SUMMARY
- The Chinese Biosecurity Law: Designated ports
- What about the Chinese health industry and antibiotics under the Chinese Biosecurity Law?
- The Chinese Biosecurity Law and “low-risk” biotechnology research and development
I. The Chinese Biosecurity Law about: Designated ports
We strongly assume that the Chinese Biosecurity Law will come effective on April 15th, 2020. As discussed before in our Blog, you know that the scope of the law is broad. Nevertheless, you do not know what the new law will bring for your China business and its pitfalls? You cannot find more detailed information online? Here are some thoughts we had when dealing with this new challenge while preparing our clients for this upcoming law.
Pay a closer look at Art. 23 (3) Biosecurity Law. Any border crossing where customs discover high biological security risks shall enter China through designated ports. You have to consider this when planning your China business activities. The question is, what will be a high biological risk? Basically, that will be the job of the competent Chinese authorities to determine and this job is not yet done. So far, we have not seen any governmental lists or indexes that have been promised. But even with this information yet to come, you cannot be sure that your goods or equipment will be differently assessed five to twelve when shipping it to China. We expect port authorities to be very strict in order to avoid violating the Biosecurity Law as an important part of China’s national security system at any cost. Calculate with higher costs and substantial delays in this context!
II. What about the Chinese health industry and antibiotics under the Chinese Biosecurity Law?
First and foremost, the Chinese health industry will have to deal with Art. 33 (1) to (3) Biosecurity Law which focuses on the use of antimicrobial drugs. The best-known representative is antibiotics and their residues. Regulatory authorities are supposed to oversee the rational use of medicines. But the Biosecurity Law does not say what a rational or irrational use of such drugs is. Here, authorities will have to clarify this in practice, again.
Also, this is a question several authorities might have a say in. Especially within the introductory phase of the Biosecurity Law, this will become an uncertain legal situation as the National Health Commission of the PRC might have a different view as the Ministry of Agriculture and Rural Affairs of the People’s Republic of China on this point, for instance. It will be of the essence to find out who is competent for your specific business dealings (further important candidates: The Ministry of Ecology and Environment and the National Medical Products Administration). As business models can fall into the area of responsibility of different authorities, you might try “authority shopping” for your business. An early registration and an elaborate strategy should offer good prospects.
III. The Chinese Biosecurity Law and “low-risk” biotechnology research and development
If you are active in the field of biotechnology research and development, it is all about your business being assessed as “low-risk” (Art. 36 to 38 Biosecurity Law), neither “medium-“ nor “high-risk” according to Art. 36 (2) Biosecurity Law. Try to take advantage of this period of legal uncertainty for your cause now. You can avoid a lot of trouble if your business dealings are assessed as low-risk. For instance, high-risk and medium-risk biotechnology research and development activities shall now be lawfully established and organized as legal persons in China according to the Biosecurity Law in the future. Furthermore, such businesses have to conduct risk assessments, draft risk control/prevention plans and emergency response plans for biosecurity incidents, see Art. 38 (1), (2) Biosecurity Law. You can be sure that this is where reviews will be conducted, first. With a low-risk determination, you will be able to save costs and worries. As a matter of fact, your registration paperwork has to be thought through and should convince the competent officials instantly without any lengthy written discussions. Once your business is classified as high-risk first, it will certainly be difficult to remove you from the firing line again.
For further information, feel free to contact us or follow our blog!
