Pharmaceutical Industry Compliance Management Upgrade: The Whole Process Of Anti-Commercial Bribery And Anti-Monopoly

"Compliance standards will eventually be implemented, promoted and implemented. We also plan to carry out a series of standard promotion work, such as publicity, training, and the establishment of industry compliance benchmarking enterprises. Through the promotion and implementation of compliance standards, we will draw a" red line "for the production and operation of pharmaceutical enterprises, provide a discretionary reference for the regulatory authorities to implement rewards and punishments, and also provide administrative reconciliation for compliance and non-compliance The exploration of regulatory incentive models such as prosecution provides a basis for industry self-discipline. " Recently, pan Guangcheng, executive chairman of the China chemical and pharmaceutical industry association, said in an interview with the 21st century economic reporter after the China chemical and Pharmaceutical Industry Association (CPIA) released the latest "pharmaceutical industry compliance management standard" (hereinafter referred to as the "specification").

It is understood that the entire "specification" has 77 pages, which comprehensively standardizes pharmaceutical enterprises from the aspects of anti-commercial bribery, anti-monopoly, finance and taxation, product promotion, centralized procurement, environment, health and safety, adverse reaction reports, data compliance and network security, so as to help pharmaceutical enterprises find loopholes in the industry and legal supervision, straighten out the supervision and reporting system, and formulate And implement effective preventive measures.

Among them, anti-monopoly and anti-commercial bribery have become the focus of the industry. After the state regulatory authorities imposed an anti-monopoly fine of 100 million yuan on Xiansheng pharmaceutical at the beginning of this year, on April 2, TIANYAO Co., Ltd. announced that TIANYAO received the notice of administrative punishment hearing issued by Tianjin market supervision and Management Commission on April 1, 2021. Tianjin market supervision and Administration Commission intends to make administrative measures against Xiansheng Pharmaceutical Co., Ltd. because it is suspected of reaching a monopoly agreement on fluoroacetate and fluor The penalty was as high as 44.02 million yuan.

Pan Guangcheng further told reporters of the 21st century economic report that the "standard" is a comprehensive standard for pharmaceutical enterprises in the whole process of production, operation and management with the concept of "big compliance". Among them, anti-commercial bribery, anti-monopoly and product promotion are the three aspects with the highest degree of concern and the most concentrated enterprise risks. In the future, we will continue to promote the preparation of compliance standards in the fields of Finance and taxation, data security and centralized procurement, and plan to cover all fields in about four years.

In the view of the industry, the birth and continuous improvement of the "code" will fill in the gap of compliance standards in the domestic pharmaceutical industry, overcome the problems such as "acclimatization" directly cited by foreign systems, provide a reference for the establishment of enterprise compliance system and the improvement of compliance management ability, and provide compliance endorsement for Chinese enterprises going abroad; help enterprises complete the transformation of new regulatory mechanism The only way for the survival and development of pharmaceutical enterprises. A person in charge of a listed pharmaceutical enterprise told the 21st century economic reporter that compliance is the guarantee for the sustainable development of the pharmaceutical industry and can also provide a guarantee for the healthy and orderly development of pharmaceutical enterprises.

Anti commercial bribery has always been a hot spot of supervision

The radiation scope of the code is wider. The member units of China chemical pharmaceutical industry association include foreign pharmaceutical enterprises, local pharmaceutical enterprises and pharmaceutical commercial companies operating in China. Pharmaceutical industry compliance management standard users also include drug or medical device marketing license holder (MAH) enterprises.

China's medical and health industry is undergoing unprecedented changes. In recent years, with the deepening of the reform of the medical and health system, the drug administration law has been comprehensively revised at the legal level, the vaccine management law and the basic medical and health promotion law have been promulgated and implemented; at the policy level, the two vote system, centralized purchase with volume and registration of medical representatives have been gradually implemented.

At the same time, the national law enforcement against commercial bribery in the pharmaceutical industry is increasingly strict, and various law enforcement activities gradually form a long-term mechanism.

According to public information, from 2013 to 2020, the frequency of anti-commercial bribery law enforcement activities specifically targeted or involved in the pharmaceutical field is about 3-5 times a year.

According to Shi lichen, founder of Beijing Dingchen medical management consulting center, commercial bribery in the pharmaceutical industry has not been banned for many times. The main reasons are reflected in two aspects: "one is the level of hospitals and doctors. Hospitals are lax in management and often default on kickbacks. At the same time, there are problems in the income structure of doctors. Selling drugs and issuing checklists can obtain more considerable income than diagnosis and treatment. Second, on the supply side, there are still a large number of homogenous generic drugs in the current pharmaceutical market. Giving kickbacks is a means for pharmaceutical enterprises to expand sales, which may also be the reason for the high sales costs of pharmaceutical enterprises. "

Fu Changyu, a lawyer of Zhonglun law firm, pointed out that in recent years, law enforcement activities have gradually become normalized and institutionalized. For example, the joint law enforcement of nine departments is carried out almost every year, as well as the inspection of large hospitals led by the health commission. The focus of law enforcement has also been constantly adjusted: from the previous emphasis on the purchase and sale of drugs, medical equipment and medical consumables, the focus of the crackdown has gradually shifted from accepting red envelopes and kickbacks to more covert commercial bribery in the name of academic conferences and donations; the cooperation between market supervision departments and tax authorities has changed from forgery In terms of the depth of law enforcement, from the form of "whether it is recorded in the account" to the substantive review of the supporting documents and the rationality of sales expenses behind the accounts.

In recent years, anti commercial bribery has always been the focus of supervision, and the "code" also listed anti commercial bribery as the first content. The general principle of product sales clearly points out that in product sales activities, enterprises shall not directly or indirectly give or promise to the staff of the opposite party of the transaction, the units or individuals entrusted by the opposite party to deal with relevant affairs, and the units or individuals who use their power or influence to influence the transaction or any other improper interests in order to obtain payment Easy opportunity or competitive advantage. For example, it is not allowed to give improper benefits to HCOs at all levels, centralized purchasing agencies and their staff directly or through a third party such as CSO, so as to seek trading opportunities or competitive costs.

On the premise of allowing enterprises and government officials to carry out interactive exchanges to legally discuss business and communication, the code reminds enterprises to be cautious about interaction with government officials who have decision-making power and whose decisions may have a substantial impact on enterprise business. At the same time, it is clear that enterprises shall not directly or indirectly give, promise or authorize to give property, or provide any improper benefits, so as to induce government officials to give improper preferential treatment or give any other improper advantages in drug marketing license, medical device registration / registration, price negotiation, supply of enterprise products, etc. It is not allowed to sponsor or provide funds for government officials to participate in forums, conferences, celebrations and other activities organized by a third party, unless written approval has been obtained from the government official's unit.

In addition to the third-party distribution companies, pharmaceutical representatives are also an important part of enterprise marketing. The standard emphasizes that medical representatives can communicate with medical and health professionals face to face in medical institutions, but the main purpose of communication is to transmit information related to pharmaceutical products, assist medical and health professionals in rational drug use, and collect and feedback information on clinical use of drugs and adverse drug reactions. In the view of the industry, gradually improving the transparency of medical exchange activities and enhancing the trust of regulatory agencies and the public on pharmaceutical enterprises and the whole industry is the top priority for the transformation and upgrading of pharmaceutical representatives.

Enforcement of anti monopoly law is getting stricter

Anti monopoly is another key point in the code. In recent years, the anti-monopoly law enforcement and supervision in the pharmaceutical field has become increasingly strict. For example, the State Administration of Market Supervision issued a huge fine of 320 million yuan to three calcium gluconate API distributors in 2020. Recently, in the action plan for building a high standard market system, the office of the CPC Central Committee and the State Council clearly pointed out that it is necessary to strengthen and improve the law enforcement of anti-monopoly and anti unfair competition, resolutely oppose monopoly and unfair competition, and formulate anti-monopoly guidelines in special fields such as API.

Shi lichen pointed out to the reporter of the 21st century economic report: "the fundamental crux of the monopoly of API lies in the scarcity of domestic API approval documents under the background of the original API registration system, which makes the monopoly easy to form. The implementation of the API record system can fundamentally solve the problem of API monopoly. "

This time, the code also takes anti-monopoly as the key regulatory field that pharmaceutical enterprises need to pay attention to. It proposes that the anti-monopoly system compliance design should be added on the basis of the overall compliance system design of the enterprise, including the establishment of compliance department or compliance director, the formulation of anti-monopoly compliance guidelines, the establishment of internal consultation and reporting system, etc. According to the requirements of the code, in the daily communication with competitors, the enterprise shall not reach any kind of agreement with competitors, including fixing or changing commodity prices, restricting the production or sales quantity of commodities, dividing the sales market or raw material purchasing market, restricting the purchase of new technologies and new equipment, or restricting the development of new technologies and new products, boycott transactions, etc.

In business contacts with upstream or downstream enterprises, the code reminds enterprises to guard against the risk of vertical price restriction, that is, enterprises shall not fix the price of reselling goods to the third party by agreement or other means (including but not limited to incentive measures such as discount, feedback and cost sharing, or punishment measures such as coercion, delay or cancellation of supply) or restrict distributors to the third party The lowest price for resale. However, in the case of enterprises participating in national centralized procurement, the above-mentioned prohibitive provisions are not applicable to the behaviors of enterprises directly determining the purchase price, signing purchase and sales contracts with public medical institutions for the drugs within the scope of centralized procurement approved by the national drug regulatory department and listed in mainland China, and the distributors distribute and supply relevant drugs to hospitals according to the price.

In addition, enterprises also need to pay attention to the risk prevention of abuse of market dominance, and should regularly evaluate the relevant market of their products and services. In accordance with one of the situations that its market share exceeds 50%, its market share with another competitor reaches two-thirds, and that with another two competitors reaches three-quarters, it may be presumed that it has a dominant market position and needs to be identified as a high-risk area. Enterprises should prohibit the abuse of market dominant position, so as to avoid repeating the heavy punishment of the three calcium gluconate API distribution enterprises mentioned above.