Four Pharmaceutical Enterprises Were Rated As "Seriously Dishonest" During The Year, And Pharmaceutical Enterprises Were Faced With Stricter Compliance Requirements

Recent cases show that pharmaceutical enterprises shortlisted for centralized purchasing will face more stringent compliance requirements.

Not long ago, Yichang humanwell Pharmaceutical Co., Ltd. (hereinafter referred to as "Yichang humanwell") and Beijing Baiao Pharmaceutical Co., Ltd. (hereinafter referred to as "Baiao pharmaceutical") were both identified as "serious" in the evaluation of medical price and credit rating of bidding and purchasing in Henan Province, just like a fallen domino, causing chain reaction in the market.

According to relevant circulars, four drugs under Yichang Renfu "have commercial bribery" in Henan Province, while Baiao Pharmaceutical Co., Ltd. has "repeatedly encountered low delivery rate supply problems, and even stopped production and supply interruption from May to June 2021". According to the four grades of "general, medium, serious and especially serious" mentioned in the guiding opinions on the establishment of pharmaceutical price and bidding credit evaluation system issued by the State Medical Security Bureau, the situation of the above two pharmaceutical enterprises should not be underestimated.

It is worth mentioning that Yichang Renfu is an 80% holding subsidiary of humanwell Pharmaceutical (600079. SH), a listed A-share company, while foreign pharmaceutical Co., Ltd. (600511. SH) holds 20% of the shares.

Perhaps to placate the market, on September 22, shortly after the subsidiary was named, Renfu pharmaceutical disclosed the plan of increasing the shareholding of AI Luming, the actual controller of the company, and Li Jie, the chairman of the board of directors. The total amount of increased holdings was no less than 20 million yuan and no more than 40 million yuan.

Prior to this, Yuheng Pharmaceutical (002437. SZ) and Huabei Pharmaceutical (600812. SH) were also listed as "serious" dishonest rating by Zhejiang Pharmaceutical equipment purchasing center and Shandong public resources trading center due to commercial bribery and product interruption.

"In the past, there have been individual enterprises" cut off supply "phenomenon, and commercial bribery can be said to be the" stubborn disease "of the pharmaceutical industry. Since this year, four related pharmaceutical enterprises have been listed in the" serious "level, which shows that pharmaceutical enterprises participating in centralized purchasing will face more and more strict compliance requirements." a pharmaceutical industry personage told reporters.

Renfu pharmaceutical subsidiary involved in commercial bribery case

According to the relevant facts disclosed in the No. 693 judgment of the people's Court of Erqi District of Zhengzhou City (2020) Yu 0103, Yichang Renfu Pharmaceutical Co., Ltd. has conducted commercial bribery in Henan Province, including sufentanil citrate injection, nabufen hydrochloride injection, hydromorphone hydrochloride injection and midazolam injection.

One of the defendants in the case, Fu XX, was the medical representative of "Yichang Pharmaceutical Co., Ltd." from January to December 2018, he gave a rebate of 571000 yuan to Li Mou, director of the Department of Anesthesiology of a hospital in Zhengzhou. The products promoted by Fumou include nabufen hydrochloride injection and hydromorphone hydrochloride injection. These two products are the exclusive products of Yichang humanwell, and also the main products of Yichang humanwell. In 2020, the sales volume of these two products will be 6.9 million and 4.36 million respectively, with a year-on-year increase of 30% and 64%.

At present, humanwell pharmaceutical holds 80% of the equity of Yichang Renfu.

"At present, the company is actively communicating with the relevant departments, striving to repair the credit as soon as possible, and minimize the impact of the matter on the company." recently, a reporter from the 21st century economic report called the Securities Affairs Department of humanwell pharmaceutical. The other side said that Yichang Renfu was an important subsidiary of the company.

In the official statement of media reports, humanwell also mentioned that "it is understood that the relevant commercial bribery is the personal behavior of the former employees of the subsidiary, which seriously violates the company's management system."

After Huabei pharmaceutical, Baiao Pharmaceutical Co., Ltd. was also on the dishonest list due to "cut off supply"

Baiao pharmaceutical is suspected of "cutting off supply", and has also been included in the blacklist of dishonest drug procurement by Henan Province.

According to a circular on the official website of Henan public resources trading center, "Entecavir tablets of bai'ao Pharmaceutical Co., Ltd. are selected in the expansion of national drug centralized procurement pilot project. However, there are many supply problems such as low delivery rate in Henan Province. From May to June 2021, problems such as production stop and supply interruption occur. Moreover, the centralized purchasing institutions and purchasing units are not informed in advance, which disturbs the clinical treatment order and seriously affects the clinical treatment order of patients in Henan Province According to the provisions of relevant documents, Baiao pharmaceutical was rated as "serious" in terms of medical price and credit rating of bidding and purchasing in Henan Province.

This means that the relevant drugs of Baiao pharmaceutical industry may face the previous experience of Huabei pharmaceutical, or will face the punishment of canceling the hanging network in Henan Province.

Entecavir tablet is a kind of drug for treating hepatitis. In the first batch of pilot scale expansion, entecavir dispersible tablets (0.5mg * 28 tablets / box) produced by bai'ao Pharmaceutical Co., Ltd. the original sales price of the drug was 302.84 yuan / box, and the winning price dropped to 5.5 yuan / box, with a decrease of 98.18%.

In this regard, the 21st century economic reporter repeatedly called the official website of Baiao pharmaceutical, but no one answered.

According to previous media reports, Baiao pharmaceutical may be due to insufficient capacity.

Prior to this, Huabei Pharmaceutical (600812. SH) was widely concerned by the market because of "supply interruption".

On September 17 this year, Shandong Provincial Public Resources Trading Center issued a notice, rating North China Pharmaceutical as "serious".

As the third batch of national drug centralized procurement of ibuprofen sustained-release capsules, Huabei pharmaceutical, the selected enterprise, failed to purchase the amount of ibuprofen sustained-release capsules according to the agreed supply agreement in Shandong Province. After many interviews and negotiations, the supply situation has not been improved. On August 11, 2021, the enterprise proposed to give up its qualification.

Huabei pharmaceutical not only was rated as "serious", but also its product ibuprofen sustained-release capsule was suspended from the Internet for three years. The starting time of time limit standard for dishonesty was August 20, 2021. In addition, Huabei pharmaceutical was also disqualified from participating in the centralized drug procurement activities organized by Shandong Province from August 11, 2021 to May 10, 2022.

In late August this year, the national organization's drug Joint Procurement Office responded to the interruption of North China Pharmaceutical's supply, saying that "the breach of contract of ibuprofen sustained-release capsules of Huabei pharmaceutical within the agreed purchase quantity stipulated in the agreement is the first time since the centralized purchase of drugs organized by the state organization.".

In this regard, on August 23, Huabei pharmaceutical explained the centralized purchase and supply of ibuprofen sustained-release capsules through an announcement. The company said that the lack of production capacity caused by insufficient attention paid by relevant enterprise leaders and the impact of the epidemic shutdown were the main reasons for its "cut-off" of ibuprofen sustained-release capsules.

As for the impact of the incident, Huabei pharmaceutical said, "The company's sales revenue of ibuprofen sustained-release capsules in 2020 is 502200 yuan, accounting for 0.0044% of the company's operating revenue in 2020; from January to July 2021, the sales revenue of this product is 2.9381 million yuan. Since the information about the products to be purchased in a centralized way by the state for the Sixth Batch of drugs has not been published, the company is unable to predict the centralized drug procurement activities organized by the state and the sales of selected products until May 10, 2022 The impact of sales on the company. "

However, the market reaction was strong, North China Pharmaceutical opened on August 23, with a total market value of 1.733 billion yuan evaporated.

The 21st century economic reporter found that the stock price of Huabei pharmaceutical fell from the highest price of 12.36 yuan / share on June 11 to the low of 8.28 yuan / share on September 1, with the total market value shrinking by more than 5 billion yuan.

Who is the next domino to fall?

So far this year, four pharmaceutical companies have been judged as "serious" dishonest.

According to the guiding opinions on the establishment of medical price and bidding credit evaluation system issued by the State Medical Security Bureau in August 2020, the dishonest items listed in the list of medical price and bidding dishonesty items mainly include "giving kickbacks or other improper interests in the purchase and sale of Medicine (i.e." commercial bribery of Medicine ") Tax related illegal activities, monopoly behavior, improper price behavior, disturbing the order of centralized procurement, malicious violation of contract agreement and other acts contrary to good faith. ".

According to the above guidance, the provincial centralized purchasing agencies assess the dishonesty of pharmaceutical enterprises in the local bidding procurement market into four levels: "general, medium, serious and particularly serious" according to the nature, plot, timeliness, influence and other factors of dishonesty behavior, which are updated dynamically every quarter.

Harbin Yuheng Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuheng Pharmaceutical Co., Ltd. (hereinafter referred to as "Harbin Yuheng pharmaceutical"), is the first leading actor with "serious" credit rating since the introduction of the credit evaluation system by the State Medical Security Bureau.

On April 12, this year, Zhejiang Pharmaceutical Equipment Procurement Center issued a circular, according to the relevant facts disclosed in the criminal judgment of the people's Court of Ouhai District, Wenzhou City, Zhejiang Province ((2020) zh0304 criminal beginning No. 428), Harbin Yuheng pharmaceutical's Lugua polypeptide injection had commercial bribery in Zhejiang Province, and the company was rated as "serious" in terms of medicine price and bidding dishonesty level in Zhejiang Province Online trading of the product on Zhejiang drug purchasing platform was suspended.

According to the judgment, the company's commercial bribery involved the deer and melon polypeptide injection products of Harbin Yuheng pharmaceutical. In order to increase the sales volume, the defendant promised to pay 8 yuan for each "deer and melon polypeptide" injection to the relevant doctors who prescribed the prescription. During this period, the defendant paid a total of more than 880000 yuan to 40 doctors (handled separately). In this case, the doctors directly or indirectly obtained cash from other doctors, totaling more than 800000 yuan.

Harbin Yuheng pharmaceutical is a wholly-owned subsidiary of Yuheng Pharmaceutical Co., Ltd. its main products are deer and melon polypeptide injection, Cefminox Sodium for injection, levocarnitine injection, etc.

From the perspective of performance contribution, in the first half of 2021, Harbin Yuheng pharmaceutical achieved a revenue of 256 million yuan and a net profit of 20 million yuan, accounting for 17% of the current listed company's revenue of 1.537 billion yuan and 2% of the net profit of 115 million yuan.

On September 26, the reporter of 21st century economic report called Yuheng Pharmaceutical Co., Ltd. to further understand the situation. The other party said that he would not accept the telephone interview and needed to send an interview email. Subsequently, the reporter of the 21st century economic report sent an interview email, but no reply was received up to the time of publication.

As for the phenomenon of "drug supply interruption", Zhejiang, Hebei, Yunnan, Hunan and other places have appeared before, but there has been no clear punishment measures.

For example, in November 2020, the Beijing Pharmaceutical sunshine purchasing platform also released, because the two selected varieties of Penglai Nuokang Pharmaceutical Co., Ltd.'s metformin tablets and Nanjing Changao Pharmaceutical Co., Ltd.'s pitavastatin calcium tablets could not be supplied in a short period of time, so the transitional period of three months was increased.

But this year, things are changing.

On September 26, a pharmaceutical industry personage pointed out to the reporter of the 21st century economic report that "the recent cases show that pharmaceutical enterprises may face serious consequences in" drug supply interruption ". This means that pharmaceutical enterprises may prudently use the strategy of unreasonable low price to win the bid for centralized procurement in the future."

The State Medical Insurance Bureau has also made clear the relevant work ideas of national drug procurement with quantity in the recent reply to the CPPCC member's proposal. On September 24, the State Medical Insurance Bureau issued the medical insurance letter [2021] No. 198. In this reply letter, the State Medical Insurance Bureau said that the drug supervision department listed the selected drugs as key supervision varieties, and urged the holders of selected drugs to fully implement the quality management standards of drug production and operation and continuously improve the quality management system according to the "four strictest" requirements; Establish emergency plan for drug quality and safety incidents, strengthen post marketing research and risk management, and ensure that patients use drugs with good quality and reasonable price.

In terms of ensuring supply, the State Medical Insurance Bureau said that recently, the state has introduced the mechanism of alternative enterprises for centralized drug procurement. If the selected enterprises can not supply the selected varieties in time and in sufficient quantity, the provinces where they are located can select alternative enterprises to ensure clinical demand.

This means that even if they fail to win the bid in the centralized purchase, the relevant enterprises still have opportunities.