Explanatory Memorandum to COM(2021)130 - Framework for issuance, verification and acceptance of certificates on vaccination, testing & recovery to facilitate free movement during COVID-19 (Digital Green Certificate)

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dossier COM(2021)130 - Framework for issuance, verification and acceptance of certificates on vaccination, testing & recovery to facilitate free ...
source COM(2021)130 EN
date 17-03-2021


1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

The right of EU citizens to move and reside freely within the European Union is one of the EU’s most cherished achievements, and an important driver of its economy.

Pursuant to Article 21 of the Treaty on the Functioning of the European Union (TFEU), every EU citizen has the right to move and reside freely within the territory of the Member States, subject to the limitations and conditions laid down in the Treaties and by the measures adopted to give them effect. However, some of the restrictions adopted by the Member States in order to limit the spread of severe acute respiratory syndrome coronavirus 2 (‘SARS-CoV-2’), which causes coronavirus disease 2019 (‘COVID‑19’), have had an impact on citizens’ right to free movement. These measures often consisted of restrictions on entry or other specific requirements applicable to cross-border travellers, such as to undergo quarantine or self-isolation or to be tested for SARS-CoV-2 infection prior to and/or after arrival. Particularly affected were persons living in border regions and crossing borders as part of their daily life, be it for work, education, health care, family or other reasons.

To ensure a well-coordinated, predictable and transparent approach to the adoption of restrictions on freedom of movement, the Council adopted, on 13 October 2020, Council Recommendation (EU) 2020/1475 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic 1 . The Council Recommendation established a coordinated approach on the following key points: the application of common criteria and thresholds when deciding whether to introduce restrictions to free movement, a mapping of the risk of COVID-19 transmission, published by the European Centre for Disease Prevention and Control (ECDC) 2 , based on an agreed colour code, and a coordinated approach as to the measures, if any, which may appropriately be applied to persons moving between areas, depending on the level of risk of transmission in those areas.

Council Recommendation (EU) 2020/1475 seeks to ensure increased coordination among Member States considering the adoption of measures restricting free movement on grounds of public health in the context of the pandemic. When adopting and applying restrictions to free movement, Member States should respect EU law, in particular the principles of proportionality and non-discrimination. Council Recommendation (EU) 2020/1475 was later amended in view of a very high level of community transmission across the EU, possibly linked to the increased transmissibility of the new SARS-CoV-2 variants of concern 3 .

In line with point 17 of the Council Recommendation (EU) 2020/1475, Member States could require persons travelling from risk areas in another Member State to undergo quarantine/self-isolation and/or to undergo a test for SARS-CoV-2 infection prior to and/or after arrival. Travellers arriving from areas marked in ‘dark red’ should, according to point 17 of the Council Recommendation, be subject to reinforced public health measures.

To show compliance with the different requirements, travellers have been asked to provide various types of documentary evidence, such as medical certificates, test results, or declarations. The absence of standardised and secured formats has resulted in travellers experiencing problems in the acceptance of their documents, as well as reports of fraudulent or forged documents being presented 4 .

These issues, which can lead to unnecessary delays and obstacles, are likely to become even more prominent as more and more Europeans are being tested for and vaccinated against COVID-19 and receive documentary proof to this effect. This has been a growing concern for the European Council. In their statement adopted following the informal video conferences on 25 and 26 February 2021 5 , the members of the European Council called for work to continue on a common approach to vaccination certificates.

There is consensus among Member States on the use of such certificates for medical purposes, such as to ensure proper follow-up between a first and second dose, as well as any necessary subsequent booster. Member States are working on developing vaccination certificates, often using information available in immunisation registries.

The Commission has been working with the Member States in the eHealth Network, a voluntary network connecting national authorities responsible for eHealth, on preparing the interoperability of vaccination certificates. On 27 January 2021, the eHealth Network adopted Guidelines on proof of vaccination for medical purposes, which it updated on 12 March 2021 6 . These guidelines define the central interoperability elements, namely a minimum dataset for vaccination certificates, and a unique identifier. The eHealth Network and the Health Security Committee established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council 7 have also been working on a common standardised set of data for COVID-19 test result certificates 8 , guidelines on recovery certificates and respective datasets, and an outline on the interoperability of health certificates 9 .

Based on the technical work carried out so far, the Commission proposes to establish an EU-wide framework for the issuance, verification and acceptance of vaccination certificates within the EU as part of a “Digital Green Certificate”. At the same time, this framework should also cover other certificates issued during the COVID-19 pandemic, namely documents certifying a negative test result for SARS-CoV-2 infection as well as documents certifying that the person concerned has recovered from a previous infection with SARS-CoV-2. This allows persons who are not vaccinated or who have not yet had the opportunity to be vaccinated to benefit from such an interoperable framework as well, facilitating their free movement. While children, for example, cannot benefit from COVID-19 vaccination for the time being, they should be able to receive a test or recovery certificate, which could also be received by their parents on their behalf.

In addition, it should be clarified that the purpose of the certificates included in the “Digital Green Certificate” is to facilitate the exercise of free movement. The possession of a “Digital Green Certificate”, in particular a vaccination certificate, should not be a pre-condition for the exercise of free movement. Persons who are not vaccinated, for example for medical reasons, because they are not part of the target group for which the vaccine is currently recommended, such as children, or because they have not yet had the opportunity or do not wish to be vaccinated, must be able to continue to exercise their fundamental right of free movement, where necessary subject to limitations such as mandatory testing and quarantine/self-isolation. In particular, this Regulation cannot be interpreted as establishing an obligation or right to be vaccinated.

To ensure interoperability between the different technical solutions being developed by the Member States, some of which have already started accepting proofs of vaccination to exempt travellers from certain restrictions, uniform conditions for the issuance, verification and acceptance of certificates on COVID-19 vaccination, tests and recovery are needed.

The “Digital Green Certificate” framework to be established should lay out the format and content of certificates on COVID-19 vaccination, testing and recovery. The Commission also proposes that the “Digital Green Certificate” framework should ensure that these certificates can be issued in an interoperable format and be reliably verified when presented by the holder in other Member States, thereby facilitating free movement within the EU.

The certificates should contain only such personal data as is necessary. Given that the personal data includes sensitive medical data, a very high level of data protection should be ensured and data minimisation principles should be preserved. In particular, the “Digital Green Certificate” framework should not require the setting up and maintenance of a database at EU level, but should allow for the decentralised verification of digitally signed interoperable certificates.

• Consistency with existing policy provisions in the policy area

The proposal complements and builds upon other policy initiatives adopted in the field of free movement during the COVID-19 pandemic, such as Council Recommendations 2020/1475 and 2021/119. In particular, Council Recommendation 2020/1475 describes the general principles based on which Member States should coordinate their actions when adopting and applying measures in the field of free movement to protect public health in response to the COVID-19 pandemic.

Directive 2004/38/EC of the European Parliament and of the Council 10 sets out the conditions for the exercise of the right of free movement and residence (both temporary and permanent) in the EU for EU citizens and their family members. Directive 2004/38/EC provides that Member States may restrict the freedom of movement and residence of EU citizens and their family members, irrespective of nationality, on grounds of public policy, public security or public health.

Existing EU legislation does not contain provisions on the issuance, verification and acceptance of certificates documenting the holder’s health status, even if the production of such certificates may be necessary to waive certain restrictions on the right to free movement imposed during a pandemic. It is therefore necessary to establish provisions in order to ensure the interoperability and security of such certificates.

• Consistency with other Union policies

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

This proposal is complemented by proposal COM(2021)/xxx, whose objective it is to ensure that the rules set out in this proposal apply to third-country nationals not covered by this proposal and who are legally staying or residing on the territory of a State to which that proposed Regulation applies and who are entitled to travel to other States in accordance with Union law.

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.

This proposal takes into account ongoing efforts at the international level, such as under the auspices of specialized agencies of the United Nations including the World Health Organization (‘WHO’), on the basis of the International Health Regulations, to establish specifications and guidance for using digital technologies for documenting vaccination status. Third countries should be encouraged to recognise the “Digital Green Certificate” when waiving restrictions on non-essential travel.

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(1) TFEU confers on EU citizens the right to move and reside freely within the territory of the Member States. Article 21(2) provides for the possibility for the EU 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 aims to facilitate the exercise of the right to free movement within the EU during the COVID-19 pandemic by establishing a common framework for the issuance, verification and acceptance of interoperable certificates on COVID-19 vaccination, testing and recovery. This should allow EU citizens and their family members exercising their right to free movement to demonstrate that they fulfil public health requirements imposed, in compliance with EU law, by the Member State of destination. The proposal also aims to ensure that restrictions of free movement currently in place to limit the spread of COVID-19 can be lifted in a coordinated manner as more scientific evidence becomes available.

• Subsidiarity

The objectives of this proposal, namely to facilitate the free movement within the EU during the COVID-19 pandemic by establishing secure and interoperable certificates on the holder’s vaccination, testing and recovery status, cannot be sufficiently achieved by the Member States independently but can rather, by reason of the scale and effects of the action, be better achieved at EU level. Action at EU level is thus necessary.

Absence to act at EU level would likely result in Member States adopting different systems, resulting in citizens exercising their free movement rights experiencing problems in the acceptance of their documents in other Member States. In particular, it is necessary to agree on the technical standards to be used to ensure interoperability, security and verifiability of the certificates being issued.

• Proportionality

EU action can add considerable value in addressing the challenges identified above and is the only way by which a single, streamlined and accepted framework can be achieved and 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 EU citizens when exercising their EU rights.

The proposal limits the processing of personal data to the minimum necessary, by only including a limited set of personal data on the certificates to be issued, by setting out that the data obtained when verifying the certificates should not be retained, and by establishing a framework that does not require the setting up and maintenance of a central database.

The provisions of the proposed Regulation regarding the issuance of vaccination, test or recovery certificates as well as the trust framework should be suspended once the COVID-19 pandemic has been overcome, since as of that point, there is no justification to requiring citizens to present health documents when exercising their right to free movement. At the same time, their applications should resume if the WHO declares another pandemic due to an outbreak of SARS-CoV-2, a variant thereof, or similar infectious diseases with epidemic potential.

• Choice of the instrument

A Regulation is the sole legal instrument ensuring the direct, immediate and common implementation of EU law in all Member States.

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 States in different fora.

• Collection and use of expertise

The proposal builds on the technical exchanges taking place within the Health Security Committee and the eHealth Network, the information published by ECDC on the epidemiological situation related to the COVID-19 pandemic, and relevant available scientific evidence.

• Impact assessment

In view of the urgency, 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 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 certificates established by this proposal will allow citizens to profit from these exemptions. As more scientific data, notably on the effects of vaccination against SARS-CoV-2 infection, becomes available, an interoperable framework of health certificates should allow Member States to lift restrictions in a coordinated manner.

This Regulation should not be understood as facilitating or encouraging the adoption of restrictions to free movement during the pandemic. Rather, it seeks to provide a harmonised framework for the recognition of COVID-19 health 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.

This proposal implies processing of personal data, including health data. There are potential impacts on individuals’ fundamental rights, namely Article 7 of the Charter on the respect of private life and Article 8 on the right to the protection of personal data. Processing the personal data of individuals, including the collection, access and use of personal data, affects the right to privacy and the right to protection of personal data under the Charter. Interference with these fundamental rights must be justified.

As regards the right to the protection of personal data including data security, Regulation (EU) 2016/679 of the European Parliament and of the Council 11 applies. No derogation from the data protection regime of the EU is envisaged and clear rules, conditions and robust safeguards must be implemented by Member States, in line with the EU data protection rules. The proposed Regulation does not establish a European database on vaccination, testing or recovery from COVID-19. For the purposes of the proposed Regulation, personal data need only to be included in the certificate issued, which should be protected against falsification or tampering.

4. BUDGETARY IMPLICATIONS

The Commission will use funds from the Emergency Support Instrument to initially support most urgent measures under the initiative and will explore, once the legal basis of the Digital Europe Programme enters into force, how some of the expenditure could be carried out under that programme. The initiative could require the use of one, or a combination of, special instruments as defined in Council Regulation (EU, Euratom) 2020/2093 12 . A Legislative Financial Statement is submitted with this proposal.

Given the health emergency, most of the preparatory expenditure will take place under the Emergency Support Instrument before the proposed Regulation enters into force. Any EU-level supporting system will be activated only after the entry into force of the proposed Regulation.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

One year after the WHO has declared the COVID-19 pandemic to have ended, the Commission will prepare a report on the application of this Regulation.

• Detailed explanation of the specific provisions of the proposal

Articles 1 and 2 of the proposal describe the subject matter of the proposed Regulation and establish a number of definitions. The proposed Regulation establishes the Digital Green Certificate, which is a framework for the issuance, verification and acceptance of interoperable health certificates to facilitate free movement during the COVID-19 pandemic.

Article 3 details the three types of certificates included in the Digital Green Certificate framework, namely the vaccination certificate, the test certificate, and the certificate of recovery. It also sets out the general requirements such certificates must meet, such as the inclusions of an interoperable barcode, and provides for the setting up of the necessary technical infrastructure. Certificates issued in accordance with this Regulation by the EEA States Iceland, Liechtenstein and Norway through the integration of this instrument into the EEA framework should be accepted. Certificates issued by Switzerland on the basis of this Regulation to persons benefitting from free movement rights should be accepted following an implementing decision by the Commission if it is satisfied that acceptance happens on a reciprocal basis.

Article 4 establishes the Digital Green Certificate trust framework, which should ensure, where possible, interoperability with technological systems established at international level. It also provides for the acceptance of secure and verifiable certificates issued by third countries to EU citizens and family members according to an international standard that is interoperable with the trust framework established by this Regulation and which contain the necessary personal data, following an implementing decision by the Commission.

Articles 5 to 7 provide further details on the issuance, contents and acceptance of the vaccination certificate, the test certificate, and the certificate of recovery.

Article 8 empowers the Commission to adopt the necessary technical specifications for the trust framework, where needed through an accelerated procedure.

Article 9 contains rules on data protection.

Article 10 establishes a notification procedure that seeks to ensure that other Member States and the Commission are informed of restrictions to the right to free movement made necessary by the pandemic.

Articles 11 and 12 contain rules on the exercise of delegation by the Commission, where needed through an urgency procedure.

Article 13 contains rules on the committee tasked with assisting the Commission in implementing the Regulation.

Article 14 sets out that the Commission should present a report on the application of the Regulation one year after the WHO declares the SARS-CoV-2 pandemic to have ended, outlining, in particular, its impact of free movement and data protection.

Article 15 provides for an expedited entry into force of the Regulation. It also states that Articles 3, 4, 5, 6, 7 and 10 should be suspended by means of a delegated act when the WHO declares that the COVID-19 pandemic has ended. At the same time, their application should be resumed by means of a delegated act if the WHO declares another pandemic due to an outbreak of SARS-CoV-2, a variant thereof, or similar infectious diseases with epidemic potential.

The Annex contains the personal data to be included in the certificates covered by the Regulation.