Experts call for the introduction of the Chinese Medicine Act as soon as possible

On April 8th, due to the lack of a production license for the Chinese herbal medicine tablets and the approval of the drug administration department as a counterfeit drug, Langzhong Ni Haiqing of Jinhu City, Zhejiang Province was sentenced to 10 years’ imprisonment by the court of first instance. On May 20, "China Economic Weekly" focused on the "original crimes of counterfeit medicines and unwashables," and reported on the case and the confusion between law and curative effect.

After the publication of the article, Ni Haiqing’s case of counterfeit medicines has caused sustained and extensive social attention. While readers are generally concerned about the fate of Ni Haiqing and whether the counterfeit medicine is really effective in treating cancer, the relevant academic community is concerned about whether the amendment to the Criminal Law (8) is open to the revision of the crime of producing and selling counterfeit medicine.

Recently, Ni Haiqing’s legal seminar on counterfeit drugs organized by the China University of Political Science and Law Center for Judicial Ideas and Judicial System Studies was held in Beijing. The focus of the seminar is still that "there should be no guilty" for "no social harmful behavior."

"Effectiveness" is the focus of attention

On June 14, Ni Haiqing, who appeared in the court of second instance, was obviously thin and pale and kept coughing. He still defended himself against the innocence and insisted that his medicine was not a fake medicine. He not only did not cause harm but he also treated many cancer patients.

The procuratorial organs also failed to put forward new evidence to prove that Ni Haiqing’s counterfeit medicines harmed the health of the patients.

Ni’s defense lawyer Huang Zhenxing once again asked the judge of the second instance to obtain 277 medical records that were sealed up by the public security authorities and asked for permission to cure the patient to testify in court. The judge of the second instance did not directly state his position and said only that he would "review after the study." The judge finally ended the trial on that day only by "adjourning" and did not reveal whether he consented to the witness appearing in court or sent a judgement.

Compared to the attitude of the judge at the first instance, Huang Zhenxing seemed to have seen a turn for the better, because the “effect of the first instance judge directly on the drug had nothing to do with this case and he directly refused the patient to appear in court to testify for Ni Haiqing.”

Whether the efficacy of the drug is related to this case has always been the focus of controversy. At a legal seminar on the case recently held in Beijing, Li Wuqing, the former President of the Criminal Court of the Supreme People's Court pointedly stated that the efficacy of the drug is the core of the case. "If the medicine is really effective, it does not cause serious harm consequences, and it does not use criminal means to solve this problem."

In recent years, however, there have been numerous casualties in the society caused by the production and sale of counterfeit drugs. The severe situation in the production and sale of counterfeit drugs has forced criminal legislation to respond. This is the revised background of the 2011 Criminal Law Amendment (VIII) on the crime of producing and selling counterfeit drugs. The amendment (viii) deleted the phrase “substantially harmful to human health”. This crime thus turns from a result of a crime into a behavioral offence. If it violates the “State's management system for drugs”, the production and sale of drugs constitute production and sales. Counterfeit drug crime.

From this point of view, Ni Haiqing's medicines produced and sold have no approvals. “In accordance with legal provisions, it is in line with the constitution of the crime and the judge is also very difficult to do.” Li Wuqing said.

However, Wang Meihong, dean of the School of Humanities at the Beijing University of Chinese Medicine and a legal expert, still believes that even if the counterfeit drug crime is changed from “committed prisoner” to “behavioural prisoner” after the revision of the criminal law, he should not leave the social harmfulness necessary for this. Essentials. "This is determined by the nature of criminal law." Article 13 of the Criminal Law stipulates that to constitute a crime must be an action that clearly harms society.

In fact, the reason for the amendment to the Criminal Law Amendment (8) of 2011 on the production and sale of counterfeit medicines was: “Compared to general product quality issues, fake and inferior drugs will give consumers more personal, economic, and spiritual On the damage, therefore, the participating experts believe that, from the intent of legislation, it is still impossible to negate the role of "harm" in conviction and sentencing.

According to the revised provisions of the offense, “If it causes serious harm to human health or other serious circumstances, it shall be sentenced to three years or more and ten years’ imprisonment and fined; if death or other serious circumstances are caused, the person’s death shall be ten years. The above shall be punished by fixed-term imprisonment, life imprisonment or death and fined or confiscation of property."

Huang Zhenxing told reporters that there is currently no evidence that Ni’s behavior has caused serious harm to human health. Therefore, Ni Haiqing should not be sentenced to 10 years’ imprisonment in any case.

In the second trial, the procuratorial agency explained the basis for the 10 year judgment made by the court of first instance: In October 2012, the Higher People’s Court of Zhejiang Province jointly issued the “Meeting Minutes on the Handling of Legal Problems Concerning Food and Drug Safety Crimes”. Where it is determined that there is one of the following circumstances, it is a "particularly other serious situation" in the crimes of producing and selling counterfeit drugs in Article 141 of the Criminal Law and in the crime of producing and selling toxic and harmful foods in Article 144: production and sale of counterfeit drugs and toxic and harmful Food, involved in more than 500,000 yuan.

According to this standard, Ni Haiqing’s case amounted to more than 500,000 yuan, which is “there are other particularly serious circumstances”.

However, as early as February 2012, the Supreme People's Court and the Supreme People's Procuratorate stipulated in the Notice that Local People's Courts and People's Procuratorates may not formulate documents concerning the nature of judicial interpretations: “Since the issuance of this notice, local people’s courts, The People's Procuratorate shall not formulate any kind of judicial interpretation documents that are generally applicable in its jurisdiction and refer to the specific application of legal issues such as 'guidance opinion' and 'regulations'. Other normative documents formulated may not be cited in legal documents."

Huang Zhenxing was very surprised. "A meeting minutes, even with regulations and guidelines, are not counted. Is it legal to rely solely on the minutes of the Zhejiang Provincial Public, Prosecutor and Law Meetings as a basis for criminal judgments?"

Can the Ni Case Force the Introduction of Chinese Medicine Law?

About half a month after the case was reported, on June 8th, the National Research Group of Traditional Chinese Medicine of the Chinese Academy of Social Sciences organized the seminar on the management of medical drugs by the private Chinese medicine practitioners on the basis of the case. On the one hand, they expressed solidarity with Ni Haiqing and the other. It also hopes to call for the introduction of the Chinese Medicine Law.

Chen Qiguang, the organizer of the seminar and executive director of the Chinese Medicine Research Group of the Chinese Academy of Social Sciences, told reporters that Ni Haiqing's case reflects the various drawbacks of the Chinese medicine management system and the general flaw in the development of Chinese medicine. “The current Chinese medicine management system is based on Western medicine. However, Chinese medicine and Western medicine are two different systems, which is not conducive to the development of Chinese medicine.”

Take the examination and approval procedures for Chinese medicine alone as an example. “The current standards and procedures for the examination and approval of traditional Chinese medicines apply all the criteria and procedures for the examination and approval of western medicine ingredients. They must not only provide drug prescriptions, but also pharmacological analysis, rationality of medicines, and chemistry. Ingredient analysis, etc. But in fact, Western medicine standards are only suitable for Western medicine approval, only for the development of Western medicine." In the view of Zhao Jiancheng, executive director of the Cancer Professional Committee of the Chinese Medical Association, whether Chinese patent medicine has any national approval number is The only criterion for true medicine and counterfeit medicine is inaccurate. “Any proprietary Chinese medicine can't be turned into a legal drug with an approval number without clinical practice. Then from the first trial of the trial we are illegal, but successful, effective Chinese patent medicine must be taken from clinical practice. Summarizing it, only after many patients have been tested effectively can they be declared as official drugs.”

Ni Haiqing's "hard injury" is that the Chinese herbal medicine tablets he developed have neither a production license nor the approval number of the drug administration department, and therefore he was identified as a counterfeit medicine.

He said that Ni Haiqing’s case was not alone. “The needs of patients caused the overwhelming majority of Chinese medicine practitioners to be assigned to pharmaceuticals, including bolus pills and decoctions. The lack of a prescription for the treatment of diseases is incomplete. But now only doctors in the clinic are allowed to start decoctions. They do not allow themselves to make medicines, resulting in a lot of inconvenience in treatment, but also affect the efficacy."

Zhao Jiancheng called for the development of a Chinese medicine examination and approval system adapted to the development of Chinese medicine according to the characteristics of Chinese medicine. "The examination and approval of traditional Chinese medicine should be based on clinical efficacy and should not be based on the analysis of medicinal ingredients in Western medicine." Standards, otherwise it will increase the difficulty of Chinese medicine approval."

It is reported that the draft of the Chinese Medicine Law that has been drafted for 30 years has now been submitted to the Legislative Affairs Office of the State Council by the national health administrative department. After the review and approval at the State Council Executive Meeting, it will be submitted to the Standing Committee of the National People's Congress for deliberation.

The Chinese medicine law, which lasted for many years, can be described as difficult. For practitioners of Chinese medicine, they now see a glimmer of hope.

But Chen Qiguang, who had read the first draft of the draft, was cautiously optimistic. He said that there is still a gap between the draft and the ideals of Chinese medicine practitioners. However, this is also a compromise that has to be made under the existing system.