"Double Envelope" system may improve multiple indicators to evaluate pharmaceutical companies

In addition to the unified pricing of essential drugs, the “scientific system” used to evaluate the level of pharmaceutical companies is expected to be introduced during the year.

“The Ministry of Health has jointly formulated a number of units to develop a 'comprehensive evaluation system for drug manufacturers'. The current project is in the acceptance stage. This evaluation system can provide some technical support for the first envelope of the double envelope tender.” Recently, the Ministry of Health Zheng Hong, Director of the Department of Policy and Essential Drugs, spoke about improving the "double envelope" system.

The project was commissioned by the Department of Drug Administration of the Ministry of Health, the Consumer Products Division of the Ministry of Industry and Information Technology, and the Chinese Pharmaceutical Enterprise Management Association to conduct research. With the project work drawing to a close, the "Pharmaceutical Manufacturing Enterprise Comprehensive Evaluation System" (hereinafter referred to as "evaluation system") is expected to be introduced during the year.

"Evaluation system" will be used for basic drug bidding, so as to solve the problem of the 56 subjective indicators in the evaluation criteria, such as the subjective nature of the evaluation.

According to the reporter, the "Evaluation System" to be issued during the year draws on the Interim Measures for the Performance Evaluation of State-owned and State-controlled Enterprises used by the SASAC to evaluate central enterprises.

According to Yu Mingde, president of the China Association of Pharmaceutical Enterprise Management, “The Interim Measures for the Performance Evaluation of State-owned and State-controlled Enterprises” is already a very mature system. Why can't we learn from it and pass the profitability, return on assets, and society? Comprehensive evaluation of responsibilities and other aspects can understand the true operating status of a company."

“A few previous evaluation indicators for enterprises were all designed by the health system to facilitate tender procurement. They were not comprehensive and did not fully consider the needs of industrial development.” Wu Qinggong, vice president of the Chinese Pharmaceutical Enterprises Management Association, pointed out: “The evaluation system The design of the "" considers both the needs of the health system and the needs of the industry."

Uniform standards

According to the reporter’s understanding, despite the “Standard for the Centralized Bidding and Purchasing of Essential Medicines” for the bidding and procurement of essential medicines, the document still cannot solve the drawbacks of “only low-cost” in the procurement of essential medicines.

Because there is no uniform standard for quality evaluation, there are too many subjective indicators for the evaluation of base drug bidding, and there are too few objective indicators, and subjective comments by experts are inevitable. As the guiding document for procurement of basic medicines, Circular 56 does not solve such problems. Therefore, in the process of “double envelope” tendering, evaluation of technical standards is inevitably flawed.

To solve this problem, the formulation of the "evaluation system" was put on the agenda. On December 22, 2010, the Ministry of Health convened a meeting of the provincial tender offices of all provinces to formally finalize the evaluation system. At present, the finalized draft has already concluded the consultation process and is expected to be launched during the year.

Wu Qinggong who participated in the topic introduced: "The purpose of formulating the "Evaluation System" is to explore a comprehensive, objective, reasonable and easy-to-manage pharmaceutical production company comprehensive evaluation index system to solve the problem of vicious competition in basic drug procurement. ”

"The "Evaluation System" adheres to the principles of objectiveness and fairness, emphasis on competence, and quantification of indicators. It insists on comprehensive evaluation and changes the practice of single assessment of quality of drugs to comprehensive evaluation of enterprises. Comprehensive evaluation of drug manufacturers highlights the priority and price of essential drugs. It is reasonable, safe, effective and easy to use; it gradually unifies standards and solves the problem of excessive differences in procurement standards for basic medicines in various regions; it persists in promoting the establishment of an honesty system in the pharmaceutical industry; fully implements the state's pharmaceutical industry policy, promotes superiority, eliminates backwardness, and actively promotes Standardized."

Multi-index evaluation company

"The product is very good is not to show that the company is very good? Not necessarily. Only one company is overall good, we can believe that the company's products are good." Wu Qinggong admits: "In the past, tendering only when the quality of the problem is often a problem, so the evaluation "The system" has undergone a major change in thinking. In order to evaluate companies instead of evaluating products, leading companies can only win the bid, companies can't lead, and even a single product can't explain the problem. This is a major principle change."

Turning to the transformation of the idea of ​​bidding for essential medicines, Wu Qinggong said: "This reversal comes from the irreversible trend in the development of the pharmaceutical industry in China. First, the rise in drug costs is irreversible; second, the decline in drug prices is irreversible; and finally, the state pushes for essential drugs. The determination is irreversible."

Under the background of the implementation of a unified national price for some basic medicines promulgated by the National Development and Reform Commission, the evaluation method for basic pharmaceutical manufacturers has become the key to whether an enterprise can win in basic drug bidding.

According to report, in the "Evaluation System", there are five major indicators for essential drugs: quality assurance system indicators, basic drug supply capability indicators, enterprise development and risk resistance indicators, corporate innovation capability indicators, corporate integrity and social responsibility indicators . The five large indicators include 29 small indicators, each of which has a score of 1000 points.

Among these indicators, the quality assurance system indicators and the essential drug supply capacity indicators are mainly used to evaluate the capabilities of enterprises in ensuring the production and supply of essential drugs.

According to the reporter’s understanding, the six indicators of the drug quality assurance system are: whether it has passed the new GMP certification of the country; the qualified rate of drug sampling; whether serious adverse drug events have occurred; whether it has passed the relevant certifications of the United States, the European Union cGMP or Japan, India; Certified by WHO Supplier; ISO14000 certified. Each item has a clear plus score.

In terms of basic pharmaceutical supply capacity indicators, comprehensive assessment will be based on the number of basic medicines actually produced by enterprises, the actual production ranks of basic medicines for enterprises, the actual production rankings of basic medicines and individual products of enterprises, and the winning bids for essential medicines in all provinces and cities. . These indicators constitute a system for evaluating the supply capacity of essential drugs.