Seven key points of drug price negotiation of health and Family Planning Commission

Source: saibelan Author: situ Yangming 2015-3-20 the drug price control released by the national development and Reform Commission has not been implemented yet, and the drug price negotiation control of the health and Family Planning Commission is coming soon!! It is understood that the "pilot work plan for establishing a drug price negotiation mechanism (Draft for comments)" drafted by the state health and Family Planning Commission has been solicited at the level of all ministries and commissions under the State Council, and the plan proposes "establishing a national drug price negotiation Steering Committee" , led by the health and Family Planning Commission, the office of the Commission is located in the health and Family Planning Commission, and a "national drug price negotiation and supervision commission" composed of relevant government departments is established Cypress blue saw the scanned version of the draft in wechat groups of many medical circles yesterday According to the letter of soliciting opinions from the general office of the health and Family Planning Commission, the plan has solicited opinions from the national development and Reform Commission, the Ministry of education, the Ministry of industry and information technology, the Ministry of finance, the Ministry of human resources and social security, the Ministry of Commerce, the audit office, the General Administration of customs, the State Administration of Taxation, the State Administration of industry and commerce, the State Administration of food and drug administration, the Intellectual Property Office, the Insurance Regulatory Commission, the State Administration of traditional Chinese medicine, and the Ministry of general post health.15 The deadline for consultation is March 17 According to the normal progress of work, it means that the consultation of the program between ministries has ended Generally speaking, the next step of the health and Family Planning Commission is to consult a wider range of institutions This plan is an industry policy that will have a significant impact on the entire drug market after the national development and Reform Commission is about to liberalize the drug price control reform It is bound to attract the high attention of almost all pharmaceutical enterprises, especially the independent pricing, high quality and good price, patented drugs, original research drugs and other products before the national development and Reform Commission released the drug price control Here are seven key points of the drug price negotiation Committee of the health and Family Planning Commission What are the objectives of the negotiation scope? What medicines will be cut? The price is high, the curative effect is exact, a number of patented drugs and exclusively produced drugs of social concern are first piloted Patent drugs and exclusive production drugs in cancer drugs, children drugs, public health drugs, Chinese patent drugs, etc are included in the scope of negotiation What is the price reference? Why bargain? Prices of Hong Kong, Macao, Taiwan and other Greater China regions, bid prices of provinces, autonomous regions and municipalities directly under the central government, historical purchase prices of medical institutions, retail prices of pharmacies, purchase prices of representative countries, etc How to talk about it? Who will have the negotiating power? 1 Patent drugs for clinical use With reference to the drugs in Hong Kong, Macao, Taiwan and other Greater China regions and other countries, relying on the budget of the health and Family Planning Commission to manage the quantity of drugs used in hospitals, provincial hospitals, affiliated hospitals of colleges and universities and military hospitals, the market price is changed, and the purchase price is negotiated and agreed by the relevant professional Negotiation Committee (national level discussion) 2 Public health patent drugs, AIDS, tuberculosis and other drugs are included in the procurement of major public health projects, and the CDC has agreed on the purchase price (national level negotiation) 3 For proprietary Chinese patent medicine, provincial negotiation organizations are entrusted to determine the price through negotiation and consultation according to the local medical insurance financing level, and link with medical insurance payment (provincial level talks) negotiation principles? Reason and condition of bargaining! We should set up the price of other drugs at the national and provincial (District, city) levels, distinguish different types of patented drugs and exclusively produced drugs, use policies and strategies such as medical insurance payment standards, public health services, medical market share, etc., and take measures such as linking volume and price, single source of goods, purchase and gift combination, package price negotiation, tax price linkage, etc to maximize the negotiation effect Duan ~ ~ top priority, Negotiation Committee! Under the leadership of the health and Family Planning Commission, the national development and Reform Commission, the Ministry of education, the Ministry of industry and information technology, the Ministry of finance, human resources and social resources security, the Ministry of Commerce, the Ministry of audit, customs, taxation, industry and commerce, food and drug administration, intellectual property rights, health care supervision, general guard and other departments The committee members are composed of ministerial leaders of relevant departments To examine and approve the varieties of negotiated drugs, the implementation plan for negotiation, the purchase price and other major issues Who will start first? The National Cancer Center, the National Cardiovascular Disease Center, Beijing Children's Hospital, China CDC, and the association of traditional Chinese medicine industry set up negotiation groups of tumor drug use, cardiovascular drug use, public health drug use, Chinese patent medicine, etc to propose negotiation strategies, undertake specific negotiation matters, and organize experts to Conduct on-site or online negotiation Some varieties can also be entrusted to the provincial recruitment office Distribution settlement encourages pharmaceutical enterprises to directly distribute If they entrust distribution, they can only entrust once "Although the drug price negotiation mechanism itself is a market-oriented and progressive idea, I'm afraid there are still many controversial contents in this document," said senior industry figures For example, it is stipulated that pharmaceutical factories can only entrust distribution once, but whether the drug distribution is within the management scope of the health and Family Planning Commission; for example, "tax price linkage" means that if the price is reduced, the tax rate of this drug can be reduced, but the tax rate is set by the state For another example, if the price is not reduced, the patient is willing to pay (his own burden), is not allowing the hospital to use drugs depriving the patient of the right of free choice? In addition, Premier Li Keqiang's government work report clearly stated that "all non administrative licensing approvals will be cancelled in 2015" Will this round of Drug Price Negotiation Committee become a disguised administrative approval for drug market access? Yesterday, the first financial daily also reported on this It is reproduced as follows: the national drug price negotiation mechanism "viviparous" patent, the most market-oriented and international management thinking drug price negotiation mechanism in the first financial Wang Weijia drug price reform, has officially entered the legislative process "The first financial daily" learned on the 19th that the "pilot work plan for establishing a drug price negotiation mechanism" (hereinafter referred to as "the plan") has officially ended the solicitation of opinions among relevant departments of the state on the 17th and entered the next round of legislative procedures According to the plan obtained by this newspaper, patent drugs and exclusive products in cancer drugs, cardiovascular drugs, children's drugs, Chinese patent drugs and public health drugs will be the first to enjoy the "negotiation" treatment The establishment of "Drug Price Negotiation Committee" for drug price negotiation is in the offing "Select a number of patented drugs and exclusive production drugs with high price, precise efficacy and social concern as pilot projects, and conduct price negotiations with the prices of Hong Kong, Macao, Taiwan and other Greater China regions as reference." The pilot work plan for establishing a drug price negotiation mechanism is specified in the draft for comments On March 18, the first drug price negotiation document formulated at the national level just ended its consultation among 15 departments, including the national development and Reform Commission, the Ministry of human resources and social security, and the State Food and drug administration "Reducing the false high price of drugs", "preventing and curbing corruption in the field of drug purchase and sale, and resisting commercial bribery" are the goals that the new market-oriented policy hopes to achieve "This time, it is proposed to establish a national, provincial, district and municipal drug price negotiation mechanism Different types of patented drugs and exclusively produced drugs will have different methods of negotiation, and market share, clinical use demand and other factors will be the reference factors for negotiation." Yesterday, some authorities close to the health and Family Planning Commission disclosed to the first financial daily And the demand of clinical practical use has become the first principle of entering into the scope of negotiation "Guided by demand, we will focus on bringing the patented drugs and exclusive products in cancer drugs, cardiovascular drugs, children's drugs, public health drugs, Chinese patent medicines into the scope of negotiation, accumulate experience, and gradually expand the number of types and varieties of negotiated drugs." The plan is clear Specifically, for clinical patented drugs, the price of drugs in Hong Kong, Macao, Taiwan and other countries will be referred to, and the quantity of drugs used in TB hospitals will be "market for price", and the purchase price will be negotiated and agreed by the professional negotiation group For public health patent drugs, HIV / AIDS and TB drugs will be incorporated into the procurement and supply mode of public health projects, with budget negotiation, volume negotiation, centralized procurement, centralized distribution, designated institutions and fixed users, and the procurement price will be negotiated and agreed by China Disease Control Center For Chinese patent medicines produced exclusively, the plan requires that provincial negotiation organizations should be entrusted to determine the purchase price through negotiation and consultation according to the local medical insurance financing level, and link with the medical insurance payment standard to promote enterprises to return to a reasonable price range "A large number of negotiations need to be carried out The responsibility of the national drug price negotiation Steering Committee is to determine the negotiated drug varieties, negotiation implementation plan and purchase price." Said the person According to the contents shown in the plan, the national drug price negotiation Steering Committee (hereinafter referred to as "the National Drug Price Negotiation Committee") will be established under the leadership of the health and Family Planning Commission, with members from the member units of the national drug price negotiation Commission, China Center for disease control, the drug management center of the health and Family Planning Commission, the statistics information center, the drug price evaluation center of the development and Reform Commission, etc According to the principles currently determined in the plan, drug price negotiation will be drawn from the national expert database of drug price negotiation, and 3 In the negotiation process, odd negotiation groups with more than one person are allowed and encouraged to explain the price, curative effect, sales and other information of drugs to the society in an appropriate way, and to accept inquiries The negotiation results will be publicized on the public information platform, and drug manufacturers are encouraged to directly distribute the drugs In the once-a-year procurement cycle, the drug prices will remain unchanged in principle Multinational pharmaceutical companies that negotiate "noble drugs" and focus on original patented drugs will undoubtedly become the first experimenters of this system "Whether or not to enter into the negotiation mechanism depends on whether these patent drugs conform to the four basic principles, namely, the first is patent drugs, which are monopolized by the supplier; the second is high price; the third is effective and has clinical value; the fourth is not in the medical insurance catalog." Dong Chaohui, deputy director of the medical insurance Department of the Social Security Institute of the Ministry of human resources and social security, disclosed this topic in an interview with this newspaper As a matter of fact, there has always been a call from the public for the price reduction of the products of multinational pharmaceutical enterprises - on the one hand, these drugs have significant curative effect; on the other hand, it is precisely because they have invested a lot of costs in the research and development stage, and in order to encourage innovation, these original developed drugs also have the right of high pricing "If this plan can be determined, it will definitely be a good thing, so that our public can use better drugs more, and for enterprises, it can also enter into a larger market." Yesterday, Zuo yuzeng, an industry representative of multinational pharmaceutical enterprises and spokesman of rdpac of China Association of foreign funded enterprises, replied to the first financial daily In 2010, the Ministry of human resources and social security tried to introduce high-quality drugs from some multinational pharmaceutical companies into medical insurance Many pharmaceutical companies, including Eli Lilly, Pfizer, Roche and Nanjing Xiansheng, participated in the pilot work of medical insurance negotiation to varying degrees "In fact, all regions are doing the work of drug price negotiation now Because the ability of medical insurance payment in each region is different, the principles and varieties of negotiation are also different." Said the person Public information shows that since 2013, Jiangsu, Zhejiang and other economically developed provinces have begun to try to negotiate high price drugs at provincial level In December 2014, 31 high-value drugs were included in social security of Zhejiang Province