Not long ago, the parents of a 6-year-old child in Zhejiang Province posted that the child went to a large general hospital for mycoplasma pneumonia, and the hospital could only prescribe domestic azithromycin injection, and later transferred to Zhejiang Children's Hospital to use imported azithromycin injection. Where did the imported azithromycin go?
For a time, the topic of "difficult to prescribe" imported drugs in hospitals aroused public concern. In response to this phenomenon, the reporter conducted on-the-spot visits to hospitals in Beijing, Zhejiang, Hunan and other places.
Many county-level hospitals cannot buy imported azithromycin
Reporter: Is there azithromycin here? Pharmacy staff of a county-level hospital in Zhejiang Province: There are no imports. Reporter: Didn't it exist before? A pharmacy staff at a county-level hospital in Zhejiang Province: That was a long time ago, not in the past two years.
Reporter: Is there any imported azithromycin (Xishumei) injection? Chen Linxia, pharmacist of the convenience pharmacy of Linxiang People's Hospital in Hunan Province: There are no imports, only domestic ones.
The imported azithromycin that people asked about, the trade name is "Xishumei", which includes azithromycin tablets, azithromycin dry suspension, and azithromycin for injection and other dosage forms. Several county-level hospitals investigated by the reporter do not have imported azithromycin at present. However, in most tertiary hospitals, there are imported azithromycin.
Zhang Lan, Director of the Department of Pharmacy, Xuanwu Hospital, Capital Medical University: At present, in our Xuanwu Hospital, in most public medical institutions, it is not that there is no original azithromycin, we only have the original oral preparation of azithromycin, and there is no original azithromycin injection preparation, because the injection preparation of azithromycin is used in specialized hospitals for children, and from the perspective of enterprises, its supply may be limited, so it does not supply general hospitals like us.
It is understood that in some public hospitals, even if there is imported azithromycin, it is difficult for patients to prescribe it, because the hospital has restrictions on the sales of this type of drug, and it is often only prescribed by individual doctors authorized by the hospital.
Pharmacy staff of a hospital in Zhejiang: There is a special doctor to prescribe it. Reporter: Is this imported or domestic? Pharmacy staff of a hospital in Zhejiang: Imported, limited to doctors. Which doctor prescribes, you have to ask.
The reporter's investigation found that although imported azithromycin is difficult to buy in hospitals, in addition to injections, other dosage forms can be purchased in retail pharmacies and e-commerce platforms, including common imported drugs such as "compound formodine" for cough suppressants and phlegm-reducing drugs "Mushutan", which can also be purchased, but this also brings inconvenience to patients to use related drugs after seeking medical treatment in hospitals.
Why is it difficult to prescribe imported drugs in public hospitals?
What is the reason why some imported drugs are difficult to find in hospitals? Let's look at the reporter's further investigation.
It is understood that the core strategy of the national centralized drug procurement implemented since 2018 is "volume for price". Generally speaking, the hospitals participating in the procurement will take out about 70% of the annual procurement volume as the promised procurement volume, and the pharmaceutical companies will conduct competitive negotiations, and the pharmaceutical companies that are willing to reduce the price will obtain higher sales volume, and the companies that are unwilling to reduce the price will lose a considerable share of the market.
In November last year, the state carried out centralized procurement of 42 kinds of drugs, including azithromycin. According to the rules, the top 9 candidates with lower quotations, the imported original drug azithromycin was quoted at 5.58 yuan/bag, which was about 4.7 times higher than the quotation of 0.98 yuan/bag in the 9th place, so it ranked last and finally failed.
According to experts, not only imported azithromycin, but also many imported original drugs in the mainland are not only higher than domestic drugs, but even significantly higher than international prices, and the prices of some drugs are even 3 to 5 times the price of some developed countries.
For example, the price of 5mg antihypertensive drug amlodipine (Luohuoxi) is 3.26 yuan / tablet in China, 1 yuan / tablet in Japan, 1.3 yuan / tablet in Italy, and 0.9 yuan / tablet in Portugal; the price of 20mg lipid-lowering drug Lipitor is 5.8 yuan / tablet in China, 0.3 yuan / tablet in United Kingdom, 1.45 yuan / tablet in Australia, and 1.39 yuan / tablet in Belgium.
Gu Hai, Director of the Center for Health Policy and Management, Nanjing University: China is still a developing country, and it is difficult for us to accept such a price for imported original drugs. China's medical insurance fund is a basic medical insurance fund, which mainly meets basic medical needs. The Chinese population is large, more than a billion people, the medical insurance fund is limited, so let's make the best use of this fund, both fair and efficient. Since the generic drug that has passed the consistency evaluation, its effect is basically the same as that of our imported original drug, of course, we choose generic drugs with lower drug prices, so that more people can use our drugs.
Adhering to the principle of "wide coverage and basic protection", the national medical insurance needs to take care of the more than one billion insured people in the country who can use drugs and be reimbursed for drug expenses, so most of the selected drugs with price advantages are generic drugs that have passed the consistency evaluation. At present, the mainland is carrying out the reform of medical insurance payment methods, and public hospitals are implementing payment according to the score of disease group (DRG) and disease type (DIP), and the payment method is mainly through grouping or converting the score of disease diagnosis and treatment, and "packaged" payment, so as to promote hospitals to actively control costs, so hospitals are more inclined to choose selected drugs that are affordable by medical insurance. Gu Hai, Director of the Health Policy and Management Research Center of Nanjing University: The National Health Commission's assessment of public hospitals is also required to increase the proportion of medical services as much as possible, and reduce the proportion of drugs in the entire hospital income, so the price of the original drug is relatively high.
According to the requirements, the procurement of public hospitals in various places is not less than about 70% of the actual use of drugs in the previous year, that is to say, hospitals still have 30% of the procurement share theoretically can be purchased from the products that are not selected, which leaves room for multi-level drug demand. The medical insurance bureaus in many places have also issued documents requiring medical institutions to still purchase a certain number of unselected drugs. But why is it so difficult to get an imported drug like azithromycin in hospitals?
It is understood that in reality, in order to complete about 70% of the volume procurement task, many hospitals choose to purchase less or no procurement for the unselected drugs in centralized procurement, and give priority to completing the hard indicators of centralized procurement, coupled with various factors such as the assessment of the proportion of drugs in public hospitals, resulting in the phenomenon that it is difficult to prescribe imported drugs in public hospitals.
Zhang Lan, Director of the Department of Pharmacy, Xuanwu Hospital, Capital Medical University: We hope that our clinical doctors can give priority to the use of high-quality and affordable domestic generic drugs purchased with volume, especially these generic drugs purchased with volume through consistency evaluation are also relatively substitutable compared with the original drugs, and they also have a price advantage over the original drugs in terms of price. The percentage of drugs is the percentage of the cost of drugs to the total cost of the patient when the doctor prescribes them. In 2009, the new medical reform began, in order to reduce the medical burden of the masses and control the irrational use of drugs in hospitals, the proportion of drugs was adjusted to the rigid indicators used to assess specific hospitals, which also prompted the proportion of drugs in public hospitals in mainland China to continue to decline in recent years, the purpose of which is to reduce the inflated drug prices, eliminate the chronic disease of "medicine for medical care", and reduce the medical expenses of the people.
When you are sick, choose to take imported original drugs or domestic generic drugs?
Behind the public's concern that "it is difficult for hospitals to prescribe imported drugs", it reflects the distrust of some patients in domestic generic drugs. In fact, in order to ensure the quality of generic drugs, the National Health Insurance Administration has always taken the consistency evaluation of quality and efficacy as the threshold for centralized procurement of generic drugs. However, in the perception of some patients, their doubts about the quality and efficacy of generic drugs have not been dispelled by consistency evaluation.
Everyone has different views on the question of whether to eat imported original drugs or domestic generic drugs. For patients with acute diseases such as fever and infection, they are eager to achieve results, and have the mentality of "eating expensive is better than cheap", and they are more inclined to import original drugs at the psychological level.
Chengdu residents: If the condition is more serious, they may still prefer to import medicines.
During the investigation, the reporter found that for some patients with chronic diseases, the drug itself has the characteristics of not being able to cure the disease and it is difficult to see the short-term effect, and long-term medication is more economically considered, so the acceptance of generic drugs is relatively good.
Chengdu resident: My father also has a chronic disease, and he usually takes domestic medicine now.
Generic drugs gradually replace original drugs and promote drug innovation
According to the statistics of the National Health Insurance Administration, since 2018, the mainland has carried out 9 batches of centralized procurement, with 1,583 domestic generic drugs selected and 70 imported original drugs, accounting for more than 95% of generic drugs. What is the difference between imported original drugs and domestic generic drugs? What is the market correlation between the two?
Original drug refers to a drug that has been developed for the first time after long-term research and development. During the patent protection period, other manufacturers are not allowed to imitate it. This type of drug can monopolize the market for a period of time, and it is more familiar and recognized by the public.
Generic drugs refer to drugs with the same active ingredient, dosage form, route of administration and therapeutic effect produced by other companies after the expiration of the patent right of the original drug, and its price is lower.
Generally speaking, after the patent protection of the original drug expires, the generic drug will enter and occupy the market at a lower price, resulting in a sharp decline in the sales of the patented drug, a phenomenon known as the "patent cliff".
Zhang Lan, Director of the Department of Pharmacy of Xuanwu Hospital, Capital Medical University: Once the original drug has passed the patent period, in fact, all its generic drugs will appear in large quantities, and then the price will be greatly reduced, even if there is no volume procurement, when the number of generic drug brands exceeds 10, the price will most likely fall to 1/10 of the original drug. Since 2018, the mainland has begun to implement centralized procurement of drugs, and pharmaceutical companies have "exchanged price for volume", and by reducing the price of drugs, they have won the qualification of centralized procurement. Due to the high price of original drugs, the vast majority of them will fail in centralized procurement, and under the requirement of "bringing volume", hospitals mainly purchase centralized drugs, and the proportion of unsuccessful original drugs has been greatly reduced.
Gu Hai, Director of the Health Policy and Management Research Center of Nanjing University: Foreign-funded enterprises have active and passive exits in the Chinese market, for example, if the price is relatively low and the profit is relatively small, it can take the initiative to give up. There are also companies that have upgraded their products and have better drugs to be introduced to the Chinese market.
The reporter learned that the imported original drugs have not "disappeared", but are being optimized and adjusted structurally. After the expiration of the patent of imported original drugs, a large number of generic drugs selected in centralized procurement will replace the original drugs, and the money saved by medical insurance will be used to purchase newly listed innovative drugs through "freeing cages for birds". According to estimates, compared with 2019, the current centralized procurement of generic drugs can save about 160 billion yuan per year, while the innovative drugs included in the national medical insurance negotiation will increase by about 90 billion yuan per year, that is, 60% of the amount saved by the centralized procurement of generic drugs will be freed up for innovative drugs. Gu Hai, Director of the Health Policy and Management Research Center of Nanjing University: From an international point of view, the profits of generic drugs are getting lower and lower, so most of the profits mainly come from innovative drugs, so foreign companies are now gradually abandoning the market of some original drugs and turning their focus to drug innovation, which also stimulates our domestic enterprises to strengthen competition in this regard.
Strengthen the quality monitoring of generic drugs and broaden the choice of drugs for patients
According to the estimation of the National Health Insurance Administration, since the launch of centralized drug procurement more than five years ago, nine batches of centralized procurement have saved more than 500 billion yuan for patients by squeezing the water in the drug circulation link. So that the majority of patients with chronic diseases such as hypertension and diabetes can eat cheap domestic generic drugs, and a large part of the saved medical insurance funds are still turned to more expensive "innovative drugs" that have passed drug negotiations. Experts believe that although a number of policy objectives of centralized procurement have been basically achieved, there is still some room for optimization in some specific aspects of patients' treatment and medication.
Experts believe that the main goal of the previous batches of national centralized procurement is to "squeeze out the water", and after the price and moisture are squeezed out, the focus of work will shift to ensuring quality and supply. The consistency evaluation is not a one-time evaluation, and the drug regulatory department should strengthen the long-term monitoring of the quality and efficacy of the selected generic drugs. Domestic generic drugs can not only be satisfied with the consistency evaluation, but should continue to improve the quality of the drug, because passing the consistency evaluation is only the passing line for market access, and there are industry standards on top of this standard, which is higher than the industry standard is the internal control quality standard of excellent enterprises.
On the other hand, relevant departments should provide patients, especially difficult and critically ill patients, with sufficient space for drug choice. For example, some designated hospitals are designated as supply guarantee units for original imported drugs; In the performance evaluation of public hospitals, the proportion of original drugs used in pediatrics, geriatrics, and gynecology should be appropriately relaxed to better meet the drug needs of special populations.
Gu Hai, Director of the Health Policy and Management Research Center of Nanjing University: We hope to explore the establishment of a reimbursement system with a unified payment standard for generic drug names. So that is to say, regardless of the original drug or generic drug, as long as it is a unified generic name, the payment standard is the same, so as not to increase the burden of our medical insurance fund, the original drug we say that its price is generally higher than our generic drug, if the patient needs it, he will pay a little more, but we must ensure that the supply can be bought in the hospital.
Experts suggest that a prescription circulation system should be established between hospitals and retail pharmacies, which will not affect the centralized procurement of hospitals and the assessment of the proportion of drugs, and can facilitate the use of drugs by patients.
Gu Hai, Director of the Health Policy and Management Research Center of Nanjing University: If there are prescriptions issued by hospitals, which can be bought in our retail pharmacies and reimbursed, it is beneficial to the medical needs of the people and reduces the anxiety of our people about the so-called lack of original or imported drugs.
Source/CCTV News Channel "Common Concern", CCTV Network
Editor/Liu Bin
Review/Mingfang
Executive Producer/Qiao Hong