SUMMARY
- What is the Chinese Biosecurity Law about?
- Who is concerned by the Chinese Biosecurity Law?
- The Chinese Biosecurity Law: What can I do?
I. What is the Chinese Biosecurity Law about?
China has passed the second Review Draft of its Biosecurity Law that will come into effect on April 15th, 2021. In the context of Covid-19, the Biosecurity Law has been finished just within a year. With about 85 provisions, this law is complex, and it will affect many Chinese businesses and foreign companies that are active in China.
The World Health Organization has defined biosecurity as “an integrated approach to manage risk to human, animal and plant life and health”. Art. 2 Biosecurity Law consequently defines biological security as the government’s capability to deal with biological dangers plus related factors and safeguard security and steady development. What does the Chinese government mean by this label exactly?
Basically, the Biosecurity Law will establish prevention, control/monitoring, warning and assessment systems in biosecurity matters. The law is intended to fight infectious diseases and epidemic outbreaks, but also intensively deals with biotechnology research and its application generally. To get an impression of the structure and functioning of the Biosecurity Law, here is its main content:
Chapter II: Risk Prevention/Control Systems
Chapter III: Prevention and Control of Major Emergent Infectious Diseases
Chapter IIII: Security in Biotechnology Research and its Application
Chapter V: Laboratory Biosecurity
Chapter VI: Security of Human Genetic Resources and Biological Resources
Chapter VII: Prevention of Bioterrorism
Chapter VIII: Building Biosecurity Capacity
Chapter IX: Legal Responsibility
Chapter X: Supplemental Provisions
II. Who is concerned by the Chinese Biosecurity Law?
If your business especially is – or is related to – medicine, food, agriculture, livestock, biotechnology or cosmetics, you are generally covered by the Biosecurity Law’s scope. You definitely have to pay attention to the new rules when introducing alien species, importing/exporting plants and animals, conducting activities in the context of pathogenic microbe labs or in biotechnology research and human genetics, first and foremost (Art. 2 Biosecurity Law). As a result of Covid-19, we are convinced that the Biosecurity Law will be applied broadly at least until there is the first implementation legislation issued (as promised) in the following months/years.
The Biosecurity Law is fact; and it will certainly not be Chinese enterprises that will be first punished for violations of this law. Nevertheless, as the explosive situation around Covid-19 shows, China has an interest in this law being taken seriously from an early stage on (Art. 3 Biosecurity Law, connection to national security or just see Art. 7 Biosecurity Law). For this, the Chinese government has to apply this law in practice. Therefore, we except severe punishments for foreign companies with affiliates in China soon. In regard to the devastating consequences of the current health crisis, the Chinese government will surely not turn a blind eye here.
Individuals and institutions can be punished for violations against this new law. Here, a focus will likely be on professionals in charge. As we know from experience in comparable context, officials will go after directors, first and foremost. At the moment, a maximum penalty of ten million yuan or ten times of the illegal income are intended. Hence, Article 70 of the law is our biggest concern: It works as a legal bridge into the general Criminal Law of the People’s Republic of China with Long prison sentences. Of course, criminal proceedings in China are to be avoided in any case.
III. The Chinese Biosecurity Law: What can I do?
a) Get involved with this complex law as soon as possible. Estimate to what degree your business is concerned and check out to what extent your commercial activities need to be registered.
b) Our recommendation: In case of doubt, try to register as early as possible!
c) Check out which authority is responsible for you. Try to establish a first contact with the local competent officials.
d) Interlace the new Biosecurity Law into your compliance management. In particular, focus on conducting regular risk assessments and monitoring the situation permanently.
e) Expect surprises! This compliance task is unprecedented, not only for you, but also for the officials having to apply this law in practice.
For domestic and foreign companies operating in the biotechnology sector, compliance challenges will increase significantly. As a result of the Covid-19 pandemic, this law will certainly stimulate the adoption of further regulations and regulations in the field of biotechnology worldwide
In case of any questions, get in touch with us: We are happy to discuss!
