Legal provisions of COM(2023)296 - Joining the global digital health certification network established by the World Health Organization and on temporary arrangements to facilitate international travel - Main contents
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| dossier | COM(2023)296 - Joining the global digital health certification network established by the World Health Organization and on temporary ... |
|---|---|
| document | COM(2023)296 |
| date | June 27, 2023 |
EXPLANATORY MEMORANDUM
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
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 pandemic1, has been a crucial element in Europe’s response to the COVID-19 pandemic. Its rapid adoption and rollout enabled Union citizens to move freely and safely during the pandemic, and the European travel sector to open in time for summer 2021.
The EU Digital COVID Certificate has proven to be a major success in Europe’s efforts to address and mitigate the impact of the COVID-19 pandemic on societies and economies. It rapidly became the standard for Europe and beyond, with 51 third countries and territories connected to the system2 in addition to the 27 Member States3. With more than two billion certificates issued, the EU Digital COVID Certificate has delivered major benefits for EU citizens and residents. It facilitated free movement within the Union when travel restrictions were deemed necessary due to the pandemic and it also allowed the coordinated lifting of these restrictions once possible. Through its external dimension, the EU Digital COVID Certificate has also proven to be the most widely used solution and tool to foster safe international travel and recovery at global level. All third countries and territories which issue certificates covered by a Commission decision pursuant to Articles 3(10) or 8(2) of Regulation (EU) 2021/953 accept EU Digital COVID Certificates when requiring incoming travellers to prove their COVID-19 vaccination, testing or recovery status.
In June 2022, the co-legislators extended Regulation (EU) 2021/953 by one year to ensure that travellers could continue using their certificates should a significant worsening of the epidemiological situation have made it necessary for Member States to temporarily reintroduce travel restrictions within the EU.
Regulation (EU) 2021/953 is set to expire on 30 June 2023. Given the current absence of any intra-EU travel restrictions, and taking into account that the epidemiological context led the World Health Organization (WHO) to declare the end of the COVID-19 as a public health emergency of international concern on 5 May 2023, the Regulation can no longer serve its declared objective and, as a result, its extension would not be justified.
The success of the EU Digital COVID Certificate in allowing free movement and travel even in the difficult circumstances of the pandemic holds lessons for the future. The Union has made it a priority to develop the policies and tools necessary to be better prepared for future health crises. The benefits of using digital solutions to mitigate the impact of communicable diseases on the ability of citizens and businesses to travel is a central pillar of this preparedness4. The benefits of such preparedness are now being taken up at the global level.
In this respect, the WHO is developing a global digital health certification network, which takes up the EU Digital COVID Certificate trust framework, principles and open technologies under its own structure. To ensure that certificates used worldwide continue to be verifiable when needed even after the expiry of Regulation (EU) 2021/953, Member States should be encouraged to join the WHO global digital health certification network as soon as it is available to support the use of the European technology and specifications for COVID-19 certificates in a global infrastructure.
On 20 December 2022, the Council adopted conclusions calling on the Commission to “explore the added value of a digital version of vaccination certificates, taking into consideration the experiences with European digital infrastructures and other existing tools, such as the International Certificate of Vaccination or Prophylaxis”5. The global digital health certification network being established by the WHO, with the EU Digital COVID Certificate trust framework at its core, is being designed to enable global interoperability and verification of such certificates. It should therefore provide a global solution to the call made in the Council conclusions.
The WHO global digital health certification network will also provide an important opportunity to use the experience gained during the COVID-19 pandemic to help mitigate the impact of future health crises. Its further development could be expected to allow Member States to be involved in the issuance, acceptance, verification, as well as the use of the global digital health certification network for the digitalisation of the International Certificate of Vaccination and Prophylaxis, if this is confirmed by the adoption of amendments to the International Health Regulation (IHR)6. The WHO global digital health certification network might also be used to support the digitalisation and certification of authenticity of routine immunisation records as well as other future use cases in digital health. Such possible future developments – building on the lessons learned of the COVID-19 pandemic and the international success of the EU Digital COVID Certificate – would be major contributions to the global health agenda.
In the very short term, a limited number of countries around the globe7 still require proof of COVID-19 vaccination, test and/or recovery as conditions for entry. Situations whereby a Union citizen or resident is requested to show a COVID certificate in a third country and cannot easily provide one because the EU Digital COVID Certificate system is no longer functional should be avoided, as this would represent a limitation to international travel by any means of transport. It is currently difficult to assess for how long these countries maintain such COVID-19 related entry requirements, including beyond 1 July 2023. As it remains uncertain how the epidemiological situation develops, it can also not be excluded that some countries among the 51 third countries and territories currently connected to the EU Digital COVID Certificate could re-impose travel requirements, while also other countries outside this system could keep or re-impose specific entry requirements.
It is therefore desirable that Union citizens and residents travelling outside of the Union continue to have at their disposal means to prove their COVID-19 related status, whenever specifically requested for travel outside the Union beyond 1 July 2023. Furthermore, Union citizens and residents should benefit from the availability of such certificates for ensuring continuity of care.
In practice, EU Digital COVID certificates have not only been used for travel purposes, but also by health services, for the purposes of continuity of care, such as cross-border vaccination. Vaccination certificates issued by one Member State showing past vaccination(s) could, for instance, be used by health workers in another Member State or a third country in order to administer a consequent dose. Similarly, certificates of recovery have also been useful to provide information about a previous COVID-19 infection.
In addition, as a resurgence of COVID-19 cases or an outbreak of another disease cannot be ruled out in any part of the world, one or several Member States could in the future introduce new, public health measures limiting the entry into their territory of persons travelling from third countries. To ensure that the public health concerns that would justify such measures are adequately addressed, Member States should be able to continue relying on certificates issued by third countries in compliance with the technology and the standards underlying the EU Digital COVID Certificate system.
It is therefore desirable that, if Member States introduce such general public health measures as a result of a resurgence of COVID-19 cases8, they have the necessary framework to continue accepting certificates issued by third countries whose systems are interoperable with the EU Digital COVID Certificate.
It is important to ensure a smooth transition for Member States from the connection to the EU Gateway established at the core of the EU Digital COVID Certificate trust framework to the connection to the WHO global digital health certification network. Therefore, the two systems could operate in parallel for a limited period of time (3 months). To ensure the verifiability of EU Digital COVID Certificates during the transition period, the public keys of countries and territories, connected to the EU Gateway will be made available in the WHO global digital health certification network. To that end, it is proposed that Member States be encouraged to renew their public keys prior to 30 June 2023, and, after connection to the WHO global digital health certification network, to keep both systems synchronised until 30 September 2023. In this respect, the Commission intends to continue financing the operation of the EU gateway through the Digital Europe Programme for the transitional period.
• Consistency with existing policy provisions in the policy area
In view of the expiry of Regulation (EU) 2021/953 of the European Parliament and of the Council, the proposed recommendation serves to facilitate and remove barriers to international travel. and to promote Member State readiness, should it become necessary for them to impose public health measures on the entry into their territory of persons travelling from third countries following the approach recommended in Council Recommendation (EU) 2022/2548.
At the same time, the proposed recommendation contributes to ensuring continuity of care in cross-border contexts (including with third countries) and preventing the spread of COVID-19 by encouraging the continued issuance of COVID-19 certificates after the expiry of Regulation (EU) 2021/953 on 30 June 2023.
• Consistency with other Union policies
This recommendation is in line with other Union policies, including those regarding external relations.
On 3 May 2022, the Commission published a proposal for a Regulation on the European Health Data Space9, Article 13 of which proposes a possibility to provide supplementary services through MyHealth@EU that facilitate the exchange or verification of digital health certificate systems. These supplementary services should strive for interoperability with systems established at international level. This Recommendation follows the same aim.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
The proposal is based on Article 168(6) of the Treaty on the Functioning of the European Union (TFEU), which provides a basis for adopting Council recommendations in the field of public health, and Article 292 TFEU together with Articles 91 and 100(2) TFEU, which provide a basis for adopting Council recommendations in the field of transport.
The achievement of a high level of human health protection will benefit from the measures recommended relating to the acceptance of COVID-19 vaccination, test or recovery certificates from third countries and to the connection to the WHO global digital health certification network. These measures contribute to addressing public health preparedness in case of a resurgence of COVID-19 cases.
Moreover, international travel and the smooth provision of international transport services thanks to the continuous availability of COVID-19 certificates, even after the expiry of Regulation (EU) 2021/953, would be facilitated if Member States take a coordinated approach, as proposed in this proposal for a recommendation.
• Subsidiarity
A consistent approach regarding the continuous possibility to issue COVID-19 certificates when needed would benefit Union citizens or residents as well as transport operators. Joining the WHO global digital health certification network would provide a common solution to continue issuing COVID-19 certificates. Participation in the WHO global digital health certification network would contribute to the global alignment of health certificate standards and establishment of a system for the recognition of digital health certificates for international travel and continuity of care.
• Proportionality
The present proposal takes account of the imminent expiry of Regulation (EU) 2021/953 and of the concurrent need to ensure that EU citizens and residents travelling outside of the EU continue to have at their disposal means to prove their COVID-19 related status, as well as to contribute to a coordinated approach to certificates that are still issued by third countries in compliance with the specifications laid down in accordance with that Regulation. Therefore, the proposal is suitable for achieving the intended objectives and does not go beyond what is necessary and proportionate.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
n.a.
• Stakeholder consultations
This proposal takes into account previous discussions with Member States, in the context of the implementation of Regulation (EU) 2021/953. No impact assessment was undertaken though the proposal takes into account the evolving measures taken by third countries as regards the conditions for entry into their territory in the context of the COVID-19 pandemic, and all available relevant evidence.
• Fundamental rights
This proposed Council Recommendation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, notably the right to the protection of personal data, laid down in Article 8.
4. BUDGETARY IMPLICATIONS
None.
Proposal for a
COUNCIL RECOMMENDATION
on joining the global digital health certification network established by the World Health Organization and on temporary arrangements to facilitate international travel in view of the expiry of Regulation (EU) 2021/953 of the European Parliament and of the Council
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(6), and Article 292 in conjunction with Article 91 and Article 100(2), thereof,
Having regard to the proposal from the European Commission,
Whereas:
(1) The EU Digital COVID Certificate introduced by Regulation (EU) 2021/953 of the European Parliament and of the Council10 has rapidly become a global standard for vaccination, test and recovery certificates, with 51 third countries and territories connected to the system in addition to the 27 Member States. Through its external dimension, the EU Digital COVID Certificate has also proven to be the most widely used solution and tool to foster safe international travel and recovery at global level. In addition to travel, the use of digital COVID certificates fostered the continuity of cross-border vaccination.
(2) The EU Digital COVID Certificate was paramount in safeguarding free movement and travel and its underlying technology could continue to serve as a tool, necessary to be better prepared for possible future health crises, allowing citizens and business to mitigate the impact of communicable diseases and ensure a proper preparedness. This is also in line with the special report of the European Court of Auditors11.
(3) Regulation (EU) 2021/953 is set to expire on 30 June 2023.
(4) The World Health Organization (WHO) will establish a global digital health certification network. The global digital health certification network is a mechanism to support the verification of certificates that are issued by participants of the global digital health certification network. Such certificates would initially concern COVID-19 certificates, and could, at a later stage, also include certification of other documents, such as routine immunisation records and the International Certificate of Vaccination or Prophylaxis for the purposes of international travel and continuity of care.
(5) The establishment of systems to mitigate the impact of global health crises on travel for citizens and businesses should be seen as a major pillar of the EU’s preparedness agenda. Participation in the WHO global digital health certification network would contribute to the global alignment of health certificate standards and establishment of a system for the recognition of digital health certificates for international travel and continuity of care.
(6) The global digital health certification network being developed by the WHO takes up the EU Digital COVID Certificate trust framework, principles and open technologies under its own structure. Member States should be encouraged to connect to the WHO global digital health certification network as soon as possible before 30 September 2023, provided that it complies with the technical specifications issued in accordance with Regulation (EU) 2021/953. For a smooth transition from the EU Digital COVID Certificate system to the WHO global digital health certification network, Member States should be invited to issue new digital signer certificates used for the issuance of the EU Digital COVID Certificates before the expiry of Regulation (EU) 2021/953 to ensure their maximum technical validity and register these in the EU Gateway.
(7) The Commission intends to ensure a smooth transition for Member States to join the WHO global digital health certification network, by maintaining the EU Gateway until 30 September 2023 in a manner that supports the objectives of this Recommendation. To that end, the Commission intends to finance the EU Gateway through the Digital Europe Programme established by Regulation (EU) 2021/694 of the European Parliament and of the Council12. This should allow the Member States and third countries connected to the EU Gateway sufficient time to adopt the procedures necessary to onboard the WHO global digital health certification network.
(8) All Union citizens and residents travelling outside the Union should have at their disposal means to prove their COVID-19 related status, whenever this is specifically requested for travelling outside of the Union. The absence of such means of proof could reduce the willingness and ability of Union passengers to travel to certain destinations, which in turn could have a negative impact on the provision of transport services. Moreover, unequal conditions for the issuance of such certificates between the Member States could affect fair competition between transport operators if international travel from certain Member States is less cumbersome because relevant COVID-19 certificates are easily accessible. Therefore, once connected to the WHO global digital health certification network, Member States should also be invited to issue, upon request, certificates in the format compatible with the technical specifications laid down in Commission Implementing Decision (EU) 2021/107313, for the purposes of facilitating international travel by any means of transport to third countries requiring such certificates. In addition to facilitating international travel, such issuance could contribute to the global alignment of health certificate standards and the development of a system for the recognition of digital health certificates facilitating the continuity of care.
(9) Member States should issue such certificates, including during the transitional period, in a digital or paper-based format, or both. The prospective holders should be entitled to receive the certificates in the format of their choice. The information contained in the certificates should also be shown in human-readable form and be provided in at least the official language or languages of the issuing Member State and in English.
(10) The uptake of the EU Digital COVID Certificate by the WHO global digital health certification network should enable third countries which still have in place COVID-19 related requirements as conditions for entry in their territories, and which are connected to the interoperability gateway of the trust framework set up under Regulation (EU) 2021/953 (the ‘EU Gateway’), to accept and verify both certificates issued before and after 1 July 2023.
(11) Situations whereby a Union citizen or resident is requested to show a COVID-19 certificate by a third country and cannot easily provide one because the EU Digital COVID Certificate system is not functional should be avoided, as this would represent a limitation to international travel by any means of transport.
(12) From the perspective of travellers to the Union, as a resurgence of COVID-19 cases or an outbreak of another disease cannot be ruled out in any part of the world, one or several Member States could in the future introduce new, public health measures limiting the entry into their territory of persons travelling from third countries. While any such restrictions should be applied in accordance with the general principles of proportionality and non-discrimination, they could be justified on public interest grounds, namely the safeguarding of public health. To ensure that such public health concerns can be adequately addressed, Member States should continue to be able to accept and verify certificates issued by third countries in compliance with the high standards currently laid down in Regulation (EU) 2021/953. Where Member States require proof of COVID-19 vaccination, test or recovery in order to waive restrictions to travel into the Union, they should accept proofs of COVID-19 vaccination, recovery or testing previously covered by an implementing act adopted pursuant to Article 3(10) or Article 8(2) of Regulations (EU) 2021/953, in line with the approach set out in Council Recommendation (EU) 2022/254814.
(13) As the issuance of appropriate, interoperable certificates can contribute to facilitating international travel to certain third countries by any means of transport, Member States should be invited to ensure, including during the transitional period, that cross-border passenger transport service operators required to implement COVID-19 related public health measures integrate the verification of such certificates into the operation of cross-border transport infrastructures, such as airports, ports and railway and bus stations, where appropriate.
(14) The Council called on the Commission to “explore the added value of a digital version of vaccination certificates, taking into consideration the experiences with European digital infrastructures and other existing tools, such as the International Certificate of Vaccination or Prophylaxis”15. Similar developments are planned by the WHO, which intends to further develop the WHO global digital health certification network, in order to, for example, support the digitisation of International Certificate of Vaccination and Prophylaxis, or vaccination certificates for routine immunisation. Therefore, the Member States should be invited to actively participate in the effort to further develop the network, as well as to issue, accept and verify other types of vaccination certificates or health data, as relevant.
(15) During a transitional period until 30 September 2023, and in order to ensure a smooth transition to the WHO global digital health certification network, Member States who have not yet connected to the WHO global digital health certification network should continue to issue, upon request, COVID-19 vaccination, test and recovery certificates in the format compatible with the technical specifications laid down in Commission Implementing Decision (EU) 2021/107316. Also, during this transitional period, where Member States require proof of COVID-19 vaccination, test or recovery in order to waive restrictions to travel into the Union, they should accept proofs of COVID-19 vaccination, recovery or testing previously covered by an implementing act adopted pursuant to Article 3(10) or Article 8(2) of Regulations (EU) 2021/953, in line with the approach set out in Council Recommendation (EU) 2022/254817.
(16) During the same period, Member States who have not yet connected to the WHO global digital health certification network should also remain connected to the EU Gateway, insofar as such gateway is being maintained by the Commission. Those Member States who have already connected to the WHO global digital health certification network should synchronise the information they upload to the WHO global digital health certification network with the EU Gateway.
(17) Member States should give effect to this Recommendation as of 1 July, which is the day after the expiry of Regulation (EU) 2021/953, so that any possible disruption, especially concerning international travel to third countries still requiring COVID certificates, is avoided. Specifically as regards the issuance of a new digital signer certificate, Member States can only do so while Regulation (EU) 2021/953 is still in force. They are therefore invited to give this certificate the maximum possible technical validity and to register it in the EU Gateway before the expiry of Regulation (EU) 2021/953 on 30 June 2023.
(18) Regulation (EU) 2016/679 of the European Parliament and of the Council18 applies to the processing of personal data carried out when implementing this Recommendation. Member States should therefore ensure at all times that the relevant provisions of Union law concerning personal data are complied with.
HAS ADOPTED THIS RECOMMENDATION:
Connection to the WHO global digital health certification network
1. Member States should adopt all necessary measures to connect to the global digital health certification network that is being set up by the World Health Organization (WHO), provided that it complies with the technical specifications issued in accordance with Regulation (EU) 2021/953. Member States are encouraged to do so as soon as possible before 30 September 2023.
2. Each Member State should issue a new digital signer certificate with the maximum possible technical validity and register it in the EU Gateway before the expiry of Regulation (EU) 2021/953.
3. The Council welcomes the Commission’s intention to facilitate a seamless transition from the EU Digital COVID Certificate system to the WHO global digital health certification network.
Issuance and acceptance of certificates under the WHO global digital health certification network
4. Once connected to the WHO global digital health certification network, Member States should:
(a) issue, upon request, COVID-19 vaccination, test and recovery certificates in the format compatible with the technical specifications laid down in Commission Implementing Decision (EU) 2021/1073;
(b) issue the certificates referred to in letter a) in a digital or paper-based format, or both. The prospective holders should be entitled to receive the certificates in the format of their choice. The information contained in the certificates should also be shown in human-readable form and be provided in at least the official language or languages of the issuing Member State and in English.
(c) where they require proof of COVID-19 vaccination, test or recovery in order to waive restrictions, continue to accept proofs of COVID-19 vaccination, recovery or testing previously covered by an implementing act adopted pursuant to Article 3(10) or Article 8(2) of Regulation (EU) 2021/953 and in line with the rules issued in accordance with that Regulation;
(d) ensure that cross-border passenger transport service operators integrate the verification of the certificates referred to in letter a) into the operation of cross-border transport infrastructures such as airports, ports and railway and bus stations, where appropriate.
Further evolution of the WHO global digital health certification network
5. Member States are encouraged to actively participate in the effort to further develop the WHO global digital health certification network, including in relation to certificates for other diseases and authentication of other health data.
Transitional period until 30 September 2023
6. The Council welcomes the Commission’s intention to maintain the EU Gateway for the EU Digital COVID Certificate in a manner that supports the objectives of this Recommendation until 30 September 2023, by making it available to third countries and territories which have been connected following the adoption by the Commission of implementing acts in accordance with Article 3(10) or Article 8(2) of Regulation (EU) 2021/953, provided that the relevant certificates of those third countries and territories continue to be issued in accordance with standards and technological systems that are interoperable with the trust framework of the EU Gateway and that allow for the verification of their authenticity, validity and integrity.
7. Until Member States are connected to the WHO global digital health certification network referred to in point 1 and in the period until 30 September 2023, they should
(a) remain connected to the EU Gateway, insofar as such gateway is being maintained by the Commission;
(b) continue to issue, upon request, COVID-19 vaccination, test and recovery certificates in the format compatible with the technical specifications laid down in Commission Implementing Decision (EU) 2021/107319;
(c) issue the certificates referred to in letter b) in a digital or paper-based format, or both. The prospective holders should be entitled to receive the certificates in the format of their choice. The information contained in the certificates should also be shown in human-readable form and be provided in at least the official language or languages of the issuing Member State and in English;
(d) where they require proof of COVID-19 vaccination, test or recovery in order to waive restrictions, continue to accept proofs of COVID-19 vaccination, recovery or testing previously covered by an implementing act adopted pursuant to Article 3(10) or Article 8(2) of Regulation (EU) 2021/953 and in line with the rules issued in accordance with that Regulation;
(e) ensure that cross-border passenger transport service operators integrate the verification of the certificates referred to in letter b) into the operation of cross-border transport infrastructures such as airports, ports and railway and bus stations, where appropriate.
8. Member States connected to the WHO global digital health certification network should also ensure, until 30 September 2023, the synchronisation of information they upload in the EU Gateway and in the WHO global digital health certification network.
9. Member States should give effect to this Recommendation as of 1 July 2023 with the exception of point 2, to which effect should be given before 30 June 2023.