On May 8, 2015, the State Council officially issued "Made in China 2025", adhered to the basic policy of "innovation-driven, quality-first, green development, structural optimization, and talent-oriented", and adhered to "market-led, government-led, based on current, Focus on the long-term, the overall principle of overall promotion, key breakthroughs, independent development, and open cooperation. Biomedicine and high-performance medical devices have become one of the top ten areas for development.

 

On July 22, 2015, since the clinical self-examination, China entered the reform zone in the pharmaceutical field. With the introduction of the consistency evaluation policy, pharmaceutical R&D and production reform entered the deep water area.

 

On April 3, 2018, the General Office of the State Council issued the "Opinions on Reforming and Improving the Policy of Supply and Use of Generic Drugs" (hereinafter referred to as "Opinions"). The release of this article represents China's willingness to change from a generic drug country to a generic drug power. The "Opinions" mainly elaborated on the three major aspects of promoting the research and development of generic drugs, improving the quality and efficacy of generic drugs and improving the support policies. The author will interpret them one by one:

 

Article 1

 

Clearly copying the catalogue of generic drugs, the government has guided the "patient-centered" era, which is a major benefit for the major infectious diseases, especially in the field of orphan drugs, and is also the gospel of many rare patients.

 

However, higher requirements are imposed on the diagnostic level of medical staff. Due to the rare disease, many doctors are not expected to be diagnosed. For example, the diagnosis rate of pulmonary hypertension is only 0.01%. Is this true? Individuals believe that the incidence should be higher than one in ten thousand.

 

Article 2

 

The country solves the technical problems in the industry in the form of major special projects, which is very helpful to improve the overall level of the industry, forming an industrial chain of “production, learning and research”, reducing the burden on enterprises, and increasing various incentive measures to achieve a double The purpose of stimulation.

 

Article 3

 

Since the country should vigorously promote generic drugs, it will strengthen anti-monopoly enforcement in the field of intellectual property and prevent the abuse of intellectual property rights.

 

Due to the regional nature of patents, the patent protection of foreign original manufacturers will be weakened in China.

 

Article 4

 

Strengthening the work of conformity assessment is more than just a national slogan.

 

At present, the state has imposed regulations on the consistency evaluation of 289 drugs, but powerful companies have also picked up clinically valuable products to carry out consistency evaluation work among their own thousands of documents.

 

This reflects the industrial layout that the company considers at its own level, and also provides a guarantee for many patients to use safe and effective drugs.

 

Articles 5 and 6

 

Promoting the consistency evaluation of generic drugs is not a work of a discipline, and requires the pharmaceutical industry to carry out the upgrading and replacement of all industrial chains, including the original auxiliary packages and preparation equipment that constitute the preparation products.

 

Articles 7 and 8

 

These two represent the country's determination of drug quality and supervision. Optimizing the review and approval process is only one aspect of the reform. Its core purpose is to ensure the safety of the people's medication and strengthen supervision during the drug life cycle.

 

Article 9

 

In this respect, we promote the research and development, production and market of generic drugs from the perspective of procurement.

 

According to the document promulgated by the State Council in the early period of the State Council, the State Council’s opinion on the evaluation of the quality and efficacy of generic drugs was issued by the State Council [2016] No.8, “the number of production enterprises that passed the consistency evaluation of the same variety of drugs reached more than three, The products that fail to pass the consistency evaluation are no longer selected in the centralized procurement of drugs, and the varieties that cannot pass the consistency evaluation will gradually withdraw from the market as the competitors gradually complete.

 

This indicates that the country will not only solve the current market distraction but not only through research and development, production, but also through the market.

 

Article 10

 

This promotes the mutual substitution of generic drugs and original drugs from the perspective of patient applicability.

 

The author believes that doctors (especially local county and city doctors) need to be promoted accordingly, rather than emphasized in the pharmaceutical industry. The pharmaceutical industry today recognizes the country's orientation and strives to pass generic evaluations through consistency. The replacement of the generic drug with the original drug is also based on the prescription issued by the doctor.

 

Many county-level doctors, even chief physicians, still stay at the cognitive level that the purity of domestically-made drugs is lower than that of imported drugs, and there is no concept at all for the consistency evaluation of generic drugs. Doctors who prescribe a prescription for patients with serious medical conditions and better economic conditions are very serious about prescribing domestically prescribed drugs for patients with mild or poor economic conditions. This is really worrying.

 

Article 11

 

According to reports, pensions in many provinces are in a hurry, and I believe that the burden of national medical insurance is also very heavy. In the next 10-30 years, China will change to an aging society. The characteristics of medications may be more concentrated, and the number of medications will increase significantly. In order to reduce the burden of medical insurance, the state encourages the use of generic drugs with equivalent efficacy. The approved generic drugs are included in the medical insurance catalogue.

 

In essence, this is a win-win situation for the country and the enterprise. Under the premise that the state can guarantee the people's health level, the burden of medical insurance can be reduced, and enterprises can also guarantee stable income.

 

Article 12

 

This article does not need to be explained too much. Although there has been no specific policy landing, it is not subject to corporate-led intellectual property rights when it encounters a serious situation such as public health safety or serious threats to public health.

 

Of course, the state may also make tax credits.

 

Article 13

 

This taxation policy has little impact on existing R&D companies. It is a high-tech enterprise or a 15% tax rate. It is not a high-tech new tax payment, as always.

 

However, after fully considering the cost of medicines and formulating scientific and reasonable purchase prices, it is expected that the purchase of a box of medicines will end in a few dollars. The price of medicines is not as good as that of the original research, but the price should be improved.

 

The monopolistic behavior of APIs is endless, which is not allowed by the credit society and is the key monitoring target of the country.

 

Article 14

 

Many pharmaceutical companies are currently making international preparations, and the country is promoting big internationalization of generic drugs.

 

At present, there are not many pharmaceutical companies that can truly make preparations internationalized because of various factors. Domestically, the consistency evaluation was vigorously promoted, and some foreign preparation experts also returned to China to push for the tide of medical reform. I believe that China's generic drug technology will soon increase in the future, and technical problems will not stop the internationalization of Chinese generic drugs.

 

Blocking the internationalization of Chinese generic drugs is the market sales and other factors. If a company has only one or two varieties of ANDA, this company is faced with a huge investment in research and development costs, and there is little success in the US market, because American agents will not play with only one or two varieties of enterprises. In this case, the ANDA in the United States has become a gimmick, which is a question worthy of alerting.

 

Article 15

 

This is a good publicity guide. Although the "Opinions" clearly stated that they should publicize the masses of the people, they personally think that the most important thing is the propaganda and education of medical workers, because many people have no concept at all about which drugs to use.

>>>>Related reading

 

State Council Office's Opinions on Reforming and Perfecting the Supply and Protection Policy of Generic Drugs State Administration [2018] No. 20 (Full Text)

 

The people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions under the State Council, and their respective agencies:

 

In order to implement the spirit of the 19th Party Congress and the work arrangements of the Party Central Committee and the State Council on promoting healthy China construction and deepening medical reform, promoting the research and development of generic drugs, improving the quality and efficacy of generic drugs, improving the supply of drugs, and better meeting the clinical use of drugs and The public health security needs to speed up the leap from a large pharmaceutical country to a strong pharmaceutical country. With the consent of the State Council, the following opinions are proposed.

 

First, promote the development of generic drugs

 

(1) Formulating a list of drugs that encourage imitation. Establish an inter-departmental drug production and use information sharing mechanism, strengthen drug supply security and use information monitoring, timely grasp and release drug supply and demand, and guide enterprise R&D, registration and production. Demand-oriented, encourage the imitation of drugs that are clinically necessary, effective, and in short supply, encourage the imitation of drugs needed for the prevention and treatment of major infectious diseases, the drugs needed to deal with public health emergencies, the use of drugs by children, and the patents before they expire. There are no drugs for registration applications in one year. The catalogue of imitation medicines encouraged by the National Health and Health Commission and the State Drug Administration shall be formulated with relevant departments, and regularly issued on relevant platforms such as the National Drug Supply and Safety Integrated Management Information Platform, and shall be dynamically adjusted. Drugs newly approved for listing or evaluated by the consistency of quality and efficacy of generic drugs are included in the list of listed drugs in China, and the contents of the listed drug list are dynamically updated and published in real time.

 

(2) Strengthening the research of generic drug technology. The key chemical technologies for key chemical drugs and biopharmaceuticals in the generic drug list will be encouraged to be included in the relevant national science and technology plans. We will improve the collaborative innovation mechanism of production, education and research, establish a generic alliance for generic drug technology, give play to the leading role of enterprises and the basic supporting role of hospitals, scientific research institutions, and institutions of higher learning, strengthen the research and development of pharmaceutical raw materials, packaging materials and preparations, and promote drug research and development. The chain and the industrial chain are organically connected. Actively introduce international advanced technology, and carry out digestion and absorption to improve.

 

(3) Improve the protection of intellectual property rights of drugs. In accordance with the principle of encouraging new drug creation and encouraging the development of generic drugs, we will study and improve the drug intellectual property protection system that is compatible with China's economic and social development level and industrial development stage, and fully balance the interests of drug patent holders and the public. Implement patent quality improvement projects and cultivate more core intellectual property rights, original intellectual property rights, and high-value intellectual property rights. Strengthen anti-monopoly law enforcement in the field of intellectual property rights, while fully protecting drug innovation, prevent the abuse of intellectual property rights and promote the listing of generic drugs. Establish and improve the patent early warning mechanism in the pharmaceutical field to reduce the risk of patent infringement of generic pharmaceutical companies.

 

Second, improve the quality of generic drugs

 

(4) Accelerate the evaluation of the consistency of quality and efficacy of generic drugs. The State Drug Administration, the National Health and Health Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, and the National Medical Insurance Bureau should refine the implementation of policies and measures to encourage enterprises to carry out the evaluation of the quality and efficacy of generic drugs, and accelerate the implementation of consistency. Evaluation work. Further release the generic drug consistency evaluation resources, and support the qualified medical institutions, institutions of higher learning, scientific research institutions and social office inspection and testing institutions to participate in the consistency evaluation work. Take effective measures to improve the enthusiasm of medical institutions and medical personnel to carry out clinical trials. For varieties with large clinical use and high proportion, the relevant departments should speed up the work; for the clinically necessary and low-priced varieties, the relevant departments should take targeted measures and provide support through improved procurement and use policies.

 

(5) Improve the quality of medicinal raw materials and packaging materials. Organize the development and revision of quality standards for pharmaceutical raw materials and packaging materials. Promote the development of pharmaceutical raw materials and packaging materials, and use new materials, new processes and new technologies to improve the quality. Through measures such as improving self-innovation ability and actively introducing advanced foreign technology, we will promote technology upgrading, break through key technologies such as purification and quality control, eliminate backward technologies and production capacity, and change the dependence of some pharmaceutical raw materials and packaging materials on imports to meet the quality of preparations. demand. Strengthen the quality supervision of pharmaceutical raw materials and packaging materials, and regularly publish inspection and sampling information for manufacturers.

 

(6) Improve the level of process manufacturing. Vigorously improve the level of pharmaceutical equipment and intelligent manufacturing, improve the research and manufacturing capabilities and equipment performance of key equipment, promote the application of new technologies, optimize and improve process production management, strengthen overall quality control, improve the control level of key processes, and promote the solution to the quality of products. Bottleneck problem. Promote the informationization of drug production quality control and realize real-time online monitoring of production processes. Improve the production process change management system of enterprises.

 

(7) Strict drug review and approval. We will deepen the reform of the drug review and approval system and strictly review the examination and approval standards. The generic drugs will be accepted and reviewed and approved according to the principle of the quality and efficacy of the original drug, so as to improve the quality and safety of drugs. Optimize the review and approval process to improve the efficiency of approval and approval of generic drugs. The application for registration of generic drugs for compulsory licensing of patents in the country, drugs listed in the catalogue for encouraging generic drugs, and generic drugs supported by major national science and technology programs shall be reviewed and approved. The State Drug Administration should improve the technical standards and guidelines for generic drug registration applications.

 

(8) Strengthen the supervision of drug quality. Accelerate the establishment of a quality management and quality traceability system covering the entire life cycle of generic drugs. Strengthen supervision and inspection of drug development, production, circulation and use processes, strengthen adverse reaction monitoring and quality spot checks, and seriously investigate and punish data fraud, cut corners, doping and false violations, strengthen accountability, and check and punish results to the public.

 

Third, improve support policies

 

(9) Timely included in the procurement catalogue. The centralized drug procurement agency shall prepare a procurement catalogue according to the generic name of the drug, and promote equal competition between the generic drug and the original drug that is consistent with the quality and efficacy of the original drug. For newly approved generic drugs, the relevant departments shall compile the drug procurement codes of public medical and health institutions in a timely manner. The corresponding generic drugs are already in the drug procurement catalogue, and the centralized drug procurement agencies shall initiate the procurement procedures in time; the corresponding generic drugs are not In the drug procurement catalogue, since the date of approval of the listing, the centralized drug procurement agency shall promptly demonstrate and actively incorporate it into the drug procurement catalogue. Drugs that are compulsory for patent enforcement by the state are unconditionally included in the drug procurement catalogues.

 

(10) Promote the alternative use of generic drugs. The generic drugs that are consistent with the quality and efficacy of the original drug are included in the catalogue of drugs that can be substituted for the original drug, and are marked in the instructions and labels, and the relevant information is released to the society in time for the medical staff and patients to choose. Health and other departments should strengthen the management of pharmaceuticals, formulate policies and incentives to encourage the use of generic drugs, and increase the supervision of clinical drugs. Strictly implement the requirements for prescribing according to the generic name of the drug. Except for special circumstances, the name of the product shall not appear on the prescription, as specified by the health and health department. Implement the prescription review system, strengthen the assessment of the rational use of drugs in medical institutions, publicize the prescription doctors who use drugs unreasonably, and establish an interview system. Strengthen the role of pharmacists in prescription review and drug deployment. When providing drugs to AIDS and tuberculosis patients according to regulations, it is preferred to purchase generic drugs.

 

(11) Give play to the incentive role of basic medical insurance. Accelerate the formulation of medical insurance drug payment standards, and the generic drugs and original research drugs that are consistent with the quality and efficacy of the original drug are paid according to the same standard. Establish and improve the dynamic adjustment mechanism of the basic medical insurance drug list, and timely incorporate qualified drugs into the catalogue. The drugs in the basic medical insurance drug list shall not be qualified according to the name of the product or the manufacturer. The medical insurance information system shall be updated in time to ensure that the generic drugs approved for listing are equally included in the scope of medical insurance payment. Encourage medical institutions to use generic drugs through health insurance payment incentives and restraint mechanisms.

 

(12) Defining the compulsory license path for drug patents. The compulsory license for drug patents shall be classified according to law to improve the accessibility of drugs. Encourage patentees to implement voluntary licenses. A unit or individual that has the conditions for implementing compulsory licenses may submit a compulsory license request to the State Intellectual Property Office in accordance with the law. In the event of a serious outbreak of major infectious diseases and other public health emergencies in the country, or a serious shortage of drugs for serious and serious diseases, which pose serious threats to public health or public health, the National Health and Wellness Committee The Ministry of Industry and Information Technology, the State Drug Administration and other departments conduct evaluation and demonstration, and propose to the State Intellectual Property Office to implement compulsory licenses. The State Intellectual Property Office has made a decision to grant compulsory licenses or refusals according to law.

 

(13) Implement tax preferential policies and price policies. Implement the current tax incentives, and the research and development expenses incurred by generic enterprises for the development of new technologies, new products, and new processes shall be deducted before the enterprise income tax in accordance with relevant regulations. If a generic drug company is recognized as a high-tech enterprise, the enterprise income tax shall be levied at a reduced rate of 15%. The National Development and Reform Commission, the Ministry of Industry and Information Technology and other departments should increase support and support the technological transformation of generic pharmaceutical companies. Encourage local governments to jointly introduce policies to support the transformation and upgrading of the generic drug industry, and further increase support. We will continue to push forward the reform of drug prices, improve the mechanism for the formation of drug prices mainly from the market, and do a good job of linking reform policies such as drug procurement and medical insurance payments. Adhere to the classification and procurement of drugs, highlight the clinical value of drugs, fully consider the cost of drugs, form a purchase price that is ups and downs, scientific and reasonable, and mobilize the enthusiasm of enterprises to improve the quality of drugs. Strengthen drug price monitoring and early warning, and severely crack down on illegal and illegal behaviors such as drug product price monopoly.

 

(14) Promote the internationalization of the generic drug industry. In conjunction with the promotion of the “One Belt, One Road” construction major initiative, strengthen exchanges with relevant international organizations and countries, and accelerate the pace of internationalization of drug research and development, registration, and sales. Support enterprises to carry out international capacity cooperation and establish a cross-border R&D cooperation platform. Actively introduce advanced management experience and key process technologies to encourage overseas enterprises to establish R&D centers and production bases in China.

 

(15) Do a good job in propaganda and guidance. Health and health, drug supervision, medical security and other departments should do a good job in publicizing and interpreting policies, popularizing drug knowledge and related information, and enhancing people's confidence in domestic generic drugs. Strengthen publicity and education of medical personnel, change irrational drug use habits, improve the level of rational drug use, and promote the use of generic drugs instead. Respond promptly to social concerns, reasonably guide public opinion and mass expectations, and form a good atmosphere for reform.

 

Reforming and improving the policy of supply and use of generic drugs is related to the safety of drug use by the people and is related to the healthy development of the pharmaceutical industry. All regions and departments should strengthen organizational leadership, combine the actual implementation of work plans and supporting rules, improve the implementation of working mechanisms and methods, and compact the responsibility, request for improvement, assessment and implementation, and actively and steadily promote the reform measures. Landing is effective.

 

Office of the State Council

March 21, 2018