Pharmaceuticals products liability in Japan

Article type: Research Article

Authors: Nagano, Fumihiro^* | Karaiskos, Antonios

Affiliations: Faculty of Law, Kyoto University, Japan

Correspondence: [*] Corresponding author: Fumihiro Nagano, Faculty of Law, Kyoto University, Japan. E-mail: nagano@law.kyoto-u.ac.jp.

Abstract: 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.

Keywords: Strict liability, manufacturing defect, design defect, information or warning defect, facilitation of proof, development risk, alternative dispute resolution (ADR), non-pecuniary damage

DOI: 10.3233/PPL-180471

Journal: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 59-74, 2018