February 25
Anjum Shabbir
Anjum Shabbir
10th February 2020
Consumer, Health & Environment Internal Market

Analysis: “Exploring the nature and scope of Article 18 TFEU: Opinion of AG Bobek in ‘Defective breast implants’ case” by Nicole Lazzerini

With the preliminary reference in TÜV Rheinland LGA Products and Allianz IARD (C-581/18), the Higher Regional Court of Frankfurt am Main asked the Court of Justice to clarify whether the prohibition on nationality grounds contained in Article 18 TFEU can be relied on horizontally. The Opinion of AG Bobek, delivered on Thursday 6 February, shifted the focus from the effects of Article 18 TFEU onto the nature of this provision and more generally onto the scope of EU law.

The case concerns a German citizen in Germany who received defective breast implants manufactured by a French company, Poly Implant Prothèse SA (PIP).

Under French law (Article L. 1142-2 of the Public Health Code), manufacturers of medical devices must conclude an insurance contract for civil liability, which grants a direct claim against the insurer to the injured third parties. The contract concluded by the undertaking PIP with the French private law insurer Allianz contains a clause limiting the cover to damages occurring in France. Assuming a breach of Article 18 TFEU had occurred, the referring court wished to know whether that provision can be relied on by the appellant horizontally against Allianz, or only vertically against TÜV Rheinland, the French body (considered as an emanation of the State) that carried out a conformity assessment of the implants with the relevant legal standards.

AG Bobek invites the Court of Justice to take a step back in the legal reasoning, establishing, first, whether EU law precludes a territorial limitation such as that at issue. Notably, the ‘relational, subsidiary nature of Article 18 TFEU’ (point 92) which applies within ‘the scope of application of the Treaties, and without prejudice to any special provisions contained therein’, implies that attention must be paid to EU (primary or secondary) law provisions other than Article 18 TFEU.

The Opinion sheds light on the difference between the abstract relevance of EU law and its applicability in concreto to a case. According to the AG, the degree of connection with EU law is sufficient to establish the jurisdiction of the Court of Justice to address the preliminary question. The damage is the consequence of intra-EU trade in goods and at least two EU secondary law measures may be relevant (Product Liability Directive 85/374, and Medical Devices Directive 93/42). Nonetheless, the AG excludes the applicability in concreto of the provisions on the free movement of goods, because the French obligation for manufacturers to have insurance concerns the subsequent use of goods and does not hinder intra-EU trade within the meaning of the Court of Justice’s case law. Nor does he find specific provisions on insurance against civil liability in the abovementioned Directives.

As a final step, the AG rejects the possibility of a self-standing application of Article 18 TFEU. In his view, this provision must be construed as prohibiting discrimination on nationality grounds only in relation to obligations that already flow from other EU (primary or secondary) law provisions. If Article 18 TFEU were used as the independent source of additional substantive obligations, it would turn into a ‘limitless harmonising provision, with the consequence of upsetting the division of competences between the EU and the Member States’ (point 93). Thus, the AG proposes that the Court rule that Article 18 TFEU does not preclude, in and of itself, the territorial limitation at issue.

As is well known, the Court of Justice has already acknowledged the capacity of specific Treaty prohibitions of discrimination on nationality grounds to be relied on directly in horizontal disputes (see, notably, Angonese (C-281/98)). In light of the (potentially) far-reaching scope of Article 18 TFEU, AG Bobek’s invitation to first clarify the nature of this provision and the limits of its application should be taken seriously.


Nicole Lazzerini is Assistant Professor of European Union Law at the University of Florence, Department of Legal Sciences. She holds a PhD (2013) and an LLM (2010) from the European University Institute. Her publications include a monograph on the scope of application of the EU Charter of Fundamental Rights (La Carta dei diritti fondamentali dell’Unione europea. I limiti di applicazione, FrancoAngeli: Milano, 2018).


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