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economic observer editorial we see fathers anxiously looking for imported azithromycin for their children - parents all over the world do their best for the health of their children; we see cancer patients searching for original capecitabine - they do not want to switch to domestic generic drugs, life is only once, and fighting cancer is a journey that cannot be tried and failed; we see patients with chronic diseases who can only buy original drugs at their own expense because the hospital is short of them - the number of people suffering from chronic diseases in china has exceeded 400 million, and some of them have been using original drugs since they were diagnosed.

this is the reality of the domestic substitution of original research drugs. the so-called "domestic substitution" is to replace original research drugs whose patents have expired with generic drugs. internationally, this is also a common model for improving drug accessibility and cost-effectiveness. in the united states, a major country of innovative drugs, generic drug prescriptions currently account for about 90%, but the cost accounts for only 20%. it can be said that generic drugs are the basic foundation for protecting national health.

in china, multinational pharmaceutical companies are the mainstream manufacturers of original drugs, and most generic drugs are produced by domestic pharmaceutical companies. logically, no one objects to obtaining equivalent drugs at a lower price, so why are so many people still looking for original drugs? looking closely, on the one hand, it is the habit of using medicines-for a long time, the foundation of china's pharmaceutical industry was weak, and some drugs could only be imported; on the other hand, it is also related to the patient's cognition. a questionnaire survey conducted by the science and technology development center of the chinese pharmaceutical association in 2022 showed that 84.06% of respondents believed that there were still differences between generic drugs that passed the consistency evaluation and original drugs, 68.08% believed that there were differences in clinical efficacy, and 60.77% believed that there were differences in safety.

consistency evaluation is an important means to ensure that generic drugs are consistent with original drugs in quality and efficacy. some people would say that the perceptions of many patients in the above survey are just empirical judgments and have no scientific basis. however, it should be admitted that this also reflects to a certain extent the image of domestic generic drugs in the minds of patients, indicating that patients lack sufficient confidence in domestic generic drugs.

objectively speaking, the quality of chinese generic drugs has been effectively improved since the consistency evaluation was carried out in 2016. previously, drug registration was based on the "drug registration management measures" issued in 2002, in which the requirements for the "equivalence" reference standard were very low and the rules were confusing, which led to the wild growth of generic drugs in those years. in 2016, the state council issued the "opinions on carrying out the consistency evaluation of the quality and efficacy of generic drugs", which clarified the principles for the selection of reference reagents and required that the oral solid preparations of chemical generic drugs approved for marketing before october 1, 2007 in the "national essential medicines list" (2012 edition) should complete the consistency evaluation by the end of 2018, involving a total of 289 varieties.

the "289 catalog" is considered to have opened the "make-up exam" for regulating the quality of generic drugs. in december 2018, the state drug administration issued the "notice on matters related to the evaluation of the quality and efficacy consistency of generic drugs", emphasizing that the consistency evaluation of generic drugs should strictly control the evaluation standards and strengthen post-marketing supervision. the goal is still to improve the quality of drugs and the overall level of the pharmaceutical industry.

at present, domestic generic drugs account for about 60% of prescriptions, which depends on the continuous catch-up of pharmaceutical companies and the continuous guidance of policies, and also benefits from the improvement of the quality of domestic generic drugs. therefore, the key to further enhance the public's confidence in domestic generic drugs is to continuously improve the quality of drugs. only in this way can we break the public's stereotype and improve the recognition of domestic generic drugs.

in this regard, the relevant departments can do more. for example, the industry believes that many domestic generic drugs have achieved pharmaceutical equivalence and bioequivalence at best, and some drugs may not meet the bioequivalence standards due to differences in excipients and processes. the higher standards of consistency evaluation also include clinical equivalence. this is because the subjects of bioequivalence experiments are healthy people, which may not be completely consistent with the use of drugs by patients in the real world.

in fact, since 2019, the national medical insurance administration has led medical institutions to conduct real-world studies on 37 representative varieties of generic drugs selected in the centralized procurement in two batches, involving 110,000 and 140,000 medical records respectively. the results show that there is no difference in efficacy and safety between generic drugs and original research drugs. these works are conducive to the public's scientific evaluation and rational understanding of domestic generic drugs. even so, compared with the 374 drugs covered by the nine batches of centralized procurement, industry insiders believe that the scope of evaluation is not enough and there is a lack of a normalized system. in addition, the monitoring of the clinical use effect of generic drugs should also be strengthened.

we understand that this is a big project. however, only when domestic generic drugs can withstand such a "big test" can they truly win the trust of patients and establish a solid confidence in domestic generic drugs among the public. otherwise, the pursuit of original drugs will not stop, which is also the right of the public to protect their health. of course, fairness is equally important. original drugs cannot become a "privilege" for some people. this is not only detrimental to justice, but also has disadvantages rather than benefits in enhancing the public's confidence in domestic generic drugs.