Every reporter Ding Zhouyang, intern Lin Zichen, every editor Zhang Haini After the "pharmaceutical merchant" lost contact, Fang...
Every reporter Ding Zhouyang, intern Lin Zichen, every editor Zhang Haini
After the "pharmaceutical merchant" lost contact, Fang Jianxian embarked on the road to "westward seeking medicine" in Bangladesh. The father of terminal cancer has been alive for nearly three years, almost relying on the targeted drug levatinib to continue his life.
Fang Jianxian first inquired from the patient group that there was a family member of a patient named Cao Lisha who could get a box of Bangladeshi generic drugs for 680 yuan, which was only a few dozen yuan more expensive than foreign pharmacies, even after being covered by medical insurance. The price of this medicine is more than 3,000 yuan per box.
When Cao Lisha and his wife, Zhang Xia, and Liu Feng who helped her take medicine in Bangladesh, were "one-potted", Fang Jianxian and nearly a hundred terminally ill patients once again faced a difficult decision.
Zhang Xia, Liu Feng, Cao Lisha, Li Guilin, their experience is almost a reprint of the movie "I am not the god of medicine". The difference is that Cao Lisha and his wife have achieved tens of millions of dollars in sales in more than a year, which is profitable.
In mid-April 2021, the Xi'an Intermediate People's Court made a first-instance judgment, and Cao Lisha's husband Li Guilin was sentenced to six years in prison for illegal business operations.
This is the first "Medicinal God" case to be convicted after the law was amended. At the end of 2019 and the beginning of this year, relevant laws have been revised successively, and "Yao Shen" has been treated more rigorously and tolerantly. However, should we use the crime of illegal business operations in the criminal law to attack the money-making "medicine god"? There are totally different views and practices in the judicial circle. The most representative is that Cao Lisha and her husband Li Guilin were arrested by the police in Jiangsu and Xi'an successively. However, unlike her husband's fate, Cao Lisha was released on bail in April this year and has not been prosecuted.
From seeking medicine to "medicine god"
When he came to the country where his wife Zhang Xia was sent to work, Liu Feng posted a circle of friends, positioning him as Bangladesh. The WeChat dialog box flickered suddenly, and a friend far away in Xiamen sent him a picture asking if Liu Feng could buy a medicine. "I just learned that he has been suffering from leukemia for a long time, he has replaced his bone marrow and needs to continue taking this medicine."
With more and more cases of sudden finding, starting from the beginning of 2019, Liu Feng and Zhang Xia contacted Bangladeshi pharmaceutical factories for bulk shipments. "We only need to provide them with the domestic address, and the locals will find a way to send it. For example, it happens to fly to China on one flight and find someone to bring three to five boxes per person, so that you can bring dozens of boxes at a time. In short, Bangladesh has special channels. Come and do this." Liu Feng told the "Daily Economic News" reporter. "They will definitely increase the price during this process. One box will add tens of yuan, but according to the exchange rate, it is already a considerable income for the locals."
After entering the country, these medicines were sent to Zhang Xia's father, who then distributed them to people who were looking for Zhang Xia and Liu Feng to buy medicines. A blogger who visited pharmaceuticals in Bangladesh once wrote: "Generic drugs, look at India ten years ago, and Bangladesh ten years later." Thanks to the regulations of the WHO (World Health Organization), Bangladesh is one of the less developed countries. Obtain an exemption from patent protection for pharmaceutical products and clinical data in developed countries until 2033. In other words, once the innovative drugs in Western countries are on the market, pharmaceutical companies in Bangladesh can imitate similar products under the protection of their own patent laws.
“Many generic drugs can be bought in ordinary pharmacies. The shopkeepers are very skilled in doing business with Chinese people. The categories that are in high demand in China will be placed in a prominent position.” Liu Feng said: “Some of them can’t be found in stores. If we buy it, we will go directly to the manufacturer based on the production address on the outer packaging."
Osimertinib, lenvatinib (also known as "lenvatinib" and "Levima"), ibrutinib, and cabozantinib, these four drugs are all anti-cancer targeted drugs. Liu Feng and his wife are mainly purchasing agents. The reporter inquired through the website of the State Drug Administration, and at present, only Cabozantinib has not been listed in the country.
Through middlemen like Zhang Xia and Liu Feng, various "tinibs" crossed the oceans and eventually flowed to the patients.
In 2017, Cao Lisha's father, who had been fighting liver cancer for four years, heard the doctor privately said that he could try levatinib. "It has been on the market for about two years abroad, but there is no channel (can) buy it in China. The doctor asked us to find it by ourselves." Cao Lisha told reporters, "I asked about the channels of overseas genuine drugs. It costs about 50,000 yuan. month."
Even for a family like Cao Lisha whose family is full of oil systems, the monthly cost of medicine for only one kind of medicine is as high as 50,000 yuan, which is unbearable. As a result, Li Guilin, a husband with a high level of English, found a Bangladeshi generic drug for several thousand yuan a month on the Internet.
"Levatinib was really effective at the beginning, but my father has reached the late stage of bone metastasis and left us in March 2018." Cao Lisha said, "Father's treatment process for more than five years, we are online every day with patients and patients from all over the country. Family members communicated and wanted to find various ways, including home remedies. Many patients saw that we bought generic drugs and used them for a period of time, so they would ask how they bought them."
With the development of her father's condition, Cao Lisha's medication experience became more and more abundant, and more patients found her, which also helped her win trust in the patient circle. Cao Lisha and his wife began to help domestic patients purchase generic anti-cancer drugs.
In March 2018, Cao Lisha's father passed away. The hopping news in the patient group seems to have nothing to do with Cao Lisha, but it does have a deeper connection with her: "The patient group has become my spiritual support, and I have gradually become the "Group leader." I didn't have a job at the time. I took care of my children at home and had relatively plenty of time. So I started to help patients buy medicines a lot."
Life-saving medicine that can't be bought or can't be bought
When I first heard about the low-priced medicines sold by Cao Lisha, Huang Lunning, a liver cancer patient, was also skeptical. “When NEXAVAR (Sorafeni) did not enter the medical insurance, if you buy a domestic genuine medicine, you will get a box of 20,000 yuan. Cao Lisha sold a box of about 680 yuan. I couldn’t believe it at first, and I was very skeptical. Curative effect."
However, Huang Lunning, who was born in the countryside and works on a construction site in a city, has no choice. In the face of life-saving drugs that he can't afford, even if he is worried that the low-priced generic drugs in Bangladesh bought from private hands are unreliable, he has to give it a try. "After eating for half a month, I didn't expect it to be really effective, and all indicators were stable within the normal range. Because I have already undergone resection, I must take targeted drugs for a long time to inhibit the activity of cancer cells."
Later, NEXAVAR entered the medical insurance, and the price dropped sharply, but for Huang Lunning, he still had to choose generic drugs. "After entering the medical insurance, the price is 3240 yuan per box. I need three boxes a month, which is more than 100,000 yuan a year. But when I bought it from Cao Lisha, it only cost 20,000 to 30,000 yuan a year, so I saved two-thirds. The money. You say this is terrifying. The difference between 30,000 yuan and 100,000 yuan is not considered by the rich. For those without money, it is an astronomical figure."
Li Guilin said that he and Cao Lisha purchased anti-cancer drugs from India, Bangladesh and Turkey in February and March 2018 and sold them in China. The purchased drugs were about 40 or 50 varieties, including Iressa, NEXAVAR, and Biokangle. Val, Wei Cai Le Val, Ibrutinib, Olapani, Teresa, Erlotinib, etc. On the basis of the purchase price, each sample will be sold after an additional price ranging from 10 yuan to 200 yuan.
According to data from the Head Leopard Research Institute, the number of cancers in China continues to grow. It is estimated that the number of cancers in China will reach 4.865 million in 2023, with a compound growth rate of 2.6% from 2018 to 2023, which means that the demand for anti-cancer drugs in the future will increase. Continuing to exist, this has also promoted the acceleration of the process of anti-cancer drugs entering medical insurance.
According to the reporter's combing, in 2020, more than 50 anti-tumor drugs will be included in the medical insurance, and the above-mentioned drugs have basically entered the medical insurance list. After medical insurance is reimbursed, gefitinib is 498 yuan/box, sorafenib is 5700 yuan/box, levatinib (4mg*30 capsules) is 3240 yuan/box; ibrutinib enters medical insurance in some areas, the price is about 6800 yuan /box. Compared with before being covered by medical insurance, the price of anticancer drugs has dropped significantly.
However, there is still a big gap between the medical insurance prices of anticancer drugs and foreign generic drugs. The main reason for this gap is that the Indian patent law guarantees that when people cannot afford high-priced drugs, they can directly imitate drugs that have not passed the patent protection period. In my country, before the patents of the original research drugs expire Imported original research drugs.
Due to the long R&D cycle of original research drugs, huge investment, and limited patent protection period, when companies set prices, in order to ensure cost recovery and have funds to invest in the next phase of research, the pricing is higher than that of general drugs.
However, the reporter noticed that in April 2018, in terms of reducing the cost of anti-cancer drugs, Yu Jingjin, the director of the National Health Commission’s Pharmaceutical Affairs Department, once stated at a press conference that as of April 18, 2018, the two batches of negotiated 17 The price reduction of a kind of anti-cancer drugs saved 4.17 billion yuan, and the reimbursement after being included in the medical insurance catalogue reduced the burden of drug costs by 6.24 billion yuan for patients. In accordance with the work arrangements of the State Council, zero tariffs on imported drugs will be officially implemented from May 1, 2018.
Disagreements and disputes after the law amendment
In August 2019, Cao Lisha, Zhang Xia, and Li Guilin were taken away by the Jiangsu police and the Xi'an police on suspicion of "selling counterfeit drugs." Liu Feng surrendered and stayed at home in Xiamen on bail pending trial.
Cao Lisha arrived in Jiangsu and gradually understood why she was arrested. In Jiangsu, someone bought medicines from foreign drug dealers and sold them in domestic packages. They were arrested on suspicion of selling counterfeit medicines. They were arrested by the Jiangsu police together because they and the people who sold the medicines were bought from Zhang Xia. . Li Guilin was taken away by the Xi'an police because he was selling drugs with Cao Lisha.
Although Cao Lisha has repeatedly stated that she has taken the main responsibility in the process of selling drugs, the police should not arrest Li Guilin. However, in the eyes of the Xi'an police, Li Guilin assisted Cao Lisha selling drugs, and the two were committed crimes.
In addition to the complex facts, it is worth noting that, unlike many past "Medicinal God" cases, Cao Lisha and others stepped on two legal amendments.
From December 1, 2019, the new "Drug Administration Law" removes "drugs that must be approved but produced or imported without approval, or that must be inspected in accordance with this law but sold without inspection" out of the category of counterfeit drugs.
"When facing the first legal amendment, we actually felt that we were the beneficiaries, because if we were to sell counterfeit drugs, we might face more than ten years of penalties." Cao Lisha said, after the release of the new "Drug Administration Law" , The prosecution’s prosecution against them was changed to illegal business.
It has been verified that Cao Lisha has no direct relationship with the person who sells the medicines, and that she did not conduct secondary treatment of the medicines in the drug sales, and did not involve the manufacture of counterfeit medicines. The drug test results confirmed that the medicines are effective, and she was detained for 8 months to change the compulsory measures. Transfer to bail pending trial.
On November 30, 2020, the Xi'an City Procuratorate filed a public prosecution against Li Guilin. Li Guilin did not have the qualification to sell drugs exclusively, and the amount of domestic sales of generic drugs exceeded 10 million, and there was a profit-making behavior. He was prosecuted on the crime of illegal business operation. The recommended sentence is 5 ~8 years. "We stated in court that the Eleventh Amendment to the Criminal Law is about to be promulgated and we should wait until the new law comes out before making a judgment." Li Guilin's defense lawyer, Lu Da, told the "Daily Economic News" reporter.
The Criminal Law Amendment (11), which came into effect in March 2021, establishes a new "crime of obstructing drug management": manufacturing, importing drugs without obtaining drug-related approval documents, or knowing that they are the above-mentioned drugs and selling them, and are sufficient to seriously endanger human health Those who cause serious harm to human health or have other serious circumstances shall be sentenced to fixed-term imprisonment of not more than three years or not more than seven years and fined.
Regarding the impact of the addition of the “crime of obstructing drug administration”, the official account of the Supreme People’s Procuratorate forwarded an article by Wang Yong, deputy procurator of the Suzhou Municipal Procuratorate of Jiangsu Province at the end of 2020. The article mentioned: After the “Eleventh Amendment” was officially implemented, sales Drugs that have not yet reached the level of "sufficient to seriously endanger human health" can no longer be deemed as the crime of illegal business operations. Otherwise, not only will there be an imbalance in crime, responsibility and punishment, but it will also violate the principle of obedience to the old and lenient.
Cao Lisha, who accompanied her father through the five-year anti-cancer journey, deeply felt that the country attaches great importance to medical care and people's livelihood issues. "Levatinib and other medicines were made from scratch and included in medical insurance. It is a huge improvement. The two legal amendments, in our view, mean that the country is tolerant of our "medicine gods". After all, genuine The review, introduction, and price reduction of anti-cancer drugs are all (have) a process. Before that, our existence has left a ray of life for patients who are struggling with life and death and cannot afford to wait or afford."
Luda predicts that, in accordance with the "Eleventh Amendment" regulations, the sale of generic drugs that endanger human health will be sentenced to three years. However, Cao Lisha and Li Guilin's drugs really helped the patient's physical recovery, so they should be innocent and exempt from criminal law. He was sentenced, and the administrative law fines were used to pursue his violations.
The result was not the case. More than a month after the implementation of the "Eleventh Criminal Law Amendment", on April 15, 2021, the Xi'an Intermediate People's Court made a judgment in the Li Guilin case: Li Guilin violated the national drug management laws and regulations and did not obtain a drug business license. Illegal sales of drugs and the crime of illegal business operations shall be sentenced to six years in prison. According to Li Guilin’s judgment, Li Guilin’s illegal business amounted to more than 14.42 million yuan; from May 2018 to August 2019, Li Guilin and his wife sold more than 12.73 million yuan in drugs.
Regarding the huge sales amount, Cao Lisha explained that the main reason is that the targeted drug itself is also very expensive (although a box is only a few hundred or a few thousand yuan, but because of long-term use, the total amount will be very large), cancer patients have rigid needs, "outsiders You may think how you sold this item, such a large amount of money seems very mysterious, but in fact this item is very easy, because I live in a group like (cancer patients) every day."
In order to learn more about the case, the reporter tried to call the public service hotline of the Xi'an Intermediate People's Court. The other party said that it only provides information consultation before and after the case is filed, and does not provide case-related information and other services to persons other than the parties.
When "the god of medicine" disappears
The following week, on April 22, 2021, the Intermediate People's Court of Dongtai City, Yancheng, Jiangsu Province opened a trial on Zhang Xia's case. The prosecutor still filed a lawsuit against Zhang Xia for illegal business operations, and suggested a six-year sentence. "The judge said that this crime ('illegal business') is very controversial and will not be discussed in court today. We will study it later." Liu Feng, who participated in the first instance, recalled.
"There are quite a lot of family members of our patients who have turned into purchasing agents, but after the implementation of the'Eleventh Xiu', they are currently arrested and are already undergoing judicial procedures. We are the first to make a verdict. The locality has not yet decided." Cao Lisha said.
On May 13, when Fang Jianxian was interviewed by a reporter from "Daily Economic News", he had just returned to China from Bangladesh. After Cao Lisha was taken compulsory measures, Fang Jianxian, who was disconnected from the "God of Medicine", went to Bangladesh to buy medicines by herself every few months and became a member of the "Taoyao Clan". "Taking Cao Lisha's medicine, the effect is really good, the price is also cheap, I think it is a good thing. But I can't get in touch with her person, I was anxious to find medicine, this is something for my father's life, and then heard people say that Bangladesh has it. So come and take a look."
During the time when he lost contact with Cao Lisha and Li Guilin, Huang Lunning went to find other pharmacies purchasing generic drugs. In his opinion, his long-term use of Cao Lisha's medicines is that on the one hand, it is good for the efficacy and on the other hand is fair price.
As for whether Cao Lisha and his wife make a profit from it, Huang Lunning doesn't care. "Even if they bought it for 200 yuan and sold me six or seven hundred yuan, I can totally accept it. They should make money when they get us the really effective medicine."
When he heard that Li Guilin had been sentenced to six years for this, Huang Lunning couldn't help being worried. "I must be very worried. If the sentence is so severe in the future, no one will dare to sell it. If the source is cut off, it will be patients like us who suffer."
"I am working on three'Yao Shen' cases, all of which have been delayed until after the promulgation of the 11th Criminal Law Amendment, so the sentencing should be very light or even innocence can be expected. But now the'Yao Shen' case of Xi'an Intermediate People's Court is convicted It’s still a six-year severe sentence for illegal business operations." Li Guilin and Zhang Xia’s defense lawyer Zhou Xiaoyang told the Daily Economic News reporter, "Of course, I don’t think that the'God of Medicine' is legal, even if it is motivated by a beautiful motive. At the very least, this is a drug. It is sold from abroad without the approval of the relevant state (department), which violates the normal order of drug distribution management. This behavior must be regulated, and if it does not endanger human health, it can be administered. Punishment; for acts endangering human health, the criminal law is then considered as a penalty and a crime. The severe punishment of 5-15 years should not be used in general."
Should we use severe penalties?
Whether the crime of illegal business operation should be applied or not is the main difference between the judicial circle on how to judge the "Yao Shen" case after the "Eleventh" of the Criminal Law.
Some legal persons believe that medicines are sold exclusively, and people who do not have the relevant business qualifications take medicines into the country. If the amount is huge and there is profit from it, it will be a crime of illegal business. "The prototype of Lu Yong in "I'm Not the God of Medicine" is not prosecuted by the prosecutor because the purchase is not a crime, and Lu Yong is only assisting others in the purchase, and there is no profit in the middle, not a sales behavior. (Therefore) just talk about it. No more crimes of selling counterfeit drugs or illegal business operations."
"I do not approve of using illegal business operations to crack down on the sale of unapproved anti-cancer drugs. This is equivalent to the fact that after the law is amended, crime A cannot be used to attack them, and finally a crime B is replaced. This cunning application of the law goes against the spirit of the whole law and completely defeats the purpose of amending the law." Peking University Law School professor Che Hao said in an interview with the reporter of "Daily Economic News", "On the surface, it is the middle sellers. In fact, the lives of many downstream patients have been cut off."
"Even if the'medicine gods' use this to make profits, they should not be attacked as illegal business crimes." Cha Hao added, "The law cannot be divorced from the reality of life, and money is not allowed. Is there anyone else doing this? The final result is still Downstream patients are damaged. There is an old saying in China that dead horses should be used as horse doctors. How many cancer patients go to the back to find folk remedies, we can all allow the existence of these remedies, why can’t we allow people who sell Indian generic drugs to make some money It's.
However, if a special product such as medicine is not strictly controlled, it will indeed cause hidden dangers to public health and public health. In Che Hao's view, what needs to be treated differently is to see what medicine is sold. "It's okay to take in and sell those normal and common drugs that are fully supplied in China from the perspective of illegal business. But if they sell life-saving drugs, they are not available in the country or they are very expensive. If they are not allowed to sell, the people behind will only die. , Then from the perspective of emergency avoidance, it should be removed from the crime of illegal business operations."
Liu Peizhen, an associate professor at Southwest University of Political Science and Law, believes that it is not about the "medicine gods" who is not concerned, but how to manage. The circulation of generic drugs harms the intellectual property rights of genuine drugs. Of course, intellectual property rights must be protected, but the issues of conscience and justice must also be considered. The giants of pharmaceutical companies sit on the ground and raise prices so that the rich can afford to eat and those who do not have money to die. This is legal. Rights and interests violate higher justice. "Therefore, the crackdown on the circulation of genuinely effective generic drugs must be within the limits of reasonableness. After the pharmaceutical companies see it, they may lower the price a bit. This is also a game that can ultimately save more people's lives."
"From the revision of the Drug Administration Law in 2019 to the implementation of the "Eleventh Amendment" this year, it can be seen that the country is designing a system for decriminalizing the behavior of the'God of Medicine' at the legislative level. Due to the lack of guidance for judicial interpretation, the There is no uniform understanding of how to deal with the "Yao Shen" case in the judicial circle. After the judgment of Li Guilin's first instance, Li Guilin has appealed to the Higher People's Court of Shaanxi Province, and I will continue to defend his innocence in the second instance of this case. "Lu Da said.
(At the request of interviewees, Fang Jianxian, Liu Feng, Zhang Xia, and Huang Lunning are all pseudonyms)
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