First of all, the problem in the "medicine for doctors" health care system. In the past 20 years, the proportion of national financial input to the total income of hospitals has been reduced year by year. As a result, hospitals have to rely on profits from the sale of medicines to sustain their operations and development. Driven by profit, the phenomenon of prescribing large prescriptions and selling high-priced medicines is more common in hospitals, resulting in a rising per capita burden of drug costs on the public.
Secondly, it is disorderly competition and market "subterfuge" environment of drug manufacturers to determine the price of drugs market price adjustment system. Hospitals are the main channels of drug sales, accounting for more than 80% of the drug sales market, companies in the process of selling drugs to hospitals, in order to win from the many pharmaceutical companies, the existence of commercial bribery is an indisputable fact. For this reason, certain drug manufacturers arbitrarily raise the price of drugs, because the higher the pricing of drugs, the greater the possibility of the formation of rebates in the intermediate links, the stronger the so-called market competitiveness of the drugs, which leads to the inflated prices of drugs.
Thirdly, drug price management is not in place. Although the price of medical insurance varieties by the National Development and Reform Commission or the provincial price authorities, respectively, but the basis of pricing is still the drug manufacturers to set their own prices. Pharmaceutical companies out of self-interest considerations, inflate the cost of various, high set drug prices is a common phenomenon. The price authorities can't detect this in time, or can't investigate and deal with it in time after detection, and local protectionism in individual regions leads to the inflated pricing of medicines.
Fourth, the laws and regulations are not perfect, and there is a lack of coordination between government departments. China's drug registration and management in the food and drug regulatory departments, while the management of drug prices belongs to the government price department's responsibility. Inadequate laws and regulations, and lack of coordination between government departments, make some enterprises in the formulation of drug prices to exploit the loopholes. For example, the "TM" logo on the packaging of drugs is neither the name of the drug or the approved trade name of the drug, nor is it a registered trademark of the drug; whether it can be used on the packaging and labeling of drugs is not stipulated in the relevant laws and regulations, such as the Drug Administration Law. However, for a long time, a considerable number of drug manufacturers take it as one of the names of drugs to the government price department for price approval, and every additional package labeled with the name "TM" will increase the price of the drug once. For example, to change the packaging specifications of drugs (including the number of packages of drugs and the number of drugs in the smallest sales unit), drug manufacturers must apply for supplemental drug registration according to the regulations, but many drug manufacturers have not obtained the approval of supplemental drug registration from the Food and Drug Administration and Supervision Department, and yet they are still able to change the packaging specifications of the drugs in the pricing department for the record of the pricing or pricing, which breaks the restriction of the price reduction policy and makes the price of drugs increase by one. The limitations of the price reduction policy have caused drug prices to soar.
Fifth, the lack of dynamic management of drug prices. Some drugs with the improvement of the production process, the renewal of production equipment, raw and auxiliary materials prices, etc., the cost of production has been substantially reduced, but the price of drugs is not with the reduction of the cost of timely downward adjustment.
Sixth, the relevant departments of the drug manufacturers, drug companies, medical institutions do not implement the national provisions of the drug price reduction measures, delay the price reduction or do not follow the provisions of the price reduction, as well as not to implement the centralized bidding and purchasing of medicines more than a reasonable difference in the price of the part of the act should be allowed to the patients are not enough to investigate and deal with.
Seventh, there is a great blindness to the pricing of new drugs. For example, domestic drugs as long as the approval of new drugs, the price department will be priced in accordance with the new drugs, and the current new drugs on the market in China, most of the original varieties of generic drugs over the protection period, or replace the dosage form, packaging, "face" drugs, according to the pricing of the new drugs, the price of these medicines immediately after the soaring.
The second question, at present, pharmaceutical rebates are widespread, the main reasons are:
One, vicious competition, giving birth to pharmaceutical rebates
Currently, China's drug manufacturers have more than 6,000, tens of thousands of distribution companies, pharmaceutical companies in order to survive, and do everything possible to make their own drugs into the medical unit. Generally speaking, the pharmaceutical company at a certain price will be sold to the medical unit, the pharmaceutical company will be sold in the amount of 10% to 30% of the money, counted in the sales costs, the medical representative as a kickback to the prescription of the doctor or the department concerned, the medical representative to mention 2%. Doctors generally believe that: kickbacks are not detrimental to the interests of the hospital, but also not detrimental to the interests of the patients, but only and the share of drug dealers, if you don't receive kickbacks, let the drug dealers get the benefits for nothing. Pharmaceutical representative Li (sound) said: the company asked to give, the doctor is willing to want, I also have the task, so I can not help it. Based on the three-way *** with the same interests, in the case of competition out of order, gave birth to the pharmaceutical rebates.
Two, high profits, supporting pharmaceutical rebates
Drug prices can not come down, the main problem in the pricing mechanism. At present, the drug pricing system is: government pricing, government guidance, market price parallel, state-controlled drugs by the central government pricing department to set the maximum retail price, the provincial government pricing department by the provincial government pricing department to set the maximum retail price, the other drugs by the enterprise pricing. There is a dual-track approach to the purchase and sale of medicines, a combination of planning and marketing, and a basic marketization of medicine wholesaling and retailing, but the pricing of medicines is not entirely market-oriented, making the gap between pricing and actual costs too wide. The current implementation of the intention to reduce drug prices, plug the source of corruption in the centralized bidding and purchasing system of drugs, due to itself is very imperfect, can not fundamentally compression of the profit margins of pharmaceutical enterprises, and therefore difficult to achieve the desired effect.
Three, the pharmaceutical system, catering to pharmaceutical rebates
Drugs from the factory until the hands of the patient, to go through a number of circulation links, the price gap in the circulation process, has been self-evident, high profits in the end into whose hands?
The bright line is: buy out the total distribution rights of large wholesale enterprises → the country's large areas or provincial agents → municipal agents → pharmaceutical wholesale company sellers → bidding agencies → hospitals or pharmacies.
The dark line is: pharmaceutical representatives → pharmaceutical committee (or bidding leading agency) personnel → hospital pharmacy department director → doctors → unified prescription personnel.
The bright line is the legitimate profit, the dark line is the pharmaceutical rebates, look at these two lines, even the normal links are layers of peeling profit, not to mention the addition of pharmaceutical rebates, of course, these pay the final by the patient "pay the bill".
A major public hospital director said: "How to control the pen of the doctor? It is really a Taoist encounter ghosts, the law are all the implementation of exhaustion." He believes that only by severing the link between drug dealers and doctors can the phenomenon of kickbacks be eliminated. At the same time, due to the doctor's right to prescribe to patients, the patient's choice of drugs is very small, the doctor chooses what kind of drugs, the interests of the hospital has a certain impact on the choice of high-priced drugs, hospitals are also more profitable, some hospitals are therefore on the pharmaceutical rebates "turn a blind eye, turn a blind eye".
Fourth, the lack of medical ethics, promote pharmaceutical rebates
The value of the doctor's labor has not been reasonably reflected, doctors in the prevailing psychology of compensation, contributing to the proliferation of pharmaceutical rebates.
Currently, the salary of public hospital doctors is determined by the government personnel department with reference to the salary of administrative institutions. Yichang City, a better public hospital, doctors earn an average of 3.9 million yuan a year, the best doctors earn about 70,000 yuan. The cost of a missed meal for an operation is only 8 yuan, and the responsibilities, risks and technical payments of doctors are not matched by the compensation they receive. Also in Yichang City, the salary of doctors in a private hospital is linked to their business, with a difference of more than 10 times between the highest and lowest incomes. Due to the imbalance of income, triggering psychological imbalance, leading to the exposure of the doctor's medical ethics defects.
Fifth, the legal blind spot, indulgence of pharmaceutical kickbacks
Pharmaceutical kickbacks secretive, low-risk. Kickbacks are medicine merchants dumped to the medical representatives, into the sales costs, medical representatives and doctors single line of contact, directly to the clinic, the doctor's home marketing, to form a coalition of interests, others are difficult to be found, but also to the judicial case brought a problem.
One is because sending and receiving is one-to-one, evidence is difficult to collect.
The second is that it is difficult to criminalize the behavior of doctors receiving kickbacks, the Criminal Law stipulates that the important condition of bribery is to use their position to seek benefits for others. The dean with management responsibilities, section chiefs or entrusted to engage in the purchase and sale of other personnel, can be convicted and punished for bribery, only title (practicing certificate) and no position of the doctor, in conjunction with the position of the person receiving bribes, can also be convicted and punished, but purely the use of the right to receive kickbacks in the prescribing, can be convicted, there is no relevant judicial interpretation, it is difficult to pursue criminal responsibility.
Third, even if the investigation is true, the handling of illegal and disciplinary personnel must be cautious, kickbacks received more, generally good technology, or the backbone of the workload, dealt with poorly, on the stability of the physician team, the interests of patients will have unpredictable consequences.
The difficulty of investigating and combating, resulting in the law and discipline on the role of medicine kickbacks constraints are quite weak, but also in recent years, medicine kickbacks are repeatedly prohibited, a factor in the intensification of the situation.
The first paragraph of Article 164 of the Criminal Law stipulates: "In order to seek undue advantage, give companies, enterprises or other units of the staff to the property, the amount of larger, shall be sentenced to less than three years of fixed-term imprisonment or detention; amount of huge, shall be sentenced to more than three years than ten years of fixed-term imprisonment, and shall be punished by a fine."
The view that the doctor's acceptance of drug kickbacks constitutes a crime is mainly based on the fact that the doctor's prescribing behavior is a kind of public power for the rationing of limited health resources after the authorization of the government, and his abuse of prescribing power directly leads to drug abuse, which is socially hazardous, and that Article 37 of the Practicing Physicians Law explicitly stipulates the legal responsibility of the bribe-taking behavior of the practicing physicians. The viewpoint that denies that the acceptance of drug kickbacks by doctors constitutes a crime argues that, since doctors in state-owned hospitals do not exercise state power, they do not meet the provisions of the subject in the constitutive elements of the crime of accepting bribes. The doctor accepts the prescription rebate behavior in the criminal law has not yet been clarified, can only be punished for party discipline, political discipline.
First of all, to clarify the relationship between commercial bribery and the crime of commercial bribery, official bribery. Commercial bribery is a term under the administrative legal relationship, while the crime of commercial bribery and official bribery is a term under the criminal legal relationship. The former refers to the illegal behavior of violating Article 8 of China's Anti-Unfair Competition Law, i.e., the use of property or other means by the operator to bribe the other unit or individual for the purpose of selling or purchasing goods, while the latter is a criminal act in accordance with Article 163 or 385 of the Criminal Law.
From this, it can be seen that only a part of commercial bribery can be recognized as a criminal act, and depending on the subject of the crime, according to the provisions of Article 163 or 385 of the Criminal Law, constitute the crime of commercial bribery or official bribery. In the crime of commercial bribery and official bribery, and part of the criminal behavior does not have commercial bribery, because there can be no "sale or purchase of goods".
State officials use the convenience of their duties, soliciting other people's property, or illegally accept other people's property, for the benefit of others; state officials use their authority or position to form the convenience of other state officials through the behavior of their duties, for the requestor to seek undue advantage, soliciting the requestor's property, or accepting the requestor's property, can constitute the crime of bribery, but there is no "sale or purchase of goods". bribery offense, but not commercial bribery. Only state officials in the economic transactions, in violation of state regulations, accept all kinds of nominal kickbacks, fees, to personal ownership, only belong to the crime of official bribery with commercial bribery.
Similarly, "companies, enterprises or other units of the staff" to use the convenience of their duties, soliciting others or illegally accepting the property of others, for the benefit of others, can constitute the crime of commercial bribery, but there is no commercial bribery. Only companies, enterprises or other units of the staff in the economic transactions, the use of the convenience of their duties, in violation of state regulations to accept all kinds of nominal kickbacks, fees, to personal ownership, is a commercial bribery with commercial bribery behavior of commercial bribery.
So, the Amendment especially clearly stipulates that, state-owned companies, enterprises or other state-owned units engaged in official duties and state-owned companies, enterprises or other state-owned units assigned to non-state-owned companies, enterprises and other units engaged in official duties, in accordance with Article 385 of the Criminal Law - - the crime of passive bribery for official duties shall be punished by conviction. -Conviction and punishment for the crime of accepting bribes for official duties.
According to the provisions of the relevant judicial interpretations, the performance of official duties refers to the performance of duties of organization, leadership, supervision and management on behalf of the state organs, state-owned companies, enterprises and institutions, and people's organizations. Public service is mainly manifested in the public **** affairs associated with the powers and functions of supervision and management of state-owned property activities. Therefore, the public medical institutions of administrative personnel, such as the dean, head of the pharmacy department, the head of the financial office, members of the Pharmaceutical Affairs Committee, can be regarded as the judicial practice of the state organs staff, so as to have the official passive bribery crime of the crime of the subject of the eligibility conditions.
Countermeasures to Eradicate Commercial Bribery in Pharmaceutical Marketing
1. Enterprises should take the initiative to make a difference
First of all, as a pharmaceutical enterprise with high technological content and high investment risks, the main thing to do is to improve the core competitiveness of the product in order to survive and develop in the severe external environment. The core competitiveness of the pharmaceutical industry is ultimately embodied in the research and development capabilities of new drugs, so China's pharmaceutical industry only to completely change the current generic drugs as a support for the development of the enterprise's "core" strength of the status quo, increase investment in independent research and development, and enhance cooperation with the Institute of Pharmaceutical Research, to strive for promising new varieties of continuous innovation of their own core products, only then can enterprises survive in the severe external environment, the main thing is to improve product core competitiveness. Only in this way can the enterprise occupy a place in the cruel market competition and continue to develop and grow.
Secondly, in view of the current changes in the macro-environment and the future development trend, enterprises should not stick to the old marketing model, but should adopt and implement the new specialized academic marketing model, to shape a good corporate image, promote corporate culture, so that it is y rooted in people's hearts and minds, and to produce a certain branding effect in the doctors and consumers.
2. The government has an unshirkable responsibility
2.1 Strengthen the regulation and control, to stop the pharmaceutical enterprises to repeat the imitation of low-level?
Adjustment of the structure of the pharmaceutical industry, integration of resources, close and merge some of the low production capacity, product competitiveness of weak enterprises, improve the market concentration of the pharmaceutical industry, the formation of scale effect, so as to make the pharmaceutical enterprises to enter into a benign development, orderly competition, and to create a good external environment for the healthy development of the pharmaceutical industry economy.?
2.2 Reform the medical income distribution system, and increase the punishment for irregularities and illegal behavior
The state should reform the current medical and health care income distribution system as soon as possible, such as increasing the outpatient fee and technical service charges, so that it can truly reflect the technical value, knowledge value and risk value of doctors, so that the income of doctors is matched with the payment, so as to improve their status, Their interests will be safeguarded and the imbalance caused by external factors will be eliminated. On the premise of protecting their interests, improve the existing relevant laws and regulations, increase the punishment of bribe-taking behavior of doctors, first of all, establish perfect laws and regulations to clarify the boundaries of commercial bribery. Crossing the boundaries of the law, once found, it is severely punished, light revocation of the qualification certificate of medical practice, violation of criminal law is criminal punishment according to law, truly reflecting the deterrent effect of the law.
2.3 Establishment of a whistleblower system?
For commercial bribery behavior is hidden, difficult to investigate and deal with the situation, the state should establish a whistleblower system, should provide for the whistleblower strict confidentiality, shall not be in any form of disclosure of the true identity of the whistleblower; shall not be dismissed for any reason, or any other way to retaliate against the whistleblower [4]. This can also play a deterrent role to some extent to some of the doctors who have a sense of fluke.
Because of the current situation of China's pharmaceutical market and health care system, caused by the prevalence of commercial bribery in the field of drug purchases and sales of diverse and complex reasons, so the above measures can not ensure that the eradication of this phenomenon. The state should also take a multi-pronged approach, from a broader level, a deeper source of governance of commercial bribery phenomenon, such as reform of the existing medical system, standardize the drug bidding system and hospitals into the drug system, etc., the only way to make the nationwide remediation of the medical industry commercial bribery is not just a formality, indeed, for the development of long-term mechanism for the prevention of commercial bribery to make a good start.
The third question
According to the State Food and Drug Administration, "Drug Administration Quality Management Standard Certification Management Measures" and other relevant provisions, in November 2006, the organization of the GSP certification period of two years of 15 pharmaceutical wholesale enterprises, 10 retail drug chain enterprises to implement the supervision and inspection, and on the deadline for rectification of the 11 business enterprises and apply for an extension of supervision and inspection of the 15 business enterprises. The follow-up inspection of the 11 enterprises and 15 enterprises applying for extension of supervision and inspection will be carried out. The relevant inspections are reported as follows:
I. Basic situation
This time, 51 enterprises should be inspected, and 33 were actually inspected. Compared with the previous supervision and inspection, this time the inspected drug business enterprise's legal awareness, quality management awareness has been significantly strengthened, the quality of drug business practitioners and quality management level has been improved, the drug warehousing and maintenance facilities and equipment is becoming more and more complete, the storage environment of the drug has been further improved, the degree of information technology has been further improved, intelligent high-tech is also increasingly integrated into the enterprise's business management.
Two, there are problems
(a) the certification of the defective items still not rectified and other serious phenomena. 1, there are seven enterprises on the implementation of the quality management system is not effective, there is a long inspection cycle, the content is not detailed, self-checking is not serious, the quality control agencies to rectify the supervision is not in place. 2, there are
4 enterprises on the direct contact with the drug position of the staff did not Timely physical examination or physical examination project is incomplete. 3, there are 9 enterprises do not pay attention to the work of staff education and training, quality management personnel without training that is on duty, insufficient learning and understanding of the provisions of the laws and regulations, ignoring the knowledge of the general staff of the post popularization. 4, there are 14 enterprises are not enough to equip the storage facilities, such as the warehouse floor is not enough to be clean, the walls can be seen on the light mold, the warehouse door and window sealing is not tight, easy to cascade the smell of the library lack of 5, there are 16 enterprises in the drug storage and maintenance measures are not perfect, individual enterprises have not been equipped with the necessary acceptance of maintenance equipment; acceptance of maintenance equipment, low utilization rate, maintenance operations are not standardized, acceptance of maintenance equipment without the use of records or records do not correspond to the actual drug maintenance personnel on the maintenance of instruments and equipment for maintenance management is not enough to maintain the staff of the library of reasonable storage of medicines in the maintenance personnel guidance is not enough, etc. 6, there are 16 enterprises The previous certification of the defects of the project has not been fully rectified in place, accounting for 44% of the total number of enterprises inspected, of which one has not been rectified 10, two have not been rectified 5, three have not been rectified 1.
(ii) unauthorized changes in licensing matters. According to the relevant provisions of drug supervision and management, enterprises should be in the licensing matters change 30 days ago, to the original licensing authority to apply for registration of changes in licensing matters. Without the approval of the license shall not be changed. Inspection found that some enterprises lack of legal awareness, quality awareness fade, very little attention to the change of licensing matters procedures, to the drug regulatory work has brought great difficulty. Unauthorized change of business address of 3 enterprises, unauthorized change of warehouse address of 4 enterprises, unauthorized change of the person in charge of the enterprise and the person in charge of quality, quality management personnel of 12 enterprises. Unauthorized changes in licensing matters of enterprises are: Suzhou Guozheng Pharmaceutical Co., Ltd., Jiangsu Neptune Star Health Pharmacy Chain Co., Ltd., Lianyungang City, Donghai Pharmaceutical Co. Ltd, Yancheng Huatai Pharmaceutical Co., Ltd, Yancheng Tongde Pharmaceutical Co.
(C) in the implementation of GSP and other relevant provisions of the existence of serious deficiencies in three. Ltd., Nanjing Machinery Hardware Minerals Medicine & Health Products Import & Export Co., Ltd. and Xuyi Duyi Liang Pharmacy Chain Co.
Three, handling opinions
(a) Kunshan Jiuzhoutong Pharmacy Chain Co., Ltd. which was again found to have serious deficiencies, shall be punished by the Food and Drug Administration of the municipality under the jurisdiction of the city in accordance with the laws and regulations; for the inspection of two enterprises with serious deficiencies in the items of Nanjing Machinery Hardware and Minerals Medicine and Health Products Import and Export Co. Ltd. and other two enterprises, the Food and Drug Administration of the province where the municipality is located shall order them to rectify in accordance with the State Food and Drug Administration's "Code of Practice for the Quality Management of Pharmaceutical Businesses" and "Measures for the Certification and Management of the Code of Practice for the Quality Management of Pharmaceutical Businesses". 12 enterprises, such as Suzhou Guozheng Pharmaceutical Co., Ltd. and other 12 enterprises, shall be ordered to rectify and be punished in accordance with laws and regulations by the Food and Drug Administration of the municipality where the municipality is located. February 10, 2007 before the Drug Market Supervision Department of the Bureau. Repeatedly ordered to rectify still does not meet the requirements, will be in accordance with relevant laws and regulations for serious investigation.
(2) For more than two times applying for extension of supervision and inspection of Jiangdu Zhongtian Pharmaceutical Company Limited, Nantong Pharmaceutical Company Limited, Nantong Jiancheng Pharmaceutical Company Limited, Hai'an Tianming Pharmacy Company Limited, Lianshui County Pharmaceutical Company, Changzhou Tongli Pharmaceutical Chain Company Limited, Nanjing Pharmaceutical Company Limited, Nanjing Pharmaceutical Zhongshan Pharmaceutical Sales Company Limited, Nanjing Pharmaceutical Dagang Pharmaceuticals Co. Ltd., Suining County Hengchang Pharmaceutical Co., Ltd. and other 10 enterprises, the Food and Drug Administration of the municipality under the jurisdiction of the city to find out the reasons and report to the Drug Market Supervision Department of the Bureau before February 10, 2007. For the enterprises that have been stopped, closed down, restructured or reorganized, the relevant procedures should be carried out in accordance with the requirements of laws and regulations.
Four, the work requirements
(a) please the relevant municipal bureau to effectively grasp the problems of the rectification work of enterprises, should put forward specific, clear rectification requirements, and take effective measures to urge enterprises to seriously implement the rectification requirements to ensure that the rectification of the implementation of the realities.
(ii) to strengthen the daily supervision of the drug business enterprises under the jurisdiction of the guidance and supervision of the strict implementation of laws and regulations and the relevant provisions of the GSP.
C) further increase the supervision and inspection of frequent changes in licensing matters enterprises. Unauthorized changes in licensing matters of non-compliant enterprises, to be dealt with seriously and will not be tolerated.
(D) seriously grasp the jurisdiction of the post-certification supervision and inspection of pharmaceutical retail enterprises, and constantly consolidate and improve the results of GSP certification.
The fourth question, reference:
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