Criminal Law Application And Legislative Improvement On The Various Conducts During The New Drug Research And Development, Declaration And Approval Process

This article discusses the criminal law application and the legislative improvement on the issues relating to the forgery acts occurred during the process of new drug research and development, declaration and approval. Since 2006, China's drugs safety incidents have occurred frequently, which arouse public concern to the drugs security. In 2007, the collective corruption case of the State Food and Drug Administration department, headed by Zheng Xiaoyu, the former chief of State Food and Drug Administration, shocked China and foreign countries. The collective corruption of national drug supervision and management system which controls the health and safety gateways of 1.3 billion Chinese populations made the public cast serious doubt on the China's drug safety, while the doubt mainly focus on the forgery acts and power-money deal during the process of new drug research and development, declaration and approval.This article is more than 60,000 words, and is divided into five chapters, besides, there is an introduction. From the view of content, this article is divided into three parts. The first chapter is PartⅠ, and the second chapter, third chapter are Part II, while the fourth chapter, fifth chapter are Part III. In the introduction part, this article makes a brief introduction and analysis on the forgery acts occurred during the new drug research and development, declaration, approval process from the perspectives of illegal phenomenon and the causes of illegal conducts. Though it has only limited significance on criminal law application and legislative improvement of forgery occurred during the new drug research and development, declaration, approval process, it is helpful for us to better understand the process of forgery and thus the criminal law can make a better evaluation.The first chapter is the first part of the main article. It makes a brief introduction to the specific procedures, the phenomenon and the danger of the acts of forgery during the new drug research and development, declaration and approval process.The second and third chapter are the second part of the main article. They focus on the legal sanctions system against acts of forgery occurred during the process of the new drug research and development, declaration, and approval. The second chapter analyzes the defects of evaluation under the existing legal sanctions system on the acts of forgery occurred during the new drug research and development, declaration, and approval process from the aspects of civil, administrative and criminal. It mainly includes three aspects: First, lacking of coordination and complementarities among legal sanctions; Second, lacking of stages among legal sanctions system; Third, the power of legal sanction is insufficient.The third chapter mainly focuses on analyzing the defects of evaluation under the existing criminal law on the forgery acts during new drugs research and development, declaration, and approval process from the view of criminal sanctions, it mainly displays in two aspects: First, the criminal sanctions against the aiding acts of committing forgery face a judicial embarrassment. Such aiding acts include the forgery did by drug testing agencies and their staff in new drug declaration, and approval stage in order to help the new drug registration applicants and also the forgery did by the non-clinical research organizations, clinical trials and their staff in new drug research and development stage to help the new drug registration applicants. The aiding conducts to forgery of drug testing agencies and their staff could be governed by section 229 of Penalty Code, which is the crime of providing false documents. But article 229 cannot directly apply to the aiding conducts to forgery of non-clinical research institutions, clinical trials and their staff unless using amplified interpretation. Second, vacuum of law is existed in the field of the criminal sanctions against forgery acts of the new drug registration applicants.Chapter IV and V are the third part of the article, and also is the problem-solving part of the article.Chapter IV first discusses and analyzes the crime subject of the crime of providing false documents specified in article 229 of the Penal Code——the nature of intermediary organizations, and then resolves the problem of applying article 229 of the Penal Code to the drug testing agencies, non-clinical research institutions, clinical trials and their staff who did aiding acts to commit the forgery.Chapter V discusses the criminalization issue of the applicants'acts of forgery during the new drug registration. In contrast with the Taiwan-related legislation and combined with the system and structure of China's Penal Code, the article suggests that add one provision to the end of chapter six and fifth section of Penal Code,, which is named as endangering bulletin health crime and constitutes the first paragraph of article 337, and the charge shall be crime of forgery or alteration of the submitted drug registration information.