News

Inherit the traditional culture of Chinese medicine and build a unique brand of Chinese herbal medicine

Home>News

The State Council General Office issued a document: insist on equal emphasis on Chinese and Western medicine, support Chinese medicine

Date:2020-04-29Views:0

Recently, the General Office of the State Council issued the "Opinions on Improving the National Essential Medicine System" (hereinafter referred to as "Opinions")

The "Opinions" pointed out that since the new round of medical reform, the establishment and implementation of the national essential medicine system have played an important role in improving the medicine supply security system, guaranteeing people's basic medicine and reducing the burden of patients' medicine. At the same time, there are also problems such as inadequate adaptation to the needs of basic clinical medicine, lack of incentive mechanisms for use, gaps in the quality and efficacy of generic and original research varieties, and inadequate guarantee supply mechanisms.

The "Opinions" pointed out that the spirit of the 19th National Congress of the CPC and the Second and Third Plenary Sessions of the 19th CPC Central Committee should be fully implemented, guided by Xi Jinping's socialist ideology with Chinese characteristics in the new era, adhere to the people's health as the center, and strengthen essential medicines. The functional orientation of prevention and control, supply guarantee, priority use, quality assurance, and lowering of the burden, comprehensively drive the construction of the drug supply guarantee system, focus on ensuring safe and effective drugs, reasonable prices, and adequate supply to alleviate the problem of "expensive medical treatment". Promote the convergence of medicines at higher and lower levels of medical institutions, assist in the establishment of a graded diagnosis and treatment system, and promote the transformation and upgrading of the pharmaceutical industry and the supply-side structural reforms.

The "Opinions" clarify five policy measures from the aspects of selection, production, circulation, use, payment and monitoring of essential medicines. One is to dynamically adjust and optimize the catalog. Regular evaluation and dynamic adjustment of the list of essential medicines, highlight the clinical value of medicines, adhere to both Chinese and Western medicines, meet the main clinical needs of common diseases, chronic diseases, emergency rescue, etc., taking into account the needs of children and other special groups and public health prevention and treatment. The second is to effectively guarantee production and supply. Adhere to the direction of centralized procurement and implement the classification of drug procurement. For essential medicines that are prone to shortages, measures are taken to ensure reasonable supply prices, fixed-point production, unified distribution, or inclusion in reserves through market matching. The third is fully equipped with priority. Adhere to the dominant position of essential medicines and clarify the proportion of essential medicines used in public medical institutions. Implement clinical use monitoring and carry out comprehensive clinical evaluation of drugs. Deepen the reform of the medical insurance payment method, formulate medical insurance payment standards, and guide rational diagnosis and treatment and rational use of drugs. The fourth is to reduce the burden of medical expenses on the masses. Prioritize the inclusion of essential medicines in the scope of medical insurance according to the procedure, and gradually increase the actual level of protection. Encourage local governments to explore effective ways to reduce the burden on patients and minimize the patient's medical expenses. Fifth, improve the quality and safety level. Carry out sampling inspections covering all varieties of essential medicines, strengthen supervision and inspection of essential medicine production links, and strengthen quality and safety supervision. For drug varieties that have passed the consistency evaluation, priority is included in the list of essential medicines in accordance with the procedure; the types of essential drugs that have not passed the consistency evaluation are gradually transferred out of the list.

The "Opinions" require that organizational leadership be strengthened, and governments at all levels should incorporate the implementation of the national essential medicine system into the government performance appraisal system. It is necessary to strengthen supervision and evaluation, establish and improve the basic medicine system and implement the supervision and evaluation system, give full play to the role of third-party evaluation, and strengthen the use of results. It is necessary to strengthen publicity and guidance, strengthen policy interpretation, and create a good social atmosphere for the implementation of the basic drug system.

The following is the full text of "Opinions on Improving the National Essential Medicine System"

Opinions of the General Office of the State Council on Improving the National Essential Medicine System

Guobanfa (2018) No. 88

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

The national essential medicine system is the foundation of the medicine supply guarantee system and an important content of basic public services in the medical and health field. Since the new round of medical reform, the establishment and implementation of the national essential medicine system have played an important role in improving the medicine supply security system, ensuring the basic medicines of the masses, and reducing the burden of medicine for patients. At the same time, there are also problems such as inadequate adaptation to the needs of basic clinical medicine, lack of incentive mechanisms for use, gaps in the quality and efficacy of generic and original research varieties, and inadequate guarantee supply mechanisms. In order to implement the National Health and Wellness Conference, the "Outline of" Healthy China 2030 "Plan" and the deployment requirements for deepening the reform of the medical and health system, and further improve the national essential medicine system, with the consent of the State Council, the following opinions are now proposed.

1. General requirements

 Fully implement the spirit of the 19th National Congress of the Communist Party of China and the Second and Third Plenary Sessions of the 19th CPC Central Committee, guided by Xi Jinping ’s new era socialist ideology with Chinese characteristics, adhere to the people ’s health as the center, and strengthen basic medicines The functional orientation of "priority use, quality assurance, and reduced burden" improves policies from the selection, production, circulation, use, payment, and monitoring of essential medicines, comprehensively drives the construction of the medicine supply guarantee system, and strives to ensure safe and effective medicines at reasonable prices. The supply is sufficient to alleviate the problem of "expensive medical treatment". Promote the convergence of medicines at higher and lower levels of medical institutions, assist in the establishment of a graded diagnosis and treatment system, and promote the transformation and upgrading of the pharmaceutical industry and the supply-side structural reforms.

2. Dynamically adjust and optimize the catalog

 (1) Adapt to basic medical and health needs. In order to meet the needs of basic medicine for disease prevention and treatment, according to China's disease spectrum and medication characteristics, fully consider the current basic national conditions and guarantee capabilities, adhere to the principles of science, openness, fairness, and justice. Based on this, Chinese and Western medicines are equally important, and an appropriate number of essential medicines are selected to meet the main clinical needs of common diseases, chronic diseases, emergency rescue, etc., taking into account the needs of children and other special groups and public health prevention and treatment. Strengthen evidence-based decision-making, highlight the clinical value of drugs; standardize dosage form specifications, can be administered orally without intramuscular injection, intramuscularly without infusion. Support the development of Chinese medicine and encourage R & D and innovation in the pharmaceutical industry.

 (2) Improve the catalog adjustment management mechanism. Optimizing the selection and adjustment procedures of the essential drug list, comprehensive clinical application practices of drugs, changes in drug standards, new drug listings and other factors, regular evaluation and dynamic adjustment of the essential drug list, the adjustment period should not exceed 3 years in principle. For newly approved drugs that have significantly improved efficacy compared to already marketed drugs and are reasonably priced, the transfer process can be initiated in due course. Adhere to the importance of both transfer and transfer, and give priority to the drug varieties with clear evidence of effectiveness and safety, and significant cost-effectiveness ratio; focus on transferring those that have been delisted, have more serious adverse reactions, and are unsuitable as basic drugs after evaluation , And alternative medicines with better risk-benefit ratio or cost-benefit ratio. In principle, medicines are not supplemented in various places, and minority nationality areas may be supplemented with a small amount of ethnic medicines.

3. Guarantee production and supply

 (3) Improve the effective supply capacity. Take the implementation of the essential medicine system as an important part of improving the pharmaceutical industry policy and industry development plan, encourage technological progress and technological transformation of enterprises, promote advantageous enterprises to build production quality systems that are in line with international advanced levels, and enhance the production and supply capacity of essential medicines. Carry out a survey of the status quo of manufacturing companies. For essential drugs that are clinically necessary, low in dosage or low in transaction prices, and insufficient in production power of the company, the market may be prone to shortages of essential drugs. Measures such as distribution and inclusion in reserves ensure supply.


 (4) Improve the procurement and distribution mechanism. Fully consider the special product attributes of medicines, give play to both the government and the market, stick to the direction of centralized procurement, implement the procurement of medicines by category, and guide the formation of reasonable prices. Do a good job in linking up and down medical institutions, promote the centralized procurement of public medical institutions in cities (counties), promote drug price reduction, standardize the varieties, dosage forms, and specifications of essential drug purchases to meet the needs of the masses. Encourage cancer and other specialized hospitals to carry out cross-regional joint procurement. As the first person responsible for ensuring the supply and distribution of essential medicines, the manufacturing enterprise should effectively fulfill the contract, especially to ensure the distribution of medicines in remote and inaccessible areas. Due to the shortage of drugs caused by the enterprise, the enterprise shall bear the responsibility for breach of contract, and the relevant departments and units shall be included in the record of dishonesty in a timely manner. The medical insurance agency shall allocate medical insurance funds to the medical institution in time according to the agreement. The medical institution shall settle the payment in time in strict accordance with the contract; if the payment is delayed, it shall be notified and criticized, and ordered to make corrections within a time limit.

 (5) Strengthen early warning response to shortages. Establish and improve a nationwide shortage drug monitoring and early warning system, strengthen the collection of multi-source information such as drug R & D, production, distribution, and use, accelerate the realization of direct reporting of shortage drug information networks at all levels of medical institutions, track and monitor the source of raw materials, enterprise inventory and market transactions Situation, comprehensively judge and judge the potential shortage factors and trends, find the shortage risk as soon as possible, and classify and respond to different causes of shortage. For those who monopolize the raw material market and push up drug prices, leading to drug shortages, suspected of constituting monopoly agreements and abuse of market dominance, anti-monopoly investigations will be carried out in accordance with the law and punishment will be increased. Incorporate the shortage of medicines required by the military into the national emergency supply system for shortage of medicines. Through the integration of military and civilians, establish a coordination mechanism for the shortage of medicines in urgent need of the military to ensure the urgent shortage of troops and the supply of emergency combat reserve medicines.

Fourth, fully equipped with priority use

 (6) Strengthen the management of equipment use. Adhere to the dominant position of essential medicines, strengthen the management of the use of essential medicines in medical institutions, clarify the proportion of essential medicines used in public medical institutions in provinces, and continuously increase the use of essential medicines in medical institutions. Public medical institutions are reasonably equipped with basic medicines according to their functional positioning and scope of diagnosis and treatment, so as to ensure the basic clinical medicine demand. The centralized drug procurement platform and the medical institution information system should label essential medicines, prompting medical institutions to give priority to purchase and doctors to use first. Take the use of essential medicines as the key content of prescription reviews, and notify those who do not prefer essential medicines for no valid reason. Increase the training of doctors, pharmacists and administrators on the basic medicine system, clinical application guidelines and prescription sets of essential medicines, and improve the rational use and management of essential medicines. Encourage other medical institutions to equip and use essential medicines.

 (7) Establish preferential use incentive mechanism. Medical institutions scientifically set the basic medicine use indexes of clinical departments and included them in the assessment. Link the use of essential medicines to the allocation of subsidies for basic medicine system implementation at the grassroots level. Deepen the reform of the medical insurance payment method, and establish and improve the incentive and risk-sharing mechanism between the medical insurance agency and the medical institution for "remaining balance and reasonable overspending". Guide medical institutions and medical personnel to make rational diagnosis and treatment and rational use of drugs by formulating payment standards for medical insurance.

 (8) Implement clinical use monitoring. Relying on existing resources to establish and improve national and provincial drug use monitoring platforms and national, provincial, prefecture, city, and county monitoring network systems, focusing on monitoring the information on the types, quantities, purchase prices, supply and distribution of essential drugs in medical institutions , And whether the prescription medications meet the diagnosis and treatment specifications. Carry out comprehensive clinical evaluation of medicines focusing on essential medicines, and guide clinical safe and rational use of medicines. Strengthen the inter-departmental information interconnection, and implement the whole process of dynamic monitoring of the basic medicine from raw material supply to production, circulation, use, price, reimbursement, etc.

V. Reducing the burden of medical expenses for the masses

 (9) Gradually increase the actual security level. Improve the medical insurance payment policy. For the therapeutic drugs in the list of essential medicines, when adjusting the medical insurance catalog, the medical insurance department will follow the procedure to include the qualified priority into the scope of the catalog or adjust the classification of A and B. For national immunization planning vaccines and basic medicines for major public health prevention and treatment such as anti-AIDS, tuberculosis, and parasitic diseases, increase government investment to reduce the burden of medication for the masses.

 (10) Explore effective ways to reduce the burden on patients. Encourage local governments to organically integrate the basic medicine system with graded diagnosis and treatment, family doctor contract services, and chronic disease health management. In the management of chronic diseases such as hypertension, diabetes, and severe mental disorders, priority is given to the use of essential medicines under the premise of ensuring the efficacy of medicines. The patient's medical expenses increase the public's sense of gain.

Sixth, improve the quality and safety level

 (11) Strengthen quality and safety supervision. Implement sampling inspections covering all kinds of essential medicines, and announce the results of sampling inspections to the society in a timely manner. Encourage enterprises to conduct re-evaluation after the drug is marketed. Strengthen the monitoring of adverse reactions of essential drugs and strengthen the drug safety early warning and emergency response mechanism. Strengthen the supervision and inspection of the production process of essential medicines, urge enterprises to comply with laws and regulations to ensure quality.

 (12) Promote the consistency evaluation of the quality and efficacy of generic drugs. The types of medicines that have passed the consistency evaluation will be included in the list of essential medicines according to the procedure. For generic drugs that have been included in the list of essential drugs, companies are encouraged to carry out consistency evaluations, and the categories of essential drugs that have not passed the consistency evaluation are gradually transferred out of the list. Medical institutions are encouraged to give priority to the procurement and use of essential medicines that pass consistency evaluation and are affordable.

Seven, strengthen organizational security

 (13) Strengthen organizational leadership. The implementation of the national essential medicine system is an important deployment made by the Party Central Committee and the State Council in the field of health care. Governments at all levels should implement leadership responsibilities, guarantee responsibilities, management responsibilities, and supervisory responsibilities. Get practical results. Relevant departments should refine policy measures, improve the full-length effect mechanism, strengthen collaboration and cooperation, and form a joint force of work.

 (14) Strengthen supervision and evaluation. Establish and improve the essential medicine system and implement the supervision and evaluation system, give full play to the role of third-party evaluation, strengthen the use of results, and improve the relevant policies of the essential medicine system in a timely manner based on the supervision and evaluation results. Encourage local governments to integrate reality, focus on guaranteeing the supply and priority use of essential medicines, reduce the burden on the masses, explore effective practices and models, and summarize and promote them in a timely manner.

 (15) Strengthen publicity and guidance. Through TV, radio, newspapers, online new media and other channels, the goal positioning, significance and policy measures of the essential medicine system should be fully publicized. Adhere to the correct public opinion guidance, strengthen policy interpretation, properly respond to social concerns, reasonably guide social expectations, and create a good social atmosphere for the implementation of the basic drug system.

Office of the State Council    

September 13, 2018