The drug price game behind "sues the development and reform commission"

Recently, a drug production company in Guangdong sued the National Development and Reform Commission for its news. The “trigger” is a regular tablet of azithromycin produced by a foreign company. Since it obtained the independent pricing right for the “identity” of the original research drug, it won the bid of more than 20 times the price of other products in the local drug bidding procurement, causing domestic companies to strongly dissatisfaction. . The pharmaceutical manufacturer in Guangdong filed an administrative reconsideration with the National Development and Reform Commission, which gave it its individual pricing power. After being rejected, the pharmaceutical development company in Guangdong sued the National Development and Reform Commission.

The controversy over the original pricing policy for the original research drug has been long-standing. At present, the direction of the country's liberalization of drug prices has been clear and a new round of drug price reform is about to start. The sustained fermentation of this incident during the sensitive period highlighted the concerns of all parties concerned with the direction of drug procurement policies.

The concept of separate pricing will no longer exist

Last November, the executive meeting of the State Council has clarified the direction of drug price reform. Although the State Council's document on advancing the reform of drug prices has not yet been formally introduced, it has long been circulated among the parties. In February of this year, the State Council issued the "Guiding Opinions on Improving the Centralized Procurement of Drugs in Public Hospitals," and clarified the principle of procurement of drugs such as tender pricing and negotiation pricing. On April 24, the newly revised "Drug Administration Law" was promulgated and the related provisions for the government's pricing were removed. The model of price control by the development and pricing departments became history, and the concept of separate pricing ceased to exist.

A number of experts interviewed all stated that as the pattern of drug price reforms becomes clearer, the pricing advantages of Ingenic Drugs in drug procurement will certainly be affected. “The separate pricing policy for original research drugs with Chinese characteristics and controversy has long been abolished,” said a drug policy research expert who declined to be named.

Patents that have passed the patent protection period and are first developed by a multinational pharmaceutical company are called original research drugs. Shi Zhaowen, director of the Center for International Management of Pharmaceutical Administration at Peking University, said that the original research drug is also a historic product with Chinese characteristics. Around 2000, in order to encourage multinational drug companies to bring new medicines developed to China, the National Development and Reform Commission gave preferential pricing policies for original research drugs as a kind of compensation for intellectual property rights of R&D companies. Although the policy is still in use today, the opposition from domestic generic pharmaceutical manufacturers has continued.

In 2013, GlaxoSmithKline issued a bribery door and launched the “Great Wall Project” after the expiration of the Hepatitis patent “Hepatin”. After using the separate pricing qualification to obtain more profit, it “spends” to relevant parties. Tens of millions of yuan, clearly demanded to boycott domestic generic drugs, once pushed the original research drug to the cusp of the storm.

The principle of purchasing quality and preferential prices will continue

Although the original research product has a lot of pricing problems, its stable and excellent quality has been recognized by industry experts. Experts said that in the upcoming round of public hospital drug procurement, how to reflect the principle of higher prices and better prices is worth studying.

The above-mentioned drug policy experts said that in the public hospital drug procurement, there is no clear statement as to whether or not the quality of the same drug product is differentiated. However, it is undeniable that there are many generic drug manufacturers in China, the quality of drugs is uneven, and some generic drugs are even difficult To meet the needs of clinical efficacy, "adherence to the principle of superior quality and price is still necessary."

“In the face of a large number of drug varieties, the tendering department has no better way. The practice of quality differentiation should continue.” In this regard, Shi Luwen made an image metaphor. “There are young and old, and there are academic qualifications. High and low, do not stratify the quality, the actual operation of tender procurement is difficult."

In addition, the other thrust of the implementation of quality-differentiated procurement may come from the insistence of the original research drug manufacturers. In the past, every time there was a news of cancelling the original pricing of the original research drug, the relevant companies and associations would “lobby” to the National Development and Reform Commission and requested to retain the preferential pricing policy for the original research drug.

However, Shi Wenwen also stated that many domestic generic drugs have made great progress in quality, and some even have better quality than original research drugs. The difference in quality should be specific to specific drugs. It cannot simply be said that the quality of the original research drug must be better than that of generic drugs. . The above-mentioned drug policy experts also stated that quality-based procurement should be carried out under the premise of determining the amount of clinical use, and determine the demand for drugs at different levels according to different clinical needs. General diseases should adhere to the use of domestic generic drugs to reduce the use of drugs for patients. burden.

Establish a linkage mechanism for different quality drug prices

The "Guiding Opinions on Improving the Centralized Procurement of Pharmaceuticals in Public Hospitals" clearly states that the implementation of quantitative procurement and improvement of double-envelope evaluation methods will be used for open tender procurement of non-patented drugs produced by a large number of companies with large clinical doses and high purchase amounts.

"If the original research drugs are divided into a single group, there is still no way to control the prices of most of the original research drugs due to the small number of competitors." The above-mentioned drug policy experts said that in the specific operations, generic drugs that will pass the quality consistency assessment should be considered. Through overseas certification of the United States, the European Union and other domestically-made generic drugs, they are placed in a group for tender procurement together with the original research drug.

However, there are few domestic generic drugs that pass the quality conformance assessment and overseas certification. The quality of differentiated procurement will make the competitors of high-quality group drugs may still be few and may form new price alliances.

In this regard, experts suggest that the efficacy, price, and economic evaluation of different brands of drugs should be evaluated. Based on actual differences in efficacy, drug price linkage mechanisms with different quality levels should be established to control the drug price gap within a reasonable proportion. Although the "Guiding Opinion" only explicitly stipulates price negotiations for some patented drugs and exclusive production of drugs, experts say that in the case where the competition for high-level non-patent drugs is still not sufficient, it can be based on the measured spread ratios in the domestic market. On the basis of the pharmaceutical bid price, the original research price negotiation process was initiated.