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recently, an article about a parent who took his child to see a doctor for mycoplasma pneumonia but could not get the imported azithromycin he wished for was widely forwarded and received attention. as a result, "imported drugs are difficult to buy" and "it is increasingly difficult for hospitals to prescribe imported original drugs" have once again become topics of discussion for many people.

so, what is the actual use of imported original drugs in domestic clinical practice? are imported drugs "difficult to buy"? why do patients feel this way? is there a better way to balance price-for-volume and choice?

imported azithromycin has not disappeared: sales exceeded 400 million yuan in the first 8 months

the aforementioned article mentioned mycoplasma pneumonia, the full name of which is mycoplasma pneumonia (mpp), which refers to lung inflammation caused by mycoplasma pneumonia infection, which can affect the bronchi, bronchioles, alveoli and lung interstitium. according to the popular science article "huashan infection", mycoplasma pneumonia is a special microorganism that is distributed all over the world and can cause different scales of transmission, and its transmission method is similar to the common cold. in most cases, some people may only have mild cold symptoms, but in a few cases it can cause pneumonia.

according to the "guidelines for the diagnosis and treatment of mycoplasma pneumonia in children (2023 edition)", mild cases do not require hospitalization, and adequate rest and energy intake are required to ensure water and electrolyte balance. take antipyretics correctly, and those with hypercoagulable state and fasting need to replenish water and electrolytes. for those whose dry cough significantly affects rest, antitussive drugs can be used as appropriate. the guidelines clearly state that macrolide antibiotics are the first choice for the treatment of mpp, including azithromycin, clarithromycin, erythromycin, roxithromycin and acetyl kitasamycin.

according to the guidelines, azithromycin is indeed an important option for the treatment of mycoplasma pneumonia. according to the official database of the national medical products administration, there are currently 624 domestic drug approvals and 9 imported drug approvals for azithromycin in china, all involving multiple dosage forms such as capsules, granules, tablets, and dry suspensions.

the imported drug mentioned in the article is pfizer's azithromycin injection from the united states. the parents finally got the drug as they wished while the child was hospitalized in a children's hospital. a domestic pharmaceutical expert told the paper that due to the company's control of supply, azithromycin injection can only be prescribed in children's specialized hospitals in the first-tier cities where he is located, and it cannot be prescribed in ordinary hospitals. as for the specific reasons for the control of supply, the pharmaceutical expert said that he was not clear.

regarding the production and supply of azithromycin products in china, including injection, the reporter of the paper contacted pfizer china, but the official did not give a positive response. the reporter learned from authoritative channels that pfizer's three dosage forms of azithromycin are normally sold online in most provinces in china, and there is no phenomenon of withdrawal from the network in many provinces. specifically, azithromycin injection is sold online in 26 provinces across the country, azithromycin dry suspension is sold online in 23 provinces across the country, and azithromycin tablets are sold online in 30 provinces across the country. the sales of pfizer's three dosage forms of azithromycin from january to august 2024 exceeded 400 million yuan.

lu yun, a professor at the school of international pharmaceutical business of china pharmaceutical university, said in an interview with the paper that imported azithromycin injection is currently being sold online in 26 provinces including zhejiang. medical institutions can independently purchase imported azithromycin injection for clinical needs, and there has been no "disappearance" of imported drugs. in addition to imported azithromycin, domestic azithromycin products currently account for about 60% of the market share in hospitals and pharmacies across the country. the domestic azithromycin dry suspension selected in the national centralized volume procurement has a winning price of no more than 1 yuan per bag, and most of them are products from well-known domestic pharmaceutical companies. azithromycin injection alone will not affect the treatment of mycoplasma pneumonia in children.

patients feel that imported drugs are "difficult to buy" because multinational pharmaceutical companies are not very enthusiastic about participating in centralized procurement

although azithromycin injection has not "disappeared", it is undeniable that the feeling of imported drugs being "difficult to buy" or "difficult to prescribe" does exist, both from the patient's side and the doctor's side.

a doctor who has worked in a domestic tertiary hospital for four or five years has a direct understanding of this and can easily name several drugs that were commonly prescribed in clinical practice before but are currently not prescribed in the daily outpatient system.

lu yun said that due to the advancement of centralized procurement and consistency evaluation policies, hospitals' prescription habits are changing. it is a trend and an international practice for high-quality, low-cost generic drugs to replace original research drugs, especially for domestically produced drugs with better effects.

the "centralized procurement" mentioned by lu yun refers to the centralized procurement of drugs organized by the state, which started in 2018 when four municipalities and seven sub-provincial cities organized a pilot program for centralized procurement of drugs. the basic logic is "quantity for price". the "quantity" here generally refers to the nationalpublic hospitalsabout 60%-70% of the demand, these public hospitals should purchase the selected products. at present, the national organized drug procurement has completed 9 batches, and the varieties involved are all common drugs with sufficient competition. taking the ninth batch of drug procurement carried out at the end of 2023 as an example, a total of 42 varieties are covered, nearly 50% of which are injection forms, and the number of qualified applicants for multiple varieties exceeds 10. in the end, 41 drugs were successfully purchased, and the average price of the selected drugs was reduced by 58%.

the specific bidding rules for centralized procurement are complex, but generally speaking, the greater the price reduction, the higher the priority of winning the bid, and thus the priority of supply areas and larger purchase volumes, which naturally means a larger market share for a certain product. since price cuts may affect performance, many multinational pharmaceutical companies are not very enthusiastic about participating in centralized procurement. taking the third batch of centralized procurement in march 2020 as an example, astrazeneca, eli lilly, pfizer and many other multinational pharmaceutical companies were directly eliminated because their bids exceeded the highest valid declared price.

if multinational pharmaceutical companies do not participate in centralized procurement or participate but abandon the bid, their products will naturally not enjoy the rights of the winning companies and will be squeezed out of the original hospital market. however, the centralized procurement that is mainly aimed at the hospital market does not mean that these products of pharmaceutical companies will withdraw from the chinese market. many multinational pharmaceutical companies are choosing to develop e-commerce, pharmacies, private medical institutions and other channels to carry out sales, and patients can purchase them at their own expense.

many imported drugs and original research drugs have also withdrawn from the chinese market. according to an article published in may 2024 on the wechat public account of "china medical insurance", a media platform affiliated with the national medical insurance administration, according to incomplete statistics, 161 imported drugs have not been re-registered in my country, including many well-known drugs that were commonly used in clinical practice in the past.glaxosmithklineadefovir dipivoxil tablets produced by glaxosmithkline (gsk) have been discontinued in the domestic market for more than two years. the resulting drug shortage has been made up by domestic drugs. real-world research results show that domestic metformin has no significant difference from imported original drugs in terms of blood sugar lowering efficacy and adverse reactions such as liver and kidney damage; adefovir dipivoxil tablets were once a commonly used hepatitis b antiviral drug, and clinical guidelines no longer recommend it as a first-line drug, but insteadentecaviras first-line antiviral drugs, adefovir dipivoxil and other drugs with improved effectiveness and safety have gradually faded out of clinical use.

the above article points out that the contribution of imported original drugs to the medical and health protection of the chinese people cannot and will not be erased. china's door to opening up will only open wider and wider. we have welcomed and will continue to welcome imported original drugs to participate in fair competition and serve clinical needs. the problem of ensuring the drug demand of 1.4 billion people also needs to be solved in a diversified way. we should take a long-term view and hope that all domestic and foreign pharmaceutical companies will work hard in the research and development of innovative drugs and generic drugs, win wide recognition in the market and clinics through quality and efficacy, and enhance the sense of gain, happiness and security of the general public in the use of drugs at appropriate prices.

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