Annexes to COM(2022)452 - EU response to COVID-19: preparing for autumn and winter 2023 - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)452 - EU response to COVID-19: preparing for autumn and winter 2023. |
|---|---|
| document | COM(2022)452  |
| date | September 2, 2022 |
The need for multi-country clinical trials
As of January 2022, with the entry into application of the Clinical Trials Regulation 28 , the assessment and supervision of clinical trials throughout the EU have been harmonised, notably via a Clinical Trials Information System (CTIS). The Clinical Trials Regulation allow swifter authorisation of clinical trials across Member States, thus improving the efficiency of clinical research as a whole. At the same time, the high quality and safety standards already set for such trials will be upheld.
With the Regulation and the CTIS, commercial and non-commercial sponsors can now apply for clinical trial authorisations in up to 30 EU/EEA countries at the same time. The new regulatory system and the platform improve information-sharing and collective decision-making on clinical trials. CTIS, whose use will be mandatory for the submission of the clinical trial applications by 31 January 2023, provides also a public searchable database for healthcare professionals, patients and the general public. On 31 January 2025, the Regulation will be fully applicable and all clinical trials will need to be compliant with the rules.
Over the coming years, this new European regulatory environment for clinical trials will facilitate, streamline, speed up and increase transparency for multinational clinical trials also for possible new COVID-19 therapeutics and vaccines. Moreover, it will ensure that the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.
The Emergency Task Force, established as part of the EMA’s revised mandate 29 , provides advice on clinical trial protocols, including joint clinical trials, to developers of clinical trials that are carried out in the Union. Ultimately, the advice will facilitate the timely development and authorisation of medical products such as vaccines and treatments and improve overall clinical trial coordination in Europe. This scientific advice by the Emergency Task Force should be taken into account by Member States when authorising a clinical trial application.
Finally, two EU clinical trial networks have been established under Horizon 2020: one focusing on COVID-19 therapeutics and one for COVID-19 vaccines. The therapeutic trials network includes large-scale adaptive platform trials carried out in intensive care populations, hospitalised patients and primary care patients 30 . In addition, the joint access advisory mechanism (JAAM) supports an efficient use of resources between the trials and avoids duplication of efforts. The vaccine trial network includes public health focused vaccine trials in the elderly, the general adult population and children 31 .
Focusing on addressing post-COVID condition (“long-COVID”)
Emerging evidence suggests that as many as 1 in 8 people who recover from COVID-19 will experience debilitating symptoms lasting much longer than expected, leading to an impaired quality of life 32 .
Although the risk of developing post-COVID condition appears to be greater among older individuals with pre-existing conditions who were admitted to hospital because of COVID-19, studies have shown how it is also prevalent among previously healthy, young people who experienced mild to no symptoms when they first contracted the virus 33 . People with post-COVID condition can experience a wide range of symptoms, including respiratory, cardiovascular, gastrointestinal, cognitive, musculoskeletal, and neurological symptoms. These symptoms can be intermittent, affect several of the body’s systems and range from mild to incapacitating, frequently impairing people’s ability to return to work. Against the backdrop of this long list of symptoms, to date there are no validated therapies to treat this condition.
This novel class of patients will require specific care, often from different medical specialisations. This is expected to add a substantial burden on European healthcare systems and can exacerbate the large backlog of non-COVID-related care accumulated throughout the pandemic. These considerations highlight the urgency of stepping up research efforts aimed at understanding the biological basis of post-COVID condition. Achieving a better understanding of the pathology underlying post-COVID condition will enable researchers to identify candidate therapies and ultimately develop large-scale clinical trials to verify their benefit.
In this context, the EU’s Horizon Europe work programme 2021- 2022 has provided funding for six research projects focused on post-COVID condition. These projects aim at better characterising post-COVID condition, as well as investigating risk factors for its development across different SARS-CoV-2 variants and population groups, with a view to identify potential biomarkers and inform treatment options.
The EU Strategy on COVID-19 therapeutics 34 refers to post-COVID condition in its framework of research, development and innovation actions. The strategy acknowledges that post-COVID condition requires a different therapeutic approach to acute COVID-19. Equally, and in keeping with the emerging hypothesis that persistent viral reservoirs may be one cause of post-COVID condition 35 , therapeutics used to treat COVID-19 (such as antivirals) could also be tested as a potential treatment for post-COVID condition.
To provide expert guidance on how healthcare systems should design and develop appropriate health services for patients affected by post-COVID condition, the Commission has tasked the Expert Panel on effective ways of investing in health 36 to provide an opinion, due at the end of 2022, on the impact of post-COVID condition on health systems. Moreover, the European Agency for Safety and Health (EU-OSHA) has published a report on the impact of post-COVID condition on workers and workplaces 37 and has issued related guidance for workers 38 and managers 39 . Member States are encouraged to join forces to gather up-to-date evidence on post-COVID condition and to increase training of health workforce in the recognition and management of post-COVID condition, especially in primary care. It should be recalled that the best way to prevent the post-COVID condition is to avoid being infected with SARS-CoV-2 in the first place.
Transport, mobility, travel
Since August 2022, all measures affecting free movement of persons in the EU have been lifted, including the requirement for travellers to hold an EU Digital COVID Certificate.
Continued efforts to facilitate free movement in the EU during the COVID-19 pandemic remain crucial, both for people and goods. It remains our shared goal to enjoy unrestricted free movement, if the epidemiological situation allows so. To respond to the specific challenges affecting the transport sector and disruption of the supply chain, the Commission and EU Member States should rely on the tools already developed so far, in particular Green Lanes 40 , Contingency Plan for Transport 41 , and appropriate health protocols.
Travel restrictions should only be introduced or reintroduced where they are absolutely necessary and proportionate for the protection of public health. For example, certain non-pharmaceutical interventions, such as mask-wearing, should be considered before introducing or reintroducing any travel restrictions. Any new measures should be communicated to key stakeholders, such as transport operators, so they can prepare and avoid any negative potential impacts. Should Member States wish to activate contact tracing of cross-border passengers, common tools, such as the EU Passenger Locator Form, are available to exchange passenger data to enhance their contact tracing capabilities while limiting burdens on passengers and transport operators.
Member States can make use of the EU Digital COVID Certificate in case the epidemiological situation this autumn and winter makes it necessary for countries to temporarily reintroduce travel restrictions. The EU Digital COVID Certificate Regulation, which has been extended until June 2023 42 , provides the necessary framework to manage the impact of restrictions on free movement and to facilitate travel. It ensures that citizens can benefit from interoperable and mutually accepted certificates of COVID-19 vaccination, test and recovery. In principle, holders of valid EU Digital COVID Certificates should not be subject to any additional restrictions when travelling within the EU.
The EU Digital COVID Certificate has been a major success in providing the public with a tool that is accepted and trusted across the EU (and in several third countries) and in avoiding fragmentation of multiple national systems. As of 1 August 2022, 75 countries and territories from across 5 continents are connected to the EU Digital Certificate system (30 EU/EEA Member States and 45 non-EU countries and territories), and several more countries have expressed interest in joining the gateway or are already engaged in technical discussions with the Commission. This makes the EU Digital COVID Certificate a global standard.
The EU Digital COVID Certificate system is sufficiently flexible to adapt to the evolution of the COVID-19 response. Possible adaptations to the validity period of certificates issued for the first booster may become necessary in light of further scientific evidence and the evolution of the pandemic.
If the use of the EU Digital COVID Certificate were to be reintroduced, it remains important to ensure that everyone can obtain a valid EU Digital COVID Certificate. This means that Member States should continue to ensure that sufficient testing and vaccination capacity is available and easily accessible. Member States should also inform citizens who underwent a SARS-CoV-2 infection of their right to receive a recovery certificate if they have done a PCR or antigen test.
In addition, Member States should do their utmost to ensure that passengers are well-informed about possible travel restrictions they may face when entering another EU/EEA Member State. The Re-Open EU web platform 43 remains a key point of reference for anyone travelling in the EU. The Commission reiterates the continued importance of timely updates 44 by Member States on possible travel restrictions, public health and safety measures, so that European citizens can continue to rely on the platform to plan their travel with confidence.
The emergency brake procedure agreed in that Council Recommendation 2022/107 45 continues to ensure a coordinated approach among Member States in response to the emergence of potential new variants of concern.
The current ECDC colour-coded country categorisation has been discontinued in light of the evolving approaches and decreasing trends in testing volumes in Member States, which in turn did not allow the ECDC to draw up an adequate depiction of the epidemiological situation.
Furthermore, in the context of travel from third countries, in June 2020, the Council adopted a coordinated approach to travel to the EU+ area, which has since then been amended three times 46 . The Commission intends to propose a revision of the Recommendation shortly, in order to take account of the changed epidemiological situation and the developments of the practices in the Member States, notably concerning the list of countries in Annex 1 to Council Recommendation (EU) 2020/912 that no longer reflect the current situation. Such a revision, that will be consulted with Member States, aims to provide a common framework for the coming months, ensuring a coordinated approach.
5.THE GLOBAL DIMENSION
In order to control and end the pandemic, world-wide efforts and support for fighting COVID-19 globally are essential. This is why, since the onset of the COVID-19 crisis, the EU, as Team Europe 47 , has played a central role in the multilateral response for the rapid development, scale-up and equitable distribution of COVID-19 vaccines worldwide. The EU remains the biggest donor of COVID-19 vaccines globally, considering doses shared by Member States via COVAX (COVID-19 Vaccines Global Access) and as bilateral donations. In total, Team Europe has now shared almost 482 million doses with countries in need and remains committed to donation and exportation efforts in the upcoming months, should there be an increased interest for original formulations and adapted vaccines. Even though the global COVID-19 vaccines supply has stabilised, many countries, especially in Africa, are still very far from achieving sufficient vaccination rates. The lack of primary vaccination also creates a risk of missing out on the benefits of boosters, including boosters with adapted vaccines.
The current situation is marked by more supply of vaccines relative to demand: the global availability of vaccines has not been matched by a corresponding increase in vaccine uptake in some countries. The challenge has clearly shifted to ‘getting shots into arms’ or administering the vaccines received. This is why, for instance, the EU has put forward a Vaccine Support Package for its African partners, which covers supply, ancillary material, and delivery support. The EU has announced additional EUR 375 million support to countries with the lowest vaccination rates through the COVID-19 Delivery Support mechanism of the COVAX Facility 48 . This funding supports national governments in service delivery, health workforce, demand generation, vaccination campaigns, supply chain systems, cold chain and rapid UCC capacity following a country needs-based approach. The funding also supports countries to sustain equitable access, reach marginalized populations, integrated COVID-19 vaccination and routine immunisation and strengthen immunisation systems.
The capacity of local healthcare systems needs to be further developed to ensure communities get vaccinated; local vaccine development and production should also be strengthened. The Commission supports strengthening of national healthcare systems in Africa, for example by engaging at the regional level to improve health security through a One Health approach, digitalisation of health systems and by supporting public health institutes.
The EU will also continue working through the Team Europe initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+) 49 . This initiative began in 2021 and is contributing to increase local and regional manufacturing capacity, diversify African pharmaceutical supply chains and to address bottlenecks in the international supply chain. Team Europe has mobilised so far more than EUR 900 million to support building capacities in South Africa, Senegal, Rwanda and Ghana and at regional level for regulatory strengthening and the African Medicines Agency (AMA), the African Union Development Agency (AUDA-NEPAD) and the Partnership for African Vaccine Manufacturing. Within the framework of matchmaking events, the EU has been enhancing collaboration between African and European companies concerning the value chains of the pharma and medical technology industry. The EU has also launched a new initiative on local manufacturing of vaccines and medicines to support efforts in Latin-America and the Caribbean.
The EU also pledged EUR 150 million to the Global Fund’s COVID-19 Response Mechanism (C19RM) 50 for ensuring access to medical countermeasures in partner countries (including diagnostics, tests, oxygen and personal protective equipment).
Moreover, the EU is actively contributing, alongside the US and other global partners, to the successful implementation of the Global Action Plan to beat the pandemic. The objective is to help coordinate actions and mobilise resources in six priority areas in relation to the global COVID-19 response. COVID-19 has taught us that only a united and multilateral response can effectively tackle a global pandemic.
The fight against anti-vaccination mis- and disinformation should be continuously addressed globally. Tackling foreign information manipulation and interference requires a specific response. The European External Action Service (EEAS), in close cooperation with the Commission and Member States, has been developing the EU’s toolbox to tackle foreign information manipulation and interference (FIMI Toolbox).
Lastly, the EU believes it is vitally important to build on the lessons learned from the COVID-19 pandemic and to strengthen the global health architecture – with a reinforced WHO at its centre. The EU is determined to be a driving force in the negotiations on a new, legally binding, international agreement on pandemic prevention, preparedness and response and on targeted amendments to strengthen the International Health Regulations 2005. These complementary processes are a priority for the EU and provide a historic opportunity to find multilateral solutions to common challenges, based on the principles of collective solidarity, equity, fairness, inclusiveness and enhanced transparency. Moreover, the new Financial Intermediary Fund (FIF) for Pandemic Prevention, Preparedness and Response 51 , to which Team Europe has already pledged at least 52 EUR 588 million, will provide funding to support pandemic prevention, preparedness and response, including the implementation of the amended International Health Regulations and the new international agreement on pandemic prevention, preparedness and response.
COVID-19 has demonstrated that the international aspect of EU health policy has become more important than ever. We are learning these lessons and taking coordinated steps to protect and promote health globally and to strengthen the EU’s leadership in, and contribution to, global health. The forthcoming EU global health strategy will provide the political framework with priorities, governance and tools, enabling the EU to speak with one influential voice and making the most of Team Europe’s capacity to protect and promote health globally.
6.CONCLUSION
While the evolution of the pandemic is unpredictable, the EU needs to prepare itself – for the third time in a row – for a challenging autumn and winter. But the future of the pandemic does not only depend on new variants that may emerge and outcompete older strains. It is also greatly determined by human behaviour and how much immunity can be built up in the population. Minimising the number of new cases also decreases the chances of new variants appearing. These are factors that can be influenced, and Member States’ healthcare systems and society must continue to adapt their collective response to this virus until the threat of COVID-19 is no longer acute.
As we have seen during the peaks of the COVID-19 pandemic, working together is essential. Now that a political agreement has been reached on the new EU regulation on serious cross-border threats to health, which is the final legislative piece of the European Health Union Package 53 , the Union will soon have a new set of tools to finish the revision of the EU health security framework and to strengthen the required infrastructure and processes for implementing COVID-19 preparedness and response measures.
The pandemic has reminded us very clearly of the importance of collaboration. Through working together, we can make a real difference and strengthen the EU’s capacity to prevent, prepare and respond to health crises – in the upcoming months as well as in the future. We are stronger, more resilient and more effective when we work together on a sustained management of the pandemic.
(1)
By the end of week 22 of 2022, the 14-day COVID-19 case notification rate for the EU/EEA was 350 (country range: 8.1-3 303) per 100 000 population, which increased to 1 207 (country range: 43.0-4 945) per 100 000 by the end of week 28 of 2022.
(2)
Hospital admission rates per 100 000 nearly doubled between early May and mid-July 2022, and current levels are at over 40% of the pandemic maximum. ICU admission and occupancy rates currently correspond to 16% and 18% (respectively) of the maximum rates reported since the start of the pandemic.
(3)
Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, COVID-19 – Sustaining EU preparedness and Response: Looking ahead (COM/2022/190 final).
(4)
The Economist, Covid-19 vaccines saved an estimated 20 m lives during their first year, 7 July 2022, https://www.economist.com/graphic-detail/2022/07/07/covid-19-vaccines-saved-an-estimated-20m-lives-during-their-first-year?frsc=dg%7Ce .
(5)
Commission Delegated Regulation (EU) 2021/756 of 24 March 2021 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 162, 10.5.2021, p. 1).
(6)
In addition to the existing contracts with Sanofi and Novavax, the EU has recently put in place a contract via the Joint Procurement Agreement to ensure Member States’ access to the HIPRA vaccine.
(7)
https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-health/eu-vaccines-strategy_en .
(8)
https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_21_4847 .
(9)
The compiled list is primarily based on experience incurred during upscaling of the production of COVID-19 vaccines. The list covers a wide range of products groups (44 essential items), such as enzymes and single-use and chromatography materials.
(10)
These recommendations build on the joint statement from the ECDC and the European Medicines Agency (EMA) on the administration of a fourth dose of mRNA vaccines of 6 April 2022 as well as Preliminary public health considerations for COVID-19 vaccination strategies in the second half of 2022, published by the ECDC on 18 July 2022.
(11)
Such as the Health Security Committee.
(12)
Such as respiratory syncytial virus (RSV) infections or new viral diseases of public health concern.
(13)
18 July 2022, ECDC, Operational considerations for respiratory virus surveillance in Europe, https://www.ecdc.europa.eu/en/publications-data/operational-considerations-respiratory-virus-surveillance-europe .
(14)
https://environment.ec.europa.eu/news/coronavirus-response-monitoring-wastewater-contributes-tracking-coronavirus-and-variants-across-all-2022-03-17_en .
(15)
Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (91/271/EEC).
(16)
Commission Recommendation of 17.3.2021 on a common approach to establish a systematic surveillance of SARS-CoV-2 and its variants in wastewaters in the EU, C/2021/1925, (OJ L 98, 19.3.2021, p. 3–8).
(17)
https://www.consilium.europa.eu/en/policies/ipcr-response-to-crises/ .
(18)
https://health.ec.europa.eu/health-security-and-infectious-diseases/preparedness-and-response/health-security-committee-hsc_en .
(19)
If adequate ventilation is not possible, the use of air-cleaning devices, such as those equipped with either HEPA (high-efficiency particulate absorbing) filters or filters with comparable effectiveness and ultraviolet germicidal irradiation (UVGI) can be considered.
(20)
Such as influenza, respiratory syncytial virus (RSV) and norovirus.
(21)
8 July 2021, ECDC, COVID-19 in children and the role of school settings in transmission - second update, https://www.ecdc.europa.eu/en/publications-data/children-and-school-settings-covid-19-transmission .
(22)
3 August 2022, ECDC, Assessment of workforce capacity and training needs for the prevention and control of communicable diseases - report on 2021 survey, https://www.ecdc.europa.eu/sites/default/files/documents/ECDC-Assessment-Capacity-Training-Needs-EUEEA-2021.pdf .
(23)
In September the following HERA call will be published: Call for proposals to support structured dialogue at national or regional level on public procurement in the health sector.
(24)
EU4 Health Programme, Call for proposals to provide training for health workforce, including digital skills, https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/eu4h-2022-pj-06 .
(25)
Erasmus+ project, EHMA, Blueprint Alliance for a Future Health Workforce Strategy on Digital And Green Skills: BeWell project kicked-off, https://ehma.org/2022/07/22/blueprint-alliance-for-a-future-health-workforce-strategy-on-digital-and-green-skills-bewell-project-kicked-off/ .
(26)
Communication from the Commission to the European Parliament, the Council, The European Economic and Social Committee and the Committee of the Regions, EU Strategy on COVID-19 therapeutics (COM/2021/355 final/2).
(27)
These cover the following therapeutics: remdesivir, bamlanivimab and etesevimab, casirivimab and imdevimab, and xevudy/sotrovimab.
(28)
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
(29)
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1–37).
(30)
REMAP-CAP trial, EU SolidAct trial and ECRAID-Prime trial.
(31)
EU-COVAT-1 AGED, EU-COVAT-2 BOOSTAVAC and EU-COVPT-1 CoVacc.
(32)
The Lancet, volume 400, issue 10350, P452-461, 6 August 2022, A.V. Ballering et.al., Persistence of somatic symptoms after COVID-19 in the Netherlands: an observational cohort study, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01214-4/fulltext .
(33)
Daugherty, Sarah E., et al. "Risk of clinical sequelae after the acute phase of SARS-CoV-2 infection: retrospective cohort study." BMJ 373 (2021).
(34)
Commission Communication, EU Strategy on COVID-19 therapeutics (COM/2021/355 final/2), https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021DC0355R(01) .
(35)
Brodin, P., Casari, G., Townsend, L. et al., Studying severe long COVID to understand post-infectious disorders beyond COVID-19, Nat Med 28, 879–882 (2022), https://www.nature.com/articles/s41591-022-01766-7 .
(36)
Expert Panel on effective ways of investing in health, https://health.ec.europa.eu/expert-panel-effective-ways-investing-health_en .
(37)
EU-OSHA, 20 May 2022, Impact of Long Covid on workers and workplaces and the role of OSH, https://osha.europa.eu/en/publications/impact-long-covid-workers-and-workplaces-and-role-osh .
(38)
EU-OSHA, 6 July 2021, COVID-19 infection and long COVID – guide for workers, https://osha.europa.eu/en/publications/covid-19-infection-and-long-covid-guide-workers .
(39)
EU-OSHA, 6 July 2021, COVID-19 infection and long COVID – guide for managers, https://osha.europa.eu/en/publications/covid-19-infection-and-long-covid-guide-managers .
(40)
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 2020/C 96 I/01 (C(2020) 1897)
(41)
Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A contingency plan for transport (COM(2022) 211)
(42)
Regulation (EU) 2022/1034 of the European Parliament and of the Council of 29 June 2022 amending Regulation (EU) 2021/953 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic (OJ L 173, 30.6.2022, p. 37).
(43)
https://reopen.europa.eu/ .
(44)
To ensure that the Re-Open EU web platform provides up to date information, Member States should inform the Commission about possible updates before introducing possible restrictions and measures.
(45)
Council Recommendation (EU) 2022/107 of 25 January 2022 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic and replacing Recommendation (EU) 2020/1475 (OJ L 18, 27.1.2022, p. 110)
(46)
Council Recommendation (EU) 2020/912 of 30 June 2020 on the temporary restriction on non-essential travel into the EU and the possible lifting of such restriction (OJ L 208I 1.7.2020, p. 1).
(47)
https://europa.eu/capacity4dev/wbt-team-europe .
(48)
As well as the EUR 100 million of support from the humanitarian budget to roll out vaccines that has been implemented since 2021.
(49)
The first support packages for Senegal, Rwanda, South Africa and Ghana have been mobilised.
(50)
https://www.theglobalfund.org/en/covid-19/response-mechanism/#:~:text=The%20COVID%2D19%20Response%20Mechanism,formal%20and%20community%20health%20systems .
(51)
https://unfoundation.org/blog/post/inside-the-new-fund-to-bolster-global-pandemic-prevention-preparedness-and-response/#:~:text=This%20new%20fund%2C%20which%20is,before%20the%20next%20pandemic%20occurs .
(52)
More EU Member States are considering to contribute or are preparing their pledge.
(53)
https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en .