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Coordinating National Responses to Serious Cross-Border Threats to Health in the European Union: European Health Union and beyond

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Jan Malíř - Senior Research Fellow, Department of Public Law, Institute of State and Law, Czech Academy of Sciences, Magdaléna Svobodová - Associate Professor, Department of European Law, Charles University School of Law*
Keywords: European Union, European Health Union, cross-border threats to health, national responses, coordination

Abstract

The project of the European Health Union (‘EHU’), a direct response to experience gained from the Covid-19 pandemic, has adapted the institutional, and legal design of the European Union (‘EU’) in order to permit the EU to react to serious cross-border threats to health in a more uniform and efficient way. While the EHU has brought about important shifts, certain gaps or weaknesses in the coordination of national responses to serious cross-border threats to health can, however, be identified even with the EHU and merit further discussion. This discussion should also encompass the issue of revisiting the separation of competences between the EU and the Member States in the area of combating serious cross-border threats to health because the existing model of the separation of competences in this area continues to impose important limits on the coordination of national responses to serious cross-border threats to health.

Introduction

In 2020, the European Union (‘EU’) was struck by the pandemic of a new communicable disease which came to be known as Covid-19. Although the EU had been confronted with serious communicable diseases before,
L Bengtsson and M Rhinard, ‘Securitisation across-borders: the case of “health security” cooperation in the European Union’ (2018) 42[2] West European Politics, 346.
 Covid-19 had unprecedented impacts, including those on the process of European integration itself.
While the EU was relatively quick in taking steps to alleviate the economic costs of the pandemic, it originally failed to effectively coordinate public health measures intended to prevent the spread of the new pandemic. Consequently, the initial response to Covid-19 was to a great extent unilateral in the EU, with the key initiative being left to individual Member States, rather than the joint one.
European Parliament, ‘The COVID-19 pandemic: lessons learned and recommendations for the future’, P9_TA(2023)0282 of 12 July 2023, para 8; it must be simultaneously emphasized that measures taken by individual Member States substantially differed which resulted, ia, to challenges brought before domestic courts both for action and inaction of these States, see, eg, M Florczak Wator and others (eds), States of Emergency and Human Rights Protection. The Theory and Practice of the Visegrad Countries (Routledge 2024) or E Chevalier, ‘The Control of Administrative Inaction in the Context of the COVID-19 Health Emergency in France: an Inadequate Response from the Interim Relief Judge?’ (2021) 14[3] Review of European Administrative Law 29.
Although many of the original shortcomings were later overcome, the pandemic of Covid-19, later described as ‘the most challenging socioeconomic crisis’ since WWII by the European Parliament (‘EP’),
ibid, para 18.
 highlighted a range of institutional, legal, and operational problems in the area of public health protection at the EU level. These problems called for a response.
For one of the first analyses, see C Blumann, ‘Les faiblesses du dispositif anti-crise de la Commission européenne face au Covid-19’ (2020) 30]2-3] Revue du droit de l’Union Européenne 237.

EHU as the Response to Covid-19 Pandemic

This response has been basically constituted by the project of the European Health Union (‘EHU’) whose origins can be traced back to the very beginning of the Covid-19 pandemic.
In Autumn 2020, under the impact of the calls from both the public
‘A European answer to the Coronavirus threat’ (Cesue.eu., March 2020) <https://www.cesue.eu/en/appeal.html> date accessed 20 November 2024; ‘Manifesto for a European Health Union’ (Europeanhealthunion.eu, 2020) <https://europeanhealthunion.eu/> date accessed 20 November 2024.
 and several Member States,
‘French-German Initiative for the European Recovery from the Coronavirus Crisis’ (Elysee.fr, 18 May 2020) <https://www.elysee.fr/en/emmanuel-macron/2020/05/18/french-german-initiative-for-the-european-recovery-from-the-coronavirus-crisis> date accessed 20 November 2024.
 which were subsequently echoed by the EP,
European Parliament, ‘Resolution on the EU’s public health strategy post-COVID-19’, P9_TA(2020)0205 of 10 July 2020; many of the measures contained in the resolution had been originally proposed in the position paper entitled ‘A European Health Union’ which had been presented by the S&D group in the EP (12 May 2020) <https://www.socialistsanddemocrats.eu/sites/default/files/2020-05/european_health_union_sd_position_30512_2.pdf> date accessed 20 November 2024.
 the European Commission (‘Commission’) presented a series of initiatives.
These measures were officially presented by the President of the Commission, see ‘State of the Union Address 2020’ (Europa.eu, 16 September 2020) <https://state-of-the-union.ec.europa.eu/system/files/2022-08/soteu_2020_en.pdf> date accessed 20 November 2024.
In 2020-2024, these initiatives led to the adoption of several legal acts which redefined the institutional, and legal framework designated to tackle serious cross-border threats to health at the EU level.
As initially explained by the Commission, see Commission, ‘Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats’ (Communication) COM (2020) 724 final.
 While these acts were adopted on the grounds of the legal bases available under the EU Treaties in their existing wording, it was emphasized that further discussion over the separation of competences between the EU and the Member States in the area of public health would be necessary as well.
European Parliament, ‘Resolution on the EU’s public health strategy post-COVID-19’, P9_TA(2020)0205 of 10 July 2020.
Moreover, since its onset, the EHU has been intended to strengthen the process of building the capacities relevant to the management of serious cross-border threats to health and to medical research in the EU. Thus, the Health Emergency Preparedness and Response Authority (‘HERA’)
Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority [2021] OJ C 393I/3; contrary to the original proposals, however, the HERA was not created as the EU agency and its control lies outside the direct reach of the EP which has led to the repeated criticism by the EP; on the HERA, see, recently, FS della Corte, ‘The EU Vaccines Strategy: A Missed Opportunity for EU Public Health?’, (2023) 15[2] European Journal of Risk Regulation 333, 340.
 and the EU4Health programme for 2021-2027 were notably created.
Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 [2021] OJ L107/1. In 2024, however, € 1 billion (c. 20%) was cut from the budget of the programme; further budgetary changes in the EU expenditures on health have been recently discussed, see ‘Leaked budget plans spark fears for EU health funding’ (Euronews, 22 October 2024) <https://www.euronews.com/health/2024/10/22/leaked-budget-plans-spark-fears-for-eu-health-budget> date accessed 20 November 2024.
 Special attention has also been paid to increasing the role of the EU in the global health cooperation through such steps as the adoption of the EU Global Health Initiative
Commission, ‘EU Global Health Strategy: Better Health for All in a Changing World’ (Communication) COM (2022) 675 final.
 or the participation of the EU in negotiating the International Pandemic Treaty.
Council Decision (EU) 2022/451 of 3 March 2022 authorising the opening of negotiations on behalf of the European Union for an international agreement on pandemic prevention, preparedness and response, as well as complementary amendments to the International Health Regulations (2005) [2022] OJ C92/1.
Importantly enough, the project of the EHU has further covered various measures intended to promote the strategic autonomy of the EU and its Member States in the area of medical countermeasures and their production,
See, notably, Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level [2022] OJ L 314/64.
 including pharmaceuticals.
Commission, ‘Pharmaceutical Strategy for Europe’ (Communication) COM (2020) 761 final.
Since the pandemic of Covid-19 faded, the EHU has been expanded beyond the strict scope of tackling the serious cross-border threats to health and, consequently, it has included such issues as combating non-communicable diseases and creating the European Health Data Space.
Commission, ‘The European Health Union: acting together for people’s health’ (Communication) COM (2024) 206 final.
While not all of the envisaged elements of the EHU have materialized,
This is eg the case of the appointment of an ‘European Chief Epidemiologist’, Commission, ‘Drawing the early lessons from the COVID-19 pandemic’ (Communication) COM (2021) 380 final.
 the EHU has, thus, gradually encompassed a wide scale of issues relevant to the protection of public health in the EU, paving the way to the more vigorous role of the EU.
This has been so in spite of the fact that the ultimate goals of the EHU have never been defined in an exhaustive way by the EU.
See eg, A de Ruijter and E Brooks, ‘The European Health Union: Strengthening the EU’s Health Powers?’ (2022) 28[3] Eurohealth 47 who put an emphasize on the symbolic and political importance of the notion of the EHU; more recently, see eg S Gallina, ‘Preparing Europe for future health threats and crises: the European Health Union’ (2023) 28[5] Euro Surveillance 1 who stresses that the EHU has been designed ‘to reinforce coordination at EU level to build healthier, more resilient and more sustainable societies for the future’.
 Simultaneously, the EHU has not brought about what could be called the ‘paradigm shift’ when it comes to protecting public health and to defining the respective roles of the EU and its Member States in this area.
T Fischer, N Mauer, and F Tille, ‘A Framework for Studying EU Health Policy through a Political Determinants of Health Lens: The Case of the European Health Union‘ (2024) 49[5] Journal of Health Politics, Policy and Law 691, 711.
 In particular, the EHU has not been, at least up to now, designed to result in the ‘communitarisation’ of public health and of health services provision, unlike the old project of Paul Ribeyre from the 1950s
A Davesne and S Guigner, ‘La Communauté européenne de la santé (1952-1954). Une redécouverte intergouvernementaliste du projet fonctionnaliste de “pool blanc”’ (2013) 41[3] Politique européenne 40.
 or some more recent proposals.
‘COVID-19 could be incentive to give EU more health powers’ (Euractive.com, 3 March 2022) <https://www.euractiv.com/section/health-consumers/news/covid-19-could-be-incentive-to-give-eu-more-health-powers> date accessed 20 November 2024.
 With the EHU, however, there can be little doubt that, when it comes to combating serious cross-border threats to health, the EU’s institutional, and legal system should allow for a more determinate joint action than 5 years ago, as the Commission indicated in May 2024.
COM (2024) 206 final (n 17) 18; doctrinally, see, eg, D Eerens, R Hrzic, and T Clemens, ‘The architecture of the European Union’s pandemic preparedness and response policy framework’ (2023) 33(1) European Journal of Public Health, 42 or T Fischer, N Mauer, and F Tille (n 20).
Nonetheless, it is no less true that ‘much work remains to be done’, as both the Commission
COM (2024) 206 final (n 17) 18.
 and the EP
P9_TA(2023)0282 of 12 July 2023 (n 2) para 559 et seq.
 have admitted.
Against this background, the present article focuses on the very process of coordination of national responses to serious cross-border threats to health in the EU. The article will first explore the role of the coordination of national responses to serious cross-border threats to health in the EU and the principal changes which the EHU has brought about into the process of coordination of national responses (chapter 3). Subsequently, several potential gaps or weaknesses in the design of the process of coordination will be identified while certain measures how to cope with those gaps or weaknesses will be proposed (chapter 4). Finally, the article will emphasize the importance of further discussion over the precise role of the EU in tackling serious cross-border threats to health (Conclusion).

Coordination of National Responses to Serious Cross-Border Threats to Health under the EHU

Serious Cross-Border Threats to Health in the Context of the EHU

In spite of its gradual expansion, the project of the EHU has been primarily linked to better tackling serious cross-border threats to health, in particular, communicable diseases, in the EU. This has been due to the fact that serious cross-border threats to health constitute a permanent challenge for the EU insofar as free movement of goods and free movement of persons, the core freedoms related to internal market, entail that communicable diseases and some other serious cross-border threats to health may move freely in the EU.
As for better tackling serious cross-border threats to health, the EHU has been specifically built on three new regulations. Their proposals were tabled by the Commission with the goal to provide ‘a reinforced framework for cross-border cooperation against all health threats in order to better protect lives and the internal market as well as to maintain the highest standards in the protection of human rights and civil liberties’.
COM (2020) 724 final (n 9).
 These Commission proposals, substantially modified in line with demands from both the EP and the Council of the EU (‘Council’),
See 2020/0322(COD) 12943/22 of 7 October 2022; one Member State abstained from voting in the Council of the EU (Bulgaria) and, on the same occasion, two Member States issued interpretative statements to Regulation (Bulgaria and Hungary), see ST 14046 2022 INIT and ST 13323 2022 ADD 1.
 were made into law as Regulation (EU) 2022/123,
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices [2022] OJ L 20/1.
 Regulation (EU) 2022/2370
Regulation (EU) 2022/2370 of the European Parliament and of the Council of 23 November 2022 amending Regulation (EC) No 851/2004 establishing a European centre for disease prevention and control [2022] OJ L 314/1.
 and Regulation (EU) 2022/2371 (‘Regulation 2022/2371’).
Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU [2022] OJ L 314/26.
 This evolution was far from being symbolic. In this regard, suffice it to say that regulations are formally the strongest legal instruments the EU has at its disposal as they are to be binding in their entirety and be directly applicable in all the Member States.
Consolidated Version of the Treaty on the Functioning of the European Union [2008] OJ C115/13, art 288; on this provision, see eg, M Klamert and P-J Loewenthal, ‘Article 288’ in M Kellerbauer, M Klamert, and J Tomkin (eds), The EU Treaties and the Charter of Fundamental Rights. A Commentary (OUP 2019) 1897-1900.
Overall, the three regulations have aimed at providing the EU with a stronger ‘health security framework’,
COM (2024) 206 final (n 17) 4.
 ie stronger institutional, legal, and operational capacities to tackle serious cross-border threats to health, as far as possible under the existing model of the separation of competences between the EU and the Member States in the area of public health. In particular, the new health security framework has been aimed at guaranteeing more uniformity and efficiency in jointly managing serious cross-border threats to health, compared to the previous health security framework whose origins dated back to the 1990s. Although substantially remodelled in 2013,
On this original framework, see, concisely, eg T K Hervey and J V. Mc Hale, European Union Health law. Themes and Implications (CUP 2015) 512-517 or N de Grove-Valdeyron, Droit européen de la santé (LGDJ 2013) 54-58.
 this previous health security framework did not withstand the challenges stemming from Covid-19 in that it did not permit for the timely and joint response to this disease, constituting a novel serious cross-border threat to health.

Coordination of National Responses to Serious Cross-Border Threats to Health: Impact of the EHU

While the new public health security framework stemming from the EHU aims at providing for a comprehensive system of ‘addressing’ serious cross-border threats to health in the EU, including i) prevention, preparedness and response planning, ii) surveillance and iii) early warning and response, it is iv) the coordination of national responses to serious cross-border threats to health which continues to lie at the heart of the whole framework.
Regulation 2022/2371, art 1(1) and, also, recital 15; doctrinally, see eg, M L Flear, Governing Public Health EU Law. Regulation and Biopolitics (Hart Publishing, 2015) 158 et seq., or, using the case of swine flu, A de Ruijter, EU Health Law & Policy. The Expansion of EU Power in Public Health and Health Care (OUP 2019) 120 et seq.
On closer inspection, this is no coincidence. As the Commission itself recognized, the coordination of health measures taken to tackle serious cross-border threats to health by the Member States ‘is central (…) to an effective practical response [to serious cross-border threats to health] by the authorities’.
COM (2020) 724 final (n 9).
 The reason is simple. Under the existing model of separation of competences in the area of public health in the EU, it is the Member States which are primarily responsible for their public health policies, including tackling serious cross-border threats to health at national level, while the EU may only complement Member States’ action and is expressly prohibited to harmonise Member States’ health law.
Regulation 2022/2371, recital 32; on complementary competences of the EU in the area of public health, see TFEU, art 168, in conjunction with art 2(5) and art 6(a); on this provision, see eg, S Garben, ‘Article 168’ in The EU Treaties and the Charter of Fundamental Rights. A Commentary (n 31) 1445-1455; see also M Klamert, ‘Public Health Policy’ in H C H Hofmann, G C Rowe, and A H Türk (eds), Specialized Administrative Law of the European Union: A Sectoral Review (OUP 2018) 405-407.
 Consequently, the coordination of Member States’ responses to emerging public health problems, including serious cross-border threats to health, does constitute the central element of any efficient public health governance at the EU level.
In line with the goal to enhance the coordinated response to serious cross-border threats to health, several notable changes have been introduced into the process of coordination of national responses in the EU by Regulation 2022/2371.
Firstly, Regulation 2022/2371 has reinstated the Health Security Committee (‘HSC’), composed of representatives of the Member States and chaired by a representative of the Commission,
Regulation 2022/2371, art 4(1), (2) and (10); a representative of the Commission, however, does not have the right to vote; the EP is represented in the HSC through a representative who has only the status of an observer, see Regulation 2022/2371, recital 4.
 as the key body in which the responses of the Member States to serious cross-border threats to health should be coordinated and opinions and guidance on specific response measures be adopted.
Regulation 2022/2371, art 4(3); on the genesis of this body prior to Covid-19, see eg, A de Ruijter (n 34) 127-129.
 In order to facilitate this coordination, the Regulation 2022/2371 has provided that the HSC should be composed of two formations, i) the senior level working group (with a more strategic and political role) and ii) the technical working groups (with a more technical and operational role).
Regulation 2022/2371, art 4(1); as further specified in the HSC Rules of Procedure.
 Furthermore, Regulation 2022/2371 has laid down the legal bases which permit the HSC to adopt its rules of procedure.
Regulation 2022/2371, art 4(8); for the current wording of the HSC Rules of Procedure, see <https://health.ec.europa.eu/document/download/c6ef8e87-5e03-4761-9898-f24bd75fcc90_en?filename=hsc_rules_procedure_en.pdf> date accessed 20 November 2024; under the HSC Rules of Procedure, the HSC senior level working group is mandated to create a general working group which is to meet each month; as for HSC technical working groups, these can be either created as permanent or ad hoc.
Secondly, Regulation 2022/2371 has expanded the material scope of the process of coordination. Consequently, the coordination now pertains not only to i) national responses, including research needs, to serious cross-border threats to health and to ii) risk and crisis communication but, also, to iii) the adoption of opinions and guidance, including on specific response measures for the Member States for the prevention and control of serious cross-border threats to health, and to iv) support for the EU Integrated Political Crisis Response Arrangements (IPCR).
Regulation 2022/2371, art 21(1)(a) – (d).
 Thus, the process of coordination should be more comprehensive than prior to the Covid-19 pandemic and, moreover, an adequate interplay should be guaranteed between the measures taken in the context of the coordination of national responses to serious cross-border threats to health and those adopted under the IPCR.
Council Decision 2014/415/EU of 24 June 2014 on the arrangements for the implementation by the Union of the solidarity clause [2014] OJ L 192, adapted by Council Implementing Decision (EU) 2018/1993 of 11 December 2018 on the EU Integrated Political Crisis Response Arrangements [2018] OJ L 320/28; as crises are understood extensively in the context of the IPCR, they may cover even those triggered by the serious cross-border threats to health.
Thirdly, Regulation 2022/2371 has elaborated on the rules concerning the process of coordination as such. In particular, the Regulation has put an express emphasis on the fact that measures which a Member State takes in order to tackle serious cross-border threats to health should be consulted with the neighbouring Member States and so should be the termination of these measures.
Regulation 2022/2371, art 21(2).
Fourthly, Regulation 2022/2371 has also substantially remodelled the process of recognizing ‘public health emergencies’ at the EU level.

Coordination of National Responses to Serious Cross-Border Threats to Health: Beyond the EHU

The importance of the changes which the EHU introduced into the process of coordination of national responses cannot be denied. However, even with the EHU, the overall effectiveness of this process continues to depend on whether the Member States, through their representatives in the HSC, succeed in agreeing on measures that should be taken in order to manage a particular serious cross-border threat to health and, also, on whether they comply with those measures. The truth is that, where specific response measures the Member States should take are to be adopted in the form of opinions or guidance by the HSC,
In this regard, it may be inferred from the corresponding provisions that the outcomes of the process of coordination of national responses may be both informal or have precisely the form of opinions or guidance adopted by the HSC, see Regulation 2022/2371, art 4(3)(c) and art 4(3)(d), and, also, HSC Rules of Procedure, art 6(8).
 Article 4(4) of Regulation 2022/2371 stipulates that, where the consensus cannot be reached between the representatives of the Member States, the HSC should take a recourse to a vote, with the outcome of the vote to be determined by a two-thirds majority. Leaving aside uncertainty over the precise moment when the HSC should proceed to a vote rather than to continue to seek a consensus (see infra, subchapter 4.1), the adoption of those opinions or guidance still requires the consent of the majority of the Member States.
Correspondingly, the coordination of national responses to serious cross-border threats to health still retains a largely intergovernmental dimension which means the process of coordination of national responses may get easily politicized, with the priorities and preferences of the respective Member States playing a non-negligible role in the overall outcome. Any deeper transformation in this regard, in particular, the introduction of the possibility for the institutions of the EU to adopt legal acts binding on the Member States and formally enforceable against them as in the context of many other EU policies,
Such as infringement procedure or excessive debt procedure, see eg P J Kuiper and others (eds), The Law of the European Union (5th edn, Wolters Kluwer 2018) 361-369 and 914-921.
 would pre-suppose the amendment of the existing model of separation of competences in the area of tackling serious cross-border threats to health in the EU.
As the EU is currently prevented from harmonising the laws of the Member States in this area.
Irrespective of these circumstances, there are reasons to believe that, even under the existing model of separation of competences in the area of public health, the rules on the process of coordination of national responses to serious cross-border threats to health and their effectiveness could be further enhanced.
Regulation 2022/2371, art 21(5), establishes an express legal basis which allows the Commission, by means of implementing acts, to adopt the procedures necessary for the uniform implementation of the information exchange, consultation and coordination, as related to the process of coordination of national responses.
 Upon the analysis of these rules, several gaps or weaknesses can be identified which are capable of potentially undermining the efficiency of the whole process of coordination where the Member States disagree on what measures should be taken in face of a particular serious cross-border threat to health. That can be especially the case of new emerging communicable diseases whose risks cannot be determined with precision in advance. These gaps or weaknesses will be addressed in the following subchapters.

Process of Coordination: Absence of an Express Time Frame

Firstly, even with the EHU, the process of coordination of national responses in the HSC is not subject to any express deadline which would specifically frame the period in which the HSC should decide whether any measures to tackle a specific serious cross-border threat to health should be taken by the Member States and what their nature should be.
The truth is that, under the HSC Rules of Procedure, in the event of a serious cross-border threat to health, a meeting of the HSC senior level group (or of its general working group) should be convened ‘without delay’.
HSC Rules of Procedure, art 6(8).
 It is true as well that, where a consensus over the adoption of an opinion or a guidance cannot be reached in the HSC, this body should proceed to a vote although the precise moment of proceeding to this vote can be subject to debate.
ibid, art 9(2).
 However, no specific deadline is imposed as for the very adoption of the decision on whether to coordinate national responses to the particular serious cross-border threat to health (or not) or on what nature these responses should have.
The fact that a search for consensus should precede a formal vote in the HSC, moreover, leaves to think that the duration of deliberations in the HSC is generally left to political considerations.
 This perspective does not seem to be substantially changed even if a recourse is taken to Commission Implementing Decision 2017/253 (‘Implementing Decision 2017/253’),
Commission Implementing Decision (EU) 2017/253 of 13 February 2017 laying down procedures for the notification of alerts as part of the early warning and response system established in relation to serious cross-border threats to health and for the information exchange, consultation and coordination of responses to such threats pursuant to Decision No 1082/2013/EU of the European Parliament and of the Council [2017] OJ L 37/23, art 4(4).
 which was adopted under the realm of Decision No 1082/2013/EU (‘Decision 1082/2013/EU’)
Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC [2013] OJ L 293/1.
 and formally remains in force. The Implementing Decision actually has limited itself to providing that all the information on the particular threat and on measures intended to be taken should by examined by the HSC without delay.
Implementing Decision 2017/253, art 4(4); the Implementing Decision 2017/253 should be replaced with the new implementing legal act, see HSC, ‘General Working Group Summary Report’ 16 July 2024.
 In case of disagreement between the majority of the Member States, thus, it might happen that no decision concerning the coordination of national measures or no opinions and guidance would be adopted in the HSC in a reasonable time, preventing, thus, a meaningful response to the given threat at the EU level.
In contrast, the existence of an express deadline could somewhat ‘discipline’ the HSC. It is also worth noting in this regard that rather strict deadlines have been applied with regard to introducing alert in the case of detecting a serious cross-border threat to health or to launching the process of consultation in the EHU under Implementing Decision 2017/253.
As for these deadlines, see Implementing Decision 2017/253 (n 51), art 4(1) and art 2(1).
 Moreover, such a deadline would especially make sense where, in the event representatives of the Member States were not able to reach decision in the HSC by the passage of the deadline, the issue were referred to another EU institution, as will be further developed (see infra, subchapter 4.3).

Process of Coordination: Effects of the Outcome Reached

Secondly, Regulation 2022/2371 fails to expressly lay down what precise effects the outcomes of the process of coordination of national responses should have with regard to Member States and to the management of the specific serious cross-border threats to health, apart from indicating—in line with the logic of complementary competences and the prohibition of harmonisation of the laws of the Member States concerning the public health—that these outcomes are legally non-binding.
Regulation 2022/2371, recital 7; the wording of this recital reflects the concerns expressed in the Council during the adoption of this Regulation and was not contained in the original proposal by the Commission.
 This is so despite the fact that, in its Communication on the EHU, the Commission aptly stressed that ‘[i]t is essential that Member States commit to implement the work of the Health Security Committee’.
COM (2020) 724 final (n 9), sub 3.
By contrast, Implementing Decision 2017/253 has laid down that ‘Member States when considering or taking public health measures to combat serious cross-border threats to health shall take account of the outcome of examination carried out within the framework of the consultation of the HSC’.
Implementing Decision 2017/253 (n 51), art 4(5).
 The truth is that, even in the Implementing Decision 2017/253, the effects of the outcomes reached in the process of coordinating national responses to serious cross-border threats to health in the HSC have not been defined in terms that would signify these outcomes are legally binding which is primarily due to the existing model of the separation of competences in this area in the EU. However, the provision contained in Implementing Decision 2017/253 has at least sensitised the Member States over the necessity to pay a due attention to the outcomes of the process of coordination, as agreed in the HSC.
Moreover, the role of such a provision would not be purely symbolic and it could have some legal relevance with respect to Member States in so far as it could operate in conjunction with the commitment of the Member States to coordinate, in liaison with the Commission, among themselves their policies in the area of combating serious cross-border threats to health. This commitment as such stems from Article 168(2) and Article 168(5) of TFEU and is, thus, undoubtedly legally binding on the Member States.
In this light, it is not clear enough why, at the moment of creating the EHU, such an express provision was not inserted into the very text of Regulation 2022/2371. The truth is that, for the time being, Implementing Decision 2017/253 remains, as already mentioned, in force. It would, however, make sense to specify the effects of the outcomes of the procedure of coordination in the very text of the basic regulation, designated as one of the key building blocks of the whole EHU. Moreover, an attempt could be made to formulate such a provision in a slightly more appealing way, highlighting the changes resulting from the creation of the EHU.
In particular, the Member States could be invited to combat the serious cross-border threats to health in the full compliance with the outcomes of the consultations in the HSC, including any relevant opinions or guidance where adopted by the HSC.

Process of Coordination: Potential Deadlocks in the HSC and their Resolution

Thirdly, no specific mechanism is foreseen in the event a deadlock occurs in the HSC over the measures the Member States should take to uniformly tackle a particular serious cross-border threat to health.
Such a deadlock is especially conceivable in cases of new emerging communicable diseases or other novel serious cross-border threats to health where substantial controversies over the risks those serious cross-border threats to health pose and over the precise measures to take in order to tackle those threats may arise between the majority of the Member States.
The controversies may also result from differing expert opinions and their assessments, see eg European Court of Auditors, ‘Special report 12/2024: The EU’s response to the COVID-19 pandemic’ (Eca.europa.eu, 4 September 2024) <https://www.eca.europa.eu/en/publications/SR-2024-12> date accessed 20 November 2024 which states the ECDC originally underestimated the seriousness of Covid-19 (see, notably, p 15).
 In case of such a deadlock, the HSC would not be likely to coordinate national responses in a reasonable time (all the more so that no specific deadline is imposed on the HSC concerning the decision on coordination of national responses).
The fact controversies do arise among the Member States over the coordination of national response to health threats in the HSC may be exemplified by the principled opposition of Denmark to the adoption of a recent opinion of the HSC, ‘Response to the increase in sexually transmitted infections in the EU/EEA’ 15 November 2024.
 Under these circumstances, there would be a direct risk that the Member States would react unilaterally, as they did at the beginning of the Covid-19 pandemic.
Already prior to Covid-19, it was emphasized how politicized the decision-making in the HSC could become, see, notably, A de Ruijter (n 34) 128.
 In the face of that risk, the referral of the decision over the coordination of national responses to the particular serious cross-border threat to health to another EU institution could constitute a way how to overcome such a deadlock and to reach an effective and timely response at the EU level.
It may be argued that, under Article 11(2) of its Rules of Procedure, the HSC is already allowed to refer issues to other EU bodies which are ‘competent under a provision of another act of the Union or under the Euratom Treaty’.
HSC Rules of Procedure, art 11(2).
 However, this referral seems to be textually limited to matters which do not come within the mandate of the HSC
ibid; see also Regulation 2022/2371, art 4(8)(c).
 and, thus, not to be applicable in the event of a deadlock over the coordination of national responses to a serious cross-border threat to health in the HSC, an issue falling precisely within the mandate of the HSC.
When it comes to the question of which institutions of the EU the issue of the coordination of national measures could be referred to, two of them, intergovernmental in nature, come specifically into mind.
In order to reflect the existing model of the separation of competences in the area of public health in the EU which attributes primary responsibility for public health to the Member States.
Primarily, it is the Council,
Consolidated Version of the Treaty on European Union (TEU) [2016] OJ C202/1, art 16.
 sitting, in particular, in its configuration of the Employment, Social Policy, Health and Consumer Affairs Council, or, in case of urgency, potentially that of the General Affairs Council.
On the configurations of the Council of the EU, see Council Decision of 1 December 2009 adopting the Council’s Rules of Procedure [2009] OJ L 325/35, Annex I; leaving aside the possibility of convening an extra Council meeting, there are normally four meetings of the Employment, Social Policy, Health and Consumer Affairs Council per year while the General Affairs Council meets every month.
 The immediate legal bases for referring such an issue to the Council could be undoubtedly sought in the provisions concerning the role which is conferred on this institution in the area of public health by Article 168 TFEU.
See, in particular, TFEU, art 168(5) and (6); see also the express call for establishing a dialogue between the HSC and relevant Council bodies in Regulation 2022/2371, recital 33; interestingly, in the past, the Council or, more precisely, its presidency already dealt with issues relevant to combating serious cross-border threats to health during the outbreak of swine flu, see A de Ruijter (n 34) 129.
Alternatively, the issue of the coordination of national responses to a serious cross-border threat to health could possibly be even referred to the European Council.
TEU, art 15(2).
 While, at first sight, the involvement of this top EU political institution may appear as a rather extraordinary step, in light of the experience from the Covid-19 pandemic, there are rather persuasive grounds why such a top institution should get involved where a deadlock over the coordination of national measures to tackle a serious cross-border threat to health cannot be resolved on lower political levels and, especially, where that threat might trigger political crisis.
For the notion, see n 42.

Process of Coordination: Recommendations on Common Temporary Public Health Measures

Apart from providing for the coordination of national responses to serious cross-border threats to health in the HSC, Regulation 2022/2371 lays down that, in relation to these threats, the Commission may complement the action of the Member States through the adoption of recommendations on common temporary public health measures.
Regulation 2022/2371, art 22.
 This is an important novelty which has no direct predecessor in Decision 1082/2013/EU. The recommendations from the Commission should actually propose the Member States a course of action, ‘should the coordination of national public health measures prove insufficient to ensure an adequate Union response’.
ibid, recital 33.
The problem is that, legally, recommendations do not truly ‘bite’.
See TFEU, art 288 and Regulation 2022/2371, recital 7.
 Consequently, it is far from certain that recommendations from the Commission would be capable of effectively overcoming controversies over the coordination of national responses to a particular serious cross-border threat to health arising in the HSC and, thus, of preventing the Member States from acting unilaterally.
In contrast, when adopting Decision 1082/2013/EU, the Commission proposed that it be conferred the competence to adopt delegated acts for the transnational aspects of the control of serious cross-border threats to health under a special legislative procedure in cases where the coordination of national responses in the HSC proved insufficient to control the spread of a serious cross-border threat to health.
Commission, ‘Proposal for a Decision of the European Parliament and of the Council on serious cross-border threats to health’ COM (2011) 866 final, recital 20 and art 12.
 Although the idea was later abandoned, delegated acts would have provided the Commission with a possibility to guide the management of serious cross-border threat to health in the Member States more effectively than through recommendations whose legal effects are limited.
See eg, M Hartlapp and E Korkea-aho, ‘Whatever-Law and Teenage Member States?: The National Reception of EU Soft Law and How to Study It’ in M Eliantonio, E Korkea-aho and O Stefan (eds), EU Soft Law in the Member States. Theoretical Findings and Empirical Evidence (Hart Publishing 2021) 57-76; with regard to public health, see, in particular, W Weiss, ‘Pandemic and Administrative EU Soft Law: Persistent Challenges to the Rule of Law in the EU and Possible Solutions’ (2022) 15[1] Review of European Administrative Law 7.
From a legal perspective, even with the EHU, thus, the possibility of adopting delegated acts using a special legislative procedure
On delegated acts in EU law, see TFEU, art 290; concerning the interpretation of this Article, see eg, PJ Loewenthal, ‘Article 290 TFEU’ in M Kellerbauer, M Klamert, and J Tomkin (eds), The EU Treaties and the Charter of Fundamental Rights. A Commentary (n 31) 1917-1924.
—rather than that of adopting non-binding recommendations from the Commission whose legitimacy may be, moreover, subject to controversies
M Eliantonio and O Stefan, ‘The Elusive Legitimacy of EU Soft Law: An Analysis of Consultation and Participation in the Process of Adopting COVID-19 Soft Law in the EU’ (2021) 12[1] European Journal of Risk Regulation 159.
—would contribute to a better guaranteeing of the joint response to serious cross-border threats to health across the EU. In light of the wording of Article 290 TFEU, in conjunction with Article 168(2) TFEU, such a possibility with regard to the transnational aspects of the control of serious cross-border threats to health does not appear, at least a priori, excluded even under the existing model of separation of competences in the area of public health in the EU.

Recognition of Public Health Emergencies: Increasing Legitimacy of the Process

Regulation 2022/2371 also elaborates on rules on public health emergencies which may be recognized in response to serious cross-border threats to health at the EU level, the possibility first introduced under Decision 1082/2013/EU.
Decision 1082/2013/EU (n 52), art 12 et seq.; for a wider context, see eg Christian Kreuder-Sonnen, Emergency Powers of International Organizations. Between Normalization and Containment (Oxford University Press 2019).
Legally, the effects of the recognition of public health emergency under Regulation 2022/2371—whose list is non-exhaustive now
Regulation 2022/2371, art 25.
—can be more extensive than under Decision 1082/2013/EU.
Compare Decision 1082/2013/EU (n 52), art 13, and Regulation 2022/2371, art 25.
 Importantly, the recognition of public health emergency under Regulation 2022/2371 may, inter alia, result in the adoption of specific measures aiming at ensuring the adequate supply of medical countermeasures relevant to the management of the particular health emergency,
Regulation 2022/2371, art 25(a).
 pursuant to Regulation 2022/2372.
Regulation 2022/2372.
In contrast to the expansion of its legal effects, however, the recognition of public health emergencies continues to be predominantly vested with the Commission, without any direct involvement of the EP or the Council under Regulation 2022/2372.
ibid, art 23(1).
True, prior to the recognition, the Commission should consider expert reports issued by the ECDC, any other relevant EU agencies or bodies or the Advisory Committee on Public Health Emergencies, a special advisory body to the Commission.
On the composition and role of this body, see Regulation 2022/2371, art 24.
 Moreover, the Commission should also liaise with the World Health Organization in order to ‘share’ its analysis of the situation.
Regulation 2022/2371, art 23(3).
However, any expedited consultations with the EP or the Council are not foreseen in Regulation 2022/2371, steps which would undoubtedly enhance the legitimacy of the recognition
German Federal Assembly, 19th Legislature, ‘Befugnisse während Gesundheitsnotlagen auf EU-Ebene demokratisch gestalten’, Drucksache 19/29748 of 18 May 2021.
 and, in turn, increase the willingness of Member States and their citizens to fully comply with measures taken to cope with the public health emergency.
No less importantly, Regulation 2022/2371 does not prescribe any specific time-limit that would circumscribe the duration of public health emergencies recognized at the EU level or make their extensions subject to co-decision by another EU institutions.
The termination of the recognition is merely limited by the general requirement that the termination should happen where the condition that led to the recognition is no longer met, an appreciation left again with the Commission, see Regulation 2022/2371, art 23(2).
 In many domestic legal systems, such a model of a state of emergency would be viewed as uneasily reconcilable with the notion of the separation of powers.
On national level, there are usually constitutional checks on declarations of emergency which primarily consists in the requirement to obtain the consent from the Parliament, see eg C Bjørnskov and S Voigt, ‘The architecture of emergency constitutions’ (2018) 16[1] International Journal of Constitutional Law 101.
 Although in the EU, the notion of institutional balance is preferred to that of the separation of powers, even this notion does imply that ‘each of the institutions must exercise its powers with due regard for the powers of the other institutions’ and in respect thereof.
Recently, see Case C-29/22 P KS and KD v Council and Others [2024] ECLI:EU:C:2024:725, para 72.

Process of Coordination: Precautionary Principle

So far, the present article has focused on the procedural aspects of the coordination of national responses to serious cross-border threats to health in the EU. There are, however, also material aspects of this coordination which might be elaborated at the normative level.
Notably, when it comes to Regulation 2022/2371, there are very few mentions of the material principles on which the coordination of national responses to serious cross-border threats to health should be based as such.
Some of these principles are mentioned in the Preamble of Regulation 2022/2371 when it comes to the selected aspects of the operation of the whole health security framework, such as the assessment of risks to public health, see Regulation 2022/2371, recital 30; there are, however, scarcely any mentions of material principles applicable to the coordination of national measures as such, apart from the emphasis on the proportionality principle, see Regulation 2022/2371, recital 32.
 In this regard, it is particularly the precautionary principle which, in our view, merited highlighting.
In EU law, the concept of precaution is treated as a general principle of law.
J Zander, The Application of the Precautionary Principle in Practice. Comparative Dimensions (Cambridge University Press 2010) 76-151.
 It is applicable not only in EU environmental law, where it is well known, but ‘in the context of other EU policies, in particular the policy on the protection of public health’.
Case C-616/17 M. Blaise [2019] ECLI:EU:C:2019:800, para 41; doctrinally, see ia, M Klamert (n 36) 408-409.
 The ‘added value’ of this principle stems especially from the fact that it is capable of guiding public action at those stages when scientific evaluation does not allow for the risks associated with a particular agent to be determined with sufficient certainty.
Commission, ‘Communication from the Commission on the precautionary principle’ (Communication) COM (2000) 1 final 14.
 As such, the precautionary principle calls for public action where risks associated with the given agent do not appear as ‘acceptable’ to the society on which they are imposed and where the public non-action may have serious consequences, inter alia, for human health.
ibid 15.
 Under this principle, moreover, health concerns should outweigh economic considerations.
ibid 19.
 Furthermore, this principle implies an intense collection of new scientific data as it ceases to be applicable where the risks stemming from the given agent can be determined with precision or fail to demonstrate.
Case C-452/20 PJ [2022] ECLI:EU:C:2022:111, para 34.
It can be argued that the precautionary principle, as a general principle of EU law, may be applied even in the absence of any express reference to it.
K De Smedt and E Vos, ‘The Application of the Precautionary Principle in the EU’ in H A Mieg (ed), The Responsibility of Science (Studies in History and Philosophy of Science 57) (Springer, 2022) 163-186.
 However, in light of recent experience, the possibility to take recourse to (unwritten) general principles of law does not appear as sufficient. While the precautionary principle was formally fully applicable at the moment of the Covid-19 outbreak, there is not much evidence that it had any strong impact on the decision-making at the EU level.
As a principle which addresses the issue of ‘how to deal with scientific uncertainty in decision making’,
ibid 185.
 the precautionary principle could, thus, constitute one of the principal material starting points for the decision-making which occurs in the context of the coordination of national responses.

Process of Coordination: Restrictions of Free Movement of Persons

As demonstrated by the Covid-19 pandemic, the management of serious cross-border threats to health may require the adoption of measures which restrict free movement of persons. Leaving aside the impact of those restrictions on fundamental rights, it is the issue of effectively coordinating those measures between the Member States which especially matters at the EU level.
Formally, the cross-border restrictions on free movement of persons justified by the protection of public health are to be taken by Member States, pursuant to Article 45(3) and 52(1) TFEU.
See eg, M Kellerbauer and D Martin, ‘Article 46’ in M Kellerbauer, M Klamert, and J Tomkin (eds) (eds), The EU Treaties and the Charter of Fundamental Rights. A Commentary (n 31) 627-629 and J Tomkin, ‘Article 52’, ibid 678-679.
 When it comes to the role of the EU, it is empowered to adopt more detailed rules for purposes of coordinating the national rules concerning the restrictions of free movement under Article 52(2) TFEU. Simultaneously, however, the EU is precluded from harmonizing national rules concerning the protection of public health through legally binding acts.
See Article 6(a) and 168(5) TFEU, in conjunction with Article 2(5) TFEU; doctrinally, see eg, A M Pacces and M Weimer, ‘From Diversity to Coordination: A European Approach to COVID-19’ (2020) 11[2] European Journal of Risk Regulation 283, 286-287.
 During the Covid-19 pandemic, thus, the EU was able to recommend coordinated framework for free movement of EU citizens, including the restrictions of their entry in the territory of other Member States, notably through Council recommendations.
Council Recommendation (EU) 2020/1475 of 13 October 2020 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic [2020] OJ L 337/3; Council Recommendation (EU) 2022/107 of 25 January 2022 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic and replacing Recommendation (EU) 2020/1475 [2022] OJ L 18/110.
 However, the EU was largely barred from harmonising the corresponding rules in a binding way.
The only notable exception being Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic [2021] OJ L 211/1, which basically provided for the mutual recognition of the Covid-19 certificates issued by the Member States; this Regulation was legally based on Article 21(2) TFEU.
 In extension, the EU was also prohibited from harmonising the duration of quarantines or self-isolations related to Covid-19.
Apart from queries which may arise at the EU level over the permissible extent of the coordination of national restrictive measures by the EU institutions in face of serious cross-border threats to health, however, there are also uncertainties which individual Member States may face when considering the introduction of cross-border restrictions on free movement of persons on the grounds of the protection of public health and defining their scope.
Under Article 27(1) of Directive 2004/38 (‘Citizenship Directive’), in conjunction with Article 29(1) thereof, freedom of movement of EU citizens and their family members or, more precisely their right of entry and residence, may indeed be restricted on account of ‘diseases with epidemic potential as defined by the relevant instruments of the World Health Organisation and other infectious diseases or contagious parasitic diseases if they are the subject of protection provisions applying to nationals of the host Member State’. Read in light of Articles 30 and 31 of the Citizenship Directive, however, the provisions of this Directive seem to allow for restrictions only in individual cases, not for acts of general application which would restrict the right of entry and of residence collectively, with regard to a selected group of nationals of another Member States or those nationals as a whole. This appears to be evident all the more so that any exceptions to provisions on EU fundamental freedoms, such as free movement of persons, are to be interpreted strictly.
Case C-47/08 European Commission v Kingdom of Belgium [2011] ECLI:EU:C:2011:334, para 84.
Recently, however, the discussion over the proper interpretation of the Citizenship Directive at this sensitive point has been relaunched after the Court of Justice of the EU (‘CJEU’) delivered its judgement in Nordic Info BV.
Case C-128/22 Nordic Info BV v Belgische Staat [2023] ECLI :EU:C:2023:951, para 62.
 Although its main aim may have been to ex-post endorse Member States’ restrictive measures taken during the Covid-19 pandemic, the judgement seems to suggest Member States are allowed to restrict free movement of persons collectively, by means of measures of general application. Even if that reading of the judgement is correct, the CJEU simultaneously stressed that, when doing so, Member States must respect principles of legal certainty and good administration and, also, the right to an effective judicial remedy.
ibid, para 69.
Anyway, in order to remove all ambiguity, it would be advisable that the Citizenship Directive be specifically amended in order to expressly stipulate the Member States are allowed to restrict free movement of persons on the grounds of public health by means of generally binding measures which may be applied collectively. Simultaneously, adequate guarantees for affected groups of persons should be prescribed, in line with the principles highlighted by the CJEU. Moreover, the process of amendment of the Citizenship Directive might also create an opportunity for revisiting the precise role of the EU and its institutions in coordinating restrictions of free movement of persons in the Member States although it is undoubtedly a sensitive area in which the competences of the EU and those of the Member States are intertwined in a rather complex way.
Interestingly, such a legislative evolution would actually match with that which took place in the case of the Schengen Border Code
Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) [2016] OJ L 77/1.
 and which concerns collective restrictions on free movement of the third country nationals.
Originally, the Schengen Border Code allowed only for individual restrictions, including on the grounds of the protecting public health; however, Regulation (EU) 2024/1717 of the European Parliament and of the Council of 13 June 2024 amending Regulation (EU) 2016/399 on a Union Code on the rules governing the movement of persons across borders, [2024] OJ L 1717/1, has recently provided for temporary general restrictions on travel to the EU and, also, temporary health-related restrictions, including testing, quarantine and self-isolation in case of ‘large-scale public health emergency’.

Conclusion

With the EHU, the joint response to serious cross-border threats to health is likely to be more vigorous at the EU level than at the onset of the Covid-19 pandemic.
When it comes to the actual process of coordinating national responses to serious cross-border threats to health at the EU level, however, even with the EHU, this process retains largely intergovernmental nature. This nature implies that this process and the implementation of its outcomes may still get easily politicized, depending on the priorities and preferences of the respective Member States. Consequently, especially in the case of the novel serious cross-border threats to health on which opinions may differ, the prospect of the timely and coordinated response to such threats at the EU level—the key guarantee against the unilateral and fragmented response to such threats by 27 Member States—does not have to be as immediate as expected.
In order to minimize the risks of the unilateral responses to serious cross-border threats to health in the EU, the effectiveness of the process of coordination of national responses to serious cross-border threats to health at the EU level could be enhanced further. In particular, more detailed rules could be introduced with regard to the temporal aspects of the coordination process itself, to the effects of its outcomes or to resolving deadlocks over the coordinated response provided that they occurred in the HSC. Similarly, steps to strengthen the effectiveness of acts on common temporary public health measures issued by the Commission might be reflected upon while the legitimacy of recognizing public health emergencies at the EU level could be increased through a more direct involvement of the EP and the Council. Material principles governing the process of coordination of national responses, including the precautionary principle, could also be expressly highlighted in EU secondary law and so could be the principles applicable to restrictions of free movement of persons on account of the protection of public health and, notably, combating serious cross-border threats to health through measures of general application.
However, apart from developing the new EU health security framework, it is also clear that, even 5 years since the outbreak of the Covid-19 pandemic, further discussion over the separation of competences in tackling serious cross-border threats to health in the EU is needed. Although most of the existing elements of the EHU were put into life based on the existing wording of the provisions of the Treaties, the fact the EU possesses only complementary competences in the area of combating serious cross-border threats to health continues to limit how far the process of coordination of national responses to these threats at the EU level can actually go and how effectively the outcomes of the process of the coordination can be enforced.
On the issue of the EU’s competences in the area of public health, the truth is that many shifts may happen–and indeed have happened–even in the context of the existing model of the separation of competences, see eg, K Purnhagen and others, ‘More Competences than You Knew? The Web of Health Competence for European Union Action in Response to the COVID-19 Outbreak’ (2020) 11[2] European Journal of Risk Regulation 297; M Blanquet and N de Grove-Valdeyron, ‘La compétence de l’Union vis-à-vis des menaces transfrontières graves de santé publique à l’épreuve de la COVID-19’ (2020) 31[1] Revue des affaires europeennes 9; at the political level, in the wake of the Conference for Future of Europe, however, there has been a significant call for extending the EU’s powers, notably by the European Parliament which proposed to establish ‘shared competences on public health matters and the protection and improvement of human health, especially cross-border health threats’, see, notably, EP, ‘Resolution on proposals of the European Parliament for the amendment of the Treaties’ P9_TA(2023)0427 of 22 November 2023.
 If the EU and its institutions were conferred shared competence with respect to combating serious cross-border threats to health, such a step would palpably expand the EU’s direct legal, and operative capacities to uniformly prevent risks related to serious cross-border threats to health or to control them. The truth is that any transformation in this regard would be felt as politically sensitive by the Member States and be subject to a demanding procedure for amendment of the EU Treaties. Interestingly enough, little attention has been attributed so far to measures which could minimize the unwillingness of the Member States to extend the competences of the EU in this area, such as the introduction of special decision-making, and legislative procedures.
Be it as it may, while their urgency has been recently somewhat overshadowed by other urgent issues,
‘The job no one wants: EU health commissioner’ (Politico.eu, 13 September 2024) <https://www.politico.eu/article/european-commission-health-commissioner-health-policy-funding/> date accessed 20 November 2024.
 serious cross-border threats to health still pose significant risks for the EU and its Member States.
‘Another pandemic is “absolutely inevitable”’, says Patrick Vallance’ (The Guardian, 25 May 2024) <https://www.theguardian.com/uk-news/article/2024/may/25/another-pandemic-is-absolutely-inevitable-says-patrick-vallance-covid> date accessed 20 November 2024.
 Moreover, the seriousness of these threats has been increased due to the consequences of the armed conflicts taking place in the very neighbourhood of the EU.
‘Wars are breeding superbugs that will spread “everywhere”’ (Politico.eu, 12 September 2024) <https://www.politico.eu/article/war-ukraine-gaza-superbugs-spread-who-amr-global-emergency/> date accessed 20 November 2024.
 Serious cross-border threats to health can, thus, materialize in the EU again. In that event, the risk is that, in the absence of an effective, timely and coordinated response at the EU level, the old prediction attributed to Louis Pasteur that ‘c’est les microbes qui auront le dernier mot’ may (anew) come true.


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