The health care Commission started to take action to recruit and adopt new policies to support the use of conformity assessment products

Source: e drug manager may 10, 2018 allows medical institutions to "temporarily break through" one product and two regulations to use generic drugs that pass the consistency evaluation, and even allows another price negotiation after the price negotiation fails In order to support consistency evaluation varieties, this place has been spelled! "To be included in the list of interchangeable drugs with the original research drugs" and "to be purchased and used preferentially" For more than three manufacturers that have passed the conformity assessment of quality and efficacy of generic drugs, it is clear that the varieties that have not passed the conformity assessment will not be used any more On May 8, 2018, Qinghai drug procurement center issued the notice on ensuring the supply of drugs for the consistency evaluation of quality and efficacy of generic drugs, which expressed a very clear support attitude for the varieties passing the consistency evaluation from drug procurement, hospital use, product pricing and other aspects At the same time, Qinghai drug purchase center also released a batch of 15 drug lists, including cefuroxime ester tablets, gefitinib tablets, irbesartan hydrochlorothiazide tablets, etc., which have passed the consistency evaluation or deemed to have passed the consistency evaluation It is clear that they are treated equally with the original research drugs in the purchase of drug collection in Qinghai Province, and are purchased online Of course, Qinghai's statement is not an example In terms of the current implementation in various regions, Shanghai, Jiangsu, Ningxia, Shaanxi, Jilin and other places have successively issued documents for the supply assurance of drugs through consistency evaluation No matter from the perspective of the policies issued by the state or the various measures implemented by various regions, we can see that the era of truly favorable generic consistency evaluation seems to have come As "focus interview" said in the topic of generic drugs: this new deal from the promotion of domestic generic drugs, expand the import of drugs at the same time, can be said to be a big game to force pharmaceutical enterprises to reform and innovate, enhance competitiveness 1 As a matter of fact, in addition to the statement of the newly released centralized drug purchase document of Qinghai Province on the consistency evaluation of drugs, the practice of Zhejiang Province is also concerned by the industry According to a widely circulated document on the Internet, on April 28, 2018, the leading group office of centralized drug procurement of Zhejiang province released the notice on direct online procurement of generic drugs through quality and efficacy consistency evaluation In addition to encouraging medical institutions to give priority to the procurement and use of generic drugs through consistency evaluation, there are two non contents It is often worth paying attention to: first, in the process of drug price negotiation and confirmation, for the products that are not negotiated due to price reasons but pass the consistency evaluation, another price negotiation can be conducted, and the specific scheme shall be determined by each region 2、 Before the end of 2018, medical institutions can temporarily break through the provisions of the "prescription management measures" on the use of one drug and two regulations, and increase the purchase and use of products that pass the consistency evaluation Compared with the previous statements of "principles" in many provinces, if the regulations are implemented in Zhejiang Province, it will undoubtedly be a real policy inclination for generic drugs through consistency evaluation Especially on the "one product, two regulations" At present, the actual implementation of many hospitals has gradually evolved from the initial provisions of "no more than two kinds of registered dosage forms and oral dosage forms under the same general name" to the potential rules of "only one imported product and one domestic product are purchased for the same variety" The competition for seats of domestic drugs is unprecedented, and the varieties that pass the consistency evaluation can break through successfully The additional price negotiation opportunities are more practical in the current centralized purchase of drugs, which means that the enterprises participating in the price negotiation of drugs will have a greater negotiating potential When other enterprises are worried about losing negotiation qualification due to excessive quotation, consistency evaluation varieties can have more opportunities to test the price bottom line acceptable to the purchasing department, so as to maintain their own price system as much as possible But the problem remains "Prescription management measures" is a department regulation issued by the former Ministry of health Does Zhejiang Province have the right to allow "temporary breakthrough" of medical institutions? Will giving an additional price negotiation opportunity to evaluate products through consistency bring more questions about the fairness of price negotiation in drug purchasing department? Although all regions are encouraging the use of generic drugs, how can we solve the "only low price theory" cycle brought about by multiple demands for price linkage? How to solve the conflict of drug proportion between national drug price negotiation varieties and generic drug varieties through consistency evaluation? 2 What we can see from admittance and pricing is that with the list of varieties that have completed the consistency evaluation coming out one after another, many regions have begun to enter the stage of online procurement of varieties that have passed the consistency evaluation For example, Shanghai Sunshine pharmaceutical procurement platform has released the second batch of drugs that have started online procurement through consistency evaluation, and Liaoning provincial centralized procurement office of drugs and consumables also released the notice on launching new approved innovative drugs, generic drugs through quality and efficacy consistency evaluation, and generic drugs directly online procurement through national negotiation on April 18 Gansu, Heilongjiang, Shaanxi, Jiangsu and other places have also issued documents in recent years to encourage medical institutions to use varieties that pass the consistency evaluation, and to purchase and use them preferentially on the basis of enjoying the same treatment of the original research or appropriately reducing the price And that's not the only good news Jiangxi, Anhui, Gansu, Zhejiang and other provinces will also give a one-time reward to the varieties that complete the consistency evaluation For example, Anhui Province stipulates that the provincial development and Reform Commission, the Provincial Department of science and technology and other departments shall give priority to supporting the application projects of drug varieties that pass the consistency evaluation under the same conditions For the generic drugs that have completed the consistency evaluation of quality and efficacy, a one-time reward of 1 million yuan will be given for each type of generic drugs, with a maximum of 3 million yuan for a single enterprise But in fact, for enterprises, the reward is still in the second place, and what really measures the competitive advantage after the consistency evaluation is nothing more than two contents, the first is access, the second is pricing At present, these two points are not able to be optimistic From the perspective of access, the overall tone is still to encourage medical institutions to give priority to the use of drugs that pass the consistency evaluation For example, Qinghai Province has stipulated that for drugs that pass the consistency evaluation, medical institutions should include them in the list of mutually replaceable drugs with the original research drugs, and give priority to purchase and use Similar to this is Jilin, whose current policy is to include the drugs through the consistency evaluation of the quality and efficacy of generic drugs into the directory of direct online purchase, and then the medical institutions through the provincial pharmaceutical purchase service platform to determine the purchase price and implement online purchase Before that, some cheap varieties were included in the direct online purchase catalogue, such as basic infusion, non patent medicine for gynecology and pediatrics, emergency medicine, etc But not all places adopt this attitude For example, Foshan Municipal Bureau of human resources and social security issued a notice on April 26, saying that it clearly did not adopt the proposal of "increasing drug varieties that pass the consistency evaluation, and medical institutions should give priority to purchasing and clinical selection", and that "clinical selection of medical institutions should be respected" And the access problems caused by the policy supporting problems also exist For example, at present, for the varieties participating in the national drug price negotiation, it is clear that they are not included in the proportion of drugs, and there is a trend of national promotion, but for the generic drugs of some products, it means that even if they pass the consistency evaluation, it is difficult to obtain access qualifications in the hospital After all, all the documents encouraging the priority use of conformity assessment varieties are "suggestions", which is not a mandatory regulation However, the impact of drug proportion on hospitals is real Hospitals will have the greatest motivation to choose drugs that do not account for the proportion of drugs, rather than the consistency evaluation varieties And pricing is the key factor to determine whether the future consistency evaluation varieties can really play a role and gain market advantage There is no doubt that in Qinghai, Jilin and other provinces that have issued documents related to consistency evaluation varieties, the pricing of related varieties is absolutely advantageous On the one hand, for example, Zhejiang Province, consistency evaluation varieties may have more special treatment of drug price negotiation On the other hand, according to the released documents of Qinghai Province, even if the products are not successfully purchased, the consistency evaluation varieties will also play a role in resisting the price of the competitive products According to the statement of the document, "if the procurement fails to pass the conformity evaluation of domestic similar varieties, the actual procurement price shall not be higher than that of the varieties passing the conformity evaluation" But at the same time, the strange circle of low price theory is still unresolved For example, the requirement of Shanghai is that its pharmaceutical purchasing sunshine platform provides price information of other provinces and cities, Shanghai and the same variety as a reference for negotiation "The result of negotiation shall not be higher than 70% of the price of the original research drug or reference preparation If there is no price of the original research drug or reference preparation of the same specification, the price difference of the original research drug or reference preparation of other specifications of the same generic name shall be determined." However, Qinghai Province made it clear in the announcement that the provincial health and Family Planning Commission regularly announced the actual purchase price of medical institutions and the bid price of western provinces during the purchase period, which will be referred to and dynamically adjusted by medical institutions For enterprises, "national linkage" and "dynamic adjustment" are undoubtedly the two most reluctant words This means that the purchase price of drugs in the province must be the lowest price, which is definitely not good news for the maintenance of the overall price system of enterprises, even for generic pharmaceutical enterprises that have passed the consistency evaluation Therefore, although the harvest period of generic conformity assessment is far ahead, there is a long way to go before we can really get there 3 As for the alternative use of generic drugs, the health care Commission has begun to take action that "if we want to really make the products work, the following policies need to be matched From the bidding, procurement, the whole medical insurance reimbursement and entering the hospital, we need to build corresponding matching mechanisms." In an interview with focus interview, the director of the Department of pharmacy management and clinical pharmacy of Peking University School of pharmacy said in the historical record In fact, the future use of varieties through consistency evaluation in clinical practice is also the same In addition to various policies issued in advance, the following supporting policies are also essential Action is already under way at the national level in this regard On April 3, 2018, the general office of the State Council officially issued the heavyweight policy "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", in which multi-dimensional explanations were made on how to promote the alternative use of generic drugs, especially for the requirements of medical staff First, the generic drugs that are consistent with the quality and efficacy of the original research drugs shall be included in the catalogue of substitutable drugs with the original research drugs, marked in the instructions and labels, and relevant information shall be released to the society in time, so as to facilitate the selection and use of medical staff and patients Second, the competent units of medical institutions also put forward clear requirements, such as health and other departments to strengthen drug management