Notice to investigate generic drugs or benefit from bidding

A few days ago, Shanghai Pharmaceutical centralized bidding and procurement management office issued the notice to investigate the foreign qualification certification of domestic drugs Relevant people said that the action is to make a preliminary investigation for the next research and development of the "volume procurement" work plan We will investigate the varieties of drugs (except APIs) that have been certified by FDA, cGMP of European Union, jgmp of Japan, incorporated into the centralized procurement qualification of Hong Kong medical authority, and exported to the corresponding countries and regions in the past year The foundation of bidding and purchasing emphasizes quality The so-called "volume procurement" is based on the centralized bidding procurement at the provincial level, with the county (city) level health administrative department as the main body, on behalf of all the medical institutions in the jurisdiction to jointly confirm the transaction with the drug production and marketing enterprises, sign the purchase and sale contract, clarify the purchase varieties, price patterns, etc., form the volume procurement, volume price linkage, and maximize the compression of the virtual high price space of drugs In August this year, Shanghai planned to carry out "volume purchase" for some medical insurance drugs, but according to the reporter, the relevant work has not been really carried out According to one insider, the main reason is that some provisions in the previous draft are controversial in the industry, and the specific implementation plan and detailed rules are still under study and development At present, in the bidding of essential drugs, drug quality stratification, comprehensive quality evaluation and other methods are used to try to block out the varieties with "low quality ranking", but the facts have proved that the evaluation criteria are controversial and easy to cause various problems In the draft of "volume purchase" in Shanghai, the original research drugs are distinguished from domestic generic drugs, but the generic drugs are not stratified in quality; in the bidding of basic drugs in Shanghai, there is no quality hierarchy, and the varieties that meet the price limit can win the bid, and the two ideas are similar According to song Ruilin, executive chairman of China Pharmaceutical Industry Research and Development Promotion Association, the investigation on the foreign qualification certification of domestic drugs is a positive signal "In drug bidding and purchase, it can not be divided by" pedigree ", but by" quality " We must see the progress of China's pharmaceutical industry The quality of generic drugs produced by some enterprises has reached the international level, which is no worse than that of the original drugs " Song Ruilin said that the research work shows that the relevant departments in Shanghai recognize the quality differences between generic drugs and are actively studying the quality problems in volume purchasing In addition, the regulations on the proportion of the same type of original research drug to the purchase of generic drugs in the Shanghai draft of "volume purchase" make many enterprises think that the price reduction of generic drugs means a large amount According to the above insiders, on the basis of quality stratification, the survey is expected to adjust the proportion of original research drugs and generic drugs purchased Volume price linked generic drugs should gradually achieve the goal of "volume price linked, single source of goods" with price for quantity, and "volume purchase" brings great pressure to enterprises On the one hand, compared with the previous centralized bidding enterprises, the number of successful enterprises in "volume procurement" will be significantly reduced, and only two enterprises with the lowest quotation for the same type of generic drugs will be selected, which will directly lead to the withdrawal of other unsuccessful generic drugs from the Shanghai market; on the other hand, the problem of high price of the original research drugs will continue to exist in a certain period of time, while the generic drugs need to "exchange price for quantity" However, "price" may not really replace "quantity" A person from a pharmaceutical enterprise told reporters that if in the price war of generic drugs, the drug prices of the winning enterprises are seriously squeezed, and under the premise of quality assurance, the profit space of the enterprises will decrease, but when the market input is reduced, whether the drug consumption can reach the purchase volume is still a problem "If the integration of bidding, procurement and payment can be implemented, it is the real meaning of" purchasing with quantity " In fact, Minhang District of Shanghai has carried out the reform pilot of drug bidding and purchase in medical institutions The relevant person in charge of Shanghai health administrative department said in an interview that the "Minhang mode" has become a sample of drug purchase in districts and counties of Shanghai, which has been affirmed by the central level The significance of bidding in Shanghai lies not in price, but in quality "But strictly speaking, Shanghai has no settlement and is not a complete procurement process Volume price linkage can be used as a principle in the bidding process, but the largest volume price linkage should be in the settlement process " The above people believe that virtual settlement can be implemented at the level of Shanghai The concept of virtual centralized volume price should be reflected in "volume purchase" at the level of city The main body of purchase has not changed, but at the level of district In addition, a number of reserves have been prepared in finance to prepay the payment for the winning drugs.