{"title":"The Proposal for a Directive on Defective Products: A Game Changer for Innovative Medicinal Products","authors":"Mathieu Guerriaud, Valérie Siranyan","doi":"10.1163/15718093-bja10117","DOIUrl":null,"url":null,"abstract":"<p>At the end of 2022, the European Commission published a proposal for a directive to revise the strict liability regime introduced in 1985. Although the main goal of this new proposal is to adapt the regulations to information technologies such as artificial intelligence, it has multiple impacts on other economic sectors, including the pharmaceutical market. Therefore, this proposal could change the deal in terms of liability in this specific market. Indeed, the proposal modifies the burden of proof, which can be quite challenging to establish in the case of adverse effects of medicinal products. It introduces a possible presumption of liability for a manufacturer who fails to communicate, to a court, the information they required, which might jeopardise the protection of trade secrets and commercial confidentiality. In addition, the proposal also extends the limitation period, and more importantly, it mandates the application of the ‘development risk defence.’</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"33 1","pages":""},"PeriodicalIF":0.6000,"publicationDate":"2024-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"EUROPEAN JOURNAL OF HEALTH LAW","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1163/15718093-bja10117","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"LAW","Score":null,"Total":0}
引用次数: 0
Abstract
At the end of 2022, the European Commission published a proposal for a directive to revise the strict liability regime introduced in 1985. Although the main goal of this new proposal is to adapt the regulations to information technologies such as artificial intelligence, it has multiple impacts on other economic sectors, including the pharmaceutical market. Therefore, this proposal could change the deal in terms of liability in this specific market. Indeed, the proposal modifies the burden of proof, which can be quite challenging to establish in the case of adverse effects of medicinal products. It introduces a possible presumption of liability for a manufacturer who fails to communicate, to a court, the information they required, which might jeopardise the protection of trade secrets and commercial confidentiality. In addition, the proposal also extends the limitation period, and more importantly, it mandates the application of the ‘development risk defence.’
期刊介绍：
The European Journal of Jewish Studies (EJJS) is the Journal of the European Association for Jewish Studies (EAJS). Its main purpose is to publish high-quality research articles, essays and shorter contributions on all aspects of Jewish Studies. Submissions are all double blind peer-reviewed. Additionally, EJJS seeks to inform its readers on current developments in Jewish Studies: it carries comprehensive review-essays on specific topics, trends and debated questions, as well as regular book-reviews. A further section carries reports on conferences, symposia, and descriptions of research projects in every area of Jewish Studies.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
