Hubei health and Health Commission supports the substitution of generic drugs! Dozens of multinational pharmaceutical enterprises were affected, and a batch of over 2 billion yuan varieties ushered in the big test!

In the follow-up policy of consistency evaluation, another province has made a new breakthrough Hubei not only opened up a green channel for high-quality generic drugs, so that high-quality drugs can enter the hospital quickly, but also for the first time stipulated that medical institutions "give priority to the use of generic drugs through evaluation" The substitution policy of generic drugs has further advanced Six days after the "announcement on promoting the priority use of drugs passing the consistency evaluation" issued by the provincial top three hospital "Hubei people's Hospital", Hubei Province has made new actions on promoting the use of generic drugs and replacing the original research drugs! On July 18, Hubei Provincial Health and Family Planning Commission issued the document "notice on the implementation of trial operation results of drug Qualification Access of KM hospital in Hubei Province" (hereinafter referred to as the "notice"), requiring all public medical institutions in the province to give priority to the inclusion of drugs passing the consistency evaluation into the hospital use directory, so as to promote the alternative use of generic drugs This shows that another province has made a new breakthrough Hubei not only opened up a green channel for high-quality generic drugs, so that high-quality drugs can enter the hospital quickly, but also for the first time stipulated that medical institutions "give priority to the use of generic drugs through evaluation" The substitution policy of generic drugs has further advanced At present, four batches of generic drugs in China have passed the consistency evaluation, which has had a significant impact and challenge on the business of multinational pharmaceutical enterprises In particular, the best-selling brand products of multinational pharmaceutical enterprises have been generally crushed by the varieties through evaluation The market is surging, both foreign companies and generic pharmaceutical companies are using their own advantages for the final competition How will the future evolve? What's the difference between spreading high-quality generic drugs in a large area? 1 The notice issued by Hubei Provincial Health and Family Planning Commission can be traced back to the announcement on Qualification Access of public hospitals in Hubei Province issued by the comprehensive management network for drug (consumables) supply and guarantee of public hospitals in Hubei Province on May 8 According to the announcement, Hubei will carry out the directory of Qualification Access trial operation, and stipulate that the directory of trial operation shall be subject to dynamic management and real-time adjustment The newly listed drugs that meet the requirements after examination since January 1, 2016 and have passed the consistency evaluation announced by the State Food and Drug Administration but have not been listed in the directory of Hubei Province can be included in the qualification access system This is equivalent to that Hubei Province has opened a green channel for high-quality generic drugs and innovative drugs through the qualification access system It is worth noting that in the "evaluation system of public hospital online drugs in Hubei Province" released with the announcement, generic drugs passing the consistency evaluation can get the same score as the original drugs The form is cut from the "evaluation system of online drugs in public hospitals of Hubei Province", and the scores of "consistency evaluation of generic drugs" and "patent drugs over the protection period" can be published are all 15 points In addition, if the pharmacoeconomics report can be provided according to the evaluation criteria of the international society for Pharmacoeconomics, an additional 5 points can be added It shows that the cost-effective factor should be paid attention to The health and Family Planning Commission of Hubei Province also responded quickly and accepted these ideas According to the requirements of the health and Family Planning Commission: the quality level of the Qualification Access Catalogue is not differentiated; all public medical institutions should give priority to the inclusion of drugs passing the consistency evaluation into the hospital use catalogue to promote the alternative use of generic drugs Before that, Hubei Provincial People's hospital took the lead in response, and the pharmacy department of the hospital issued a notice that "it is recommended that clinicians give priority to the use of drugs that pass the consistency evaluation when issuing medical orders" At present, Hubei is the first province that stipulates "priority" for public medical institutions to include generic drugs through evaluation into the hospital use catalogue, and also the first province that recommends clinicians to give priority to generic drugs through evaluation Before that, the promotion policies of each province were mainly limited in the scope of bidding and network Hubei has taken another step forward A large number of brand original research products have shrunk According to a data held by e drug managers, at present, there are four batches of generic drugs in China, 41 varieties and specifications have passed the consistency evaluation, and the original research drugs corresponding to these varieties belong to 10 foreign enterprises such as BMS and Pfizer Table 1: multinational pharmaceutical enterprises are affected by the consistency evaluation Among the top 10 brand products in sales volume of multinational pharmaceutical enterprises in 2017, 5 products have passed the consistency evaluation, and the market is shrinking Including Lipitor (2017 sales: 6.96 billion yuan), Plavix (2017 sales: 5.78 billion yuan), luohuoxi (2017 sales: 3.08 billion yuan), Keding (2017 sales: 2.53 billion yuan), and boluting (2017 sales: 2.084 billion yuan) Table 2: top ten brand products of multinational pharmaceutical enterprises are affected by consistency evaluation Among them, red indicates that there has been generic drug consistency evaluation that has passed the consistency evaluation, which has had a significant impact and challenge on the business of multinational pharmaceutical enterprises Generic medicine plays a very important role in China's primary medical market, while the original research medicine has always occupied a stable position in public hospitals In 2017, the scale of chemical medicine sector in China's pharmaceutical market was 1094.1 billion yuan, including 906 billion yuan for generic drugs and 188.1 billion yuan for original research drugs, accounting for 17% However, the original drugs in public hospitals accounted for up to 80% of the scale of drug use At the level of public hospitals, there is a huge replaceable space for high-quality generic drugs, which is why it is particularly important for generic drugs to "take" public medical institutions through consistency evaluation It is worth thinking that the characteristics of multinational pharmaceutical companies are brand recognition and academic education system in public hospitals, especially in high-end medical and critical areas, and the doctors and patients themselves are more receptive to imported brands For local enterprises, a reasonable pricing system and price management system, making full use of the new drug procurement opportunities under the leading mode of medical insurance, and strengthening the brand communication of high-quality generic drugs are the key points for the consistency evaluation to quickly seize market share 3 The key issues still need to be clarified In the opinions of the general office of the medical reform office of the State Council on reforming and improving the supply guarantee and use policy of generic drugs (hereinafter referred to as "No.20 document"), in order to change doctors' prescription habits, the following regulations are made at the level of medical institutions: Firstly, generic drugs will be included in the list of alternatives to the original drugs through consistency evaluation, which will be marked in the instructions and labels; secondly, drugs in the health sector will strengthen drug management, formulate policies and incentive measures to encourage the use of generic drugs, and strengthen the supervision of clinical drugs; In addition, we should strictly implement the requirements of prescribing according to the generic name of drugs, implement the prescription evaluation system, and strengthen the role of pharmacists in prescription audit and drug allocation From the perspective of the framework of national policies, the current policies of all provinces are still lack of education and concept popularization at the doctor level According to No 20 document, health, drug supervision, medical security and other departments should do a good job in policy publicity and interpretation, popularize drug knowledge and relevant information, and enhance people's confidence in domestic generic drugs We should strengthen the publicity and education of medical personnel, change the habit of irrational use of drugs, improve the level of rational use of drugs, and promote the alternative use of generic drugs We should respond to social concerns in a timely manner, reasonably guide public opinion and public expectations, and create a good atmosphere for reform From the perspective of global generic pharmaceutical industry, the market demand for cheap pharmaceutical products is increasing, governments of all countries are increasing their efforts to control medical expenses, and the demand for high-value pharmaceutical substitutes is increasing It is an irreversible trend to give priority to the development of high-quality generic drugs China is pushing forward supply side reform and product quality improvement, and generic drug consistency evaluation in the drug field is in full swing Medical treatment, medical insurance and other links should comply with the general trend of the country, do a good job in system design and concept publicity at the doctor level, and lay a good foundation for the market acceptance of high-quality generic drugs So that high-quality generic drugs can replace the original research drugs with expired patents and improve the accessibility of drugs Combing the local policy documents, we can find that the current consistency evaluation follow-up policy still lacks clear provisions on some key issues For example, at the purchasing level, after determining the purchasing catalogue, how to choose the purchasing proportion of original research drugs and generic drugs? In terms of price, the national "No 20 document" failed to clarify the relationship between generic drugs and the price of original research drugs In particular, when the price of generic drugs is close to that of original research drugs, or even the price of original research drugs is lower than that of generic drugs, how should doctors choose to use drugs? At the prescription level, "strictly implement the requirements of prescribing according to the generic name of drugs Except for special circumstances, there shall be no trade name on the prescription." Once there is no trade name on the prescription, who will decide which manufacturer's products the patient will get and how to decide? In addition, at the level of medical insurance, when will the policy of "generic drugs with the same quality and efficacy as the original research drugs and the payment of the original research drugs according to the same standard" be implemented? It's all unknown at the moment There is still a long way to go before the policies are fully straightened out and institutionalized and normalized.