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In the Opinions Draft, when it comes to establishing and improving the drug supply security system, it was mentioned that the national basic drug system was established and the central government unifiedly formulated and published the national essential drug list, and fixed drug production, unified pricing, centralized purchasing, and unified distribution were adopted for essential drugs.
On October 21st, Gao Qiang, Secretary of the Party Group Secretary of the Ministry of Health, pointed out in the seminar on “Establishing the National Essential Drug System and Guaranteeing Basic Drug Use by the Masses†jointly organized by the Ministry of Health, SFDA, and the State Administration of Traditional Chinese Medicine. The basic drug system also has 7 A basic policy framework includes government-sponsored fixed-point production, centralized procurement, and direct distribution of essential medicines, and the use of basic medicines in basic medical and health institutions.
However, the problem is that policy makers want to ease the rise in drug costs and supervise rational drug use by providing “essential drugs†to the public, and to establish a government-led basic drug supply system for this purpose. This not only meets the “market principleâ€. Experts questioned, at the same time, under the premise of reform of the medical service system that public hospitals are not in place, the basic drug system faces challenges both in terms of operations and goals.
How to choose the "essential medicine" The first problem lies in the selection of essential medicines and the identification of varieties. A person in charge of a Henan pharmaceutical company asked reporters: What are basic medicines? How to select essential drugs?
In response, the Ministry of Health document stated that for the selection of essential medicines, it will “reasonably determine the types and quantities of basic drugs in China, including clinical basic drugs, vaccines, and blood products, in accordance with the principles of safety, effectiveness, appropriate prices, ease of use, and equal emphasis on Chinese and Western medicine. And so on, and establish a dynamic management mechanism to continuously optimize the variety and structure of basic drugs."
"But what is clinically necessary? How can I determine?" The above-mentioned business people put forward that, for example, high blood pressure drugs, different groups of people may apply different drugs, in the end which can enter the "essential drugs" ranks?
Moreover, according to the requirements of the WHO, essential medicines are mainly inexpensive and affordable varieties that are clinically necessary. Therefore, generic medicines and generic medicines will be the main components of essential medicines. Some patent drug manufacturers have expressed their opinions on this, and a marketing person from a pharmaceutical company in Nanjing, which mainly produces patent medicines and first generic medicines, told reporters that the basic medicine list should be promptly updated according to the practice of the medical frontline, and some new medicines with good efficacy should be included. You can't just keep old.
Followed by how to determine, how to determine the manufacturer and distributor. The above-mentioned Henan entrepreneurs pointed out that it is the national fixed point or provinces and cities to choose their own fixed point? If a variety nationwide selects five fixed-point manufacturers and several distributors, it will inevitably form local protectionism, and the drug circulation industry will have the suspicion of purchasing and marketing through planned economic periods.
Pricing and clinical use problems Since the implementation of the national essential drug system, relevant supporting policies must be implemented, including pricing and clinical use, but how can a reasonable price be set for "essential drugs" compared to the selection of species and fixed-point manufacturing enterprises? How to ensure the clinical use of essential drugs? In these two links, multi-sector management is involved and the contradiction is revealed.
The uniform pricing of essential drugs is also a big challenge to the pricing department. "Evaluation of pharmacoeconomics in China is immature. It is still difficult to correctly calculate the cost of drugs and provide a reasonable price for drugs." An official of the National Development and Reform Commission recently admitted to the newspaper that how to determine the cost of profits and the true cost of the company? Is pricing based on the principle of the lowest market price or is it based on product quality or sub-level pricing? All are pricing problems. Moreover, since the prices of all raw materials and the introduction of environmental protection standards in the pharmaceutical industry this year have increased the production costs of the pharmaceutical industry, it is difficult to predict the trend of raw material prices in the future, and it is quite difficult for basic drugs to give manufacturers certain profit margins in pricing.
Even after basic medicines are uniformly priced by the state, in the centralized procurement of medicines in each province as a unit, are all essential medicines entering the scope of government procurement at this price, and then the medical institutions will add prices at a rate of 15%? These issues need to be considered before implementing this system.
In the seven basic policy frameworks for the implementation of the national essential medicine system, it was mentioned that the basic medicine use system of medical and health institutions should be established, and basic medical and health institutions such as urban community health service agencies, township health centers and village clinics should all use essential medicines. , other types of medical institutions should clearly use the proportion of essential drugs.
“But the problem is that without solving the nature of medical institutions and the source of income, even if the proportion of hospitals at all levels is defined, hospitals may not necessarily use essential medicines. Hospitals do not use them and manufacturers do not produce them. Ultimately, they will only lead to further price increases. There is a further shortage of uplifts and essential drugs,†said Xiao Wei, deputy to the National People’s Congress and chairman of Jiangsu Kangyuan Pharmaceuticals. The prerequisite for the implementation of the basic medicine system is that the state increases investment in medical institutions and guarantees the basic wages and benefits of medical personnel.
At the same time, the Opinions also pointed out that in order to improve the payment and reimbursement mechanism for essential medicines, the public health services and basic medicines used for emergency assistance should be mainly paid by the government. The basic medicines used in basic medical services should be reasonably shared by the government, society and residents. Basic medicines are all included in the basic medical insurance system drug reimbursement catalog, and the reimbursement rate should be higher than non-essential drugs.
In this regard, Xiao Wei told reporters, "This means that the basic drug list and the medical insurance list must be connected, and all essential drugs should be included in the scope of the medical insurance list. However, the establishment of the medical insurance list is the responsibility of the social security department. On this issue, the contradiction between departments is It also highlights that the list of social security departments set up by the health department may not be willing to pay."
In fact, as Zhu Changhao, executive vice president of the China Pharmaceutical Business Association, said, the key to essential medicines is to ensure clinical use, whether medical institutions can implement reforms as soon as possible, and whether or not the basic drug catalog and the medical insurance catalog can be connected can be realized through implementation. The basic drug system of the country is the key to solving the problems of "taking drugs to support medical care" and "expensive medical services."
On October 14th, the National Development and Reform Commission announced the "Opinions on Deepening the Reform of the Pharmaceutical and Health System (Consultation Draft)" (hereinafter referred to as the "opinion"). It has been half a month since the volume expansion brought about by the medical reform has been recognized, but the medical reform has been recognized. Before the detailed implementation rules were introduced, the company was still uncertain. The pharmaceutical industry, which focuses on the production of generic drugs, is most concerned about the basic drug system.