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S ECTION IV. Methodology and structure

The present thesis is essentially a legal work and is the result of an analysis of different sources, namely legislation, case law, and doctrinal sources. While adopting this legal perspective, we are aware that the Union’s external action is ‘not neutral from the perspective of “political union”’ and from the perspective of political developments in the global environment.95 The research will also consider (EU and global) political aspects and references will be made to political documents of EU and international institutions. Based on these sources, this work will be organised as follows.

In the first part, the EU public health constitutional framework will be defined. The analysis will determine the institutional aspects influencing the promotion of public health by the European Union. The EU holds a limited competence in public health matters under Article 168 TFEU, which has been overcome by the use of other legal bases. This situation has contributed to a fragmented environment, where public health is discussed by all EU institutions under different compositions. Added to this difficulty, the increasing role of EU agencies and their prominent role in public health adds a layer of complexity to this area. Fragmentation is significantly relevant in the external dimension of public health. The European Union is represented in a heterogeneous manner in international organisations and agreements, which has an impact on its influence in the global scene. These features obstruct the fulfilment of the consistency obligation in public health, but some mechanisms have been developed in order to overcome this hindrance. The first part of the work will define the legal tools that will be used in the following parts of the thesis. Internal complexities will affect the promotion of public health in EU external relations.

It is then argued that the influence of the European Union at the global level is determined by the convergence or divergence between EU public health standards and those of third parties.

The alignment between EU public health priorities and those of the rest of the international community facilitates the successful promotion of EU standards at the global level (convergence scenario), whereas the lack of such alignment will render the leadership of the Union more difficult (divergence scenario). For all areas scrutinised in this work, it will be necessary to determine whether standards at EU level and at international level converge or diverge. We will thus analyse what has been done by the Union from a legislative and an institutional point of view and how a certain area has developed through the case law of the

95 Bart VAN VOOREN and Ramses WESSEL, EU External Relations Law, op. cit., p. xxix.

22 CJEU. This analysis will allow us to draw some conclusions on the standards developed at EU level in a certain area. We will then consider developments at the international level. This encompasses actions in international organisations, international agreements as well as the national practice of some States. Following this comparative analysis, it will be appropriate to examine actions that the European Union has undertaken in order to promote public health in the area under scrutiny at the global level. This will allow us to assess whether the EU has been successful or not and to determine the reasons of such outcome. We assume that the successful promotion of public health by the European Union will be easier in the convergence scenario, but the two remaining parts of the research will confirm, or disprove, such assumption.

With this methodology in mind, the second part of this research will deal with the convergence scenario. In this situation, the European Union and the rest of the international community meet in a cooperative environment and aim at reaching common objectives. The alignment between EU public health standards and those of third parties allows the Union to fully promote public health. Yet, the European Union does not always fully succeed in negotiations and this research reveals that other elements influence the outcome of such procedures. EU competences, the role of the Union as a frontrunner at the global level, and its status in international organisations and agreements will strongly affect the outcome of international negotiations. The third part of this work, by contrast, deals with the divergence scenario, where EU public health standards are not aligned with those promoted by other parties. International negotiations are more difficult in this case and the priority of the Union will be protecting minimum public health standards rather than promoting extensive public health standards. This situation is typically seen in trade matters, where many third parties advocate for strong economic ties at the expense of public health while the Union supports a balanced relationship between trade and health. However, divergent interests in this area are compensated by the attractiveness of the European Union as a trading partner. This element strengthens the capacity of the Union to promote strong public health standards at the global level despite diverging interests. Consequently, the third part of the thesis highlights that the existence of a strong bargaining tool, such as market access, deeply influences the outcome of international negotiations and can facilitate the promotion of public health in a hostile environment.

In the concluding part, the findings of this work will be summarised and some remaining challenges will be considered. In general terms, the European Union is having an increasing success at promoting public health. To some extent, it can be considered as a normative power

23 that has been able to push its public health agenda. This has been done by promoting some causes such as communicable disease control, tobacco control or antimicrobial resistance, but it has also been successful at imposing restrictions to trade based on public health reasons.

While the alignment between the European Union and third parties is a relevant factor for the successful promotion of public health, it is not the unique determinant. We have identified five other factors that have an impact on the outcome of public health negotiations: the competence of the Union in the area under the discussion, the status of the European Union in the international organisation or agreement concerned, the position of the Union as a frontrunner or a follower in the topic under negotiation, the existence of an attractive bargaining tool in the negotiations, and the promotion of a moderate position that can be easily promoted. All these elements should therefore be reinforced for the Union to successfully promote public health at the global level.

However, the Union’s heterogeneous competence in public health matters hinders the development of a consistent and comprehensive external public health action. In particular, the limited or nonexistent competence in some specific areas of public health limits the role of the Union as a global public health actor. The examples of mental health or vaccination illustrate these limits. It is concluded that a more consistent EU public health action is needed in order to successfully promote EU standards at the global level in a comprehensive manner. Currently, public health is still approached on a case-by-case basis, which damages the role of the Union as a global actor. This work proposes a number of modifications to Article 168 TFEU and clarifies the relationship between the different provisions related to public health matters in the Treaties.

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PART I. F

RAGMENTATION IN THE

EU

PUBLIC HEALTH