Our country lacks the real listing licensor's system of medicines

Our country lacks the real listing licensor's system of medicines
Our country lacks the real listing licensor's system of medicines
In recent years, the voice of revising " law of medicine management " is constant. How to improve " law of medicine management ", what views and suggestions each side has, from today, this edition will publish the relevant article successively, will welcome reader contributions from all walks of life. The People's University of China visiting professor east medicines whether high-level administrative licensing it manages administrative licensing to be whether of various countries the intersection of government and institution are manage society slowly, the daily control means at the time of the economic affairs, we usually call that the examination and approval. The implementation of the system of administrative licensing mainly has three purposes: Control the risk that the relevant activity may initiate, allocate resources rationally through the administrative licensing, provide the essential prestige assurance for relevant activity. Generally only with supreme intensity society and economic activity to potential risk adopt the administrative licensing system licensed in the government. Medicines are a kind of special goods, possess the general attribute of the goods, while have many kinds of special goods attribute, such as public beneficial, defect, high substitutability, disadvantaged groups, information unsymmetry,etc.. The hopeless most countries implement the top administrative licensing management system to medicines in the world - -License the administrative licensing, our country is also like this. Our country's current medicines administrative licensing including GLP authorizing, GMP authorizing, GAP authorizing and new medicine certificate, medicines production licence,etc., medicines are listed to permit the system is only one of them. The difference of listing licensor's systems of domestic and foreign medicines is in the administrative licensing law construction of medicines, there are medicines listing licensor's system and difference of the production licensor's system abroad. Western main country merchandize, permit, issue give medical the intersection of enterprise group and general headquarters or R D institution medicines generally, and issue the production permit of medicines to the concrete pharmacy factory. Under this system, the listing licensor of medicines can trust production licensor the production of medicines to be responsible for, and the civil liability, compensation responsibility and security responsibility for medicines are taken charge of by listing licensor of medicines. This kind of system put one's back into and accelerated the course of transformation of scientific and technical result after reducing industry's fixed assets effectively. Produced listing licensor of many kinds of medicines of contract production, licensed-type production, consigned processing, wrapping up outside etc. and medicines at the same time and produced the cooperation mode between the licensors. The current medicines administrative licensing mode of our country has essential differences in this and advanced country. Our country adopted the listing licensor to amalgamate the management mode with production licensor a few days ago. At first, my traditional Chinese medicines supervise the department to getting the legal person who produces the application out of on behalf of the country, carry on in many aspects verification, then pay production permit, commonly called as " GMP certificate " . At the same time our country and models medicines to carry out strict technology to evaluate and examine and approve to new medicine listed, medicines that only obtain the authentication code can be produced and sold, and the medicines authentication code of our country is only awarded to the enterprises of pharmacy with production permit of medicines. Though current medicines of our country are listed and permitted certain difference that system and western countries' relevant management system exist, but the setting-up of this system accommodates ability to supervise of medicines, system of scientific and technical innovation, relevant laws and regulations of our country,etc. national conditions in the past. As to this, the current listing licensor's system of medicines of our country of our Israel explains in conjunction with actual conditions of scientific and technological construction of innovation system. The system of scientific and technical innovation is formed by knowledge innovation system, technological innovation system, technological transfer system to technological innovation of knowledge innovation. The knowledge innovation system of our country was mainly undertaken by university and national scientific research institution in the past, but produce the technological innovation systemming is undertaken by the manufacturing enterprise. But before the 1990s of last century at least, we have not set up innovation between the two to transfer the system. A large number of private scientific research institutions join the knowledge innovation system, but the majority relies mainly on modelling, changing dosage forms, the innovative intensity is relatively low. Up until now, we still lack ripe medicines and innovate and transfer the system. In cases this is realistic, pharmaceutical industry and medicines regarded as the technological innovation subject are listed and can relieve this contradiction to permit being concerned with while standing up. Medicines of our country are listed to permit though the listing licensor's system of extant medicines of our country of existing problem of the system is in conformity with national conditions in the past, but is accompanied by the fast development of national economy, the relevant legal construction obviously lags behind. It is analyzed to this that I am from angle of industry development: Medicines are listed and permitted trussing up production permit cause the fixed assets to invest the proportion to pass big because medicines are listed and permitted bundling with production permit together, so when a lot of scientific research institutions are unable to seek the appropriate technological transfer route or manufacturing enterprise not to approve their value of knowledge innovation, have to make the investment and establish the pharmaceutical factory by oneself. For example, the medical science and technology of the middleman in Anhui is a scientific research entity composed of a group of scientific research personnel of university, they rely on university and oneself what has been mastered accuses of clearing up technology, transform to plant parenteral antineoplastic into dosage form, make the side effect reduce, validity is improved. But the transfer has no result. Listed permitting, have no alternative but to set up the pharmacy of middleman of Wuhu in order to obtain. This has not only wasted 45 years during that time, and exhausted the fund. After first product 5 - FU was planted into pharmaceutical and gone on the market, unable to put into and research and develop, enterprises were purchased by the pharmacy of first sign at last. The pharmacy industry under-capacity operation 40% of our country, medicines are listed and permitted that should become one of the roots of the trouble with production permit while trussing up the policy. Authentication code replace list, permit system legal liability have lack our country, adopt authentication code replace, merchandize, permit system now in the the intersection of medicines and practice, but the authentication code produces one of the requirements of this medicines. Under the intersection of medicines and the intersection of authentication code and system, of our country law define that stipulate who has been responsible for medicines after being listed. Not only the product liability of a piece of medicines not merely has quality responsibility, but also there are other civil liability, compensation responsibility,etc.. For example because silent the intersection of sand and east company conceal side effect that hold in place with a net Wan, cause patient's death. After the incident was revealed in 2004, caused the east company of silent sand to recall the products and initiate the claim of 18 billion dollars. The east company of silent sand has finished the claim lawsuit of North American consumers with the cost of more than 5 billion dollars this year. The sad one is that have not compensated injured consumers in our country in the east of the silent sand, because the agreement of the legal liability after lacking relevant medicines and is listed under the circumstances that our country has management system of medicines now. Three respect hold the intersection of medicines and the intersection of authentication code and of our country medicine, list, permit state confused of our country medical trade lack real the intersection of medicines and listing licensor's system, and relevant to work with the intersection of medicines and situation that production permit truss up, medicines licensor's situation of city cause anxiety in fact. The statistics show, China has authentication codes of 176000 medicines to permit at present, its real holder, besides pharmacy enterprise, three kinds of organizations or individuals hold codes actually in a large amount: First, scientific research institution, second, medical commerce, third, natural person. They are with the so-called OEM, general agent, always separately Various items of selling etc., the research and development of the actual investment products, and sign the formal or informal contract with industry, apply to country for the authentication code in the name of factory, then organize selling by oneself. Among them a large amount of violation, violating discipline, breaking the law and even criminal offence exist, and one of the disorder most crucial origins of circulating as the medical trade. How many codes do these three kinds of organizations and individuals really hold? There is no accurate statistic so far. But guard estimating, 10% of the medicines code of our country are held in their hand actually in accordance with the author. The supervision after this kind of state is listed to our medicines has brought challenges. Once products list go wrong, medicines code holder on the surface unable unwilling to responsible for in pharmaceutical industry, but the real holder has left, it. Revise the listing licensor's system of medicines and is listed and permitted the question of the system to be far above herein as medicines of our country of focus, revising the thinking of the relevant laws and regulations and disputing to emerge constantly. At the tenth China medical new and high technology fair in 2007, national the intersection of Bureau of Drugs Supervision and medicines register the intersection of department and Ding JianHua division chief and the intersection of Ministry of Science and Technology and the intersection of high-tech industry and the intersection of development centre and the intersection of horse and the intersection of swallow and democracy, let on this question publishing each viewing. Director Ma thinks, should explore innovative technological transformation and operating mechanism, effective way and supervision mode spread in the new practice actively. But division chief Ding point out, should let holder, authentication code of medicines, become real person liable of medicines merchandize, further, the national relevant department is revising the relevant regulation. The information that I obtain from a plurality of channels shows, in order to meet the thinking of the national medical reform and two adjustment of the relevant trade administrative regulator of the government after the meeting, it is already imperative to revise " law of medicine management ". Revise the focus that the listing licensor's system of medicines has already revise as the relevant law been among them. The relevant work should be started before the end of this year. I express several points to the new institutional improvement to expect here in terms of industry's sound development too: First, protect the original motive force of the scientific research institution, this is that a medical industry of our country catches up with the foundation of the international most advanced level. Second, bring into play the function that the medical trade of our country has already invested the effective fixed assets of the pharmaceutical industry to the maximum extent. In order to lighten industry's fixed assets to invest too big, operation is insufficient seriously, too high enormous burden of cost. Third, want, list, permit actual confused state of holder fully consider medicines that exist at present among the new judicial practice, combine effectively, manage effectively. Fourth, want the difference of state of development of domestic and foreign industry of sufficient attention, especially bear the difference of responsibility ability in the listing licensor of medicines of our country, so as to ensure consumer's interests.


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