Regulation (EU) 2021/953 of the European Parliament and of the Council (2) lays down the framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. It also contributes to facilitating the gradual lifting of restrictions to free movement put in place by the Member States, in accordance with Union law, to limit the spread of SARS-CoV-2, in a coordinated manner.
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According to Regulation (EU) 2021/953, test certificates are to be issued on the basis of two types of tests for SARS-CoV-2 infection, 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.
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Regulation (EU) 2021/953 does not cover laboratory-based antigenic assays, such as enzyme-linked immunosorbent assays or automated immunoassays. 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 established pursuant to Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council (3), 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.
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As a result of those developments and to enlarge the scope of the different types of diagnostic tests that may be used for the issuance of an EU Digital COVID Certificate, the definition of rapid antigen tests should be amended to include laboratory-based antigenic assays. It should thus be possible for Member States to issue test certificates and, following the adoption of Commission Delegated Regulation (EU) 2022/256 (4), certificates of recovery on the basis of the antigen tests included in the EU common list of COVID-19 antigen tests agreed, and regularly updated, by the Health Security Committee as meeting the established quality criteria. Given that Member States' COVID-19 testing strategies differ, the possibility for Member States to use antigen tests for the issuance of recovery certificates should thus remain optional, to be used in particular when there is a shortage of NAAT capacity due to a high number of infections in the area concerned or for another reason. Where sufficient NAAT capacity is available, Member States can continue to issue certificates of recovery only on the basis of NAAT tests, which are considered as the most reliable methodology for the testing of COVID-19 cases and contacts. Similarly, during periods in which there is an increase in SARS-CoV-2 infections, resulting in high demand for testing or a shortage of NAAT tests, Member States could have the possibility, temporarily, of issuing certificates of recovery based on antigen tests. When infections decrease, Member States can continue to issue certificates of recovery only on the basis of NAAT tests.
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In accordance with Article 5 of Regulation (EU) 2021/953, vaccination certificates issued by Member States are to include the number of doses administered to the holder. It is necessary to clarify that this requirement is intended to reflect all doses administered, in any Member State, not just those administered in the Member State issuing the vaccination certificate. To include only those previous doses received in the Member State issuing the vaccination certificate could lead to a discrepancy between the total number of doses actually administered to a person and the number indicated on the vaccination certificate, and could prevent holders from making use of their vaccination certificate when exercising the right to free movement within the Union. The administration of previous doses in other Member States is proven by means of a valid EU Digital COVID Certificate. A Member State should not require additional information or evidence from Union citizens holding such vaccination certificates, such as the batch number of previous doses. It should be possible for a Member State to require a person to present valid proof of identity and a previous vaccination certificate or certificate of recovery. In this context, the rules for accepting vaccination certificates issued by other Member States set out in Article 5(5) of Regulation (EU) 2021/953 apply. In addition, certificates covered by an implementing act adopted pursuant to Articles 3(10) and 8(2) of Regulation (EU) 2021/953 are, for the purpose of facilitating the holders’ exercise of their right to free movement, to be accepted under the same conditions as EU Digital COVID Certificates issued by Member States. In accordance with Article 3(4) of Regulation (EU) 2021/953, the holder of an EU Digital COVID Certificate is entitled to request the issuance of a new certificate if the personal data contained in the original certificate are not accurate, including with regard to the vaccination of the holder.
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In accordance with Article 5(1) of Regulation (EU) 2021/953, the Member State in which a COVID-19 vaccine was administered is to issue a vaccination certificate to the person concerned. Nevertheless, this should not be understood as preventing a Member State from issuing vaccination certificates referred to in point (a) of Article 3(1) of Regulation (EU) 2021/953 to persons who provide proof that they have been vaccinated in another Member State.
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In particular 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. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. It should therefore be possible for Member States to issue vaccination certificates to participants in clinical trials that have been approved by Member States’ ethical committees and competent authorities, regardless of whether the participant received the COVID-19 vaccine candidate or, to avoid undermining the studies, the dose administered to the control group.
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In addition, it is necessary to clarify that it should be possible for other Member States to accept vaccination certificates for COVID-19 vaccines undergoing clinical trials in order to waive restrictions to free movement put in place, in accordance with Union law, in response to the COVID-19 pandemic. The acceptance period of such vaccination certificates should not be longer than that of certificates issued based on COVID-19 vaccines that have been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council (5). The acceptance period of such vaccination certificates can differ, depending on whether the vaccine was administered as part of the primary vaccination series or as a booster. Within that period, Member States can accept such vaccination certificates unless they have been revoked following the conclusion of the clinical trial, in particular where the COVID-19 vaccine is subsequently not granted a marketing authorisation or where the vaccination certificates were issued for a placebo administered to the control group as part of a blinded trial. In this regard, the issuance of vaccination certificates to participants in clinical trials for COVID-19 vaccines and the acceptance of those certificates is a Member State competence. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004, vaccination certificates for that vaccine fall, from the date of the issuance of that marketing authorisation, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach, the Commission should be empowered to ask the Health Security Committee, the European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA) to issue guidance with regard to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004, which should take into account the ethical and scientific criteria necessary for carrying out clinical trials.
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Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. Despite there being variations in the level of vaccination in different Member States, by 31 January 2022, more than 80 % of the adult population in the Union had completed their primary vaccination cycle and more than 50 % had received a booster dose. Increasing vaccine uptake remains a crucial objective in the fight against the COVID-19 pandemic, given the increased protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted.
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In addition, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused an increase in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 infections, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by the ECDC in its Rapid Risk Assessment of 27 January 2022, Omicron infections appear less likely to lead to a severe clinical outcome requiring hospitalisation or admission to intensive care units. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Furthermore, given the very high levels of community transmission, leading to many people being ill at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole, mainly through absence from work and education.
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After the peak in Omicron infections in early 2022, a high proportion of the population is expected to enjoy, at least for a certain period, protection from COVID-19 either due to vaccination or prior infection, or both. As a result of the COVID-19 vaccines currently available, a significantly higher percentage of the population is also better protected from falling seriously ill and dying from COVID-19. However, it is not possible to predict the impact of a possible increase in infections in the second half of 2022. In addition, the possibility of a worsening of the COVID-19 pandemic because of the emergence of new SARS-CoV-2 variants of concern cannot be ruled out. As also noted by the ECDC, significant uncertainties remain at this stage of the COVID-19 pandemic.
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In view of the remaining uncertainties regarding the further evolution of the COVID-19 pandemic, it cannot be excluded that Member States continue to require Union citizens and their family members exercising their right to free movement to present proof of COVID-19 vaccination, test result or recovery after 30 June 2022, the date on which Regulation (EU) 2021/953 is due to expire. It is thus important to avoid a situation in which, in the event that certain restrictions to free movement based on public health remain in place after 30 June 2022, Union citizens and their family members are deprived of the possibility of using their EU Digital COVID Certificates, which are an effective, secure and privacy-preserving way of proving COVID-19 vaccination, test result or recovery, where their possession is required by Member States in order to exercise their right to free movement.
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In that context, Member States should require Union citizens and their family members exercising their right to free movement to present proof of COVID-19 vaccination, a test result or recovery, or should impose additional restrictions such as additional travel-related testing for SARS-CoV-2 infections or travel-related quarantine or self-isolation, only where such restrictions are non-discriminatory, and necessary and proportionate for the purpose of safeguarding public health based on the latest available scientific evidence, including epidemiological data published by the ECDC on the basis of Council Recommendation (EU) 2022/107 (6), and in line with the precautionary principle.
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When imposing restrictions to free movement on grounds of public health, Member States should pay particular attention to the specificities of the outermost regions, exclaves and geographically isolated areas and the likely impact of such restrictions on cross-border regions, given the strong social and economic ties of those regions.
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Any verification of the certificates making up the EU Digital COVID Certificate should not lead to further restrictions to the freedom of movement within the Union or to restrictions on travel within the Schengen area.
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At the same time, given that any restrictions to the free movement of persons within the Union put in place to limit the spread of SARS-CoV-2, including a requirement to present EU Digital COVID Certificates, should be lifted as soon as the epidemiological situation allows, the extension of the period of application of Regulation (EU) 2021/953 should be limited to 12 months. In addition, the extension of the period of application of that Regulation should not be understood as requiring Member States, in particular those that lift domestic public health measures, to maintain or impose restrictions to free movement. The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union delegated to the Commission pursuant to Regulation (EU) 2021/953 should also be extended. It is necessary to ensure that the EU Digital COVID Certificate framework can adapt to new evidence regarding COVID-19 vaccination, reinfection after recovery, or testing and to scientific progress in containing the COVID-19 pandemic.
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By 31 December 2022, the Commission should submit a third report to the European Parliament and to the Council on the application of Regulation (EU) 2021/953. The report should contain, in particular, an overview of the information received pursuant to Article 11 of that Regulation regarding the restrictions to free movement put in place by the Member States to limit the spread of SARS-CoV-2, an overview describing all developments regarding domestic and international uses of the EU Digital COVID Certificate, any relevant updates regarding the assessment included in the second report, and an assessment of the appropriateness of the continued use of EU Digital COVID Certificates for the purposes of that Regulation, taking into account epidemiological developments and the latest available scientific evidence, and in the light of the principles of necessity and proportionality. When drawing up the report, the Commission should request guidance from the ECDC and the Health Security Committee. Without prejudice to the Commission’s right of initiative, the report should be accompanied by a legislative proposal to shorten the period of application of Regulation (EU) 2021/953 taking into account the evolution of the epidemiological situation with regard to the COVID-19 pandemic and any recommendations from the ECDC and the Health Security Committee to that effect.
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Regulation (EU) 2021/953 should therefore be amended accordingly.
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Since the objective of this Regulation, namely to facilitate the exercise of the right to free movement within the Union during the COVID-19 pandemic by establishing a framework for the issuance, verification and acceptance of interoperable COVID-19 certificates on a person’s COVID-19 vaccination, test result or recovery, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
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In order to allow for its prompt and timely application to ensure the continuity of the EU Digital COVID Certificate, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.
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The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(1) and (2) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (7) and delivered a joint opinion on 14 March 2022 (8),
