Chapter 10 4. Who Slays the Devil with a Broadsword

Manufacture and sale of counterfeit medicines is an out-and-out act of killing people for money, a disguised form of murder with despicable means, both state leaders and farmers in the valley are looking forward to - to curb the turbidity of counterfeit medicines Flow, kill the fake medicine demon. Many countries regulate pharmaceuticals as a controlled product no less than arms.If China wants to stop the black tide of counterfeit medicines, there is only one way to monopolize them.The person in charge of the national pharmaceutical management department said sadly: "At present, my country's pharmaceutical market is extremely chaotic. There are more than 3,000 pharmaceutical factories in the country, double the number in 1985, and the number of pharmaceutical business enterprises has increased by at least 30,000. , this does not include the tens of thousands of unlicensed business operators. Provinces, cities, counties, villages, workers, peasants, and soldiers all set up pharmaceutical factories, and state-owned, collective, and individual businesses all engage in wholesale, giving criminals an opportunity to counterfeit medicine , posing a great threat to the drug safety of the people. This situation is rare in the world."

From the practice of developed countries, although they practice market economy and advocate free trade, almost all of them have adopted strict management without any flexibility for the special commodity of medicine.In some western countries such as the United States, the management of medicines is almost stricter than that of arms.Because the killing by arms can still be prevented, but the harm caused by counterfeit medicine is hard to prevent.Most countries implement a closed monopoly system for pharmaceuticals.From pharmaceutical production, wholesale to retail, we implement exclusive management.In Sweden, all drugs, including foreign drugs, must be strictly inspected, registered and issued a license by the Medical Products Agency in accordance with international quality standards before they can be produced and sold in Sweden.The 361 pharmacies in the country are all under the direct leadership and management of the Swedish Pharmacy United Company, and are responsible for the supply of drugs, so that the quality and curative effect of the drugs are guaranteed, and fake and inferior drugs cannot enter the market.In the United States, the Drug and Food Administration uniformly approves drugs to enter the market.

Our country is currently a chaotic situation in which all businesses operate.Uncontrolled circulation has opened the door to the proliferation of counterfeit medicines. Before 1978, state-owned pharmaceutical companies formed a network in the form of four-level wholesale stations, occupying 100% of the domestic pharmaceutical market. The "Drug Administration Law" and the relevant departments of the State Council stipulate that an enterprise that deals in medicines should hold a medicines business license, a medicines business certificate and an industrial and commercial business license.However, the current situation of my country's pharmaceutical market is that there are all kinds of medicines, and the circulation is out of control.According to incomplete statistics, in the early 1980s, there were only 2,253 enterprises engaged in pharmaceutical wholesale in the country, and the number increased to more than 30,000 in the 1990s, of which collective and individual wholesale enterprises accounted for 65%.According to another statistic, there are currently about 28,000 illegal stalls in the pharmaceutical market across the country, and the chaos in circulation is unprecedented.Wuji in Hebei, Fuyang in Anhui, Nanping in Chongqing, Houma in Shanxi, Zhanjiang in Guangdong, and Hehuachi in Chengdu were once distribution centers for counterfeit and inferior drugs.

Under the circumstances that there is no law to follow, why does illegal business expand so much until it gets out of control?People have to put a heavy question mark. For a special commodity such as medicine, it is necessary to implement the monopoly of national professional departments for a certain period of time.Fixed-point production, unified layout, except for the main state-owned channels, collectives and individuals cannot operate pharmaceutical wholesale business.The production and operation of pharmaceutical products must be uniformly certified and approved by the national pharmaceutical administrative department.In this way, the production and operation of drugs will be brought into a strict supervision and management system, so that the production and sales of counterfeit and inferior drugs will be seamless.Since 1991, my country has carried out trials of drug monopoly in Nanyang of Henan, Mianyang of Sichuan, Wuzhong of Ningxia, Gansu, Ningxia Hui Autonomous Prefecture and Inner Mongolia Autonomous Region, all of which have received obvious results.Since then, no case of counterfeit and counterfeit medicines has been found to enter the market in Nanyang area.

Medical experts agreed that it has become an urgent task to implement the monopoly of medicine and implement special management according to the particularity of medicines.This is the only way to ensure the safety and effectiveness of drug use for the people.It is imminent to curb the turbidity of counterfeit medicines! In 1998, the central government made up its mind to set up the State Drug Administration, which was established on the basis of the former State Medical Administration, the Department of Original Drug Administration of the Ministry of Health, and the relevant functional departments of the Administration of Traditional Chinese Medicine. A new agency, directly under the State Council, is endowed with drug supervision and management and administrative law enforcement functions, responsible for the supervision and management of the entire process of drug research, production, distribution, and use.This is a major decision made by the Party Central Committee and the State Council to correct the shortcomings in the past drug supervision and management from the perspective of ensuring the safety and effectiveness of people's medication and improving people's health.

After the establishment of the State Drug Administration, it quickly played its role in drug management and supervision. In the second half of 1998, the Bureau issued three notices in succession, requiring the drug supervision and management departments in relevant regions to strictly investigate and deal with counterfeit drugs "Zenggao Zhuchangling", fake acetamide injection, fake gentian grass, etc. It is imperative to strictly investigate and deal with counterfeit and inferior drugs, crack down on criminals who manufacture and sell counterfeit drugs, and ensure the safety and effectiveness of people's medicines.Zheng Xiaoyu, director of the State Drug Administration, pointed out that the current chaotic drug business order is directly related to the non-standard purchase and sales behavior of drug dealers. Using unit random inspections and penalties for illegal acts, uniformly arrange the rectification work of the drug market, strive to purify the drug market, and standardize the order of circulation.

Most western developed countries and organizations have strict medical legislation.First of all, the law has a high level and strong binding force.Countries and organizations such as the United States, Japan, and the European Union have several laws related to medicine. For example, Japan has nearly ten such laws. In addition to the Pharmaceutical Affairs Law, many laws that are equivalent to laws and regulations in China have risen in Japan. Laws, such as Pharmacist Law, Marijuana Control Law, Adverse Drug Reaction Law, Poisonous and Harmful Substances Control Law, etc.; secondly, the system is strict and standardized. In addition, there are many supporting laws and regulations, which make the entire legal system more rigorous; third, it involves a wide range of areas, and manages both things and people.The pharmaceutical regulations in the United States include not only drugs, but also medical devices, biological products, food and cosmetics, etc., and drugs include human and veterinary drugs, as well as medicated feed and articles.The law not only governs things, but also has a pharmacist law that manages medical practitioners according to law. All aspects of pharmaceutical activities, such as new drug development, review, production, sales, product tracking, etc., are managed according to law; Fourth, legal responsibilities are clear , the punishment is severe. In the legal system of the United States, Japan and other countries, there are clear provisions on legal responsibility and punishment. , rights, etc. have all made extremely strict regulations. Whenever there is a violation of the law, it is very easy to find out the responsibilities of all parties in accordance with the law.At the same time, Japan also implements the system of concurrent punishment of legal persons, which forces corporate legal persons to strictly supervise enterprise management.The law stipulates that anyone who produces or sells drugs without a license, or produces or sells drugs other than the licensed variety, even if they are qualified drugs, will be punished with a prison sentence of less than three years and a fine of less than 500,000 yen. Those who wait for special drugs are subject to a maximum sentence of life imprisonment.

With the implementation of the "Drug Administration Law" as an important symbol, my country has basically established the framework of the medical legal system since the mid-1980s, which has played a good role in the legal management of medicine.In addition to the Drug Administration Law, there are laws and regulations formulated by the State Council such as "Administrative Measures for Narcotic Drugs", "Administrative Measures for Psychotropic Drugs", and "Administrative Measures for Radioactive Drugs"; Management Measures", "Good Manufacturing Practice for Drugs", "Fake and Substandard Drugs Reporting System", etc.However, it cannot be ignored that most of the current medical laws and regulations are based on a planned commodity economy, and many contents are now outdated and outdated, which are not suitable for the establishment and development of the socialist medical market economy.Medical laws and regulations should be the sum of codes of conduct that regulate the economic and administrative legal relations that occur during the development of the pharmaceutical industry.The so-called pharmaceutical business includes not only the content of drug administration, including the research and development, production, operation, and use of drugs, but also the production, operation, and use of other pharmaceutical products (medical devices, chemical reagents, glass instruments, and drug packaging materials, etc.) However, there are no supporting laws and regulations on the production, operation and use of drugs and other pharmaceutical products.On the issue of my country's pharmaceutical management system, the "Drug Administration Law" clearly stipulates that the health administrative department of the State Council is in charge of national drug supervision and management, and the production and operation of drugs are managed by the competent department of drug production and operation, but who is the competent department? Act is not clear.As a result, there are multiple branches of government and the separation of responsibilities and powers.In the face of the chaotic order of pharmaceutical production and operation in recent years, the competent authorities of the pharmaceutical production and operation industry have basically no basis for regulating these market behaviors.In addition, the lack of distinction between government and enterprises and political affairs makes it difficult for supervisory agencies to stand as a third party, and supervision lacks neutrality and impartiality.

The current medical laws and regulations are generally not very operable, the legal liability is relatively light, and the monitoring of law enforcement is not strong.Some existing medical laws and regulations do not stipulate legal liability, that is, the norm lacks the element of sanction, lacks mandatory features, and does not need to bear legal responsibility. , went beyond the reality, and wrote the requirements and goals that could not be met into the norms. No; there are other laws and regulations whose penalties are too light to deter offenders, let alone make an example to others; there are even some laws and regulations that, after they are promulgated, have no supervisory agencies, or have no time to take care of them, or manage them. Ineffectiveness has made these laws and regulations a dead letter.

In view of the status quo of my country's medical legislation, experts in the medical department believe that no matter whether it is reforming the old law or establishing a new law, the improvement of the medical legislation should not be delayed. Accelerating the improvement and improvement of medical legislation and strengthening the crackdown on the manufacture and sale of counterfeit and inferior drugs are the key to curbing the black tide of counterfeit drugs. The new "Criminal Law", which came into effect on October 1, 1997, significantly intensified the efforts to crack down on the production and sale of fake and inferior drugs.The law stipulates that anyone who produces or sells counterfeit medicines that seriously endangers human health shall be sentenced to fixed-term imprisonment of not more than 3 years or be arrested; Whoever causes particularly serious harm to human health shall be sentenced to fixed-term imprisonment of not less than 10 years, life imprisonment or death.At the same time, a fine of more than 50% but less than twice the sales amount or confiscation of property may be imposed concurrently.Whoever produces or sells inferior drugs that cause serious harm to human health shall be sentenced to fixed-term imprisonment of not less than 3 years but not more than 10 years; if the consequences are particularly serious, he shall be sentenced to fixed-term imprisonment of not less than 10 years or life imprisonment, and at the same time, he may be sentenced to not less than 50% of the sales amount. times the fine or confiscation of property.Another source confirmed that the relevant departments have begun to brew the revision of the "Drug Law". The new Drug Law will further intensify the crackdown on the manufacture and sale of counterfeit and inferior drugs, and standardize the development, production, sales, management and supervision of drugs.

On May 1, 1999, the State Drug Administration issued five newly revised administrative regulations on drug supervision and management - "New Drug Approval Measures", "New Biological Products Approval Measures", "New Drug Protection and Technology Transfer Regulations", The "Measures for the Examination and Approval of Generic Drugs" and the "Measures for the Administration of Imported Drugs" were officially implemented.This has strong practical significance for regulating the development, production and sales of drugs, and also has a relatively clear method of operation for preventing and combating counterfeit and inferior drugs. Houma, Shanxi was once known as one of the eight major counterfeit drug markets in the country. 106 of the 108 distribution units operate illegally, with monthly sales of more than 10 million yuan, of which counterfeit and inferior drugs account for 66%, covering 46 counties in 8 provinces. Cases of counterfeit drugs causing disability and death are common, and the country loses money here every year The tax revenue is 20 million yuan.Today, the counterfeit drug market in Houma has been wiped out. In October 1992, Cui Huimin had just been transferred to the director of the Linfen District Medical Administration, and a murder case involving counterfeit medicine deeply shocked his heart.An 8-year-old boy, because of a cold and cough, went to the township hospital for an injection of kanamycin. The child only yelled: "Mom, I'm numb..." and then stopped breathing. The father who worked in Urumqi was crowded for three days When the night train came back, the son was buried, the wife went crazy, and a family was ruined just like that.Pushing back the time a little further, from July 10 to September 20, 1992, seven children died of counterfeit medicines in a period of more than two months! Why are counterfeit drugs repeatedly banned?The primary crux of the problem is that local protectionism and departmental interests have caused troubles, resulting in ineffective crackdowns.If the anti-counterfeiting of medicines is to be taken seriously, it has to pass this level first.To this end, they went to the prefectural committee, the upward department, and various functional departments of the government to seek cooperation, and went to Houma five times to seek cooperation from the local government.Finally, in March 1993, led by the regional pharmaceutical department and jointly issued by the six departments of health, industry and commerce, public security, procuratorate, and metrology, the circular on rectifying the pharmaceutical market was officially issued, and an inspection team composed of six departments was established at the same time.The inspection brigade, together with the local government, banned the illegal medicine market in Houma, which had been endangering society for eight years. At the same time, they have established a professional anti-counterfeiting team, which is always fighting tirelessly.With the cooperation of the public's reports, the anti-counterfeiting professional team members blocked the roads and checked in the vehicles, which made the criminals who produced and sold fake and inferior medicines all over the place.In just half a year, 645 individual drug dealers operating illegally in the whole region were investigated and dealt with, more than 1,000 kinds of counterfeit drugs, 375 kinds of inferior or expired drugs, and 20,000 sets of unqualified disposable infusion sets were investigated and punished. There were more than 70 suspects, 30 major cases were seized, and more than 30 million yuan in profit and tax losses were recovered for the country. Because Linfen has played a real role in cracking down on counterfeit medicines, the common people affectionately call the Linfen Pharmaceutical Administration Bureau "the guardian god of the people's safe medicine use". Shanghai has launched a series of measures to eradicate counterfeit and inferior drugs, which are also worthy of reference: complete the supervision of drugs in rural clinics, factories, and school health departments within 1999; strengthen the supervision of in vitro diagnostic reagents in the city, The use of those that do not meet the standards shall be prohibited; the quality inspection of antibiotic drugs and community-use drugs shall be done well; special inspections shall be carried out on drug labels and instructions, and the production and operation of drugs without licenses or incomplete licenses shall be severely punished according to law; the supervision of adverse drug reactions shall be carried out, Strengthen the re-evaluation of drugs; strengthen the supervision of drug advertisements to prevent misleading false advertisements. Drugs are related to our lives, health and safety. Only by strictly investigating and cracking down on manufacturers and sellers of counterfeit and inferior drugs, so that they have no gaps, no opportunities to take advantage of, and no way to escape, can we truly purify the drug market and ensure The safety of people's medication ensures the safety of people's lives and health. The Chinese who have been victimized by counterfeit and shoddy products have now learned the ability to distinguish the fake from the fake and keep the real from the fake.The child who bought cigarettes for his father can actually get a general idea after "looking, smelling, asking, and cutting" the cigarettes, and the old lady in the country will carefully touch and pinch the cigarettes after receiving the RMB. For medicines, few people identify the authenticity. On the one hand, we trust hospitals and pharmacies too much, but on the other hand, we do not have the ability to distinguish genuine and fake medicines at all. On December 7, 1998, Wang Hai and several senior drug inspection experts gathered in Beijing to discuss how to identify counterfeit drugs. A director of a drug control institute with decades of experience took more than 500 sets of comparison samples of genuine and fake drug packaging from a suitcase.Among these colorful drug packages, there are familiar Niuhuangjiedu pills and spiramycin... If there is no comparison of samples, it is difficult for ordinary people to distinguish the authenticity of drugs from the drug packages. Another drug testing expert pulled out more than a dozen commonly advertised drugs, but they were all fake.The expert asked Wang Hai to try penicillin, and he licked it with the tip of his tongue, saying that it had no taste.Experts told him that genuine penicillin should be slightly bitter, and this medicine is made of starch.Pointing to the counterfeit medicines, the experts said that the packaging of Contac was rough, the production batch number was uneven, the packaging of morphine was irregular, and the writing on the packaging of Lijunsha was not clear. The reason why sellers of counterfeit drugs are desperate is that the profits of counterfeit drugs are very large. For example, 12 tablets of fake spiramycin are 1.2 yuan, which can be sold for more than two yuan.What's more, the method of changing the label of the medicine is adopted, and the ampicillin sodium worth a few cents is replaced with an imported label and sold for a few yuan. Wang Hai gave each expert a copy of the book "I'm a Troublemaker" co-authored by him and his friend, which records many cases of counterfeit medicines.Wang Hai said: "This summer, I heard that the Ministry of Health issued a document confirming that a drug for treating sexually transmitted diseases 'Zhuangbizhi' was a counterfeit drug, so I began to go to pharmacies and hospitals to investigate whether this counterfeit drug is still being sold. I went to dozens of pharmacies and STD clinics in more than 20 hospitals in eight cities including Tianjin, Shanghai, and Hefei, and found that almost all of them were selling this fake drug. Some merchants expressed aggrievedly that they did not deliberately sell fake drugs. Hefei The manager of a large pharmacy said that they sell thousands of medicines, but they don’t have testing equipment and testing capabilities. The drug testing department conducts random checks on medicines, and the salesperson cannot identify every medicine. He wants me to tell them about identification. The knowledge of genuine and counterfeit medicines helps check the purchases in the store.” After returning from Hefei, Wang Hai came up with the idea of ​​holding drug screening training courses for purchasers of pharmacies and hospitals.However, he felt that his knowledge of medicines was limited. If he held training courses, he needed to hire experts as teachers.Wang Hai told some drug testing experts about his thoughts. The experts said that drugs are different from other commodities. There are only genuine products and no defective products. It is necessary to hold drug knowledge training courses for drug purchasers.Although the drug management department has been doing this work, but because the pharmaceutical market is too large, it is inevitable that there will be loopholes.Wang Hai wants to hold drug knowledge training courses for drug purchasers. This is a good thing and should be supported.At present, Wang Hai has formulated a drug screening training plan, and is working with experts to prepare teaching materials such as physical objects and slides.He is also going to regularly provide drug buyers with information on fake drugs on the market in the near future as a reference for their purchases. It is indeed a good thing that Wang Hai prepares to hold drug knowledge training courses for drug purchasers, but as millions of consumers, we cannot put all our hopes on Wang Hai's training, and Not to mention that Wang Hai's training area is quite limited. Even if all drug purchasers in China have participated in the training and can identify genuine and fake drugs, there is no guarantee that we will not be threatened by counterfeit drugs.Because there are still irresponsible drug purchasers, drug purchasers who are greedy for kickbacks and put our lives at risk... This means that for our health and life safety, it is also necessary for us to learn some drug identification knowledge.For the majority of consumers, this is indeed a very difficult thing, but it is also a very necessary thing.With the reform of the medical system and the increase of people's knowledge of medicine and health care, "go to the pharmacy for minor illnesses, and go to the hospital for serious illnesses" has become a new choice for many patients.In the face of numerous and complicated pharmacies, it is obviously impossible to have certain knowledge of drug identification. Some experts pointed out that as an individual to identify fake and inferior drugs, there are five basic principles: 1. Look at the label: When buying a whole bottle or box of medicines, you must first check whether the label is printed properly and whether the items are complete.National regulations: The label of the drug must be printed with a registered trademark, approval number, drug name, product batch number, and manufacturer.Among them, the trademark and approval number are particularly important. If there is no one or the printing is not standardized, it can be regarded as a counterfeit drug. 2. Look at medicines: Regardless of needles, tablets, pills, powders, water, tinctures, and medicinal materials, if there is mold, deliquescence, agglomeration, or odor, peculiar smell, and tablet color is inconsistent, it can be regarded as inferior medicine.The expiry date is printed on the label, and any medicine beyond the expiry date can also be regarded as inferior medicine. 3. Traveling doctors, street drug dealers and "entertainers", in order to make money, most of these people talk nonsense, or say "gift", or "refund for invalid", etc. Most of them sell fake medicines. 4. Advertisements posted on street walls boasting so-called "ancestral secret recipes" and medicines that "cure" so-and-so are basically counterfeit medicines. 5. There is no need to identify the medicines "begged" by gods and ghosts, and all of them are counterfeit medicines. "Don't easily believe the drug advertisements in the mailbox." This is also the advice of some medical experts.In recent years, urban residents often receive some medical advertisements in their mailboxes, such as "improving yang medicine", "kidney tonifying ointment", etc., which are magical.Many people followed the instructions in the advertisements to buy, but after taking it, they shouted that they were cheated.Some manufacturers publish advertisements without being reviewed by the drug advertising and publicity department. It is not a drug or a health care product that has not been approved, and it is neither a drug nor a health care product. There is no need to make any distinctions about it, and it is the best choice to ignore it. Counterfeit and inferior drugs are so pervasive, seamless, omnipresent, and ubiquitous. On the one hand, governments at all levels and departments need to work together to strictly investigate and crack down on them. On the other hand, we also need to strengthen our own defenses. Awareness, improve the ability to distinguish. For the health of our bodies and the safety of our lives, we must curb and eliminate counterfeit medicines, and return the society to a healthy, safe and regulated pharmaceutical market!