Because No One is Immune to the Law
July 22, 2020 - Biotech, Pharma, Regulatory, Asia

China to Criminalize Human Genetic Resources Violations

China Patent Eligibility Update: Human Embryonic Stem Cells

On June 28, 2020, the draft 11th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human Genetic Resources Regulations (the “Regulations”) and its draft Biosecurity Law, and sends a strong signal that China’s legislature is determined to strengthen the penalties and punishments for the protection of China’s biosecurity. The Draft has been published for public comments, which may be submitted by August 16, 2020.

China’s current Criminal Law includes a number of crimes for violation of other laws and aimed for the prevention and control of infectious diseases and bioterrorism, e.g., certain crimes in violation of China’s Law on Prevention and Treatment of Infectious Diseases and causing the spread of, or a serious risk of spreading, a Category A infectious disease determined by that law, crimes for causing the spread of bacterial or viral agents for infectious diseases resulting in serious consequences, and crimes for violating health and quarantine regulations at the national border. The current Criminal Law also includes a number of crimes aimed at the prevention and control of biological invasions and for biological resource conservation, e.g., crimes for violation of certain national regulations on animal and plant epidemic prevention and quarantine. The current Criminal Law, however, lacks provisions on misuse of biotechnology, illegal use of human genetic resources (HGR), and other acts resulting in the destruction of ecological environment or biological resources. This is in part due to the slow legislation in other areas of law, because the Criminal Law, in the context of biosecurity, rather than defining crimes from scratch, typically provides for penalties and punishments against serious violations of other laws or regulations. The legislative progress in China’s Biosecurity Law provides the motivation for speeding up the corresponding legislative update to China’s Criminal Law.

The Draft proposed to add the following provisions to the crimes in connection with the collection and supply of blood and the production and supply of blood products:

Any person committing any of the following acts, in violation of relevant State regulations and endangering public health or social public interest, shall be sentenced to, in cases of serious circumstances, not more than 3 years of fixed-term imprisonment or criminal detention or control, and/or a fine, and, in cases of especially serious circumstances, imprisonment of not less than 3 years but not more than 7 years, and a fine: (i) illegally collecting China’s human genetic resources; (ii) illegally transporting, mailing or carrying China’s human genetic resources materials abroad; and (iii) supplying or providing open access to China’s human genetic resources information to foreign organizations or individuals or institutions established or actually controlled thereby.

Although proposed to be added to the existing provisions related to blood and blood products, the new provisions related to HGR have far broader implications than curbing mishandling of blood products. Human genetic resources, as defined in the Regulations and the draft Biosecurity Law, include not only HGR materials, of which blood is but one example, but also the data and other information generated from the utilization of those materials, which is broad enough to cover medical images and laboratory test results. Both the Regulations and the draft Biosecurity Law, which is intended to codify significant portions of the Regulations, prohibit foreign organizations and individuals and institutions established or actually controlled thereby (collectively, “Foreign Persons”) from collecting or preserving China’s HGR within China, or providing China’s HGR abroad. Therefore, Foreign Persons are subject to the punishments provided for in items (i) and (ii) of the newly proposed HGR-related Criminal Law provisions.

The Draft also includes punishments of up to seven years of imprisonment and a fine against the implant of genetically edited embryos or cloned embryos into humans or animals in violation of relevant State regulations, as crimes of illegal medical practice. This is an obvious countermeasure taken by the legislators in light of the gene-edited babies scandal that broke out in China in 2018.

The inclusion of HGR-related crimes in the Draft is hardly surprising. Both the Regulations and the draft Biosecurity Law state that any violation thereof that constitutes a crime shall be prosecuted according to the law, and in the absence of the corresponding crimes in the Criminal Law, those provisions have so far been toothless when it comes to HGR. Foreign Persons should pay special attention to the Criminal Law’s legislative progress, because in addition to the economic consequences that they may have to bear for violating the Regulations and the Biosecurity Law, they may face criminal prosecution for the same violations in the event the circumstances are serious, which the courts in China will have considerable discretion to determine when imposing sentences.

For a summary and analysis of the Regulations, please refer to this author’s article, and for a summary and analysis of select provisions of the draft Biosecurity Law, please refer to this author’s article.