The Proposal for a Directive on Defective Products: A Game Changer for Innovative Medicinal Products

被引:0
作者
Guerriaud, Mathieu [1 ,2 ]
Siranyan, Valerie [3 ]
机构
[1] Univ Burgundy, Fac Hlth Sci, Credimi Lab EA 7532, 7 Blvd Jeanne Arc, F-21000 Dijon, France
[2] Univ Burgundy, Fac Hlth Sci, Lab Excellence Lips TIC ANR 11 LABX 0021, 7 Blvd Jeanne Arc, F-21000 Dijon, France
[3] Lyon 1 Univ, Fac Pharm, P2S UR 4129, 6 Ave Rockefeller, F-69008 Lyon, France
关键词
drug; medicines; patient; pharmaceutical industry; product liability directive;
D O I
10.1163/15718093-bja10117
中图分类号
D9 [法律]; DF [法律];
学科分类号
0301 ;
摘要
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.'
引用
收藏
页码:95 / 109
页数:15
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