1.  The European Union (EU) is not a State. Often described (unhelpfully) as ‘sui generis’, it may be conceptualised as a particularly dense form of intergovernmental organisation, or a ‘supra-national’ or ‘quasi-federal’ organisation. While few think of the EU as a ‘State-in-waiting’, equally, few go to the other extreme of thinking of the EU as only a vehicle through which the governments of its Member States pursue their interests. The EU is neither an emerging ‘United States of Europe’ nor merely a regional World Trade Organization (WTO). It is probably best to conceptualise the EU as a multi-level system of governance, within which heterarchical relationships structure relations between Member State and EU-level institutions. For information about the Member State-level of Covid-19 law, readers are referred to the country reports for EU Member States. This report covers only the EU-level response.

2.  However it is conceptualised, the EU is a rules-based organisation. Its founding treaties (the Treaty on European Union (TEU) and Treaty on the Functioning of the European Union (TFEU)) operate as a quasi-constitution. The Treaties establish the institutions of the EU, determine their powers and the procedures through which they must act, and the checks and balances and processes of accountability for their decision-making.⁴

3.  The European Commission (‘Commission’) is the EU’s main executive arm. When acting as executive and exercising implementing powers, the European Commission is subject to control by so-called comitology committees which are made up of representatives of the executive in each Member State, chaired by the Commission. The Commission also formally adopts executive acts which can be based on advice and opinions provided by EU agencies, which give scientific and technical regulatory support.

4.  The European Council is composed of the Heads of States or Government of the Member States, together with the European Council President and the President of the Commission.⁵ The European Council has important strategic executive functions, as it determines the political directions and priorities of the EU.⁶

5.  Among the European Commission’s powers is the power to propose new legislation,⁷ which, if adopted by the European Parliament and Council of the European Union (‘Council’)—not to be confused with the aforementioned ‘European Council’—binds all the Member States.⁸ The European Parliament is directly elected by the EU’s citizens.⁹ The Council of the European Union, consists of the representatives of the governments of the 27 EU Member States at ministerial level meeting in 10 topic-specific configurations.¹⁰ The EU legislature consists of the European Commission, which has the power only to propose legislation, the European Parliament, and the Council, acting together in accordance with the co-legislative procedures set out in the treaties which formally established the EU.¹¹

6.  The Court of Justice of the European Union (CJEU) has power to judicially review all acts of the EU institutions for compliance with the EU treaties.¹² This includes both procedural and substantive grounds of review. The CJEU is composed of the General Court (formerly Court of First Instance) and the Court of Justice.

7.  The EU institutional structures are also used by some groups of Member States to establish deeper forms of economic integration: the Schengen area¹³ and the Eurozone¹⁴ are two examples.

8.  The Treaties set out the division of power between the EU and its Member States.¹⁵ The EU has exclusive competence in only a small number of areas, such as external trade relations.¹⁶ The Member States have exclusive competence in any areas where the EU does not have competence. In many areas, especially concerning the regulation of trade within the EU, the EU shares competence with its Member States.¹⁷

9.  Health protection, as defined in the TFEU, is a shared competence between the EU and its Member States.¹⁸ Health is also a ‘transversal’ area of EU law,¹⁹ cutting across the EU’s competences in several areas, such as internal trade, free movement of people, research and innovation, environment, and so on. The EU has rule-making powers for some aspects of health protection; many aspects remain a national competence.²⁰ Enforcement of EU law, including its health protection law, is predominantly a matter for national administrative and judicial authorities. Individuals may rely directly on some provisions of EU (health) law before domestic courts.²¹ Allocation of resources to healthcare systems is a domestic competence within the EU.²² The EU supports national healthcare systems in only relatively minor ways, for example, through funding biomedical and other health research,²³ through its regional and structural development policies,²⁴ or through the coordination of social security systems for intra-EU migrants.²⁵ In general, responsibility for responding to emergencies lies at the national level, but the EU also has an emergency power which applies ‘in particular if severe difficulties arise in the supply of certain products’.²⁶

10.  The EU’s response to the Covid-19 pandemic has not altered the basic ‘constitutional’ arrangements detailed above. The EU is considering its ‘constitutional’ structures through a process called the ‘Conference on the Future of Europe’,²⁷ and the European Commission has proposed a ‘European Health Union’.²⁸ However, the modesty of the Commission’s proposal²⁹ and the fact that the Conference’s Joint Declaration³⁰ mentions health just once suggest that, in all likelihood, neither will result in a significant change to the EU’s constitutional arrangements as a response to the pandemic. Either might result in modest adjustments to the EU’s powers in the health domain.

11.  The EU does not have competence to declare a constitutional state of emergency, in the sense of a normative act that extends powers or suspends provisions concerning the protection of basic rights, the operations of legislatures, and access to courts beyond what is possible and acceptable in normal times. The first formal step taken by the EU institutions was the European Commission’s DG SANTE opening an alert notification in the European Centre for Disease Prevention and Control’s (ECDC) Early Warning and Response System on 9 January 2020. ³¹ However, in response to Covid-19, the EU did adjust the procedural rules pertaining to its legislature and judiciary.

12.  Further details are in Part III below. In summary, new provisions within the European Parliament’s Rules of Procedure³² which allow for—and, in the case of the majority of Members of the European Parliament (MEPs) and staff, required—remote working, including debating and voting, were made under the President’s legal responsibility for the ‘security and integrity’ of Parliamentary premises.³³ The European Parliament held its first plenary with some MEPs present for the first time since March 2020 on 7 June 2021: most MEPs continued to join remotely. The Court of Justice of the European Union suspended all hearings on 16 March 2020, and extended the procedural time limits until 1 September 2021, although urgent proceedings continued.³⁴ Its ‘e-Curia’ system for electronic document submission was already in place,³⁵ and this supported the Court continuing to provide a judicial service through remote working. The CJEU physically re-opened in May 2020, with changes to its working arrangements concerning access to its buildings, with mandatory temperature checks; mask wearing; suspension of provision of gowns; and disinfection of tables, microphones, and earphones.³⁶

13.  The EU is a party to numerous international trade agreements; and also to some United Nations (UN) instruments, such as the Convention on the Rights of Persons with Disabilities. The EU’s common customs code allows the EU to impose export authorisations to prevent or remedy a critical situation ‘arising on account of a shortage of essential products’, a provision on which the EU relied to block Covid-19 vaccine exports in February 2021.³⁷ Whether this is consistent with the EU’s WTO obligations is less clear. Article XXI.2(a) of the General Agreement on Tariffs and Trade (GATT) permits ‘export prohibitions or restrictions temporarily applied to prevent or relieve critical shortages of foodstuffs or other products essential to the exporting contracting party’,³⁸ and Article XX GATT provides a more general human health exemption from GATT obligations.³⁹ The EU would presumably take the view that its Covid-19 response does not breach any of its WTO obligations. There is also the question of whether the EU might have breached either or both of the EU-UK Withdrawal Agreement⁴⁰ and the EU-UK Trade and Cooperation Agreement,⁴¹ again which the EU would presumably deny.

14.  The EU institutions refer consistently to the WHO’s 11 March 2020 declaration of Covid-19 as a global pandemic.⁴² The European Centre for Disease Control, an agency of the EU, draws on WHO epidemiological guidance in developing its policy recommendations for the EU. For example, its Technical Report of 17 March 2021, ‘Introducing a coherent European framework for tuning Covid-19 response measures’,⁴³ relies on WHO epidemiological thresholds to establish a series of proposed ‘tiers’ based on Covid-19 cases and deaths, and estimates a ‘contact budget’, to demonstrate how much latitude each Member State has to lighten Covid-19 response measures without shifting to a more negative tier, or how much needs to be done to achieve a more positive one.

15.  The EU’s Treaties (its ‘constitution’)⁴⁴ provide for two types of legislative provisions to be adopted by the EU legislature: Regulations—usually a legislative, not a delegated executive act—and Directives. However, delegated and implementing acts can also take the form of a regulation, eg a Commission Delegated Regulation (see further Part II.C below).

16.  The EU’s Health Security Committee, established informally in 2001 and formalised in 2013,⁴⁵ consisting of representatives of the health ministries of all Member States, with Iceland, Lichtenstein, Norway, Serbia, and Turkey as observers, began to discuss the emerging situation on 17 January 2020,⁴⁶ and continues to do so to date (January 2022). The European Commission established a Covid-19 response team on 2 March 2020,⁴⁷ to coordinate the various EU activities and policies to tackle the pandemic. But the EU legislature has not formally declared a public health emergency nor has any new general EU law been introduced to respond to the Covid-19 pandemic: indeed, the EU does not have competence to do so. The European Commission does have an executive power to ‘recognize a situation of public health emergency’,⁴⁸ but only where the WHO has not yet done so in accordance with the international health regulations. Instead, existing competences and pre-existing legislation has been applied, for example, where the legislation provides for public health exceptions or flexibilities, or built upon, for example, where the legislation enables further legislative or executive acts. In general, this approach has been supported by all relevant stakeholders. However, there are instances of opposition, for example litigation arguing that the EU has used the pandemic to unlawfully extend its competences.⁴⁹ For example, the outcome of the European Commission’s initiation of infringement proceedings under Article TFEU against Germany, on 9 June 2021, for the decision in the Bundesverfassungsgericht in the Weiss case is likely to have a bearing on such Covid-19 litigation concerning EU competence.⁵⁰

17.  In the constitutional system of the EU, rule-making power in the form of non-legislative but legally binding acts may be formally delegated to the European Commission.⁵¹ These acts are used to either supplement and/or amend non-essential parts of legislative acts, known in EU law as ‘delegated acts’, or ensure the uniform implementation of EU law, known in EU law as ‘implementing acts’.

18.  The EU’s heterarchical relationships with its Member States, especially as embodied in its ‘comitology’ processes, which were established by EU legislation,⁵² are an important feature of accountability for some executive acts of the EU institutions (see Part I above).⁵³ Formal and binding legal acts of the EU institutions are judicially reviewable before the CJEU, at the suit inter alia of the Council and European Parliament (two of the three institutions that comprise the EU legislature, see Part I above).⁵⁴ Moreover, national courts may raise questions of interpretation or validity of acts of the EU institutions and bodies by referring questions to the Court of Justice using the preliminary ruling procedure.⁵⁵ The European Ombudsman is also part of the landscape of accountability for EU executive rule-making (see Part III.G below).

19.  In a crisis like the Covid-19 pandemic, the EU executive—in the form of the European Commission, but also the European Council and other bodies, such as EU agencies—plays an important role. Generally, the EU executive steered the EU through the pandemic, and few measures were adopted by the legislator via the ordinary legislative procedure. Instead, many responses adopted by the European Commission as the EU’s main executive arm took the form of non-legislative but legally binding acts and soft law (see Part II.D below). Where EU agencies are involved, such as the European Medicines Agency (EMA), formally speaking the European Commission takes the formal executive act, on the basis of a Recommendation by the EU agency. Key examples of such acts of delegated executive power used to respond to Covid-19, include the following. The Commission took measures to implement EU legislation like the EU’s Digital Covid-19 Certificate Regulation,⁵⁶ by establishing the technical specifications for the Certificate in an implementing act (see further Part IV.A.2 below).⁵⁷ The Commission took measures implementing the various elements of the way in which the EU contributed to steering Covid-19 economic recovery, in general or in specific sectors such as the transport sector (see further Part V below). The EU used executive acts to adjust market-structuring rules such as trade or State aids rules in response to the pandemic (see further Part V below). The Commission took Implementing Decisions to authorise Covid-19 vaccines (see further Part IV.A.8 below).⁵⁸

20.  Like in previous crisis situations, such as the financial crisis⁵⁹ or the migration crisis,⁶⁰ the European Council—the meeting of Heads of State or Government—determined the political directions for the EU’s response to the crisis and also the economic recovery measures.⁶¹ However, the European Council’s role has been more concerned with the establishment of political consensus and providing the programmatic guidelines for the EU’s action than with actual executive rule-making.

21.  In the overwhelming majority of instances, the EU’s response to the Covid-19 pandemic was given shape by soft law measures.⁶² The EU’s Treaties provide for two types of non-binding measures to be adopted by the EU institutions: Recommendations and Opinions.⁶³ However, many other forms of soft law, such as Communications or Guidelines, are also adopted by EU institutions and bodies.⁶⁴

22.  Non-binding measures were used to provide guidance to the Member States and coordinate the national Covid-19 responses in accordance with EU law. These included some policy-specific instances, for example, Council Recommendations and Commission Communications were used extensively in the context of travel restrictions in the EU. Soft law was also extensively used by the EU institutions to adopt more general coordinating measures. There are seven such instruments: the Joint European Roadmap towards lifting COVID-19 containment measures,⁶⁵ and the Communication on Short-term EU health preparedness for COVID-19 outbreaks,⁶⁶ Communication on additional COVID-19 response measures,⁶⁷ Staying safe from COVID-19 during winter,⁶⁸ A united front to beat COVID-19,⁶⁹ A common path to safe and sustained re-opening,⁷⁰ and Addressing together current and new COVID-19 challenges.⁷¹

23.  The legitimacy of the extensive use of soft law is by no means uncontested.⁷² The perceived downside of guidance and other soft law measures is that they do not create legally binding obligations, therefore, their efficiency in coordinating Member State actions is dependent on the political will of the Member States.⁷³ Thus, wherever an EU institution or body adopted a Recommendation, Guideline, or other type of non-binding measure, this does not automatically mean that this measure was followed by the Member States. The Commission’s more general Communications aimed at coordinating the Member State responses (described in the previous paragraph), in general are worded carefully in terms of recommending actions and pointing to the different epidemiological situations of the Member States. Exceptions are the Communications on Staying safe from COVID-19 during winter⁷⁴ and the Addressing together current and new COVID-19 challenges,⁷⁵ which use language that borders on imperative or is directive in tone, with statements such as ‘decisions must be taken in a coordinated and targeted manner’,⁷⁶ ‘in the current epidemiological context in the EU, it is difficult to justify lifting control measures’,⁷⁷ ‘[t]he Commission strongly encourages Member States to consider this guidance’,⁷⁸ ‘Member States need to have booster campaigns immediately in place’,⁷⁹ ‘should rapidly deploy booster doses’,⁸⁰ ‘vaccination efforts must be continued’,⁸¹ and ‘Member States must … coordinate restrictions for all types of travel into the EU+’.⁸²

24.  Finally, as discussed more extensively in Part IV below on the public health measures imposed and Part VI below on human rights and vulnerable groups, EU agencies, particularly the ECDC, have provided extensive scientific guidance that informed the EU and Member State response, especially in terms of non-pharmaceutical interventions.

25.  The EU is thus responsible for developing a dense web of guidance for its Member States, which seeks to coordinate national law and policy, especially so as to protect the fundamental values of the EU, in particular: free movement, but also human rights such as data protection and the GDPR (see Part VI.B below);⁸³ to steer national decision-making; and to support mutual learning through the creation and analysis of comparative datasets. Even where the EU institutions could have used ‘hard’ law, they did not always do so. Instead, the EU institutions have developed a strong sense of the ‘EU science’, which covers population indicators (viral circulation including of vaccine-resistant variants and vaccination coverage); individual indicators (age over 60 years, pre-existing medical conditions listed non-exhaustively, negative rapid antigen test, previous infection, or vaccination status, distancing, and respiratory and hand hygiene); and situational indicators (outdoors versus indoors, distribution of people, ie crowds and moving or seated, and scale and effect on contract tracing), all of which are necessary when making law or policy in response to the Covid-19 pandemic. The EU’s guidance also steers its own law and policy. We are not aware of any instances where the EU’s ‘hard law’ deviates in any significant respect from the EU’s guidance or advice.

26.  The EU may be conceptualised as a multi-level system of governance. It operates through its own institutions, but its legally binding Regulations, Directives, Decisions, and general principles of EU law are given effect by the institutions of its Member States. Like other international organisations, the EU also deploys a range of soft law measures which are persuasive only, but can have an effect on national law and policy decisions. For discussion of the ways in which the provisions covered in this report were implemented in the EU Member States, and institutional oversight of such implementation, readers should consider the relevant country reports, even if they are not explicit about the EU as the source of or inspiration for a legal or policy decision. This report concentrates on the EU-level.

27.  In considering how the EU legislature supervises the EU executive, we need to understand how the EU legislature is formed, and the relationships between the EU institutions when they act as a legislature and when they exercise executive powers. Formally speaking, the basic EU legislative process involves the European Commission proposing legislation, and Parliament and Council acting as co-legislature. In practice, informal relations tend to have a constraining effect on the Commission’s willingness to propose legislation unless it believes it will enjoy sufficient support from the other legislative institutions. The EU legislature is constrained by the formal competences given in the Treaty on European Union and Treaty on the Functioning of the European Union, and may not lawfully extend its own powers, including powers to delegate its own decision-making. This is a complex area of EU law, because in practice the formalist approach of the CJEU to delegated rule-making, first articulated in the 1950s,⁸⁴ has been significantly modified.⁸⁵ Amendments to EU competence—as opposed to reinterpretations of EU competence—must take place through reform of the Treaties, which involves the agreement of each Member State, in accordance with its constitutional requirements. The EU’s competence rules thus play a role in constraining EU executive power.

28.  Where EU legislation grants specific delegated power to take executive acts within the EU’s ‘constitutional’ arrangements, the executive power is formally granted to the European Commission. That power may be removed at any time by the EU legislature. The European Commission may not formally extend its own powers, although of course the Commission has significant discretion in adopting the often quite technical and detailed executive measures and interpreting its delegated powers broadly. However, the key constraint on executive rule-making in the EU is a matter of process and institutional design. In most important instances, the Commission must act through a set of structures and procedures known as ‘comitology’ (see also Part II.C above).⁸⁶ The effect of these structures is to ensure national executive control over the EU’s decision-making processes, as the committees are made up of a representative from each Member State, although they are chaired by the European Commission. Acting largely through the comitology procedure (for instance, in allocating grants under a specified amount) the European Commission may take ‘implementing acts’, which ensure the detail of EU law is implemented uniformly across the Member States—although in some instances the enabling legislation permits the European Commission to take implementing acts without using the comitology procedure. Where the European Commission is granted power to adopt binding acts that either supplement and/or amend non-essential parts of legislative acts (‘delegated acts’), the comitology procedure does not apply, but the Parliament or Council may raise objections within a short time frame (usually two months) after the act is adopted.

29.  In addition to those oversight mechanisms, in theory, the European Parliament can terminate the powers of the European Commission as a whole as co-legislature by adopting a motion of censure (vote of no confidence). A censure requires a two-thirds majority of the votes cast, representing a majority of Members of the European Parliament.⁸⁷ In practice, this power has never been exercised, although the European Parliament has rejected proposed Commission candidates at the approval stage.⁸⁸

30.  The European Parliament also has formal oversight over Commission Decisions through judicial review proceedings.⁸⁹

31.  In terms of more persuasive modes of oversight, the European Parliament has power to adopt non-binding resolutions, expressing views on actions of the other EU institutions, and calling on them to take further action.⁹⁰ Acting by a simple majority, the European Parliament may request the Commission to propose legislation or other acts where required to implement the Treaties.⁹¹ As far as we are aware, the European Parliament has not used these powers to extensively steer Covid-19-related action of the other legislative institutions, but the Parliament has indicated support for relevant Commission initiatives, such as the proposed new pharmaceutical strategy for Europe.⁹²

32.  The European Parliament, Council, and Commission continue to function, in modified ways, during the Covid-19 pandemic.

33.  The European Parliament’s business was significantly disrupted in spring 2020. A plenary session took place in late March 2020, but with only one debate, three voting sessions, and 11 votes. By October 2020, it was possible for the plenary sitting to include 18 debates, 13 voting sessions, and over 1,500 votes. From 19 March to end November 2020, a quickly-arranged remote system involving the Parliament’s translation service was used for over 1,500 meetings.⁹³ In November 2020, because of the rapidly deteriorating position in Belgium, France, and Luxembourg, all parliamentary business took place remotely.⁹⁴ Parliament deployed its liaison offices, situated across the EU to enable continued remote participation of MEPs.⁹⁵ The arrangements for plenary parliamentary meetings originally allowed only entirely in-person or entirely online meetings,⁹⁶ but hybrid plenary sessions were held from October 2020.⁹⁷ Many MEPs continued to participate remotely in parliamentary committees, which allowed for meetings with some MEPs present and some attending online, when the European Parliament reopened in early June 2021.

34.  The European Parliament amended its Rules of Procedure⁹⁸ in December 2020⁹⁹ to add a new Title (XIIIa) on ‘Extraordinary Circumstances’. The changes were adopted nem con by the European Parliament’s 25-member pre-existing Committee on Constitutional Affairs. The new rules apply where the President determines, on the basis of reliable evidence, that for ‘reasons of security, or safety, or as a result of the non-availability of technical means it is, or will be, impossible or dangerous for Parliament to convene in accordance with its usual procedures’.¹⁰⁰ Special provisions apply to permit remote participation of MEPs using information technology, where the political balance in Parliament is severely impaired because a significant number of MEPs cannot take part in parliamentary proceedings because of safety or security, including occurring in a regional context.¹⁰¹ The remote participation regime is outlined in Rule 237c, and includes ensuring that MEPs continue to be able to speak in both plenary and committees, to table texts and to vote.¹⁰² MEPs who are participating remotely are included in a quorum count. To ensure physical distancing, several meeting rooms may essentially be deemed to be a parliamentary chamber.¹⁰³ As in every workplace, changes to working practices in the European Parliament changed the nature of interactions between MEPs, staff, and ‘visitors’ (including stakeholders representing various interests), and affected how they conducted their work, including legislative activities and scrutiny of executive acts.¹⁰⁴ A legal challenge seeking interim relief for the decision of the Bureau of the European Parliament, of 27 October 2021, making access to the Parliament buildings in Brussels, Luxembourg, and Strasbourg conditional on the presentation of an EU Digital Covid-19 Certificate¹⁰⁵ (see further Part IV.A.2 below) was, however, unsuccessful on the grounds of lack of urgency.¹⁰⁶

35.  Time limits for the ‘European Citizens Initiative’, whereby EU citizens may petition Parliament,¹⁰⁷ were adjusted.¹⁰⁸

36.  From 10 March 2020, the European Council (meetings of Heads of State of the Member States) was meeting by videoconference, as were other European Council configurations. Videoconferencing for some meetings continues to date, as at end December 2021,¹⁰⁹ although the European Council met in person in Brussels on 24—25 June 2021 and in person meetings have been held regularly since then. The European Council adopted a first formal Decision temporarily derogating from its normal rules of procedure in March 2020.¹¹⁰ This Decision has been regularly updated.¹¹¹ It allows COREPER—the ministerial arm of the European Council that carries out the its day-to-day business—to continue under circumstances where members are unable to travel to meetings.¹¹² In March 2021, the European Ombudsman called on the European Council to improve transparency of its decision-making under Covid-19 procedures (see further, Part III.G below).¹¹³

37.  The European Commission amended its Rules of Procedure to permit remote teleworking and formal virtual meetings on 22 April 2020.¹¹⁴ The aim of the amendment was to ensure continued smooth running of the Commission’s decision-making processes. Remote working practices and virtual meetings were also put in place for the EU’s regulatory agencies. For example, the European Medicines Agency announced on 30 March 2020 that it would replace printed medicines licenses with electronically signed and authenticated certificates, so as to maintain the medicines licensing process through the pandemic.¹¹⁵

38.  The Court of Justice and the General Court continued to operate during the pandemic. On 19 March 2020, the CJEU announced, via its website, temporary changes to its working arrangements, giving priority to urgent, expedited, and interim proceedings.¹¹⁶ Listed hearings were adjourned. Prescribed time limits for proceedings were extended until 1 September 2021.¹¹⁷ Documents continue to be formally filed and served through ‘e-Curia’, a system which pre-dates the Covid-19 pandemic.¹¹⁸ Parties who are unable to travel to Luxembourg are permitted to attend the oral stage of a hearing by videoconference. As far as we are aware, no formal complaints have been raised about these arrangements. Some oral hearings are replaced with written proceedings only. These arrangements to not appear to have negatively affected access to justice before the CJEU.¹¹⁹

39.  European Parliament elections were held in May 2019, just under a year before potent public health interventions began to be taken throughout Europe. MEPs are elected for a five-year period. Some new MEPs have been elected during the pandemic,¹²⁰ because sitting MEPs resigned in order to take up national office. Elections to the European Parliament take place according to national rules and procedures: for further details on these, see the relevant country reports.

40.  The EU Treaties formally oblige the EU legislature and/or executive to ‘strengthen its scientific and technological bases’ through a ‘European research area’,¹²¹ and to base its environmental policy on the precautionary principle, taking account of available scientific and technical data.¹²² The precautionary principle is a ‘general principle’ of EU law,¹²³ with which all EU legislation—including in the public health domain—is presumed to comply, although whether the EU’s courts appropriately scrutinise such compliance by the EU is contested.¹²⁴ Other than this, there is no general obligation on the EU to make decisions based on scientific advice.

41.  The role of scientific advice is deeply embedded in practice where the EU institutions, especially the CJEU, scrutinise national administrative or other actions for compliance with EU law.¹²⁵ Scientific advice is especially relevant where the CJEU scrutinises national laws, policies, or activities which could have the effect of protectionist exclusions of actors from other Member States from access to the market. The EU’s complex acquis on free movement,¹²⁶ for instance, recognises ‘public health’ as a legitimate ground for national measures impeding access of products, persons, or services across the EU’s internal borders.

42.  The European Centre for Disease Control, established in 2004,¹²⁷ is a non-regulatory agency of the EU charged with information gathering, analysis, and dissemination of threats to human health from communicable diseases. It is bound by transparency obligations.¹²⁸ The agency is formally-speaking independent from the EU legislature and executive, but is best understood as the hub for a network of national communicable disease entities, rather than a free-standing entity.¹²⁹ This configuration reflects the heterarchical nature of EU law and policy-making, where decisions are taken through institutional structures where Member States’ expertise and interests are represented. Although an attempt is made through the ECDC to define ‘public health’ scientifically, and implicitly neutrally, in practice, the EU managed the scientific uncertainties surrounding Covid-19 by both articulating an EU notion of ‘the science’—primarily through the ECDC, which itself works closely with national entities and also with the WHO—and at the same time respecting national scientific assessments.¹³⁰

43.  Further, in many areas where the EU has competence, regulatory decision-making is formally required, by the relevant enabling legislation, to take place on the basis of scientific advice. An example is Decisions taken by the European Commission, on the basis of the European Medicine Agency’s advice, to grant an EU marketing authorisation for medicines.¹³¹ EMA evaluations must provide the EU institutions and the Member States with ‘the best possible scientific advice’.¹³² This advice must be published, subject to redaction of commercially confidential information.¹³³ Members of the EMA’s formal committees are appointed by the governments of the Member States,¹³⁴ and the committees may co-opt additional members on the basis of their scientific competence.¹³⁵ Although the EMA opinion is not binding on the Commission, occasions where the EMA opinion is not followed are extremely rare, and the Commission has to provide a detail explanation for the differences.¹³⁶

44.  The EU institutions have no obligation to follow ‘independent’ scientific advice outside of the regulatory and agency structures described above.

45.  Freedom of the press is a national, rather than EU, competence, although the EU’s Charter of Fundamental Rights—a formal part of the EU’s founding Treaties—requires that ‘the freedom and pluralism of the media shall be respected’.¹³⁷

46.  All EU institutions, agencies, offices, and bodies are formally required to ‘conduct their work as openly as possible’.¹³⁸ EU citizens and residents have a right of access to documents of the EU institutions.¹³⁹ We were unable to find evidence of significant interruptions to access to documents during the pandemic. The regime is covered by a Regulation (primary law) of 2001.¹⁴⁰ Transparency of EU decision-making concerning the pharmaceutical industry has long been a point of contention. The Covid-19 pandemic exacerbated pre-existing tensions, especially concerning access to clinical trial data, where the industry seeks to protect what it regards as commercial secrets, but public health and risk regulation imperatives suggest that openness would secure better decision-making and greater public confidence. The question of whether the global pharmaceutical industry is sufficiently transparent has been widely discussed for decades in literature on global and national medical/health law, the pharmaceutical industry, and risk regulation.¹⁴¹ In general, the EMA has been willing to publish data, especially concerning Covid-19 vaccines, on the basis of the need to secure public confidence (see Part III.G below).

47.  The European Ombudsman is elected by the European Parliament, and investigates complaints of maladministration in the EU’s institutions and agencies, brought either on its own initiative, directly by citizens, or by an MEP on their behalf.¹⁴² The European Ombudsman is also obliged to report to the European Parliament on an annual basis, on the outcomes of its inquiries.¹⁴³ The European Ombudsman has no formal power to require compliance, but relies on persuasion and publicity. It is regarded as an effective example of an Ombudsman model.¹⁴⁴

48.  The European Ombudsman responded to complaints about lack of transparency of the EU’s response to the pandemic, both in general,¹⁴⁵ and in specific instances. One area of concern is transparency of vaccine purchase. An inquiry into the failure of the European Commission to disclose the terms on which the EU purchased vaccines was closed on 12 May 2021,¹⁴⁶ after the European Commission released redacted documents. Further inquiries concerning a text message exchange about vaccine purchase,¹⁴⁷ and access to documents related to the purchase of the BioNTech Pfizer vaccine,¹⁴⁸ are ongoing as at 14 January 2022.

49.  A second area concerns transparency of risk regulation decisions about Covid-19 vaccines. An Ombudsman inquiry,¹⁴⁹ which concluded on 10 November 2021, concerned the EMA’s refusal to release information on the manufacturing process and the composition of the mRNA Comirnaty and Moderna vaccines. This ‘Module 3’ of the marketing authorisation application includes information on the raw materials used to manufacture the vaccine, their quantity, and their concentration. It is, in essence, a ‘road map’ to making the vaccines. The Ombudsman found no maladministration, on the basis that a public health or other ground did not displace the need to protect the commercial interests of the manufacturers. The Ombudsman also noted with approval that the EMA had proactively published non-clinical and clinical data about the safety and efficacy of the mRNA vaccines (‘Modules 4 and 5’ of the marketing authorisation application).

50.  The Ombudsman conducted an own-initiative inquiry about transparency of the ECDC’s work,¹⁵⁰ focused in particular on the early stages of the pandemic (January–April 2020). The Ombudsman praised the ECDC for its approach in general, but found some room for improvement, especially in terms of information flow from the Member States to the ECDC, and the ECDC’s capacity to communicate with the general public, pointing out that ‘crises not only require extraordinary responses from public administrations, but also extraordinary efforts to maintain public trust’.¹⁵¹ The Ombudsman is playing a key role in securing and/or encouraging a new mode of ‘proactive transparency’¹⁵² of data supporting executive decisions in response to Covid-19. At the same time, it is calling for the ECDC’s formal powers to be enhanced. The Ombudsman’s calls for increased ECDC capacity and formal powers will feed into broader discussions about a ‘European Health Union’ and the ‘Conference on the Future of Europe’ (see Part I above).

51.  The European Union’s responses to the Covid-19 pandemic were constrained by the formal legal competences of the EU institutions, as well as by the lack of political will among Member States, especially initially, to act collectively rather than individually at national or sub-national/regional level.¹⁵³ Many relevant public health measures were taken by each Member State acting alone, and are discussed in the relevant country reports, rather than in this report, which focuses only on EU-level action. The EU’s general approach may be characterised as strongly focused on coordination and sharing of information and scientific advice; partnership and collaboration with Member States, drawing on the benefits of economies of scale. The EU adopted few legally binding public health measures that harmonise national level responses, mainly in the context of the internal market, and mostly relied on guidance and other forms of soft law. This narrow approach to the EU’s competence has been the subject of criticism.¹⁵⁴

52.  In the EU’s multilevel governance system, many public health measures are a matter of national, or sub-national, competence. The EU’s role has, in general, been to provide advice, guidance, and to recommend, rather than to adopt binding measures. The European Commission’s guidance also seeks to support the well-functioning of the EU’s ‘internal market’, an area within which products, services, people, and capital are permitted to move with minimum hindrance. The internal market is profoundly challenged by many public health measures put in place to combat Covid-19, especially those curtailing freedom of movement for human beings.

53.  The European Commission adopted several general Communications to coordinate the public health measures adopted by the Member States (see Part I above). In April 2020, the Commission, together with the European Council, published the Joint European Roadmap towards lifting COVID-19 containment measures (‘Roadmap’) providing recommendations to the Member States, applicable since 17 April 2020.¹⁵⁵ The Roadmap was concerned with providing a common framework for the lifting of Covid-19 containment measures such as travel bans, prohibitions of gatherings/events, national restrictions on movement, or the closure of non-essential shops or schools. It can be seen as a benchmarking exercise, within which Member States exercise their public health powers.¹⁵⁶ The Roadmap presents a set of three criteria—epidemiological evidence showing a decrease in spread of the disease, sufficient health system capacity, and appropriate monitoring capacity in terms of testing—to be taken into account by the Member States when they decide about the relaxation of public health measures in the context of the Covid-19 pandemic. It stresses the individual decision-making power of the Member States, meaning that it is recognised that the detailed measures will differ and that relaxation of measures will appear at different points in time. However, the Commission and the European Council emphasise, as guiding principles, actions based on science, coordination of the measures, and their notification to other Member States and the Commission, as well as respect and solidarity between the EU’s Member States.

54.  However, the EU has very little competence to adopt legally binding harmonising measures that would directly affect the legal situation of individuals, especially where non-pharmaceutical responses to the pandemic are concerned. Yet, the role of the EU in providing scientific and technical guidance to the Member States, in an attempt to coordinate national measures, prevent disruption of the functioning of the internal market, and enhance the efficiency of the Covid-19 response measures adopted on national level, should not be underestimated. The EU’s agencies, especially the European Centre for Disease Prevention and Control, have offered a vast amount of guidance based on their assessment of the scientific evidence. The European Commission also sought to coordinate scientific guidance, through a ‘scientific advice platform’ bringing together scientific advisors to national governments of the EU Member States, which has been meeting once or twice a month since October 2020.¹⁵⁷ Moreover, the Health Securities Committee offered a platform for discussion and coordination amongst Member States. Nonetheless, given the mostly non-binding form of the measures discussed below, it is important to note that guidance adopted at EU-level was not necessarily used or followed at national level. Whether it was followed should be assessed on the basis of the individual country reports.

55.  The EU is not competent to engage in the restriction of individual mobility by imposing stay-at-home orders or curfews. Where stay-at-home orders restrict the free movement of persons within the EU, they are discussed in the following section. However, in an effort to support and coordinate the non-pharmaceutical responses, the Commission also addressed individual mobility restrictions in its more general policy guidance documents.

56.  In July 2020, the Commission, pointing to the economic as well as social costs and the impact on the free movement of people and goods, called on the Member States to ‘avoid large-scale lockdown measures’ in favour of ‘targeted and localised medical countermeasures’.¹⁵⁸ However, the risks were evaluated differently in the winter of 2020, when, before the festive season, the Commission adopted its Communication on Staying safe from COVID-19 during winter, in which it ‘strongly encouraged’ the Member States to maintain or introduce curfews,¹⁵⁹ together with other measures, discussed in the following sections.

57.  Importantly, the ECDC has continuously provided scientific advice on non-pharmaceutical responses to the pandemic. While the ECDC Guidelines for the use of non-pharmaceutical measures from February 2020 had not yet included stay-at-home orders as potential measures,¹⁶⁰ at the end of March 2020, when the majority of EU countries had implemented stay-at-home policies (voluntary or enforced) as a response to the drastically increased infection rate, the ECDC provided guidance on considerations to take into account when adjusting and lifting stay-at-home orders.¹⁶¹ In September 2020, the ECDC stated that ‘[s]tay-at-home measures are a last-resort option due to their significant impact on both society and individuals. Targeted implementation, both geographically and temporally, is preferred and can be considered to control outbreaks which are not responding to other measures. Available evidence does not prove that stay-at-home measures are more effective than other measures, such as the closing of (some) high-risk businesses.’¹⁶² In March 2021, the ECDC published a framework for fine-tuning non-pharmaceutical responses which can serve as a guide to Member States seeking to adjust their Covid-19 response measures, including the introduction or lifting of stay-at-home orders and curfews.¹⁶³

58.  The free movement of persons is one of the four freedoms of the EU’s internal market and a core ‘constitutional’ value of the EU deeply intertwined with EU citizenship.¹⁶⁴ It is not surprising, therefore, that restrictions on intra-EU travel, as well as on travel into the EU from third countries imposed by the Member States, often combined with the reintroduction of border control measures within the EU, became a core concern in the EU’s Covid-19 response.

59.  In principle, EU citizens may move freely within the EU. The power to restrict the free movement of persons within the EU on a narrow list of public interest objectives, and to limit the entrance of third country citizens into the internal market on the basis of public health, lies with the Member States, subject to compliance with EU law and potential judicial control by the EU.¹⁶⁵ Where Member States introduce measures limiting the free movement of persons, as they did during the Covid-19 pandemic based on the justification of public health protection, these measures must be proportionate and are subject to procedural safeguards as laid down in Directive 2004/38 on Citizens Rights.¹⁶⁶ Many of the EU measures discussed in the following have as their aim to provide a framework for assessing the proportionality of national measures by providing harmonised criteria on when travel restrictions should be maintained or lifted.

60.  Specifically with regard to the reintroduction of border controls, for those Member States within the Schengen arrangements, the Schengen Borders Code is also relevant.¹⁶⁷ Currently 22 of the EU Member States, as well as Iceland, Norway, Switzerland, and Liechtenstein, are part of the Schengen Area—Member States that are not part of the Schengen Area are Bulgaria, Croatia, Cyprus, Ireland, and Romania—which abolished border controls, but provides the possibility for countries to exceptionally and temporarily reintroduce border controls in case of a serious threat to public policy and internal security,¹⁶⁸ which is deemed to also include the ‘risk posed by a contagious disease’.¹⁶⁹ Notably, the Schengen Borders Code itself does not expressly mention public health as a reason for the reintroduction of Border Controls. The reintroduction of border controls must be notified to the other Schengen members and the Commission, while simultaneously informing the European Parliament and the Council.¹⁷⁰

61.  In March 2020, almost all EU Member States introduced measures that closed their borders and reintroduced border controls,¹⁷¹ restricting the free movement of persons within the EU and travel from third countries into the EU, in a diverging and inconsistent manner in terms of the scope of the measures.¹⁷² These uncoordinated and diverging national measures triggered a response on the EU level aiming to coordinate travel restrictions and facilitate the free movement of EU citizens to the largest extent possible. These response measures were mostly adopted as non-binding soft law—Commission Communications and Guidelines, Council Recommendations, and technical/scientific guidance of EU agencies and expert bodies. This use of soft law measures is in itself remarkable, because in the area of free movement of persons the EU has far reaching legislative competence and could use mechanisms such as the infringement procedure to guard a core value such as free movement of EU citizens against unjustified interference.¹⁷³ Therefore, the legality of the reintroduction of border controls and travel restrictions for citizens within the EU is by no means undisputed.¹⁷⁴ Yet, although instruments like Council Recommendations are not legally binding instruments and depend on the implementation of Member States, especially in the context of the travel restrictions within the EU, at least according to some commentators, they proved to be effective measures to coordinate national restrictions.¹⁷⁵

62.  As an initial measure on 16 March 2020, the European Commission adopted a Communication to the European Parliament, European Council, and the Council on COVID-19: Temporary Restriction on Non-Essential Travel to the EU,¹⁷⁶ calling on the European Council to adopt a coordinated decision concerning the temporary restriction of non-essential travel from third countries into the EU, as measures by individual Member States are ineffective to control the EU’s external borders. At this time, the Commission was still of the view that closing the EU’s external borders would facilitate lifting travel restrictions within the EU. The Commission recommended the temporary restriction of non-essential travel from third countries into the EU for 30 days, with potential prolongation after assessment. The Communication made clear that citizens of EU Member States as well as Schengen Associated States (Iceland, Liechtenstein, Norway, and Switzerland) when returning to their homes must be exempted. This exemption also applied to their family members, as well as long-term residents under Directive 2003/109/EC,¹⁷⁷ as well as other persons who derive a right of residence from EU law, Member State national law, or national long-term visas. Rather than defining non-essential travel, the Communication provided a non-exhaustive list of essential functions and needs, which included: (i) healthcare professionals, health researchers, and elderly care professionals; (ii) frontier workers; (iii) transport personnel engaged in haulage of goods and other transport staff to the extent necessary; (iv) diplomats, staff of international organisations, military personnel, and humanitarian aid workers in the exercise of their functions; (v) passengers in transit; (vi) passengers travelling for imperative family reasons; and (vii) persons in need of international protection or for other humanitarian reasons. Terms like ’imperative family reasons’ were not further defined in the Communication. The Commission Communication of 16 March was phrased as a (non-binding) recommendation to the European Council, calling on the Heads of States or Government of the Schengen Member States to adopt these measures in coordination with the Schengen Associated States.

63.  On the same day, the Commission adopted Guidelines for border management measures to protect health and ensure the availability of goods and essential services,¹⁷⁸ in order to establish common principles for border management, calling on the Member States to ensure that their border control measures do not interrupt the supply of essential goods (via so called ‘green lanes’) and to maintain the free movement of goods and supply chain integrity.¹⁷⁹ The guidance also proposed measures for the external border, calling on the Member States to put in place screening measures for travellers. For the internal EU borders, the guidance states that it would be acceptable for Member States to ‘reintroduce temporary border controls at internal borders if justified for reasons of public policy or internal security’.¹⁸⁰ However the measures must be proportionate, non-discriminatory, and based on the health of the individual. Thus, although the guidance constitutes soft law, it reminds the Member State to act within the legally binding procedural rules applicable to the adoption of such measures under EU law.¹⁸¹

64.  On 30 March 2020, following up on this Guideline, the Commission adopted Guidelines concerning the exercise of the free movement of workers during COVID-19 outbreak for frontier workers, posted workers, and seasonal workers, especially those exercising critical occupations,¹⁸² advocating a coordinated EU approach to ensuring that these persons can continue to cross borders, but at the same time leaving room for health screening under the same conditions as for nationals working in the same professions.

65.  In April 2020, the Commission published the Joint European Roadmap towards lifting COVID-19 containment measures,¹⁸³ applicable since 17 April 2020. In terms of travel restrictions, the Roadmap advocates a staged approach of first lifting internal border measures unilaterally adopted by the Member States in a coordinated manner when the epidemiological situation permits, placing priority on ensuring the free movement of cross-border workers and service providers. Opening of external borders and lifting of travel restrictions for non-EU residents was envisaged in a second stage. The Roadmap makes reference to various adopted or planned guidance measures. It was supplemented by a ‘Tourism and Transport Package’ aimed at introducing a phased approach towards reopening travel and supporting the tourism and hospitality sector.¹⁸⁴

66.  In the following adoption of measures in terms of travel restrictions, the EU adopted a bifurcated approach, on the one hand, addressing the restrictions on travel and the free movement of persons within the EU, and on the other hand, adopting measures for the travel restrictions to be enforced against travellers from third countries at the EU’s external borders.

67.  After the initial disharmony in terms of uncoordinated and individually adopted travel restrictions by the Member States and the first steps towards more harmonisation via the European Roadmap, in October 2020,¹⁸⁵ the Council, acting upon a Commission proposal,¹⁸⁶ adopted its first Recommendation concerning travel restrictions as an attempt towards lifting the restrictions on free movement within the EU. The Recommendation aimed to provide a coordinated framework for the Member States upon which to base their decisions surrounding the adoption of travel restrictions or border control measures, to prevent a patchwork of different approaches throughout the EU. Central to the Recommendation is the establishment of common criteria on which the adoption of measures should be based: the 14-day cumulative case notification rate per 100,000 people; the test positivity rate; as well as the testing rate, ie the number of infection tests per 100,000. Data on these parameters is provided by the Member States to the European Centre for Disease Prevention and Control, which has attempted to harmonise national testing strategies (see Part IV.A.8 below). The ECDC subsequently processed the data and turned it into a weekly map showing the countries marked in green, orange, and red.¹⁸⁷ The criteria for a country to be a certain colour was laid down in the Recommendation, which on the basis of this categorisation proposed potential measures such as imposing a quarantine or testing for travellers. As a common threshold, it was agreed in the Council that the free movement of persons to or from green areas should not be restricted.

68.  In early February 2021, this Recommendation was amended, taking into account the start of the vaccination campaign and the increase in testing capacity, but also the spread of new, more infectious virus variants.¹⁸⁸ ‘Dark red’ was introduced as a new category to apply to areas with very high infection levels. Member States were called upon to discourage non-essential travel—as before, not explicitly defined in the Recommendation, which refers only to travellers with an essential function or need—to red and dark red areas. On 14 June 2021, the Recommendation was updated again, opening up the possibility for Member States to take into account factors like vaccination uptake and the prevalence of virus variants of concern or interest, in their decisions.¹⁸⁹ Most importantly, the update introduced changes to adapt the Recommendation for the entry into force of the EU Digital COVID-19 Certificate, exempting persons in possession of a Certificate from additional measures such as testing and quarantining. The Member States agreed on a standard duration of validity of test results, and determined when a person would be regarded as fully vaccinated and for how long persons will not be subject to restrictions because they recovered from a Covid-19 infection.

69.  The measures to coordinate Member State responses are supplemented by the EU with several tools that are meant to provide information to citizens about the epidemiological situation in various Member States via the ECDC and the Re-Open EU portal.¹⁹⁰ Through providing a basis for informed decision-making to travellers, the EU intends to facilitate travel and tourism as far as the situation in the Member States permits.

70.  Regarding the EU’s external borders and travel into the EU from third countries, the actions of the Member States were more coordinated from an earlier stage of the pandemic. After the Commission had recommended, on 16 March 2020, restricting non-essential travel into the EU for 30 days,¹⁹¹ the Heads of State or Government of the EU and the four Schengen Associated States agreed to implement the temporary restriction of non-essential travel in their respective States on the following day.¹⁹² What is sometimes referred to as the EU entry-ban was thus not initially based on a legally binding measure, but rather the coordination of Member State action by means of executive soft law in the form of a Commission Communication and an agreement within the European Council, leading to concerted national measures in the Schengen area.

71.  After several prolongations of the restrictions of travel into the EU recommended by the Commission,¹⁹³ the time had come in summer 2020 to move forward with a common strategy towards lifting the restrictions. The Council, upon proposal by the Commission,¹⁹⁴ adopted its first measure on the restrictions on non-essential travel into the EU on 30 June 2020,¹⁹⁵ asking the Member States to lift their restrictions on non-essential travel into the EU starting from 1 July 2020 for certain countries.¹⁹⁶ EU citizens and citizens of Iceland, Norway, Liechtenstein, Switzerland, and the United Kingdom, as well as their respective family members; long-term residents and their families; as well as people with essential functions such as healthcare workers or diplomats are exempted. The Recommendation contained a list of third countries in its annex for which the restrictions should be lifted and travel into the EU for their residents should be facilitated. This list is regularly updated through amendments. The Recommendation determined that third countries would be included in the list on the basis of epidemiological criteria, including the number of Covid-19 cases, also taking into account trends such as decreasing case numbers, as well as the overall response of the country in question in terms of testing and containment.

72.  The Recommendation concerning travel into the EU was amended on 20 May 2021. It aims to coordinate lifting of travel restrictions and quarantine requirements for fully vaccinated individuals travelling into the EU from third countries, as well as the lifting of restrictions for certain countries.¹⁹⁷ However, so that Member States could react swiftly to changing epidemiological situations or the occurrence of virus mutations, the measure contains an ‘Emergency Brake’ mechanism, leaving room for Member States to individually adopt rapid, temporary travel restrictions, subject to subsequent discussion and coordination at EU-level.

73.  The travel policies mentioned above were supplemented by the ECDC with scientific guidance, assessing the travel-related risks of Covid-19 transmission and giving consideration to potential responses.¹⁹⁸ The ECDC advised on quarantine and testing requirements, also in the context of the arising Covid-19 variants.¹⁹⁹ In cooperation with the European Union Aviation Safety Agency (EASA), the ECDC adopted an Aviation Health Safety Protocol which is regularly updated and also contains guidance on testing and quarantine.²⁰⁰ Travel by ship²⁰¹ and rail²⁰² also received attention from the ECDC.

74.  With regard to both travel within the EU and travel from third countries into the EU, the next big step towards a coordinated lifting of restrictions was made through the EU Digital COVID-19 Certificate, which should be placed in the context of the attempts to coordinate reestablishment of free movement within the EU and opening towards travel from third countries in view of the summer and vacation season of 2021.²⁰³ The Commission proposed two Regulations, one for a common EU certificate that attests Covid-19 vaccination, testing, and recovery for EU citizens and their families,²⁰⁴ and a second, complementary measure with a certificate for third-country nationals who are legally staying or residing in the EU.²⁰⁵

75.  The two measures were adopted by the European Parliament and the Council on 14 June 2021.²⁰⁶ The measures are applicable as of 1 July 2021 and, while the Commission proposal had foreseen the suspension at the end of the pandemic with a possibility to reactivate,²⁰⁷ it establishes a concrete end date for the applicability of Regulation 2021/953/EU on 30 June 2022 subject to potential prolongation through adoption of a legislative proposal, should this be required in the context of the Covid-19 pandemic.²⁰⁸ Regulation 2021/953/EU which establishes the EU Digital COVID-19 Certificate is adopted on the basis of Article 21(2) TFEU and thus applies to EU citizens and their families, whereas Regulation 2021/954/EU, based on Article 77(2)(c) TFEU and building upon the Schengen acquis, makes the certificate accessible to third country nationals legally staying and residing in the territory of the Member States, under the same conditions as EU citizens.

76.  Legally speaking, the certificate as introduced by Regulation 2021/953/EU is not required for persons to exercise their free movement rights.²⁰⁹ The core idea of the certificate is that the freedom of movement, without conditions like testing or quarantining, will be facilitated for persons who can prove that they have either been fully vaccinated with a vaccine centrally authorised in the EU under Regulation 726/2004/EU,²¹⁰ or have tested negative for Covid-19, or recovered from an infection. The issuing of the certificate is organised by the Member States. The individual Member States may also accept vaccines which were authorised on a national basis under Directive 2001/83/EC, temporarily authorised under Article 5(2) of Directive 2001/83/EC, or completed the WHO Emergency Use Listing procedure.²¹¹ The main concerns for the EU are that the certificate, which will be issued by the Member States, is interoperable and mutually recognised, as well as compatibility with data protection and privacy.²¹²

77.  Regulation 2021/953/EU also contains provisions on certificates issued by non-EU countries. According to Article 8(1) a person that has been vaccinated in a non-EU country with a centrally authorised vaccine—or, where accepted by the Member State, a vaccine authorised by another Member State or WHO Emergency Use listed vaccine—can request a Member State to issue an EU COVID-19 Digital Certificate. This provision allows third country certificates to be in effect translated into EU certificates, on an individual basis. Moreover, under Article 8(2) the Commission may, via the adoption of an implementing act, confirm that certificates issued by third countries are equivalent to the EU certificates issued by the Member States. The certificates issued by these countries are accepted in the EU under the same conditions as the EU certificate and vice versa. Via this option, by November 2021, 24 countries had joined the EU Digital Certificate system: Albania, Andorra, Armenia, Switzerland, Faroe Islands, Georgia, Israel, Iceland, Liechtenstein, Moldova, Monaco, Morocco, New Zealand, North Macedonia, Norway, Panama, San Marino, Serbia, Singapore, Togo, Turkey, Ukraine, THE United Kingdom, and the Vatican.

78.  The Digital EU COVID-19 Certificate is not uncontested, including because it makes the right of free movement conditional upon certification,²¹³ while access to testing and vaccination remains a national competence, and thus there is the risk of inequalities.²¹⁴ Moreover, as the certificate needs to be checked, it will lead to the de facto reintroduction of border controls within the EU. At the time of writing (January 2022), the Digital EU COVID-19 Certificate Regulation is subject to an ongoing act of annulment procedure at the General Court, challenging the Regulation as discriminatory against unvaccinated people and an unlawful restriction of their free movement rights.²¹⁵ A request for interim measures concerning the suspension of application of the Regulation was denied by the General Court.²¹⁶

79.  As with most non-pharmaceutical interventions, the EU has no competence to introduce limitations on public and private gatherings. Again, the role of the European Commission was to coordinate national measures as far as possible and make general policy recommendations in terms of Covid-19 response measures, supported by the scientific advice of the ECDC. The Member States remained free to follow this guidance or not, with no consequences in terms of their EU law obligations. Especially in preparation for winter 2020, the Commission called on Member States to maintain measures limiting social contacts, including closure of public places and limitations of the number of people for indoor and outdoor gatherings.²¹⁷ The Commission strongly encouraged Member States to consider: ‘not allowing mass gatherings and define clear criteria for exceptional events’, ‘defin[ing] clear criteria for small social gatherings’, ‘continu[ing] to set clear criteria for household gatherings’, ‘encourag[ing] the organisation of online social gatherings’, and it also recommended that ‘any temporary loosening of rules on social gatherings and events should be accompanied by strict requirements for people to self-quarantine before and after for a number of days (preferably at least seven)’.²¹⁸

80.  In terms of scientific guidance, early on in its rapid risk assessments, the ECDC not only discussed the risk level of the pandemic for the EU, but also provided countermeasures which it stressed were ‘necessary’. These included social distancing, including the cancellation of mass gatherings.²¹⁹ In February 2020, the ECDC found that the ‘cancellation of mass gatherings in the EU/EEA may be justified in exceptional cases’ and should be based on ‘a risk assessment, taking into consideration the severity of the epidemic, the local epidemiological situation, the timing, duration, type of venue (indoor/outdoor), the size of the event, and the area the attendees are coming from (affected or non-affected).’²²⁰ However, additional guidance in September 2020 also clarified that ‘[l]imiting the size of indoor and outdoor gatherings is a measure to reduce the likelihood of SARS-Co-V-2 spreading to large numbers of people. It is recommended when there is community transmission, regardless of the incidence levels’.²²¹

81.  The closure of premises and facilities falls squarely within the competence of the Member States and there is virtually no room for EU action in this regard. Even the Commission Communication on Staying safe from COVID-19 during winter in December 2020, which contained the most concrete recommendations on non-pharmaceutical intervention, remained largely silent on this topic.²²² The only relevant reference to schools is that the Commission recommended the Member States to consider the extension of school holidays or a switch to online learning before and after the holidays.²²³ As for churches, the Commission recommended encouraging online services and avoiding larger services in person, and it also stressed the importance of requiring face masks and the banning of singing.²²⁴ Member States have adopted national policies on such matters (see the relevant country reports).

82.  In spring 2021, the Commission did address the effect the Covid-19 crisis had especially on the cultural, hospitality, and tourism sector and in its strategy for re-opening promised to develop guidance for the safe reopening of that sector.²²⁵ The Commission guidance, which was developed together with the ECDC and the Health Security Committee, was published in June 2021, with the aim of providing a common approach to reopening the sector based on indicators to be taken into account by the Member States.²²⁶

83.  The ECDC guidance, on the other hand, extensively addressed the closure of premises and facilities, especially schools. When providing guidance on school closures already featured in the list of potential measures in February 2020, while the ECDC noted that ‘[s]chool children and children attending day-care facilities are considered to be one of the main drivers of respiratory virus spread in the community’, it pointed out that their role in Covid-19 transmission is unclear and that proactive closures during the containment phase of the pandemic ‘are not justified’.²²⁷ However, in March 2020, due to the changed/different epidemiological risk level, school closures were deemed necessary.²²⁸ In September 2020, the ECDC advised that reactive school closures in the situation of widespread transmission may be necessary, however, pointing out that they will ‘probably not reduce the impact of the epidemic, but may be necessary due to high absenteeism and operation issues.’²²⁹ Since August 2020, the ECDC has published guidance on the role of children and schools in the transmission of the virus,²³⁰ as well as the objectives of Covid-19 testing in schools.²³¹ On a more general level, the ECDC provides advice on the closure of non-essential businesses excluding grocery stores and pharmacies,²³² and also factors measures such as school closure or closure of gyms and restaurants into its framework for fine-tuning non-pharmaceutical responses, published in March 2021. The ECDC does not define ‘non-essential businesses’, presumably because this is left to national level public health measures.

84.  Physical distancing was recognised as a key prevention mechanism for the spread of Covid-19, but again the EU is not competent to adopt legislation on this matter. Member States were not precluded by EU law from adopting different strategies. Yet, the Commission recalled the importance of these measures and called on Member States to pursue them.²³³

85.  The ECDC, however, since early on in the pandemic in March 2020, has published information videos aimed at the general public on the importance of physical distancing.²³⁴ The agency, throughout the pandemic, stressed the importance of physical distancing, and its correct application by the public, in its guidance.²³⁵

86.  The EU does not have competence to take legal measures ordering all or certain population groups to wear face coverings or other personal protective equipment (PPE)—again, the Member States were free to adopt different approaches. However, the EU undertook action to ensure the availability of PPE by several means. First of all, to ensure the availability of medical devices, the Commission postponed the application of the new Medical Device Regulation, which was meant to become applicable on 26 May 2020, for one year, in order to not burden producers and authorities additionally.²³⁶

87.  As medical devices are regulated products and—depending on their level of risk—require certification before being allowed on the market,²³⁷ the Commission undertook measures to remove some barriers in this regard. In March 2020, it called on notified bodies to prioritise the conformity assessment of medical devices required in the context of the pandemic,²³⁸ and it also adopted guidance on derogations from certification requirements which allow national authorities to allow non-CE-marked products on the market.²³⁹ Furthermore, upon request of the Commission, the standards for certain goods like masks and protective clothing were made available for free, to enable faster market access for new equipment manufactured by companies that were not traditionally producing those items and had to familiarise themselves with the standards.²⁴⁰ Additionally, revised standards were adopted with a faster conformity assessment procedure.²⁴¹

88.  The fact that certain Member States in the beginning of the pandemic adopted export bans or restrictions on goods like PPE was a source of concern for the EU.²⁴² In order to encourage the lifting of national bans while ensuring the sufficient availability of equipment within the EU, the Commission adopted two subsequent Implementing Regulations which temporarily made the export to third countries of certain goods (including PPE and face masks) subject to an export authorisation to be issued by national competent authorities.²⁴³ Under the second export restrictions scheme applicable from 26 April until 26 May 2020, according to the Commission, the Member States received over 1,300 authorisation requests of which 95% were approved.²⁴⁴

89.  Moreover, the Commission coordinated the Joint Public Procurement for medical equipment,²⁴⁵ and also eased the public procurement rules applicable to national procurement.²⁴⁶ Moreover, the EU financed stockpiling of medical equipment which was redistributed to the Member States under the rescEU mechanism.²⁴⁷

90.  As with other non-pharmaceutical interventions, the EU also provided scientific support in terms of assessing the use of face masks and other personal protective equipment as Covid-19 response measures via the ECDC. In the early stages of the pandemic, this mainly concerned the use of facemasks and other protective equipment for health-care workers, while it was stated that ‘[t]here is no evidence on the usefulness of facemasks worn by persons who are not ill as a community mitigation measure’.²⁴⁸ This changed in April 2020 with an expert opinion of the ECDC, stating that although the use of facemasks in healthcare settings must be prioritized, ‘use of face masks in public may serve as a means of source control to reduce the spread of the infection in the community ‘and that ‘use of face masks in the community could be considered, especially when visiting busy, closed spaces, such as grocery stores, shopping centres, or when using public transport, etc.’²⁴⁹ More extensive guidance on the effectiveness of the use of facemasks was provided in February 2021, making clear that the effectiveness is small to moderate and should be relied on as a complementary measure with other non-pharmaceutical interventions.²⁵⁰

91.  Isolation of infected individuals and quarantine of individuals suspected of infection only became of concern for the EU in the context of travel restrictions (see above), but there is no competence for the EU to order such measures. However, in this context, again, it was the ECDC that provided (non-binding) scientific advice to the Member States including isolation timelines for different types of Covid-19 cases,²⁵¹ and also published an information leaflet aimed at the general public for national authorities to use.²⁵²

92.  A first response of the EU was to raise financial resources for the development of medical products: in May 2020, the European Commission, launched a pledging marathon and itself pledged significant financial resources for the funding of diagnostics, as well as treatments and vaccines, which was joined by the Member States and other governments around the world, raising almost EUR 16 billion.²⁵³

93.  However, in this area the activities of the EU were quite wide-ranging and did not stop with the funding of research. In the regulation of medical devices like those used for testing and also for pharmaceuticals, the EU has extensive competence—as will become clear from the following analysis—to ensure their quality, safety, and efficacy. However, generally questions like the purchase of such products or stockpiling them is a matter for the Member States. The same holds true for questions of regulating access, reimbursement, or pricing.

94.  As far as testing is concerned, especially at the beginning of the pandemic, Covid-19 tests were a scarce resource and there was divergence in the testing policies and methods of the Member States.²⁵⁴ The EU supported the Member States via launching joint public procurement processes, for example with regard to laboratory equipment.²⁵⁵ Moreover, with increasing scientific progress on testing, the Commission supported the Member States by procuring rapid antigen tests funded by the Emergency Support Instrument (ESI).²⁵⁶

95.  However, the role of the EU extended beyond the procurement of tests, because Covid-19 tests are medical devices which are subject to regulation in the EU.²⁵⁷ In April 2020, the Commission adopted guidance on the application of the EU’s in vitro medical device legislation to Covid-19 tests for professional use and for self-tests, strongly recommending that additional clinical performance tests are carried out for the test for clinical use by national competent authorities and reference laboratories before they are introduced in the clinical routine.²⁵⁸ The Commission provided guidance on performance criteria.²⁵⁹

96.  While the development of testing strategies is a national competence, at the end of October 2020, the Commission adopted guidance on Covid-19 testing strategies, making recommendations on prioritisation and asking Member States to define criteria for the selection of rapid antigen tests.²⁶⁰ This guidance supplemented the coordination of the testing strategies in the framework of the Health Securities Committee, where recommendations for a common testing approach were adopted in September 2020,²⁶¹ and the guidance on Covid-19 testing was adopted by the ECDC.²⁶² In November 2020, the Commission added guidance on the use of rapid antigen testing, setting selection criteria for test and recommended setting of use.²⁶³ It called on Member States to make use of the technical guidance by the ECDC when validating the tests,²⁶⁴ and emphasised the importance of mutual recognition of test results.

97.  In terms of rapid antigen testing, the Council followed up on the Commission guidance in January 2021 with a Recommendation on the use of rapid antigen tests and mutual recognition of Covid-19 test results.²⁶⁵ The Health Securities Committee adopted a common list of rapid antigen tests, the results of which will be mutually recognised.²⁶⁶

98.  The EU interest—both of the Commission and the Council—in coherent testing strategies amongst the Member States was not only based on public health reasons, but also on the realisation that the free movement of persons depends on the mutual recognition of test results. Therefore, the EU was involved in supporting the supply of tests, but also attempted to streamline the testing strategies of the Member States, based on scientific advice of the ECDC. In January 2021, the Commission called on Member States to urgently improve genome sequencing to track the spread of virus variants.²⁶⁷ In March 2021, when Covid-19 self-tests entered the market, their use in the testing strategies became a discussion item in the Health Securities Committee,²⁶⁸ and the ECDC published guidance on their use.²⁶⁹

99.  Vaccination, as was clear from the beginning of the pandemic, would form a central pillar of the public health response to the pandemic. By contrast to other fields of health law, the EU does have legislative powers when it comes to the regulation of pharmaceuticals such as vaccines,²⁷⁰ and these products are subject to EU law throughout their life-cycle from development, clinical trials, manufacturing, marketing, and post-marketing surveillance (‘pharmacovigilance’).²⁷¹ However, the development of vaccination policies—such as the definition of priority groups, and so on—as well as the actual conduct of the vaccination campaigns—such as the modalities of their implementation, for example who administers vaccines and where they are administered—falls within the remit of the Member States.

100.  On a more programmatic level, the European Commission published its Communication for the EU Strategy for Covid-19 vaccines in June 2020,²⁷² based on centralisation of Advance Purchase Agreements with vaccines under development, as well as on ensuring sufficient regulatory flexibility in the regulatory framework applicable to vaccines and their respective authorisation procedures in response to this public health crisis.²⁷³ While the first negotiations with vaccine producers were concluded and potential vaccines were subject to review by the European Medicines Agency, the Commission published a Communication on preparedness for Covid-19 vaccination strategies and vaccine deployment in October 2020.²⁷⁴ This Communication includes an action plan with a timeline for Member States, specifying a list of proposed actions which Member States should take in terms of ensuring the capacity of the vaccination services, preparing for the deployment of different vaccines which might require specific storage and transport infrastructure, and maintaining registries to ensure the collection of vaccination data. The Communication also contained an indication with regard to potential priority groups (health care workers, senior citizens, essential workers outside the health sector, etc), and called on the Member States to define priority lists for the targeting of certain population groups and to start modelling—with support of the ECDC²⁷⁵—their vaccination strategies. The Communication was mostly limited to establishing priorities and important considerations in the development of the national strategies, leaving a lot of room for divergent national vaccination policies, for example with regard to determination of the priority groups to receive vaccinations first. Yet, the role the Commission played in the coordination of the vaccination strategy is remarkable and noteworthy in terms of the competence division between the EU and its Member States.

101.  In terms of the marketing authorisation of the vaccines, the EU played a central role as they were authorised via the centralised procedure,²⁷⁶ which involved a benefit-risk assessment of the vaccine based on its quality, safety, and efficacy by the EMA and authorisation Decision by the European Commission based on this EMA opinion, which is valid throughout the EU. By January 2022, five Covid-19 vaccines had received a conditional marketing authorisation in the EU: Comirnaty (BioNTech/Pfizer); Vaxzevria (AstraZeneca); Spikevax (Moderna); Covid-19 vaccine Janssen; and Nuvaxovid (Novavax). In the EU, no specific emergency authorisation procedure for pandemics exists or was introduced. The conditional marketing authorisation as foreseen in Article 14(7) of Regulation 726/2004/EC for situations like a public health emergency or other unmet medical needs, allowed for a more rapid authorisation.²⁷⁷ It entails that, where a medicinal product has a positive benefit-risk balance, it can be authorised where certain data, like the duration of immunisation after vaccination, needs to still be generated by the applicant. According to Commission Regulation (EC) 507/2006,²⁷⁸ such conditional authorisations are granted for products fulfilling an unmet medical need which do have a positive benefit-risk balance, but not all data for a full authorisation is available yet. The missing data needs to be provided by the applicant before the conditional authorisation can be converted into a regular one. It is worth mentioning that EU law does provide the possibility under Article 5(2) Directive 2001/83/EC to temporarily authorise the distribution of an unauthorised pharmaceutical product. This option was used for instance by the UK—which was still bound by EU law at the time—for the AstraZeneca vaccine before that vaccine was authorised in the EU;²⁷⁹ and by Hungary to authorise the Sputnik V vaccine.²⁸⁰

102.  The marketing authorisation process adhered to the usual standards of a risk assessment of the quality, safety, and efficacy of the vaccines in question. However, it was accelerated through the EMA providing scientific advice early in the development process and the use of the so-called ‘rolling review’ where the EMA starts review of scientific data as they become available as opposed to when the full marketing authorisation dossier is ready.²⁸¹ This approach speeds up the review process without compromising on the completeness of the data to be reviewed. By January 2022, four vaccines were under rolling review at the European Medicines Agency (Sputnik V (Gam-COVID-Vac); Covid-19 Vaccine (Vero Cell) Inactivated; Vidprevtyn; and VLA2001). CureVac had withdrawn its vaccine CVnCoV from rolling review in October 2021.

103.  The role of the EMA in the context of the pandemic response has been subject to review by the European Ombudsman (see Part III.G above), where the inquiry was closed with a positive view of the Ombudsman especially in terms of the transparency of the EMA activities.²⁸² The Ombudsman also confirmed that the refusal of the EMA to grant access to certain documents detailing the manufacturing of the mRNA vaccines was justified.²⁸³ The applicants contested the positive benefit/risk balance and the fulfilment of conditions to grant a conditional marketing authorisation.²⁸⁴ In line with the well-established case law concerning the standing for act of annulment procedures (see Part III.C above), the cases were declared inadmissible by the General Court due to a lack of interest of the applicants in bringing an action, as well as the absence of direct and individual concern.²⁸⁵ The lawyer that brought the strategic litigation against the four conditional marketing authorisation procedures filed two new cases in November 2021, this time concerning the authorisation extension of Cominarty and Spikevax for children from the age of 12.²⁸⁶

104.  As far as vaccine procurement is concerned, the Commission had agreed with the Member States to centrally procure vaccines, with the Commission coordinating a negotiation team that included experts from national administrations.²⁸⁷ In this context, the Commission used the Emergency Support Instrument²⁸⁸ in order to conclude Advance Purchasing Agreements with vaccine producers. These agreements are entered into by the Commission on behalf of the Member States. For the right to buy the respective vaccines, the Commission contributes to the costs faced by the companies in the production process. By December 2021, advance purchase agreements were in place with Sanofi-GSK, Novavax, Valneva, and CureVac (the latter having withdrawn its marketing authorisation application), while purchase agreements were concluded for the four authorised vaccines.²⁸⁹

105.  The vaccine procurement was subject to an inquiry by the European Ombudsman (see Part III.G above), who was especially concerned with the transparency of the process, both the negotiation of the agreements,²⁹⁰ and the publication of redacted agreements.²⁹¹ In September 2021, the Ombudsman opened an inquiry concerning access to text messages between the Commission President and the CEO of a pharmaceutical company concerning a vaccine purchase.²⁹² Moreover, by December 2021, three cases were pending before the CJEU in the context of the vaccine procurement, as a German citizen had requested access to several documents, which was denied by the Commission.²⁹³

106.  In January 2021, the European Commission called on the Member States to speed up their vaccination campaigns.²⁹⁴ By the end of June 2021 over half of the EU population had received one vaccine dose and over one third were fully vaccinated,²⁹⁵ and by early November 2021 around 65% of the total EU population, and 76% of adults, were fully vaccinated.²⁹⁶ The progress of national vaccination programmes is monitored and published by the ECDC,²⁹⁷ while the EMA monitors the safety and efficacy of the vaccines on the market.²⁹⁸ Where safety concerns arise, such as with the rare cases of blood clots connected to the AstraZeneca vaccine, the EMA assesses whether the risk/benefit assessment is still positive or if risk prevention measures are needed.²⁹⁹

107.  The EU and its Member States (‘Team Europe’) are a significant contributor to making vaccines available globally, contributing to the COVAX initiative and via its vaccine-sharing mechanism.³⁰⁰ Nonetheless, in order to ensure that the EU Member States receive the vaccines in line with the contracts concluded with the respective producers, the export of vaccines and their active substances from the EU to third countries was made subject to an export authorisation requirement during the year 2021.³⁰¹ The export to some third countries was excluded from this authorisation scheme. Especially the supply of AstraZeneca vaccine became a concern for the EU, and ultimately led to litigation brought by the European Commission and the Member States against the company before the Court of First Instance in Brussels, which granted interim measures under Belgian civil law, given that the company had committed a serious breach of contract and ordered the delivery of 50 million doses according to a set schedule.³⁰² The dispute between the Commission and AstraZeneca was settled with an agreement concerning the delivery of the remaining doses.³⁰³ While the export authorisation requirement was lifted as of 1 January 2022, the Commission maintained an export surveillance scheme.³⁰⁴

108.  In early summer 2021, EU attention shifted towards preparedness for mutations of the virus and the adaptability of the vaccines for such mutations. The European Commission has initiated the HERA Incubator, a bio-defence preparedness plan which aims to detect and respond to Covid-19 mutations.³⁰⁵ The Commission will boost research on variants through funding and has amended the variations procedure, which authorised vaccines must undergo, in order to adjust the authorisation to changes to the vaccine to make it efficient also for respective mutations.³⁰⁶

109.  Whereas the vaccination campaigns got under way quickly, the situation in the EU with regard to Covid-19 treatments progressed more slowly. By July 2020, only Veklury (Remdesivir) had been authorized as treatment for Covid-19 in the EU. By summer 2021, five other treatments had been positively reviewed for use in the EU by the EMA under Article 5(3) of Regulation 726/2004/EC.³⁰⁷ However, there was an urgent need for additional treatments, especially in the context of ‘long Covid-19’, ie the symptoms, like fatigue and shortness of breath, that some Covid-19 infected people experience weeks or months after the infection.³⁰⁸

110.  In May 2021, therefore, the Commission adopted the EU Strategy for Covid-19 therapeutics, including additional funding and potential joint procurement, the establishment of a platform to connect relevant stakeholders in the development of therapeutics, and access to EU-wide clinical trials. Notably, in the Strategy, the Commission states that it considers proposing new legislation containing an EU emergency-use authorisation procedure.

111.  The Strategy seems to have resulted in increased Covid-19 treatments being available in the EU. By January 2022, in addition to Veklury (Remdesivir), five other treatments had received authorisation: Kinaret (Anakinra); Regkirona (Regdanvimab); Ronapreve (Casirivimab/Imdevimab); RoActemra (Tocilizumab); and Zevudy (Sotrovimab). Three further potential treatments were currently undergoing the marketing authorisation procedure and another medicine was currently under rolling review. The EMA keeps an updated website on Covid-19 treatments authorised for marketing in the EU.³⁰⁹

112.  Most EU Member States have resorted to launching national Covid-19 tracing and warning apps, which can be voluntarily used. No central EU contact tracing and warning app was introduced in the EU, but again the focus at EU level was the coordination of Member State actions and ensuring the interoperability of apps to ensure effectiveness, as well as ensuring compliance with data protection and privacy rules. Some apps, depending on their functions, would qualify as medical devices and therefore be subject to EU legislation.³¹⁰

113.  In April 2020, the Commission adopted a Recommendation to define guiding principles for those Member States that wanted to introduce such apps.³¹¹ This soft law measure included an emphasis on the need for these apps to be voluntary in use, as well as several data protection and privacy concerns like data minimisation and encryption of the data.³¹² Based on this Recommendation, the Member States, in a forum called the e-Health network,³¹³ supported by the Commission, developed an EU toolbox on contact tracing and warning apps setting baseline requirements and functionalities,³¹⁴ as well as Guidelines on interoperability³¹⁵ and further technical details.³¹⁶ After the Commission had adopted an Implementing Decision on cross-border exchange of data between national Covid-19 apps,³¹⁷ an EU interoperability gateway went live in October 2020, which connects the national apps and allows the tracing and warning also if the user is travelling within the EU.³¹⁸ The Implementing Decision is ‘hard’ law, and although it is formally binding only on those Member States which have opted in to the EU’s e-Health network,³¹⁹ in fact all Member States, plus Norway, have done so.³²⁰ The technical work of the Commission and the e-Health network was supported with guidance on the epidemiological use of contact tracing, like the classification of the risk level of a contact, adopted by the ECDC to ensure consistency throughout the EU.³²¹

114.  The EU has no competence to adopt measures for long-term care facilities or homes for the elderly, but the Commission has stressed the importance of protecting vulnerable groups including elderly people, especially in residential homes, through monitoring and testing.³²² Together with the ECDC, the Commission encouraged Member States to share best practices,³²³ although, as with many public health provisions, Member States are not obliged to follow the EU’s advice here. Additionally, in May 2020, the ECDC published guidance on monitoring Covid-19 in long-term care facilities, including testing strategies and information on infection prevention.³²⁴ This supplemented the guidance on infection prevention in healthcare facilities in general.³²⁵

115.  After an increase of fatal cases in long-term care facilities, the ECDC published a rapid risk assessment with guidance on options to respond.³²⁶ A second rapid risk assessment taking into account the vaccination coverage was published in July 2021.³²⁷ An ECDC surveillance protocol from February 2021,³²⁸ and updated guidance on data collection for long-term care facilities with a completed vaccination programme,³²⁹ encourage Member States to report data on Covid-19 in their long term care facilities in a way that allows comparison.³³⁰ In November 2021, the ECDC published a technical report with the data obtained by this surveillance activity.³³¹

116.  One category of public health measures is specific to the EU: the facilitation of cross-border health care. In this regard, the Commission contributed to coordinate the collaboration and mutual support of health care facilities, especially in border regions.³³² The Commission was able to build on the long-standing ‘Euregios’, in which health cooperation has been a strong dimension since the 1990s, especially on the Germany-Netherlands, Germany-Netherlands-Belgium, Denmark-Sweden, Finland-Sweden-Norway, and Spain-Portugal borders.³³³ For example, ‘the Euregio Meuse-Rhine (NL/BE/D) in the Maastricht-Aachen-Liege-Hasselt area set up a tri-lateral crisis management centre (Task Force Corona). The cross-border Cerdanya Hospital (ES) between France and Spain co-operates with French hospitals to share intensive care capacity and personnel, working with the border police to ensure access for patients and health professionals.’³³⁴

117.  A special focus from earlier on in the Covid-19 pandemic was to ensure that essential cross-border workers in the healthcare sector, such as health professionals and care workers, were not impaired in reaching their workplace by travel restrictions and border controls, and the Commission called on Member States to ensure this.³³⁵ In terms of addressing the shortage of workers in the healthcare sector, this was supplemented by additional guidance adopted in May 2020 on professional training. The guidance supplements and clarifies the core legal measure in the field, Directive 2005/36/EC on the recognition of professional qualifications, which governs the recognition of qualifications for regulated professions such as doctors or nurses.³³⁶ The guidance entailed information on certain ways to speed up the mutual recognition of qualifications and clarified how earlier graduation of the 2019–2020 cohort would affect the cross-border recognition.³³⁷

118.  While the organisation of healthcare is a Member State competence,³³⁸ EU law regulates the rights of patients to cross-border healthcare and the reimbursement of such services.³³⁹ In the face of the Covid-19 pandemic, the Commission adopted guidance on how to coordinate the transfer of Covid-19 patients to other Member States.³⁴⁰

119.  These soft law guidance measures were supplemented by financial support for patient transfer and the transport of medical personnel via the Emergency Support Instrument.³⁴¹ Moreover, the Health Security Committee, composed of Member States representatives and chaired by the Commission, took an important role in coordinating the assistance provided to each other by the Member States.

120.  The EU has no powers to enforce public health measures against individuals. The overwhelming majority of the EU’s public health measures are not legally binding, and are addressed to the Member States with the aim of coordinating their respective Covid-19 response measures. Please refer to the country reports of EU Member States for further detail on enforcement in this regard.

121.  When considering the enforcement powers of the EU in the public health context, it should be mentioned that the ‘constitutional’ framework of the EU does foresee the enforcement of EU law against Member States by means of the infringement procedure under Articles 258–260 TFEU. Under this procedure, the Commission—or another Member State—can bring legal action against a Member State breaching its obligations under EU law. According to the annual report of infringement procedures for 2020, the Commission reacted to national export restrictions on protective equipment and medicines relevant in the pandemic with urgent infringement procedures, persuading Member States to lift such restrictions.³⁴² Another area in which the Commission has been actively pursuing infringement procedures against Member States is passenger rights. In July 2020, the European Commission launched infringement proceedings against Italy and Greece for adopting national legislation that allowed vouchers as the only form of reimbursement for travel cancelled by the carrier due to the pandemic, which is contrary to EU law.³⁴³ Under the EU passenger rights regulations passengers have the right to choose between reimbursement in money and other forms of refund, such as a voucher. According to the Commission, it opened procedures against a total of 11 Member States to safeguard the rights of passengers, with most procedures being closed after amendment or expiry of the national legislation.³⁴⁴ Ten proceedings were closed, but the Commission’s case against Slovakia is pending.³⁴⁵

122.  Outside the context of the formal infringement procedure, the Commission called upon Member States in February 2021, via a letter by Commissioner Reynders (Justice) and Commissioner Johansson (Home Affairs), to adhere to the Recommendations on travel restrictions.³⁴⁶ Reportedly, six letters were sent to EU Member States individually, calling on them to bring their travel restrictions in line with EU law in March 2021,³⁴⁷ and it is also reported that a letter was sent in April 2021 to Ireland due its introduction of a mandatory hotel quarantine regime which was deemed disproportionate and diverged from the EU Recommendations by requiring travellers from certain EU countries to quarantine at their own costs without exceptions for essential travel.³⁴⁸ However, no formal legal action was taken against Member States.

Tamara Hervey, City, University of London

Sabrina Roettger-Wirtz, University of Maastricht