Official explanation "unreliable"? Summary analysis of "screen door" in Anhui basic drug bidding

Source: Medical observer report 2014-08-25 this year, Anhui Province launched the implementation plan of centralized bidding and procurement of essential drugs, and failed to pass the new version of GMP The information of certified blood products, injections and other sterile drugs has been screened, hundreds of enterprises have been excluded from Anhui market, which leads many domestic excellent enterprises to fall into business difficulties and seriously affects the development of China's medical and health undertakings Now the key issues in this incident are comprehensively and objectively analyzed, so that relevant organizations can see the nature of the problem, clarify their ideas, correct their behaviors in time, and reduce and eliminate many negative effects brought by this incident Anhui official explanation "unreliable" explanation 1: in the new bidding regulations for basic drugs, pharmaceutical enterprises that have passed GMP certification and are passing GMP certification and whose list has been publicized on the official website of CFDA are not in the shielding list, so it can be said that this new regulation is in line with the policy and leaves the most room Analysis: the enterprises not in the shielding list have nothing to do with this matter, so it needs to have a scientific way of thinking Explanation 2: the bidding policies of each province are formulated by each province, so the bidding details shall be formulated according to the situation of each province Analysis: it is true that the bidding policies for basic drugs are formulated by all provinces, but they must be carried out according to law when formulating policies Article 25 and Article 71 of the government procurement law of the people's Republic of China stipulate: "the parties involved in government procurement shall not collude with each other to damage the national interests, the public interests and the legitimate rights and interests of other parties; It is not allowed to exclude other suppliers from participating in the competition by any means "In case of any of the following circumstances, the purchaser or the procurement agency shall be ordered to make corrections within a time limit, given a warning and may also be fined The person in charge who is directly responsible and other persons who are directly responsible shall be punished by the administrative department or the relevant organ and notified." Anhui's practice is to discriminate or discriminate against suppliers under unreasonable conditions Explanation 3: the four ministries and commissions only permit the way of entrusted processing for production and retail, but it is not the same as the recognition that these entrusted processing enterprises are at the same level as the enterprises that have really obtained GMP certification, so a province can fully use high standards in purchasing basic drugs Anhui Province, as the benchmark province of drug bidding, adopts the new GMP certification, which is to improve the quality threshold and ensure the reliable curative effect of essential drugs Analysis: first of all, the state expressly requires enterprises to transform the original GMP and reach the new GMP According to the requirements of the state, entrusted processing is a process that enterprises must go through in response to the requirements of the state to transform and upgrade themselves The state recognizes this process and gives the corresponding transformation period Enterprises transform according to the requirements of the state and invest a lot of money Now in this legal process, Anhui does not allow the products of enterprises（ During the transformation, the entrusted production mode is adopted, and the product itself completely meets the quality requirements of the new GMP.) In terms of sales, Anhui's approach is to make the production lines built with huge investment according to the requirements of the state unable to produce products in the future, because Anhui does not allow you to sell products The production lines built with tens of millions or even hundreds of millions of yuan of capital will face the situation of no product production What does Anhui want to do with this kind of bidding? Do you want some legal enterprises to go bankrupt? Secondly, Anhui believes that the enterprises that entrust others to produce products due to the ongoing transformation are not at the same level as the enterprises that have obtained the new version of GMP, which is a false proposition The two enterprises with different quality standards are different in themselves, but in the current situation, there is no difference According to the national regulations, the transformation of the new version of GMP should be completed by the end of 2014 Some enterprises completed it in March and some enterprises completed it in May Are there any differences between them? Finally, Anhui said that it is to improve the standards, but in fact, at present, all the products provided to the market by the enterprises carrying out the transformation of the new version of GMP are entrusted with the new version of GMP The products produced by enterprises are all of a quality level What standard has Anhui improved? Explanation 4: adopt the new GMP certification, so as to further force enterprises to improve the quality level and realize industrial upgrading, merger and reorganization This is in line with the national policy for the entire pharmaceutical industry Before the new regulations of Anhui basic drug bidding came out, many regulations had made it clear that the priority should be given to purchasing the products of pharmaceutical enterprises that have passed the new GMP certification, so pharmaceutical enterprises should have psychological preparation for a long time Analysis: Anhui believes that the purpose of their illegal bidding is to force the enterprise to improve the quality level It's hard to imagine the level of the people who cover up the ugly Doesn't Anhui know that the enterprise is improving the quality level according to the national requirements? The enterprise is already carrying out the work and will finish it within the time limit required by the state This is arranged by the state What do you need to be forced by Anhui pharmaceutical administration department? What is your real pressure on the enterprise? Is it to make the production line which costs tens of millions of yuan to build waste? Is it to make many enterprise personnel unemployed? Is it to make the enterprise bankrupt? Or to let some competitors in Anhui withdraw from Anhui market? Secondly, the pharmaceutical administration department of Anhui has found a very high shield, which is to achieve industrial upgrading and merger and reorganization Is this what you do in Anhui pharmaceutical administration? Do you do it? Are you able to do it? Are you qualified to do it? Your goal is to improve the global competitiveness of Chinese enterprises Anhui pharmaceutical administration department is indeed the national benchmark, as you said, unique benchmark In addition, Anhui said that it is required to give priority to the purchase of pharmaceutical products that have passed the new GMP certification In the national document, it refers to the basic drugs At the same time, it is emphasized that the former is preferred only when there are both enterprises that have passed the new GMP certification and enterprises that have not passed the new GMP certification The document does not deprive them of the new GMP certification Enterprises have the right to participate in the bidding, and this practice in Anhui not only deprives the enterprises that fail to pass the new GMP certification of the basic drugs of the right to participate in the bidding, but also rejects the entrusted processing products out of the list of non essential drugs in violation of the regulations of the state (Chen Shengyun) pharmaceutical companies are not "lambs to be slaughtered" There is no discrimination in the practice of Anhui Province When bidding, the bid inviter can release my subject matter and ask for what kind of qualification and above I think the purchaser should have such basic rights (Chen Qiulin, deputy researcher of the Institute of population and labor economics, Chinese Academy of Social Sciences) analysis: at present, there are no other opinions expressed in support of Anhui pharmaceutical administration department on the Internet, and the essential error of this view is that we do not know the difference between government bidding behavior and buying things by ourselves It's not against the law to buy things by yourself or by non-public units, and of course you can call whoever you want But the government's behavior is different The state has the relevant government bidding law, which is to remove the corruption and unfair behavior in the bidding work, and has quite strict regulations It is proposed in the point of view that the government can require what kind of qualification is necessary, which can be done in some cases, such as some individual projects, because of their different difficulties, so enterprises with certain qualifications are required to participate, but Anhui is a market access problem, which has nothing to do with a single project If all provinces in the country require something with more than one qualification to be sold, why should the state issue other qualifications? What's more, the quality assurance of the products entrusted for processing is the same as that of the products not entrusted, and they are all products with the same qualification Anhui's approach is to set clear limits for people If the government can do what it wants to do in the bidding process, how many enterprises with more than employees can be required to participate in the bidding? Is it possible to ask the width of the gate of the enterprise to participate in the bidding? At present, it is the time for the upgrading of the new GMP nationwide Hundreds of enterprises across the country are actively responding to the national documents and making great efforts to invest In this process, no one has any shortcomings at present (there are no deficiencies in the products entrusted for production, but the enterprise is still in the process of transformation) And the right to let businesses die suddenly The events in Anhui are still evolving in a direction that is not conducive to social progress and development Experts and scholars should represent the enterprises that have been unfairly treated to negotiate with the pharmaceutical administration department of Anhui to correct their mistakes Recently, many enterprises have been sitting outside the door of Anhui pharmaceutical administration department to express their appeals Their rights should be protected Anhui pharmaceutical administration department should understand that these enterprises are subject to you, but they are not the lambs that you can kill at will Anhui pharmaceutical administration department and some illegal profit-making enterprises in this event should never take chances with their illegal behaviors, find some far fetched reasons and find some spokesmen who can never cover up the fact of violations Even if the bidding work is over, it does not mean that the problem will pass The waste production lines of enterprises, the failure of bank loans, the unemployment of employees, etc., will lead to Ask deeper questions We do not speculate on the real purpose of excluding the entrusted processing products in Anhui We also understand that it is legal for each province to make specific policies But there is an objective fact: if Anhui succeeds in illegal bidding, many enterprises will get huge benefits in Anhui market I hope that the relevant national departments can give a clear explanation on whether Anhui's current practice in this matter is legal, and I hope to get the following answers: 1 When the enterprise invests a lot of money to upgrade and transform according to the relevant national requirements, it temporarily entrusts the relevant products to produce according to the national requirements, and whether the products themselves are legal (legal / illegal)? 2 Is there any qualification for market sales（ Yes / no)? 3 Does the quality of the products commissioned meet the requirements of the new GMP (yes / no)? 4 Is there any difference (yes / no) in product quality between the products commissioned by the enterprises with the new GMP and the products manufactured by the enterprises themselves with the new GMP?