The embarrassing situation of domestic generic drugs: in the doorway of the hospital, not to the patient's hands.

The embarrassing situation of domestic generic drugs: in the doorway of the hospital, not to the patient's hands.

Original title: embarrassing situation of domestic generic drugs after viewing headlines: before reaching the patient's hands, they fell to the door of the hospital.

In the view of the industry, apart from the disparate market share, we need to explore the growing pains of a country's pharmaceutical industry.

"They can not afford to import expensive drugs, so they can only wait for death or even commit suicide." Cheng Yong, the movie "I am not a drug God", said in court. He was prosecuted for smuggling generic drug Glenin from India.

This is in 2002. If Cheng Yong in court passes through 2018, what kind of voice will he see?

Five years ago, gleevo patent period has arrived. At present, there are three generic drug manufacturers in China. The price of Gleevec is down and down. Even so, the price of its generic drug is still only 1/10 of its price. Generic drugs are the products with similar active ingredients and therapeutic effects. The cheapest generic drug price is less than 900 yuan that Cheng Yong brought back from India. But gleevo still occupies 80% of the domestic market. Some scholars keep asking, why can't we use cheap and quality generic drugs?     

Behind such questioning is the reality of home-made generic drugs. The market has more than 4300 pharmaceutical companies, but their products have never been as popular as India's generic drugs. In the view of the industry, apart from the disparate market share, we need to explore the growing pains of a country's pharmaceutical industry.

80% and 20%

"21600 yuan for medicine." Mr. Wan revealed to reporters a recent bill for out-patient charges in Tongji Hospital, which is the price of two boxes of gleevein, 60 pieces per box, and his child, Xiao Jun (pseudonym), needs to take a box and a half a month. Jun, 6, was diagnosed with chronic myeloid leukemia a year ago. He needed 3 tablets of Gleevec every day for continuous treatment.

Greve is the trade name of Novartis pharmaceuticals, commonly known as imatinib mesylate. In 2018, gleback included medical insurance B in Hubei, and the child's charge could be reimbursed 40%, and the Chinese Charity Federation also had the gleeve special patient assistance program, that is, for 3 months in a year's cycle, it could be free for the rest of the 9 months.

It took about 32 thousand yuan to buy gleevi last year. Jun now has only one month's cost in 2002. At that time, Greve was first listed in China, and the price of one box was 23500 yuan. Now the price of one box has dropped to about 10800 yuan. The homemade drugs of the same specification are cheaper. Jiangsu hausen has successfully listed the first imitinib generic drug in China, which is the first copy of the drug. Its product "Xin Wei" is at the current price of 1160 yuan a box, which is about 12 thousand yuan per year, and twenty thousand cheaper than the import. In addition, the price of "nullin" and "Ge Nike", launched by Ouyi, is cheaper. The price is 900 yuan and 870 yuan, respectively. The price is slightly different in different provinces.

However, Mr. Wan did not plan to change his child's dressing. "Gleevin has been listed in China for more than 10 years, that is to say, the clinical use of CML patients for more than 10 years, and the domestic medicine has not been so long clinical." Mr. Wan himself is also a grass-roots doctor.

In China, because of the imbalance of economic development, there are obvious differences in the payment of medical insurance in different provinces and cities, and the proportion of the three basic medical insurance payments is also different. The actual cost of the patient is very different every month. As far as gleant is concerned, some areas can be reimbursed up to 80%, and the self payment of gleevet can be lower to about 1600 yuan per month for adult patients. The gap with the use of domestic drugs is further narrowed, but many patients are still reluctant to change the domestic medicine for the difference price of one thousand yuan per month.

This is reflected in the market share of the drug.

According to the calculation of Chinese health information, the total sales of imatinib mesylate in China reached 3 billion yuan in 2016, of which 1 billion 920 million yuan was sold by public medical institutions, 1 billion 540 million yuan and 80.29% in Novartis, 210 million yuan in Jiangsu hausen's annual sales and 10.97% in the market. Nike's annual sales volume is 160 million yuan, accounting for 8.53%, and Ouyi's market share is only 0.21%. China health information is a third party organization engaged in Information Research of China's pharmaceutical industry and Research on China's pharmaceutical retail industry.

This is not the case. The same is true for the anticancer drug gefitinib.

Ireissa (effective composition gefitinib) is a targeted drug for non-small cell lung cancer. It was first developed by AstraZeneca and was listed in China in 2005. The price is about 7000 yuan per box, 10 grains per box, and the patient's monthly drug cost is more than twenty thousand yuan. The price of the drug was reduced to 5000 yuan. In 2016, Iressa entered the national negotiating catalogue, which dropped to $2350 per box. In contrast, the domestic drug gefitinib is priced at 1680 yuan per box. As of June this year, the original drug Iressa entered more than 1200 hospitals nationwide, and the domestic generic drugs of Qilu pharmaceutical entered only more than 200 hospitals.

The reason is that the quality of homemade medicines has not yet been convinced by doctors and patients, said Cheng Zengjiang, founder of the new drug research and Development Forum. In the monopoly period of the last ten years, foreign companies have established strong brand recognition in doctors and patients, including trust in their quality and efficacy.

The movie "I am not a drug God" re - realities the reality of Chinese generic drugs. This is an old question: why foreign capital has passed the patent period of the original research medicine can account for 80% of the market share, domestic generic drugs only 20%, although the domestic generic drug prices are less than the original research 1/3 or even 1/10.

This is a common phenomenon. Because of this, in other researchers' eyes, patient preference can not fully explain the current weakness of domestic generic drugs.

Who prefers high price drugs

In China, a drug from the factory to the hands of the patient, the whole chain of sales from the hospital application, centralized bidding, hospital procurement, commercial distribution, doctor prescription and so on.

In 2009, a new round of medical system reform was launched, and public procurement of drugs in government hospitals was implemented by government led procurement. Among the varieties of large and large amounts of clinical use, the government led government led drug purchase by the provincial government is carried out, and the exclusive or patent medicines are negotiated by negotiation. After winning the bid, the product is delivered to the hospital by the successful pharmaceutical enterprise.

Generally speaking, the imported drugs in the mouth of the patient, if they are still in the patent protection period, will be negotiated to reduce the price of the purchase, and the patent medicine (that is, the original research) has been included in the scope of the bid procurement.

Drug bidding in different provinces is divided into two parts: technical standard and business standard. The technical standard is based on the principle of "one product, two regulations", that is to say, one species chooses one domestic import. Take gleevin, the equivalent of the domestic three generic pharmaceutical companies need to compare the quality of the first, the domestic generic pharmaceutical enterprises to play group competition, the original research has already got the admission ticket. After entering the business standard, the price is lower and who wins the bid. Proprietary drugs are usually classified as different levels of quality and are priced separately. The original drugs like Gleevec enjoy better pricing power.

According to the data of 2016, hausen got the mark of 16 provinces and cities, the standard of the 16 provinces, the standard of the 17 provinces of the stone medicine group, and gleevin got more than 19 provinces, and entered the local medical insurance supplement in the 19 provinces.

Even through provincial bidding, the local medical insurance directory is entered, and parity generic drugs must be purchased through hospitals and prescribed by doctors so as to finally reach the patients. Usually, if a hospital wants to sell a drug, it must open a pharmacy meeting to determine whether to purchase the medicine. If the members of the Pharmaceutical Association pass, they will execute the purchase of the hospital.

Zhu Hengpeng, deputy director of the Economic Research Institute of the Chinese Academy of Social Sciences, thinks the problem lies in the hospital link. Why do we not use cheap and good quality generic drugs? Zhu Hengpeng's answer is clear: our strong public hospitals prefer expensive drugs.

In a recent series of articles, Zhu Hengpeng said that more than 75% of drug retail in public health institutions in China, whether for patients or pharmaceutical companies, is firmly monopolized. At the same time, the public medical institutions are subject to various price controls, so the monopoly profits are realized through the rebate of drugs (consumables) and various stealth rebates (such as arrears of Medicine), that is, the so-called "medicine for medicine". When buying and selling drugs and medical consumables in public hospitals, we should consider not only the efficacy but also the rebate and rebate.

After the health care reform, the total drug abolition will be abolished in China, so the hospital can no longer get the profit from the wholesale zero price difference. How can we get the rebate? According to Zhu Hengpeng's research, the conclusion is that hospitals can still obtain the benefits of selling drugs through indirect secret box operation through the control of the prescription rights, such as the compulsory collection of business performance bond and the accumulation of interest income.

However, a professor at Peking University People's Hospital said: "most doctors do not deliberately prescribe expensive drugs for their interests, and more consider the patient's condition." He explained that although the molecular formula is the same, the homemade drugs often fail to achieve the same effect due to the preparation process, especially in the control of impurities. But the impurity control is not good, the side effect is high. Therefore, when the original drug is not particularly expensive, doctors prefer to use the original drug. In addition, in some special dosage forms, such as slow - controlled release preparation, doctors are willing to use the original medicine, because the original drug release curve is more stable, the patient will not appear on the patient's index is not high and low.

Arguably, according to the principle of "one product and two regulations", hospitals should have the position of generic drugs even if they like expensive drugs. However, the real headache for pharmaceutical companies is that hospitals in many provinces do not hold pharmaceutical associations for many years and can not initiate drug procurement. An example is that in February 2017, the domestic generic drug R & D produced by Qilu Pharmaceutical Co. Shortly after obtaining the drug approval number, he passed the quality conformity assessment of generic drugs, which means that it is equivalent to the quality of the original drug and the curative effect is the same. However, most hospitals do not open the Pharmaceutical Association and purchase drugs. Therefore, drugs can not enter the hospital system quickly.

Inverse effect of drug occupation ratio

In the industry view, generic drugs are "disliked", the proportion of drugs is also a factor that can not be ignored.

In January 2018, a hospital prescription purchase application form was circulated in a circle of friends. The application form of the prescription purchase application was returned by the pharmacy department, and the use of imported gefitinib was recommended because the import drug was not accounted for. "It may be true. Now, no matter which hospital has the index pressure of drug proportion." Mr. Wan said. Reporters confirmed that many hospital workers found this indeed.

The proportion of drugs refers to the proportion of drug expenses in the income of medical institutions. In 2009, the new health care reform started, and the "drug share" was used as a routine statistical and monitoring index at the beginning of the reform. The monitoring data of the former health and Family Planning Commission showed that in 2010, the proportion of out-patient drugs in public hospitals was about 60%, and the proportion of inpatient drugs was 45%.

In September 30, 2017, the comprehensive reform of public hospitals was launched in all public hospitals.

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