Implementation opinions on reforming and improving the policy of supply and use

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Implementation opinions on reforming and improving the policy of supply and use of generic drugs
 
The people's governments of all districts, the municipal government committees, offices, bureaus, and municipal agencies:
In order to thoroughly implement the "Opinions of the General Office of the State Council on Reforming and Perfecting the Supply and Guarantee Policy of Generic Drugs" (Guo Ban Fa [2018] No. 20), accelerate the improvement of the city's generic drug research and development capabilities, improve the quality and efficacy of generic drugs, and improve drugs. Supply support capacity, better meet the clinical drug and public health security needs, and promote the transformation and upgrading of the city's pharmaceutical industry. With the consent of the municipal government, the following implementation opinions are proposed.
1.promote the development of generic drugs
(1) Clearly encourage generic drugs. Establish a multi-sector coordination mechanism to promote cross-sectoral drug information sharing, demand-oriented, and focus on supporting generic drugs with large clinical doses, high proportions, and curative effects. Drugs that have not yet applied for registration in the year before the patent expires and major Specialized drugs such as infectious disease prevention and treatment drugs will be put on the market as soon as possible. Support qualified pharmaceutical companies to declare and build a national production base for small-scale pharmaceutical products to ensure the supply of clinically short-term drugs.
(2) Strengthening the research of generic drug technology. Make full use of the resources of hospitals, scientific research institutions and institutions of higher learning in the city, establish a generic drug technology research alliance, build a drug research and development service platform, and introduce a professional R&D team to increase technical research efforts around technical difficulties and common needs. Give play to the role of the main body of the enterprise and support enterprises to establish high-level R&D centers. The use of special funds for foreign trade and economic development will encourage pharmaceutical companies in this city to introduce key technologies and key products to digest and absorb them.
(3) Improve intellectual property protection. Vigorously implement the patent quality improvement project 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 pharmaceutical 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, carry out intellectual property policy guidance, and reduce the risk of patent infringement of generic pharmaceutical companies.
2. improve the quality of generic drugs
(4) Accelerate the evaluation of the consistency of quality and efficacy of generic drugs. Relevant departments of the city should actively provide policy guidance and technical services according to the needs of enterprises to carry out the work of conformity evaluation of generic drugs, and speed up the work according to their respective duties, and improve the efficiency of declaration and approval of generic drug conformity evaluation. Actively promote the construction of biological sample testing platform and reference preparation procurement service platform, standardize biological sample testing management, and optimize the reference preparation procurement process.
(V) Strengthen the capacity building of clinical trials of generic drugs. Through a variety of ways to increase clinical trial resources, support tertiary hospitals in the process of optimizing the allocation of medical resources to set aside resources to set up research-type wards, and promote drug clinical trial institutions and hospitals with bed conditions. Encourage qualified social medical institutions and inspection and testing institutions to participate in the clinical trial work of generic drugs. Strengthen the professional ability training of practitioners in drug clinical trial institutions and improve their work level. Medical staff who undertake clinical trials of generic drug conformity assessment support in terms of job title promotion, research awards, and performance distribution.
(6) Improve the quality of 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. Support enterprises to carry out technological upgrading, break through key technologies such as purification and quality control, and change the situation that some pharmaceutical raw materials and packaging materials depend on imports to meet the quality requirements of preparations. Implement the examination and approval system for the distribution of raw and auxiliary materials and packaging materials and drugs, and strengthen quality supervision according to national requirements.
(7) Improve the level of process manufacturing. Support enterprises to carry out the construction of digital workshops, smart factories, etc., vigorously improve the level of pharmaceutical equipment and intelligent manufacturing, and improve the research and manufacturing capabilities and equipment performance of key equipment. Support generic drug companies to optimize and improve production process management, strengthen overall quality control, and improve key process control levels. Promote the informationization of drug production quality control and realize real-time online monitoring of production processes. Implement and improve the enterprise production process change management system.
(8) Strengthening the quality supervision of generic drugs. Implement quality management and quality traceability systems covering the entire life cycle of generic drugs. Strengthen supervision and inspection of the whole process of research and development, production, circulation and use of generic drugs, urge enterprises to implement the reporting system for adverse drug reactions, and issue quality announcements on a regular basis; seriously investigate and punish data fraud, cut corners, doping and falsehood, etc.; Open to the public.
 
3. improve support policies
(9) Increase scientific research and industrial support. Funding for key generic products will be funded at a maximum of 50% of the R&D investment. We will use the city's high-tech industry development funds to increase support for the transformation of generic drug production processes. Relevant districts that regard the pharmaceutical and health industry as the leading industry should study and introduce policies and measures, and encourage the generic enterprises that have been approved for listing and the consistency evaluation of major innovative varieties in China.
(10) Timely incorporated into the pharmaceutical sunshine procurement platform. Establish a dynamic access mechanism for pharmaceutical sunshine procurement, and unconditionally incorporate drugs that are compulsory for patents in the country into the drug procurement platform; and newly approve the generic drugs that have passed the consistency assessment after listing and listing, and timely incorporate them into the scope of drug procurement, and promote the original drug Generic drugs and original research drugs with the same quality and efficacy are equally involved in market competition.
(11) Promote the alternative use of generic drugs. Establish and improve a comprehensive drug evaluation system, and encourage medical institutions to prioritize the procurement and use of generic drugs with clear curative effects and reasonable prices. 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. 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.
(12) Give play to the incentive role of basic medical insurance. The generic name management is applied to the drugs in the basic medical insurance drug list, the name of the product and the manufacturer are not distinguished, and the medical insurance information system is updated in time, and the generic drug and the original drug are equally included in the scope of medical insurance payment. In accordance with the principle of “total advance payment, balance sharing, and overspending”, we will promote the reform of medical insurance payment methods. According to the relevant requirements of the state, we will promote the work related to the payment standards for medical insurance drugs, and encourage medical institutions to use generic drugs of high quality and low price.
(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%. Implement a mechanism for the formation of drug prices mainly by the market, and do a good job of connecting with reform policies such as drug procurement and medical insurance payment. 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, standardize the price behavior of generic drugs, 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 “Belt and Road” initiative, strengthen exchanges with relevant international organizations and countries, organize the international certification of pharmaceutical production lines, and accelerate the internationalization of the generics industry. Enterprises that have been approved for listing in generic countries in Europe and the United States will be given corresponding incentives. Support enterprises to carry out international capacity cooperation and establish a cross-border R&D cooperation platform. Support overseas companies to establish high-quality drug research and development centers in this city.
(15) Strengthen publicity and guidance. The municipal health, drug regulatory, medical security and other departments should take measures to publicize and interpret the generic drug policy, popularize the knowledge of generic drugs, enhance the people's confidence in domestic generic drugs, and gradually change the concept and habit of drug use. It is necessary to strengthen the education and training of medical personnel, improve the level of rational drug use, and promote the substitution of generic drugs. It is necessary to respond to social concerns in a timely manner, reasonably guide public opinion and the expectations of the masses, and form a good atmosphere for reform.
All districts and relevant departments must fully understand the significance of reforming and improving the supply and use policies of generic drugs, effectively strengthen organizational leadership, improve working mechanisms, refine work plans, work closely together, and actively and steadily promote to ensure effective results.
February 25, 2019