Explanatory Memorandum to COM(2022)50 - Amendment of Regulation (EU) 2021/953 on a the EU Digital COVID Certificate to facilitate free movement during the COVID-19 pandemic - Main contents

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dossier	COM(2022)50 - Amendment of Regulation (EU) 2021/953 on a the EU Digital COVID Certificate to facilitate free movement during the COVID-19 ...
source	COM(2022)50
date	03-02-2022

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

The right of Union citizens to move and reside freely within the European Union, enshrined in Article 21 of the Treaty on the Functioning of the European Union (TFEU), is one of the Union’s most cherished achievements, and an important driver of its economy. At the same time, the ongoing coronavirus disease 2019 (‘COVID‑19’) pandemic continues to pose an extraordinary threat to public health across the Union. This has led Member States to adopt public health measures seeking to protect individuals’ health as well as the capacity of their healthcare systems, some of which have been related to travel between Member States.

To facilitate safe free movement during the COVID-19 pandemic, the European Parliament and the Council adopted, on 14 June 2021, Regulation (EU) 2021/953 ¹ establishing the EU Digital COVID Certificate framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates ² . Regulation (EU) 2021/953 facilitates free movement by providing citizens with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, the EU Digital COVID Certificate allows citizens to profit from these exemptions.

Since its adoption, the EU Digital COVID Certificate has been successfully rolled out across the Union, with more than 1 billion certificates issued by the end of 2021. The EU Digital COVID Certificate is thus a widely available and reliably accepted tool to facilitate free movement during the COVID-19 pandemic. According to a Eurobarometer survey published in September 2021, about two-thirds (65%) of respondents agreed that the EU Digital COVID Certificate is the safest means for free travel in Europe during the COVID-19 pandemic ³ . Almost all Member States also use the EU Digital COVID Certificate for domestic purposes, with studies estimating that its use has resulted in increased vaccination uptake ⁴ , lower hospital admissions, fewer economic losses and, most importantly, fewer deaths ⁵ .

In addition, the EU Digital COVID Certificate system has proven to be the only functioning COVID-19 certificate system operational at international level on a large scale. As a result, the EU Digital COVID Certificate has gained increasing global significance and contributed to addressing the pandemic at the international level, by facilitating safe international travel and international recovery. By 31 January 2022, the three non-EU European Economic Area countries ⁶ , Switzerland ⁷ and 29 other third countries and territories ⁸ are connected to the EU Digital COVID Certificate system, with more expected to join in the future. The EU Digital COVID Certificate system has been recognised as one of the key digital solutions to restore international mobility ⁹ , with the International Air Transport Association urging countries to adopt the EU Digital COVID Certificate as the global standard ¹⁰ . The Commission will continue its efforts to support third countries interested in developing interoperable COVID-19 certificate systems. This may include offering additional open source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate, as it is also possible to connect third countries the certificates of which are made interoperable by means of conversion ¹¹ .

To make best use of the EU Digital COVID Certificate framework, the Council has adopted several recommendations on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. According to the most recent update, Council Recommendation (EU) 2022/107 adopted on 25 January 2022 ¹² , holders of EU Digital COVID Certificates meeting certain requirements should, in almost all circumstances, not be subject to any additional requirements when exercising their free movement rights. This ‘person-based approach’ thus necessitates the continuous availability of EU Digital COVID Certificates.

Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States ¹³ . Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the 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.

On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused significant increases in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect their healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union.

As noted by the European Centre for Disease Prevention and Control (ECDC) in its Rapid Risk Assessment of 27 January 2022 ¹⁴ , Omicron infections appear less likely to lead to a severe clinical outcome that requires 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 sick 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.

After a peak in Omicron cases, 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. 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 pandemic situation because of the emergence of new SARS-CoV-2 variants of concern cannot be ruled out.

In view of the above, it cannot be excluded that Member States continue to require Union citizens exercising their right to free movement to present proof of COVID-19 vaccination, test or recovery beyond 30 June 2022, that is, the date when Regulation (EU) 2021/953 is currently set to expire. It is thus important to avoid that Union citizens and their family members are deprived of the possibility to make use of their EU Digital COVID Certificates, which are an effective, secure and privacy-preserving way of proving one’s COVID-19 status, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022.

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 the requirement to present EU Digital COVID Certificates, should be lifted as soon as the epidemiological situation allows, the Commission proposes to limit the extension to 12 months. Furthermore, the extension of the Regulation should not be understood as requiring Member States, in particular those that lift domestic public health measures, to maintain or impose free movement restrictions.

In addition, the Commission also proposes to amend a small number of other provisions of Regulation (EU) 2021/953.

According to Regulation (EU) 2021/953, test certificates are to be issued based on two types of tests for SARS-CoV-2 infection, namely molecular nucleic acid amplification tests (NAAT), including those using reverse transcription polymerase chain reaction (RT-PCR), and rapid antigen tests, which rely on 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. On the other hand, Regulation (EU) 2021/953 does not cover other types of antigenic assays, such as enzyme-linked immunosorbent assays (ELISA) or automated immunoassays, which test for antigens in a laboratory setting.

As of July 2021, the technical working group on COVID-19 diagnostic tests ¹⁵ , responsible for preparing updates to the common list of COVID-19 rapid antigen tests ¹⁶ agreed by the Health Security Committee, also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. These proposals are 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 these criteria. As a result, and in an effort to enlarge the scope of the different types of diagnostic tests that may be used as the basis for the issuance of an EU Digital COVID Certificate, the Commission proposes that it should be possible for Member States to issue test certificates on the basis of listed laboratory-based antigenic assays.

Scientific progress also takes place in other areas of the fight against COVID-19, in particular vaccination. Vaccine manufacturers continue the development of new and/or adapted COVID-19 vaccines, and studies are carried out regarding the continued effectiveness of existing ones. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new developments in this area, such as a possible rollout of COVID-19 vaccines targeting SARS-CoV-2 variants. This progress may require future adaptations to the information included in the vaccination certificate, in particular regarding the COVID-19 vaccines administered, such as by way of a delegated act adopted pursuant to Article 5 i of the Regulation.

In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines remains crucial. In this 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. Voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. 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.

For this purpose, persons participating in clinical trials that have been approved by Member States’ ethical committees and competent authorities should be able to receive an EU Digital COVID Certificate. These may be issued by the Member State where the dose is administered regardless whether the participants have received the COVID-19 vaccine candidate or the dose administered to the control group to avoid undermining the studies. It should be clarified that other Member States may accept such certificates in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 ¹⁷ , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation, the Health Security Committee, ECDC or the European Medicines Agency (EMA) may be asked to issue guidance, which should take into account the ethical and scientific criteria necessary for carrying out clinical trials.

Vaccination certificates issued by Member States in the EU Digital COVID Certificate format must contain, among other information, the number of doses administered to the holder. The Commission proposes to clarify that this obligation is not limited to doses administered in the Member State issuing the certificate, but covers all doses administered to the holder, including in other Member States. Limiting the indication of previous doses to those received in the Member State issuing the certificate could lead to a divergence between the number actually administered and that indicated on the certificate. The administration of previous doses in other Member States is proven by means of the corresponding valid EU Digital COVID Certificates, which must be issued to the persons concerned pursuant to Article 5 i of Regulation (EU) 2021/953. Where the information in the certificate is incorrect, the holder is entitled, pursuant to Article 3 i of Regulation (EU) 2021/953, to request the issuance of a new certificate.

The Commission does not propose to extend the scope of Regulation (EU) 2021/953 as far as the domestic use of EU Digital COVID Certificates is concerned. As noted in Recital 48 of Regulation (EU) 2021/953, Member States may process personal data contained in EU Digital COVID Certificates for other purposes, if the legal basis for the processing of such data for other purposes, including the related retention periods, is provided for in national law, which must comply with Union data protection law. Regulation (EU) 2021/953 thus neither prescribes nor prohibits the domestic use of EU Digital COVID Certificate, which remains within the remit of Member States and subject to judicial control by national courts.

On 18 October 2021, the Commission published its first report on the EU Digital COVID Certificate ¹⁸ . Pursuant to Article 16 i of Regulation (EU) 2021/953, the Commission is to submit a second report to the European Parliament and to the Council on the application of the Regulation by 31 March 2022. That report is to contain, in particular, an assessment of the impact of this Regulation on the facilitation of free movement, including on travel and tourism and the acceptance of the different types of vaccine, fundamental rights and non-discrimination, as well as on the protection of personal data during the COVID-19 pandemic.

As noted in the first report, the Commission is putting forward this proposal prior to the adoption of the second report in order to ensure that, for reasons of legal certainty, the necessary legislative procedure can be concluded sufficiently in time before June 2022. At the same time, this proposal builds on an analysis of the different aspects to be covered in that report. For the reasons set out in this proposal, the Commission considers that the EU Digital COVID Certificate has positively affected free movement within the EU, given that its absence would likely have resulted in the development of incompatible national solutions. To widen the scope of the different types of vaccines accepted, the Commission proposes to include COVID-19 vaccines undergoing clinical trials. The impact of extending the EU Digital COVID Certificate Regulation on fundamental rights, non-discrimination and the protection of personal data is addressed below.

• Consistency with existing policy provisions in the policy area

The proposal complements other policy initiatives adopted in the field of free movement during the COVID-19 pandemic, such as Council Recommendations (EU) 2020/1475, 2021/119, 2021/961 and 2022/107. In particular, Council Recommendation (EU) 2022/107 provides that the holders of valid EU Digital COVID Certificates should, in almost all cases, not be subject to additional restrictions.

Directive 2004/38/EC of the European Parliament and of the Council ¹⁹ sets out the conditions for the exercise of the right of free movement and residence (both temporary and permanent) in the Union for Union citizens and their family members. Directive 2004/38/EC provides that Member States may restrict the freedom of movement and residence of Union citizens and their family members, irrespective of nationality, on grounds of public policy, public security or public health.

Regulation (EU) 2021/953 is the only existing Union legislation containing provisions on the issuance, verification and acceptance of certificates documenting the holder’s COVID-19 status. As Member States may, as a public health measure, continue to require the production of such certificates in order to waive certain restrictions on the right to free movement imposed during the COVID-19 pandemic, it is necessary to extend the period of application of the Regulation.

• Consistency with other Union policies

This proposal is part of the package of Union measures to respond to the COVID-19 pandemic. It builds, in particular, on work carried out in the Health Security Committee, the eHealth Network, and the EU Digital COVID Certificate Committee.

This proposal is complemented by proposal COM(2022) 55 final, which seeks to extend the application of 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 ²⁰ .

In its proposal for a Council Recommendation amending Recommendation (EU) 2020/912 on the temporary restriction on non-essential travel into the EU and the possible lifting of such restriction ²¹ , the Commission proposed to establish a clear link between Council Recommendation (EU) 2020/912 and the EU Digital COVID Certificate so to assist the Member States authorities in verifying the authenticity, validity and integrity of the certificates issued by third countries.

This proposal is without prejudice to the Schengen rules as regards the entry conditions for third country nationals. The proposed Regulation should not be understood as encouraging or facilitating the reintroduction of border controls, which remain a measure of last resort subject to the conditions of the Schengen Borders Code ²² .

This proposal also fully respects Member States’ competences in the definition of their health policy (Article 168 TFEU).

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

Article 21 i TFEU confers on Union citizens the right to move and reside freely within the territory of the Member States. Article 21 i provides for the possibility for the Union to act and to adopt provisions with a view to facilitating the right to move and reside freely within the territory of the Member States if action to attain this objective is necessary to facilitate the exercise of this right. The ordinary legislative procedure applies.

The proposal would amend Regulation (EU) 2021/953, which is equally based on Article 21 i TFEU.

• Subsidiarity

The objectives of this proposal, namely to extend the application of Regulation (EU) 2021/953 and amend certain provisions thereof, cannot be achieved by the Member States independently. Action at Union level is thus necessary.

Absence to act at Union level would result in Regulation (EU) 2021/953 ceasing to apply, including the legal basis to operate the EU Digital COVID Certificate trust framework. In addition, Union citizens and their family members would no longer enjoy a right to receive interoperable COVID-19 vaccination, test and recovery certificates. Finally, Member States would no longer be required to accept EU Digital COVID Certificates when waiving restrictions for persons who can provide proof of a certain COVID-19 status.

• Proportionality

Union action can add considerable value in addressing the challenges identified above and is the only way by which a single, streamlined and accepted COVID-19 certificate framework can be maintained.

The adoption of unilateral or uncoordinated measures regarding COVID-19 certificates on COVID-19 vaccination, testing and recovery is likely to lead to restrictions on free movement that are inconsistent and fragmented, resulting in uncertainty for Union citizens when exercising their rights.

The proposal does not alter the existing provisions of Regulation (EU) 2021/953 on the processing of personal data.

The amended Regulation would again be time-limited, to ensure that any restrictions to the free movement of persons within the Union put in place to limit the spread of SARS-CoV-2, including the requirement to present EU Digital COVID Certificates, are lifted as soon as the epidemiological situation allows.

• Choice of the instrument

As it is proposed to amend Regulation (EU) 2021/953, a Regulation is the only possible legal instrument.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

• Stakeholder consultations

The proposal takes into account the discussions held at regular intervals with Member State authorities in different fora.

• Collection and use of expertise

The proposal builds on the epidemiological information and assessments provided by ECDC, the assessment of the safety, effectiveness and quality of COVID-19 vaccines carried out by EMA, the technical exchanges taking place within the Health Security Committee, its technical working group on COVID-19 diagnostic tests and the eHealth Network, as well as relevant available scientific evidence.

• Impact assessment

In view of the urgency and the limited scope of the proposal, the Commission did not carry out an impact assessment.

• Fundamental rights

This proposal positively affects the fundamental right of freedom of movement and residence under Article 45 of the Charter of Fundamental Rights of the European Union (Charter). It does so by ensuring that citizens continue to enjoy access to interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, EU Digital COVID Certificates will allow citizens to continue to profit from these exemptions.

The extension of Regulation (EU) 2021/953 should not be understood as facilitating or encouraging the adoption of public health related restrictions to free movement during the pandemic. Rather, it seeks to provide a harmonised framework for the recognition of COVID-19 certificates in the event that a Member State applies such restrictions. Any limitations to the freedom of movement within the EU justified on grounds of public policy, public security or public health must be necessary, proportionate and based on objective and non-discriminatory criteria. The decision as to whether to introduce restrictions to free movement remains the responsibility of the Member States, which must act in compliance with EU law.

Equally, Member States retain the flexibility not to introduce restrictions to free movement, in particular those that lift domestic public health measures.

The EU Digital COVID Certificate framework ensures non-discrimination by including interoperable vaccination, test and recovery certificates. All Member States are obliged to issue the three different types of certificates, and Council Recommendation (EU) 2022/107 sets out a coordinated approach as to their acceptance. As a result, as many persons as possible are able to benefit from an EU Digital COVID Certificate when exercising their right to free movement. Not extending Regulation (EU) 2021/953 would likely result in obstacles in this regard, as Union citizens would no longer enjoy a right to receive the three different types of certificates throughout the Union, but would likely be subject to different national COVID-19 certificate systems, which may not necessarily cover, at the same time, vaccination, test and recovery. At the same time, the medical events proven by the certificates – vaccination, test or recovery – cannot be considered as equal from a public health point of view, given that unvaccinated and partially vaccinated people remain at much higher risk of severe outcomes ²³ . This is also reflected in the inherently different rules regarding the validity of the certificates.

By extending the application of Regulation (EU) 2021/953, this proposal implies processing of personal data, as set out in that Regulation, by another year. The Commission does not propose changes to the Regulation’s data protection framework. In particular, personal data contained in the certificates that is processed during their verification must not be retained beyond the verification process. Regulation (EU) 2016/679 of the European Parliament and of the Council ²⁴ continues to apply.

4. BUDGETARY IMPLICATIONS

The Commission will use funds from the Digital Europe Programme to support the initiative. A Legislative Financial Statement is submitted with this proposal.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The Commission will continue to closely monitor the implementation of Regulation (EU) 2021/953, the evolution of the epidemiological situation, as well as relevant scientific progress.

• Detailed explanation of the specific provisions of the proposal

1. Article 1 contains the proposed changes to Regulation (EU) 2021/953, which are:

–A broadening of the definition of SARS-CoV-2 tests that rely on the detection of viral proteins (antigens) to include antigenic assays performed in a laboratory setting and not only rapid antigen tests that give results in less than 30 minutes. Corresponding changes are proposed to Articles 3 i, 6(2)(b), 7 i and point 2(i) of the Annex.

–An explicit clarification that vaccination certificates are to contain the number of doses administered to the holder, regardless of the Member State in which they have been administered, to make sure that the overall number actually administered is accurately reflected.

–A clarification that EU Digital COVID Certificates may also be issued to persons participating in clinical trials for COVID-19 vaccines, and that such certificates may be accepted by other Member States in order to waive restrictions to free movement. The Health Security Committee, ECDC or EMA may be asked by the Commission to issue guidance on the acceptance of COVID-19 vaccines undergoing clinical trials. If the COVID-19 vaccine is later granted marketing authorisation at EU level, such certificates fall under the obligatory acceptance set out in Article 5(5), first subparagraph, of Regulation (EU) 2021/953.

–An extension by 12 months of the period of application set out in Article 17 of Regulation (EU) 2021/953, as well as of the power to adopt delegated acts set out in its Article 12.

–The correction of a wrong cross-reference in Article 13 i of Regulation (EU) 2021/953.