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Pedro Caro de Sousa

Traditional approaches to the debate on the so-called ‘horizontal’ effect of the EU fundamental freedoms tend to focus on whether these freedoms apply directly to private relationships. The main argument of this article is that these approaches are misguided: EU fundamental freedoms inherently affect private relationships as a consequence of their direct effect, but this can occur through a number of different legal mechanisms. In any event, and as emerges clearly from comparative constitutional law, differences in the way through which the fundamental freedoms filtrate to private relationships do not alter the substantial outcome of decisions concerning, or the legal framework applying to, those relationships. Accordingly, it is submitted that the debate on horizontal effect should be reframed as a debate about the scope of the fundamental freedoms. In particular, questions about whether private behaviour is susceptible of infringing the fundamental freedoms only need to arise in the absence of state action—as in all other cases the situation can be assessed through a review of the state measure regulating such behaviour. In relation to situations where there is an absence of state regulation, it is argued that only those private actions which are able to restrict the fundamental freedoms in a manner akin to state action should fall within the scope of the freedoms—and that, in these cases, the infringement of the fundamental freedoms should be ascribed to failures by a state to prevent the restrictive private behaviour.

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Pedro Caro de Sousa

EU law on pharmaceuticals is an area where the regulatory framework, fundamental freedoms and competition law are deeply and closely intertwined. Understanding one branch of the law regarding pharmaceuticals requires knowing the others, and how these branches interact with one another. This chapter provides an overview of free movement cases on pharmaceuticals, with a view to frame such case law within the European regulatory framework and to identify its impact on competition law enforcement. It is structured as follows: a first section will provide an overview of the structure of the European market for pharmaceuticals, including the basic European regulatory framework; a second section will review the case law on free movement and pharmaceuticals; and a last section will detail how the basic pharmaceutical regulatory framework, free movement law and competition law interact to determine the shape of European pharmaceutical markets.