Opinion of Advocate General Bobek delivered on 6 February 2020.

• Jurisdiction: European Union
• Celex Number: 62018CC0581
• ECLI: ECLI:EU:C:2020:77
• Date: 06 February 2020
• Court: Court of Justice (European Union)

Provisional text

OPINION OF ADVOCATE GENERAL

BOBEK

delivered on 6 February 2020(1)

Case C‑581/18

RB

v

TÜV Rheinland LGA Products GmbH,

Allianz IARD SA

(Request for a preliminary ruling from the Oberlandesgericht Frankfurt am Main (Higher Regional Court, Frankfurt am Main, Germany))

(Reference for a preliminary ruling — Medical devices — Defective breast implants — Insurance against civil liability for the use of medical devices — Territorial limitation — Purely internal situations — Article 18 TFEU — Applicability of EU law)

I. Introduction

1. A German patient received, in Germany, defective breast implants manufactured by Poly Implant Prothèse SA (‘PIP’), a French undertaking that is now insolvent. The patient seeks compensation before the German courts from Allianz IARD SA, the French insurer of PIP. In France, manufacturers of medical devices are under a statutory obligation to be insured against civil liability for harm suffered by third parties arising from their activities. That obligation led PIP to conclude an insurance contract with Allianz, which contained a territorial clause limiting the cover to damage caused on French territory only. Thus, PIP medical devices that were exported to another Member State and used there were not covered by the insurance contract.

2. In this context, the Oberlandesgericht Frankfurt am Main (Higher Regional Court, Frankfurt am Main, Germany) enquires whether the fact that PIP was insured by Allianz for damage caused by its medical devices on French territory only, to the exclusion of that potentially caused in other Member States, is compatible with Article 18 TFEU and the principle of non-discrimination on grounds of nationality contained therein.

II. Legal framework

A. EU law

3. Article 18, first paragraph, TFEU provides that:

‘Within the scope of application of the Treaties, and without prejudice to any special provisions contained therein, any discrimination on grounds of nationality shall be prohibited.’

4. Pursuant to Article 34 TFEU:

‘Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States.’

5. According to Article 35 TFEU:

‘Quantitative restrictions on exports, and all measures having equivalent effect, shall be prohibited between Member States.’

6. Article 56, first paragraph, TFEU reads as follows:

‘Within the framework of the provisions set out below, restrictions on freedom to provide services within the Union shall be prohibited in respect of nationals of Member States who are established in a Member State other than that of the person for whom the services are intended.’

B. French law

7. Article L.1142‑2 of the Code de la santé publique (Public Health Code) (2) provides that:

‘Health professionals in private practice, health establishments, health services and bodies referred to in Article L.1142‑1 and all other legal entities, other than the State, carrying out preventive, diagnostic or healthcare activities, as well as the producers, operators and suppliers of healthcare products, in their finished state, referred to in Article L.5311‑1 with the exception of point 5°, subject to the provisions of Article L.1222‑9 and of points 11°, 14° and 15°, used in those activities, shall be required to hold insurance intended to cover them for their third-party or administrative liability which may be incurred as a result of harm suffered by third parties arising from personal injury occurring in the context of that activity as a whole.

The Minister responsible for health may, by decree, grant a derogation from the insurance obligation laid down in the first paragraph to public health establishments which have available financial resources sufficient to enable them to compensate for harm in a manner equivalent to that resulting from an insurance contract.

The insurance contracts taken out in accordance with the first paragraph may provide that their guarantees are capped …

…

In the event of failure to comply with the insurance obligation laid down in the present article, the competent disciplinary body may order disciplinary sanctions.’

8. Pursuant to Article L.252‑1 of the Code des assurances (Insurance Code): (3)

‘Any person subject to the insurance obligation laid down in Article L.1142‑2 of the Public Health Code who, having attempted to take out an insurance contract with an insurance company in France covering the third-party risks referred to in that article, has twice been refused cover, may bring a claim before a bureau central de tarification [(Central Pricing Office; ‘the BCT’)], the establishment criteria and operating rules of which shall be laid down by decree adopted in the Conseil d’État [(Council of State)].

The Central Pricing Office shall have the exclusive role of setting the amount of the premium at which the insurance company concerned is bound to guarantee the risk proposed to it. It may, on conditions laid down by decree of the Council of State, determine the amount of the excess which shall fall to be paid by the insured party.

The Central Pricing Office shall advise the State representative of the department when a person subject to the insurance obligation under Article L.1142‑2 of the Public Health Code constitutes an abnormally high insurance risk. It shall inform the professional involved thereof. In that case, it shall set the amount of the premium for a contract the duration of which may not exceed six months.

Any reinsurance contract clause which seeks to exclude certain risks of the reinsurance guarantee as a result of the amount of the premium set by the Central Pricing Office shall be null and void.’

III. Facts, procedure and the questions referred

9. PIP was a manufacturer of breast implants established in France. The Dutch undertaking Rofil Medical Nederland BV (‘Rofil’) marketed those implants. It packaged them and provided them with a package insert. TÜV Rheinland LGA Products GmbH (‘TÜV Rheinland’), in its capacity as a ‘notified body’ within the meaning of Directive 93/42/EEC, (4) had been commissioned by PIP since October 1997 to carry out the conformity assessment in accordance with German, European and other international standards. To that end, TÜV Rheinland performed several supervisory audits of PIP between 1997 and 2010.

10. In autumn 2006, the appellant in the main proceedings underwent surgery in Germany, during which she received breast implants marketed by Rofil. It was subsequently confirmed that instead of the ‘NuSil’ material described in the product documents and specified and approved in the scope of the marketing authorisation, those implants were filled with unauthorised industrial silicone.

11. In March 2010, the French health authorities first discovered, during an inspection, that PIP was unlawfully using industrial silicone. In April 2010, the German authorities recommended that doctors who had used PIP silicone implants should inform the patients concerned and discontinue use of those breast implants. In 2012, the complete removal of those implants was recommended.

12. PIP became insolvent and was liquidated in 2011. In December 2013, the founder of the undertaking was sentenced to four years’ imprisonment by a French court for manufacturing and selling products that were dangerous to health.

13. The appellant brought an action before the German courts against the doctor who performed the surgery, against TÜV Rheinland, and against Allianz.

14. She argued that she had a direct claim against Allianz under French law. According to Article L.1142‑2 of the Public Health Code, manufacturers of medical devices are under an obligation to conclude an insurance contract with an insurance company (‘the insurance obligation’). That insurance against civil liability grants a direct claim (Direktanspruch) against the insurance company to third parties who have suffered harm.

15. Pursuant to Article L.252‑1 of the Insurance Code, any person subject to the insurance obligation who, having attempted to take out an insurance contract with an insurance company in France covering the third-party risks referred to in that article, has twice been refused cover, may bring a claim before the BCT. The BCT shall then set the amount of the premium at which the insurance company concerned is bound to guarantee the risk proposed to it.

16. In 2005, the BCT obliged AGF IARD, the predecessor of Allianz, to provide PIP with insurance cover. The BCT set the amount of the insurance premium in the light of PIP’s turnover on French territory. In the special contractual terms of the insurance contract, under the heading ‘Geographic scope’, it was agreed that the cover exclusively applies to cases of damage occurring in metropolitan France and the French Overseas Territories (‘the territorial limitation’). The BCT did not object to the territorial limitation. It was furthermore provided that, in the event of serial damages, the maximum cover amount per case of damage is EUR 3 000 000 and the maximum cover amount per insurance year is EUR 10 000 000.

17. The appellant’s action was rejected by the first-instance court. She filed an appeal against that judgment before the Oberlandesgericht Frankfurt am Main (Higher Regional Court, Frankfurt am Main), the referring court, with regard to the findings in the first-instance judgment concerning TÜV Rheinland and Allianz, but not as far as the liability of the doctor who performed the operation is concerned. Before the referring court, the appellant seeks the annulment of the judgment in respect of TÜV Rheinland and Allianz. She also requests that TÜV Rheinland and Allianz be ordered to pay her damages.

18. According to the appellant, the first-instance court erred in law in holding that the territorial limitation of insurance cover to the French territory was lawful and by ruling out any infringement of the free movement of goods.

19. The questions posed by the referring court...