** Drug prices are expected to unify the reform of drug price management

In April 2011, the General Office of the State Council issued the Notice on Printing and Distributing the Major Work Arrangements for the Five Major Reforms of the Pharmaceutical Health System in 2011. As a reimbursement basis for medical insurance, more than one part is paid by the individual. In June 2010, the National Development and Reform Commission published on the official website the Measures for the Administration of Drug Price (Draft for Soliciting Opinions), and entrusted seven associations such as China Price Association, China Chemical Pharmaceutical Industry Association, and China Traditional Chinese Medicine Association to collect opinions. After the price adjustment for some drugs on March 28 this year, the industry was hotly discussing when the new "Drug Price Management Measures" will be issued. In response, relevant officials of the National Development and Reform Commission stated that the drug price management measures have basically matured and are being improved in accordance with the overall requirements of the medical reform work. According to the established work plan, the prices of drugs within the pricing range of other governments will be reduced in batches. The price adjustment will be based on the average social cost of pharmaceutical production and operation, taking into account factors such as market supply and demand. For raw drugs that have passed the patent protection period, the price difference with ordinary generic drugs should be further reduced. For medicines that have entered the medical insurance list, it is necessary to explore and formulate uniform prices as the basis for reimbursement of medical insurance. It is widely believed in the industry that the policy on the uniform price of new drugs entering the Medicare Catalogue will have a profound impact on the pharmaceutical market.

Price confusion

In June 2010, a number of media reported that prices of various medicines rose sharply before the medical insurance catalog was announced. According to reports, according to industry sources, the existence of some loopholes in China's drug price formation mechanism gives companies opportunities to exploit loopholes. The formulation of the National Health Insurance Catalog is led by the Ministry of Human Resources and Social Security, but the formulation of specific prices is the responsibility of the National Development and Reform Commission. When the National Health Insurance Catalogue publishes new varieties, the National Development and Reform Commission cannot immediately formulate corresponding prices. Instead, they must conduct price research in each province before they can issue government pricing. As a result, some companies learned that their products entered the National Medical Insurance Catalog, they immediately fill out the form, set out the reasons for the price increase of the species, to the local price department for price adjustment filing, after receiving the approval of the local price department, the company used this as a basis All localities participate in drug bidding. If the price increase of certain species in certain provinces and cities is not recognized, some companies will simply give up bidding in these areas in order to maintain their high prices. After using this method for six months or one year, the National Development and Reform Commission will only be able to grasp the price of the species after the increase. Based on this, the government’s pricing will naturally be “higher”.

In response to this phenomenon, in June 2010, the National Development and Reform Commission initiated the verification of the price of drugs entering the 2009 version of the National Health Insurance Catalogue, carried out cost and price surveys, and clearly stated that for companies that entered the National Health Insurance Catalog before the company’s sudden price increase, Strict cost verification, if it is an unreasonable price increase, will not be recognized at the time of pricing; for the price increase after entering the catalog and before the government pricing, the relevant company will be ordered to restore the original price. The National Development and Reform Commission also announced that it is studying and formulating new drug price management methods.

For drugs entering the medical insurance catalog, the price difference between the same components of the drug may be very large. Whether Medicare should “pay the bill” for high-priced drugs is also a big issue in the industry. According to Yu Mingde, president of the China Pharmaceutical Enterprise Management Association, China's pharmaceutical production has passed strict GMP certification, and the quality of medicines can fully meet clinical treatment requirements. In China, the quality of most drugs is very good, except for very few drugs. Professor Yang Yuejin of Fuwai Hospital of Cardiovascular Diseases in Beijing believes that in the medical insurance policy, the price of generic drugs of the same quality should be reimbursed. The cost of high-priced drugs above the prescribed price should be paid by patients or through commercial insurance. Avoid Medicare as a high-priced drug “pay the bill” and save the country's limited medical insurance funds.

According to relevant persons from the National Development and Reform Commission, the establishment of uniform prices for new drugs in the medical insurance catalog is an important measure to deepen the reform of the medical and health system and further improve the drug price management policy, which is conducive to the reasonable control of drug price levels, giving full play to medical security and drug costs. The restrictive role of guiding medical institutions to use drugs rationally and controlling the unreasonable rise in medical expenses. For new drugs entering the medical insurance list, the price management department should formulate a uniform price according to the common name as the highest retail price for drug sales, and as the highest payment standard for the reimbursement of the drug medical insurance. In principle, unified pricing should be based on the average social cost and reasonable profit, and should be formulated in consideration of market supply. After review by experts and listening to opinions from related parties, the pricing authority will release it to the public.

The reporter learned that the formulation of uniform prices for medicines entering the medical insurance list is also a common practice in many countries. In Japan, the government uniformly determines the prices of all medicines applicable to medical insurance, and adjusts the pricing of relevant medicines in a timely manner in accordance with changes in factors such as the cost of production of medicines. When determining the price of drugs, the Japanese government mainly considers whether the drugs contribute to medical treatment and whether it has originality, and at the same time it must ensure that drug development companies have appropriate profits.

Prudent exploration

According to relevant persons from the National Development and Reform Commission, the reform of drug prices in the future will mainly include three keywords: "three combinations", "two priorities", and "one enhancement." The "three combinations", that is, the combination of government regulation and market regulation, the combination of encouraging innovation and supporting essential drugs, the combination of cost pricing and curative effect evaluation, and the "two-based" approach, focusing on central management, and unified pricing Lord; "a strengthening" is to strengthen the management of price behavior in circulation.

Establishing uniform prices for new drugs in the medical insurance catalog will have a huge impact on the pharmaceutical market. Those drugs with guaranteed quality and reasonable prices will undoubtedly gain more room for development. According to Professor Li Xiaoying, deputy to the National People's Congress and General Hospital of the People's Liberation Army, the technological progress of a country's pharmaceutical industry has a long process. The government should increase the procurement of domestically produced medicines, support domestically produced innovative medicines to enter the medical insurance list preferentially, and promote industrial development.

Some industry experts also believe that the establishment of uniform prices for new drugs in the medical insurance catalog has a wide range of impacts and needs careful exploration. While reasonably controlling drug prices, it is also necessary to pay attention to the interests of patients, encourage innovation, and coordinate with relevant ministries and commissions. Convergence, and the smooth transition of reimbursement methods.

Ms. Liu, a multinational company’s government affairs department, told reporters that the formulation of a uniform price policy for new medicines in the Medicare Catalogue will have a greater impact on the relatively high prices of multinational products. In order to encourage multinational corporations to take more new products into the Chinese market, the government should give corresponding policy support in terms of relevant policies and patent protection for innovative drugs entering the market.

Dr. Zhang of a top-three hospital in Beijing believes that establishing a uniform price for new drugs in the medical insurance list is conducive to reasonable control of the drug price level. However, two preconditions cannot be ignored: First, the quality level of drugs must be guaranteed in order to ensure clinical practice; The reform of the hospital must be put in place. This is because the patient does not have the right to decide what medicines to be purchased and used by the hospital. If the hospital reform is not put in place, the problem of taking medicine to raise the doctor is not eradicated, and the doctor shall only prescribe high-priced drugs to the patient for his own interests. And beyond the pricing part needs the patient to bear, which is bound to infringe the legitimate interests of patients.

Recently, some pharmaceutical companies have reported to reporters that the NDRC's draft on the new entry into the Medicare Catalogue for the development of a uniform price for drugs suggests that for a single pharmaceutical manufacturer that meets one of the following conditions, its retail price may be controlled by the pharmaceutical manufacturer. Self-determination by enterprises: Chinese patent protection drugs, Chinese administrative protection drugs; patents whose patent filing date was obtained before January 1, 1993, were patented abroad and still in protection; domestic enterprises before January 1, 1993 Produced listed original medicines (within 20 years from the date of listing); First generic medicine (within 5 years from the date of approval of production); Medicines awarded by the State Council for national awards (within 15 years from the date of award); China Production within the country, as a drug product that is stably exported to the international mainstream market (excluding preparations commissioned by overseas companies). Some experts pointed out that this policy shows that the state encourages the direction of pharmaceutical innovation and R&D.