Constructing a "blacklist" of pharmaceutical companies Skynet. Those who have the following actors will be severely punished!
Source: Medical Network
From December 1, Shaanxi Province will strictly implement a "blacklist" information sharing and joint disciplinary system.
This is the province’s recent hit on drug safety: as required, Shaanxi Province will announce to the public the basic information and information of drug marketing license holders and drug manufacturers (including users) who have serious dishonest behaviors. The reasons for being included in the "blacklist" of dishonesty, the result of punishment, the date of removal, etc. Shandong and Guangdong have also introduced similar policies.
A few days ago, the National Medical Insurance Administration successively issued two "Notice on Printing and Distributing Medical Price and Recruitment Credit Rating Judgment Benchmark (2020 Edition)" and "Regarding the Printing and Distributing of Medicine Price and Recruitment Credit Evaluation Operation Specification (2020 Edition)" "Notice" (hereinafter referred to as "Operation Regulations"), once again detailed the operating specifications and evaluation criteria for the previously promulgated medical prices and recruitment credit evaluation.
Nine types of situations are never soft
It is reported that the Shaanxi Province Drug Safety "Blacklist" Information Sharing and Joint Disciplinary Measures (Trial)" (hereinafter referred to as the "Measures") will apply to enterprises or drug research and development institutions that have obtained drug registration certificates in Shaanxi Province, and in their borders Various types of untrustworthy entities engaged in the production and marketing of pharmaceuticals.
Which behaviors will be the focus of supervision? The “Measures” points out that there are nine situations: 1. The credit rating is assessed by the drug regulatory authority as D level; 2. The drug regulatory authority found false certifications, documents, samples, or other methods when reviewing administrative licensing matters. Obtaining licenses or approval documents by deception; 3. Subject to administrative penalties of revocation of licenses and approval documents; 4. Subjects of untrustworthy drugs being punished not to engage in drug production and business activities within the legal period; 5. Crimes involving drugs Criminal punishment; 6. Failure to implement administrative punishment decisions in accordance with the law; 7. Large or above drug safety liability accidents; 8. Unlicensed illegal drug production and business activities; 9. Drug regulatory authorities determined that other needs to be included in the " "Blacklist" is a serious violation of the law.
As long as one of the above-mentioned violations of laws and regulations occurs, and there is no room for luck, they will be included in the "blacklist" of untrustworthy subjects. What has attracted the attention of the industry is that Shaanxi has made newer explorations in joint punishment: that is, the untrustworthy subjects on the "blacklist" of drugs will be pushed to the Shaanxi Provincial Credit Information Platform and the National Bureau Credit Platform, and the relevant administrative agencies and financial institutions In government procurement and other public resource transactions and government public service projects, the organization will grant honorary titles to financial activities involving credit, guarantees, financing and other matters related to administrative approval, new projects, land use, and import tariff quotas. In the work of granting government preferential treatment, new scientific and technological project support fund declaration and financial support, take restrictive measures in accordance with the law; prohibit them from participating in the unified bidding and procurement activities of medicines and medical devices in the whole province; at the same time, apply the joint punishment stipulated by the national ministries and commissions and the provincial government authorities Measures and other supervision and disciplinary measures required by laws, regulations and rules.
That is to say, the safety of medicines "simply move the whole body", and once the hair is pulled, the whole body is restricted.
The firewall to avoid responsibility was broken
If Shaanxi’s approach has pushed the local blacklist to a climax, then the overall layout of the National Medical Insurance Administration has realized the vertical and horizontal integration of the drug, medical and equipment safety skynet.
For example, according to the aforementioned "Code of Practice", a list of credit evaluation catalogs was established. The evaluation scope includes pharmaceutical companies’ pricing, marketing, bidding, implementation of legal prohibitions in the process of contract performance, and acts contrary to integrity and fair competition to seek improper benefits, such as in the purchase and sale of pharmaceuticals. Rebates or other illegitimate benefits are granted, monopolistic behaviors, price and tax-related violations, malicious violation of contractual agreements, disrupting the order of centralized procurement, etc.
Note that pharmaceutical companies’ promises of trustworthiness include promises to commit untrustworthy behaviors to their employees (including employment relationships, labor dispatch, purchase services, entrusted-agent relationships, etc.), or distribution companies with entrusted-agent relationships, to enable their own drugs or medical consumables to obtain or Those who increase trading opportunities and competitive advantages shall bear the responsibility for breach of trust and breach of contract. It is difficult to blame the pharmaceutical companies for the medical bribery of many pharmaceutical representatives and agents before, because as long as it is not the bribery of pharmaceutical companies, there can be a similar saying that "medical bribery is the behavior of representatives and agents. But now the credit evaluation system of pharmaceutical equipment companies has broken this firewall of evading responsibility.
The submission of a letter of commitment by a pharmaceutical company is a prerequisite for entering the hospital, and the pharmaceutical representatives, agents and pharmaceutical companies are required to perform credit binding. After credit binding, how to record the record of dishonesty also directly affects the subsequent marketing behavior of pharmaceutical companies. In the future, once medical device sales or downstream distributors have untrustworthy behaviors, relevant companies will also be directly investigated and punished. In the assessment of the implementation level of behavior, the National Medical Insurance Bureau will assess the untrustworthiness of pharmaceutical companies in the local bidding and procurement market according to the nature, circumstances, timeliness, and influence of the untrustworthy behavior into four levels: general, medium, serious, and particularly serious , Updated quarterly.