First of all, the problem lies in the medical and health system of "taking medicine to support doctors". In the past 20 years, the proportion of national financial investment in the total hospital income has decreased year by year. Therefore, hospitals should rely on the profits from drug sales to maintain their operation and development. Driven by interests, it is common for hospitals to prescribe large prescriptions and sell high-priced drugs, which leads to the rising per capita drug cost burden of the masses.

Secondly, it is due to the market-regulated price system in which drug manufacturers decide their own drug prices under the environment of disorderly competition and market "hidden rules". Hospitals are the main channel of drug sales, accounting for more than 80% of the drug sales market. In order to win from many pharmaceutical companies, it is an indisputable fact that enterprises sell drugs to hospitals. For this reason, some pharmaceutical manufacturers raise drug prices at will, because the higher the drug price, the greater the possibility of kickbacks in intermediate links, and the stronger the so-called market competitiveness of drugs, which leads to the inflated drug prices.

Third, drug price management is not in place. Although the prices of medical insurance varieties are set by the National Development and Reform Commission or the provincial price departments respectively, the basis of pricing is still the independent pricing of pharmaceutical manufacturers. It is not uncommon for pharmaceutical companies to inflate various costs and set high drug prices for their own benefit. The competent price department can't find this in time, or can't investigate it in time after it is found. Local protectionism in some areas leads to inflated drug prices.

Fourth, laws and regulations are not perfect, and there is a lack of coordination between government departments. China's drug registration management is in the food and drug supervision department, and the management of drug price belongs to the responsibility of the government price department. The imperfection of laws and regulations and the disharmony between government departments have made some enterprises exploit loopholes in the formulation of drug prices. For example, the "TM" logo on the drug packaging is neither the drug name and the approved drug trade name, nor the registered trademark of the drug. Whether it can be used on drug packaging labels is not stipulated in the Drug Administration Law and other relevant laws and regulations. However, for a long time, a considerable number of pharmaceutical manufacturers took it as one of the drug names and went to the government price department for price approval. Every time a package with the name "TM" is added, the price of medicine will double. For another example, to change drug packaging specifications (including drug packaging materials and the minimum number of drugs sold per unit), pharmaceutical manufacturers must apply for supplementary registration of drugs according to regulations, but many pharmaceutical manufacturers can still change the pricing or price filing of drug packaging specifications in the price department without obtaining the approval documents of drug supplementary registration from the food and drug supervision and administration department, breaking the restrictions of drug price reduction policy and making drug prices soar all the way.

Fifth, there is a lack of dynamic management of drug prices. With the improvement of production technology, the renewal of production equipment and the decline of raw and auxiliary materials prices, the production cost of some drugs has been greatly reduced, but the price of drugs has not been lowered in time with the reduction of costs.

Sixth, the relevant departments have not done enough to investigate and deal with drug manufacturers, drug trading enterprises and medical institutions for not implementing the measures for reducing the price of drugs stipulated by the state, delaying or not reducing the price according to the regulations, and not implementing centralized bidding to purchase drugs exceeding the reasonable price difference.

Seventh, there is great blindness in the pricing of new drugs. For example, as long as domestic drugs are approved as new drugs, the price department will price them according to the new drugs. At present, most of the new drugs listed in China are generic drugs whose original varieties have passed the protection period, or "face-changing" drugs whose dosage forms and packaging have changed. After the new drugs were priced, their prices soared immediately.

Second, at present, the proliferation of medical rebates, the main reasons are:

First, vicious competition, the birth of medical kickbacks

At present, there are more than 6,000 pharmaceutical production enterprises and tens of thousands of circulation enterprises in China. In order to survive, pharmaceutical companies try their best to get their drugs into medical units. Generally speaking, pharmaceutical companies sell drugs to medical units at a certain price, and the pharmaceutical companies include 10% to 30% of the sales amount in the sales expenses, and the medical representatives return them as kickbacks to the doctors who prescribe drugs or relevant personnel in departments, and the medical representatives raise 2%. Doctors generally believe that kickbacks do not harm the interests of hospitals or patients, but only share them with drug dealers. If the deduction is not recovered, the drug dealer will benefit in vain. Li, a medical representative, said: the company wants it, the doctor wants it, and I have a task, so I can't help it. Based on the common interests of the three parties, in the case of disorderly competition, medical kickbacks came into being.

Second, high profits support medical rebates.

The main problem that drug prices can't come down is the pricing mechanism. At present, the pricing system of drugs is: government pricing, government-guided price and market price are in parallel, the highest retail price of state-controlled drugs is set by the central government price department, the highest retail price of provincial drugs is set by the provincial government price department, and other drugs are priced by enterprises themselves. The dual-track system of medicine purchase and sale combines planning with market, and the wholesale and retail of medicine is basically marketized, but the pricing of medicine is not completely marketized, which makes the gap between pricing and actual cost too large. At present, the centralized bidding and purchasing system of drugs aimed at reducing drug prices and blocking the source of corruption is not perfect, which can not fundamentally reduce the profit space of pharmaceutical enterprises and achieve the expected results.

Third, the medical system caters to medical kickbacks.

Drugs go through several circulation links from factory to patients. It is self-evident that there is a big price gap in the circulation process. Who will the high profits flow to?

The bright line is: large wholesale enterprises that buy exclusive distribution rights → regional or provincial agents → prefecture-level agents → distributors of pharmaceutical wholesale companies → bidding agencies → hospitals or pharmacies.

The hidden line is: medical representatives → personnel of the Pharmaceutical Affairs Committee (or bidding leading organization) → hospital pharmacy department director → doctors → unified personnel.

Open lines are legitimate profits, while hidden lines are medical kickbacks. Look at these two lines, even the normal links are stripped of profits, not to mention medical rebates. Of course, these expenses are ultimately "paid" by patients.

The dean of a large public hospital said, "How to control the doctor's pen? It' s really like a Taoist meeting a ghost, and all the methods are exhausted. " He believes that only by cutting off the contact between drug dealers and doctors can kickbacks be eliminated. At the same time, due to the influence of doctors' prescription right on patients, the chances of patients choosing drugs are very small. What kind of drugs doctors choose has a certain influence on the interests of hospitals. When hospitals choose high-priced drugs, their profits are also relatively high, so some hospitals turn a blind eye to medical rebates.

Fourth, the lack of medical ethics encourages medical rebates.

The value of doctors' labor has not been reasonably reflected, and the widespread psychological compensation among doctors has contributed to the proliferation of medical kickbacks.

At present, the salary of doctors in public hospitals is determined by the government personnel department with reference to the salary of administrative institutions. A public hospital with good benefits in Yichang, the average annual income of doctors is 39,000 yuan, and the income of the best doctors is about 70,000 yuan. The cost of a meal for an operation is only 8 yuan, and the responsibilities, risks and technical efforts of doctors do not match the remuneration. Also in Yichang, the salary of doctors in a private hospital is linked to business, and the difference between the highest and lowest income is more than 10. Due to income imbalance, psychological imbalance is caused, which leads to the exposure of doctors' medical ethics defects.

Five, legal blind spots, laissez-faire medical kickbacks

Medical kickbacks are secret and low-risk. The rebate money was dumped by the pharmaceutical manufacturer to the medical representative and turned into a sales expense. Medical representatives contact doctors in a single line and go directly to clinics and doctors' homes to promote them, forming an interest alliance. It is difficult for others to be found, which also brings difficulties to judicial handling.

First, because sending and receiving are one-to-one, it is difficult to obtain evidence.

Second, the withholding behavior of doctors is difficult to convict. According to the criminal law, the important condition of accepting bribes is to take advantage of one's position to seek benefits for others. The dean, section chief or other personnel entrusted with the purchase and sale work can be convicted and punished for accepting bribes. Doctors with professional titles (practicing certificates) but no positions can also be convicted and punished for taking bribes in collusion with those with positions. However, if he simply uses the prescription right to accept kickbacks, it is difficult to pursue criminal responsibility.

Third, even if the verification is true, we should be cautious in dealing with those who violate the law and discipline. Generally, those who take kickbacks are backbones with good skills or heavy workload. If they are not handled well, it will have unpredictable consequences for the stability of doctors and the interests of patients.

It is difficult to investigate and deal with the crackdown, which makes the binding effect of law and discipline on medical kickbacks quite weak, and it is also a factor that medical kickbacks have been repeatedly banned and intensified in recent years.

The first paragraph of Article 164 of the Criminal Law stipulates: "Whoever gives property to the staff of a company, enterprise or other unit for the purpose of seeking illegitimate interests, if the amount is relatively large, shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention; If the amount is huge, he shall be sentenced to fixed-term imprisonment of not less than three years but not more than ten years and fined. "

The view that doctors accept drug kickbacks constitutes a crime is that doctors' prescription behavior is the public right to allocate limited health resources after government authorization, and their abuse of prescription right directly leads to drug abuse, which is harmful to society. Article 37 of the Law on Medical Practitioners clearly stipulates the legal responsibility of medical practitioners for accepting bribes. It denies the view that doctors accepting drug kickbacks constitutes a crime, and holds that doctors in state-owned hospitals do not exercise state power, which does not meet the main requirements of the constitutive elements of bribery crime. In the case of unclear criminal law, doctors can only be punished by party discipline and political discipline.

First of all, make clear the relationship between commercial bribery, commercial bribery crime and official bribery crime. Commercial bribery is a term under the administrative legal relationship, while commercial bribery and official bribery are terms under the criminal legal relationship. The former refers to an illegal act in violation of Article 8 of China's Anti-Unfair Competition Law, that is, an operator uses property or other means to bribe the other unit or individual in order to sell or buy goods, while the latter is a criminal act in line with Article 163 or Article 385 of the Criminal Law.

It can be seen that only some illegal acts in commercial bribery can be identified as criminal acts, and according to the different criminal subjects, according to the provisions of Article 163 or Article 385 of the Criminal Law, it constitutes commercial bribery or official bribery. Among the crimes of commercial bribery and official bribery, some crimes do not exist commercial bribery, because there is no need to "buy and sell goods".

State functionaries take advantage of their positions to ask for other people's property, or illegally accept other people's property to seek benefits for others; Any state functionary who, by taking advantage of his authority or position, seeks illegitimate interests for the trustee through the behavior of other state functionaries, and asks for or accepts the trustee's property can constitute the crime of accepting bribes in official duties, but there is no commercial bribery. Only when state functionaries violate state regulations and accept kickbacks and service fees in various names in economic exchanges and keep them for themselves, can they be regarded as official bribes in commercial bribery.

Similarly, "the staff of a company, enterprise or other unit" takes advantage of his position to ask for or illegally accept other people's property and seek benefits for others, which can constitute the crime of commercial bribery, but there is no commercial bribery. Only the staff of companies, enterprises or other units take advantage of their positions in economic exchanges, accept kickbacks and service fees in various names in violation of state regulations and take them for themselves, which is the crime of commercial bribery.

Therefore, the "Amendment" specifically stipulates that those who engage in public service in state-owned companies, enterprises or other state-owned units and those who are appointed by state-owned companies, enterprises or other state-owned units to engage in public service in non-state-owned companies, enterprises and other units shall be convicted and punished in accordance with Article 385 of the Criminal Law.

According to the provisions of relevant judicial interpretations, engaging in official business refers to performing duties such as organization, leadership, supervision and management on behalf of state organs, state-owned companies, enterprises, institutions and people's organizations. Official business is mainly manifested in public affairs related to authority and duty activities of supervising and managing state-owned property. Therefore, the managers of public medical institutions, such as the dean, the chief of pharmacy department, the chief of finance department and the members of pharmacy Committee, can all be regarded as the staff of state organs in judicial practice, thus having the main qualifications for the crime of accepting bribes on official business.

Countermeasures to eradicate commercial bribery in drug marketing

1. Enterprises should take the initiative to do something.

First of all, as a pharmaceutical enterprise with high technology content and high investment risk, to survive and develop in the severe external environment, it is mainly to enhance the core competitiveness of products. In the final analysis, the core competitiveness of the pharmaceutical industry is reflected in the research and development ability of new drugs. Therefore, China's pharmaceutical industry can only completely change the current situation that generic drugs are the "core" force to support the development of enterprises, increase investment in independent research and development, strengthen cooperation with pharmaceutical research institutes, strive for promising new varieties, and constantly innovate their own core products. Only in this way can enterprises occupy a place in the cruel market competition and continue to grow and develop. ?

Secondly, in view of the changes in the current macro-environment and the future development trend, enterprises should not stick to the old marketing model, but adopt and implement a new professional academic marketing model, shape a good corporate image, publicize corporate culture, make it deeply rooted in people's hearts, and produce a certain brand effect among doctors and consumers. ?

The government has an unshirkable responsibility.

2. 1 strengthen regulation and control to stop low-level repeated imitation of pharmaceutical companies?

Adjust the structure of pharmaceutical industry, integrate resources, merge some enterprises with low productivity and weak product competitiveness, improve the market concentration of pharmaceutical industry, form scale effect, make pharmaceutical enterprises enter a state of benign development and orderly competition, and create a good external environment for the healthy economic development of pharmaceutical industry. ?

2.2 Reform the medical income distribution system, and increase penalties for violations and illegal acts.

The state should reform the current medical and health income distribution system as soon as possible, such as increasing outpatient fees and technical service fees, so that it can truly reflect the doctor's technical value, knowledge value and risk value, and match the doctor's income with his contribution, thus improving the doctor's status, safeguarding the doctor's interests and eliminating the unbalanced psychology caused by external factors. On the premise of protecting their interests, we should improve the existing relevant laws and regulations and increase the punishment for bribery of doctors. First of all, it is necessary to establish perfect laws and regulations and clarify the boundaries of commercial bribery. Those who illegally cross the border, once found out, hell to pay, shall have their doctor's qualification certificate revoked. Those who violate the criminal law will be punished according to law, which truly reflects the deterrent power of the law. ?

2.3 Establish a whistleblower system?

In view of the characteristics of commercial bribery, which is hidden and difficult to investigate, the state should establish an informer system, which should stipulate that the informer should be kept strictly confidential and the true identity of the informer should not be revealed in any form; Do not take revenge on informants for any reason or in any other way [4]. To a certain extent, this can also play a deterrent role for some doctors who are lucky.

Due to the current situation of China's pharmaceutical market and medical system, the reasons for the prevalence of commercial bribery in the field of drug purchase and sale are diverse and complicated, and the above measures alone cannot guarantee the eradication of this phenomenon. The state should also take a multi-pronged approach to control commercial bribery from a broader level and a deeper source, such as reforming the existing medical system, standardizing the drug bidding system and the hospital drug intake system. Only in this way can the nationwide rectification of commercial bribery in the medical industry become a mere formality and really make a good start for formulating a long-term mechanism to prevent commercial bribery. ?

Third question

According to the "Regulations on Quality Management and Certification Management of Pharmaceutical Products" issued by the US Food and Drug Administration, in June 2006, 1 1 organized 15 pharmaceutical wholesale enterprises and 10 pharmaceutical retail chain enterprises whose GSP certification had expired for two years, as well as1which had been rectified within a time limit and applied for extension of supervision and inspection. The relevant inspection situation is hereby notified as follows:

I. Basic information

This time, 5 1 enterprises should be inspected, and 33 enterprises were actually inspected. Compared with the previous supervision and inspection, the legal awareness and quality management awareness of the drug trading enterprises under investigation have been significantly enhanced, the quality and quality management level of drug trading employees have been improved, the facilities and equipment for drug storage and maintenance have been improved day by day, the drug storage environment has been further improved, the degree of informatization has been further improved, and intelligent high technology has been gradually integrated into enterprise management.

Second, the existing problems

(1) The defects proposed by the certification have not been rectified seriously. 1. There are seven enterprises whose quality management system is not implemented in place, and there are generally problems such as long inspection period, not detailed content, not careful self-inspection and not in place supervision by quality control institutions. 2. Yes

Four enterprises did not have timely physical examination or incomplete physical examination items for staff who were in direct contact with drugs. 3. There are 9 enterprises that don't pay attention to the education and training of employees, and the quality management personnel of enterprises are untrained, have insufficient understanding of laws and regulations, and ignore the knowledge popularization of general post personnel. 4. There are 14 enterprises with insufficient storage facilities, such as the warehouse floor is not bright enough, the walls are slightly mildewed, the doors and windows in the reservoir area are not tightly sealed, and the warehouses that are prone to odor lack ventilation facilities. 5. There are 16 enterprises with imperfect drug storage and maintenance measures, and individual enterprises have not completed the necessary acceptance and maintenance documents; The utilization rate of acceptance and maintenance instruments is low, the maintenance operation is not standardized, the acceptance and maintenance instruments have no use records or the records are inconsistent with the actual situation, the drug maintenance personnel do not have enough maintenance management for the maintenance instruments and equipment, and the maintenance personnel do not have enough guidance for the rational storage of drugs in the reservoir area. 6. There are 16 enterprises that have not completely rectified the defective items proposed in the previous certification, accounting for 44% of the total number of enterprises inspected, including 1 enterprise that has not been rectified, 5 enterprises that have not been rectified, and 3 enterprises that have not been rectified 1 family.

(2) changing the licensing items without authorization. According to the relevant provisions of drug supervision and administration, an enterprise shall apply to the original license-issuing authority for registration of change of licensed items 30 days before the change of licensed items. Without approval, the licensing matters shall not be changed. During the inspection, it was found that some enterprises lacked legal awareness and quality awareness, and did not pay attention to the procedures for changing licensing items, which brought great difficulties to drug supervision. Three enterprises changed their business addresses, four enterprises changed their warehouse addresses, and 12 enterprises changed their responsible persons, quality managers without authorization. Enterprises that change the licensing items without authorization include: Suzhou Zhengguo Medicine Co., Ltd., Jiangsu Neptune Star Health Pharmacy Chain Co., Ltd., Lianyungang Donghai Medicine Co., Ltd., Ganyu County Medicine Co., Ltd., Lianyungang Guanyun Medicine Co., Ltd., Lianyungang Jiuyuan Medicine Co., Ltd., Changjiang Medicine Group Jiangsu Hailing Medicine Co., Ltd., Jiangsu Medicine and Health Products Import and Export (Group) Co., Ltd., Nanjing Machinery, Hardware, Minerals, Medicine and Health Products Import and Export Co., Ltd., Yancheng Huatai Medicine Co.,

(3) Three enterprises have serious defects in implementing GSP and other relevant laws and regulations. They are: Kunshan Jiuzhoutong Pharmacy Chain Co., Ltd., Nanjing Machinery, Hardware, Minerals, Medicines and Health Products Import and Export Co., Ltd. and Xuyi Douliang Pharmacy Chain Co., Ltd..

Three. Handle opinions

(1) If Kunshan Jiuzhoutong Pharmacy Chain Co., Ltd. is found to have serious defects again, the food and drug administration of the local provincial municipality shall punish it according to laws and regulations; For two enterprises with serious defects, such as Nanjing Machinery, Hardware, Minerals, Medicines and Health Products Import and Export Co., Ltd. and Xuyi Douliang Pharmacy Chain Co., Ltd., the food and drug administration of the local province shall order them to make rectification within a time limit according to the National Food and Drug Administration's Standards for the Quality Management of Pharmaceutical Trading and Measures for the Certification and Management of Pharmaceutical Trading Quality Management Standards; For Suzhou Zhengguo Pharmaceutical Co., Ltd. and other 12 enterprises with serious violations, the local food and drug administration shall instruct them to rectify and punish them according to law; And report the above results to the drug market supervision office of our bureau before February 2007 10. Those who fail to meet the requirements after repeated rectification will be severely punished according to relevant laws and regulations.

(2) Jiangdu Zhongtian Pharmaceutical Co., Ltd., Nantong Pharmaceutical Co., Ltd., Nantong Chengjian Pharmaceutical Co., Ltd., Haian Tian Ming Pharmacy Co., Ltd., Lianshui Pharmaceutical Co., Ltd., Changzhou Tongli Pharmaceutical Chain Co., Ltd., Nanjing Pharmaceutical Sinopharm Co., Ltd., Nanjing Pharmaceutical Zhongshan Pharmaceutical Sales Co., Ltd., Nanjing Pharmaceutical Factory Pharmaceutical Co., Ltd., Suining Heng Chang Pharmaceutical Co., Ltd. and other/kloc-0 enterprises have applied for supervision and inspection to postpone the closure, closure and restructuring of the enterprises under their jurisdiction for

Fourth, the job requirements

(a) please ask the relevant municipal bureau to do a good job in the rectification of enterprises with problems, should put forward specific and clear rectification requirements, and take effective measures to urge enterprises to seriously implement the rectification requirements to ensure the implementation of rectification.

(two) to strengthen the daily supervision of pharmaceutical trading enterprises within the jurisdiction, guide and urge them to strictly implement laws and regulations and relevant provisions of GSP.

3) Further strengthen the supervision and inspection of enterprises with frequent changes in licensing matters. Illegal enterprises that change the licensing items without authorization should be dealt with seriously and will not be tolerated.

(four) do a good job in the supervision and inspection of drug retail enterprises within the jurisdiction after certification, and constantly consolidate and improve the GSP certification results.

The fourth question, reference:

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