How much impact does the new Biosecurity Act have on the biopharmaceutical industry?

Since the 18th National Congress of the CPC, the CPC Central Committee, with Comrade Xi Jinping as its core, has attached great importance to biosecurity, incorporated biosecurity into its national security strategy, and proposed the establishment and improvement of a sound system of biosecurity laws and regulations.
October 17, the 22nd session of the Standing Committee of the 13th National People's Congress voted to adopt the Biosecurity Law of the People's Republic of China (hereinafter referred to as the Biosecurity Law), which will come into effect on April 15, 2021.
Biosecurity Law is a basic, comprehensive, systematic and leading law in the field of biosafe in China, and its introduction will help solve the problems in the field of biosafe management in China from the legal system level, and help to ensure the healthy development of biotechnology, protect people's life and health, and safeguard national biosecurity.
As an industry closely related to biosecurity, biopharmaceutical research and development, production, circulation and other links will be included in the scope of biosecurity law, biosecurity law will bring new global impact on the standardized development of biopharmaceutical industry.
, the global biosecurity situation at home and abroad is becoming increasingly serious.
At present, with the progress of technology, climate change and the deterioration of the natural environment, the global biosecurity problem has become more prominent, all kinds of major new and sudden infectious diseases, animal and plant outbreaks continue to occur, the risk of biological terrorist attacks increased.
statistics, since the 1980s, nearly 40 new and re-ed infectious diseases have been found and confirmed worldwide, and they are also facing problems such as biological terror, genetically modified safety and alien biological invasion.
Most new and severe infectious diseases are zoonotic diseases with infectious, fast-spreading and widespread characteristics, such as Severe Acute Respiratory Syndrome (SARS), highly pathogenic avian influenza (H5N1, H7N9), Middle East Respiratory Syndrome (MERS), Ebola, Marburg and Hantan viruses.
2005, the World Health Organization (WHO) has declared six public health emergencies of international concern (PHEIC).
figure 1: World Health Organization (WHO) announced the "international public health emergency" (PHEIC) Photo Source: Firestone creation according to public information collated in recent years, China's urbanization rate has accelerated significantly, the super-large urban area gathered tens of millions of permanent residents and millions of mobile population, but the national and urban biosecurity and public health risk prevention and emergency management capacity-building far from the development of the situation.
the outbreak of neo-crown pneumonia, highlighting the importance and complexity of biosecurity issues.
New and re-caused infectious diseases, genetically modified organisms safety, laboratory biosecurity, misuse of biotechnology results, plagiarism of human genetic resource loss, antibiotic abuse, invasive alien species, etc. continue to challenge the bottom line of national biosecurity, biosecurity risks are becoming increasingly serious and complex.
II. Building a strict system for biosecurity risk prevention and control (i) The Biosecurity Law builds the "four pillars and eight pillars" for biosecurity risk prevention and control In November 2020, the Biosecurity Law of the People's Republic of China was considered and adopted by the 22nd Session of the Standing Committee of the 13th National People's Congress.
10 chapters and 88 articles of the Biosecurity Law, focusing on the main risks in the field of biosecurity, improving the institutional mechanism for the prevention and control of biosecurity risks, and focusing on improving the national biosecurity governance capacity.
biosethics is defined by the Biosafare Act.
Biosecurity refers to the effective prevention and response of the state to the threat of dangerous biological factors and related factors, biotechnology can be stable and healthy development, people's life and health and ecosystems are relatively free from danger and threat, the biological field has the ability to maintain national security and sustainable development.
the biosecurity law to build a biosecurity risk prevention and control system.
central national security leading agency is responsible for the leadership of the national biosecurity work, the establishment of the national biosecurity coordination mechanism.
coordination mechanism for the work of biosecurity shall be composed of the competent departments of health and health, agricultural and rural areas, science and technology, foreign affairs and other relevant military organs under the State Council.
coordination mechanism for biosecurity work in all provinces, autonomous regions and municipalities directly under the Central Government to clarify the responsibilities of local people's governments at all levels and their relevant departments.
biosecurity law perfects the basic system of biosecurity risk prevention and control.
provide for the establishment of biosecurity risk monitoring and early warning system, risk investigation and assessment system, information sharing system and other 11 basic systems.
same time, the law has improved all kinds of specific risk prevention and response measures, and has set up special chapters to make specific provisions for biosecurity risks such as major new outbreaks of infectious diseases, animal and plant outbreaks, biotechnology research, etc.
figure 2: Biosecurity Law to build biosecurity risk prevention and control of the "four beams and eight columns" picture source: Firestone creation according to public information collation (ii) according to the biosecurity law as the core to build biosecurity prevention and control legal system biosecurity is an important guarantee of people's health, society and national interests.
In recent years, China has issued and implemented the Measures for the Administration of Safety in Biotechnology Research and Development (July 2017) and the Regulations of the People's Republic of China on the Management of Human Genetic Resources (March 2019), and established and activated the highest level (P4) biosecurity laboratory, initially forming a national biosecurity laboratory system.
At present, China has basically established a well-structured and well-established biosecurity prevention and control system consisting of laws, administrative regulations, departmental regulations and technical standards system in various fields related to biosecurity, with the Biosecurity Law as its core.
figure 3: China has established a multi-level biosecurity prevention and control laws and regulations system picture source: Firestone creation according to public information finishing III, biosecurity law on the impact of biopharmaceutical industry analysis (1) the state encourages bio-science and technology innovation, innovative bio-pharmaceutical enterprises will get more support biosecurity law clearly stated that the state encourages bio-science and technology innovation, strengthen bio-security infrastructure and bio-tech personnel team building, support the development of bio-industry, innovation drive to enhance bio-technology level, enhance biosecurity capabilities.
, China is relatively backward in biotechnology research and development and infrastructure construction, there is a large gap in technology, products and standards, biosafe original technology less, less excellent results.
Incorporating national biosecurity capacity-building into law, fixing industrial and scientific and technological policies that encourage independent innovation in legal form, firmly grasping the core key biotechnology, safeguarding and promoting the development of biotechnology in China in accordance with the law, and enhancing the ability to prevent risks and threats.
In the national key research and development plan, including "biosecurity key technology research and development" key special projects, specifically for people and plants and animals and other new outbreaks of infectious diseases, biotechnology fallacy, alien biological invasion, laboratory biosecurity, as well as human genetic resources and the loss of special biological resources and other key areas of national biosecurity, to carry out scientific and technological research, to achieve basic research, common key technology and major product research and development, typical application demonstration breakthrough, to promote China's biosecurity science and technology support capacity to reach the international advanced level.
to encourage the joint declaration of production, learning and research, the project undertaker has the obligation to promote the transformation and application of research results.
Table 1: National Key Research and Development Plan "Biosecurity Key Technology Research and Development" Key Annual Declaration Topics (2017-2020) Source: Firestone Creation According to Public Information Collation (2) National Biosecurity Uniform Standards, Biopharmaceutical Enterprises Need to Pay Attention to "Compliance" Building Biosafety Law for Biotechnology Research, Development and Application, Pathogen Microbiology Laboratory, The human genetic resources and biological resources and other parts of the special section to provide that these three parts have a direct correlation with biomedical enterprises, in general, the future of biomedical research, must comply with the national unified development of biosecurity standards Figure 4: biopharmaceutical enterprises should abide by the legal provisions of the photo source: Firestone creation according to public information to organize the state on biotechnology research and development activities to carry out classification management.
Enterprises engaged in biotechnology research and development shall, in accordance with the relevant provisions of the List of Pathogenic Microorganisms Transmitted from Humans, the List of Animal Pathogenic Microbes, the List of Animal Quarantine Epidemics in the People's Republic of China, the Convention prohibiting the development, production and storage of bacterial (biological) and toxin weapons and the destruction of such weapons, make risk category judgments, pay close attention to changes in risks and take timely measures to respond to them.
according to the protective measures taken against the biological factors operated, the level of laboratory biosecurity protection is divided into one, two, three and four levels.
biopharmaceutical enterprises must strictly abide by the requirements and usage norms of bioseal safety experiments at all levels.
before biopharmaceutical companies conduct clinical research, ethical review of drug clinical trials will be the focus of work, and it should be ethical to conduct drug clinical trials.
international multi-center clinical trials will also usher in more stringent management, especially related to human genetic resources, must be filed with the State Council scientific and technological authorities.
the future, in addition to following GMP, GCP and other routine, biosecurity-related regulations must also be strictly adhered to, the government departments responsible for routine flight inspection will focus on enterprises in biosecurity compliance construction.
table 2: Classification of biosecurity laboratory Source: Firestone creation according to public information collation (iii) biosecurity industry ushered in the "wind mouth", the relevant biopharmaceutical enterprises are expected to usher in new development opportunities countries have clearly strengthened capacity-building for biosecurity.
mainly adopt the methods of increasing investment, infrastructure construction, personnel training, encouraging and supporting independent research and development innovation, and the development of science and technology industries to give financial and policy support to biosecurity work.
Against the backdrop of biosecurity being integrated into national security and strengthening biosethic capacity-building through financial financial support and policy support, bios security will rapidly shift from a concept that was neglected in the past to an industry that has much to offer.
in the fields of public health, animal and plant diseases, laboratory biosecurity, biological defense, genetic resources and other industries, the industry began to fully integrate, technological innovation is emerging rapidly, and the industry is constantly iterating and upgrading.
High-tech Zone plans to build a national biosecurity industrialization demonstration base, Guangzhou Development Zone to build a national biosecurity management test area, all over the layout of biosecurity industry.
biosethics industry has a wide range of areas and more layout opportunities.
Biosecurity industry a wide range of small to masks, gloves and other basic products, large to CT machines and other imaging equipment, biosecurity products from a single tangible products, to services, consulting, standard certification and other intangible products to expand, and began to extend to the lives of ordinary people.
all levels of enterprises have the opportunity to enter the biosecurity industry, in raw materials, design, management, standards, monitoring, certification, logistics and other links to seize market opportunities.
emergency materials reserve system to protect market demand.
China has established national and local multi-level reserves of drugs, medical devices, protective drugs, protective equipment and equipment in response to general disasters, outbreaks and emergencies.
this provides a stable market demand for related biopharmaceutical and medical device enterprises.
new opportunities for the development of the industry through technological innovation.
system of biosecurity products such as negative pressure ambulances, medical protective clothing, medical masks and electric masks is sound, and the difficulty of research and development innovation is reduced.
big data, cloud computing, Internet of Things, gene editing and other technologies have fully entered the field of biosecurity, P3, P4 biosecurity laboratory and other important technology facilities in full swing, for emergency management, technology development has laid a solid foundation.
Table 3: Distribution of the nine major protective materials distribution source: Firestone creation according to public information finishing four, the introduction of the conclusion biosecurity law, for biopharmaceutical enterprises is both a challenge and an opportunity.
The future biopharmaceutical enterprises should not only pay attention to the traditional norms of production safety, quality control, environmental protection requirements, but also bring biosecurity into the scope of enterprise management considerations, which to a certain extent increases the operating costs of enterprises;
biopharmaceutical enterprises should master the relevant provisions of the Biosecurity Law, do a good job in "compliance" construction, grasp market development opportunities, actively lay out the biosecurity industry, and contribute to the protection of China's biosecurity cause.
author | Sun Xiangyu