The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims relating to infringement of third-party intellectual property (IP) rights and for product liability claims resulting from defective equipment.

Formal notification of the two indemnities was given by the Minister for the Cabinet Office, Michael Gove, to the Public Accounts Committee on 3 April 2020.[1] In the notice, Minister Grove noted that he could not give the normal fourteen sitting days’ notice because “commercial negotiations have only just concluded and contract signature did not allow further delay”. Details of the terms of the referenced agreement have not, however, been provided, as they were said to be commercially sensitive and would continue to be until negotiations had been finalised. It is therefore not yet clear who are the parties to the agreement, whether any cap will apply to the indemnities, whether the government will offer the same terms across the board, or whether it will negotiate them in individual supply agreements.


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Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.

Case against PIP’s insurer

The Opinion of Advocate-General Bobek in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IARD SA concerns a German claimant (RB) who pursued a case for compensation in respect of defective breast implants in Germany against Allianz,[2] the insurers of the now-defunct PIP in France. Medical device manufacturers were required under French law to have insurance cover for harm suffered by third parties arising from their activities. PIP had a policy of cover with Allianz, but the cover was limited to damage caused in France. Allianz relied on that territorial limitation. RB maintained that the territorial limitation of insurance cover to French territory was not lawful and constituted an infringement of free movement of goods.

The German court referred the case to the Court of Justice of the European Union (CJEU), asking whether the territorial limitation in the Allianz insurance policy constituted a violation of Article 18 TFEU, which prohibits discrimination on the grounds of nationality.

Within the scope of EU law

Allianz and the French government argued that the case fell outside the scope of EU law on the basis that the issues involved a German patient who underwent surgery in Germany and were therefore purely internal to Germany. The Commission seemingly adopted a similar view.

Advocate-General Bobek disagrees, concluding that it is not possible to say that the situation in the present case falls outside the scope of EU law as it involved the cross-border movement of goods (PIP implants) and provision of services (insurance) in the context of the partial harmonisation of medical devices and liability for defective products under EU law.


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