Research On Criminal Liability Of Medicaments-related Crimes

The development of the pharmaceutical industry started from Emperor Yan Shen Nong's Tasting Herbs,the later Compendium of Materia Medica,and the current research and use of vaccines,which marks the advancement of human society.The close association between medicaments and human life contribute to the elimination of human illnesses and the extension of life.The impact of the continuous improvement of pharmaceutical science and technology,however,is not entirely positive.While some people make every effort to eliminate illness and death,some are conducting medicaments-related crimes and other acts that endanger medicament safety at various stages including medicament research and development,medicament production,medicament sales and medicament use.Undisputedly,medicaments-related crimes result in criminal liability.To clarify the criminal liability of medicaments-related crimes,we must understand medicaments-related crimes themselves.The study of criminal liability issues shall begin with an understanding and analysis of medicaments-related crimes of various stages.Meanwhile,considering that medicament regulation is involved in the whole medicament supply chain and maintains medicament safety of every stage,severe dereliction of duty shall constitute a medicaments-related crime and be held liable.From a macro perspective,the investigation of the above-mentioned criminal liability of medicaments-related crimes cannot be separated from the guidance of criminal policy.The criminal policy of medicaments-related crimes is not only unavoidable,but also in need of being studied and clarified in the first place.Criminal policy refers to the direction that may effectively crack down on crimes,including fundamental criminal policy and specific criminal policy.The former is universal and comprehensive,while the latter is a concrete manifestation of the former under specific circumstances.“Justice tempered with mercy”,the fundamental criminal policy in China,is applied stringently or mercifully when it comes to different criminal cases.The “Four Strictests” put forward by General Secretary Xi Jinping regarding medicaments-related crimes establishes the “strict” direction of specific criminal policy in this field.Research and development represent the initial step of the production and development of medicaments,which may exert an influence upon the effectiveness and safety of medicaments.Medicament research and development can be divided into three stages,including project approval of new medicaments,clinical trials of new medicaments and registration of new medicaments.Out of various reasons,unlawful practices,such as project approval violation,unauthorized human medicament testing,and obtainment of medicament approval through fraudulent means,can be seen from time to time.China's Criminal Law lacks stringent regulations concerning the above serious violations.Not only are there no specific crimes,but there are no relevant crimes that are available to refer to.This is inconsistent with the criminal theory of the Criminal Law and inconsistent with criminal policy regarding medicaments-related illegal acts.This paper holds that the “crime of illegal medicament research and development” shall be included in the Criminal Law.For unauthorized human medicament testing that causes serious injury or death and negligently causes serious injury or death shall be considered as crimes of infringing upon the rights of the person such as the crime of negligently causing the death of another and the crime of negligently injuring another,respectively.Medicament production equals to the process of producing medicaments,which determines the quality of medicaments directly.Illegal acts at the stage of medicament production,such as producing bogus medicaments and inferior medicaments,impair the quality of medicaments.The Criminal Law in China has established corresponding crimes for the purpose of controlling such behaviors.Similar as they may be,the provisions of the crime of producing bogus medicaments and the crime of producing inferior medicaments are different from each other.Since the current judicial interpretation does not include “medicaments containing poisonous or harmful materials”,it is of difficulty to define the act of illegally providing “questionable” pharmaceutical raw materials.This paper proposes the suggestion of “turning complicity into principal offense” to solve this problem.Other crimes involving medicament production include the crime of producing manufacturing and selling fake and shoddy products,the crime of using dangerous means to endanger public security,and the crime of causing serious casualty or serious consequences in production or operations,the application of which needs to clarify the relationship between single crime and plural crimes.In the context of market economy,medicament sale refers to the process by which medicament producers sell medicaments to hospitals,pharmacies and individuals to make their medicaments circulate,which is also a stage that is necessary for medicaments to be used by terminal patients.The conduct of selling bogus and inferior medicaments at this stage shall refer to the specific crimes in Criminal Law.Also,these crimes shall be interpreted and applied in an accurate manner in judicial practice.The Criminal Law does not include specific crimes to regulate the conduct of illegal deal in medicaments.However,certain acts of illegal deal in medicaments,such as medicament sales without obtaining the qualification,illegal sales of controlled medicaments,bribing medical personnel for medicament promotion,and false publicity of medicaments to seize the market,may commit the crime of giving property to a staff member of a company,an enterprise or any other entity for illicit benefit,the crime of illegal business acts,and the crime of false publicity,and thus such crimes fall into the scope of our analysis.In view of the fact that the Criminal Law does not include a specific crime to control the smuggling of medicaments,this paper,from the point of view of strictly cracking down on medicaments-related crimes,proposes an addition of “crime of smuggling medicaments”.Medicament use refers to the process by which medicaments are used to treat patients.Standardized use of medicaments in a proper manner represents the only way to heal the sick and rescue the dying.In practice,however,it is not uncommon to see illegal use of medicaments by irresponsible medical mainstay and non-medical mainstay.Should medical mainstay abuse their power of prescribing and medical workers disregard “due care” imposed by the Criminal Law and misuse medicaments,when causing the death or severe harm to the health of patients,they may commit the crime of medical accident and the crime of illegal medical practice.Since no specific crimes are set for medical institutions' use of bogus or inferior medicaments,this paper proposes an addition of “crime of illegal use of medicaments by medical mainstay”.Medicament regulation covers the whole process from medicament research and development to medicament use.If relevant regulators are involved in illegal conducts such as abusing authority,dereliction of duty,playing favoritism and committing irregularities,when causing severe damages,they may be considered to be negligent and may even commit the crime of dereliction of duty and be held liable.Given that the current Criminal Law does not include a specific crime to control dereliction of duty regarding medicament regulation,this paper,taking into consideration that “medicament safety” and “food safety” are equally important,proposes an addition of “crime of dereliction of duty of medicament regulation”.