Core Tip: In our country, “the original study medicine” mainly refers to the period of patent protection over the import of drugs. At present, the “original study medicine” in China’s pricing is far higher than the “Drug government pricing,” the required standard. China-made generic drugs of equal quality with the “original research medicine” spread disparity.
Although the “original study medicine” and the generic drug may be in process and so there are certain differences, but there are differences in the extent to reflect the effect, there are no clinical data support the lack of evidence of evidence-based medicine.
“Original research medicine” and the generic drug there is a huge price difference, so that domestic enterprises have lost an equal right to compete, survive severely squeezed.
To change this unfair situation, it is recommended the Government to formulate drug policy conducive to fair competition. To increase the intensity of government procurement domestically produced drugs, support of domestic medical insurance directory given preferential access to new medicines. In the health insurance policy, should be of equal quality, the price of generic drugs for reimbursement, “the original study medicine” in part by higher pay or by patients with commercial insurance payments, to avoid Medicare pay for the expensive medicine to save the country’s limited health-care funding.
Similarly, the price disparity ① Composition
Yang, 65, suffers from high blood pressure, all year round to eat an imported medicine “Norvasc”, a 5 yuan, the blood pressure has been controlled pretty well. Most recently, he went to Guangzhou, a small hospital, by the way a prescription drug. The doctor told him that here, they can not, “Norvasc” can only be made to open generic drug “peace inside true”, the active ingredient is amlodipine besylate, the same effect, but the price than the “Norvasc” cheap lot, a less than 1 yuan. Yang doubtful, try to eat for some time, blood pressure can be controlled at normal levels. Although the two drugs can be reimbursed Medicare, but the Lao Yang is very confused: the same ingredients of antihypertensive drugs, why the prices of domestic and imported so the gap?
“Norvasc” in general, called amlodipine besylate, Pfizer produced by the United States in the country known as the “original research medicine.” It is Pfizer’s global first apply and obtain patent protection. Today, it has passed its patent protection period, other companies can imitate.
According to the State Development and Reform Commission promulgated the “Drug government pricing approach,” State invention patent protection period has expired the original development of drugs than the GMP production of generic drugs, injection rate does not exceed 35% of the difference, other formulations spread rate does not exceed 30%. Also provides pharmaceutical government pricing, and comprehensive consideration of their reasonable operating costs of production, profits, the same price of drugs or alternative medicines, if necessary, to make reference to the international market price of the same kinds of drugs.
Since 2004, the state several times down the retail price of drugs, the most recent price cuts, domestic pharmaceutical companies in drug prices more than 60% Heavy, foreign patent drug price reduction 20%, but generics only about 25% lower prices. Ceftriaxone for injection, for example, Roche’s production of the original study medicine “Rocephin” the price of up to 80 yuan, while China-made generic drugs are only 4-5 yuan, the price difference between the two nearly 20-fold.
China Pharmaceutical Enterprise Management Association, vice president of Yung-Pei that, according to our laws, patent medicine patent law can be protected. However, there is no law or regulation provides for an “original research medicine” of protection. The so-called “original research” in the name of the patent after a period of illegal imports of drugs to be protected.
② no clinical evidence of efficacy differences
In accordance with China stipulates that “the original study medicine” can be individually priced. Beijing is the first SECCO Pharmaceutical Generic Norvasc companies, trade names as “pressure’s up” (amlodipine besylate). In 2008 in the United States according to U.S. standards of bioequivalence tests proved that the “pressure’s up” and “Norvasc” completely equivalent, the two have the same clinical efficacy and safety.
National Development and Reform Commission published in the “About arginine 354 kinds of medicines notice of the maximum retail price (the price Development and Reform Commission [2006] No. 2989)” file, despite the pressure’s up to this product has been fully achieved the international quality level, but confined to the current price management policies, the pricing of the product in China is still pricing in accordance with national GMP standards, namely, the maximum retail price of 27.5 yuan (5 mg × 7 films), and “Norvasc”, the maximum retail price of 42.3 yuan ( 5 mg × 7 films) a difference of 1 / 3.
It is reported that China’s introduction of the “original research medicine” is designed to fill some gaps in the country do not have medicines. Yung-Pei said that if Taiwan does not have the same drug, for preventing and curing diseases of the consideration, in terms of price policy to give preferential treatment, it should be. However, if after a period of patent protection, in particular, is the quality of generic drugs have the same post, there is no need for further price discounts.
Then, “the original study medicine” in terms of quality is not much better than the domestic generic drug? China Pharmaceutical Enterprise Management Association, Yu Ming said that China’s pharmaceutical production are strictly GMP certified, pharmaceutical quality can be achieved clinical requirements. In our country, in addition to very few drug quality is not high, most of drug quality is still very good.
The industry believes that, despite the “original study medicine” in the production conditions, raw and auxiliary materials, process equipment, process equipment, technology level, quality management, etc., and there are certain differences between generic drugs, but there is little difference in efficacy of reflection no clinical data support the lack of evidence of evidence-based medicine. In general, generic generic drug companies would put imitation drugs being compared to right, with a view to achieve the same quality. If imitation “Norvasc” enterprises, will choose “Norvasc” as the control cultivar, to compare the safety, efficacy, plasma drug concentration. If there exists an obvious quality difference between drugs, the state will not be approved, companies will not get the country medicine accurate approval documents.
③ squeezing domestic drug space
In the drug tender, dubbed “the original study medicine” name expired patent medicine as a separate quality levels, the absence of competition, thereby gaining a monopoly advantage.
In the drug throughout the bidding process, the successful decline in domestic drug prices much higher than imported drugs. Last year, Guangdong, Shanghai, Chongqing, Henan and Tianjin won the bid of antihypertensive drugs as an example: generic name for amlodipine besylate, there are four different trade names are the Norvasc (Pfizer), Anneli True (Suzhou East Switzerland), Randy (Yangtze River) and Ning (the anti-Lu), 5 mg × 7 is also the specifications of Norvasc in Guangdong, the lowest price at 34.7 yuan in Chongqing in the price up to 38 Yuan, there are six provinces and cities all successful. While the other three kinds of generic drugs, and in some provinces and cities did not bid. In order to bid, security in the real price in Guangdong, is only 5.83 yuan.
In the process of using drugs, hospital implementation of the “prescription regulations” in the “one product two rules” (with a drug, in principle, only two manufacturers of the products). Beijing Millennium Monument Hospital, Shui-Xiang Yang, director of Cardiology, said that in the process of implementation, it becomes an import product, and a domestic variety. Such as antihypertensive drugs, a variety of “Norvasc” and the other species is produced domestically. Domestic production of such drugs, many manufacturers, in order to squeeze this one of those places pay a high price, while the import of drugs sit tight in the Diaoyutai State Guesthouse. “A product of two rules” provisions in virtually limited domestic use of drugs, so that people spend more money.
SECCO vice president of Beijing Pharmaceutical Co., WANG Wen-feng said that the original research of drugs and generic drugs there is a huge price difference between domestic-funded enterprises have lost the right to fair competition, survival of severely squeezed.
To occupy the Chinese pharmaceutical market in the forefront of high blood pressure drugs, for example, since the 2005-2007 occupation of the hospital market share of the top 10 manufacturers, 8 companies are foreign-funded enterprises. In 2007, it occupied a total of eight foreign sales of high blood pressure medicine for 60% of the hospital. China’s pharmaceutical industry in the press on a large scale foreign-funded enterprises under the market share is dwindling continuously.
Yung-Pei said, “the original study medicine” in the Chinese market to enjoy all the preferential policies of “super-national treatment.”
④ high-priced drugs will pay for health insurance should not be
Earlier this year, the State Council Information Office news conference in Beijing, the National Development and Reform Commission deputy director of the Penson has said that the resolution of the original study drugs and generic drug price gap is a very sensitive issue. To this end established the principle of medical reform, on the one hand to encourage pharmaceutical companies to conduct innovative research and investment, the first imitation listing after listing of generic drugs still adopt from low prices, to prevent low-level duplicated construction. At the same time to promote fair competition among enterprises, in the original research on drugs and generic drug prices to have a narrow process. Listing in the future for new drugs, will maintain the original study the prices of generic drugs and a reasonable convergence.
Beijing Fu Wai Cardiovascular Hospital, Professor Yang Yuejin that the pricing policy, the original research generic medicine can be distanced, according to the required proportion increases, but not too far. In the health insurance policy, should be of equal quality, the price of generic drugs for reimbursement, the original drug research in part by higher pay or by patients with commercial insurance payments, so as to avoid medical insurance will pay for the expensive drug to save the country’s limited health-care funding.
National People’s Congress, People’s Liberation Army General Hospital, said Professor Li Xiaoying, a State Pharmaceutical industries technological advances, the need for a lengthy development process. Recommends that the Government formulate drug policy conducive to fair competition. To increase the intensity of government procurement domestically produced drugs, support domestic priority access to health insurance directory new medicines to reduce the cost of unreasonable expenditure of health insurance. (PRC – People’s Daily)
