Adding one more piece to the puzzle: consistency at the global level

The external dimension of EU public health does not involve solely the Union’s public health policy. The institutional setting in this field includes the participation of the Union and/or its Member States in health-related international organisations and agreements. However, here again, several bodies are potentially involved and there is a risk that the instruments developed in those institutions conflict with each other.⁴⁴⁸ The European Union will then have to incorporate to its legal order potentially conflicting norms. Consistency cannot be truly achieved unilaterally by the European Union since its action requires links with international organisations that deal with related issues.⁴⁴⁹

International organisations are independent institutions with their own rules of procedure and functioning methods.⁴⁵⁰ This seems to suggest that international law cannot be considered as a legal system on its own but that, on the contrary, it is constituted by a number of

sub-447 C-25/94 Commission v Council.

448 Jan WOUTERS and Bart DE MEESTER, ‘Safeguarding Coherence in Global Policy-Making on Trade and Health’, op. cit., p. 295.

449 Ibid., p. 322.

450 Wilfred C. JENKS, ‘The Conflict of Law-Making Treaties’ (1953) 30 British Yearbook of International Law 401, p. 403.

94 systems that coexist.⁴⁵¹ Although this statement can be contested, there is certainly no hierarchy between branches of international law. However, interactions between international organisations are frequent and the treaties and rules they adopt can easily conflict with each other. As a consequence, consistency in the international legal order has received some attention.⁴⁵² The relationship between the WHO, the WTO and the Codex Alimentarius Commission illustrates the lack of consistency in global public health. As a response to potential conflicts that can arise (A), several solutions can be found to increase consistency (B). As the European Union is only one actor among others in the international community, its influence on the outcome of the treaty-making process is limited. Accordingly, finding tools to make such outcome consistent in its legal order is crucial.

A. Potential conflicts between the WHO, the WTO and the Codex Alimentarius Commission

Conflicts of norms are common in international law. An examination of global public health brings into light some of those conflicts, which arise from the interaction of different international organisations such as the WHO, the WTO or the Codex Alimentarius Commission. All these institutions are particularly active in public health, so they have the potential to conflict with each other.

1. Conflicts between WHO agreements and WTO agreements

Both the WHO and the WTO have treaty-making powers. While the WTO has been more active in this regard, the WHO has also adopted several international agreements. In addition to nomenclature regulations, the International Health Regulations and the Framework Convention on Tobacco Control have been briefly presented in this work. These public health instruments might be in conflict with WTO agreements.

A source of conflict might arise between the SPS Agreement and the International Health Regulations. The SPS Agreement applies to all sanitary and phytosanitary measures which may affect international trade. It covers, amongst others, measures applied to ‘protect human life or health within the territory of the Members from risks arising from diseases carried by animals,

451 It has to be reminded, though, that the International Law Commission Study Group on the fragmentation of international law stated that ‘international law is a legal system’; see United Nations General Assembly, Report of the International Law Commission, UN GAOR 61^st Sess. Supp. No. 10, UN Doc. A/61/10 (2006).

452 International Law Commission, ‘Fragmentation of International Law: Difficulties Arising from the Diversification and Expansion of International Law – Report of the Study Group of the International Law Commission’, UN Doc A/CN.4/L.682 (13 April 2006); Wilfred C. JENKS, ‘The Conflict of Law-Making Treaties’, op. cit.; Gabrielle MARCEAU, ‘A Call for Coherence in International Law: Praises for the Prohibition Against

“Clinical Isolation” in WTO Dispute Settlement’ (1999) 33(5) Journal of World Trade 87; John TOBIN, The Right to Health in International Law (Oxford, Oxford University Press, 2012), pp. 104-110.

95 plants or products thereof, or from the entry, establishment or spread of pests’.⁴⁵³ The purpose of the IHR, on the other hand, 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’.⁴⁵⁴ Both instruments are thus closely interconnected and could overlap. A potential conflict of norms is therefore likely in this context.⁴⁵⁵

The Framework Convention on Tobacco Control can also be in contradiction with WTO agreements. The FCTC recommends State parties to adopt measures such as plain packaging, which could conflict with the TBT Agreement, the TRIPS Agreement, or the GATT 1994.

When Australia adopted plain packaging legislation in accordance with the guidelines implementing the FCTC, several WTO members claimed that it had violated WTO rules.⁴⁵⁶ While the Panel confirmed the compatibility of the measures adopted by Australia, this dispute highlighted the conflicts that divergent legal settings could trigger.

2. Conflicts between WTO agreements and international public health standards Another example of interaction between international organisations in public health concerns the relationship between the WTO, the Codex Alimentarius Commission and the WHO as regards international standards. The SPS Agreement requires Member States to harmonise sanitary and phytosanitary measures based on international standards, guidelines or recommendations.⁴⁵⁷ These standards are defined in Annex A of the Agreement, where it is stated that ‘for food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice’.⁴⁵⁸ However, standards developed in other international organisations are not recognised. For example, national measures implementing the IHR will not necessarily be considered consistent with the SPS Agreement.⁴⁵⁹ While a consistency effort has been made between the WTO and the Codex Alimentarius Commission regarding sanitary and

453 Annex A.1 (c) SPS Agreement.

454 Article 2 IHR.

455 Jan WOUTERS and Bart DE MEESTER, ‘Safeguarding Coherence in Global Policy-Making on Trade and Health’, op. cit.

456 WTO, DS435/DS441/DS458/DS467 Australia – Certain measures concerning trademarks, geographical indications and other plain packaging requirements applicable to tobacco products and packaging (Australia Plain Packaging), Panel Report, 28 June 2018, WT/DS435/R, WT/DS441/R, WT/DS458/R, WT/DS/467/R.

457 Article 3 SPS Agreement.

458 Annex A.3 (a) SPS Agreement.

459 Jan WOUTERS and Bart DE MEESTER, ‘Safeguarding Coherence in Global Policy-Making on Trade and Health’, op. cit., p. 328.

96 phytosanitary measures, no such effort is perceived between the WTO and the WHO. Similarly, Article 2.5 of the TBT Agreement considers that a technical regulation does not create an obstacle to international trade if it is in accordance with international standards. While no list of such standards exists in the TBT Agreement, the Panel considered in the Australia Plain Packaging case that the Article 11 and Article 13 FCTC Guidelines did not constitute relevant international standards.⁴⁶⁰ This conclusion highlights that a conflict might arise between the TBT Agreement and the FCTC, thus confirming that no consistency exists between WTO and WHO agreements.

Conflicts are likely to arise between public health-related instruments of international law.

Once an international rule is adopted and the European Union becomes a party to it, it has to integrate it in its legal order. The following question is how to interpret conflicting norms of international law so that the European Union can fulfil its international obligations while developing a consistent public health action.

B. Potential solutions to the conflicts of norms at the global level

Traditional rules of public international law are not applicable in cases of conflicts of norms and no higher authority exists to take decisions on the matter. A solution is therefore not easy to find but some proposals are presented in the following paragraphs.

1. Balancing the different interests at stake

A balancing exercise between interests could be considered. However, depending on the body that will undertake the balancing exercise, the outcome might differ.⁴⁶¹ In a conflict between the WHO and the WTO, the latter institution will consider health matters as an exception under Article XX of the GATT 1994, whereas the former will prioritise health issues over trade. The application of this principle in a real case is useful to understand this idea. The Dispute Settlement Body of the WTO requires Panels and the Appellate Body to interpret WTO Agreements in accordance with customary rules of interpretation of public international law, which implies that any relevant rules of international law applicable in the relations between the parties have to be taken into account.⁴⁶² While this suggests that the IHR might be used in

460 Australia Plain Packaging, paras. 7.290-7.397.

461 Ralf MICHAELS and Joost PAUWELYN, ‘Conflict of Norms or Conflict of Laws?: Different Techniques in the Fragmentation of Public International Law’(2012) 22 Duke Journal of Comparative & International Law 349, pp.

367-371.

462 Article 31 (3) (c) Vienna Convention on the Law of the Treaties, Vienna, 23 May 1969, 1155 UNTS 331.

97 a dispute as a tool of interpretation, this international instrument will not modify or add to the existing WTO rules.⁴⁶³

2. Private international law rules of interpretation

An alternative solution is the development of private international law rules on the basis of connecting factors. The goal would be defining, in a specific case and based on objective factors, whether the rules to be applied are the ones emanating from the WHO or from the WTO, for example. This does not mean that the issue discussed belongs uniquely to one or the other area. The rules would be an instrument with a practical purpose allowing to clearly define the legal regime to be applied.⁴⁶⁴

3. The ‘Bosphorus’ solution

The Bosphorus case, brought before the European Court of Human Rights (ECHR), led to what is now known as the ‘Bosphorus presumption’.⁴⁶⁵ In this judgment on the relationship between EU law and the European Convention of Human Rights, the ECHR dealt with the need to comply with international legal obligations when there is a potential conflict between such obligations.⁴⁶⁶ It stated that ‘compliance with such obligations is justified as long as the relevant organisation is considered to protect fundamental rights, as regards both the substantive guaranteed offered and the mechanisms controlling their observance, in a manner which can be considered at least equivalent to that for which the Convention provides’.⁴⁶⁷ The ECHR found that the protection of fundamental rights by Community law (now, Union law) could be considered equivalent to that of the European Convention of Human Rights.⁴⁶⁸ A similar solution could be considered in public health, in which a presumption of equivalence among different regimes would apply.⁴⁶⁹

463 Jan WOUTERS and Bart DE MEESTER, ‘Safeguarding Coherence in Global Policy-Making on Trade and Health’, op. cit., pp. 328-329; on the consideration of a WHO resolution by the Panel to interpret the TRIPS Agreement, see WTO, DS114 Canada – Patent Protection of Pharmaceutical Products (Canada – Pharmaceutical Patents), Panel Report, 17 March 2000, WT/DS114/R, para. 109; on the consideration of other international instruments, see WTO, DS58 United States – Import prohibition of certain shrimp and shrimp products (US – Shrimp), Appellate Body Report, 12 October 1998, WT/DS58/AB/R, para. 130; on the non-modification of WTO rules by other international instruments, see WTO, DS50 India – Patent protection of pharmaceutical and agricultural chemical products (India – Patents (US)), Appellate Body Report, 16 January 1998, WT/DS50/AB/R, para. 46.

464 Ralf MICHAELS and Joost PAUWELYN, ‘Conflict of Norms or Conflict of Laws?’, op. cit., p. 369.

465 ECHR, Judgment of 30 June 2005 in the case of Bosphorus Hava Yollari Turizm Ticaret Anonim Sirketi v Ireland, Application No 45036/98.

466 Ibid., para 153.

467 Ibid., para. 155.

468 Ibid., paras. 159-165.

469 Ralf MICHAELS and Joost PAUWELYN, ‘Conflict of Norms or Conflict of Laws?’, op. cit., p. 370-371.

98 4. Other international agreements as international standards

Another mechanism to reach consistency between different legal regimes is considering other international agreements as international standards. This solution is found in some WTO agreements. The SPS Agreement and the TBT Agreement establish the conformity of national measures with those agreements if based on international standards. However, both agreements are unsatisfactory from a public health perspective. The wording of the SPS Agreement is very restrictive and does not cover the most relevant public health international agreements.⁴⁷⁰ While the TBT Agreement is more encompassing, the interpretation of its provisions by the WTO Dispute Settlement Body also limits the possibility to consider public health instruments as international standards.⁴⁷¹ Although those provisions could potentially contribute to a more consistent reading of international agreements, their interpretation should be adapted to allow for such possibility.

5. Rule of harmonious interpretation

Another possibility, closely related to the previous one, would be the interpretation of one branch of international law in conformity with the other, as long as it is possible to do so. This rule of harmonious interpretation has also been applied to some extent. For example, the IHR contains a provision stating that ‘the IHR and other relevant international agreements should be interpreted so as to be compatible’ and that ‘the provisions of the IHR shall not affect the rights and obligations of any State Party deriving from other international agreements’.⁴⁷²

6. Cooperation mechanisms between international organisations

All the above-mentioned mechanisms can be useful tools to prevent conflicts of norms.

However, truly preventing incompatibilities between branches of international law – and therefore inconsistency – is only possible with an enhanced cooperation between organisations.

The WHO has been granted observer status at the WTO Committee on Sanitary and Phytosanitary Measures. No representatives of the WTO were part of the first Intergovernmental Working Group on the Revision of the IHR.⁴⁷³ However, a representative from the Agriculture and Commodities Division of the WTO was included in the second Working Group, and the WHO and the WTO have held technical and expert meetings since

470 Article 3 SPS Agreement; Annex A.3 SPS Agreement; Jan WOUTERS and Bart DE MEESTER, ‘Safeguarding Coherence in Global Policy-Making on Trade and Health’, op. cit., pp. 327-328.

471 Article 2.5 TBT Agreement; Australia Plain Packaging, paras. 7.264-7.397.

472 Article 57 (1) IHR; Jan WOUTERS and Bart DE MEESTER, ‘Safeguarding Coherence in Global Policy-Making on Trade and Health’, op. cit., p. 325.

473 Jan WOUTERS and Bart DE MEESTER, ‘Safeguarding Coherence in Global Policy-Making on Trade and Health’, op. cit., p. 324.

99 then.⁴⁷⁴ Such cooperation systems are essential. The ultimate goal should be for rules to be compatible when they are being drafted instead of creating additional rules to solve conflicts of norms that have already been drafted in an inconsistent manner.

Consistency at the global level is more difficult to reach than at the EU level since there are no clear rules on how to deal with fragmentation. In this scenario, conflictive rules are likely to be adopted at the global level. In order to facilitate a consistent implementation of such rules in the EU legal order, mechanisms need to be found to solve potential conflicts of norms at the international level.

Conclusions on Section III

This section has completed the examination of the EU public health constitutional framework by reviewing the impact of fragmentation on the consistency principle. This principle has become crucial in the EU legal system and the variety of legal bases, of institutions, and of international statuses in public health raises consistency concerns. Having recalled the duties attached to the consistency principle in EU law, a review of the instruments that have been used in public health to comply with this requirement has followed. While these instruments should facilitate consistency within the Union, some conflicts remain, as the participation of the European Union in the FAO highlights. Cooperation among institutions and the establishment of clearly delimited rules are key to the attainment of more consistency in public health. An additional concern is raised when examining the external dimension of public health since consistency at the global level is equally subject to constraints. Conflicts of norms among health-related international instruments are likely to arise. Mechanisms to solve those conflicts are to be found so that the Union can ensure a consistent implementation of global public health measures in its legal order. A review of the most useful tools and how these should be implemented has been developed in this section.

474 Ibid., p. 325.

100

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The EU public health constitutional framework is complex and fragmented. The complexity results from the asymmetry between public health objectives established in the Treaties and the Union’s competence in public health matters under Article 168 TFEU. While public health objectives are extremely broad, the Union’s competence in this field is, as a general rule, limited to coordination and support activities. In order to overcome this asymmetry, the European Union uses different legal bases to legislate on public health matters. In addition to Article 168 TFEU, public health is mentioned in several provisions of the Treaties, some of which grant the Union more extensive powers to act. Article 114 TFEU is undoubtedly the most frequently used provision in this area. Tobacco-control legislation illustrates how Article 114 TFEU can be used to pursue public health objectives. It has consequently been argued that the mainstreaming of public health objectives in the Treaties has created an asymmetry, but it has also allowed legislating on public health matters despite a limited competence in the field.

The use of diverse legal bases has led to a strong institutional fragmentation that can be observed both internally and externally. Internally, all EU institutions and agencies are involved in EU public health. The simultaneous involvement of numerous actors makes it difficult to predict how an event will be dealt with and leads to a patchwork of measures across all policies.

The necessary coordination between the Union and its Member States in EU public health adds a layer of complexity. Externally, the European Union has a varying degree of participation in health-related international organisations. While it is a full member at the WTO, the FAO or the Codex Alimentarius Commission, it is an observer at the WHO. The rights and obligations of the Union in international organisations will vary in accordance with its status. A similar observation is made with regard to the Union’s participation in international agreements. The Union is not always able to become a contracting party to health-related international agreements and has to rely on its Member States to promote its positions. The influence of the Union at the global level will vary in accordance with its status in international organisations and agreements.

Institutional fragmentation raises concerns related with the principle of consistency. This principle is of outmost importance in the EU legal system and requires a broad range of duties.

The variety of legal bases and actors involved in EU public health could lead to a lack of consistency, but a number of mechanisms have been established to avoid this outcome. Several provisions in the Treaties underline the need to ensure consistency in EU public health.

Cooperation activities among EU institutions and agencies have been developed. Although

101 powers are not clearly delimited between the Union and its Member States in EU public health, declarations of competences and internal arrangements aim at clarifying this point at the

101 powers are not clearly delimited between the Union and its Member States in EU public health, declarations of competences and internal arrangements aim at clarifying this point at the