Legal experts have urged anyone who handles biological materials in China to take the country’s first biosecurity law seriously after it took effect on Thursday, with certain activities now deemed criminal acts.
The law applies to a long list of activities, including the handling of pandemics, biotechnology research and human genetic materials, and the management of laboratories. Those who break the law could be jailed and face 10 million yuan (US$1.53 million) in penalties.
Industries ranging from health care and biotechnology to food and agriculture could be affected by the law, the passage of which was accelerated by the Covid-19 pandemic.
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Ethical dilemmas over genetic engineering also likely prompted the drafting of the law.
In 2018, Chinese scientist He Jiankui shocked the world when he claimed he had genetically engineered a pair of female babies to be resistant to HIV. He was sentenced to three years in jail and fined 3 million yuan in 2019.
Xiao Ting, a senior associate with international law firm DLA Piper in Shanghai and a former research scientist, said the law consolidated several existing regulations.
She said it was designed with security in mind and aimed to promote the development of biology technology in a safe way and to protect people’s well-being and the ecology. People who could be affected should be proactive to ensure they complied, she added.
“We believe that the life sciences companies should take the law a lot more seriously, as some violations have already been coded into the criminal law,” Xiao said.
“The industry is aware but I think we need to do more than just being aware of this. For example … they could conduct an audit and establish an internal compliance system.”
Xiao said more details were expected on how the law would be implemented in certain areas.
Foreign entities are banned from collecting human genetic resources in China without approval, and those in China who illegally transport resources overseas could be fined or jailed for between three and seven years. Illegal human genetic engineering attracts the same punishment, according to China’s criminal law.
There are some exceptions, such as clinical trials for drugs entering the Chinese market, but prior registration is required, the biosecurity law says.
The new legislation has 10 chapters and 88 articles, with number 74 saying biological research that is not approved by authorities could result in a penalty of up to 10 million yuan or 20 times any illegal income amounting to over 1 million yuan.
Michael Chin, a partner with legal practice Simmons and Simmons in Hong Kong and Shanghai, said the question most frequently asked by clients was about how the law would affect the establishment of research and development centres in mainland China, and carrying out research with Chinese parties using human genetic resources.
Chin said businesses in relevant sectors should review their current programmes, set up an appropriate internal governance structure for biosecurity, and train staff on the requirements of the law.
The legislation covers a wide range of areas under a broad definition of “biosecurity”. Businesses that work with human genetic resources are encouraged to proactively communicate with the Ministry of Science and Technology, especially for vague areas, according to Chin.
The biosecurity law also aims to protect against bioterrorism and biological weapon threats, with national information sharing, monitoring and early warning systems for biosecurity to be set up.
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