From the beginning of June to the end of September, the national inspection jointly launched by nine major departments for the pharmaceutical industry will continue to be staged. 360-degree inspection of industry, commerce, sales terminals and pharmaceutical marketers without dead ends.
Be careful that your GMPGSP certificate is withdrawn, be careful that your products are reported as unqualified, be careful that the drugs you put in the office or car are seized, be careful that your drugs are exposed because the gap between the factory price and the sales price is too large, be careful that your invoice has become an iron proof of bribery, be careful that your sales contract has become a handle, be careful that you are taken away on the way to talk business with customers. ...
For the next four months, you have to be careful, careful, careful...
Scope of inspection: A national inspection in the field of medicine
There is no knowing which areas will suddenly be inspected and which areas will not be inspected. Don\'t take any chances; Legal operation, compliance marketing is the king.
Second, inspection objects: pharmaceutical industry + pharmaceutical business + sales terminals + pharmaceutical marketers, full coverage, a check to the end.
Inspection industry: GMP flight inspection, product sampling inspection, fare tax inspection;
Business inspection: GSP flight inspection, affiliated operation, fare tax inspection;
Check the sales terminal: price execution, price publicity, nine prohibitions (commercial bribery), large prescription, excessive drug use;
Check whether pharmaceutical marketers have the qualifications to sell drugs.
3. Inspection method: double random + secret visit + multi-department + cross-region
In May, many provinces issued the "Unannounced Inspection Measures" and special rectification notices, indicating that various inspections should adhere to the "double random" principle: random random inspections of inspected enterprises, random determination of inspectors, emphasizing the suddenness of flight inspections.
The major renovation of the pharmaceutical industry coincides with the Prime Minister\'s push to "release, management and service". Guofa [2016] No. 30 said: fully promote the "double random", random inspection matters to reach more than 70% of the department\'s market supervision and law enforcement matters; Establish and improve cross-departmental and cross-regional law enforcement joint response and cooperation mechanisms, realize the interconnection of illegal clues, the sharing of regulatory standards, and the mutual recognition of processing results, and eliminate regulatory blind spots.
As the "double random" inspection and cross-departmental and cross-regional joint law enforcement rise to the national will, the all-round 360-degree random inspection of all links without dead corners and multi-department joint law enforcement and joint supervision will become the new normal.
Fourth, the inspection main body: the Food and Drug Administration, the Health and Family Planning Commission, the Development and Reform Commission attack the front, the medical reform office beat the drum, the industry and commerce, taxation, audit side encircling, and the public inspection law ends.
The recent inspection trends of various ministries and commissions in the field of medicine are attached.
5. Check what: Check both production and operation; Those who sell drugs should be checked, and so should those who prescribe them.
Ticket inspection: whether there is a ticket, whether the ticket has passed the ticket, whether the bill of lading is consistent, whether the two tickets, whether the fee bill is reasonable;
Check the goods: the source of the goods, whether the goods are purchased from the personal hand, whether the conditions of the goods in the warehouse and in the way meet the requirements, product sampling inspection;
Price check: price monopoly, fraud, the difference between the cost price and the sales price is too large, the execution of the bid price and the zero price difference, and the price publicity;
Tax inspection: finding tickets to offset accounts, falsifying invoices, invoice sales and other tax evasion;
Check procedures: whether the import and sale procedures are complete and legal, and whether the GSP requirements are strictly implemented;
Check the contract: whether there is a purchase and sales contract, and whether the terms of the purchase and sales contract have sensitive content such as supply at a reserve price, promotion fees, and rebates;
Check the cost: whether the sales expense expenditure details are reasonable, whether the proportion of each expense is reasonable, and whether the cost is substantiated;
Qualification check: When the business personnel work in the front line of the market, they should be able to confirm their identity and qualifications at any time and anywhere;
Check behavior: When visiting major hospitals, there is no physical medicine in the bag, there is no red envelope, and there is no product reserve price.
Sixth, inspection action: For the pharmaceutical industry, not a department in the fight, multi-department joint action, clues interconnection, eliminate regulatory blind spots.
1, the State Drug Administration: the end of the enterprise self-inspection, into the unannounced inspection stage;
On May 31, the State Food and Drug Administration announced the list of the first batch of 302 national drug GMP inspectors to be rehired (see the Food and Drug Administration (2016) No. 73), and it is believed that in the near future there will be more news such as "pharmaceutical factories have been recalled GMP certificates and drugs have been unqualified by random inspection".
On May 3, the State Food and Drug Administration issued Notice No. 94 of 2016 for GSP inspection, requiring all localities to carry out centralized rectification of illegal business activities in the field of drug circulation. The announcement requires all drug wholesale enterprises to first carry out self-inspection, and check whether there are 10 aspects of the enterprise such as suspected affiliations and invoicing, and the current self-inspection reporting period has ended.
In order to implement the spirit of the State Administration, the provincial and municipal drug Administration has issued a special rectification notice and the "Secret Inspection Measures" for illegal business activities such as "affiliations and ticket sales". Up to now, there have been 30 provinces and cities Liangjian drugs illegal business, a huge net has fallen from the sky. If you do not check and rectify yourself, the relevant departments will "inspect secretly".
2. National Health and Family Planning Commission: Pharmaceutical purchase and sale and medical service;
On May 20, the 18th meeting of the Inter-Ministerial Joint Conference on Correcting improper practices in medicine purchase and Sale and medical services and the video conference on the construction of health and Family planning practice in 2016 were held at the National Health and Family Planning Commission.
At the meeting, SAIC made a statement on continuing to increase the investigation and punishment of unfair competition acts such as commercial bribery in the pharmaceutical field, including acts that harm the interests of patients such as accepting kickbacks, paid referrals, false publicity, and further strengthening the effective supervision of medical institutions and relevant market players.
The State Administration of Taxation introduced the normal management of the investigation and punishment of the use of invoices in the pharmaceutical industry, the crackdown on illegal and criminal activities in the pharmaceutical and medical device industries, and the inspection of tax related purchases of pharmaceutical purchase and sales enterprises.
Ma Xiaowei, deputy director of the National Health and Family Planning Commission, attended the meeting and made a speech, pointing out that it is necessary to fully exert efforts in regulating the order of drug circulation, tightly grasp the key issues such as the "nine prohibited" and the special rectification of medical consumables.
This is the continuation of a new round of commercial bribery governance since the implementation of the "Provisions on Establishing Bad Records of Commercial Bribery in the Field of Pharmaceutical Purchase and Marketing" after the "nine forbids". According to the regulations, a "blacklist" is set up for pharmaceutical companies that touch the "red line" of commercial bribery, and once they enter the blacklist and are listed in the bad record of commercial bribery, pharmaceutical production and operation enterprises and their agents will be marked down when their products are bidding and purchasing scores in public medical institutions, and serious cases will even be banned.
3. National Development and Reform Commission: Launch special inspection of drug prices;
In order to regulate drug price behavior and maintain the order of drug market prices, the National Development and Reform Commission issued the Notice on the Special Inspection of Drug Prices Nationwide, and decided to carry out the special inspection of drug prices nationwide from June 1. Drug production and operation enterprises (including the production enterprises of raw materials and drugs, circulation enterprises and social retail pharmacies) ranked first in the inspection object!
Price frauds such as abuse of market dominance and high price sales, false and misleading price labeling of original prices, non-implementation of the zero-margin price increase policy of government-priced drugs, government-priced drugs breaking through the maximum ex-factory (retail) price sales stipulated by the government, and non-implementation of the clearly marked price publicity system are listed as key inspection contents.
On the contrary, the National Development and Reform Commission will continue to strengthen the price supervision of the pharmaceutical industry, protect the independent pricing power of operators in accordance with the law, give play to the decisive role of the market in the allocation of resources, while strengthening the production and sales activities of operators and pricing behavior, serious investigation and punishment of monopoly agreements, abuse of market dominance and other illegal acts.
4, The State Council medical reform Office: comprehensively promote the "two-vote system";
In mid-May, The State Council medical reform Office issued two consecutive "Notice on determining the fourth batch of public hospital reform national contact pilot cities and related work", "Letter on increasing Shanghai and other 7 provinces (regions, cities) to carry out comprehensive medical reform pilot", the direct result of the document is: comprehensive medical reform pilot provinces have been expanded from 4 to 11; The number of pilot cities for comprehensive reform of public hospitals was expanded to 200.
According to the spirit of the relevant documents, the "pilot" provinces and cities will implement the "two-vote system".
In other words, the current "two-vote system" has seamlessly covered 14 provinces, spread to more than 200 prefecture-level cities distributed in 31 provinces and cities, covered about 8,000 public hospitals, and re-divided the market cake share of nearly one trillion! Are you a friend of the public hospital market?
5. Ministry of Public Security: Cooperate with tax and drug administration departments to crack down on illegal crimes;
On May 24, according to the Interim Measures for the Operation of the Liaison Mechanism of the Ministry of Public Security dispatched to the State Administration of Taxation jointly issued by the Ministry of Public Security and the State Administration of Taxation, the Ministry of Public Security set up the "Liaison Mechanism Office of the Ministry of Public Security dispatched to the State Administration of Taxation" in the State Administration of Taxation, and selected specialized personnel as liaison officers. The official listing of the Liaison Office marks a new stage of the substantive operation of the liaison mechanism and a new stage of police and tax cooperation in preventing and combating tax-related crimes.
Meng Qingfeng, Vice minister of the Ministry of Public Security, pointed out that all localities should be combined with local realities, with reference to the practice of the Ministry of Public Security accredited to the State Administration of Taxation, and actively promote the establishment of a sound public security accredited tax liaison mechanism at the provincial and municipal levels. Emphasis will be placed on cracking down on invoice overwriting, illegal invoice trading, and serious tax evasion.
Since the issuance of special rectification notices such as "attached tickets" in the provinces, the local drug supervision and public security departments have cooperated closely with the rectification work to wait near the logistics company, intercept the terminal inspection, and spot check the vehicles in the medical warehouse. Focus on the individual management of drugs, drugs without a license, not according to the requirements of transportation and distribution of drugs, linked to the operation of extracorporeal circulation is not stored, and the serious inconsistency of certificates and goods shall be corrected and punished.
6, the State Administration of Taxation: joint drug supervision incentive punishment, create a credit supervision environment;
On April 15, the State Administration of Taxation and the State Food and Drug Administration signed the "Credit Interaction Cooperation Framework Agreement", through the establishment of a credit interaction mechanism, play their respective functions and advantages, to achieve joint incentives and punishments in the field of tax administration and food and drug supervision and administration.
In the future, the tax department and the food and drug regulatory department will actively participate in the construction of the social credit system at the same time, highlight the cooperation between the two departments, strengthen information sharing, increase joint efforts to crack down on illegal and untrustworthy enterprises, and create a credit regulatory environment of "one place of untrustworthy, everywhere limited".
7. National Audit Office: strengthen the monitoring and analysis of pharmaceutical companies and strengthen tax inspections;
The audit department also listed the chaos in the pharmaceutical industry as the key audit object. At the 15th meeting of the Standing Committee of the 12th National People\'s Congress in 2015, Liu Jiayi, the auditor general of the National Audit Office, said in the audit report that due to the lax supervision of invoices, tax evasion and false VAT invoices of pharmaceutical companies were prominent, and 65 companies that were checked falsely issued drug sales invoices of more than 20 billion yuan and evaded taxes of more than 6 billion yuan! It said that in the future, it will promote the strengthening of the monitoring and analysis of drug distribution enterprises, further improve the VAT collection and management system, and strengthen the tax inspection of key areas such as medicine.
8. Ministry of Human Resources and Social Security: Eliminate excessive medical treatment and reduce irrational drug use;
In 2015, the Ministry of Human Resources and Social Security issued the "On Comprehensively Promoting Basic Medical insurance.