The Standing Committee of the National People's Congress deliberated and passed the Biosafety Law of the People's Republic of China
Biosafety risk prevention and control will have laws to follow (adhere to and improve the people's congress system)
Core reading
Since the 18th National Congress of the Communist Party of China, the Party Central Committee with Comrade Xi Jinping at its core has attached great importance to biosafety work, incorporated biosafety into the national safety system, and proposed to accelerate the establishment of a national biosafety legal system and institutional guarantee system.
On October 17, the "Biosafety Law of the People's Republic of China" was deliberated and adopted at the 22nd meeting of the 13th National People's Congress Standing Committee, and will come into effect on April 15, 2021.
Formulate basic laws in the field of biosafety
In recent years, traditional biological threats such as African swine fever and other major new outbreaks of infectious diseases and animal and plant epidemics have occurred frequently, and non-traditional biological threats such as misuse of biotechnology have become prominent... While biotechnology has brought human progress and benefits, It also brings biosecurity issues and threats.
"According to the deployment of the Party Central Committee and adapting to the new situation, new problems, and new tasks facing my country's biosecurity, it is necessary, important and urgent to formulate a basic, systematic, comprehensive and overarching biosecurity law." Said Gao Hucheng, chairman of the Environment and Resources Protection Committee.
NPC deputies have proposed biosafety legislation bills for many years. During the first and second sessions of the 13th National People’s Congress, a total of 214 NPC deputies proposed 7 bills on biosafety legislation, demanding to speed up the process of biosafety legislation and fully express their views on the law. The voice of safeguarding national biosecurity and safeguarding the interests of the people.
"Biosafety involves a wide range of fields and rapid development and changes. The existing relevant laws and regulations often only regulate a single specific biosafety risk, which is relatively fragmented and fragmented. Some have a lower level of effectiveness, and some cannot fully meet the needs of practice. In some areas, there is still a lack of legal regulations, and a basic law in the field of biosafety needs to be formulated.” Yuan Jie, Director of the Administrative Law Office of the Legal Work Committee of the Standing Committee of the National People’s Congress, said that the biosafety law system sorts out and comprehensively regulates various biosafety risks. Clarify the biosafety risk prevention and control system and basic systems, fill the gaps in basic laws in the field of biosafety, and help improve the biosafety legal system.
On October 21, 2019, the 14th meeting of the Standing Committee of the 13th National People's Congress heard an explanation on the proposal for review of the "Biosafety Law of the People's Republic of China (Draft)", which pointed out that biosafety legislation is to enhance the national biosafety capability The need for construction.
At present, my country is relatively backward in biotechnology research and development and infrastructure construction. There is a large gap in technology, products and standards, and there are few original biosafety technologies and few outstanding achievements.
Incorporate the national biosafety capacity building into the law, fix the industrial policies and science and technology policies that encourage independent innovation in legal form, firmly grasp the core key biotechnology, guarantee and promote the development of my country's biotechnology in accordance with the law, and enhance the ability to prevent risks and threats .
“The Biosafety Law regards the protection of people’s life and health as its legislative purpose, and it is clear that the maintenance of biosafety should adhere to the people-oriented principle. When preventing and responding to various types of biosafety risks, we always adhere to the people’s supremacy and life supremacy, and safeguard people’s life safety and physical health. As the starting point and end point." Yuan Jie said.
Improve the basic system of biosafety risk prevention and control
Turning to the Biosafety Law, the first article clearly stated the purpose of the legislation: "In order to maintain national security, prevent and respond to biosafety risks, protect people's lives and health, protect biological resources and the ecological environment, promote the healthy development of biotechnology, and promote the construction of humanity. A community of destiny, to realize the harmonious coexistence of man and nature, formulate this law."
Prevention and control of major emerging infectious diseases, animal and plant epidemics; research, development and application of biotechnology; biosafety management of pathogenic microorganism laboratories; safety management of human genetic resources and biological resources; prevention of alien species invasion and protection of biodiversity; response Antimicrobial resistance; prevention of bioterrorism attacks and defense against threats of biological weapons; other activities related to biosafety and other eight aspects of behavior and related management activities are included in the scope of the regulations and adjustments of the biosafety law.
“Relevant departments of the State Council strengthen the training of basic biological science research talents and professional and technical talents in the biological field according to the division of responsibilities, and promote the construction of basic biological sciences and scientific research.” “The state strengthens the biosecurity of major emerging infectious diseases, animal and plant epidemics, etc. Material reserves for risk prevention and control."... The biosafety law has a special chapter that stipulates the capacity building of biosafety.
According to Gao Hucheng, biosafety capacity building is mainly embodied by increasing funding, infrastructure construction, talent training, encouraging and supporting independent R&D and innovation, and scientific and technological industry development to provide financial support and policy support for biosafety work to promote peace Strengthen the capacity building of biosafety.
At the same time, it is also required to improve my country's biosafety capacity building in terms of systems and mechanisms.
"The Biosafety Law completes the basic biosafety risk prevention and control system. It stipulates the establishment of a biosafety risk monitoring and early warning system, a risk investigation and evaluation system, an information sharing system, an information release system, a directory and inventory system, a standard system, a biosafety review system, and emergency response. There are 11 basic systems including the system, the investigation and traceability system, the national access system, and the response system for major overseas biosafety incidents. The whole chain builds the "four beams and eight pillars" of biosafety risk prevention and control." Yuan Jie said.
"In violation of the provisions of this law, staff who perform biosafety management duties abuse their powers, neglect their duties, engage in malpractices for personal gains or commit other illegal acts in biosafety work, they shall be punished according to law";
"In violation of the provisions of this law, those who engage in biotechnology research, development, and application activities prohibited by the state shall be ordered by the health, science and technology, agricultural and rural authorities of the people’s government at or above the county level to stop illegal activities and confiscate illegal gains and technologies according to the division of responsibilities. Data and tools, equipment, raw materials and other items used for illegal acts shall be fined not less than one million yuan but not more than ten million yuan"...
The Biosafety Law stipulates penalties for non-action or non-action of public officials in accordance with the law in the legal liability section. At the same time, it has perfected the corresponding responsibilities and penalties for acts and incidents such as the misuse of biotechnology that occurred in the previous period.
Actively respond to new challenges facing biosafety
On June 2, the Ministry of Ecology and Environment issued the "Communiqué on the State of China's Ecological Environment in 2019".
The communiqué shows that more than 660 invasive alien species have been discovered nationwide.
Among them, 71 species have caused or have potential threats to the natural ecosystem and are included in the "List of Invasive Alien Species in China".
The survey results of invasive alien species in 67 national nature reserves indicate that 215 invasive alien species have invaded the national nature reserves.
In order to prevent and respond to the invasion of alien species and protect biodiversity, the Biosafety Law stipulates that the relevant departments of the State Council strengthen the investigation, monitoring, early warning, control, evaluation, removal and ecological restoration of invasive alien species according to the division of responsibilities.
No unit or individual may introduce, release or discard alien species without approval.
Anyone who violates the provisions of this Law and introduces alien species without approval shall be confiscated by the relevant departments of the people’s government at or above the county level according to the division of responsibilities and imposed a fine of 50,000 yuan to 250,000 yuan.
In recent years, controversy over ethical issues caused by biotechnology has continued.
In this regard, the Biosafety Law clarifies that engaging in biotechnology research, development, and application activities should comply with ethical principles.
The clinical research of new biomedical technologies shall pass ethical review and be carried out in medical institutions with corresponding conditions; the operation of human clinical research shall be carried out by health professionals who meet the corresponding conditions.
Relevant scientific research institutions, medical institutions, and other enterprises and institutions shall incorporate biosafety laws and regulations and biosafety knowledge into the content of education and training, and strengthen the cultivation of biosafety awareness and ethical awareness of students and practitioners.
The field of biosafety is generally an emerging field, covering a wide range and rapid development and changes. Some fields have been adjusted by laws and regulations, and some activities lack legal standards.
Yuan Jie said that the existing regulations should be integrated, refined and improved, upgraded to a basic system, and connected to form a joint force.
For those that have not yet been stipulated but can be seen right now, make targeted regulations to fill in the legal gaps; for those that still need to be explored, make principled regulations to leave room for practice and to make and amend relevant laws and regulations. interface.
Our reporter Xu Jun