In recent years, the National Health Insurance Administration has implemented the centralized procurement policy of strategic purchase of medical insurance funds, integration of recruitment and procurement, and exchange of volume for price, which has greatly reduced the price of relevant selected drugs, benefiting hundreds of millions of people who use drugs in public hospitals. With the successive implementation of 9 batches of state-organized centralized drug procurement results, the proportion of selected products among generic drugs that have passed the consistency evaluation of quality and efficacy used by patients has increased rapidly from less than 10% before centralized procurement to more than 95%. While drug prices and drug costs have fallen off a cliff, the quality and efficacy of the selected generic drugs have always been the focus of widespread public attention.
In order to correctly understand the concept of treatment and efficacy of generic drugs, it is necessary to clarify the connotation and interrelationship of three important terms: generic drugs, reference preparations and original drugs.
Generic drug refers to a generic substitute drug with the same active ingredient, dosage form, route of administration and therapeutic effect as the generic drug. Under most mature regulatory systems, the generic drug is the reference preparation or the original drug. The reference preparation refers to the control drug used for the consistency evaluation of the quality and efficacy of the generic drug, usually the object of the imitation, such as the original drug or the internationally recognized same drug. The original drug is the first drug approved for marketing at home and abroad, and has complete and sufficient safety and efficacy data as the basis for marketing, and is usually produced or authorized by the earliest enterprise with drug patent rights. Internationally recognized isodrugs refer to generic drugs that have been approved for marketing in the European Union, the United States, and Japan and have obtained the status of reference preparations.
From the above definition, it can be seen that under a mature and effective drug regulatory system, generic drugs have the same or similar safety and efficacy as the original drug and reference preparation in clinical practice, and can generally be used interchangeably.
From the perspective of clinical use experience, because most of the original drugs come from multinational drug manufacturers in developed countries under the mature regulatory system of ICH (International Conference on Harmonization of Technical Requirements for the Registration of Drugs for Human Use), most medical personnel and patients around the world recognize the quality, safety and efficacy of the original drugs. These original drugs have not only accumulated the necessary evidence of quality, safety and efficacy during research and development, but also have relatively complete drug regulatory laws and regulations in the countries or regions where they are marketed. Strict professional supervision and extremely high illegal costs require drug manufacturers to abide by integrity and strict self-discipline, take the initiative to establish and improve a complete comprehensive quality management system, maintain and improve drug quality, and provide relevant evidence of drug quality, safety and efficacy.
However, the high price is an important reason for the further expansion of the use of original drugs. In order to encourage innovation and ensure that the original drug companies can recover the R&D and production costs of the drug after it is marketed, the original drug cannot be imitated before the patent expires, and enjoys policy protection such as separate pricing. Not only that, the abnormally high pricing, differential pricing and even discriminatory pricing mechanism caused by the excessive market power of the original drug manufacturer and the lack of market competition are also the hidden reasons for the high price of the original drug during the patent period.
The listing of generic drugs has effectively restrained the high price and huge cost of original drugs. Generic drugs can not only effectively reduce the medical burden of patients and improve the availability of drugs, but also intensify the healthy competition in the drug market and promote industry innovation and development. Widely used within the health service system
Generic drugs can significantly reduce drug costs, reduce medical expenditures, improve drug accessibility, and improve the level of medical services. Therefore, the drug policies of developed countries such as Europe, the United States and Japan and most developing countries actively encourage the widespread use of generic drugs, and the number of uses far exceeds that of innovative drugs and original drugs, which has played a huge role in ensuring global health.
Whether a generic drug can be recognized by clinicians and patients depends on its intrinsic quality, clinical safety and efficacy, as well as whether the quality of related pharmaceutical services can continue to be consistent with that of the original drug or reference preparation. The relevant documents of the international mainstream mature drug regulatory system point out that a generic drug that can be approved by the ICH system must meet the following conditions: it contains the same active ingredient as the generic product; Consistent with the indications, dosage form, specification, and route of administration of the generic product; Bioequivalent; The quality of the drug meets the same requirements; Good Manufacturing Practice (GMP) for the production of drugs is as stringent as for the products being imitated.
Continental became a member of ICH in June 2017, was elected as a member of the ICH Management Committee in 2018 and was successfully re-elected in 2021. Although it is still in the transition period of ICH supervision, and the drug review and approval has not yet fully integrated with the international mainstream regulatory system, the current generic drug review and approval system has achieved major reforms, redefined the concept of generic drugs under the principle of integrating with the ICH regulatory concept, and restarted the consistency evaluation of the quality and efficacy of chemical generics.
As of December 18, 2023, a total of 987 varieties and 8,137 products from 1,241 companies across the country have passed the consistency evaluation of generic drugs (including products deemed to have been evaluated), of which 374 varieties have participated in 9 batches of centralized drug procurement organized by the state. Great progress has been made in the evaluation of the consistency of generic drug quality and efficacy.
In order to ensure that patients can use high-quality generic drugs, the National Health Insurance Administration takes the consistency evaluation as the threshold for the shortlisting of generic drugs in centralized procurement, and organizes relevant scholars to conduct multi-center and large-sample real-world research and evaluation of the first three batches of selected drugs organized by the state for centralized drug procurement. The results show that these selected generic drugs have the safety, efficacy and quality that can completely replace the original drugs.
Passing the consistency evaluation does not mean that it is done once and for all. The regulatory authorities are also continuing to supervise the quality of the whole chain of production, circulation and use; Carry out full-coverage inspections for the selected enterprises in the centralized drug procurement organized by the state, carry out full-coverage sampling inspections for the selected drugs, and continue to do a good job in the monitoring of adverse drug reactions; Supervise and urge enterprises to continue to comply with regulations, and consolidate the main responsibility of enterprises for drug quality and safety. For problems found in inspection and inspection, the drug regulatory department shall take severe penalties in accordance with the law, and implement joint disciplinary action in conjunction with the medical insurance department.
Strict quality assurance systems, clinical real-world evaluation results, and widespread use in large-scale patient populations all show that generic drugs selected in centralized procurement are not inferior drugs, but good drugs that more patients can afford.
Although driven by the centralized procurement system, since 2018, the cumulative number of drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs in the mainland has risen rapidly from less than 200 at that time to more than 8,000 at present, it is still necessary to see that the stock of generic drugs in the mainland is as high as nearly 170,000 pieces, involving 15,000 varieties and 35,000 specifications, of which 3,244 are chemical generic drugs, and the overall number of drugs that have been evaluated and deemed to have been evaluated is still in a very low state. This is also one of the important reasons why medical staff and patient groups are currently questioning the quality and efficacy of generic drugs.
If it is expected that the generic drugs used in clinical practice truly have the safety and efficacy of medical staff and patients to use with confidence, in addition to continuing to vigorously promote the consistency evaluation of the quality and efficacy of generic drugs, and continue to deepen the centralized procurement of drugs, it is also necessary for drug regulatory authorities, drug manufacturers, medical personnel and scientific research workers to make multi-directional efforts. On the one hand, the drug regulatory authorities should vigorously promote the re-evaluation of the quality, safety and efficacy of existing generic drugs; On the other hand, generic drug manufacturers and relevant licensees should be urged to use integrity, self-discipline and scientific management to organize the research and development, production, supply chain maintenance of generic drugs, as well as the generation and collation of evidence-based evidence necessary for the re-evaluation of the quality and efficacy of generic drugs. At the same time, clinical medical personnel and scientific researchers should also observe, study and comprehensively evaluate the unevaluated generic drugs that are still in use to determine their final clinical trade-offs and rational use. （ZGYB-2024.03）
Author | Chen Hao, Director of the Drug Policy and Management Research Center of Tongji Medical College, Huazhong University of Science and Technology
Source | China Medical Insurance
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