| Recently, false price of the medicine has always been a focused problem drawing the attention of the society. Though the National Development and Reform Commission has implemented many measures and decreased the price of medicine for 17 times in succession, the current situation of hard to see a doctor and expensive of seeing a doctor is still unchanged. Currently, the margin of medicine is big and when the price is still to be solved, series of safe problems on medicine occur continuously. First of all, the incident about producing false drugs of Qiqihar No. 2 Pharmaceutical Co. has caused 11 deaths and serious adverse reactions on many persons, which has shock the whole country. In succession, the Clindamycin organic phosphate amylaceum (XINFU) produced by ANHUIWORLDBEST BIO-PHARMACEUTICAL CO., LTD. has caused 10 deaths and 99 incidents of adverse reaction. Recently, Guangdong Bioyee Pharmaceutical Co., Ltd. produces intravenous injunction HIg which is against regulations. However, when drug safety incidents frequently happen and tragedies continue, Zheng Xiaoyu, the ex-direct general of State Food & Drug Administration (SFDA), who retired one year and six months ago, is interrogated by Central Commission for Discipline Inspection of the CPC for being a suspect of bribery. The series problems of false price of medicine, adverse reaction of medicine, drug safety, medicine with different names and official corruption etc. make the public increasingly suspect the capability of Pharmaceutical supervision system and the inside story of the system. As a supervision institution which should have shown fairness and safety for medicine, the justness and safety of SFDA suffer unprecedented suspicion. As the objects of social regulation, medication safety and drug quality have public good characteristics, non-value characteristics, external negative characteristics and non-symmetry of Information. These are all reasons causing market failure, so the government should focus on the interests of the public using environment regulation, price regulation, product quality regulation and other social regulations to complement or replace the problems that can not be solved by Markey mechanism.This article basing on the theory of social regulation systematically, studies the current situation and problems of pharmaceutical supervision system, and then I will propose several suggestions to consummate the pharmaceutical supervision system in our country.IWith the development of market economy, the role of social regulation is becoming more and more important; the field of social regulation extends consistently and the means and instruments of regulation are continuously improved. Social regulation emphasizes particularly on the unhealthy and unsafe problems towards consumers, producers and society which may be brought by activities of disposing action bodies. Essentially speaking, social regulation is mainly used to solve the external and non-symmetry of information problems which can not be solved by market mechanism in the process of economic activities, in case of causing low efficient implementation and usage of non-value goods and public goods by market failure. The attention paid by the government to social regulation is the reaction of social advancement and life improvement in a way. More over, it directly shows its attention on the protection of consumers'interests and sustainable development. Pharmaceutical supervision is through setting up a governmental department according to medicine law, endowing with certain authorities to adopt to special instruments of economic, administration law to control the admittance of main body in medicine market, development of medicine, production, and the limitation of its circulation (including used by medical organizations). Pharmaceutical provision is to ensure the consumers obtain more medical information and health service, so as to decrease the trade cost and health risk.Medical industry (including medical development, production and circulation) is a competitive industry. The main reason why it suffers so strict and complicated regulations in every country in the world includes two aspects: the first one is the particularity of medicine, and the other one, from a deeper lever, is the government's interference on market economy for market failure.IIFrom 1998 to 2007, the National Pharmaceutical Supervision Bureau is an 8-year old institution. In the 8-year's supervision, from building systems to anti-corruption storm, from medical classification to GMP recognition, it is constructing itself while safeguarding the public medical safety. In 1998, the National Pharmaceutical Supervision Bureau is founded, subjecting the State Department, carrying out the all-round supervision functions from the medical development, examination and approval and production to its distribution; in 1999, it implemented classified management of medicine; in 2000, it carried out vertical management and GMP recognition; in 2001, it made great efforts to building systems; in 2002, the rights of approval was returned to the CPC; in 2003, it opened Green Channel because of SARS. The tenet of pharmaceutical supervision is to guarantee that consumers obtain more medical information to reduce trade cost and healthy risks, improve the drug quality, and ensure the public medical safety and effectiveness. According to Drug Administration Law of PRC and Good Manufacturing Practice, the State Food and Drug Administration has promulgated many relative supervision management regulations and standards to implement on production corporations and enterprises. From 2004 to 2006, the incidents of medical adverse reaction, medical safety and official corruption occurred in succession, which exposes serious problems in medical development, production and circulation. Meanwhile it also exposes the deficiency in the pharmaceutical supervision.IIIThe foundation of medical industry in our country is still very weak. The medical development, production, circulation, usage have exposed series of supervisory failure; in the process of medical development, falsification of random enrollment exists; in the process of circulation, the problem of false price of medicine can not be solved all through; in the process of usage, the notifying mechanism, pre-warning mechanism, revaluation mechanism and emergency disposing procedure of medical safety incidents and adverse reaction incidents are still incomplete. The pharmaceutical supervisory problems which ever occurred in developed countries are exposed in the current phase of our country. The medical safety situation we are facing now is not optimistic.The problems existing in our pharmaceutical supervision system are listed as follows: the secret worry in the early stage of the pharmaceutical supervisory institutions designed; the defects exists in the system of medical registration has caused new medicine overflow; the pharmaceutical supervisory institution and pharmaceutical corporations have born paternity; the failure of medical price regulation causes the false price of medicine.IVAt present, there are many pharmaceutical supervisory modes in the world, and each mode has its advantages and disadvantages. However, from the analysis, we can see that, the American DFA management mode dose have certain advantages, and this mode is implemented by more and more countries. This is also a good reference for designing our own pharmaceutical supervisory system.FDA is a subjection of U.S. Department of Health, Education and Welfare, taking charge of the management of national medicine, food, bio-products, cosmetics, veterinary drugs, medical devises, and Diagnosis Products etc. FDA includes Medicines Agency, Food Authority, Center for Veterinary Medicine, Radiation Center, Bio-production Center, Medical Devises Department, Diagnosis Products Department and a National Center for Toxicological Research, regional administrative institutions, which represent six departments (some journals say it as six centers), a center and a regional administrative institution. First of all, FDA relatively thinks more of technology field, such as sufficient evidences of safety and effectiveness are indispensable for a medicine to be launched. They adopt the most advanced check instrument to exam food and medicine etc. Secondly, FDA emphasizes on improving the relations with consumers. When FDA introduces itself to consumers it emphasizes itself as a protection organization to safeguard the public health, but not as a federal executive organization, additionally, FDA pays much attention to cooperation, although FDA has clear and different responsibilities with other federal government institutions, it still needs full cooperation with other department in many aspects in supervision field.However, before using the mode for reference, we should know the profound meaning and soul first, but not only in the form. There are many differences in the situation of the two countries, so the experience of America will not work well unless it is combined with the situation of China. In addition to that, the food and medical supervision systems in all countries are under continuous improvement, and the supervisory level is going up ceaselessly in the process of finding problems and solving them.VI would like to propose several suggestions to consummate the pharmaceutical supervision system in our country, they are listed as follows: first, establish and complete medical law and regulation standards system. Completing Drug Administration Law of PRC is the guarantee in law of the success of pharmaceutical supervision, and I suggest that the new Management of supervision of medical circulation should be promulgated as soon as possible, and clarify the content that not mentioned in Drug Administration Law of PRC and Regulations for Implementation of The Drug Administration Law, particularly, the ones about quality control and false medicine production and invasion. Meanwhile, to perfect the procedure of approval for new medicine, according to the Pharmaceutical Administration Law of PRC, the revised edition of Pharmaceutical registration administration law re-defines the definition of new medicine in the current edition of Pharmaceutical registration administration law. Second, build integrated vertical system. Third, establish strict system, and stick to separating administrations and enterprises. In the future of our country, pharmaceutical supervision administrations must completely separate with its corporations. Some methods should be made to prohibit officials of pharmaceutical supervision department having concurrent post in other enterprises, and make further clear of the property right relations in pharmaceutical corporations. Forth, promote health care reform; make greater effort on the supervision of the price of medicine. To make the governmental visible hand function, we should pay more attention to the supervision of price. The government should enhance analysis of medical production cost and market supply and demand, meanwhile, the price should be marked clearly and honestly to solve the problem completely. Fifth, complete and perfect the medical adverse reaction reports and information system. Establish a supervisory net about medical adverse reaction covering the whole country, and complete adverse reaction information regular announcement system and serious incidents issue mechanism to protect right to know of the public through publishing complete information in time, getting over their weak position of information. Sixth, promulgate the system of sending supervisor to pharmaceutical corporations. Put emphasis on the supervision and examination of pharmaceutical corporations according to Good Manufacturing Practice, particular on the validity of the source of materials, the coherence between producing techniques and approved techniques, whether medicine is checked according to standards and quality guarantee measures etc. As to some special medicine, we should examine its product plan, purchase and sale volume and deposited condition. Seventh, complete the system of medical label and instruction. In the future, the adverse reaction stored in database should not be useless, but to make it function in the process of supervision, such as launching admission and medical quality certification. In the course of approving and certifying, the check on the instruction and adverse reaction on the label should be paid more attention to. Eighth, pharmaceutical corporations should be responsible of the safety of medicine. Ninth, build a whole-process supervision system with the core of admission system. Pharmaceutical supervision is a dynamic whole-process supervision system with core of admission system. The supervisors in the future should build a supervision system with core of admission system and inspection as support to implement the whole process dynamic supervision, in order that supervisors can copy and upgrade information in time and keep close and continuous relationship with the corporations being supervised.
|
PDF Full Text Request