The International Health Regulations (IHR) are the major international agreement dealing with cross-border health threats (A). The influence of the European Union regarding the IHR has been limited by the text of this international agreement, which does not allow regional organisations to become contracting parties. Such a barrier is a major difficulty for a successful global role in the area of cross-border health threats, and it could be argued that the EU has only played an accessory role at the multilateral level. However, while the European Union has not been able to ratify the IHR, it has managed to get a voice in the negotiation process, and it has played a significant role in its implementation within its internal legal order (B). The achievements of the Union in this area are nonetheless limited and the global legal order has had a greater influence in the one of the Union than the other way around. The final paragraph thus examines whether the role of the EU at the multilateral level could be reinforced, taking the prospects of the IHR into account (C).
137 A. The International Health Regulations as a multilateral response to cross-border health
threats
The IHR are the modified version of the International Sanitary Conventions of 1892, 1897 and 1903 and of the International Sanitary Regulations of 1951.641 The first IHR were adopted in 1969, but the current version dates from 2005 and entered into force on 15 June 2007. All these instruments are intended to respond to infectious diseases and highlight the relevance of this burden in international law.
The IHR are a binding international legal instrument. Together with the Framework Convention on Tobacco Control,642 these are the only two international agreements adopted by the WHO so far.643 The purpose of the IHR is ‘to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade’.644
Previous versions of the IHR limited the scope of application to an exhaustive list of diseases.
In the most recent version of the regulations prior to the adoption of the IHR of 2005, the list included cholera, plague and yellow fever. However, with the emergence of HIV/AIDS and the advent of SARS, it became obvious that a revision of the scope of application was needed. An
‘all-hazards’ strategy was embraced by the revised version of the IHR.645 The IHR of 2005 do not limit the scope of application to specific diseases or forms of transmission but instead cover
‘illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans’.646 This formulation allows the text to be relevant in the long term despite the continued evolution of diseases.647
One of the most important elements established in the IHR is the determination of public health emergencies of international concern (PHEIC). These are extraordinary events constituting public health risks to other States and requiring a coordinated international
641 See supra, Part II, Section I, I, A.
642 WHO Framework Convention on Tobacco Control, Geneva, 16 June 2003, 2302 UNTS 166; Council Decision 2004/513/EC of 2 June 2004 concerning the conclusion of the WHO Framework Convention on Tobacco Control, OJ L 213 of 15 June 2004, p. 8 (Decision 2004/513).
643 Apart from the Nomenclature Regulations; see Gian Luca BURCI and Claude-Henri VIGNES, The World Health Organization (The Hague/London/New York, Kluwer Law International, 2004), pp. 132-134.
644 Article 2 IHR.
645 Lawrence O. GOSTIN and Rebecca KATZ, ‘The International Health Regulations: The Governing Framework for Global Health Security’ (2016) 94(2) The Milbank Quarterly 264, pp. 266-267.
646 Article 1 (1) IHR.
647 Foreword IHR, p. 2.
138 response.648 The difficulty lays in evaluating whether, in a specific case, an event constitutes a PHEIC. Different situations might arise. If a State considers that an event constitutes a public health emergency of international concern, it has to notify the WHO within 24 hours of assessment of public health information.649 A State party might also decide that there is insufficient information to consider that there is a public health emergency but it may keep the WHO advised.650 The WHO can decide that an event constitutes a PHEIC by taking into account other reports and sources of information, such as NGOs or the media. In this case, the WHO seeks verification from the State where the event occurs.651 In all cases, it is solely for the WHO Director-General to officially determine whether an event constitutes a PHEIC and to take appropriate measures.652 Those measures can consist either of temporary recommendations or standing recommendations.653
Since 2007, the WHO Director-General has declared five public health emergencies of international concern: during the 2009 H1N1 influenza pandemic; for polio and Ebola in 2014;
in the case of the Zika virus in 2016; and during the COVID-19 outbreak in 2020. However, in all those cases the WHO was criticised either for over-reacting or for under-reacting. During the H1N1 influenza pandemic, it was considered that the WHO was fuelling public fear and many State Parties disregarded its recommendations. In the case of polio, the declaration of a PHEIC surprised some State Parties, as there had not been an increased number of cases compared to other years. During the Ebola outbreak, the WHO Director-General was criticised for waiting too long before declaring a public health emergency of international concern. It was only four months after the outbreak declaration by Médecins Sans Frontières.654 Concerning the Zika case, a public health emergency of international concern was declared very quickly.655 However, this declaration was not followed by an effective action plan to fight the virus.656 The declaration of COVID-19 as a PHEIC has also been considered too slow. The WHO declared a public health emergency on 30 January 2020 despite numerous warnings from experts for
648 Article 1 (1) IHR.
649 Article 6 (1) IHR.
650 Article 8 IHR.
651 Articles 9-10 IHR.
652 Article 12 IHR.
653 Articles 15-16 IHR.
654 Editorial, ‘Ebola: What Lessons for the International Health Regulations?’ (2014) 384 The Lancet 1321, p.
1321; Lawrence O. GOSTIN, Mary C. DE BARTOLO and Eric A. FRIEDMAN, ‘The International Health Regulations 10 Years On: The Governing Framework for Global Health Security’ (2015) 386 The Lancet 2222, p. 2222.
655 Belinda BENETT and Terry CARNEY, ‘Public Health Emergencies of International Concern: Global, Regional, and Local Responses to Risk’ (2017) 25(2) Medical Law Review 223, p. 229.
656 Lawrence O. GOSTIN, ‘The WHO Has Not Done Enough to Fight Zika’, Time, 2 February 2016, available at http://time.com/4204079/who-zika/ (last accessed 15 December 2016).
139 several weeks.657 It can be questioned whether the procedure to declare a PHEIC is properly addressed in the International Health Regulations or whether a more systematic approach should be sought.
In addition to the rules on the determination of the existence of a PHEIC, the IHR also provide preventive measures. These include the obligation for States to develop the capacity to respond to emergencies within five years since the entry into force of the IHR,658 hygiene measures at the borders,659 and public health measures for travellers.660
The IHR were developed as a multilateral instrument to fight against cross-border health threats. As a unique international agreement in this area, it was the perfect opportunity for the European Union to shape international rules in the field and to promote its own standards at the global level. Yet, the Union has not seized this opportunity.
B. EU participation in the negotiation and implementation of the IHR
The participation of the European Union in the negotiation and conclusion of the IHR was limited by the rules applicable to that international agreement. The WHO Constitution provides that regulations adopted by the World Health Assembly shall come into force for all WHO members except for those that notify their rejection or that make reservations.661 As a general rule, only WHO members may become contracting parties to a WHO regulation. Exceptionally, States that are not members of the WHO but that notify the acceptance of the IHR may also become contracting parties to this agreement.662 The European Union is neither a member of the WHO nor a State, and thus could not become a contracting party to the IHR. The impossibility for the Union to become a contracting party to the IHR constituted a significant limit, as the scope of the IHR could overlap some areas of EU competence.663
As a solution to the difficulties resulting from the text of the IHR, the European Union managed to obtain some special arrangements allowing it to participate in the negotiations (1).
However, the negotiation of the IHR underlines the limited influence of the European Union in the global promotion of public health standards on cross-border health threats. This case study
657 David N. DURRHEIM, Laurence O. GOSTIN, Keymanthri MOODLEY, ‘When Does a Major Outbreak Become a Public Health Emergency of International Concern?’ (2020) 20(8) The Lancet Infectious Diseases 887.
658 Article 13 IHR.
659 Articles 19-22 IHR.
660 Articles 23 and 30-32 IHR.
661 Article 22 WHO Constitution, read in conjunction with Article 21.
662 Article 64 (1) IHR.
663 Gian Luca BURCI, ‘The European Union and World Health Organization: Interactions and Collaboration from a Governance and Policy Perspective’ in Christine KADDOUS (ed), The European Union in International Organisations and Global Governance: Recent Developments (Oxford/Portland, Hart Publishing, 2015), p. 167.
140 further proves that the influence has actually gone in the opposite direction. The Union has actively implemented the IHR in the EU legal order and this international agreement has accordingly had a strong impact in EU legislation on cross-border health threats (2).
1. EU participation in the negotiation of the IHR
While the European Union could not become a contracting party to the IHR, the memorandum attached to the exchange of letters between the EU and the WHO opens the door to the participation of the Union in the negotiation of international agreements.664 It grants the WHO Director-General the power to draw the attention of the competent governing body to the question of ‘the participation of the Commission on the work of that body in specific cases, such as, for example, the negotiation of international agreements and on the status of the European Communities under such agreement’.665 This possibility was used in the case of the IHR.
The legal basis for the participation of the Union in the negotiation of the IHR can be found in the Resolution of the World Health Assembly on the Revision of the International Health Regulations.666 This document provided that ‘regional economic integration organizations constituted by sovereign States, members of WHO, to which their Member States have transferred competence over matters governed by this resolution, including the competence to enter into international legally binding regulations, may participate, in accordance with Rule 55 of the Rules of Procedure of the World Health Assembly, in the work of the intergovernmental working group referred to under paragraph (1)’.667
In the EU side, the European Commission adopted a communication in September 2003 on the revision of the IHR.668 As several areas of Union activity overlapped with the objectives of the revised IHR, the Union needed to be strongly involved in the negotiation.669 Some of the areas concerned with Union activity were food safety, restrictions on trade, transport or civil
664 Exchange of letters between the World Health Organisation and the Commission of the European Communities concerning the consolidation and intensification of cooperation - Memorandum concerning the framework and arrangements for cooperation between the World Health Organisation and the Commission of the European Communities, OJ C 1 of 4 January 2001, p. 7 (Exchange of letters and Memorandum).
665 Section D, para. 1(4), Memorandum.
666 World Health Assembly, Revision of the International Health Regulations, 28 March 2003, Resolution WHA56.28 (Resolution WHA56.28).
667 Ibid., para. 2 (2).
668 European Commission, COM(2003) 545 final.
669 Ibid., para. 11.
141 protection.670 The revised IHR should also be compatible with the EWRS and the ECDC.671 The European Commission concluded that the Union and the Member States should work in close cooperation and in a coordinated manner.672 Regarding the practical implications of this decision, the European Commission and EU Member States should take part in the deliberations and play an active and leading role in the revision process to obtain an international agreement in accordance with the Community acquis.673 The European Commission would coordinate with the technical experts from Member States in the areas of EU competence.674 It would also coordinate with Member States and would participate alongside with them during the regional meetings organised by the WHO to ensure a coordinated position.675 This communication was endorsed by the Council in April 2004 and the European Commission was authorised to open negotiations on the revision of the IHR shortly after that.676
The arrangements coming from the WHO and from the EU itself allowed the participation of the Union in the negotiation of the IHR. The representation of the Union was ensured either by the Europen Commission or by the Presidency of the Council depending on the topic under discussion.677 The participation in the negotiation is as a significant achievement for the European Union, considering the initial circumstances. However, the role of the European Union during the negotiation phase has been described as essentially one of facilitation and coordination between EU Member States.678 The Member State holding the Presidency of the Council usually organised coordination meetings before any negotiation session. In those preliminary meetings, the European Commission prepared documents on the EU position for each issue to be discussed in the negotiations and on the speaking rules to coordinate who would
670 Ibid., para. 24.
671 Ibid., paras. 25-27. The ECDC did not exist yet at the time but its establishment was provided for in Decision No 2119/98 and a regulation on its creation was proposed by the Commission precisely in 2003; see European Commission, COM(2003) 441 final.
672 European Commission, COM(2003) 545 final, p. 10.
673 Ibid., p. 10, para. 1.
674 Ibid., p. 10, para. 3.
675 Ibid., p. 10, paras. 4-5.
676 European Commission, Adaptation of the Council Decision Authorising the Commission to Open Negotiations on the Revision of the International Health Regulations under the Framework of the WHO, 20 April 2004, SEC(2004) 475.
677 Barbara EGGERS and Frank HOFFMEISTER, ‘UN-EU Cooperation on Public Health: The Evolving Participation of the European Community in the World Health Organization’ in Jan WOUTERS, Frank HOFFMEISTER and Tom RUYS (eds), The United Nations and the European Union: An Ever Stronger Partnership (The Hague, TMC Asser Press, 2006), p. 165.
678 Didier HOUSSIN, ‘The EU’s Role in the International Health Regulations and the Pandemic Influenza Preparedness Framework Agreement’ in Thea EMMERLING, Ilona KICKBUSCH and Michaela TOLD (eds), The European Union as a Global Health Actor (Singapore, World Scientific Publishing, 2016), p. 275.
142 intervene. Cooperation between the European Commission and Member States has been considered effective in the negotiation of the IHR.679
Despite the involvement of the European Union in the negotiation of the IHR, only WHO members could vote on the final agreement under Articles 2 (k) and 21 of the WHO Constitution. Accordingly, the Council authorised Member States to accept the final text in the interest of the Union, and the Union has unilaterally declared to fully apply the IHR.680
The role of the European Union during the negotiation of the IHR was weak and the influence of the Union in the final text of the agreement has been limited. Although its participation was allowed, the EU mostly filled a coordination role among Member States. The influence of the IHR in the EU legal order was comparatively greater. As several areas covered by the IHR are of EU competence, the Union has implemented many of the rules contained in the IHR.
2. EU role in the implementation of the IHR
The European Union is fully committed to the IHR. In 2006, the European Commission published a communication on the implementation of this international agreement.681 This document underlines the interest of the European Union in the good implementation of the IHR.
It first submits that Article 57 (3) of the regulations requires State Parties members of a regional economic integration organisations to apply the common rules in force in such organisation in their mutual relations. Such obligation notably arises where the IHR deals with matters of Union competence. The European Commission stresses that such is the case in relation to rules on the processing of personal data, in transport matters or in trade issues.682
Where the IHR require Member States to adopt measures that could have an impact on EU law, the Union should act collectively at the initiative of the European Commission.683 The IHR need to be implemented in a coordinated manner in the EU to respect the principle of unity in international representation.684 Consequently, the communication requires the adoption of a memorandum of understanding between the Union and the WHO to ensure the proper
679 Barbara EGGERS and Frank HOFFMEISTER, ‘UN-EU Cooperation on Public Health’, op. cit., p. 166.
680 Ibid., p. 168.
681 European Commission, The International Health Regulations, 26 September 2006, COM(2006) 552 final (European Commission, COM(2006) 552 final).
682 Ibid., p. 4.
683 Idem.
684 Ibid., p. 7. See Opinion of the Court of 19 March 1993 in Opinion 2/91 Convention No 170 ILO on safety in the use of chemicals at work, EU:C:1993:106, para. 36; Opinion of the Court of 15 November 1994 in Opinion 1/94 Agreements annexed to the WTO Agreement, EU:C:1994:384, para. 108.
143 implementation of the IHR.685 Such memorandum of understanding was concluded between the Europe regional office of the WHO and the ECDC in 2005, and an administrative arrangement was adopted in 2011. The collaboration between both organisms focuses on communicable diseases surveillance, prevention and control, on the one hand, and on the use of the IHR to prevent and respond to health threats, on the other hand.686
Where a common EU response is necessary, the European Commission tries to conciliate in its communication the alert mechanisms at the international and at the EU levels. The EWRS and the PHEIC systems are similar.687 Consequently, the communication of a health threat should be done simultaneously at both levels, and EU instruments should be used to coordinate alerts and responses within the Union before getting to the international level.688 In order to reach this degree of coordination, several measures had to be adopted. The scope of application of the EWRS was enlarged in Decision No 1082/2013 in order to make it compatible with the PHEIC system and to avoid the duplication of some tasks.689 The EWRS is thus not only applicable to communicable diseases, as it was in its origin, but also to other health threats.690 Reciprocally, the WHO is part of the network established by the EWRS since the adoption of the IHR, and therefore collaborates with the European Union.691
The ECDC is granted significant powers regarding the implementation of the IHR. It provides expertise in the field of cross-border health threats, undertakes surveillance activities, decides when a health threat requires IHR notification, and assists Member States in the implementation of the international rules.692
All these measures confirm the strong commitment of the European Union towards the IHR, but they do not imply any significant influence of the Union at the international level. However, in its communication, the European Commission also proposes a number of EU experts that
685 Idem.
686 World Health Organization, WHO/Europe and the ECDC intensify collaboration on infectious diseases and health emergencies, 19 January 2018, available at http://www.euro.who.int/en/health-
topics/emergencies/international-health-regulations/news/news/2018/01/whoeurope-and-ecdc-intensify-collaboration-on-infectious-diseases-and-health-emergencies (last accessed 31 January 2020); European Centre for Disease Prevention and Control, Minutes of the Twenty-first Meeting of the ECDC Management Board,
topics/emergencies/international-health-regulations/news/news/2018/01/whoeurope-and-ecdc-intensify-collaboration-on-infectious-diseases-and-health-emergencies (last accessed 31 January 2020); European Centre for Disease Prevention and Control, Minutes of the Twenty-first Meeting of the ECDC Management Board,