Drug testing institute should also be market-oriented

As China's food and drug supervision moves towards modern supervision, people are increasingly aware that the technical support system represented by inspection and testing institutions and professional talent teams is a vital part of the food and drug supervision system, and it is also the current one. Short board.

One of the core issues of the latest round of food and drug regulatory system reform is to integrate food and drug testing resources. At the same time, the curtain of the marketization of testing institutions was officially opened in 2014.

Integration models are varied

"One word, a mess!" Hu Yinglian, an associate professor at the National School of Administration who inspected the food and drug reform in 17 provinces across the country, concluded. Different from other testing institutions, the testing system of food and drug system was gradually established after the Sanlu milk powder incident in 2008, the year of food safety crisis. Some local testing institutions are still under construction, and a new round of reform has begun.

According to the guiding opinions of the State Council on local reform and improvement of food and drug supervision and management system issued in 2013, the idea of integration is to transfer the corresponding food safety testing institutions of industry and commerce and quality inspection departments to the food and drug regulatory departments, including personnel, equipment and funds.

However, in the process of reform, the integration model is varied. According to Xu Fuxin, Director of the Office of the Food and Drug Administration of Anhui Province, Anhui has integrated the former Provincial Food and Drug Inspection Institute, the former Provincial Drug Research Institute, and the former Anhui National Agricultural and Sideline Processing Food Quality Supervision and Inspection Center, and established the Anhui Food and Drug Inspection Research Institute. There are three institutes, namely the Food Inspection Institute, the Drug Inspection and Research Institute, and the Medical Device and Drug Packaging Material Inspection Institute.

This is an example of a more successful transfer at the provincial level. Shanxi Province has established comprehensive testing institutions at the city and county levels. However, in most provinces and cities, the integration of testing institutions has not been promoted in essence, and only a small number of personnel have been transferred. This leads to the lack of professional law enforcement personnel and inspection and testing equipment to become a prominent contradiction in the establishment of grass-roots food and drug testing institutions.

Take Xiaogan City, Hubei Province as an example, there are only more than 20 people in the municipal food and drug testing institute. "We can only complete the testing tasks issued by the province, and we can't take care of the daily testing." Xiaogan City Food and Drug Administration Office Deputy Director Gao Pei said. In order to quickly transfer in place, in some cities in Hubei, some older nurses and midwives have even been transferred to food and drug regulatory departments or testing institutions, with very little technical ability.

"Guangzhou did not transfer the testing agency because the quality supervision department did not agree." A staff member of the Guangzhou Food and Drug System told the Southern Weekend reporter that this situation is widespread across the country. In response, the Guangzhou Food and Drug Administration has adopted a flexible approach, transferring a small food inspection institute from the Light Industry Group and a liquor testing center from the Economic and Trade Commission.

In some places where transfer is difficult, food and drug regulatory agencies can only re-purchase equipment to build their own technology platform. But Hu Yinglian worries that this will cause a lot of "repeated construction and waste of funds".

"Food and drug technical support should establish a unified platform." An insider of the China Food and Drug Control Institute (hereinafter referred to as the China National Inspection Institute) is not optimistic about the integration of local governments. As a unit directly under the State Food and Drug Administration and the highest technical arbitration institution, the Central Inspection Institute has submitted reports to the State Food and Drug Administration many times, hoping that the food and drug testing institutions will unify the vertical management and establish a relatively independent technical system from top to bottom to form a data sharing and academic exchange platform without interference from local administrative factors. But the situation has not changed.

At present, there is no subordinate relationship between the Central people's Procuratorate and the provincial inspection institutions, and the same is true for all provinces, cities and counties. Li Bo, vice president of the Central Inspection Institute, called this structure "an obstacle to the overall strength of the (testing) system" at the 2014 National Symposium on Food, Drug and Medical Device Inspection ".

Testing institutions market-oriented ice-breaking

In addition to the integration led by administrative forces, promoting the third party of testing institutions is considered to be another way to improve the technical support capacity of food and drug. In fact, the industry has discussed the marketization of testing institutions for many years, which officially broke the ice in 2014.

According to data released by the General Administration of Quality Supervision, Inspection and Quarantine, at present, the number of state-owned inspection and testing institutions in China accounts for nearly 80% of the total number of testing institutions, the number of private inspection and testing institutions accounts for about 19.5, and the number of foreign-funded inspection and testing institutions accounts for only 0.5, which is a huge disparity.

Since the beginning of this year, the State Council has clearly put forward requirements for the reform of testing institutions in at least five documents. The key words are "marketization" and "separation of inspection and management". The latest document announced that the integration of inspection and testing operations in multiple departments will be basically completed by 2015. In principle, the government no longer runs a general inspection and testing certification body.

This means that after the integration of government testing institutions, the next step will enter the process of marketization.

"At present, domestic testing is still a lemon market (economic term: refers to the phenomenon of survival of the fittest caused by information asymmetry), and a large number of inspection institutions are in a small and scattered state." Zhang Jihong, associate professor of the Institute of quality development strategy, Wuhan University, said.

In Zhang Jihong's view, there are now more than 20000 inspection and certification institutions in China, with obvious fragmentation, lack of unified planning and effective supervision, and different departments may even issue completely opposite test results.

Another prominent problem is the industry barriers caused by administrative monopoly. The general manager of a third-party testing organization specializing in honey testing complained that the bidding and sampling mode of the testing organization is now designed for state-owned institutions. For example, the government does not accept subcontracting projects, which is a great disadvantage to organizations that are only good at doing certain types of testing. In the five years since the establishment of the organization, he has not undertaken any government projects. Despite its strong technical strength, it is more difficult for foreign food and drug testing companies to enter the Chinese market.

Do you want to keep the "national team"?

Under the parallel of the two forces of institutional integration and market promotion, a question that has to be raised is: should food and drug testing institutions be market-oriented without reservation?

The view of one side is that all testing institutions should be pushed to the market, the survival of the fittest, the integration will be completed naturally, and there is no need for administrative leadership. The other side believes that in addition to marketization, some "national teams" should be retained ". Because once they enter the market, companies will ignore the public safety attributes and social responsibility of food and drug supervision for profit.

The "drug damage" in developed countries is considered a warning. In 1997, the United States Food and Drug Administration (hereinafter referred to as FDA) had a systematic failure, and there were huge loopholes in the approval and testing of drugs. It relied heavily on external review experts instead of internal professionals. Many drugs were withdrawn from the market due to safety problems. The biggest one was the "Ruisuling" incident. This drug was suitable for oral drugs that lowered blood sugar. However, serious liver damage occurred at the same time of treatment, in the end, 94 people had complete liver failure and 66 people died.

"In the past, the finance has funds allocated to the testing center. If there is an urgent task to the testing center, send how much are checked. If it becomes a third party, send can be so happy to test?" Anhui food and drug administration office director Xu Fuxin worried that in the face of food safety crisis, the use of third-party agencies may not be handy.

At present, most developed countries have two parallel institutions to provide inspection and testing services-public welfare and business. The government meets the public welfare testing services by establishing government testing agencies or purchasing government services from third-party agencies. The operating institutions, on the other hand, are as far as possible in line with international standards and seek marketization.

"The United States has a very mature testing agency market, but all drug approval testing, food additives, color agent testing all belong to FDA headquarters, and have not been delegated to local or market." Hu Yinglian pointed out that the situation in Japan and the European Union is similar.

U.S. FDA Director Margaret Hamberg previously said in an interview with Southern Weekend reporters that the FDA management model has shifted to risk management, and one of the most important tasks is that the government uses new testing and enforcement tools to ensure "pre-prevention"., Not "after-the-fact reaction".

They will invest heavily in the development of "predictive" systems (PREDICT)-using new data analysis methods based on the complete life cycle of the product to better position high-risk products before they enter the country-obviously, this requires government leadership.

In addition, in addition to some regular testing, institutions with government background tend to increase investment in some basic and forward-looking research, which may be the short board of market-oriented institutions.

In the view of some scholars, the market-oriented law of survival of the fittest cannot fully guarantee food and drug safety. The government needs a "national team" dedicated to food testing that is strategic and high-risk.

"For example, the testing of important food and drugs such as vaccines and milk powder still needs to be done by the government, but all routine, more common, and strategically insignificant testing items and institutions should be put back on the market." Hu Yinglian said that public welfare testing institutions should not participate in commercial projects. He suggested that a public welfare research institution should be established at the national level, such as the Central people's Procuratorate, and similar agencies should be set up in major regional centers to ensure a certain degree of independence.