Medical network February 10th hearing on February 9th, the general office of the State Council issued the "opinions on further reform and improvement of drug production and circulation of the use of policies" (hereinafter referred to as the "opinions"). This is the focus of the pharmaceutical industry's most important pharmaceutical industry policy, from the three aspects of drug production, circulation, use, is to cover the entire pharmaceutical industry chain important reform documents.
As early as November 5, 2016, the game took the lead in the State Council, the State Council brewing heavy files, the generation of drugs or will be the liberation of the title of the above policy exclusive reports, and in the State Council in December 4th will be a heavy file! Millions of drugs! "The new progress on the document further reports, until now the documents formally introduced, we believe that since 2016 this is the most important pharmaceutical policy documents, more than two votes, the file specification is a deeper influence, in the country and the people in enterprises, more rational and operational documents, especially the first mention" multi bin coordination "and" Internet plus drugs "will bring revolutionary change to the circulation of medicines and drug agent.
"A number of opinions," the amount of information is very large, involving the production, circulation, use of the entire circulation chain, a total of 17. The following are a few key points lie blue finishing:
Man drug production and circulation of big reshuffle
For the word "big reshuffle", believe that since last year we have for having heard it many times. The reason why I continue to refer to the old words, as is clearly mentioned in the "some opinions" opinions, "support the merger and reorganization of pharmaceutical production enterprises, foster a number of internationally competitive large enterprise groups, improve the pharmaceutical industry concentration". "To break the market segmentation and local protection of pharmaceutical products, to promote the trans regional and cross ownership mergers and acquisitions of drug distribution enterprises, and to cultivate the backbone enterprises of large-scale modern pharmaceutical distribution".
"A number of opinions" by improving the evaluation of registration approval, quality, safety and other standards, strict market access, form the market Daobi mechanism, promote the transformation and upgrading of traditional enterprises, promote the restructuring of pharmaceutical producing enterprises and backward enterprises exit. For example, the same varieties of drugs through the consistency of the evaluation of the production enterprises to reach more than 3, in terms of centralized drug procurement and other aspects of the selection is not inconsistent evaluation".
At the same time, the "opinions" for drug circulation from a number of aspects of the reform measures. The most prominent is the two vote system and the regulation of drug circulation. Experts in the industry to Sai Lan Lan said that in the two vote policy intervention, the company has long been able to survive the space is compressed, the ticket function collapse. Plus since May 2016 in the nationwide implementation of "replacing business tax with value-added tax(VAT) tax policy, a large number of" survival of the company in the business by scalping the combination of these policies, the loss of original value, are eliminated, crack down on illegal affiliation, commercial bribery, tax evasion, a large number of proxy based commercial pharmaceutical companies, small and medium-sized commercial pharmaceutical companies will forced transition to be merged and a large group of certain subsidiaries.
Man, accelerate the separation of medicine prescription outflow
"A number of opinions" put forward to encourage conditional area can be carried out online pharmacist prescription audit, medication guidance services, it will be a major breakthrough in promoting the development of pharmaceutical electricity supplier, but also greatly promote the hospital prescription outflow. Means that, with the advance of reform, drug distribution enterprises and medical institutions, medical insurance department, the electronic commerce enterprise cooperation medical service providers to provide drugs to patients' network set (Medicine) store "," network set (Medicine) service model shop ", the integration of online and offline development will accelerate.
At the same time, the "opinions" explicitly mentioned, "patients can choose in medical institutions or retail pharmacies, medical institutions shall not restrict the outpatient prescription to retail pharmacies. Conditions can be explored in the outpatient pharmacy from medical institutions stripping". The combination of these ideas and reform Medicare payment mechanism reform policies such as superposition, future hospital prescription of drugs outside the hospital may become the norm, the great good medicine retail market, provides an excellent opportunity for development for the pharmaceutical retail enterprises.
Man on behalf of the Chinese medicine occupation re positioning
In the past, the State Council heavy paper, rarely see the wording of the medical representative. In a number of opinions, clearly put forward to strengthen the management of pharmaceutical representatives, the establishment of the medical representative registration system, the timely disclosure of information on the record. Pharmaceutical representatives can only engage in academic promotion, technical advice and other activities, shall not assume the task of drug sales, their dishonesty in personal credit records".
According to statistics, the number of medical representatives in China has reached 3 million ~ 4 million people, most of them and their role expectations serious deviation. A large number of pharmaceutical representatives to become drug sales, commercial bribery, drug kickbacks phenomenon.
On behalf of the Chinese medicine doctor in exposure and the details of the deal at the end of last year, CCTV, on behalf of the pharmaceutical occupation once placed in the public opinion in the teeth of the storm. The State Council, heavy files specifically mentioned in a medical representative medical representative can only engage in academic promotion, technology consulting and other activities, shall not be liable for drug sales tasks, believe that many pharmaceutical companies will in order to strengthen compliance management, adjust KPI. Perhaps, after the bribery door GSK drug management model is likely to be fully promoted?
"A number of opinions" of the requirements are also consistent in the "occupation ceremony", the definition of "medical representatives"
Several opinions of the general office of the State Council on further reforming and perfecting the policy of drug production and circulation
The people's governments of all provinces, autonomous regions and municipalities directly under the central government, all ministries and commissions of the State Council, and all institutions directly under the state council:
In order to deepen the reform of medical care system, improve the quality of drug efficacy, regulate the drug circulation and use behavior, to better meet people's demand for medical treatment, to promote the healthy China construction, approved by the State Council, we will further reform and improve the drug production and circulation using the relevant policies put forward the following opinions:
First, improve the efficacy of drug quality, promote the adjustment of the pharmaceutical industry structure
(a) strict drug listing approval. Clinical value of new drug evaluation. In accordance with the principles of quality and efficacy of the original drug research. Enrich the evaluation of the strength, to strengthen the guidance of enterprise research and development, the establishment of an effective communication mechanism with the applicant in advance, to speed up the settlement of the backlog of drug registration applications. Optimization of drug approval process, the urgent need for new drugs and drugs to speed up the review and approval. Learn from the advanced experience of international exploration on rare diseases, children, the elderly, emergency rescue medication (ROB) and Chinese medicine (classical) classification review and approval, guarantee the prevention and treatment of children and the elderly population and major disease drug demand. For the prevention and control of major diseases of the patented drugs, if necessary, the implementation of compulsory licensing. Strengthen clinical trial data verification, severe data fraud. Full disclosure of drug approval information, strengthen social supervision.
(two) to speed up the evaluation of the quality and efficacy of marketed generic drugs. To encourage pharmaceutical enterprises to actively participate in the preparation of the reference preparation according to the relevant guiding principles, to select the evaluation method, to carry out research and evaluation. On the need to import the reference preparations, accelerate import approval, improve customs clearance efficiency. The implementation of the record management system on bioequivalence test, allow qualified medical institutions, universities, research institutions and other social organizations to carry out inspection and do consistency evaluation of bioequivalence trial implementation measures shall be formulated according to law. Food and drug supervision departments should strengthen the guidance of the enterprise, to promote the consistency of the evaluation tasks completed on schedule. Through the consistency of the evaluation of drugs, the timely disclosure of relevant information to the community, and its inclusion in the original drug can be replaced with a list of drugs. With the variety of drugs through the consistency evaluation of the production enterprises reached more than 3, in the centralized drug procurement and other aspects of the consistency evaluation no longer used varieties; no more than 3, and preferential procurement has been used by the consistency evaluation of varieties. Accelerate the development of medical insurance payment standards in accordance with the generic name, as soon as possible to facilitate the formation of an incentive mechanism for the use of generic drugs.
(three) promoting the pilot system of drug listing holders. Give priority to the approval of the listing of new drugs and through the consistency of the evaluation of the implementation of the system of listed drug license holders to encourage new drug research and development, and promote new products, new technologies and existing capacity docking. Timely sum up the pilot experience, improve relevant policies and measures, and strive to push the country as soon as possible.
(four) to strengthen the supervision of drug production quality and safety. Urge enterprises to strictly implement the pharmaceutical production quality management standards (GMP), truthfully record the production process of information, to ensure that the data is true, complete, accurate, traceable. To strengthen the supervision and inspection of the implementation of pharmaceutical production quality management standards, the results of the inspection to the public, and take timely measures to control risk. The enterprise should fully verify the changes of the raw materials and the production process. Crack down on illegal and criminal acts of selling counterfeit drugs.
(five) increase the intensity of pharmaceutical industry restructuring. To strengthen the technological innovation, the implementation of a major new drug major science and technology projects such as the national science and technology plans (projects, funds, etc.) to support qualified enterprises and research institutes, research and development of new drugs and key technology, enhance the innovation ability and the quality of clinical medicine. Promote backward enterprises to quit, efforts to resolve the number of pharmaceutical production enterprises, small scale, low level issues. We will support the merger and reorganization of pharmaceutical production enterprises, simplify the procedures for the approval of the cross regional transfer of products listed in the group, and foster a number of large scale enterprise groups with international competitiveness. To guide the small and medium-sized enterprises with brand, technology, characteristic resources and management advantages to do a good job in a variety of ways, such as industrial alliances. Improve the level of intensive production, and promote the formation of a number of clinical value and high quality brand drugs.
(six) ensuring effective supply of drugs. Health and family planning, industry and information technology, commerce, food and drug supervision departments should cooperate closely, improve the shortage of drugs, cheap drug monitoring and early warning and classification of coping mechanisms, establish and improve the shortage of medicines information collection, reporting, analysis and consultation system, grasp the dynamics of production of key enterprises, and take the point of production, reserves, production, emergency medicine consultation adjustment measures to ensure market supply. Take the registration price commitment, negotiation, centralized purchasing, Medicare payment and other comprehensive measures to promote the realization of patent medicines and patent drugs listed on China's sales price is not higher than the country of origin or China's neighboring comparable price, and the implementation of dynamic management. To strengthen the management of narcotic drugs and psychotropic drugs. The use of traditional Chinese medicine preparations for reliable and effective medical institutions.
Two, to rectify the order of drug circulation, promote the reform of the pharmaceutical distribution system
(seven) to promote the transformation and upgrading of drug distribution enterprises. Breaking the pharmaceutical market
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