How long will it take for high-quality generic drugs to survive the consistency evaluation of variety recruitment and procurement?

In some places, the incentive policies of generic drug consistency evaluation have not been implemented, and generic drugs through the consistency evaluation have been repeatedly frustrated in bidding, procurement and clinical use Recently, Foshan Municipal Bureau of human resources and social security of Guangdong Province issued the implementation plan for centralized drug procurement of public medical institutions in Foshan City to solicit the feedback of public opinions It did not adopt the encouraging policy of "for drug varieties passing the consistency evaluation, medical institutions should give priority to purchasing and selecting in clinical practice", and the reason was that "clinical selection of medical institutions should be respected" It's a blow to pharmaceutical companies that have passed the consistency assessment
Shan Yanqiang, director of R & D Department of Qilu Pharmaceutical (Hainan) Co., Ltd., said to the reporter of pharmaceutical economic news: "although China's innovation environment is getting better and better, and the inclination of policies to high-quality generic pharmaceutical enterprises is becoming more and more clear, but because the relevant supporting policies are not sound, generic pharmaceutical enterprises still face difficulties, we do not want to fall into the dilemma of" bad currency expelling good currency " ”However, like many business people, he also believes that this is the only way for the transformation and upgrading of China's pharmaceutical industry, and the quality of drugs must be improved, which is the general trend On April 3, the general office of the State Council issued the opinions on reforming and improving the supply guarantee and use policy of generic drugs, which proposed the policies of timely inclusion in the procurement catalogue, promoting the alternative use of generic drugs, and giving full play to the incentive role of basic medical insurance to encourage the clinical use of generic drugs through consistency evaluation Since this year, many places have also issued notices to encourage medical institutions to purchase and use varieties that have passed the consistency evaluation Shaanxi Province issued a notice to encourage medical institutions to purchase and use the varieties that passed the consistency evaluation All purchasing consortiums and medical institutions at all levels should include them in the list of interchangeable drugs with the original research drugs, and give priority to purchase and use Heilongjiang Provincial Health and Family Planning Commission issued the notice on further reform and improvement of the specific opinions on the policy of drug production, circulation and use For drugs passing the consistency evaluation, medical institutions at all levels should give priority to purchase and use them in clinical practice At present, although 19 provinces have put the drugs and reference preparations that have passed the consistency evaluation at the same level and quality level for bidding, in the specific implementation process, the situation that the bidding is not smooth, the hospital does not purchase and the clinical does not use becomes the normal The reporter learned that Hainan Shuangcheng pharmaceutical industry, whose main business is the research and development, production and sales of chemical synthetic peptide drugs, was taken as an example Last year, its main varieties of thymus injection new APIs and preparations passed the EU certification, and were deemed to have passed the consistency evaluation in China However, the product encountered "Waterloo" in the bidding and procurement of provincial medical institutions Wang Chengdong, chairman of Shuangcheng Pharmaceutical Co., Ltd., told reporters: "after the thymus method of Shuangcheng Pharmaceutical Co., Ltd has newly completed the" quality upgrading ", it can only win the bid at the" lowest price "in some provincial bidding Compared with other local generic drugs, it has no advantage of" priority procurement ", nor can it compete with the imported original research products at the same quality level Even if some provinces open up the technology price comparison, they still need to set a price ceiling, that is, refer to the "historical lowest price" In addition, in China, although the imported original research products have passed the patent protection period, they can still be sold in accordance with the price that has not passed the patent period High quality generic drugs have not yet put substantial pressure on their price reduction Purchasing on the basis of this unfair pricing means that the products that have passed the consistency evaluation of generic drugs can only be sold at a loss, while "purchasing with quantity" means that the more the products are sold, the more the losses According to the reporter, 29 drug regulations have passed the consistency evaluation, but there is still a long way to go to complete the consistency evaluation of 289 varieties According to iqvia, by the middle of 2018, 50% of 289 varieties will be tested by be; by the end of 2019, 70% of varieties are expected to complete the consistency evaluation Why can't we finish it on time? According to Wang Chengdong, the consistency evaluation of generic drugs means time cost, human cost and capital investment for any enterprise, but if the product price or sales volume does not go up, the enthusiasm of enterprises to carry out this work will naturally be affected The approved enterprises look forward to a fairer competition environment, a pharmaceutical industry expert told reporters, The consistency evaluation seems to be single, but its impact and synergy have breadth and depth, which need the joint effect of policies such as drug purchase, drug prescription and medical insurance payment Therefore, for local enterprises, including those that have passed the consistency evaluation, there is no doubt that they need to live a period of "tightening their belts", because the policies have not yet been linked 。
In this regard, Hu Jiqiang, chairman of Zhejiang Kangenbei Pharmaceutical Co., Ltd., said that even if the consistency evaluation is passed, the future generic pharmaceutical enterprises may face price reduction He pointed out that "the current situation in China is that before the market share of the original research drugs has dropped to a lower proportion, its price will basically remain unchanged at the original level." In the face of this situation, the domestic generic drugs that pass the consistency evaluation may not raise the price, but have a great chance to adopt the price reduction strategy and fight the price war with the original research drug factory " Multinational pharmaceutical companies have been working hard in the Chinese market for many years, and their brand influence is deeply rooted They are not willing to be passive targets With the support of doctors and patients in the market, and the experience of coping with generic drug competition around the world, these multinational enterprises will also make changes in the Chinese market, "authorized generic drugs" in the U.S generic drug market is a typical case The above industry figures further pointed out that the strict data integrity management of consistency evaluation is likely to push up the cost of drug production, while the environment of medical reform and market competition will still force the price of drugs to go down further Such "two end blocking" situation will only continue to generate profit pressure for major pharmaceutical enterprises "Only with sufficient scale, leading technology and management ability can enterprises survive, which is the shaping process of new core competitiveness of China's pharmaceutical industry in the context of supply side structural reform." The person stressed In this regard, as one of the representatives of high-quality generic pharmaceutical enterprises, Wang Chengdong said: "on the one hand, it is the original intention of Shuangcheng pharmaceutical industry and all responsible domestic pharmaceutical enterprises to let the nation and the people make good use of drugs Enterprises will also take improving product quality, technology and enterprise management of aquatic products as the foundation, but also It is hoped that the policy will further provide a relatively fair market environment for local high-level generic drugs, including fair competition with imported drugs in the bidding system, immediate access to the Internet and purchase after winning the bid, breaking the "one product, two regulations" in hospitals, and reasonably conducting the "drug proportion" assessment "