On November 23, 2017, "News 1+1" made an in-depth report on the drug abuse of children with leukemia, and interacted with the guests to explore the causes and coping strategies of this phenomenon. On December 12th, "News Network" reported on the instructions of Premier Li Keqiang at Wuhan Union Hospital: Nothing can be short-term treatment, and there is no shortage of "life-saving drugs".
In recent years, products such as digoxin, protamine, actinomycin D, compound sulfamethoxazole, allopurinol, ergometrine, and Niuhuangjiedu pills have been in a state of tight supply or even out of stock. These drugs that are tight or even out of stock are usually "old medicines", low-cost medicines, pediatric medicines, and first-aid medicines. These products are often characterized by low prices, low dosage, and low profits. The smashing of the goods was resolved by the Prime Minister’s special instructions. Obviously, the urgent need for drug out of stock should not become the norm, nor can it be expected to be resolved by the Prime Minister every time the drug supply crisis occurs. To this end, all medical professionals, including government regulators, should reflect on the reasons, from the system. Solve it.
Just as the report of the 19th National Congress of the Communist Party of China judges the main contradictions of the current society, the current main contradiction is the contradiction between the growing good life needs of the people and the development of the imbalance. The shortage of some drugs at the current stage is structural rather than Productivity is absolutely behind. The shortage of medicines such as emergency medicines, pediatric medicines, and cheap and effective medicines is caused by many specific factors:
(1) The drug pricing policy does not adequately protect the shortage of drugs. Since 1992, China has begun to try the basic drug system and medical insurance system to implement government pricing or government guidance prices for selected drugs. In order to reduce the burden of patients' medical treatment, the government has carried out many “medical reformsâ€. Drug procurement has gradually used the method of bidding and procurement to lower the price of medicines. This has made it more difficult to produce medicines with low profit margins and even created space for rent-seeking power. As a result, low-cost drug manufacturers are reluctant to produce, and circulation companies are reluctant to operate. Some people in the industry said that drugs entering the medical insurance catalogue are equivalent to "finding the death penalty."
(2) Vulnerabilities in drug review and supervision. Some manufacturers have changed their prices of cheap drugs in the name of new drugs, which has increased the burden on patients and is unfair to low-cost pharmaceutical companies that produce in good faith.
(3) “medication with medicine†has intensified the shortage of cheap drugs. In the past, because drugs sold in hospitals were allowed to increase sales by 15% based on the bid price, this means that higher-priced drugs can create more profits for hospital doctors. The profit-seeking behavior of medical institutions has further worsened the market survival environment of low-cost drugs.
(4) Misunderstanding of some patients. Due to lack of medical knowledge and misleading advertisements, some patients think that "new drugs" and expensive drugs are good drugs, and they actively ask doctors to prescribe new drugs and high-priced drugs, which also affects the sales of cheap drugs to some extent.
The good news is that in the past five years, the above-mentioned factors leading to the shortage of low-cost and effective drugs have gradually become clear, and the government departments are adjusting their policies to respond positively to reverse the adverse effects:
(1) The Third Plenary Session of the 18th CPC Central Committee pointed out that it is necessary to "make the market play a decisive role in resource allocation and better play the role of the government." In May 2015, the Health Planning Commission, the Ministry of Human Resources and Social Welfare and other departments jointly issued the "Notice on Printing and Advancing the Opinions on Drug Price Reform", canceled the government pricing of most drugs, improved the drug procurement mechanism, and played the role of medical insurance control fees. The actual transaction price is mainly formed by market competition.
(2) After the release of the drug price, a small number of drugs and APIs have skyrocketed. For example, in the second half of 2015, the heart failure treatment drug Digoxin tablets rose from the original 6.7 yuan/bottle to 68 yuan/bottle. The raw material medicine Di Gaoxin also rose from 75,000 yuan/kg to 400,000 yuan/kg in half a year. On June 28, 2017, the Health Planning Commission issued the “Implementation Opinions on Reforming and Perfecting the Short-Term Drug Supply Security Mechanismâ€, and by the end of 2017, established a mechanism for collecting and summarizing the shortage of drug information, and improved the monitoring and early warning and inventory management system for shortage drugs. National drug supply support integrated management platform and shortage drug monitoring and early warning information system based on big data application. In November 2017, the National Development and Reform Commission issued the “Guidelines on the Price Behavior of Shortage Medicines and APIs Operatorsâ€, further developing a mechanism to regulate market prices, and cracking down on illegal activities such as drug prices and monopoly operations. For a long time in the past, a major problem that plagued the pharmaceutical industry was the backlog of reviews. On July 22, 2015, the Food and Drug Administration issued the “Notice of the State Food and Drug Administration on Conducting Self-inspection and Verification of Drug Clinical Trial Dataâ€, which was revamped by the industry as “722 Tragedyâ€. It was released on August 9, 2016. The General Office of the General Administration of the People's Republic of China publicly solicited opinions on the announcement of the drug production process check (consultation draft). The issuance of the two announcements inhibited the blind and disorderly declaration, and imposed strict requirements on enterprise R&D, effectively alleviating the backlog of the review. Unblocking and uncoupling, on February 26, 2016, the Food and Drug Administration issued the “Opinions of the State Administration of the People's Republic of China on Resolving the Approval of Drug Registration Applications for Priority Review and Approval†to promote the listing of new drugs with clinical value and clinically urgently needed generic drugs. Commentary "formally landed.
(3) On April 19, 2017, the seven departments of the Health Planning Commission and the Ministry of Finance jointly issued a “Notice on Comprehensively Opening the Comprehensive Reform of Public Hospitalsâ€. Before September 30, comprehensive reform of public hospitals was launched, all public. All hospitals canceled the drug addition (except for Chinese herbal medicines). The "completely canceling the medical treatment of medicines and improving the supply system for medicines" was written into the report of the 19th National Congress.
(4) Guide the masses to rationally use drugs, so that the people have more understanding of drugs, health products and their effects.
The US FDA and the European Union EMA have established a platform for shortage of drugs, and maintained close interaction with the public, medical personnel and production companies to maintain the dynamic adjustment of the shortage of drug catalogs. I believe that these are also beneficial to China's shortage of drug management. In addition to low-cost and low-margin shortages, those drugs used to treat rare diseases are also discouraged by companies because of their low dosage, high investment, and high risks. The latter is often referred to as “orphan drugsâ€. In 1983, the United States enacted the world's first orphan drug bill. The European Medicines Agency (EMA) officially implemented the Orphan Drug Act in April 2000. The Japanese Ministry of Health and Welfare began supporting orphan drug research and development in 1985. All countries have given special care to orphan drugs in research and development fund support, market exclusive rights, and listing review channels.
It is worth noting that CCTV's report on the supply crisis is no longer limited to talking about drug prices and medical insurance control fees, but also pays more attention to deep-seated reasons, focusing on the root cause of the problem, and the practical difficulties for pharmaceutical manufacturers. Reasonable interest claims have given a larger length of storytelling. The author believes that this round of "three medical linkages" as a new feature of a series of medical reform policies and CCTV's media guidance are releasing such signals: the government should better play the role of examination and approval and supervision, market entities must be responsible for the health of the masses The initial heart of honesty.
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