Controversy Arises: Revocation of Bio-Transformed Bear Bile Powder Standard by Hainan Province
The Political Research Office of China Biodiversity Conservation and Green Development Foundation (CBCGDF) was informed by some experts that Hainan Provincial Drug Administration issued the “Announcement on Revocation of Chinese Medicinal Material Standard for Bio-transformed Bear Bile Powder in Hainan Province” on August 17, 2023.
Bio-transformed bear bile powder is a new alternative product that responds to the country’s call to reduce and gradually ban live bear bile harvesting, replaces live bear bile harvesting with in vitro cultured bear bile technology, and at the same time ensures that bio-transformed bear bile powder has the same performance as bear bile. On December 17th, 2022, Hainan Provincial Drug Administration officially issued the Chinese Medicinal Material Standard for Bio-transformed Bear Bile Powder (standard number: Qiong YCB2022-001), and the local standard was officially implemented as of the date of publication.
According to professionals, bear bile refers to the dried bile of the animal, such as black bears or brown bears. Bear bile powder is a dried product obtained by draining bile from bears through gallbladder surgery. Bear bile has long been used as a raw material for medicinal materials in the medicine market because of its sedative and detoxification effects. However, bear bile products such as bear bile powder currently used in the market are mostly derived from the cruel technology of taking bile alive from bears. Although tubeless drainage has been widely adopted since 1996, it is worth noting that this method still causes trauma on live bears. And in order to ensure that the wound is not infected, the bears need to take quantitative antibiotics every day, which also causes the serious phenomenon that the antibiotic content in most bear bile in the market exceeds the standard. According to the data, the life span of live bears which have suffered from bile extraction for a long time is several years or even more than ten years shorter than that of normal bears, which is far from the concept of protecting wild animals and building ecological civilization.
In 2016, the Development Research Center the State Council issued a report, suggesting that China should withdraw from the live bear bile market in the next 20 years and eliminate the industry. In December 2020, the Hainan Provincial Party Committee and the Provincial Government held a meeting to thoroughly study and implement the Ecological Civilisation’s important spirit of “emancipating the mind, daring to try and innovate boldly”. On March 20th, 2022, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Strengthening the Ethical Governance of Science and Technology. The Article One is about strengthening the institutional guarantee of ethical governance of science and technology, in which Provision 4 states that to formulate and improve the ethical norms and standards of science and technology.
On June 30th, 2023, the Expert Working Group for Research on Regulatory Policies and Technical Requirements for Substitutes of Rare and Endangered Chinese Medicinal Material of the National Medical Products Administration held its establishment meeting and expert research symposium in Beijing to comprehensively implement the work arrangement indicated in the Opinions on Promoting the Inheritance, Innovation and Development of Traditional Medicinal Materials issued by the CPC Central Committee and the State Council about “strengthening the protection of rare and endangered wild medicinal animals and plants, and supporting the research, development and utilization of substitutes for rare and endangered Chinese medicinal materials”. The Special Provisions on the Registration and Management of Traditional Chinese Medicine supports the research, development and utilization of substitutes for endangered Chinese medicinal materials.
Some industry insiders have reported to CBCGDF that the publication and implementation of the standard for bio-transformed bear bile powder is of positive significance for the application of this technology as a substitute for rare and endangered Chinese medicinal materials. This technology is now mature. If it is standardized and put on the market with standard, it will have a great positive influence on the country’s promotion of traditional Chinese medicine inheritance and innovation and healthy and sustainable development, and can also save a large number of bears from the pain and rapid death of their lives caused by taking bile. It is a pity that the standard was announced to be revoked in less than one year, which is embarrassing.
What caused the standard to be revoked in less than one year? Does the revocation of this standard conform to the Ecological Civilisation’s vision of “to actively promote the Chinese modernization of harmonious coexistence between man and nature and implement major projects for biodiversity protection”? Is it contrary to the above-mentioned policy orientation of the Central Government to encourage innovation in replacing endangered Chinese medicinal materials? Does the procedure for revoking this standard as a local standard comply with the law? Has the revocation of an innovative technology been judged by the Expert Working Group for Research on Regulatory Policies and Technical Requirements for Substitutes of Rare and Endangered Chinese Medicinal Material?
Regarding the above problems, the Political Research Office of CBCGDF will continue to pay attention to the progress of this case.
Translator: Irene
Checked by Ahua
Editor: Irene
Contact: v10@cbcgdf.org; +8617319454776
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