In an Opinion delivered on Thursday 6 February (Case C-581/18), Advocate General Michal Bobek stated that, as a consequence of the fact that EU law has not harmonised, it is for the Member States to regulate insurance policies applicable to medical devices used on their territory, even when those devices are imported from another Member State.
In Germany, a German patient is seeking compensation from Allianz IARD, the insurance company that provided liability insurance for the French company Poly Implant Prothèse (PIP), which gave her breast implants filled with unauthorised industrial silicone. As the insurance contract limited cover to French territory only, PIP implants that were exported to another Member State were not covered.
The Higher Regional Court in Frankfurt am Main asked the Court of Justice of the European Union whether the insurance contract was compatible with the principle of non-discrimination on grounds of nationality (Article 18 TFEU).
In his Opinion, the Advocate General notes that European Union secondary legislation does not contain specific provisions regarding insurance against civil liability for harm caused to end users of medical devices.
Bobek notes that, although directive (85/374/EEC) on product liability establishes a strict regime of liability for producers, it is silent on compulsory insurance. And the Medical Devices Directive (93/42/EEC) requires only notified bodies to take out civil liability insurance; this requirement does not apply to manufacturers.
The Advocate General stated that the rules on free movement apply to national provisions which impede the entry or exit of goods into or from a given Member State. They do not, however, regulate the subsequent use or consumption of the goods once they have been moved to another Member State. While those goods are moving freely on the territory of another Member State, they must comply with the rules of that Member State within the exercise of its regulatory autonomy.
Bobek therefore believes that the fact that PIP's insurance does not “travel” to Germany with the goods, even if it is compulsory in France for subsequent use of those goods in France, does not fall within the provisions on the free movement of goods.
With regard to Article 18 TFEU, the Advocate General explains why this Article cannot be interpreted as a free-standing provision that would produce enforceable obligations. In his view, such an interpretation would upset the division of competences between the European Union and the Member States, whereas the starting principle for the regulation of the internal market is respect for regulatory diversity in matters not explicitly harmonised by EU law. Moreover, by displacing any territoriality in the application of laws, it would generate conflicts of regulatory regimes between the Member States.
To read the conclusions, go to: http://bit.ly/2S1zyIu (Original version in French by Mathieu Bion)