The principle of consistency in EU public health

The application of the above-mentioned duties in EU public health reveals a complex scenario. The two first sections have underlined how fragmented this field is. All EU institutions and Member States act on public health matters, the Union is represented in different manners in health-related international organisations and agreements, and several health-related

424 Marise CREMONA, ‘Coherence through Law’, op. cit., pp. 14-15; Declaration 17 concerning primacy of the Treaty on the Functioning of the European Union, OJ C 202 of 7 June 2016, p. 344.

425 Marise CREMONA, ‘Coherence through Law’, op. cit., p. 15.

426 Articles 2-6 TFEU.

427 Opinion 2/91, para. 5; C-399/12 Germany v Council, para. 52.

428 Judgment of the Court of 14 June 2016 in Case C-263/14 Parliament v Council, EU:C:2016:435, para. 72.

89 instruments have been adopted in different policy fields. Reaching consistency in such circumstances is difficult. EU Treaties and EU institutions have advanced different mechanisms to build a more consistent public health policy. Examples of ways to reach horizontal and vertical consistency, on the one hand (A), and positive and negative consistency, on the other hand (B), will be assessed.

A. Horizontal and vertical consistency in EU public health

The European Union has made an effort to make public health more consistent. While most legislative efforts relate to horizontal consistency (1), the CJEU ensures vertical consistency (2).

1. Horizontal consistency in EU public health

Several Treaty provisions preserve horizontal consistency in EU public health. Articles 9 and 168 (1) TFEU require a high level of human health protection in the definition and implementation of all Union policies and activities. These provisions ensure a consistent public health action across policies and thus reflect the principle of consistency. Article 21 (3) TEU requires consistency between the EU external action and other policies. This provision ensures consistency between the external action and public health.

Horizontal consitency has also been recognised by the CJEU in its case law on tobacco-control legislation. The Court has stated that public health requirements form ‘a constituent part’ of the Union’s other policies.⁴²⁹ It has recognised that a harmonising measure needs to guarantee a high level of human health protection, therefore highlighting the need for consistency between the internal market and public health actions.⁴³⁰ To justify the link between both areas, the Court refers to Articles 168 (1) TFEU and 114 (3) TFEU, which impose a high level of human health protection in achieving harmonisation.⁴³¹

EU institutions and organisms are also willing to reinforce consistency in their activities.

Coordination mechanisms have been established in the European Commission: interservice consultations, consultations between the cabinets of the commissioners and collective considerations by the College of Commissioners. The Council Presidency also contributes to ensuring consistency across policies. Although health events are discussed in different Council formations, the Council Presidency is in charge of reaching a consistent approach in all

429 Tobacco Advertising I, para. 78.

430 Philip Morris, para. 61.

431 Idem.; see also Tobacco Advertising II, para. 40.

90 discussions.⁴³² EU agencies, on the other hand, are developing joint reports that allow all interests to be taken into account and that favour synergies among different organisms.⁴³³

Horizontal consistency is therefore pursued through different mechanisms in the Treaties and through the activity of EU institutions.

2. Vertical consistency in EU public health

Vertical consistency requires cooperation between the Union and Member States in public health matters. Such cooperation is particularly relevant in the EU external action since the Union is not always represented in international organisations and agreements. Vertical consistency finds its reflection in the principles of attributed powers and sincere cooperation.⁴³⁴

The delimitation of powers in public health matters is reflected in Article 168 TFEU, where it is provided that the Union holds a support competence in most areas of public health. An exception is provided for in Article 168 (4) TFEU, where the competence is shared between the Union and Member States. However, the use of different legal bases in EU public health makes the delimitation of competences sometimes difficult. The participation of the EU to the FAO illustrates the (unsuccessful) efforts made by the Union to ensure vertical consistency in public health.⁴³⁵ A declaration of competences was made when the Union joined the FAO. The General Rules of the FAO and the internal arrangements concluded between the Union and Member States complement this declaration. These are examples of – rather unsuccessful – delimitation rules. The obligation to respect such delimitation of powers and to ensure close cooperation between the Union and Member States in the FAO was underlined by the CJEU in Commission v Council.⁴³⁶

432 See, for example, Council of the European Union, Together for Europe’s Recovery – Programme for Germany’s Presidency of the Council of the European Union (1 July-31 December 2020), available at https://www.eu2020.de/blob/2360248/e0312c50f910931819ab67f630d15b2f/06-30-pdf-programm-en-data.pdf (last accessed 2 September 2020). The German Council Presidency has established the framework for the response to COVID-19, which comprises several measures that will have to be discussed by different Council compositions.

433 For example, European Centre for Disease Prevention and Control, European Food Safety Authority, European Medicines Agency, ‘ECDC/EFSA/EMA first joint report on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from human and food-producing animals’ (2015) 13(1) EFSA Journal 2015 1 (ECDC/EFSA/EMA first joint report); see also European Centre for Disease Prevention and Control, European Food Safety Authority, European Medicines Agency,

‘ECDC/EFSA/EMA second joint report on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals’ (2017) 15(7) EFSA Journal 2017 1.

434 Article 5 (1) TFEU and Article 4 (3) TEU.

435 See supra, Part I, Section II, II, A, 1.

436 C-25/94 Commission v Council, para. 48.

91 The principle of sincere cooperation has played a significant role in EU public health. The Court highlighted the relevance of this principle in Commission v Sweden (PFOS).⁴³⁷ In this case related with the Stockholm Convention on persistent organic pollutants, the Court underlined the obligation to strictly observe the principle of sincere cooperation. Sweden unilaterally proposed the addition of PFOS⁴³⁸ to the list of dangerous substances of the Stockholm Convention whereas the Council adopted a decision on a proposal, on behalf of the Union and the Member States, to add three substances in the Annex of the Stockholm Convention. PFOS were not included among those chemicals. The parties disagreed over whether Sweden should have waited for the Council to adopt a decision on PFOS or whether it could unilaterally submit a proposal, as it had raised the issue to the Council and the proposal had not been taken into account. The Court concluded that Sweden’s behaviour compromised the principle of unity in the international representation of the Union and its Member States.⁴³⁹ Member States are subject to the principle of sincere cooperation as soon as a concerted common strategy exists. Such a common position can flow from a legally binding document, from a decision authorising the European Commission to negotiate a mixed agreement on behalf of the Union⁴⁴⁰ or, as implied from this judgment, from situations where the Council has not adopted any formal decision, as soon as a matter is discussed within the EU institutions.⁴⁴¹ The Court held that ‘Member States are subject to special duties of action and abstention in a situation in which the Commission has submitted to the Council proposals which, although they have not been adopted by the Council, represent the point of departure for concerted Community action’.⁴⁴² Although the Council had not adopted any formal decision on the substances to be included in the Annex, there was a common strategy not to propose the listing of PFOS immediately.⁴⁴³ Sweden therefore dissociated itself from that common strategy of the Council, which constituted a breach of the principle of sincere cooperation.

437 Commission v Sweden (PFOS); see also C-25/94 Commission v Council; Marise CREMONA, ‘Case C-246/07, Commission v Sweden (PFOS), Judgment of the Court of Justice (Grand Chamber) of 20 April 2010, nyr’ (2011) 48 Common Market Law Review 1639.

438 The acronym PFOS stands for perfluorooctane sulfonic acid.

439 Commission v Sweden (PFOS), para. 104.

440 C-266/03 Commission v Luxembourg, para. 60; C-433/03 Commission v Germany, para. 66.

441 Peter VAN ELSUWEGE and Hans MERKET, ‘The Role of the Court of Justice in Ensuring the Unity of the EU’s External Representation’ in Steven BLOCKMANS and Ramses A. WESSEL (eds), Principles and Practices of EU External Representation (The Hague, TMC Asser Press, CLEER Working Papers, 2012), p. 48.

442 Commission v Sweden (PFOS), paras. 74 and 89.

443 Ibid., para. 76.

92 B. Positive and negative consistency in EU public health

In addition to horizontal and vertical consistency, measures to ensure consistency in EU public health can also be classified through the positive/negative dichotomy.

Several cooperation mechanisms have been established in order to ensure positive consistency in EU public health. The example of EU agencies developing joint reports on public health matters illustrates this argument. By working together, EU agencies bring their expertise and avoid overlaps. Another example of public health cooperation is the negotiation of the International Health Regulations. Although the EU is not a party to this international agreement on cross-border health threats, it actively participated in the negotiations. In order to justify such participation, the European Commission stated that Member States and the Commission should work in cooperation and coordination in order to fulfil the requirement of unity in the international representation of the Union.⁴⁴⁴ The communication on the revision of the International Health Regulations provided several cooperation mechanisms between the Union and Member States. For example, the European Commission coordinated with technical experts from Member States and with Member States themselves in areas of EU competence.⁴⁴⁵

The use of various legal bases to adopt public health measures results in the difficulty for the Union and its Member States to determine the extent of their powers, leading to potential conflicts and contradictions. A clear delimitation of powers is thus the most effective tool to reach negative consistency. Some efforts are made by the Union and its Member States in this regard. For example, the European Union makes declarations to delimit its powers when concluding international agreements where some aspects of the agreement fall within EU competence and other aspects fall within national competence.⁴⁴⁶ The declaration of competences made upon accession to the FAO is the most extensive one. This declaration has been complemented by internal arrangements to facilitate the exercise of voting rights. Yet, this

444 European Commission, ‘The Revision of the International Health Regulations under the Framework of the World Health Organisation’, 19 September 2003, COM(2003) 545 final, p. 10 (European Commission, COM(2003) 545 final).

445 Ibid., pp. 10-11.

446 For example, the EU declaration upon formal confirmation of the FCTC provides that the European Union ‘is competent to adopt measures, which complement the national policies of its Member States, directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health’.

It further specifies that EU competence ‘exists in areas already covered by Community legislation. The Community acts listed below are illustrative of the Community’s sphere of competence in accordance with the provisions of the Treaty establishing the European Community. The exercise of competence that Member States have transferred to the Community by virtue of the Treaties is, by its very nature, bound to continuously evolve. Therefore in this regard, the Community reserves its right to issue further declarations in the future’. Similar declarations can be found in the Stockholm Convention on Persistent Organic Pollutants, in the Cartagena Protocol on Biosafety, in the Convention on the Transboundary Effects of Industrial Accidents, or in the Convention on Biological Diversity.

93 case highlights that reaching negative consistency is complex. The CJEU plays a crucial role in this context. In the case of the FAO, the Court was required to delimit powers between the Union and the Member States in this organisation.⁴⁴⁷ The principle of sincere cooperation also aims at avoiding contradictions between the Union and its Member States. For example, in Commission v Sweden (PFOS), the Court referred to the principle of sincere cooperation to prevent Sweden from making a proposal at the international level that would contradict an EU position.

The principle of consistency is an essential principle of EU law and it is of particular relevance in EU external relations. This principle requires a wide range of duties on behalf of EU institutions and of Member States. However, reaching consistency is challenging in EU public health, where fragmentation is the rule. Despite this difficulty, several measures have been adopted. The establishment of cooperation mechanisms and a proper application of the principles of conferral and of sincere cooperation are the most useful tools. To add one more layer of difficulty, the Union’s public health external action requires a brief examination of what is being made at global level. Reaching consistency in this case is an added challenge of the Union as it does not constitute an obligation as such.