World Clinical Drugs: In the context of industrial upgrading, where should generic drugs go from here?

This paper collects china's policies to promote the innovation, supply guarantee and clinical use of generic drugs, with a view to perfecting China's generic drug policy.
China's generic drug support policy is gradually improving, related measures are gradually landing, but still need to further improve the top-level design, strengthen coordination, improve the supporting policy system, accelerate the actual landing of the policy, to create a good atmosphere to promote the replacement of high-quality generic drugs.
keywords: generic drugs; policy; incentive 01 question suggests that generic drugs are those with the same active ingredients, dosage forms, specifications, adaptation certificates, dosing routes and usages, dosages of API and their preparations.
the development of generic drugs is of great significance to improve drug access, reduce drug expenses, deepen the reform of the medical and health system and enhance the safety of the pharmaceutical industry.
years, China has paid more and more attention to the development of generic drug industry, the national government departments have issued a series of policy documents.
In April 2018, the General Office of the State Council issued the Opinions on Reforming and Perfecting the Policy of Supply Guarantee and Use of Generic Drugs, No. 20 of the State Administration (2018), which actively explores and defines a series of specific incentive policies in promoting innovation, supply assurance and clinical use of generic drug research and development.
In December 2018, in order to further improve China's generic drug supply guarantee capacity and better meet the people's demand for high-quality generic drugs, the National Health and Wellness Commission and 12 other ministries jointly issued the "Notice on the issue of a work programme to speed up the implementation of the policy on the supply and use of generic drugs" (2018) No. 53.
the author will comb through these policies, analyze the progress of specific reform measures, the impact and still existing problems, in order to improve China's generic drug policy system.
02 China's generic drug market is developing rapidly, by the end of 2019 its batch number of about 95% of all chemical drug batches, from the market size, 2019 accounted for about 66% of the chemical drug market, generic drugs have become the main body of the domestic pharmaceutical consumer market.
the China Pharmaceutical Industry Information Center, china's generic drug market will be about 842.5 billion yuan in 2019, with a market growth rate of about 4.2%.
However, due to various reasons, China's generic pharmaceutical industry is large but not strong, mainly reflected in: unreasonable industrial structure, the current generic drug market repeat construction phenomenon is serious, the market concentration is low, did not form an innovative enterprise-centered industrial pattern.
the quality level of generic drugs is uneven, China's generic drugs in raw materials, accessories, packaging materials quality and technical technology level and developed countries there is a certain gap, the field of production for a long time lack of high-level quality standards and quality control system.
market competitiveness is not strong, although there are a large number of generic drug companies in China to participate in the competition, but the high-quality drug market is still mainly occupied by foreign original research drugs.
internationalization needs to speed up, China lacks the standard of evaluation of generic drug technology in line with international standards, generic drug application for foreign listing approval is more difficult, the international market share is small, the international competitiveness is weak.
03 China's generic drug policy analysis 3.1 issued to encourage generic drug catalog, guide generic drug research and development in October 2019, the National Health and Health Commission jointly with the Ministry of Science and Technology and other five ministries formulated and issued the "first batch of encouraging generic drug catalog", involving a total of 33 drugs.
to encourage generic drugs is divided into two main situations: one is the domestic patent expired and the patent is about to expire, but has not yet filed a registration application for the drug.
the preparation technology of these drugs is difficult, the market size is small, and the review and approval speed is slow.
another is clinically available or under-competitive medicines, which often have little market potential, lower product prices or shortages of API.
According to the International Comprehensive Information Bank of Generic Medicines of the Academy of Military Medical Sciences, as of October 2020, 19 first drugs in the list of drugs to encourage imitation have been approved for drug approval, 14 drugs have been accepted by the Drug Review Center into the declaration stage, and the role of catalog guidance in encouraging the development of generic drugs is gradually emerging.
3.2 Strengthen the research and development of generic technology, promote the upgrading of the generic drug industry from 2017 to date, the relevant national science and technology plans for drug imitation key technology research and development, preparation process upgrading and transformation and high-end preparation innovation and other aspects to give project support.
"Major New Drug Creation" science and technology major special project (hereinafter referred to as "New Drug Special"), supported the "drug consistency evaluation key technology and standards research" project, has produced a number of technical guidelines and evaluation of the preparation catalog, for generic drug consistency evaluation work provides a strong scientific and technological support.
's new drug special also "major generic drugs" as the focus of support direction, focusing on supporting clinically urgent needs, market prospects of generic drugs and biosimilar drugs, while supporting the improvement of new dosage form technology, hot-melt extrusion technology and 3D printing technology and many other key common drug preparation technologies.
The National Three-Year Action Plan for Strengthening the Core Competitiveness of Manufacturing Industry (2018-2020) (No. 2000) clearly proposes to support the development and industrialization of the first chemical generics and biosimilars with high market potential and high clinical value patents.
3.3 Perfecting intellectual property protection and exploring the first generic drug system Drug patent link system is an early resolution mechanism of patent disputes, the core of which is that generic drug listing examination is linked with the patent status of the original drug under study, which can effectively reduce the risk of generic patent infringement.
The prototype of the drug patent link system has appeared in China: "Opinions on Deepening the Reform of the Review and Approval System to Encourage Drug Medical Device Innovation" issued by the General Office of the CPC Central Committee and the General Office of the State Council in October 2017 , and "Opinions on Strengthening the Protection of Intellectual Property Rights" issued in November 2019 (2019) No. 56 In March 2020, the General Office of the Supreme People's Court issued the "Supreme People's Court's 2020 Judicial Interpretation Project Plan", which includes the formulation of "Regulations on Certain Questions of the Law Applying to the Trial of Drug Patent Link Disputes", and in September 2020, the State Drug Administration and the State Intellectual Property Office drafted the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) (Draft for Comments).
And the more perfect U.S. drug link system includes the new drug-related patent information disclosure (orange book system), generic patent declaration system, approval waiting period system, the first generic drug market exclusive period system four main content, of which the first generic drug market exclusive period system can greatly improve the enthusiasm of generic drug manufacturers to challenge patents, worthy of China's active exploration.
3.4 To promote the evaluation of the quality and efficacy of generic drugs and improve the quality of generic drugs In February 2012, the State Council issued the "National Drug Safety "12th Five-Year Plan" (National Development Agency (2012)5), which for the first time proposed the quality consistency evaluation of generic drugs approved before the implementation of the 2007 revised Measures for the Administration of Drug Registration.
August 2015, the State Council issued the Opinions on Reforming the Drug Medical Device Review and Approval System, No. 44 of the State Development Agency (2015) and proposed to "strive to complete the national evaluation of the quality consistency of oral and ginseng preparations for essential drugs by the end of 2018".
In March 2016, the General Office of the State Council issued the Opinions on the Conduct of consistent evaluation of the quality and efficacy of generic drugs, which clearly stipulates the rules including the object and time limit of evaluation, the selection principle of the evaluation preparation, the selection of evaluation methods and the purchase of the evaluation of the consistent evaluation of the quality and efficacy of generic drugs in China.
May 2020, the State Drug Administration issued the Notice on the Conduct of The Evaluation of the Conformity of The Quality and Efficacy of Chemical Injection Imitations (No. 62 of 2020), marking the official launch of the Evaluation of The Conformity of Chemical Injections.
Since the 2012 proposal to carry out consistency evaluation, the country has published pharmaceutical research, biological equivalent test evaluation methods and the list of evaluation agents, and gradually clarified the evaluation methods and evaluation preparations of basic drug varieties, straightened out the evaluation mechanism, China's consistency evaluation system gradually improved.
As of March 2020, the Drug Review Center of the State Drug Administration has accepted a total of 1,956 applications for consistent evaluation of chemical generics, of which 1,286 applications for oral solids (328 varieties) and 670 applications for injections (149 varieties), and 521 applications for consistency evaluation of oral solids (159 varieties).
evaluation of generic drugs will eliminate low-competitive approval, with research and development capabilities and cost control capabilities excellent enterprises will benefit, is conducive to further enhance the concentration of the pharmaceutical industry, promote the high-quality development of the pharmaceutical industry.
3.5 Improving the drug tendering and procurement mechanism to support the use of high-quality generic drugs In November 2018, the pilot work on centralized drug procurement and use by the State organization was officially launched, with the selection of "4 plus 7" (4 municipalities directly under the Central Government, 7 A total of 11 cities, from the quality and efficacy of consistent evaluation of generic drugs selected pilot varieties, medical institutions scattered procurement volume concentrated "packaging", the formation of a large-scale group purchase effect, through the national level with pharmaceutical manufacturers to negotiate prices.
, under the premise of strict quality assurance, to achieve the purchase of volume, volume for price.
the final 25 varieties were shortlisted for the first round of the "4 plus 7" collection, of which 22 generics, or 88 per cent, were evaluated for consistency, with an average reduction of 52 per cent in the winning bid price.
According to the 2019 Medical Security Development Statistics Express, by the end of 2019, 25 selected drugs had completed an average of 183% of the agreed purchase volume in the pilot areas of the "4-plus-7" drug centralized belt procurement, with the purchase volume of the selected drugs accounting for 78% of the purchase volume of generic drugs, and the generic drug substitution effect was apparent.
September 2019, on the basis of the "4 plus 7" volume procurement pilot, the national organization of drug centralized procurement pilot areas to the whole country.
in January 2020 and August 2020, the State organized and carried out the second and third batch of drug belt procurement, respectively.
-band procurement to through the quality and efficacy of consistency evaluation as a generic drug entry criteria, to solve the simple price competition caused by the "bad currency expulsion of good currency" problem, to give generic drugs and the original drug fair competition opportunities to promote generic drug substitution.
provides a new model for promoting the high-quality development of China's generic pharmaceutical industry, promoting pharmaceutical manufacturers to improve quality and attach importance to research and development, and changing from marketing-driven to innovation-driven.
3.6 Deepening the reform of medical insurance payment methods and promoting the replacement of generic drugs In February 2020, the CPC Central Committee and the State Council issued the latest Opinions on Deepening the Reform of the Medical Security System, which clearly emphasizes the need to do a good job in accepting and reviewing the consistent evaluation of the quality and efficacy of generic drugs, and to support the development and use of high-quality generic drugs by improving the standards for payment for medical insurance and the mechanism for bidding and purchasing pharmaceutical products.
centralized procurement of drugs has become a mechanism for drug price discovery, but to achieve a unified payment standard, it is necessary to continue to explore in practice.
3.7 Strengthening anti-monopoly enforcement and maintaining a level playing field The monopoly of API has a negative impact on the stability of generic drug prices, market competition order and the accessability of the public, as well as seriously affecting the operation and development of downstream generic pharmaceutical companies.
to strengthen anti-monopoly enforcement and maintain market competition order.
2017, the National Development and Reform Commission (NDRC) issued a Guide to Price Behavior of Operators of Shortage Drugs and API To Further Promote Antitrust Enforcement of API.
2020, the State Administration of Market Supervision and Administration issued the Antimonopoly Guidelines on THEODs (Drafts for Comments), which set out in detail the monopoly violations in the field of API.
Between 2015 and 2020, the relevant departments of the State have continuously stepped up efforts to crack down on monopoly practices in the field of API, actively carried out law enforcement activities, and punished enterprises that implement API monopolies in accordance with the law (as shown in Table 1).
cases have dealt a powerful blow to the monopoly in the field of API, formed a law enforcement deterrent, and maintained market fairness.
china should continue to increase the crackdown on monopoly behavior in the field of API, curb the monopoly phenomenon of API, and guide API operators to operate in accordance with the law.
04 On encouraging the development of high-quality generic drugs policy recommendations China's generic drug support policy is gradually improving, related measures gradually landing, but also need to further improve the top-level design, strengthen coordination, improve the supporting policy system, to create a good atmosphere to promote the replacement use of high-quality generic drugs.
4.1 Improve the top-level design, strengthen overall coordination and policy implementation At present, China has not yet formed a clear and unified national generic drug policy planning system, the relevant departments of the state have not formed a coordination mechanism under the generic drug policy framework.
Therefore, China needs to establish a close cooperation and coordinated system of generic drug policy at the national level, covering all aspects of the life cycle of generic drugs such as generic drug research and development, market access, pricing and reimbursement, supervision of physician prescription behavior, and prescription supervision of pharmacists.
In addition, the relevant departments should take the lead in holding regular work promotion meetings, timely grasp of the landing situation of generic drug policy, combing the results of phased work, negotiating to solve the problems adlyssed in the promotion of work, to ensure that the actual effect of the policy landing.
4.2 To establish a notification system for the unequal efficacy of drugs, and to improve the post-market monitoring system, we should establish a continuous quality tracking mechanism for drugs after consistent evaluation of the quality and efficacy of generic drugs.
the regulatory authorities may grade the subjects of supervision according to the risk level and strengthen the supervision of high-risk drugs in high-risk enterprises.
, the clinical consistency between generic and original drugs should be tracked and observed for a long time, and the efficacy of generic drugs should be assessed.
China's current clinical equivalent of generic drug evaluation and regulatory policy has not been perfected, can learn from the practice of Taiwan, the establishment of drug efficacy assessment mechanism, including the establishment of drug efficacy notification system, when found abnormal, immediately start investigation and treatment to ensure that generic drugs safe and effective.
4.3 To implement the health insurance package