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The Japanese liability system regarding pharmaceutical products consists of two basic categories: the general fault-based liability is accompanied by the liability system based on the Product Liability Act (PLA), which is established under the influence of American doctrine and the EC directive. The PLA liability is originally supposed to be a strict liability, but this characterisation is recently more and more doubted. The other features of Japanese law relating to pharmaceutical products liability include some state-operated compensation schemes, several measures to facilitate proof, development risk defence, lack of market share liability and class action.
Pharmaceuticals Policy and Law – IOS Press
Published: Jan 1, 2018
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