LS&HC Horizons 2022 - Flipbook - Page 14
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
14
Clinical Trials
Risk management for the handling of Human
Genetic Resources in China
With the Biosecurity Law, the Personal Information Protection
Law and the Criminal Law taking effect in 2021, China is striving
to emphasize the safety of human genetic resources (HGR). The
Human Genetic Resources Administration of China (HGRAC) also
continues to play an active role in interpreting relevant regulations.
Multinational life sciences corporations need to be cautious when
dealing with HGR in clinical trials and other research programs
in China, and comply with the appropriate regulatory procedures
outlined below.
• C
ollaboration with Chinese Parties. Foreign parties are prohibited
from collecting, preserving, or supplying HGR in China with
only limited exceptions. Therefore, foreign parties will need to
collaborate with Chinese medical institutions in the handling of
HGR. The local Chinese institutions shall be the ones involved in
collecting HGR, substantively involved in the whole process of
clinical trials and research programs, and able to access the full
HGR records and data. The relevant trial data backups shall also be
provided to HGRAC.
• R
ecord-Filing/Approval from HGRAC. Different activities are
subject to different administrative requirements, specifically:
•P
rior record-filing is needed for the international clinical
trials conducted for product registration and the exportation
of HGR data.
• Prior
approval is needed for the international collaborative
scientific research and the exportation of HGR materials.
• IP
Sharing. Patent rights generated during international
collaborative scientific researches need to be jointly applied and
owned by the foreign and Chinese parties.
• Informed
Consent. An appropriate “separate consent” mechanism
needs to be included in the informed consent form to be signed by
the data subjects for handling of the non-anonymous HGR data.
Lu Zhou
Partner, Beijing
Jessie Xie
Counsel, Beijing
Tong Zhu
Associate, Beijing
