The production and use of pharmaceutical products involve the lives, health, and safety of the public, and their safety risks exhibit modern risk characteristics that are remarkably uncertain, anthropogenic, and global. Furthermore, current pharmaceutical production and sales have evolved into an intensive and integrated industry with a long industrial chain and broad coverage, encompassing numerous stages such as research and development, production, circulation, utilization, supervision, and pharmaceutical information security. Once potential risk factors erupt in any of these stages, irreversible damage will be inflicted upon public safety. Traditional culpability-based criminal law theory pursues stability and certainty, whereas contemporary risk society presents unprecedented uncertainty. Consequently, a contradictory relationship emerges between traditional culpability-based criminal law, which is founded on certainty, and the risk society, which is centered on uncertainty. The inherent limitations of traditional culpability-based criminal law theory—such as the increasingly spiritualized and abstracted concept of protected legal interests, the lagging nature of legal interest protection, and the difficulty in proving causality—render it inadequate and powerless in handling the continuous emergence of new risks in a risk society, including pharmaceutical safety risks. When confronting such new modernization risks, the risk criminal law theory demonstrates advantages over the traditional culpability-based criminal law theory in aspects including the protection of legal interests, the intervention point of protection, and the imputation model. In particular, as crimes endangering pharmaceutical safety are public safety crimes characterized by high technological content, substantial risks, and uncontrollable consequences, the risk criminal law theory possesses a natural compatibility for regulating them. However, this does not imply that the traditional culpability-based criminal law theory is entirely useless in regulating crimes endangering pharmaceutical safety. Having undergone a long historical evolution to the present day, traditional culpability-based criminal law occupies an irreplaceable position within the legal system. It is merely due to rapid social development and the inherently lagging nature of the law itself that it appears inadequate when confronting certain types of risk crimes. Therefore, it becomes necessary to introduce the risk criminal law theory, which is more aligned with the risk society, to compensate for its own deficiencies. Regarding the regulation of crimes endangering pharmaceutical safety, the risk criminal law theory possesses natural rationality and necessity. It is justified to serve as an "exceptional supplement" to traditional culpability-based criminal law, functioning to resolve the intractable problems brought about by modern risks that are beyond the reach of traditional culpability-based criminal law.
목차
Ⅰ. A Realistic Analysis of Drug Safety Risks Ⅱ. Key Features of Crimes Jeopardizing Drug Safety in a Risk Society Ⅲ. Limitations of Traditional Culpability-Based Criminal Law in Regulating Crimes Jeopardizing Drug Safety Ⅳ. The Rationale for Introducing Risk Criminal Law Theory into Drug Safety Protection Ⅴ. Conclusion Bibliography ABSTRACT
키워드
Pharmaceutical safety; Crimes endangering pharmaceutical safety; Risk society; Risk criminal law; Traditional culpability-based criminal law
저자
Zhao Hui [ Associate Professor, Law School, Shanghai University ]