new rule!

Medical Network, September 3, the State Administration for Market Supervision and Administration previously announced the "Administrative Measures for the List of Seriously Illegal and Untrustworthy in Market Supervision and Administration" (hereinafter referred to as the "Measures"), "Regulations on the Publicity of Administrative Punishment Information on Market Supervision and Administration", and "Market Supervision and Administration Credit Restoration" Three departmental regulations and normative documents including the Management Measures will be formally implemented on September 1, 2021
.
Corporate integrity and compliance operations will be fully supervised under the new policy system.
The long-existing drug monopoly, commercial bribery, and illegal quotations in the pharmaceutical field will surely be severely beaten by the regulatory authorities
.

Severely cracking down on violations of laws
and regulations For a long time, the pharmaceutical industry has been the worst-hit area of ​​corruption.
Bribery and acceptance of bribes have been repeatedly prohibited.
Incidents such as the bribery case of Tiansheng Pharmaceutical and the bribery of the director of the Anesthesia Department of Hengrui Pharmaceutical Marketing Co.
, etc.
, have far-reaching impacts.
In the case of GlaxoSmithKline (GSK) bribery, supervision is gradually increasing
.
In 2017, after the new version of the Anti-Unfair Competition Law was reviewed by the National People’s Congress, the Shanghai Administration for Industry and Commerce responded quickly and announced the punishments for three commercial bribery cases in the pharmaceutical field, including representatives of foreign-funded pharmaceutical companies, Squibb, Tai Ling Pharmaceuticals, and Casey Pharmaceuticals of Italy consulting (Shanghai) Co.
, Ltd
.
In 2018, nine ministries and commissions including the National Health Commission and the National Medical Insurance Administration jointly issued the "Key Points for the Special Treatment of Improper Practices in the Field of Pharmaceutical Purchase and Sales and Medical Services in 2018".
Subsequently, various provinces and cities successively issued anti-corruption documents on the purchase and sales of pharmaceuticals to crack down on illegal businesses.
Behavior
.
In September 2020, the National Medical Insurance Administration issued the "Guiding Opinions of the National Medical Security Administration on Establishing a Credit Evaluation System for Pharmaceutical Prices and Recruitment", clearly establishing a list of credit evaluation catalogs, establishing channels for recording untrustworthy information reports, conducting credit ratings for pharmaceutical companies, Disposing of untrustworthy breaches at different levels, encouraging pharmaceutical companies to restore credit, and other related content
.
Subsequently, the "Pharmaceutical Price and Recruitment Credit Evaluation Operational Specification (2020 Edition)" and the "Pharmaceutical Price and Recruitment Credit Rating Discretion Benchmark (2020 Edition)" were officially released, addressing "serious dishonesty" and "particularly serious dishonesty" behaviors.
Defined:
serious
According to the facts of the case as determined by the court’s judgment or the administrative punishment of the relevant law enforcement agencies, in the past three years, within the province, there have been acts of giving kickbacks and other medical commercial bribery to medical institutions, centralized procurement institutions and their staff at all levels and in the same case.
The accumulative bribery amount is more than 500,000 yuan but less than 2 million yuan, or the single bribe amount is more than 300,000 yuan but less than 2 million yuan
.
Among the cases of false issuance of value-added tax invoices investigated and dealt with by the local taxation department, the party who obtained the false value-added tax invoices was involved, and the total amount of value and tax involved in the case was more than 1 million yuan, but less than 10 million yuan
.

　　Particularly serious.

According to the facts of the case as determined by court judgments or administrative penalties by relevant law enforcement agencies, in the past three years, within the province, kickbacks and other medical commercial bribery have been carried out against various medical institutions, centralized procurement institutions and their staff at all levels.
The cumulative or single bribe amount in the case was more than 2 million yuan
.
Among the cases of false issuance of value-added tax invoices investigated and dealt with by the taxation authorities in this region, the party who obtained the false value-added tax invoices was the party who obtained the false value-added tax invoices
.
Industry insiders pointed out that under the overall medical reform environment dominated by the "three-medicine linkage", the trend of deepening the reform of the medical insurance payment system and reducing the profit margins of drug prices is irreversible.
Severely cracking down on commercial bribery and market manipulation is obviously to ensure drug prices.
An important means of monitoring the effectiveness of today's pharmaceutical companies in the process of bidding, procurement and marketing promotion, once they are included in the list of untrustworthy due to violations of regulations and laws, they may instantly lose the market
.

　　Purging the order of the pharmaceutical market
Since the national medical insurance and market supervision departments initiated the construction of the medical price and credit evaluation system, the provincial medical insurance departments and centralized pharmaceutical procurement agencies have accelerated the implementation of the credit evaluation system across the country, and at the same time, continue to study and improve the credit evaluation system to strengthen deterrence Role
.

　　The "Measures" stipulate:
Article 6 Implement the following drugs and medical devices1.
Any illegal act in the cosmetics field that falls under the circumstances stipulated in Article 2 of these Measures shall be included in the list of severely illegal and untrustworthy: (1) Production and sale of counterfeit and inferior drugs; illegal production and sale of drugs (including vaccines) that are subject to special administrative requirements by the country ; Production, import, and sales of drugs (including vaccines) that have not obtained drug approval documents; (2) Production and sales of unregistered Class II and III medical devices; (3) Production and sales of illegally added substances that may harm human health (4) Other illegal acts that violate the laws and administrative regulations on drugs, medical devices, and cosmetics, and seriously endanger the health and life safety of the people
.

The pharmaceutical industry is a key area of ​​market supervision.
In response to outstanding issues such as rebates and market monopoly in the pharmaceutical field, the regulatory authorities will give full play to their guiding and standardizing role to promote the return of reasonable prices for pharmaceutical products
.
In April of this year, the Zhejiang Pharmaceutical Equipment Procurement Center issued the "Notice on the Evaluation Results of Medical Prices and Untrustworthy Levels of Recruitment and Procurement in Our Province (First Issue of 2021)", targeting Harbin Yuheng Pharmaceutical Co.
, Ltd.
's Lugua Polypeptide Injection in Zhejiang Province The existence of commercial bribery acts as a warning, and at the same time, the company’s pharmaceutical prices and the rating of untrustworthy in Zhejiang Province were rated as "serious", and the company's online trading of Lugua polypeptide injection was suspended
.
This is the first case in the country where the credit evaluation reached the “serious” level since the establishment of the medical price and credit evaluation system
.
Since the end of 2020, anti-monopoly law enforcement agencies have successively investigated and dealt with the case of Wanbond Pharmaceutical Group and Simcere Pharmaceutical Group
.
On April 15 this year, the State Administration for Market Regulation imposed a fine of 764 million yuan on Yangtze River Pharmaceutical's implementation of a vertical price monopoly agreement, setting a record for anti-monopoly fines in China's pharmaceutical industry
.
In fact, in the first half of this year, the central government put "strengthening anti-monopoly and preventing the disorderly expansion of capital" as the focus of this year's work, and stated that it would "enrich the anti-monopoly supervision power and enhance the authority of supervision.
"
.
On August 30, the Central Committee for Comprehensively Deepening Reforms held its 21st meeting and reviewed and approved the "Opinions on Strengthening Anti-monopoly and Deepening the Implementation of Fair Competition Policies
.
" What is clear is that the country will increase the supervision and law enforcement of pharmaceutical companies in the next step, and heavy supervision in the pharmaceutical industry will become the norm in the future
.
Industry analysis believes that the pharmaceutical industry has begun to transition from the traditional "reserve price agency + commercial billing" model to the "high opening and high return + business reform + two-invoice system" model.
Enterprises not only need to pay attention to the price declaration rules during the price declaration process.
To avoid stepping on the “red line” of the rules, it is also necessary to continuously improve the level of compliance operations and jointly create a fair and just business environment for the pharmaceutical industry
.