Annexes to COM(2022)753 - Report on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate)

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2022)753 - Report on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery ...
document COM(2022)753 EN
date December 22, 2022
Annex I.

2.3.2.EU Gateway and work at technical level

2.3.2.1.Developments since the March 2022 report

The technical specifications, standards and guidelines for the common issuance, verification and acceptance of the EU Digital COVID Certificate were jointly developed by the Commission and the Member States within the framework of the eHealth Network 47 . All of the specifications developed by the eHealth Network are based on open standards and are published as open source on the eHealth Network website 48 and GitHub 49 . This has facilitated interoperability with systems developed by third countries.

Since March 2022, work at technical level to further improve the EU Digital COVID Certificate system has included the adoption of a mechanism for the automatic exchange of lists of revoked EU Digital COVID Certificates via the EU Digital COVID Certificate Gateway, the central part of the trust framework. It also included an update to the technical specifications to reflect the new possibilities included in the extension of the EU Digital COVID Certificate regarding the issuance of vaccination certificates for ongoing clinical trials and the issuance of recovery and test certificates on the basis of laboratory-based antigen tests.

2.3.2.1.Mechanism to exchange lists of revoked certificates

Revoking certificates may help safeguarding public health when certificates have been issued erroneously, because of fraud or following the suspension of a COVID-19 vaccine batch found to be defective. In this context, the EU Digital COVID Certificate Regulation already provided that its trust framework may support the bilateral exchange of certificate revocation lists, which are lists that contain the unique certificate identifiers of revoked certificates 50 . Certificate revocation lists exchanged should not contain any personal data other than unique certificate identifiers.

To facilitate the cross-border automatic exchange of certificate revocation lists via the central EU Digital COVID Certificate Gateway in full compliance with data privacy and data protection requirements, the Commission, in cooperation with the Member States, developed the revocation mechanism specifications, which are set out in Commission Implementing Decision (EU) 2022/483 51 . The revocation mechanism consists of two parts. The first part pertains to the EU Digital COVID Certificate Gateway and is binding in its application. The second part relates to how Member States distribute the revocation lists from their national infrastructure to their verifier applications and is non-binding. For the latter, Member States are free to choose among a range of different options, all of which take privacy concerns into account.

2.3.2.1.Changes to the technical specifications as a result of Regulation (EU) 2022/1034

As explained in more detail in Sections 2.4.1 and 2.4.2, the amendment extending the EU Digital COVID Certificate Regulation also allows for the issuance of certificates for COVID-19 vaccines undergoing clinical trials and the issuance of recovery and test certificates on the basis of laboratory-based antigen tests. Commission Implementing Decision (EU) 2022/1516 52  was adopted to reflect these changes in the technical specifications and rules to populate the EU Digital COVID Certificate, complemented by an updated version of the Guidelines on Value Sets for EU Digital COVID Certificates 53 .

2.3.2.2.Encoding of adapted COVID-19 vaccines

Following recommendations by EMA 54 , the Commission adopted, on 1 September 2022, decisions on the EU-wide authorisation of the adapted COVID-19 vaccines Comirnaty Original/Omicron BA.1 55 and Spikevax bivalent Original/Omicron BA.1 56 , which are adapted versions of the original vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2. Later that month, the Commission also authorised Comirnaty Original/Omicron BA.4-5, an adapted COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2 57 , following a corresponding recommendation from EMA 58 . With Spikevax bivalent Original/Omicron BA.4-5, the Commission authorised a second bivalent Original/Omicron BA.4-5 vaccine on 20 October 2022 59 .

The Commission consulted the Health Security Committee on the question as to how to encode these adapted vaccines in the EU Digital COVID Certificate. In response, most Member States did not see a strong need to differentiate, in the EU Digital COVID Certificate, between adapted vaccines and their original version for the purposes of facilitating free movement. At the same time, many Member States do differentiate between the different vaccine types in their national healthcare systems or databases for other purposes, notably pharmacovigilance and public health. As a result, adapted COVID-19 vaccines are encoded in the EU Digital COVID Certificate in the same way as the corresponding original version. For reasons of preparedness, the eHealth Network nevertheless prepared a proposal as to how such adapted vaccines could be encoded differently, should there be a decision that such a differentiation would be necessary.

In the eHealth Network’s updated Guidelines on Value Sets for EU Digital COVID Certificates published on 19 October 2022 60 , the encoding of adapted COVID-19 vaccines is described as outlined above.

2.3.2.1.Encoding of COVID-19 vaccines with three primary doses

Following EMA’s recommendation 61 , the Commission approved, on 20 October 2022, paediatric formulations of Comirnaty 62 and Spikevax 63 COVID-19 vaccines for children from 6 months of age. In the case of Comirnaty, the primary vaccination consists of three doses, with the individual doses being lower compared to those for already authorised age groups. Previously, EU-approved COVID-19 vaccines had been single-dose or two-dose vaccines.

In this context, the Commission clarified the encoding of this three-dose paediatric formulation of Comirnaty in the EU Digital COVID Certificate to Member States and representatives of third countries and territories connected to the EU Digital COVID Certificate Gateway 64 . This clarification did not require a modification of the technical specifications.

2.4.Developments regarding EU Digital COVID Certificates

2.4.1.Extension: inclusion of laboratory-based antigen tests

Prior to its extension, the EU Digital COVID Certificate Regulation provided that test certificates may be issued on the basis of two types of tests for SARS-CoV-2 infection only, namely molecular nucleic acid amplification tests (NAAT tests), including those using reverse transcription polymerase chain reaction (RT-PCR), and rapid antigen tests, which rely on the detection of viral proteins (antigens) using a lateral flow immunoassay that gives results in less than 30 minutes, provided they are carried out by health professionals or by skilled testing personnel. When extending the Regulation, the Parliament and the Council included high-quality laboratory-based antigen assays among the types of tests for which an EU Digital COVID Certificate can be issued, to widen the scope of the types of diagnostic tests at a time where COVID-19 tests are in high demand 65 .

Indeed, from July 2021, the technical working group on COVID-19 diagnostic tests, which is responsible for preparing updates to the EU common list of COVID-19 antigen tests agreed by the Health Security Committee, has been reviewing the proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. Those proposals have been assessed against the same criteria as those used for rapid antigen tests, and the Health Security Committee has established a list of the laboratory-based antigenic assays that meet those criteria.

As a result, Member States are now able to issue test certificates and recovery certificates 66 on the basis of the laboratory-based antigenic assays included in the EU common list of COVID-19 antigen tests 67 .

2.4.2.Extension: inclusion of vaccination certificates for clinical trial participants

In light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines is a crucial factor in the fight against the COVID-19 pandemic. In that context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines and voluntary participation in clinical trials therefore needs to be encouraged. Preventing participants in clinical trials from obtaining vaccination certificates could constitute a major disincentive to participating in such trials, delaying the conclusion of such trials and, more generally, having a negative impact on public health. The Commission therefore wanted to facilitate and encourage participation in clinical trials.

The extension of the Regulation provides 68 that Member States may issue an EU Digital COVID Certificate to persons participating in ongoing clinical trials for COVID-19 vaccines which have not yet been granted a marketing authorisation, regardless of whether the participant received the COVID-19 vaccine candidate or the dose administered to the control group, as long as the trial has been approved by Member States’ ethical committees and competent authorities. Such certificates may be accepted by other Member States in order to waive restrictions to free movement, unless their acceptance period has expired or they have been revoked following the conclusion of the clinical trial, in particular on the grounds that the COVID-19 vaccine was subsequently not authorised or that the vaccination certificates were issued for a placebo administered to the control group as part of a blinded trial.

As explained in Section 2.1.3.2.1 above, the Health Security Committee adopted guidance on a mutual approach for the acceptance of these certificates on 5 October 2022 69 , which includes a list of ongoing clinical trials that Member States agree to accept mutually, to be updated when necessary.

2.4.3.Validity period of vaccination certificates

As explained in the March 2022 report, the Commission adopted, in December 2021, Delegated Regulation (EU) 2021/2288 establishing a binding acceptance period of 270 days for vaccination certificates covering the primary vaccination series for the purposes of intra-EU travel 70 . Such certificates are therefore not to be accepted if more than 270 days have passed since the last dose. 

On 29 March 2022 71 , the Commission adopted Delegated Regulation (EU) 2022/503 exempting minors from the 270-day acceptance period for primary vaccination certificates. Although EMA had recommended the administration of vaccines for adolescents aged 12 or more, it also noted that it was for the experts guiding the vaccination campaign in each Member State to advise on the optimum decision and timing for their country. When consulted by the Commission, a large number of Member States considered that, irrespective of whether booster vaccinations were offered to minors nationally, it was appropriate to exempt these minors from the standard acceptance period.

The maximum acceptance period of 270 days currently does not apply to vaccination certificates issued for booster doses – regardless whether they have been issued following the administration of a first or second booster – meaning that they currently are to be accepted with no expiry date.

2.4.4.Other issues

No new scientific evidence has emerged since the March 2022 report to justify a change to the policy not to issue recovery certificates based on results from antibody tests. The reasons laid out in that report remain up-to-date. Likewise, there is no change in the position regarding the validity period of certificates of recovery.

2.5.International aspects of the EU Digital COVID Certificate system

2.5.1.Connecting Europe and third countries

The EU Digital COVID Certificate Regulation stipulates that the Commission can issue a decision establishing that the certificates of a third country are to be considered as equivalent to EU Digital COVID Certificates (‘equivalence decisions’) for the purpose of facilitating their holders’ exercise of their right of free movement 72 . This results in the third country concerned being connected to the EU Gateway. Detailed information on this process can be found in the October 2021 report.

In addition to the 27 Member States, 49 non-EU countries and territories have been connected to the EU Digital COVID Certificate system for the purpose of facilitating the right of free movement within the EU. This brings the total number of countries and territories connected to the EU Digital COVID Certificate system to 76, making it the largest system of interoperable COVID-19 certificates worldwide.

Since the adoption of the March 2022 report and by the end of November 2022, the Commission adopted additional equivalence decisions regarding Bahrain 73 , Brazil 74 , Colombia 75 , Ecuador 76 , Indonesia 77 , the Republic of Korea 78 79 , Kosovo 80* 81 , Madagascar 82 , Malaysia 83 , Oman 84 , Peru 85 , the Philippines 86 , Seychelles 87 , and Vietnam 88 .

The Regulation as such does not explicitly require that third countries seeking an equivalence decision reciprocally accept the EU Digital COVID Certificate for travelling to their respective countries. However, before adopting an equivalence decision, the Commission has systematically asked all third countries concerned to accept the EU Digital COVID Certificate and to guarantee that they uphold data protection requirements. As explained in Section 2.1.3.4, a rigorous ‘onboarding’ process is applied to all third countries wishing to participate to verify their compliance with security requirements.

In order to obtain an overview as to the status of implementation of equivalence decisions, a questionnaire was sent by EU Delegations to the third countries and territories whose certificates are covered by equivalence decisions and who have been part of the system for a sufficient period of time to provide feedback. The 27 countries and territories 89 that provided input to the questionnaire reported very few problems concerning vaccination, recovery, and test certificates and data protection 90 . The few issues reported have since been addressed or fall outside of EU competence.

2.5.2.Interoperability with systems developed at international level

In accordance with Article 4(3) of the Regulation, the EU Digital COVID Certificate trust framework should ensure interoperability with technological systems established at international level.

The Commission has maintained an ongoing dialogue and cooperation with international institutions and organisations to explore options for interoperability among the existing technological systems. In March 2022, the Indonesian presidency of the G20, supported by the WHO, Organization for Economic Cooperation and Development and the Global Digital Health Partnership launched a pilot project to test the technological feasibility of harmonising COVID-19 global health protocol standards, including by developing a universal verifier application that can validate COVID-19 certificates issued under different technical standards, in full compliance with national legal and health frameworks. The Commission and some Member States actively participate in the discussions, sharing know-how, experience and lessons learned from the EU Digital COVID Certificate as the major digital COVID-19 certificate system implemented at global level.

In the context of the negotiations on an international agreement on pandemic prevention, preparedness and response, as well as amendments to the International Health Regulations (2005) (‘IHR’), the negotiating directives annexed to the Council Decision (EU) 2022/451 of 3 March 2022 authorising the Commission to negotiate on behalf of the EU 91  for issues falling under EU competence, provide that amendments to the International Health Regulations should aim at clarifying and strengthening existing provisions, including by promoting the use of new digital tools that may improve their implementation.

On 30 September 2022, the EU and its Member States submitted a set of proposed amendments to the IHR, including one proposed amendment which aims at enabling the use of digital vaccination certificates for international travel. This proposal is now being considered, together with all proposed amendments submitted by other State Parties to the International Health Regulations, in a Working Group composed of members of the World Health Organization, with the view of proposing a package of targeted amendments for the consideration and possible adoption by the World Health Assembly in May 2024.

2.6.Future of the EU Digital COVID Certificate

Article 16(3) of the EU Digital COVID Certificate Regulation provides for this report to assess the appropriateness of the continued use of the EU Digital COVID Certificate for the purposes of the Regulation, taking into account epidemiological developments and the latest available scientific evidence. In addition, the Regulation underlines that, without prejudice to the Commission’s right of initiative, the report may be accompanied by a legislative proposal, in particular to shorten the period of application of this Regulation, currently 30 June 2023 92 . 

As far as the period of application of the EU Digital COVID Certificate Regulation is concerned, the Commission would like to reaffirm that the extension of the Regulation in June 2022 until June 2023 was necessary in view of the remaining uncertainties regarding the evolution of the COVID-19 pandemic. It was important to avoid a situation in which, in the event that certain restrictions to free movement based on public health remained in place after 30 June 2022, EU citizens would have been deprived of the possibility of using an important tool that had facilitated free movement until that moment 93 .

As the Commission has continuously emphasised, any restrictions to the free movement of persons within the EU put in place to limit the spread of SARS-CoV-2 should be lifted as soon as the epidemiological situation allows. This also applies to requirements to present EU Digital COVID Certificates.

Since the March 2022 report and the extension of the Regulation, the Omicron variant has – in the form of different sub-variants – remained the dominant variant in the EU 94 . Omicron is less severe than the previously observed Delta variant, which can be attributed at least partially to the protective effect of vaccination and previous infection 95 . As a result, and in combination with these higher levels of protection, pressure on healthcare systems currently remains at manageable levels, even during momentary peaks of infections such as the wave driven by the Omicron BA.4 and BA.5 sub-variants observed during the summer of 2022 or the wave observed in mid-October 2022. On 20 October 2022, the European Centre for Disease Prevention and Control (ECDC) designated a new sub-variant BQ.1, including its sub-lineages, as variant of interest. Based on modelling estimates, it is expected that by the beginning of 2023, more than 80% of SARS-CoV-2 cases will be due to BQ.1 and its sub-lineages 96 (see also Annex II for the input received from ECDC).

By August 2022, Member States had indeed lifted all measures affecting free movement of persons in the EU, including the requirement for travellers to hold an EU Digital COVID Certificate. In addition, during the subsequent momentary peaks of infections, no Member State re-introduced requirements for travellers to hold EU Digital COVID Certificates. This is because in the current situation, domestic factors can be expected to be more powerful drivers of the epidemiological situation than cross-border travel. As a result, domestic non-pharmaceutical interventions, such as mask-wearing, ventilation and physical distancing, rather than travel restrictions, may be effective in slowing down the spread of COVID-19, if implemented early and comprehensively and sufficiently put into practice by society 97 . In addition, the Commission is not aware of any plans by Member States to re-introduce travel restrictions. As also noted by ECDC, “the current variant and immunity landscapes in the EU/EEA countries suggest that the impact/value of the use of EU Digital COVID Certificates would be currently low from a public health perspective” (see Annex II for the input received from ECDC). 

In view of the above, the Commission is of the opinion that the EU Digital COVID Certificate Regulation has achieved its intended purposes, namely to facilitate the holders’ exercise of their right to free movement during the COVID-19 pandemic and to contribute to facilitating the gradual lifting of restrictions to free movement put in place by the Member States, in accordance with EU law, to limit the spread of SARS-CoV-2, in a coordinated manner.

Nevertheless, as also noted in the Communication of 2 September 2022 98 , the Commission considers that it is necessary to remain vigilant over the coming winter months. As also indicated by ECDC, there are certain key elements that will be particularly decisive for the timing and magnitude of future COVID-19 waves. First, the vaccine-induced and naturally-acquired protection against infection and severe outcomes wanes over time, which has a substantial impact on the likelihood and severity of future waves of infections. Second, the emergence of more immune-evasive or transmissible (sub-)lineages of SARS-CoV-2 will be a crucial factor which will, together with any change in severity of new variants, be decisive for the related disease burden. Third, temporal fluctuations of COVID-19 will be amplified or reduced by human behaviour. Lastly, there might be potential for seasonality patterns to arise that are caused by other factors such as climate, which can result in oscillations of the COVID-19 burden over the year. As far as the BQ.1 variant of interest is concerned, there is, based on limited available data, no evidence of it being associated with a greater infection severity than the circulating variants BA.4/BA.5. Still, ECDC underlines that Member States should remain vigilant for signals of its emergence and spread  99 .

It is in this context that the Commission, in its proposal of 14 October 2022 to update the coordinated approach on travel within the EU during the COVID-19 pandemic 100 (see also Section 2.1.1), underlined that the absence of pandemic-related restrictions to free movement should, at this point in time, remain the norm. Member States should reintroduce requirements to be in the possession of a valid EU Digital COVID Certificate only if the epidemiological situation would worsen severely. To make this determination, Member States should in particular take into account the strain on their healthcare systems due to COVID-19, notably in terms of admissions and number of hospital and intensive-care unit inpatients.

It is thus primarily for reasons of epidemiological vigilance that the Commission does not intend to adopt a proposal to shorten the period of application of the Regulation. Any such proposal would also create legal uncertainty for Member States and connected third countries seeking to plan and prepare for the Regulation’s expiry.

At the same time, the Commission does not intend, at this stage, to propose a further extension of the EU Digital COVID Certificate Regulation beyond its current expiry date of 30 June 2023. As ECDC has also pointed out, the most acute phase of the COVID-19 pandemic has passed. Thus, the Commission considers that it is unlikely that restrictions to the fundamental right to free movement will be justified going forward. In a survey conducted in the IPCR network in November 2022, when asked whether they would expect a need for EU Digital COVID Certificates for the purpose of intra-EU travel after June 2023, no Member State clearly indicated such a need 101 . The Commission will re-assess the situation by the end of March 2023 with a view to making a definitive decision as to its position regarding the period of application of the Regulation.

It is also important to note that, on 19 September 2022, the Commission adopted a proposal for a Regulation establishing a Single Market Emergency Instrument 102 . This instrument aims to put in place a flexible and transparent mechanism to respond quickly to emergencies and crises that threaten the functioning of the single market. The objective is to ensure coordination, solidarity and coherence of the EU crisis response and protect the single market’s functioning, ensuring, in particular, the continued free movement of persons, goods, and services. According to the proposal, the Commission and the Member States would also be entitled to set up interoperable digital tools or IT infrastructures supporting the objectives of the Single Market Emergency Instrument Regulation, which could, where relevant for a specific future crisis, be useful also for purposes similar to those of the EU Digital COVID Certificate. The legislative procedure on the Commission’s proposal is currently ongoing and the envisaged framework therefore not yet available.

Lastly, given the global success of the technology underpinning the EU Digital COVID Certificate, the Commission and Member States are reflecting if and how such a technical architecture could potentially be used for use-cases other than the facilitation of free movement within the EU, including to facilitate travel to and from third countries. The technology could also be considered, for example, for the authentication of documents in the health domain and for further developing usability and security of cross-border digital health services (such as, for example, vaccination cards for the purposes of continuity of care, access to and dispensation of electronic prescriptions, access to patient summaries, etc.). Such other use-cases could support citizens seeking or receiving healthcare in a Member State other than their own. To ensure synergies, the potential implementation of such use-cases could be explored in the context of the development of the European Health Data Space 103 . Supporting initiatives to foster the digital interoperability of health certificates at a more global level could also be considered. EU-level support for any such use-cases will depend, among other things, on whether or not there is an EU competence to act in the area concerned. In addition, the Commission underlines that any such use-cases must not result in restrictions to EU citizens’ exercise of their right to free movement.

3.Conclusion

With more than two billion certificates issued, the EU Digital COVID Certificate has delivered tangible benefits for EU citizens: it has facilitated free movement when travel restrictions were still deemed necessary, and, at the same time, it has allowed for a coordinated lifting of these restrictions once possible. In addition, the EU Digital COVID Certificate has been easy to use, free of charge and versatile to adapt to new developments. Finally, the EU Digital COVID Certificate framework has also established a standard in Europe and best practice at global level, with 76 countries and territories being connected to the system.

Without the EU Digital COVID Certificate, EU citizens would not have enjoyed a right to be issued interoperable vaccination, test or recovery certificate, and have them accepted by other Member States for the purposes of exercising their fundamental right to free movement. It has demonstrated the capacity of EU institutions and Member States to develop innovative solutions in record time, with key EU values such as data protection and open access guaranteed.

For reasons of epidemiological vigilance, it remains prudent to maintain the EU Digital COVID Certificate system during the 2022-23 winter period. The Commission will continue to follow closely the development of the epidemiological situation, and in particular the key elements that will be, according to ECDC, particularly decisive for the timing and magnitude of future COVID-19 waves. On this basis, the Commission will re-assess the situation by the end of March 2023 and decide whether to propose a further extension, or whether to have the Regulation expire in June 2023.

Being able to move between Member States using just one’s passport or identity card is one of the fundamental achievements of European integration. Any limitations to that right, including when they result from unprecedented events such as a global pandemic, must remain limited to what is strictly necessary. Ultimately, the EU Digital COVID Certificate Regulation will be a victim of its own success: its expiry will be proof that its declared aim, the restoration of unrestricted free movement, has been achieved.


(1)

     Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 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 211, 15.6.2021, p. 1).

(2)

     Regulation (EU) 2021/954 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) with regard to third-country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic (OJ L 211, 15.6.2021, p. 24).

(3)

     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); and Regulation (EU) 2022/1035 of the European Parliament and of the Council of 29 June 2022 amending Regulation (EU) 2021/954 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) with regard to third-country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic (OJ L 173, 30.6.2022, p. 46).

(4)

     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).

(5)

     Commission proposal for a Council Recommendation amending Recommendation (EU) 2022/107 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic (COM(2022) 681 final).

(6)

     Cut-off date of 31 October 2022. A detailed breakdown per Member States is included in Annex I.

(7)

     As provided for by Article 8(2) of the EU Digital COVID Certificate Regulation.

(8)

     Report from the Commission to the European Parliament and the Council pursuant to Article 16(1) of Regulation (EU) 2021/953 of the European Parliament and of the Council 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 (COM(2021) 649 final).

(9)

     Report from the Commission to the European Parliament and the Council pursuant to Article 16(2) of Regulation (EU) 2021/953 of the European Parliament and of the Council 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 (COM(2022) 123 final).

(10)

     Article 16(3) of the EU Digital COVID Certificate Regulation.

(11)

     See Commission proposal of 4 September 2020 for a Council Recommendation on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic (COM(2020) 499 final), Commission proposal of 17 March 2021 for a Regulation of the European Parliament and of the Council on a framework for the issuance, verification and acceptance of interoperable certificates on vaccination, testing and recovery to facilitate free movement during the COVID-19 pandemic (Digital Green Certificate) (COM(2021) 130 final), Commission proposal of 25 November 2021, Proposal for a Council Recommendation on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic and replacing Recommendation (EU) 2020/1475 (COM(2021) 749 final) and Commission Proposal of 3 February 2022 for a Regulation of the European Parliament and of the Council 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 (COM(2022) 50 final).

(12)

     Order of 29 April 2022, Abenante and Others v Parliament and Council, T-527/21, EU:T:2022:278, paragraphs 46-48.

(13)

     See also Recital 14 of the EU Digital COVID Certificate Regulation: “This Regulation is intended to facilitate the application of the principles of proportionality and non-discrimination with regard to restrictions to free movement during the COVID-19 pandemic, while pursuing a high level of public health protection. It should not be understood as facilitating or encouraging the adoption of restrictions to free movement, or restrictions to other fundamental rights, in response to the COVID-19 pandemic, given their detrimental effects on Union citizens and businesses […]”.

(14)

     Recital 16 of Regulation (EU) 2022/1034.

(15)

     Commission proposal for a Council Recommendation amending Recommendation (EU) 2022/107 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic (COM(2022) 681 final).

(16)

     Council Recommendation of 13 December 2022 amending Recommendation (EU) 2022/107 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic (not yet published).

(17)

    https://www.ecdc.europa.eu/en/covid-19/situation-updates/weekly-maps-coordinated-restriction-free-movement  

(18)

     Data based on the Commission’s continuous information-gathering on travel restrictions and confirmed by Member States in a survey carried out in the IPCR Network in November 2022. All Member States except BG and DK replied to this survey.

(19)

     Article 11 of the EU Digital COVID Certificate Regulation.

(20)

     Article 5(5), fourth and fifth subparagraph, of the EU Digital COVID Certificate Regulation.

(21)

   For more information see Annex II.

(22)

      https://health.ec.europa.eu/publications/guidance-mutual-acceptance-eu-digital-covid-certificates-issued-participants-clinical-trials-covid_en  

(23)

     Article 5(5), first subparagraph, of the EU Digital COVID Certificate Regulation. List available here: https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans_en  

(24)

     Article 5(5), second subparagraph, of the EU Digital COVID Certificate Regulation.

(25)

      https://extranet.who.int/pqweb/key-resources/documents/status-covid-19-vaccines-within-who-eulpq-evaluation-process  

(26)

     Based on the provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(27)

     OJ L 208I , 1.7.2020, p. 1.

(28)

     Commission proposal for a Council Recommendation on a coordinated approach to travel to the Union during the COVID-19 pandemic and replacing Council Recommendation (EU) 2020/912, COM(2022) 680 final.

(29)

     Commission proposal for a Council Recommendation amending Recommendation (EU) 2022/107 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic, COM(2022) 681 final.

(30)

     Council Recommendation of 13 December 2022 amending Recommendation (EU) 2022/107 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic (not yet published).

(31)

     Eurostat, ‘Commercial flights by reporting country – monthly data’, 10-02-2022, available at https://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=avia_tf_cm&lang=en  

(32)

      https://www.eurocontrol.int/sites/default/files/2022-10/eurocontrol-seven-year-forecast-2022-2028-october-2022.pdf  

(33)

     See Section 2.2 of the March 2022 report.

(34)

     Order of 29 April 2022, Abenante and Others v Parliament and Council, T-527/21, EU:T:2022:278.

(35)

     Order of 29 April 2022, Abenante and Others v Parliament and Council, T-527/21, EU:T:2022:278, paragraph 21.

(36)

     Order of 29 April 2022, Abenante and Others v Parliament and Council, T-527/21, EU:T:2022:278, paragraph 22.

(37)

     Order of 29 April 2022, Abenante and Others v Parliament and Council, T-527/21, EU:T:2022:278, paragraphs 25-26.

(38)

     Order of 29 April 2022, Abenante and Others v Parliament and Council, T-527/21, EU:T:2022:278, paragraphs 33.

(39)

   Order of 7 October 2022, OG and Others v Commission, T-101/22, not published; and Order of 7 October 2022, ON v European Commission, T-103/22, not published.

(40)

     Order of 7 October 2022, OG and Others v Commission, T-101/22, not published, paragraph 11.

(41)

     Order of 7 October 2022, OG and Others v Commission, T-101/22, not published, paragraphs 13-14.

(42)

      https://reopen.europa.eu/  

(43)

      https://european-union.europa.eu/contact-eu/write-us/answering-your-questions_en  

(44)

      https://ec.europa.eu/info/sites/default/files/edcc_annual_activity_report_2021.pdf  

(45)

     Data based on a survey carried out in the IPCR Network in November 2022. All Member States except Bulgaria and Denmark replied to the survey.

(46)

     The remaining Member States are DE, ES, IT, CY and AT. ES has specific territorial regulations, which means that only some regions are still using the EU Digital COVID Certificate domestically.

(47)

     The eHealth Network is a voluntary network connecting national authorities responsible for eHealth designated by the Member States set up on the basis of Article 14 of Directive 2011/24/EU.

(48)

      https://ec.europa.eu/health/ehealth/covid-19_en

(49)

      https://github.com/eu-digital-green-certificates  

(50)

     Article 4(2) of the EU Digital COVID Certificate Regulation.

(51)

     Commission Implementing Decision (EU) 2022/483 of 21 March 2022 amending Implementing Decision (EU) 2021/1073 laying down technical specifications and rules for the implementation of the trust framework for the EU Digital COVID Certificate established by Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 98, 25.3.2022, p. 84).

(52)

     Commission Implementing Decision (EU) 2022/1516 of 8 September 2022 amending Implementing Decision (EU) 2021/1073 laying down technical specifications and rules for the implementation of the trust framework for the EU Digital COVID Certificate established by Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 235, 12.9.2022, p. 61).

(53)

      https://health.ec.europa.eu/system/files/2022-11/eu-dcc-value-sets_en.pdf  

(54)

      https://www.ema.europa.eu/en/news/first-adapted-covid-19-booster-vaccines-recommended-approval-eu  

(55)

     Commission Implementing Decision of 1.9.2022 amending the conditional marketing authorisation granted by Decision C(2020) 9598(final) for “Comirnaty - tozinameran, COVID-19 mRNA vaccine (nucleoside-modified)”, a medicinal product for human use (C(2022) 6459 final).

(56)

     Commission Implementing Decision of 1.9.2022 amending the conditional marketing authorisation granted by Decision C(2021) 94(final) for “Spikevax - elasomeran”, a medicinal product for human use (C(2022) 6458 final).

(57)

     Commission Implementing Decision of 12.9.2022 amending the conditional marketing authorisation granted by Decision C(2020) 9598(final) for “Comirnaty - tozinameran, COVID-19 mRNA vaccine (nucleoside-modified)”, a medicinal product for human use (C(2022) 6632 final).

(58)

      https://www.ema.europa.eu/en/news/adapted-vaccine-targeting-ba4-ba5-omicron-variants-original-sars-cov-2-recommended-approval  

(59)

     Commission Implementing Decision of 20.10.2022 amending the marketing authorisation granted by Decision C(2022)7163(final) for “Spikevax - elasomeran”, a medicinal product for human use. EMA recommendation (C(2022) 7632 final) available here: https://www.ema.europa.eu/en/news/ema-recommends-approval-second-adapted-spikevax-vaccine  

(60)

      https://health.ec.europa.eu/system/files/2022-11/eu-dcc-value-sets_en.pdf  

(61)

      https://www.ema.europa.eu/en/news/ema-recommends-approval-comirnaty-spikevax-covid-19-vaccines-children-6-months-age  

(62)

     Commission Implementing Decision of 20.10.2022 amending the marketing authorisation granted by Decision C(2022) 7342(final) for “Comirnaty - tozinameran, COVID-19 mRNA vaccine (nucleoside-modified)”, a medicinal product for human use (C(2022) 7630 final).

(63)

     Commission Implementing Decision of 20.10.2022 amending the marketing authorisation granted by Decision C(2022)7163(final) for “Spikevax - elasomeran”, a medicinal product for human use (C(2022) 7632 final).

(64)

     The administration of the first dose is to be encoded as ‘1/3’, the second dose as ‘2/3’, and the third dose is to be encoded as ‘3/3’. Given the age of the children vaccinated, it can be identified that 3/3 is not a booster but the finalisation of the primary cycle.

(65)

     Article 2(5)(b) of the EU Digital COVID Certificate Regulation.

(66)

   Following the adoption of Commission Delegated Regulation (EU) 2022/256 of 22 February 2022 amending Regulation (EU) 2021/953 of the European Parliament and of the Council as regards the issuance of certificates of recovery based on rapid antigen tests (OJ L 42, 23.2.2022, p. 4), which provides that certificates of recovery can also be issued following a positive result of a rapid antigen test listed in the EU common list and carried out by health professionals or by skilled testing personnel by the Member State where the test was carried out.

(67)

      https://health.ec.europa.eu/system/files/2022-11/covid-19_eu-common-list-antigen-tests_en.pdf  

(68)

     Article 5(5), fourth and fifth subparagraph, of the EU Digital COVID Certificate Regulation.

(69)

      https://health.ec.europa.eu/publications/guidance-mutual-acceptance-eu-digital-covid-certificates-issued-participants-clinical-trials-covid_en

(70)

     The Commission had already included a proposal for a standard acceptance period of nine months in its proposal of 25 November 2021 for a Council Recommendation on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic and replacing Recommendation (EU) 2020/1475.

(71)

     Commission Delegated Regulation (EU) 2022/503 of 29 March 2022 amending Regulation (EU) 2021/953 of the European Parliament and of the Council as regards exempting minors from the acceptance period of vaccination certificates issued in the EU Digital COVID Certificate format (OJ L 102, 30.3.2022, p.8).

(72)

     Article 8(2) of the EU Digital COVID Certificate Regulation.

(73)

     Commission Implementing Decision (EU) 2022/1099 of 30 June 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Kingdom of Bahrain to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 176, 1.07.2022, p. 73).

(74)

     Commission Implementing Decision (EU) 2022/1948 of 13 October 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Federative Republic of Brazil to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 268, 14.10.2022, p. 43).

(75)

     Commission Implementing Decision (EU) 2022/533 of 1 April 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of Colombia to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 105, 4.4.2022, p. 60).

(76)

     Commission Implementing Decision (EU) 2022/1100 of 30 June 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of Ecuador to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 176, 1.07.2022, p. 76).

(77)

     Commission Implementing Decision (EU) 2022/726 of 10 May 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of Indonesia to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 134, 11.05.2022, p. 34).

(78)

     Commission Implementing Decision (EU) 2022/1096 of 30 June 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of Korea to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 176, 1.07.2022, p. 66.

(79)

     Corrigendum C2022/5580 to Commission Implementing Decision (EU) 2022/1096 of 30 June 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of Korea to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 201, 1.8.2022, p. 74).

(80)

* 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.

(81)

     Commission Implementing Decision (EU) 2022/1098 of 30 June 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by Kosovo to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 176, 1.07.2022, p. 70).

(82)

     Commission Implementing Decision (EU) 2022/1097 of 30 June 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of Madagascar to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 176, 1.07.2022, p. 67).

(83)

     Commission Implementing Decision (EU) 2022/534 of 1 April 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by Malaysia to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 105, 4.4.2022, p. 63).

(84)

     Commission Implementing Decision (EU) 2022/1339 of 29 July 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Sultanate of Oman to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 201, 1.8.2022, p. 57).

(85)

     Commission Implementing Decision (EU) 2022/1340 of 29 July 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of Peru to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 201, 1.8.2022, p. 60).

(86)

     Commission Implementing Decision (EU) 2022/1338 of 29 July 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of the Philippines to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 201, 1.8.2022, p. 54).

(87)

     Commission Implementing Decision (EU) 2022/724 of 10 May 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Republic of Seychelles to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 134, 11.05.2022, p. 28).

(88)

     Commission Implementing Decision (EU) 2022/725 of 10 May 2022 establishing the equivalence, for the purpose of facilitating the right of free movement within the Union, of COVID-19 certificates issued by the Socialist Republic of Viet Nam to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 134, 11.05.2022, p. 31).

(89)

     Albania, Andorra, Armenia, Benin, Cabo Verde, Colombia, El Salvador, Georgia, Israel, Lebanon, Malaysia, Moldova, Monaco, Montenegro, North Macedonia, San Marin, Serbia, Seychelles, Singapore, Taiwan, Thailand, Togo, Tunisia, Türkiye, the United Arab Emirates, the United Kingdom and Uruguay.

(90)

     For example, some countries reported issues concerning certain vaccines not being accepted by certain Member States, which is in line with the provisions of the EU Digital COVID Certificate Regulation. The issue of certificates based on clinical trials was also raised, which has been addressed by Regulation (EU) 2022/1034.

(91)

     Council Decision (EU) 2022/451 of 3 March 2022 authorising the opening of negotiations on behalf of the European Union for an international agreement on pandemic prevention, preparedness and response, as well as complementary amendments to the International Health Regulations (2005) (OJ L 92, 21.3.2022, p. 1).

(92)

     Article 17, second paragraph, of the EU Digital COVID Certificate Regulation.

(93)

     Recital 12 of Regulation (EU) 2022/1034.

(94)

      https://www.ecdc.europa.eu/en/covid-19/variants-concern  

(95)

      https://www.ecdc.europa.eu/en/covid-19/latest-evidence/clinical  

(96)

      https://www.ecdc.europa.eu/en/publications-data/spread-sars-cov-2-omicron-variant-sub-lineage-bq1-eueea  

(97)

     See also Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on COVID-19 - Sustaining EU preparedness and response: Looking ahead (COM(2022) 190 final).

(98)

     Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – EU response to COVID-19: preparing for autumn and winter 2023 (COM(2022) 452 final).

(99)

      https://www.ecdc.europa.eu/en/publications-data/spread-sars-cov-2-omicron-variant-sub-lineage-bq1-eueea

(100)

     Commission proposal for a Council Recommendation amending Recommendation (EU) 2022/107 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic, COM(2022) 681 final.

(101)

     13 Member States replied “no” and 12 “maybe”.

(102)

     COM(2022) 459 final.

(103)

     COM(2022) 197 final.