Medical network on February 3rd reporter recently hosted by the competition law of China university of politics and law research center of symposium on antitrust issues "pharmaceutical industry, at present the anti-monopoly law enforcement agencies to investigate and punish several pharmaceutical industry monopoly cases involving both market of active pharmaceutical ingredients, active pharmaceutical ingredients market monopoly phenomenon has become a pharmaceutical antitrust problems cannot be ignored.
API to enormous market power
According to the national development and reform commission, the price supervision and inspection and li qing, deputy director of the anti-monopoly bureau, according to our country product medicine has 1500 kinds of active pharmaceutical ingredients, including one of 50 API can produce qualified approval, 44 API only two firms can produce, only three companies can produce 40 kinds of active pharmaceutical ingredients. 10% of the API can only be produced by single production enterprises, API production in the hands of special minority production enterprises. And the corresponding preparation according to the API manufacturers proportion sampling survey, an enterprise corresponds to a maximum of 169 home dosage, it serves to show its market power.
Actually, API market monopoly fueled price monopoly downstream pharmaceutical preparations, medical monopoly has become the most common characteristic of case.
On June 9, 2011, shandong weifang shun tong (hereinafter referred to as "shandong shun tong) drug companies and weifang huaxin pharmaceutical trading company (hereinafter referred to as" shandong huaxin), respectively, with two promethazine hydrochloride production companies signed a "product sales agent agreement", the monopoly of promethazine hydrochloride in domestic sales. The regulation, the two companies to be the sole agent for two enterprises produce promethazine hydrochloride in domestic sales. Immediately after the two companies control API source, the sales price increased from less than 200 yuan per kilogram to 300 yuan to 300 yuan. Several compound reserpine production enterprises can't afford to, was forced to stop production altogether in July 2011. Cause at that time only on the inventory to the medical institutions to maintain supply and market supply tense situation.
API monopoly has become a public secret
According to a person who spoke on condition of anonymity, said API monopoly has become the industry open secret, and intensified. Manufacturers with none of the voice, price negotiation are monopolies give guidance price quotation.
For example, chongqing qingyang since July 2012, is the only production and sales don't Piao alcohol for pharmaceutical production enterprises, with don't Piao alcohol completely monopoly of API production sales. The personage inside course of study thinks, in chongqing qingyang API's situation, jiangsu wto-day order, Shanghai sym joint two don't Piao alcohol piece production companies complicity or "forced" is helpless.
According to the media disclosure, Shanghai sym joint had responded in the case, because the don't Piao alcohol piece of raw material suppliers has uniqueness, once appear raw material gains, the tight supply situation. To ensure normal production of products, sym joint have to accept the raw material rises in price considerably.
As upstream API production of pharmaceutical production enterprise, through raw material control downstream enterprises, companies can't buy raw material can only allow them to control price at random, leading some commonly used low drug prices.
High market access threshold is monopoly
The following case is very telling.
Domestic don't Piao alcohol by API, including the production of GMP certification enterprises, a total of six. GMP certification of the four companies was all expire in January 2012. The four companies, there are 3 companies never production don't Piao alcohol API, only some enterprise in jiangsu before January 2012 in the actual production don't Piao alcohol API, and in July 2012 sales over the last don't Piao alcohol API in stock. The other one in the GMP certification of the chongqing some enterprise did not expire, but never the actual production, the sale don't Piao alcohol active pharmaceutical ingredients.
At present, the CFDA did not approve the import foreign don't Piao alcohol active pharmaceutical ingredients. Chongqing qingyang pharmaceutical since July 2012, with complete monopoly don't Piao alcohol production and sales of API, there is no other competitors to compete.
Then, in the existing legal framework, active pharmaceutical ingredients industry market access threshold is higher, was the cause of API monopoly.
According to Wei Shi Lin lawyer, API manufacturing enterprise in production before, need to hire a third-party eia agencies have corresponding qualifications, the environmental assessment report issued by review and submitted to the environmental protection department. To pass the examination, the production enterprise to professional institutions for "three wastes" treatment design. And then, through the professional evaluation institution of security review and occupational-disease-prevention review. Production safety supervision department according to professional organizations and the safety evaluation report issued the occupational-disease-prevention pre-assessment of enterprise safety facilities for acceptance. After issuing the acceptance of the safety production license. In addition, companies need to through fire control acceptance criteria, make food agency "drug registration certificate" issued by the pharmaceutical production license and the pharmaceutical GMP certificate. To obtain the drug registration certificate "that need to be in accordance with the" measures for the administration of drug registration requirements. Finally, after review for the medicine GMP certificate ".
After this series of examination and approval, the enterprise into the time, energy and money.
This Wei Shi Lin lawyers argue that the API facts monopoly situation, relevant regulatory authorities must be to monitor the supply price. Otherwise, preparation of production enterprises should not only face the upstream raw material price increases constantly, in the face of similar variety price competition, to face all kinds of bidding under the second negotiation for preparation of drug, will only become more difficult.
Teachers of Beijing university of Chinese medicine Deng Yong thinks, our country anti-monopoly law regulation antitrust committee have three law enforcement agencies, antitrust behavior manifestation of medicine material industry complex, a kind of behavior may involve a variety of forms, three law enforcement work scope, conflict will occur as a result, the anti-monopoly committee shall build information sharing mechanism, integrate the content of the API production, market supervision, etc. |
