How to treat the problem of high drug prices?

Experts remind that rational treatment of multiple drugs is not the root cause of the high drug price. Not all drugs can use trade names. According to relevant laws and regulations, drug names are divided into generic names and trade names. On June 1 day, the Regulations on the Administration of Drug Instructions and Labels formulated by the US Food and Drug Administration was officially implemented. According to this regulation, the generic name must be clearly marked on the drug package, and the word area of the trade name should not be larger than 1/2 of the generic name. In other words, in the future, drugs sold by pharmaceutical manufacturers should not only appear on the packaging, but also list the generic names of drugs in a prominent position. For example, whether it is Gankang or Gai Ke, the words "compound paracetamol and amantadine" will also appear in a prominent position on its outer packaging. In the past, the most striking thing about drug packaging was the trade name. "The generic name is the legal name of the drug, which is characterized by universality. Drugs of the same variety can only use the same generic name. " The relevant person in charge of the Drug Registration Department of the US Food and Drug Administration said that the names of drugs listed in the national drug standards are generic names of drugs, which is an international practice. The trade name of medicine belongs to the category of trademark, which refers to the registered legal symbol name that is different from other similar products, and its characteristic is exclusiveness. Trade names only show the image of pharmaceutical manufacturers and their exclusive rights to trade names. For example, the most common compound paracetamol and amantadine (generic name) used to treat colds has the trade names of more than a dozen drugs, such as Gankang, Renhe Kelik, Jingang Tablet and Gai Ke. "But not all drugs can use trade names." The person in charge said that only new chemicals, new biological products and drugs with compound patents can use trade names after approval. Up to now, only 4% of the drugs with trade names have been approved by the US Food and Drug Administration. It is understood that the current international practice is that each drug can apply for a trade name. At the same time, drug regulatory authorities in various countries have strict regulations and approval procedures for the approval of drug trade names. "In this sense, the simple' one medicine and many medicines' is a normal phenomenon that exists all over the world." Long Zhixian, former president of Beijing University of Chinese Medicine, said. According to the relevant person in charge of the Drug Registration Department of the State Administration of Medical Products, there were some drug-related accidents in the United States 10 years ago. However, since then, the US Food and Drug Administration has not imposed strict restrictions on enterprises to declare drug trade names, but focused on the similarity review of drug names, requiring drug trade names to be easy to identify and distinguish, including evaluating whether drug names have the problems of "looking similar" and "sounding similar". If similarity problems are found, the US Food and Drug Administration will require enterprises to change the names of drugs. In the European Union, the fifth discussion draft of "Guidelines for Acceptability of Names of Medicines for Human Use Registered by Central Procedures" was released in February this year. The guide points out the criteria used to examine the trade names of drugs from different angles, focusing on whether they will cause public health problems and other potential safety risks. Product names are required not to convey misleading therapeutic and pharmaceutical implications, not to mislead the ingredients of products, and not to be confused with existing drugs in printing, writing and oral. At the same time, we should also examine issues related to public health and product specificity. It is understood that the "Measures for the Administration of Drug Registration", which is soliciting opinions from the society, proposes that the State Pharmaceutical Product Supervision and Administration will gradually establish an early warning and prompt mechanism in the process of drug approval. When the application for the same dosage form of a certain ingredient reaches a certain number, the examination and approval department will promptly remind pharmaceutical manufacturers and R&D units, effectively reducing blind development and low-level repeated production, and ensuring the safety of public medication from the source. What causes the abuse of more than one drug? Although he is doing drug research, Long Zhixian, the former president of Beijing University of Chinese Medicine, is also puzzled by the name of the drug. Every time he buys medicine, he should carefully check the ingredients of the medicine. "Just look at the name, I don't know how many drugs are. After reading the ingredients, I suddenly realized that it was a commonly used medicine. " Long Zhixian introduced that there are actually benefits behind a variety of drugs. On the one hand, enterprises change the name of drugs into brands, on the other hand, they want to raise prices. "The State Drug Administration has strict regulations on drug names, but the supervision is not enough and the punishment is not enough to deter drug manufacturers." Long Zhixian said that there are too many domestic pharmaceutical manufacturers and it is very difficult to supervise. Long Zhixian believes that to solve the problem of multiple drugs with one drug, both enterprises and the Food and Drug Administration should manage it well. Enterprises should abide by relevant laws and regulations, and the Food and Drug Administration should strictly examine and approve and strengthen supervision. The State Administration of Pharmaceutical Products has done a lot in controlling one drug and multiple drugs, but it still needs to be strengthened. "One drug and many drugs are very complicated, involving drug registration and new drug approval." A person in the pharmaceutical industry in Beijing told reporters that the key lies in how the state drug regulatory authorities identify new drugs. If a drug with the same generic name has dozens of names, it is not appropriate. Generally speaking, if the main components of a drug remain unchanged, other parts will change, which may bring about changes in drug efficacy, applicability, human metabolism and so on. In this case, whether it is a new drug needs a standard. However, although some drugs have some changes in composition, they have not brought about corresponding changes in drug activity and metabolism. In this case, applying for a new trade name violates the original meaning of the drug trade name. "It can't be said that with a common name, there can't be multiple trade names." The industry insider said. According to the information provided by Professor Li Dakui of Peking Union Medical College Hospital, different pharmaceutical preparations have many different preparation production processes, such as immediate release, sustained release and simple sustained and controlled release, and different drug release systems can be used. Although these drugs use the same generic name, the release rate of drugs in human body is different, so the absorption, metabolism and elimination rates of drugs are very different, and the specifications, dosage and usage of drugs will be different. For example, the instructions of the same generic drug often have different administration schemes: some drugs are taken twice a day, while others are required to be taken once a day. In this case, it is obviously inappropriate to standardize pharmaceutical preparations only by common names, and different trade names are needed to distinguish them. As we all know, China is a big producer of generic drugs. There are many companies producing the same drug, and the market competition is fierce. "Aspirin has many trade names, some of which haven't changed at all, but the pharmaceutical factory has a name that even doctors don't know. Because it can be priced independently, the medical representative can tell the doctor that the commission for the aspirin sold by 30 yuan is 10 yuan, and the doctor will give up other cheap aspirin and open this aspirin when prescribing. " The industry insider said. The insider believes that in fact, to technically control more than one drug, the country needs to invest a lot of research, formulate a standard, and how many changes can make a new trade name. With this standard, it is not difficult to control a variety of drugs. "More than 90% of drugs in China are generic drugs. If new drugs are identified according to the strictest standards, the market will soon be standardized, but it is likely that there will be negative results that ordinary people have no medicine to eat. Because real drug research and development needs a lot of money and time. This is the difficulty of our country. " The insider said that the key is how to grasp this degree. Insiders believe that more than one drug can not be solved in a day or two, and it takes a lot of time to do analysis and research. It is reported that the new "Measures for the Administration of Drug Registration" to be issued by the State Administration of Pharmaceutical Products has revised the application for new drugs, and made it clear that drugs not listed in China are new drugs. This scale is expected to solve the phenomenon of multiple names of one drug brought about by new drug identification. According to Guan Xiaohong, director of the Institute of Medical Molecular Biology of Nanjing Medical University, it is not so much a medicine as a face-changing medicine. "China spent less than 0/%of the research funds of the United States/KLOC, but made drugs 0/00 times that of the United States/KLOC. This is really a joke. " Guan Xiaohong said, what is a new drug? How should this standard be formulated? These are all issues that need to be seriously considered. In the eyes of many experts, "one medicine with many medicines" is a normal phenomenon in itself. China's problem is that it is used by some enterprises to reduce prices and raise product prices to avoid national policies, thus leaving room for prescription rebates for hospitals and doctors. In March this year, 1, 100 pharmaceutical manufacturers jointly wrote a letter to the State Council, arguing that the system of supporting doctors with medicines provided a living space for unfair competition, thus causing the problem of expensive medical treatment. It is understood that if the products of pharmaceutical companies want to enter the hospital, they need to carry out public relations with hospital pharmacies, pharmaceutical affairs committees and clinicians. These costs will eventually be passed on to the drug price. Statistics show that the annual profits of hospitals in China are more than 50 billion yuan, and the "public relations fees" and "kickbacks" that hospitals and doctors get from pharmaceutical companies every year are also amazing figures, reaching tens of billions of yuan. Hospitals occupy the working capital of pharmaceutical companies10 billion yuan for free, maintaining the operation of hospitals. Long Zhixian, former president of Beijing University of Chinese Medicine, believes that drug pricing in previous years is also very problematic. There are almost no drug experts in the relevant state departments to set the drug price, mainly doctors to review the price. Doctors are obviously not familiar with the production of drugs, so the prices of many drugs are very high from the source. After the circulation of medical representatives, drug wholesale, drug distribution and other links, it will be ridiculously high in the hands of consumers. "Changing face medicine and taking medicine to support doctors are all the reasons why it is expensive to see a doctor now." Guan Xiaohong said that the relevant departments need to come up with a clear idea, but they have not seen it yet. According to the current drug pricing mechanism in China, the National Development and Reform Commission has reduced the price for more than 20 times, but it has not stopped the inflated drug price, and it has also fallen into the strange circle of "reducing the price-some drugs disappear-changing the price-inviting tenders from hospitals-reducing the price again". In this strange circle, the development of the entire pharmaceutical industry has been greatly affected. Some experts believe that the high drug price is not caused by more than one drug, but by the system of medicine supporting doctors. To reform this system, we need the joint efforts of drug supervision, medical and health care, social security, drug price management and other departments.