In 2014, the marketization of testing institutions may officially open

Source: Southern Weekend 2014-12-15 as China's food and drug industry moves towards modern supervision, people are increasingly aware that the technical support system represented by inspection and testing institutions and professional talents is an important part of the food and drug supervision system, and also a short board at present 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 marketization of testing institutions was officially opened in 2014 The integration mode is "one word, chaos!" Hu Yinglian, an associate professor at the National School of administration who investigated the food and drug reform in 17 provinces, concluded Different from other testing institutions, the testing system of food and drug system was gradually established from the year of food safety crisis to 2008 Sanlu milk powder incident Some local testing institutions are still under construction, and a new round of reform has begun According to the guidance of the State Council on local reform and improvement of the food and drug supervision and management system issued in 2013, the integrated idea is to transfer the corresponding food safety testing institutions of the industrial and commercial and quality inspection departments to the food and drug supervision departments, including personnel, equipment and funds However, in the process of reform, there are various modes of integration According to Xu Fuxin, director of the office of Anhui food and drug administration, Anhui Province has integrated the former provincial food and Drug Inspection Institute, the former provincial drug research institute, the former Anhui national agricultural and sideline processing food quality supervision and inspection center, and established the Anhui food and drug inspection and Research Institute, which has three institutes, namely, the Food Inspection Institute, the drug inspection and Research Institute, the medical equipment and drug packaging material inspection Laboratory This is an example of a successful transfer recognized at the provincial level Shanxi Province has set up comprehensive testing institutions at the city and county level But in most provinces and cities, the integration of testing institutions has not been promoted in essence, only a small number of personnel have been transferred This leads to the lack of professional law enforcement personnel and inspection and testing equipment, which has become a prominent contradiction in the establishment of grass-roots food and drug testing institutions In Xiaogan City, Hubei Province, for example, there are only 20 Municipal Food and drug testing institutes "We can only complete the inspection tasks issued by the province, and we can't pay attention to the daily inspection." Gao Pei, deputy director of the office of Xiaogan food and drug administration, said In order to quickly transfer to the right place, some elderly nurses and midwives have even been transferred to food and drug supervision departments or testing institutions in some cities of Hubei Province, with little technical ability "There is no transfer of testing institutions in Guangzhou because the quality supervision department disagrees." A staff member of Guangzhou's food and drug system told Southern Weekly that the situation was widespread nationwide To this end, Guangzhou food and drug administration has adopted a flexible approach, transferring a small food inspection institute from light industry group and a liquor inspection center from economic and Trade Commission In some places where transfer is difficult, food and drug regulators can only re purchase equipment to build their own technology platform But Mr Hu worries that this will lead to a lot of "repeated construction and waste of funds" "Food and drug technology support should establish a unified platform." An insider at the China food and drug inspection and Research Institute (hereinafter referred to as CFDA) is not optimistic about local integration As the direct subordinate unit and the highest technical arbitration institution of the State Administration of food and drug, the Chinese Academy of inspection has submitted reports to the State Administration of food and drug for many times It hopes that the food and drug testing institutions will be managed vertically and set up a relatively independent technical system from the top to the bottom to form a platform for data sharing and academic exchange without interference from local administrative factors But nothing has changed At present, there is no subordinate relationship between the Chinese Academy of inspection and the provincial inspection institutions, and the same situation exists in the provincial, municipal and county offices Li Bo, vice president of the Chinese Academy of inspection, at the 2014 National Symposium on food, drug and medical device inspection, referred to this framework as "an obstacle to the overall strength of the (detection) system" 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 marketization of testing institutions discussed for many years in the industry has officially broken the ice in 2014 According to the data released by the AQSIQ, at present, the number of state-owned inspection and testing institutions 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 inspection and testing institutions only accounts for 0.5%, which accounts for a large proportion Since 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 by 2015, the integration of inspection and testing businesses of multiple departments will be basically completed In principle, the government will no longer establish general inspection and testing certification bodies This means that after the integration of government testing institutions, the next step will enter the market-oriented process "At present, domestic testing is still a lemon market, with a large number of testing institutions in a state of small disorder." Zhang Jihong, associate professor of the Institute of quality development strategy, Wuhan University, said In Zhang Jihong's view, there are more than 20000 inspection and testing certification institutions in China, which are obviously divided into different sections, lack of unified planning and effective supervision, and different departments will even issue completely opposite test results Another outstanding problem is the trade barrier caused by administrative monopoly The general manager of a third-party honey testing organization complains that the bidding and sampling mode for testing organizations are designed for state-owned organizations For example, the government does not accept the subcontracting of projects, which is a great loss for the institutions that are only good at some kind of testing He has not undertaken any government projects since its establishment five years ago Despite the strong technical strength, it is more difficult for foreign food and drug testing enterprises to enter the Chinese market Do you want to keep the national team? Under the two forces of institutional integration and market promotion, a question has to be raised: should food and drug testing institutions be market-oriented without reservation? One side's point of view is that all testing institutions should be put into the market The survival of the fittest and integration are naturally completed without administrative guidance On the other hand, some "national teams" should be retained in addition to marketization Once entering the market, enterprises will ignore the public safety attribute and social responsibility of food and drug supervision for profit The "drug harm" of developed countries is regarded as a warning In 1997, the U.S Food and Drug Administration (hereinafter referred to as FDA) suffered from internal system failure, huge loopholes in drug approval and testing, and relied heavily on external review experts rather than internal professionals Several drugs were withdrawn from the market due to safety problems, and the largest one was "risulin" However, serious liver damage occurred at the same time of treatment, which eventually resulted in complete liver failure in 94 people and death in 66 people "In the past, financial funds were allocated to the testing center If there is an urgent task to be handed over to the testing center, check as much as possible If it becomes a third party, can it be tested so happily? " Xu Fuxin, director of the office of Anhui food and drug administration, worries that in the face of the food safety crisis, the use of third-party institutions may not be handy At present, most developed countries have two kinds of parallel institutions to provide inspection and testing services - public welfare and business The government satisfies the public welfare testing service by establishing the government testing agency or purchasing the government service of the third party agency While the operational organizations try to be in line with the international standards and seek marketization "The United States has a very mature market for testing institutions, but all drug approval tests, food additives, color agent tests belong to the FDA headquarters, and there is no place for decentralization or marketing." Hu pointed out that the situation in Japan and the EU is similar Margaret hanberg, director of the US FDA, said in an interview with Southern Weekly that the FDA management model has shifted to risk management One of the most important tasks is that the government uses new inspection and implementation tools to ensure "prevention in advance" rather than "response afterwards" They will invest a lot of money in the research and development of "forecast" - using a new data analysis method based on the full life cycle of products, to better position the high-risk products before the products enter the country - obviously, this needs the government to lead In addition, in addition to some routine tests, institutions with government background tend to increase investment in some basic and prospective 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 can not fully guarantee the safety of food and drug The government needs to have a "national team" dedicated to food testing that is strategic and high-risk "For example, the testing of important food and drug products such as vaccines and milk powder still needs to be done by the government, but the routine, more common and non strategic testing projects and institutions should all be released to the market." Hu said public welfare testing agencies should not participate in commercial projects He suggested that a public welfare research institution should be established at the national level, such as the Chinese Academy of inspection, and similar agencies should be set up in major regional centers to ensure a certain degree of independence.