标签： 广州葵花蒲典

　　　　　　　　According to Xinhua News Agency, the reporter learned from the State Bureau of Letters and Calls on July 28 that the investigation results of the incident of "collectively drinking pesticides at the gate of the people’s newspaper office" which has attracted much attention have been announced. The relevant departments of Sihong County, Jiangsu Province reflected by the visitors did violate the rules in the old city reconstruction project in 2013. At present, 14 responsible persons, including the county party secretary of Sihong County and the executive deputy magistrate of Sihong County, were punished by party discipline and political discipline.

　　　　　　　　On the morning of July 16th, seven petitioners in Beijing collectively drank pesticides in front of China Youth Newspaper, which aroused widespread public concern. What are they petitioning for? Why do you take such extreme measures to express your demands? In this regard, the reporter followed the Central Joint Inspection Team to investigate in Sihong, Jiangsu Province.

Controversial old city reconstruction project

　　　　　　　　It is reported that the seven petitioners who drank pesticides are all from Qingyang Town, Sihong County, Jiangsu Province, and they are relocated households in the renovation project of Qiganzhuang and the dilapidated area of the overhaul factory in Sihong County. Because they disagreed with the compensation for house demolition and resettlement, they repeatedly reported the situation to the petition departments at all levels from 2013 to 2014.

　　　　　　　　According to the survey, these seven petitioners came to Zhongqing Newspaper twice in the first half of 2014 to seek media attention, but failed. Therefore, when they visited Beijing for the third time in July 2014, they collectively drank pesticides in front of Zhongqing Newspaper.

　　　　　　　　After the incident, the leaders of Jiangsu Province immediately gave instructions to rescue the wounded and organize the special treatment of land acquisition and demolition in the province; The State Bureau for Letters and Calls, the Ministry of Housing and Urban-Rural Development and other departments also quickly formed a central joint inspection team to investigate the places involved.

　　　　　　　　According to a complaint found at the scene of the incident, these seven people were relocated households in the renovation project of Qiganzhuang and the dilapidated area of the overhaul factory in Sihong County in 2013, and petitioned because the compensation for project relocation was too low. According to the materials, there are many illegal acts in the process of promoting the project, and they were once put into a "black prison" during the petition process.

　　　　　　　　According to the survey, the compensation standard for the two renovation projects involved is 2300-2500 yuan/square meter. According to relevant regulations, the compensation for the value of the expropriated house shall not be lower than the market price of similar real estate in the same period. Although the price of resettlement houses built by Sihong County is only 60% of the price of commercial houses in the same area, the price of new commercial houses around the project has reached 3000-3400 yuan/m2, and the compensation standard is relatively low. Especially for relocated households who choose monetary resettlement, it is difficult to buy commercial houses with the same area with compensation, which has caused some relocated households’ dissatisfaction.

　　　　　　　　The reporter also learned that a considerable part of the houses expropriated by the seven petitioners who drank pesticides were used to operate marinated vegetables, cakes, beauty shops and other projects. These petitioners said that their family income would be affected after the houses were expropriated, but the government did not compensate them accordingly.

　　　　　　　　The opposition did not affect the strong promotion of the project. After investigation, these two plots violated the regulations of the Ministry of Land and Resources that the right to use construction land must be "net land" and were sold in the "gross land" state; After the land transfer, the demolition work was started before the publicity of the survey and registration results of the house expropriation was completed; There are even some homeowners who still have objections to the agreement, but the houses are forcibly removed by the relevant departments.

　　　　　　　　A county leader explained that most of the reconstructed plots are dangerous buildings, lacking supporting facilities, and the people have a strong desire to transform, so forced demolition is a last resort. Gao Yuguang, a resident of Sunhe Community, who also belongs to the scope of this dangerous renovation, also confirmed to reporters that when it rains in this area, sewage flows everywhere, and most residents are looking forward to demolition, and they also moved away shortly after the announcement of expropriation. "Everyone was shocked after the accident. These people’s feelings of safeguarding interests are understandable, but they should not take life as a child’s play." He said.

Going to the province to petition, but encountering "halfway interception"

　　　　　　　　According to incomplete statistics, since 2013, seven visitors who drank pesticides have made 29 normal letters and visits about the compensation of the rebuild project through letters, visits and online complaints. However, the contradiction has not been resolved, but has intensified step by step.

　　　　　　　　On September 23, 2013, when 11 relocated households involved in the project were petitioning normally by Jiangsu Provincial Bureau of Letters and Calls, they were stopped by the staff on duty at the reception center of Sihong County in the provincial bureau and informed Qingyang Town. Qingyang Town sent staff to take them to a hotel in Sihong County for a talk overnight, and they were not allowed to leave until the agreement was signed. Some people stayed for more than 24 hours. Several petitioners said that the agreement signed under such circumstances was against their true wishes. In May this year, six petitioners who were detained at that time filed a complaint with Sihong County Court to cancel the signed agreement, four of whom were the parties to the pesticide drinking incident.

　　　　　　　　According to the investigation of the inspection team, the petition departments of the state, province and city all handed over several letters and visits to the local authorities in time. However, as the main body responsible for handling letters and visits, the Sihong County Housing and Construction Bureau and Qingyang Town Government failed to respond positively to the petitioners’ demands, but only gave simple answers, and the contradiction escalated.

　　　　　　　　When the road to letters and visits was blocked, the petitioners turned to the media for help. A relocated household who had petitioned with these seven petitioners told reporters that in March and May 2014, they came to Zhongqing Newspaper twice to deliver materials, but the result was nothing. "In fact, the second time we went, we had the idea of drinking pesticides, but we finally gave up the action." He said.

　　　　　　　　Only two months later, these seven people didn’t say hello to their families and didn’t bring their mobile phones, and collectively disappeared from the eyes of the "responsible person" in the village. It was not until the news was overwhelming that everyone knew that they had gone to the China Youth Daily again and fell in front of the newspaper.

Under the new pattern of letters and visits, local governments must earnestly implement territorial responsibilities.

　　　　　　　　In March of this year, the Central Office and the State Council issued the Opinions on Handling Letters and Visits Involving Lawsuits in Law, requiring that letters and visits involving civil and commercial, administrative, criminal and other litigation rights relief should be handled by political and legal organs according to law; On May 1st, the Measures of the State Bureau for Letters and Calls on Further Standardizing the Procedures for Accepting Letters and Visits and Guiding Visitors to Visit Step by Step according to Law was officially implemented, and the higher authorities no longer accept leapfrog visits.

　　　　　　　　Shan Guangnai, a researcher at the Institute of Sociology, China Academy of Social Sciences, said that two major actions in the field of letters and visits show that with the deepening of the reform of the system of letters and visits in China, the pattern of letters and visits has undergone major changes. However, judging from this case, local governments have not adapted to the new situation, and there is a mentality of "waiting, relying and wanting" in handling letters and visits.

　　　　　　　　"In the past, the channels for letters and visits were only smooth in form, but not in practice. The phenomenon of buck-passing between superiors and subordinates and various departments was serious, which seriously affected the relationship between the party and the masses and the credibility of the government; The purpose of promoting the reform of the petition work system and implementing step-by-step visits according to law is to further compact the responsibility of territorial responsibility and related responsible subjects, so that the reasonable demands of the masses can be solved in time at the grassroots level. "

　　　　　　　　On July 22nd, jiangsu provincial party committee made a decision to inform the whole province of this case, demanding that we should learn a lesson seriously, draw inferences from others, seriously reflect on it, and put an end to the recurrence of similar vicious incidents. Fourteen responsible persons, including the county party secretary and the deputy county magistrate of Sihong County, were dealt with by the corresponding party discipline and political discipline.

　　　　　　　　Shan Guangnai pointed out that the new regulations put forward stricter requirements for administration according to law. Local governments should change their working methods that rely too much on administrative promotion, and gradually bring the issue of letters and visits involving law and litigation into the track of rule of law; In view of the complex problems involving a wide range, such as land acquisition and demolition, all departments need to form a joint meeting system to focus on solving related problems and resolve social contradictions in time; Letters and visits departments at all levels should also earnestly shoulder the responsibility of reflecting people’s feelings and voices in a timely manner.

　　　　　　　　"In a society ruled by law, the public should’ safeguard rights according to law’ and the government should’ maintain stability according to law’. The balance point is the law, and the appeal point is the interest. When dealing with specific problems, local governments need to take into account fairness, reasonableness and legality in order to make social contradictions less generated and less intensified. " He said.

　　　　　　　　According to the Beijing police, seven petitioners who drank pesticides are in good health. At present, they are all criminally detained on suspicion of seeking trouble. For more information about this matter, the relevant departments are still investigating further.

In order to strengthen the supervision and management of medical device recall and effectively promote the implementation of the main responsibility of enterprise recall, according to the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulations), the State Food and Drug Administration has formulated and promulgated the Measures for the Administration of Medical Device Recall (hereinafter referred to as the Measures). The Measures will be implemented on May 1, 2017, and the relevant contents are now interpreted as follows:

I. Why should the Measures be revised?

As a special commodity, medical devices play an important and irreplaceable role in improving people’s health and quality of life. The safety and effectiveness of medical devices is directly related to people’s health and social harmony and stability, and is a major livelihood and public safety issue. If the listed products are defective and cannot be recalled and controlled in time, it may endanger the health and safety of consumers. Therefore, the establishment and implementation of the recall system of medical device products by the state plays an important role in controlling the risks of defective medical device products after listing, eliminating potential safety hazards of devices and protecting public safety. The practice in other countries and other fields also shows that the recall system is a powerful guarantee to safeguard the safety and rights of consumers. Based on the importance of the medical device recall system, in order to strengthen the supervision and management of the recall-related work, in 2011, the Ministry of Health of the People’s Republic of China issued the Administrative Measures for Medical Device Recall (Trial) (Order No.82), which came into effect on July 1, 2011. The publication and implementation of the "Measures (for Trial Implementation)" provides legal guarantee for timely controlling the risks of medical devices after listing and protecting the safety of public equipment. The implementation of medical device recall system is not only an effective method to control the risk of medical devices, promote the progress of production technology and improve product design, but also an important measure to promote production enterprises to improve product quality awareness and standardize market competition order.

The newly revised Regulations in 2014 included the recall system, which also became a highlight of the new version of the Regulations. In order to further strengthen the management of medical device recall, according to the requirements of the Regulations, on the basis of full investigation of recall systems at home and abroad in the early stage, combined with China’s national conditions and practice, and after soliciting opinions from all parties, the "Measures (Trial)" version was repeatedly discussed and revised, and the "Measures" was revised.

2. What are the main contents stipulated in the Measures?

(1) What is the definition of medical device recall?

The recall of medical devices mentioned in the Measures refers to the actions taken by medical device manufacturers to deal with the defective medical device products of a certain category, model or batch that they have sold on the market according to the prescribed procedures, such as warning, inspection, repair, re-labeling, modification and improvement of instructions, software update, replacement, recovery and destruction.

(2) What are the recall obligations of medical device manufacturers?

Medical device manufacturers are responsible for the quality and safety of their medical devices. We should establish and improve the management system of medical device recall in accordance with the provisions of the Measures, collect information related to the safety of medical devices, investigate and evaluate possible defective products, and recall defective products in time.

The agent designated by the overseas manufacturer of imported medical devices in China shall report the relevant information about the recall of medical devices only abroad to china food and drug administration in time; Where the recall is carried out in China, the designated agent in China shall organize the implementation in accordance with the provisions of the Measures.

(3) What are the recall obligations of medical device enterprises and users?

Medical device enterprises and users shall actively assist medical device manufacturers to investigate and evaluate defective products, actively cooperate with the manufacturers to fulfill the recall obligations, timely convey and feedback the recall information of medical devices according to the recall plan, and control and recover the defective products.

(4) What are the categories of medical device recalls?

According to the different starting conditions of medical device recall, medical device recall can be divided into active recall and ordered recall.

Voluntary recall is a legal obligation of medical device manufacturers to evaluate the quality of medical device products according to relevant requirements or information such as product adverse events, and to determine the defects of medical device products, which are voluntarily implemented by the manufacturers. Ordered recall refers to the recall of medical devices by the food and drug supervision and administration department after investigation and evaluation, which believes that medical device manufacturers should recall defective medical device products without taking the initiative to recall them. In practice, enterprises should take the initiative to recall, supplemented by government departments ordering recalls.

(5) What are the levels of medical device recall?

According to the severity of medical device defects, medical device recalls are divided into:

(1) First-class recall: the use of the medical device may or has caused serious health hazards;

(2) Secondary recall: the use of the medical device may or has caused temporary or reversible health hazards;

(3) Three-level recall: it is less likely that the medical device will cause harm, but it still needs to be recalled.

Medical device manufacturers should determine the recall level according to the specific situation and scientifically design the recall plan and organize its implementation according to the recall level and the sales and use of medical devices.

If a medical device manufacturer makes a decision on medical device recall, the first-level recall shall be within 1 day, the second-level recall shall be within 3 days, and the third-level recall shall be within 7 days, and the relevant medical device business enterprises, users or users shall be notified.

The recall notice shall at least include the following contents:

(1) Recall the basic information such as the name and batch number of medical devices;

(2) the reasons for the recall;

(3) requirements for recall, such as immediately suspending the sale and use of the product, forwarding the recall notice to relevant operating enterprises or users, etc.;

(four) the way to deal with the recalled medical devices.

(six) how to punish medical device manufacturers for refusing to recall medical devices?

Medical device manufacturing enterprises, in violation of the provisions of Article 24 of the Measures, refuse to recall medical devices. According to the provisions of Article 66 of the Regulations, the food and drug supervision and administration department of the people’s government at or above the county level shall order them to make corrections and confiscate the medical devices illegally produced, operated or used; If the value of medical devices illegally produced, operated or used is less than 10,000 yuan, a fine ranging from 20,000 yuan to 50,000 yuan shall be imposed; If the value of the goods is more than 10,000 yuan, a fine of more than 5 times and less than 10 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business until the original issuing department revokes the registration certificate, production license and business license of medical devices.

(seven) how to punish the medical device operating enterprises and users who refuse to cooperate with the medical device manufacturing enterprises to fulfill the recall responsibility?

Medical device enterprises and users who refuse to cooperate with the investigation of medical device defects or assist medical device manufacturers in recalling medical devices shall be given a warning and ordered to make corrections within a time limit; Those who refuse to make corrections within the time limit shall be fined up to 30,000 yuan.

3. What are the amendments to the Measures?

The Measures include six chapters and thirty-seven articles, including general principles, investigation and evaluation of medical device defects, voluntary recall, ordered recall, legal liability and supplementary provisions. The revision of the Measures retains the framework and main contents of the Measures (for Trial Implementation). According to the Regulations, the scope of recall and individual operating procedures are supplemented and adjusted, the main responsibility and legal responsibility of production enterprises are strengthened, and the punishment for violations of laws and regulations is intensified. The main amendments include:

(a) the implementation of the main responsibility of medical device recall. It is clear that the registrants or filers of domestic medical device products and the agents designated by overseas manufacturers of imported medical devices in China are the main bodies of medical device recall.

(2) The scope of application has been clarified. The Measures (for Trial Implementation) stipulates that "these Measures shall apply to the recall of medical devices sold in People’s Republic of China (PRC) and their supervision and management", and the Measures shall be amended as "the recall of listed medical devices in People’s Republic of China (PRC) and its supervision and management", which clarifies that all medical device products registered in China shall be implemented or reported in accordance with the requirements of these Measures.

(3) Adjusting the scope of defective products. The Measures (Trial) stipulates that "the recall of medical devices mentioned in these Measures refers to the behavior of medical device manufacturers to eliminate defects by warning, inspecting, repairing, relabeling, modifying and perfecting the instructions, upgrading the software, replacing, recalling and destroying a certain category, model or batch of products that have been sold in the market according to the prescribed procedures", "The defects mentioned in these Measures", It means that medical devices have unreasonable risks that may endanger human health and life safety under normal use, that is, the scope of recall is medical devices that have unreasonable risks that may endanger human health and life safety under normal use. According to the newly revised Regulations, the Measures expand the scope of defective products to "(1) products with unreasonable risks that may endanger human health and life safety under normal use; (two) products that do not meet the mandatory standards and the technical requirements of registered or filed products; (three) products that do not meet the relevant provisions of the quality management of medical device production and circulation, which may lead to unreasonable risks; (4) Other products that need to be recalled ".

(4) The content of defect assessment has been added. In response to the revision to expand the scope of defective products, the item "Does the product meet the mandatory standards, registered or filed product technical requirements" has been added in the main content of evaluating the defects of medical devices.

(5) The regulatory authorities that supervise the destruction of recalled products have been adjusted. The "Measures (Trial)" stipulates that "if it needs to be destroyed, it shall be destroyed under the supervision of the drug supervision and administration department at the place of destruction". But in practice, this method is not conducive to practical operation. At the same time, with the rapid development of information technology, the diversification of supervision methods is the general trend. Therefore, the "Measures" were amended as "Those that need to be destroyed shall be destroyed under the supervision of the food and drug supervision and administration department."

(6) Adjusted the requirements for notification of recall information. The "Measures (Trial)" stipulates that "the drug supervision and administration department shall review the report within 10 days from the date of receiving the summary report and evaluate the recall effect. The conclusion of the review and evaluation shall be notified to the medical device manufacturer in written form and copied to the health administrative department at the same level ". In practice, it is difficult to inform medical device manufacturers and health administrative departments at the same level in written form of review and evaluation conclusions. Therefore, the "Measures" cancel the requirement of notifying production enterprises in written form, and change the information notification to the health administrative department to "notify relevant information to the health administrative department at the same level when necessary".