Encourage the hypothesis of generic drugs catalog

Recently, the general office of the State Council put up the "key tasks of deepening the reform of the medical and health system in 2019" (GBF [2019] No 28), calling for deepening the joint reform of medical treatment, medical insurance and medicine, and unswervingly promoting the implementation of medical reform to achieve results and benefit the people In this document, "release the list of drugs to encourage imitation" is put on the agenda, and the plan will be in the charge of the national health and Health Commission and completed by the end of June 2019 Similar documents issued by the State Council are available every year This document also specially indicates the leading department of each task and the completion time node This practice is quite good The insiders are more concerned about the effect of the policy after implementation As for the release of the catalogue of drugs to be imitated, it is required to be completed by the end of June by the health and Health Commission, and now it has entered June, so it can be understood that there has been a first draft of the catalogue, and the implementation, promotion and final completion of policies need the full cooperation of other departments In particular, the Ministry of industry and information technology of the people's Republic of China, the State Food and drug administration, the State Finance Bureau and the Ministry of Commerce of the people's Republic of China should all participate in it Without their involvement, it is estimated that the expected effect cannot be achieved Of course, why this catalogue is completed under the leadership of the national health and Health Commission is a question that has to be considered It is possible that at present, the national level pays more attention to the clinical efficacy and the level of clinical medication, which is a great change In my opinion, the contents of drug imitation are being updated In addition to the patent drugs that are about to expire in foreign countries, there are generic generic drugs that have not been officially listed in China Some varieties with more advantages in clinical efficacy than similar products should also be included The purpose of the policy is to encourage the aforementioned drugs to pass the consistency evaluation as soon as possible, so as to improve the quality of domestic drugs in China, and let high-quality domestic drugs replace the original drugs with obvious clinical efficacy In view of this, from this point of view, the catalogue will also include drugs that are urgently needed in clinical practice and are in short supply in China Manufacturers rarely produce, so the state will formulate corresponding policies to encourage enterprises to copy, because clinical practice really needs it very much The "shortage" here does not refer to the traditional old medicine and general medicine The concept of understanding should be different from the previous thinking Moreover, considering that the development of the drug catalogue to encourage imitation is led by the health care Commission, it indicates that it must be re expanded on the basis of the National Essential Drug Catalogue (2018 version) that has been promulgated, or select the excellent varieties that are not made in China in clinical practice The concept of essential drugs was first put forward at the World Health Assembly in the 1970s Its original definition is: the most important, basic and indispensable drugs for health care of all residents With the improvement of clinical medication level, the meaning is constantly changing Nowadays, the basic drugs are no longer limited to general drugs, but pay more attention to the cost-effectiveness ratio The purpose is to improve the medication level of medical institutions and improve the quality of drugs In addition, it is necessary to fill in the gaps of domestic drugs in the field of treatment From this point of view, it should also be noted that the sixth of the key tasks of this work - the formulation of "drug administration measures for medical institutions" is still under the charge of the national health and Health Commission, and is planned to be completed by the end of September 2019 In other words, when the health and Health Commission formulates the drug administration measures for medical institutions, its role should be complementary to the catalogue encouraging the production of generic drugs, which will be considered more from the perspective of clinical use Of course, the author still has some doubts at present: the drug catalog encouraged to copy is led by the health care Commission, and how other relevant ministries and commissions can better cooperate is the key For example, the national drug administration may focus on how to speed up the review of new drugs in the catalogue of generic drugs From the perspective of the Ministry of industry and information technology of the people's Republic of China, it is how to do a good job in innovation support Then from the perspective of the Ministry of Commerce, how to ensure the current implementation of the two ticket system to complete the distribution of drug terminals At the national level, it may also consider how to do a good job of post marketing supervision while the rapid development of the Internet In recent 10 years, the task of deepening the new health care reform for special varieties or to be included in it has been arranged every year Many of the latest documents are issued around the current situation of some industries and the implementation of new policies Next, we need to see the scope of the new version of the National Health Insurance catalogue of the state health insurance bureau Before the national health and Health Commission issued the 2018 version of the basic drug catalog, now it will complete the drug catalog to encourage imitation There are many catalogs How to combine many catalogs organically? Relevant enterprises must have rational analysis on the adjustment of the enterprise's variety structure, and avoid "high-level repetition" The incentive catalogue to be completed by the end of June must be aimed at the urgent needs of clinical varieties As for the development of local innovative drugs, or that the local government should keep pace with the imitations of foreign drugs that are about to go through the patent period, the implementation of specific policies should be greater in the functional departments of the industry and pharmaceutical administration Since it is the work led by the national health and Health Commission to encourage generic drug catalogue, the drugs selected at that time should be based on clinical efficacy, clinical urgent need and domestic shortage Of course, it may also take into account some licensed overseas drugs (especially anti-tumor drugs and rare disease drugs that are speeding up the review and approval process and are not available in some countries) In short, the purpose of the policy is to consider how to improve the pharmaceutical level, improve the treatment level, improve the quality of drugs, fill in the gaps, and move from a big country of drugs to a powerful country of drugs as soon as possible, with the ultimate goal of strengthening the country and benefiting the people This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.