Internal fragmentation in EU public health

The use of a variety of legal bases to legislate on public health generates a strong institutional fragmentation. On the one hand, EU institutions will be involved in different manners depending on the act at stake and different services within an institution will be involved in

226 The possibility for the EU to participate in an international organisation depends both on its competence to act in the field covered by the organisation and on whether the constitutional charter of the organisation allows regional economic integration organisations to participate; see Christine KADDOUS, ‘The European Union in International Organisations – Functional Necessity or General Aspiration?’ in Christine KADDOUS (ed), The European Union in International Organisations and Global Governance: Recent Developments (Oxford and Portland, Hart Publishing, 2015), pp. 7-13; Bart VAN VOOREN and Ramses A. WESSEL, EU External Relations Law: Text, Cases and Materials (Cambridge, Cambridge University Press, 2014), pp. 247-248.

50 accordance with the legal basis of the measure. The role of the European Parliament will vary and the Directorate General (DG) involved within the European Commission will change.

These elements reveal an inter-institutional and an intra-institutional fragmentation (A). On the other hand, the increasing role of agencies in the EU system encompasses a new source of fragmentation, as several agencies deal with public health matters. EU agencies do not only bring new actors to the institutional framework, but they also pose fundamental questions on the legal nature of the acts they adopt. Despite these concerns, the active role of health-related agencies and their international dimension are also seen as interesting opportunities (B).

A. Inter-institutional and intra-institutional fragmentation

EU institutions are increasingly engaged in public health discussions. This leads to a lack of coordination that may create two sorts of problems: an inter-institutional fragmentation, where all institutions are willing to take the lead in the development of a policy field (1); and an intra-institutional fragmentation, as several divisions within an institution may get involved in the adoption of specific measures (2).

1. Inter-institutional fragmentation

EU public health is characterised by the adoption of measures by numerous actors, leading to an inter-institutional fragmentation. The Bovine Spongiform Encephalopathy (BSE) crisis revealed the lack of coordination among involved parties (a). This outbreak resulted in institutional changes that contributed to a better-established structure. Yet, the participation of all EU institutions and Member States to the development of this policy still leads to fragmented actions (b).

a. The BSE crisis as a turning point in the institutional structure of EU public health The BSE crisis that occurred in the 1990s illustrates the damaging effect of a lack of coordination in EU public health actions.²²⁷ At the time, no provision on public health protection existed in the Treaties and EU institutions had to deal with this event with the available tools. The European Commission adopted several measures to fight against BSE, essentially introducing export bans and restrictions on bovine products from the United Kingdom. The measures were strongly criticised by different actors. These conflicts reveal some of the difficulties that come with the lack of clear EU powers in public health.

227 See Keith VINCENT, ‘“Mad Cows” and Eurocrats – Community Responses to the BSE Crisis’ (2004) 10(5) European Law Journal 499.

51 The European Parliament put in place an investigation committee and applied a ‘conditional motion of censure’ on the European Commission.²²⁸ In 1996, a few years after the emergence of the BSE outbreak, the European Parliament set up a temporary Committee of Inquiry that led to a report in relation to BSE.²²⁹ This report provided that the European Commission ‘ha[d]

given a priority to the management of the market, as opposed to the possible human health risks existing in the light of the numerous scientific uncertainties concerning the possible effects of the BSE on humans’.²³⁰ It further noted coordination problems with the Scientific Advisory Committee set up as a result of the outbreak. The report also highlighted the late response of the European Commission and the opaqueness and complexity of the commitology system. It revealed a ‘disinformation’ policy carried out by the European Commission that had implied misleading public opinion, suspending the legislative activity on BSE and debates on the crisis, and preventing France and Germany from restricting the import of British beef.²³¹

The Court of Auditors issued two special reports on the control and regulation of the BSE crisis.²³² It raised problems within the EU system of governance and required the European Commission to be given emergency powers to avoid having to follow the lengthy and complex legislative procedure when a crisis emerged.

The role of the CJEU was crucial in delimiting powers between the Union and the Member States during the BSE crisis. In the BSE case and the NFU case judgments, Commission Decision 96/239/EC on emergency measures to protect against BSE was challenged.²³³ The United Kingdom contested the European Commission’s ability to adopt measures to stop the spread of BSE through an export ban from the United Kingdom to other Member States and to

228 Thea EMMERLING, ‘The EU as an Actor in Global Health Diplomacy’ in Ilona KICKBUSCH, Graham LISTER, Michaela TOLD and Nick DRAGER (eds), Global Health Diplomacy: Concepts, Issues, Actors, Instruments, Fora and Cases (New York, Springer, 2013), p. 225.

229 European Parliament, Temporary Committee of Inquiry into BSE, Report on alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts, 7 February 1997, A4-0020/97 (BSE Report); followed by European Parliament, Temporary Committee instructed to monitor the action on the recommendations made concerning the BSE, Report on the European Commission’s follow-up of the recommendations made by the Committee of Inquiry into BSE, 14 November 1997, A4-0362/97.

230 BSE Report, A I, part I.4.1.

231 Ellen VOS, ‘EU Food Safety Regulation in the Aftermath of the BSE Crisis’ (2000) 23 Journal of Consumer Policy 227, p. 232.

232 Court of Auditors, Special Report No 19/98 concerning the Community financing of certain measures taken as a result of the BSE crisis, accompanied by the replies of the Commission, OJ C 383 of 9 December 1998, p. 1;

Court of Auditors, Special Report No 14/2001 Follow up to Special Report No 19/98 on BSE, together with the Commission’s replies, OJ C 324 of 20 November 2001, p. 1.

233 Commission Decision 96/239/EC on emergency measures to protect against bovine spongiform encephalopathy, OJ L 78 of 28 March 1996, p. 47.

52 third countries. The decision had been adopted on the basis of Directives 90/425 and 89/662.²³⁴ The United Kingdom pleaded that these instruments did not grant the power to adopt an export ban to third countries. The Court ruled that such ban was valid under EU law. The objective of the directives was to enable the European Commission to intervene rapidly in the event of a disease. These directives authorised the European Commission to adopt all necessary measures, including an export ban, to fight against the spread of disease.²³⁵ The Court added that the European Commission enjoyed a wide margin of discretion as to the nature and extent of the measures to be adopted.²³⁶

The role played by EU institutions during the BSE crisis highlighted that the definition of the powers conferred to the European Commission in EU public health and the delimitation of powers between the Union and the Member States were not clear. It also revealed shortcomings in the way the European Commission should undertake its functions. Consequently, the European Commission was reorganised. Prior to the BSE crisis, the scientific committees set up by the European Commission felt under the responsibility of several Directorate Generals.

In 1997, the European Union endeavoured an integration process through the establishment of a DG on Consumer Policy and Consumer Health Protection.²³⁷ However, the limited EU competence in public health still makes EU actions fragmented under the current legislative framework.

b. Role of EU institutions in public health

The organisation of EU public health activities has strongly evolved since the BSE crisis.

Article 168 TFEU now defines the role of EU institutions and Member States. However, coordination among all actors involved remains difficult and some gaps are still observed.

In accordance with Article 168 TFEU, the Union shall encourage cooperation between Member States, and these shall coordinate among themselves their policies and programmes.²³⁸ The Council plays an essential role at coordinating national positions in public health matters.

This coordinating role of the Council has been experienced during the COVID-19 pandemic,

234 Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market, OJ L 395 of 30 December 1989, p. 13; Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra- Community trade in certain live animals and products with a view to the completion of the internal market, OJ L 224 of 18 August 1990, p. 29.

235 Judgment of the Court of 5 May 1998 in Case C-157/96 National Farmers’ Union (NFU case), EU:C:1998:191, paras. 30-37; BSE case, paras. 51-59.

236 NFU case, para. 39; BSE case, para. 60.

237 European Commission, Consumer Health and Food Safety, 30 April 1997, COM(97) 183 final.

238 Article 168 (2) TFEU.

53 where frequent meetings of health ministers have been held.²³⁹ These meetings aimed at avoiding isolated actions of EU Member States. The Council has also activated the integrated political crisis response (IPCR), a mechanism used to coordinate the political response to major crises.²⁴⁰ The IPCR brings together members of the European Council, the European Commission, the European External Action Service (EEAS), affected Member States and other relevant parties. It facilitiates the monitoring of a crisis, information sharing, and the adoption of measures.²⁴¹

The European Commission, under its executive role, is a powerful institution in EU public health. It initiates the adoption of legislation and has a specific Directorate-General for health and food safety, DG SANTE. The European Commission proposes EU public health programmes, which are the most relevant instrument in EU public health. They define public health priorities for several years. Three programmes have been adopted until now and the fourth one is currently under negotiation.²⁴² When a legislative initiative is proposed by the European Commission, the ordinary legislative procedure is followed, with the participation of the Council and the European Parliament.²⁴³

The European Parliament plays a role beyond its participation in the legislative procedure.

This institution has been essential at recalling the importance of taking public health into account in all EU activities and controlling other EU institutions when carrying out their tasks.

The above-mentioned role of the European Parliament during the BSE crisis illustrates this

239 See, for example, Council of the European Union, Council Conclusions on COVID-19, 13 February 2020, 6038/20. Following the adoption of these conclusions, the Council held regular videoconferences with all EU Member States.

240 Council of the European Union, Croatian Presidency activates EU’s Integrated Crisis Response in relation to corona virus, 28 January 2020, available at https://eu2020.hr/Home/OneNews?id=160 (last accessed 17 August 2020); Council of the European Union, COVID-19 outbreak: the presidency steps up EU response by triggering full activation mode of IPCR, 2 March 2020, available at https://www.consilium.europa.eu/en/press/press- releases/2020/03/02/covid-19-outbreak-the-presidency-steps-up-eu-response-by-triggering-full-activation-mode-of-ipcr/ (last accessed 17 August 2020).

241 Council Implementing Decision (EU) 2018/1993 of 11 December 2018 on the EU integrated Political Crisis Response Arrangements, OJ L 320 of 17 December 2018, p. 98; Council of the European Union, The Council’s response to crises (IPCR), available at https://www.consilium.europa.eu/en/policies/ipcr-response-to-crises/ (last accessed 17 August 2020).

242 Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008), OJ L 271 of 9 October 2002, p. 1;

Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the field of health (2008-13), OJ L 301 of 20 November 2007, p. 3;

Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme for the Union's action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC, OJ L 86 of 21 March 2014, p. 1; Proposal for a Regulation of the European Parliament and of the Council on the establishment of a Programme for the Union's action in the field of health –for the period 2021-2027 and repealing Regulation (EU) No 282/2014, 28 May 2020, COM(2020) 405 final.

243 Article 168 (5) TFEU.

54 statement. The European Parliament has also recalled the importance of public interests, notably public health, in the negotiation and conclusion of free trade agreements.²⁴⁴

The CJEU has been crucial at defining and developing EU public health. It has delimited powers between the Union and its Member States in this area,²⁴⁵ it has confirmed the importance of public health in other EU policies and activities,²⁴⁶ and it has defined some of the most relevant principles in EU public health, such as the precautionary principle.²⁴⁷

Recent outbreaks reveal that other EU institutions might also get involved in public health, although not expressly mentioned in Article 168 TFEU. The EEAS has provided humanitarian aid during the Ebola outbreak or the COVID-19 pandemic. It has also established a so-called

‘Team Europe’ combining resources from the EU, its Member States, and financial institutions to support third countries in their fight against the coronavirus pandemic.²⁴⁸ The European Central Bank has adopted measures to contain the negative economic consequences of the COVID-19 pandemic.²⁴⁹ The involvement of institutions not expressly mentioned in Article 168 TFEU is the result of the use of a variety of legal bases in EU public health. It reveals the complexity of this area and makes the examination of EU public health actions significantly difficult.

Alongside the role of EU institutions, the participation of Member States needs to be underlined, as the latter retain most of the powers in public health matters. They are repeatedly mentioned in Article 168 TFEU and they are primarily responsible for public health actions.

While the Union might adopt legislation, it does not harmonise national measures. The example of border health threats illustrates this situation. Decision No 1082/2013 on serious cross-border health threats lays down rules to prevent and control public health outbreaks.²⁵⁰ However, this instrument exclusively aims at supporting cooperation and coordination between Member States.²⁵¹ To reach coordination, Decision No 1082/2013 highlights the role of the

244 See infra, Part III, Section I, II, B.

245 BSE case; NFU case.

246 See all the case law on the choice of the legal basis; see supra, Part I, Section I, II.

247 See infra, Part III, Section I, I, A.

248 European External Action Service, Stronger together against COVID-19, available at https://eeas.europa.eu/headquarters/headquarters-homepage/76341/coronavirus-latest-updates-eeas_en (last accessed 17 August 2020).

249 European Central Bank, Our response to the coronavirus emergency, 19 March 2020, available at https://www.ecb.europa.eu/press/blog/date/2020/html/ecb.blog200319~11f421e25e.en.html (last accessed 17 August 2020).

250 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, OJ L 293 of 5 November 2013, p. 1 (Decision No 1082/2013).

251 Article 1 (2) Decision No 1082/2013.

55 Health Security Committee, an organism composed of representatives from all Member States.²⁵² The Health Security Committee has met regularly throughout the COVID-19 pandemic, for example, in order to share information among Member States. Under Decision No 1082/2013, the European Centre on Disease Prevention and Control (ECDC) oversees surveillance of cross-border health threats, based on the information provided by national authorities.²⁵³ This decision therefore reflects the necessary coordination between Member States and EU institutions and organisms.

Many actors are involved in EU public health. While most of them are mentioned in Article 168 TFEU, the use of other legal bases to adopt public health measures brings new, and sometimes unexpected, actors. The participation of numerous institutions in EU public health can be enriching but it also adds a layer of complexity. The use of a variety of legal bases also implies that public health measures will be adopted under numerous policy fields. This results in a variety of services within each institution being involved in public health matters, leading to an intra-institutional fragmentation.

2. Intra-institutional fragmentation

The use of different legal bases to adopt public health legislation has resulted in the involvement of different policy fields and consequently of different DGs within the European Commission.²⁵⁴ The most involved DG in public health matters is of course DG SANTE.

However, we can also mention the role of DG ENV (environment), DG JUST (justice and consumers), DG GROW (internal market, industry, entrepreneurship and SMEs) or DG EMPL (employment, social affairs and inclusion), amongst others. Furthermore, several DGs are involved in the global promotion of public health. In addition to the above-mentioned directorates, we can highlight the role of DG TRADE, DH ECHO (European civil protection and humanitarian aid operations), DG DEVCO (international cooperation and development) and DG NEAR (neighbourhood and enlargement negotiations). The plurality of directorates involved in public health allows the European Commission to shift a legislative proposal to a different policy domain when facing opposition.²⁵⁵ Nevertheless, this fragmentation can also result in a lack of consistency. The Commissioner for health can only adopt measures falling

252 Article 17 Decision No 1082/2013.

253 Article 6 (3) Decision No 1082/2013.

254 Tamara K. HERVEY and Jean V. MCHALE, European Union Health Law: Themes and Implications (Cambridge, Cambridge University Press, 2015), p. 64.

255 Idem.

56 within the public health competence, whereas other Commissioners act in many other areas even where the impact of those measures on public health is significant.

Intra-institutional fragmentation goes beyond the European Commission, as the example of the Council of the European Union illustrates. In some occasions, the ministers responsible for public health meet in the framework of the Health Council; yet, other ministers also meet to discuss topics that have an impact on public health.²⁵⁶ One formation of the Council cannot engage with the decisions taken in another. Consequently, a whole range of health-related measures are decided in the Council by ministers other than health ministers.²⁵⁷

B. EU agencies in the public health institutional framework

To add one more piece to this puzzle, the ‘agencification’²⁵⁸ process of the European Union has introduced a new category of actors directly and indirectly dealing with public health.

Agencies are permanent bodies governed by European public law. They are established by EU institutions through secondary legislation but are institutionally separate from them. EU agencies have been endowed with their own legal personality.²⁵⁹ While their contribution to the development of a strong public health policy is significant, EU agencies also bring more fragmentation by introducing new actors in this already complex scenario. The EU

‘agencification’ process has been closely linked to public health crises. Several EU agencies therefore deal with public health, adding one more layer of fragmentation to the public health institutional framework (1). Nevertheless, EU agencies are also an opportunity for the promotion of public health beyond EU borders (2).

1. EU agencies as an additional layer of fragmentation in EU public health

EU agencies have flourished over time, from the first three agencies established in the 1970s to the more than 30 that exist today.²⁶⁰ A brief examination of this evolution reveals that many

256 See, for example, Council of the European Union, Timeline - Council actions on COVID-19, available at https://www.consilium.europa.eu/en/policies/coronavirus/timeline/ (last accessed 1 September 2020). This document illustrates how all Council formations have been involved in the response to COVID-19 (health, home,

256 See, for example, Council of the European Union, Timeline - Council actions on COVID-19, available at https://www.consilium.europa.eu/en/policies/coronavirus/timeline/ (last accessed 1 September 2020). This document illustrates how all Council formations have been involved in the response to COVID-19 (health, home,