exponential use of technology for daily activities such as communication, receiving information, shopping, working and learning posed a challenge for all those with limited or no access to such ICT.

In view of this economic and social impact, it is in the general interest to avoid large-scale lockdown measures in case of further outbreaks and to address impact of different sectors, including transport and tourism
[40](#footnote40)
. Rather, the response should be to have targeted and localised non-medical countermeasures, informed by research and evidence. Aggregated and anonymised mobility data allowing an assessment of the effectiveness of such measures will help. Once compiled, this can provide the basis for scenario planning of possible evolutions of further outbreaks and the corresponding non-pharmaceutical measures to introduce. Ensuring that workplaces are safe is instrumental to the continuity of work and economic activities, as well as providing childcare services and education for children to allow continuous work life balance for all parents. Preventive and protective measures based on EU rules on occupational health and safety and specific guidance
[41](#footnote41)
 should be put in place to protect workers’ health and prevent the spread of the virus at the workplace. In particular, the obligation on the employer of an updated risk assessment and preventive measures adapted to the changing context is essential in line with the legal framework.

The reestablishment of ineffective restrictions and internal EU border controls must be avoided moving forward. Any measures that imply restrictions on the movement of persons or goods within the EU should be used only in situations where it is strictly necessary. Such restrictive measures should be coordinated and proportionate and non-discriminatory to address public health risks. Temporary controls at borders may only be used in exceptional circumstances to provide a response to situations seriously affecting public policy or internal security and, as a last resort measure, they should last only as long as the extraordinary circumstances persist.

Restrictions inside the territories of the Member States need not necessarily be accompanied by travel restrictions and internal border controls. If border controls are nevertheless introduced, this should be done in consultation with the other Member States, using existing channels and in line with the existing rules, while the free movement of goods, workers exercising critical occupations and essential transport workers should be safeguarded at all times. Green lanes
[42](#footnote42)
 and the existing guidance on border management measures
[43](#footnote43)
, air cargo
[44](#footnote44)
, as well as the free movement of workers
[45](#footnote45)
 and crew changes
[46](#footnote46)
, should be immediately implemented. The Single Market Enforcement Task Force will continue monitoring and addressing any unjustified obstacles to free movement of goods. As regards the continuation of passenger transport, the guidelines on transport services
[47](#footnote47)
 and passenger rights
[48](#footnote48)
 remain relevant and should be applied in accordance with the epidemiological situation. Restrictions on non-essential travel to the EU are under continuous assessment. It is essential that any progressive lifting of the travel restrictions to the EU are done in a fully co-ordinated way between EU Member States.

|  |  |
| --- | --- |
| Action area: Non-pharmaceutical measures | |
|  | Timeline |
| ØTimely exchange of Member States information on effectiveness of measures and any re-introductions to respond to secondary outbreaks  A data entry website and database will be hosted by JRC and will be populated by JRC and ECDC with contributions from the Member States and available for use in modelling, risk assessment, monitoring of the situation in Member States. | July to September |
| ØEU handbook on COVID-19 non-pharmaceutical interventions (ECDC and JRC)  Compiling best practices and scientific guidance informed by modelling results to assist Member States with the calibration of public health measures (including mass gatherings) based on different parameters, criteria and triggers. | August |
| ØSharing of information and best practices related to internal and external border crossings for limiting the negative consequences for the freedom of movement of persons and goods (European Commission & Member States) | Ongoing |

5.Support to vulnerable groups

Certain groups are more vulnerable to the virus than others. This relates to three categories: (1) medically vulnerable – such as the elderly and those with underlying health conditions (e.g. hypertension, diabetes, obesity, etc.); and (2) socially marginalised – such as those residing or working in certain physical settings prone to high density and reduced ability to social distance or a reduced financial budget for protective measures (such as people in poverty) as well as (3) professions which entail closer proximity to confirmed or suspected COVID-19 cases. About half of all fatalities in some Member States were among the elderly, in particular in nursing homes. Additionally, the COVID-19 crisis has highlighted and exacerbated existing inequalities, including increased cases of domestic violence, and as it has hit marginalised communities in our society disproportionately hard. Further outbreaks should not lead to expansion of socio-economic divergences in the European societies. Given the array of different groups, measures to protect their health must therefore be tailored to each specificity, as there will be differing needs and requirements in each case. This includes their needs also with regard to mental health support, addressing for example isolation and loneliness. 

Specific settings require specific measures. The situation of healthcare workers, workers in long-term care settings and other front-line workers, as well as vulnerable groups and settings such as residential homes, will need continuous and adequate monitoring through regular testing in order to avoid further spread of the virus in these settings. In addition, outbreaks in settings such as slaughterhouses, mines,
[49](#footnote49)
 certain air-conditioned areas, necessitate immediate deployment of outbreak control capacities to ensure such outbreaks remain localised. Communities of migrant or seasonal workers need specific attention too.

|  |  |
| --- | --- |
| Action area: Support to vulnerable groups | |
|  | Timeline |
| ØDesign and implement specific high density, low threshold testing strategies for vulnerable groups & settings (Member States and ECDC) | July to August |
| ØSharing best practices in supporting COVID-19 prevention, testing and care in socially and marginalised groups and medically vulnerable groups and settings (European Commission & ECDC) | July to September |
| ØSharing of best practices and provision of mental health and psychosocial support to vulnerable prone to COVID-19 (European Commission and Member States) | July to September |
| ØProvision of specific online trainings to frontline staff working with vulnerable groups (ECDC) | July to September |

6.Reducing the burden of seasonal influenza

Every year, seasonal influenza creates a burden on health systems
[50](#footnote50)
. Simultaneous outbreaks of seasonal influenza and COVID-19, would place a considerable strain on health systems. Therefore, activities that would reduce the burden of seasonal influenza - covering, for example, increased surveillance, testing, access to vaccines and differential diagnosis - need immediate consideration.

|  |  |
| --- | --- |
| Action area: Mitigate seasonal influenza | |
|  | Timeline |
| ØIncrease influenza vaccination coverage: anticipated start for vaccination campaigns and broadening of target groups (Member States)  Member States should consider the anticipation of vaccination campaigns and broadening of target groups. | July to September |
| ØEnsure additional national procurements for influenza vaccines (e.g. through excess supply production) (Member States) | July to September |
| ØScientific guidance for vaccination infrastructure for seasonal influenza in a COVID-19 outbreak setting (ECDC) | July |
| ØPrepare adapted vaccination infrastructures for seasonal influenza in a COVID-19 outbreak setting (e.g. to cater to potentially larger seasonal influenza vaccination uptake) (Member States) | July to September |
| ØSharing best practices in national influenza immunisation programmes (European Commission and ECDC)  This can include adapted plans for seasonal influenza vaccination in a COVID-19 outbreak, anticipate population demand and ensure vaccination in case of confinement. | July to September |
| ØIncrease vaccination coverage through targeted awareness raising campaigns at workplaces (EU-OSHA) | September to October |
| ØGuidelines for clinical management and treatment protocol for differential diagnosis and management of influenza and COVID-19 (ECDC) | July |

III.CONCLUSION

The EU must ensure that it is ready for possible resurgences of COVID-19 cases. This requires short-term and strongly coordinated action to strengthen key areas of preparedness and response. Early detection of cases and a rapid response to prevent further spread, combined with specific measures to protect the most vulnerable in our societies, are currently our best shot to avoid having to reinstate large-scale restrictions such as lockdowns. Building on the ongoing work in the Member States, the Commission and EU Agencies, this Communication has set out the necessary actions to be taken.

These efforts should be underpinned by robust evidence and extensive public communication efforts. Preventing a resurgence of cases largely depends on individual behaviours and adherence to public health recommendations. Sustained vigilance by all is key to ensure that a core set of basic individual precautions remains in place at all time. This, in turn, relies on the public’s acceptance and understanding of the well-founded nature and importance of these measures. Monitoring the degree of social acceptance and addressing early societal concerns will be a key determinant of future developments. These communication efforts also entail a systematic and immediate response to disinformation about the coronavirus pandemic
[51](#footnote51)
, whilst further efforts should also be made to enhance the cyber resilience of key health infrastructure. In case a Member State would reintroduce emergency measures, these should be designed in a measured and limited way so that they do not obstruct the rule of law and parliamentary democracy.

The virus does not stop at EU borders and this is why the EU and its Member States provide over EUR 36 billion with emergency aid, humanitarian aid bridges and longer-term support to third countries in need. It has also set up an EU Humanitarian Air Bridge to maintain vital transport links for humanitarian and emergency health workers and supplies.

Efforts should thus continue in coordination with other global actors, including the UN and WHO, to ensure the required international response to this global health threat, including equitable access to a COVID-19 vaccine. This should go hand in hand with efforts to address the socio-economic impacts of this crisis, which threaten to unravel progress made in achieving the SDGs as well as investment in the resilience of partner countries, notably through health-system strengthening, hence underpinning the global recovery
[52](#footnote52)
. This is the only way to bring an end to the current pandemic crisis in the EU and globally.

More than any other year, attention must be given to reducing the impact of seasonal influenza for 2020/2021 and activities must be put into place now to mitigate this scenario. The combined effects of simultaneous outbreaks of COVID-19 colliding with a heavy influenza season could stretch even further the limits of our healthcare systems.

The European Commission will continue working side by side with Member States in the fight against COVID-19. Together, we will continue funding research for predicting the spread and resurgence and to support the development of necessary medical countermeasures. We will also promote the identification and dissemination of local good practices. Through an ambitious recovery plan supported by a revamped long-term budget 2021-27 and the Next Generation EU instrument, Europe will also invest to secure its recovery and resilience against possible future Covid-19 outbreaks, support structural changes across healthcare systems and reinforce the Union’s crisis management systems and capacities. Europe will thoroughly draw the lessons from the COVID-19 crisis to ensure it comes out stronger, more united and better equipped to face future crises.

:   [(1)](#footnoteref1)

    Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC Text with EEA relevance. OJ L 293, 5.11.2013, p. 1–15 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
:   [(2)](#footnoteref2)

    Contact tracing for COVID-19: current evidence, options for scale-up and an assessment of resources needed: https://www.ecdc.europa.eu/sites/default/files/documents/COVID-19-Contract-tracing-scale-up.pdf
:   [(3)](#footnoteref3)

    As already outlined in the Joint European Roadmap towards lifting COVID-19 containment measures
:   [(4)](#footnoteref4)

     This was exacerbated by challenges in scaling up contact tracing activities by, for example, using innovative solutions such as the use of non-medical staff and the adoption of on-line software
:   [(5)](#footnoteref5)

    In line with the Joint European Roadmap towards lifting COVID-19 containment measures
:   [(6)](#footnoteref6)

    Data on the number of RT-PCR tests performed by country are reported weekly by the EU/EEA national public health authorities to The European Surveillance System (TESSy)
:   [(7)](#footnoteref7)

    Further information on joint procurements can be found in the annex
:   [(8)](#footnoteref8)

    https://www.ecdc.europa.eu/en/publications-data/rapid-risk-assessment-coronavirus-disease-2019-covid-19-pandemic-tenth-update
:   [(9)](#footnoteref9)

    https://ec.europa.eu/health/sites/health/files/ehealth/docs/covid-19\_apps\_en.pdf
:   [(10)](#footnoteref10)

    Regulation (EU) 2016/679 (General Data Protection Regulation) in the current version of the OJ L 119, 04.05.2016; cor. OJ L 127, 23.5.2018
:   [(11)](#footnoteref11)

    Commission Recommendation (EU) 2020/2296 of 8 April 2020 on a common Union toolbox for the use of technology and data to combat and exit from the COVID-19 crisis, in particular concerning mobile applications and the use of anonymised mobility data
:   [(12)](#footnoteref12)
     https://ec.europa.eu/health/sites/health/files/ehealth/docs/covid-19\_apps\_en.pdf
:   [(13)](#footnoteref13)

    Based on the European Interoperability Framework an interoperable solution is being implemented for the apps in the so called “decentralised” architecture, where the calculation of infection risk happens on the device and work is ongoing for the interoperability with “centralised” systems, where the risk calculations takes place on the backend server of the health authority.
:   [(14)](#footnoteref14)

    Communication from the Commission Guidance on Apps supporting the fight against COVID 19 pandemic in relation to data protection 2020/C 124 I/01 C/2020/2523. OJ C 124I , 17.4.2020, p. 1–9 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV) & The European Data Protection Board’s Guidelines 04/2020 on the use of location data and contact tracing tools in the context of the COVID-19 outbreak, Adopted on21 April 2020
:   [(15)](#footnoteref15)

     Commission Implementing Decision (EU) 2020/1023 of 15 July 2020 amending Implementing Decision 2019/1765 as regards the cross-border exchange of data between national contact tracing and warning mobile applications with regard to combatting the COVID-19 pandemic. OJ L 227 I, 16. 07.2020, p. 1.
:   [(16)](#footnoteref16)

    This refers inter alia to the measures concerning transport referred to in section 4 of this Communication such as the implementation of the guidelines on transport services, as well as the guidance issued by the Joint Action Healthy Gateways (https://www.healthygateways.eu/), EASA/ECDC protocols (
    <https://www.easa.europa.eu/sites/default/files/dfu/EASA-ECDC_COVID-19_Operational%20guidelines%20for%20management%20of%20passengers_v2.pdf>
     ) and the work of other relevant EU Agencies, including the work of the European Maritime Safety Agency (EMSA) and the European Union Agency for Railways (ERA)
:   [(17)](#footnoteref17)

    International Health Regulations (IHR) define a point of entry as “a passage for international entry or exit of travellers, baggage, cargo, containers, conveyances, goods and postal parcels, as well as agencies and areas providing services to them on entry or exit”
:   [(18)](#footnoteref18)

    Molecular typing is a way to sequence and identify specific strains of the virus. The integration of molecular typing in epidemiological surveillance is an important instrument to monitor and control the pandemic. It helps track how the virus actually spreads and identify possible evolutions over time.
:   [(19)](#footnoteref19)

    Infection in medical and healthcare facilities
:   [(20)](#footnoteref20)

    Several MS took the initiative to monitor the presence of COVOD-19 residues in their wastewaters. The JRC together with DG ENV and with the involvement of DG SANTE took the initiative to launch a pan-European Umbrella Study connecting the leading national and regional reference study in a unique approach.
:   [(21)](#footnoteref21)

    Such studies aim to gather information on infection rates across populations.
:   [(22)](#footnoteref22)

    Under the Union Civil Protection Mechanism, the EU supports coordination and co-finances EU Member States and six additional Participating States in providing assistance to countries requesting EU assistance. As of 23 June, the ERCC has received 47 requests for assistance, related to COVID-19 pandemic, concerning medical items and PPEs. Of these requests, only 16 have been partially answered.
:   [(23)](#footnoteref23)

    The pharmaceutical industry plays an important role in overcoming the risk of shortages of essential products and services resulting from COVID-19 outbreaks in the EU. The exceptional circumstances and resulting challenges may trigger the need for undertakings to cooperate with each other in order to overcome, or at least to mitigate, the effects of the crisis to the ultimate benefit of citizens. In this context, on 8 April 2020, the Commission adopted the communication Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak (“Temporary Framework”, OJ C 116I, 8.4.2020, p. 7–10). This sets out the main criteria that the Commission will apply when assessing under EU competition rules cooperation projects aimed at addressing shortages of supply of essential products and services during the coronavirus outbreak. The Temporary Framework also foresees the possibility of providing companies with written comfort (via ad hoc “comfort letters”) on specific cooperation projects falling within its scope. On the basis of the Temporary Framework, the Commission has issued on 8 April 2020 a comfort letter to “Medicines for Europe”, an association of pharmaceutical manufacturers, and participating companies in relation to a voluntary cooperation project to address the risk of shortages of critical hospital medicines for the treatment of coronavirus patients (
    <https://ec.europa.eu/competition/antitrust/medicines_for_europe_comfort_letter.pdf>
    ).
:   [(24)](#footnoteref24)

     COMMISSION IMPLEMENTING REGULATION (EU) 2020/568 of 23 April 2020 making the exportation of certain products subject to the production of an export authorisation
:   [(25)](#footnoteref25)

    Temporarily provided by CEN and CENELEC, on request of the Commission, for medical and protective face masks, gloves, clothing and respiratory ventilators, to support production and placing on the market of essential supply.
:   [(26)](#footnoteref26)

     EU joint procurements cover personal protective equipment, ventilators and ICU medicines – more information is available in the annex
:   [(27)](#footnoteref27)

    In May 2020, the European Commission requested CEN to develop technical specifications on community face coverings. On 17 June 2020, the CEN Workshop Agreement CWA 17553 on « Community face coverings - Guide to minimum requirements, methods of testing and use » was released.
:   [(28)](#footnoteref28)

    guidelines set out in Annex 2 of the Communication on the coordinated economic response to the COVID-19 outbreak: COM(2020)112 of 13.3.2020
:   [(29)](#footnoteref29)

    C (2020) 2272 of 8.4.2020.
:   [(30)](#footnoteref30)

    Commission Decision (EU) 2020/491 of 3 April 2020 on relief from import duties and VAT exemption on importation granted for goods needed to combat the effects of the COVID-19 outbreak during 2020. The measure applies until 31 July, but will probably be extended until 31 October 2020 as Member States still reported shortages in these goods.
:   [(31)](#footnoteref31)

    This makes funds available to transport vital medical supplies into and within the EU and which support transport of medical staff and patients between Member States
:   [(32)](#footnoteref32)

    The Commission’s Clearing House reports ongoing shortages related to gowns/coveralls/caps/shoe covers, surgical/medical masks, FFP masks (all types), medical gloves, accessories of ventilators, endotracheal tubes, PCR tests, antigen tests, hardware of tests (lab machines, etc.); reagents; laboratory consumables, swabs, anaesthetic/sedative medicines, muscle relaxers, antibiotics & analgesics/corticosteroids.
:   [(33)](#footnoteref33)

    The Commission will continue monitoring, national measures taken by Member States and assisting Member States in order to prevent any unnecessary obstacles to free movement of goods using available tools such as the Single Market Enforcement Task Force, the Single Market Transparency Directive (Directive 2015/1535 EU laying down a procedure for the provision of information in the field of technical relations).
:   [(34)](#footnoteref34)

    Additional joint procurements can be launched to cover, for example, intensive care unit medicines and therapeutics.
:   [(35)](#footnoteref35)

    From the budget of the Emergency Support Instrument, €100 million are earmarked for purchasing healthcare related material.
:   [(36)](#footnoteref36)

    Implementing Decision (EU) 2020/414 of 19 March 2020 amending Implementing Decision (EU) 2019/570 as regards medical stockpiling rescEU capacities (notified under document C(2020) 1827). It enables stockpiling of medical countermeasures such as vaccines and therapeutics, laboratory supplies, intensive care medical equipment or personal protective equipment aimed at combatting serious cross-border threats to health.
:   [(37)](#footnoteref37)

    This includes sufficient capacities for alternative hospital structures (e.g. primary care structures to manage patients outside hospitals) and intensive care beds, as well as sufficient trained surge healthcare personnel across primary, hospital, tertiary care and homecare settings and alternating healthcare personnel to mitigate staff fatigue.
:   [(38)](#footnoteref38)

    For example, when national level planning for exchanges of healthcare personnel and transfer of patients is exhausted.
:   [(39)](#footnoteref39)

    The Commission and the ECDC have worked with Member States to support the gradual and phased lifting of these measures as well as the coordinated lifting of the temporary restriction on non-essential travel to the EU. Epidemiological assessment has been regularly provided via the ECDC’s Rapid Risk Assessments.
:   [(40)](#footnoteref40)

    With specific regard to tourism and transport, the Commission put forward a package of guidelines and recommendations to support Member States: https://ec.europa.eu/commission/presscorner/detail/en/QANDA\_20\_870
:   [(41)](#footnoteref41)

    Healthy Workplaces Stop the Pandemic: COVID-19: Resources for the workplace. (https://osha.europa.eu/en/themes/covid-19-resources-workplace)
:   [(42)](#footnoteref42)

    Communication from the Commission on the implementation of the Green Lanes under the Guidelines for border management measures to protect health and ensure the availability of goods and essential services, OJ C 96I , 24.3.2020, p. 1.
:   [(43)](#footnoteref43)

    Covid-19 Guidelines for border management measures to protect health and ensure the availability of goods and essential services, OJ C 86I , 16.3.2020, p. 1.
:   [(44)](#footnoteref44)

    Communication from the Commission European Commission Guidelines: Facilitating Air Cargo Operations during COVID-19 outbreak, OJ C 100I , 27.3.2020, p. 1.
:   [(45)](#footnoteref45)

    Communication from the Commission Guidelines concerning the exercise of the free movement of workers during COVID-19 outbreak, OJ C 102I , 30.3.2020, p. 12.
:   [(46)](#footnoteref46)

    Communication from the Commission Guidelines on protection of health, repatriation and travel arrangements for seafarers, passengers and other persons on board ships, OJ C 119, 14.4.2020, p. 1.
:   [(47)](#footnoteref47)

    Communication from the Commission Guidelines on the progressive restoration of transport services and connectivity – COVID-19, OJ C 169, 15.5.2020, p. 17.
:   [(48)](#footnoteref48)

    Commission Notice Interpretative Guidelines on EU passenger rights regulations in the context of the developing situation with Covid-19, OJ C 89I , 18.3.2020, p. 1.; Commission Recommendation (EU) 2020/648 of 13 May 2020 on vouchers offered to passengers and travellers as an alternative to reimbursement for cancelled package travel and transport services in the context of the COVID-19 pandemic, OJ L 151, 14.5.2020, p. 10.
:   [(49)](#footnoteref49)

    These are current examples of further outbreak settings but does not negate the risk of further outbreaks in other settings.
:   [(50)](#footnoteref50)

    With about 40.000 deaths in the 2018/19 season in the EU.
:   [(51)](#footnoteref51)

    JOINT COMMUNICATION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Tackling COVID-19 disinformation - Getting the facts right

    JOIN/2020/8 final
:   [(52)](#footnoteref52)

     The European Commission has provided additional support to international collaboration in response to COVID-19 by, inter alia, support for the WHO’s call for global collaboration for accelerated development, production and equitable global Access to COVID-19 Tools – the ACT Accelerator, notably via the Commission and global partners initiating the Coronavirus Global response (a global pledging campaign)

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![european flag](./../../../images/eclogo.jpg)EUROPEAN COMMISSION

Brussels, 15.7.2020

COM(2020) 318 final

ANNEX

to the

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

Short-term EU health preparedness for COVID-19 outbreaks

ANNEX 
  
. 
  
OVERVIEW – JOINT PROCUREMENT

The Joint Procurement Agreement - Legal Basis and Objectives

On 10 April 2014, the Commission adopted the Joint Procurement Agreement (JPA)
[1](#footnote1)
 for the EU institutions, together with States that have joined JPA, to purchase: Vaccines; Antivirals and Medical countermeasures for serious cross-border threats to health. As of April 2020 the JPA has been signed by all 27 EU countries, the UK, the 3 EEA countries (Norway Iceland and Liechtenstein) and Albania, Bosnia and Herzegovina, Montenegro, Serbia, North Macedonia and Kosovo
[2](#footnote2)
 as well.
[3](#footnote3)
 These countries may participate in any future joint procurement procedure. The Joint Procurement Agreement has been signed by 37 partners and covers 537 million people. The joint procurement mechanism was established with the objective of improving the preparedness of Member States to respond to emergency situations, namely to establish stocks of medical countermeasures before an emergency situation occurs. It was not primarily designed as a tool to be used during an emergency situation. Current circumstances highlight the relevance of preparedness while placing enormous strain on the mechanism. Nevertheless, the instruments, pressed as they might be, are already starting to prove useful.

Practical modalities & Speed of implementation of Joint Procurements related to COVID-19

In the context of COVID-19, the negotiated procedure for reasons of extreme urgency is used. This means that potential tenderers are identified through a market analysis and only invited companies may submit a tender. Once the tender is awarded, participating Member States receive the total quantity of the ordered or reserved measures. However, the rate of delivery depends on the production capacity of the manufacturers and the applicable allocation criteria. The final allocation of available amounts of medical countermeasures is allocated by the specific steering committee. The Commission has on its initiative proposed a number of measures of exception to speed up the processes. Processes are slowed down by time required for all interested member states to finish submitting needs and by reactivity of the companies/market.

Ongoing Joint Procurements related to COVID-19

Five joint procurements procedures have been launched covering personal protective equipment, ventilators and laboratory equipment. For the first procurement on PPE, Member States could order gloves as of the beginning of April onwards. As of beginning of May, Member States can also place orders for coveralls. For the second procurement on PPE, Member States can order goggles, face shields and masks since the beginning of April. For the third procurement on ventilators, Member States can order since 15 April. For the fourth joint procurement on laboratory equipment, Member States already have the possibility to order since May. For the fifth joint procurement on the ICU medicines tender has been launched on 17 June.

Contracts for personal protective equipment and ventilators and laboratory equipment will provide Member States with a total ceiling budget of over € 3.3 billion of critical supplies that they can procure over the course of 1 year.
[4](#footnote4)

Further joint procurements can be launched at any time if the need arises. It requires at least four Member States and the Commission to be launched.

:   [(1)](#footnoteref1)

    The provisions for the JPA are included in Article 5 of Decision 1082/2013/EU.
:   [(2)](#footnoteref2)

    This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.
:   [(3)](#footnoteref3)

    Following the European Council call of 26 March 2020 to open the Joint Procurement Agreement to the Western Balkans, discussions started with the six partners concerned. Some countries have not yet completed their national approval procedures. Until they notify the Commission by submitting Annex II, they shall not be taken into account for the purposes of reaching a common accord, qualified majority or simple majority under the Agreement.
:   [(4)](#footnoteref4)

     (Adjustments to the ceilings may occur as more contracts are negotiated.)

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