State Council issued a letter, generic drugs to meet the major benefits

Medicine Network April 4th, the State Council issued a letter, send five good, domestic generic drug enterprises should be ecstatic!income tax is 15%, drugtendersprocurement are treated equally, health insurance payment is a standard ..Out of the policy to encourage hospitals to use more generic drugsthe State Council issued a letter, the domestic pharmaceutical enterprises boilingYesterday (April 3), the General Office of the State Council issued the Opinions on Reforming and Improving the Policy on the Guarantee and Use of Generic Drugs (hereinafter referred to as "Opinions")This article a hair, warm wind, domestic pharmaceutical enterprises boilingreform and improvement of the relevant policies on generic drugs, which is related to the health and well-being of the masses, and to the future of the nation1.4 billion people are boiling!the full text of the Opinion series of more than 3,000 words, divided into "promoting the research and development of generic drugs, improve the quality of generic drugs efficacy, improve support policies" three partsThe logic is clear: encourage the development of generic drugs, and after consistency evaluation, the state gives policy supportexpert review: an expert involved in the drafting process of the document told Seiberland yesterday: to promote the supply and use of generic drugs, the document can be summarized in nine words, "quickly have (incremental), good (quality), use (available).", the industry is undoubtedly the most concerned about the "support policy" part, Seiber Blue selected as follows:, the first time put forward: drug collection, imitation and original research drugs, equal treatment oftimely into the procurement catalogDrug collection institutions shall compile a catalogue of procurement according to the generic name of the drug Promote equal competition between generic and original drugs consistent with the quality and efficacy of the original drug for newly approved generic drugs, relevant departments should promptly prepare the public medical and health institutions drug procurement code, the corresponding generic name drugs have been in the drug procurement catalog, the drug centralized procurement agency should start procurement procedures in a timely manner; the state to implement the compulsory licensing of drugs, unconditionally included in the local drug procurement catalogue replace the original drug, encourage the use of consistency evaluation generic drugs
promote the use of generic drugs The generic drugs that are consistent with the quality and efficacy of the original drug will be included in the catalogue of alternative drugs with the original drug, marked in the instructions and labels, and the relevant information is published to the public in a timely manner, so as to facilitate the choice of medical personnel and patients to use health and other departments to strengthen drug management, the formulation of policies and incentives to encourage the use of generic drugs, and increase the supervision of clinical drug use Strict implementation of the requirements for the prescription of drugs in accordance with the generic name, except in special cases, the prescription shall not appear on the name of the commodity, specifically by the health and health department implement the prescription evaluation system, strengthen the assessment of the rational use of drugs in medical institutions, make public the prescription doctors who use unreasonable drugs, and establish an interview system Strengthen the role of pharmacists in prescription audits and drug dispensing Priority is given to the procurement of generic drugs when providing drugs to AIDS and tuberculosis patients as required expert comments: With the forum promoter Dr Cheng Zengjiang said to Seiberan, not long ago, the State Council announced the reform of the large-scale system, the Drug Administration into the General Administration of Markets, the industry is worried about whether the consistency evaluation will slow the promotion of the case, this opinion once again in the name of the State Council Office issued a document to promote the consistency evaluation work personal lying view that the core of the opinion is to accelerate the replacement of generic drugs for imported medicines, which is undoubtedly the greatest driver of the consistency evaluation, and indicates that the organizational restructuring of the FDA will not adversely affect the post-2015 review and approval process promoted by Director-General Bi It is also not known whether such a strong support for speeding up the replacement of generic drugs in the original research is a gesture of China's current Sino-US trade war , for the first time, clearly stated that the standard of payment of medical insurance without discrimination play the incentive role of basic medical insurance We will speed up the formulation of standards for the payment of medical insurance drugs, and pay for generic and original drugs according to the same standards consistent with the quality and efficacy of the original drugs establish a mechanism for the dynamic adjustment of the list of basic medical insurance drugs and promptly include eligible drugs in the catalogue The drugs in the list of basic medical insurance drugs shall not be limited by the name or manufacturer of the commodity, and the medical insurance information system shall be updated in a timely manner to ensure that the generic drugs approved for listing shall be equally included in the scope of medical insurance payment Medical institutions are encouraged to use generic drugs through the incentive and restraint mechanism for medical insurance payments expert comments: Last night, there are industry experts familiar with the process of drafting the policy to Seiberblue said: the document proposed "accelerate the development of medical insurance drug payment standards, with the quality and efficacy of the original drug, the original research drug paid according to the same standards", is the first time in the official document mentioned, further clarify the policy orientation of the standard of medical insurance payment the expert said that before, the 13th Five-Year Medical Reform Plan has mentioned "establish and improve the standard of payment of medical insurance drugs, combined with the quality and efficacy of generic drugs consistent evaluation work, and gradually according to the common name to develop drug payment standards", the "Opinion" further clarified with the quality and efficacy of the original drug, the original research drug according to the same standard suing, reflecting a clearer direction of the national health insurance payment standard policy but he also warned that the policy on generic drug research and development, production and clinical drug structure will have a certain impact, but this impact is gradual, in the short term will not change the market competition pattern the implementation of mandatory licensing of drug patents
clear the path of mandatory licensing of drug patents According to the law, the implementation of compulsory licensing of drug patents, improve the availability of drugs The patentee is encouraged to implement voluntary licensing Units or individuals that have the conditions for enforcing compulsory licensing may, in accordance with the law, submit a request for compulsory licensing to the State Intellectual Property Office in the country in the emergence of major infectious disease outbreaks and other public health emergencies or drug shortages, public health safety or serious threats to public health and other extraordinary circumstances, in order to maintain public health, by the National Health and Health Commission in conjunction with the Ministry of Industry and Information Technology, the State Drug Administration and other departments to evaluate and demonstrate, to the State Intellectual Property Office to implement compulsory licensing recommendations, the State Intellectual Property Office in accordance with the law to give compulsory licensing or rejection of the decision high-tech generic drug enterprises, tax reduction substantially implement preferential tax policies and price policies To implement the current preferential tax policies, the research and development expenses incurred by generic pharmaceutical enterprises for the development of new technologies, new products and new processes shall be deducted before and after tax on enterprise income tax in accordance with the relevant provisions generic drug enterprises shall be subject to enterprise income tax at a reduced rate of 15% if they are recognized as high-tech enterprises The National Development and Reform Commission, the Ministry of Industry and Information Technology and other departments should step up support to support the process transformation of generic drug enterprises encourage local governments to further strengthen support in conjunction with the actual introduction of policies to support the transformation and upgrading of the generic drug industry We will continue to push forward drug price reform, improve the mechanism for drug prices, which is mainly formed by the market, and make good connections with reform policies such as drug procurement and medical insurance payment adhere to the procurement of drug classification, highlight the clinical value of drugs, fully consider the cost of drugs, form a rise and fall, scientific and reasonable procurement prices, mobilize enterprises to improve the quality of drugs enthusiasm We should strengthen drug price monitoring and early warning, and crack down on illegal and illegal activities such as price monopoly of raw materials in accordance with the law the big pattern, promote the internationalization of domestic pharmaceutical enterprises
for domestic pharmaceutical enterprises, this is a big document! saiper blue first invited to participate in the drafting process of the document of an expert to interpret, he said: the entire document is divided into three parts: the first part to promote generic drug research and development, is to focus on solving the "yes" problem, so that the Chinese market as soon as possible to have some of the original generic products; the third part of the improvement of support policies, is to focus on solving the problem of making ordinary people "use", through a series of policy support, such as "timely inclusion in the procurement catalog, promote the use of generic drugs, play the role of basic medical insurance incentives, the implementation of preferential tax policies and price policies " on the one hand to encourage enterprises to actively invest in generic drug research and development innovation, but also help to reduce prices, reduce the burden of ordinary people, "promote the internationalization of the generic drug industry" is mainly in line with the national strategy "belt and road", so that generic drug enterprises to expand the international market, promote pharmaceutical supply-side structural reform National Will: Elimination of backward, strengthening advanced pharmaceutical enterprises this document, and the State Office issued on March 5, 2016 on the implementation of the quality and efficacy of similar evaluation of the opinion (State Office issued (2016) No 8), May 5, 2017 "on deepening the issuance of the medical and health system reform of the 2017 key tasks of the notice " (State Office issued (2017) No 37), a similar issue to solve the problem summed up, "on the implementation of the quality and efficacy of the results of the opinion" can be understood as, the need to improve the quality of generic drugs, so that the Chinese people with excellent quality of good drugs, otherwise they will be eliminated, and gradually clean up those drugs whose quality does not reach the consistency yesterday's document can be understood as, in order to protect the market supply of drugs (especially generic drugs), in the elimination of the same, but also to the generic drug research and development innovation, production innovation in the enterprises to invest in support Thus, the national policy can be seen very clearly: one hand to eliminate backwardness, one hand to promote advanced expert comments: some experts to Seibo Blue said that in recent years, the national supply-side structural reform is advancing rapidly, the introduction of the document, is conducive to China's pharmaceutical industry to the high-level proposed "to achieve higher quality, more efficient, more equitable and more sustainable development" goal requires better progress also, the same day the National Health and Reform Commission on this document, also gave an interpretation the previous of the previous page, "
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