Major changes in food and medicine: medical examination and approval, production and circulation to change?

On the eve of the convening of the NPC and CPPCC on February 24, a topic once again raised the concern of all walks of life: is there any new trend in the reform of the government ministry system in the new year?

In accordance with the 19-nation deployment and the new round of institutional and administrative reform, we must not only consider the establishment of all kinds of institutions, but also make all-round use of all kinds of resources and give more autonomy to provincial and subordinate governments; not only strengthen the protection of ecological civilization The overall design of the construction will also set up state-owned natural resources asset management and natural ecological regulatory agencies.

Many scholars said that the central ministries and commissions have the space to further promote the reform of most departments, and for the moment there is a high voice for the reform of most departments in the fields of food and drug regulatory agencies and the environmental protection sector.

Can try to consider the new model of big health, big market supervision parallel. drug , medical instruments , Special foods as high-risk varieties into the category of large health, general food safety work under the supervision of the big market. '' Long-term study of food and drug regulatory system of the State Administration Institute of Social and Cultural Studies Associate Professor Hu Yinglian said on the First Financial.

In terms of environmental protection, according to the unified management and protection idea of ​​'Mountain, Water, Forest, Field and Lake', the report of the 19th National Congress has been made clear that a state-owned natural resources asset management and natural ecological regulatory body should be set up. In addition, some reform proposals have also taken the lead '.

The 'majority system' is characterized by a number of issues related to the affairs under the jurisdiction of a ministry to maximize the avoidance of cross-functional government, politics out of doors, long management and improve administrative efficiency in the expert opinion, the Chinese food Twenty years after the drug regulatory system emerged, there is still room for further reform and perfection, such as the new regulatory model of trying out big health and big markets in parallel.

The establishment of the State Food and Drug Administration in 1998 was the starting point for the reform of China's food and drug regulatory system. After 20 years, the food and drug regulatory system has undergone several changes and has undergone changes from 'vertical fragmentation' to 'geo-integration' and in 2013 Food and Drug Regulatory Reform and Integration Large-scale food safety regulatory agencies and teams formed by governments at all levels and integrated with the departments of Quality Supervision, Industry and Commerce and Food and Drug Administration have resolved the fundamental problem of 'water management in Kowloon' through relatively centralized regulation. 2014 Years of Market Supervision After the comprehensive law enforcement reform, some localities and cities and counties have also implemented the market-supervising department's 'all-in-one' reform.

However, the impact of comprehensive law enforcement on the regulatory expertise in food and drug administration remains controversial. In some parts of the system reform, the regulatory level and ability of food and drug safety supervision are not highlighted. Simply pursuing institutional mergers alienated the original intention of the reform.

The NPC Standing Committee's law enforcement inspection team also said in its report that the comprehensive law enforcement reform has weakened or even marginalized the food safety regulatory functions in some places. The comprehensive law enforcement reform has weakened the drug regulatory power, and many supervisors have been transferred from other departments , Personnel aging, lack of professional knowledge, professional loss more serious. "Hu Ying-lien said.

In addition, in accordance with the general law, agricultural and animal husbandry production and large-scale food and drug production and processing areas should set up a food and drug regulatory agencies to achieve regulatory and industrial match, but the current situation is not the case.Research statistics found that the country's top 500 food industry In large counties, only a single food and drug regulatory agency accounted for only 48%.

At present, many of our country's agricultural products and food production have ranked first in the world, but the industry as a whole is characterized by 'big but not strong', imbalanced and underdeveloped performance is particularly evident. The pharmaceutical industry is exactly the same, the current national pharmaceutical production enterprise Nearly 5,000, to solve the lack of medical treatment, industrial growth, is changing from a big country of generic drugs to a new country of innovative drugs.

'There are only over 180,000 food and drug regulatory bodies in the country with only 180,000 food and drug regulators, and there is a structural mismatch between regulatory resources and regulatory tasks.' Hu Yinglian said: 'Taking the road of food and drug safety with Chinese characteristics in a new era can be Try to consider the new model of big health and big market regulation in parallel, namely medicine, medical equipment, special food (including infant formula, Healthy food , Special medical food) as a high-risk species into the category of general health, general food safety work assigned to the large market regulation areas. Can be considered in the Department of Health under the special medicines, medical equipment, special food centers, and conditions permitting Appropriate high-level administrative allocation, the formation of regulatory approval, supervision and inspection, inspection and handling, emergency response closed-loop, rather than the current sub-section of regulation. "Hu Ying-lien said.

Hu Ying-Lian believes that the examination and approval of pharmaceuticals and medical devices and their production can be classified as vertical management by the state, and that the professionalization of high-risk food products, especially special foodstuffs, and handling of major cases should be conducted from the national level to the end. At the same time, China's food and drug sector faces multiple tasks such as industrial development, market order, quality and safety, and requires all-round and strong support from local governments at all levels.

In the long run, food and drug safety should also be considered as a basic public service for the entire population. Food and drug safety must establish a strategic, fundamental and long-term mechanism for guaranteeing financial input so as to ensure that territorial liability is fulfilled. " .

Hu Yinglian said some localities are already basing themselves on the "13th Five-year Plan for Promoting the Equalization of Basic Public Services", draw lessons from the practice in the field of public health, and on the basis of sampling lots per thousand people, the number of professional inspectors, the standardization rate of the supervision team's equipment and equipment Indicators, scientific estimates of permanent residents per capita regulatory funding and regulatory resources needed to avoid regional imbalance.

Unlike previous years, the concept of empowerment of the environment-friendly 'major system' has a new concept of support for the launch of a new round of 'major system' of environmental protection in the future.

At the 3rd Plenary Session of the 18th CPC Central Committee, General Secretary Xi Jinping pointed out to the Plenary at the Third Plenary Session of the "CPC Central Committee's Decision on Some Important Issues of Deepening Reform in an All-Round Way" that the Shanshui Lintian Lake is a community of life ... Use control and ecological rehabilitation must Follow the laws of nature, if only planted tree planting trees, water treatment only water, pure nurse field protection of the field, it is easy to care about this, eventually resulting in the systematic destruction of ecology.

Xi Jinping pointed out that it is very necessary for a department to take charge of all the territorial control over space and land use in the territory and to uniformly protect and rehabilitate the landscape forest lakes.

At present, China's environmental protection functions are divided into three major areas: pollution prevention and control functions are scattered in the departments of ocean and harbor supervision, fishery administration, fishery supervision, army environmental protection, public security, transportation, railways and civil aviation; resources protection functions are scattered in mineral resources, forestry, Agriculture, water conservancy and other departments; integrated control management functions scattered in the NDRC, finance, economy and trade (ICBC), land and other departments.

Cross-functional, resulting in the dispersion of law enforcement and monitoring powers, multi-head enforcement of environmental protection issues prominent. 'Horizontal decentralization, the lack of effective coordination; lack of vertical supervision, lack of implementation constraints.' 'State Council Development Research Center, Deputy Director of Resources and Environmental Policy Institute often Ji Wen once said to CBN reporter in June 2015.

Wang Xi, director of the Institute of Environmental Resources Law at Shanghai Jiaotong University, also said earlier that in law, different laws Regulations There is a "fight" phenomenon.

For example, he said: Article 12 of the Water Law of the PRC revised in 2002 stipulates: 'The water administrative department under the State Council shall be responsible for the unified management and supervision of water resources throughout the country.'

In China's environmental administrative agencies, in fact, has formed three "unified" department: First, "Environmental Protection Law" authorized by Article 7 of the environmental protection department, the implementation of unified supervision and management of environmental protection work; the second is established in 1998 Ministry of Land and Resources, in charge of the unified supervision and management of the country's natural resources such as land, mineral resources and sea areas; Third, the water administrative department in charge of the unified management and supervision of the national water resources.

'This long system of management led to everyone being the reunification of the department, who does not appease who' Wang Xi said.

'We hope that the MEP is a super-departmental decision-making body and will also be able to continuously strengthen its own regulatory and law enforcement capabilities, but all of these rely on the construction of a legal environment for the entire society.' "Zhang Shijiu, a professor of environmental science and engineering at Peking University, said .

The 19th National Congress of the Communist Party of China made clear that the overall design and organizational leadership for the construction of ecological civilization should be strengthened and that the state-owned natural resources asset management and natural ecological regulatory agencies should be established. The ecological environmental management system should be improved and the responsibilities of owners of all natural resources assets should be uniformed and uniformly exercised Land and space use control and ecological protection and restoration responsibilities, and exercise unified supervision of various types of urban and rural pollution discharge and administrative law enforcement responsibilities.

In the "Institutional Reform and Management of China" published in December 2017, Huang Lu, director of the Central Organization Office for the second division, introduced that in recent years, some attempts have been made to strengthen regional environmental governance in our country. It is summarized as "co-ordination and integration , Responsibility, a total of governance 'four key words.

'The State Council has entrusted the MEP with the responsibility of co-ordinating coordination but it lacks sufficient co-ordination and coordination due to the lack of sufficient authority and necessary means.' Huang said that this must be achieved through the integration of elements, the synthesis of functions and the means of integration and organic integration Decentralized ecological protection functions and effectively prevent and control pollution in the region to prevent and control in order to achieve the overall protection of the ecological environment and system repair.

According to the idea of ​​unified management and protection of mountain, water, forest, field and lake, a set of plan put forward by the CAS Sustainable Development Strategy Research Group is to sort out the decentralized management functions of property rights of natural resources assets in all departments, concentrate and set up natural resources Assets Management Committee; to focus on natural resources protection and ecological protection and other functions scattered in land, agriculture, water conservancy, environmental protection, forestry and other departments, set up natural resources and ecological protection department, co-ordinate the supervision of natural resources and ecological protection; to disperse in the ocean , Water conservancy, housing construction and other departments focus on pollution prevention and control functions to the Ministry of Environmental Protection.

In its policy advice to the Chinese government, China International Committee for the Development of Environment and Development also proposed the idea of ​​a large part of the system reform: the first step is to build a high-level leadership and coordination mechanism for ecological civilization construction, such as establishing a leading group for the construction of ecological civilization and setting up the environment of the State Council The second step is to establish an ecological and environmental management system with scientific functions, structural optimization, uniform power and responsibility and efficient operation in accordance with the mode of ecosystem management, integrate pollution prevention and control functions scattered in all departments and realize all sources of pollution, pollutants and the environment The third step is to strengthen the unified environmental regulatory functions and independent law enforcement powers and improve the implementation of the state to strengthen national environmental performance supervision of local governments, environmental quality as an important indicator of performance evaluation of local governments, organizations, regular third-party Conduct an independent assessment of the environmental performance of relevant departments and make the results public.