LCQ13: Supporting development of Chinese medicine industry
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Question:
Some members of the Chinese medicine (CM) sector have relayed to me that they hope the Government will further support the development of the local CM industry. In this connection, will the Government inform this Council:
(1) whether it will consider providing financial assistance to local manufacturers of CM drugs with Good Manufacturing Practice (GMP) certification to assist them in continuing to innovate and upgrade their equipment to ensure that the quality of their products meets international standards, as well as establishing an intellectual property (IP) protection mechanism (covering applications for patents, registration of trade marks, development of technologies to keep formulae confidential, and engagement of professional legal consultants) to cope with possible IP litigation both within and outside the country;
(2) whether it will consider collaborating with local universities and industry organisations to provide CM enterprises with professional training related to IP management, so as to assist such enterprises in enhancing their awareness and application of IP, including how to apply for patents and trade marks both within and outside the country, protect traditional knowledge and techniques from improper use, and cope with IP disputes in the international market, etc;
(3) whether it will consider stepping up local law enforcement efforts to strengthen the combat against IP infringement activities in the CM market (including expediting investigations into and the handling of infringement cases), so as to lower enterprises' cost of safeguarding their IP rights; whether it will strengthen its co-operation with other countries or regions in respect of IP to assist local CM enterprises in applying for and protecting IP rights overseas more conveniently;
(4) whether it will consider providing support for local pharmaceutical companies to step up publicity efforts on their GMP-compliant CM products, and enhancing the promotion and publicity of the brand image of local CM products (e.g. assisting pharmaceutical companies in participating in international and Mainland exhibition events), with a view to facilitating the export of local CM products and better integrating the local CM industry into the market of the Guangdong-Hong Kong-Macao Greater Bay Area;
(5) whether it will consider subsidising local proprietary CM manufacturers' employment of graduates in CM disciplines from local institutions, so as to entice more young people to join the CM industry, thereby solving the talent shortage problem in the industry and facilitating the transmission and innovation of relevant techniques;
(6) of the respective testing methods currently adopted by the Government for traditional CM decoction pieces and purified granules; as some members of the sector have relayed that the testing methods adopted by the Government for CM products such as CM decoction pieces cannot cater for actual situations, thus hindering the development of the CM industry (for example, the current testing methods have failed to address cases where, even if exceedances of toxic elements are detected in respect of the decoction pieces of a single CM upon testing, the substances in the medicinal broth produced by decocting such pieces with other CMs are different from the single CM as the raw material), whether the Government has, over the past five years, discussed with the sector how to improve the relevant testing methods, and considered changing the existing testing requirements for CM decoction pieces and ways of handling exceedances, so as to improve the relevant regulatory regime; and
(7) as some members of the sector have relayed that the batches of CM decoction pieces supplied to Hong Kong are relatively small, making it difficult for the sector to carry out comprehensive testing, whether the Government has formulated measures to facilitate the operation of the sector in the light of this situation; if so, of the details; if not, the reasons for that?
Reply:
President,
In consultation with the Commerce and Economic Development Bureau and the Department of Health (DH), the consolidated reply to the question raised by the Hon Shiu Ka-fai is provided by the Health Bureau as follows:
The Government has been supporting the development of the Chinese medicine (CM) industry in various aspects through different policy measures, including talent training, testing and certification, intellectual property (IP) protection, brand building and market development. In addition, the Government established the Government Chinese Medicines Testing Institute (GCMTI) in 2017 to develop reference standards for Chinese medicines (CMs) and their products, so as to strengthen the sector’s relevant quality control techniques through technology transfer. Taking into account the cost-effectiveness and properness of the use of public money, the Government promotes the development of the industry through the above policy measures and resources, instead of directly subsidising the operation of individual enterprises.
IP protection for CM
The Government continues to enhance Hong Kong's IP protection system and strengthen IP protection relating to CM, including patents, plant varieties protection, trade marks, undisclosed commercial information, copyright and registered designs. Technological achievements of the CM sector that meet the patentability requirements, such as being new, inventive and susceptive of industrial application, may apply for patent protection. In addition, the industry may apply for trade mark registration protection in respect of the names or signs of the CMs products. The packaging design of CMs products may also be protected through registered designs.
Regarding IP training, the Intellectual Property Department (IPD) has been collaborating with various stakeholders to support and promote local enterprises (including the CM sector) to properly protect, manage and commercialise their IP assets, including launching the IP Manager Scheme since May 2015 under which IP training courses and practical workshops covering a range of topics (including applications for registration of patents, trade marks and designs, IP rights enforcement, etc) are being organised. In October 2020, the IPD launched the IP Manager Scheme PLUS to provide more comprehensive and in-depth IP training courses and practical workshops. The IPD has also been collaborating with the Law Society of Hong Kong to provide free IP consultation services for small and medium-sized enterprises (SMEs), helping them deepen their understanding of IP and formulate effective strategies for IP protection, management and commercialisation. The CM sector is welcomed to use relevant consultation services.
In addition, the IPD and the Hong Kong Productivity Council are pressing ahead with the establishment of a World Intellectual Property Organization Technology and Innovation Support Centre in Hong Kong, targeting for official commissioning by the end of 2025 the earliest. The Centre will focus on providing local start-ups and SMEs, including those in the CM sector, with high-quality IP (especially patents) information and services to assist them in creating, protecting, managing and commercialising their IP, and also promoting IP transformation and trading.
With respect to assisting the CM sector in resolving IP disputes, mediation and arbitration are effective means to resolve such disputes. The provisions related to IP disputes under the Arbitration (Amendment) Ordinance 2017 (Cap. 609) came into effect in January 2018, clarifying that all IP disputes could be resolved by arbitration and that the arbitral awards concerned could be enforced in Hong Kong. Since 2015, the Department of Justice has been organising a thematic session on resolution of IP disputes annually at the Business of IP Asia Forum co-organised by the Government and the Hong Kong Trade Development Council, and has also been sending representatives to attend the IP training programmes organised by the IPD (including regular courses on IP Basics and courses dedicated to mediation of IP disputes) and to introduce to local enterprises (including the CM sector) the benefits of resolving IP disputes by mediation and the procedures involved.
As regards IP enforcement, the Customs and Excise Department (C&ED) adopts a multi-pronged approach to combat IP infringement activities at cross-boundary, market and online/technology crime levels. The C&ED has been maintaining close liaison with IP owners (including the CM sector) to jointly monitor the market situation. Upon identifying infringement activities, with the assistance of the IP owners, the C&ED will take prompt enforcement actions against those illegal shops. The C&ED also maintains close liaison with other government departments in the Mainland, Macao and Hong Kong, overseas law enforcement agencies and the World Customs Organization to exchange intelligence and take joint enforcement actions against suspected infringement activities.
Supporting the CM sector in market development and talent nurturing
CMs traders are obligated to plan and invest for their own business operations, equip themselves with personnel who meet the necessary qualification requirements and establish sales channels. Meanwhile, the Government provides various policy support to assist the CM sector in enhancing quality and developing new markets outside Hong Kong.
The Chinese Medicine Development Fund (CMDF), officially launched in 2019 with a total injection of HK$1 billion, aims to enhance the overall standards of the CM sector and to promote high-quality CM development in Hong Kong on all fronts. Various support programmes cover areas including talent nurturing, quality enhancement, market development, research and applied studies, and publicity and promotion. New and enhanced initiatives have been rolled out continuously as to meet with the latest development needs of the sector. Measures to support talent nurturing and industry development in CMs include:
(a) Through the "Chinese Medicine Personnel Training Funding Scheme" (A1-1, A1-2, and A1-3 Schemes), financial support is provided to CMs personnel for enrolling eligible training courses, including courses recognised under the Qualifications Framework (A1-1 Courses), training courses with assessment (A1-2 Courses) and general training courses (A1-3 Courses);
(b) In May 2025, large-scale international or regional CM conferences, forums, exhibitions and events are listed as priority themes under the "Chinese Medicine Promotion Funding Scheme" (B1-2 Scheme), raising the relevant funding ceiling to HK$5 million;
(c) Through the "Proprietary Chinese Medicine Quality and Manufacturing System Enhancement Funding Scheme" (A2 Scheme), subsidy is provided to local manufacturers of proprietary Chinese medicines (pCm) for enhancement in technology and hardware, so as to optimise their systems in achieving Good Manufacturing Practice (GMP) standards for pCm production. The eligibility criteria have been extended to manufacturers who have already hold a GMP certificate for pCm production to maintain their quality production environment; and
(d) Hong Kong and Macao registered traditional pCm for external use can be registered and sold on the Mainland through the streamlined approval procedures since August 2021. In January 2025, the National Medical Products Administration further extended the streamlined approval procedures to traditional pCms for oral use (with production subject to GMP requirements). To this end, the CMDF has set up the "Guangdong-Hong Kong-Macao Greater Bay Area Proprietary Chinese Medicine Industry Development Support Scheme" (A5 Scheme), to provide financial support to Hong Kong pCm manufacturers or wholesalers in respect of registration application, supporting them to make applications to Guangdong Provincial Medical Products Administration for eligible pCms through the streamlined approval procedures, facilitating market expansion into the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) and the Mainland.
Regarding the aforementioned streamlined approval procedure for traditional pCms for external and oral use, the Chinese Medicine Regulatory Office of the DH has been actively assisting the trade in grasping the relevant details through various channels, including conducting seminars on a monthly basis to exchange views with the industry on the development of CMs in the GBA, and at the same time responding to enquiries from the industry on the relevant applications and providing appropriate assistance.
In addition, the Government has established other funds to support the business development of enterprises in different sectors. The Dedicated Fund on Branding, Upgrading and Domestic Sales (BUD Fund) is one of the examples providing subsidy to individual non-listed enterprises registered in Hong Kong (including the CM sector) to undertake projects to develop brands, upgrade and restructure their business operations and promote domestic sales. The SME Export Marketing Fund also provides financial support to SMEs to encourage their participation in export promotion activities.
On the work of promoting and branding of Hong Kong's CMs products, the DH introduces Hong Kong's pCm registration system to various countries through different international platforms, such as the World Health Organization's International Regulatory Cooperation for Herbal Medicines and the Western Pacific Regional Forum for the Harmonization of Herbal Medicines, in order to elevate the international credibility of registered pCms from Hong Kong. The GCMTI of the DH has been actively taking forward the work on research, education, as well as promotion of international collaboration on CMs testing. Such work includes developing a set of internationally recognised reference standards and testing methods for CMs and their products, and promoting the commercial application of these methods in the CM and testing sectors through training and technology transfer programmes, with a view to establishing the brand image of Hong Kong's CM and developing the city into an international centre for CM testing and quality control.
Continuously optimising local CMs testing methods and ensuring the safety of CMs
Through the GCMTI, the DH assists the CM and testing sectors in enhancing testing capabilities. To facilitate the industries in testing Chinese herbal medicines (Chms) (including decoction pieces and single-ingredient granules), the GCMTI develops multidisciplinary and multiple modalities testing methods, such as macroscopic identification, chemical and DNA testing, and through publishing monograph, providing training and technology transfer, assisting these sectors to apply these testing methods.
To ensure that the research projects undertaken by the GCMTI align with industry needs, the DH has established the Advisory Committee of the GCMTI with a view to advising the GCMTI on strategies, measures, and specific proposal conducive to the continuous development of the GCMTI.
Moreover, the DH has engaged with the CM and testing industry on multiple occasions over the past five years to exchange views on the safety standards and testing methods for Chms formulated by the Chinese Medicine Council of Hong Kong (CMCHK). In 2024, in order to assist the testing industry in mastering the pesticide residue limit standards and testing technical requirements for Chms revised by the CMCHK in accordance with the Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia), the GCMTI organised a series of technology transfer activities. These initiatives aimed to enable local private laboratories to better master the testing requirements of the Chinese Pharmacopoeia and align with national standards.
The current safety standards and testing methods for Chms set by the CMCHK are based on the 2020 edition of the Chinese Pharmacopoeia and the current Hong Kong market situation. The limit for some harmful residues have been set by taking into account of the extraction ratio during the decoction process. However, owing to different CMs prescriptions, decoction methods, and methods of administration of different CMs, as well as the physical and chemical characteristics of different harmful residues, there is no single testing method applicable to all. The CMCHK will continue to review the current testing standards and methods, and establish safety and testing methods from a scientific perspective while ensuring the safe use of medicines.
As to the relatively high cost for testing small batches of stock expressed by specific CMs traders, the CMCHK currently does not mandate CMs traders to conduct tests on all Chms for heavy metals and toxic element, pesticide residues and sulphur dioxide residues. However, according to the "Practising Guidelines for Wholesalers of Chinese Herbal Medicines", CMs traders should purchase CMs only from reputable suppliers and require suppliers to ensure that the quality of each batch of CMs purchased meets the required standards. Therefore, local wholesalers of Chms could request suppliers or manufacturers of processed herbal medicines to provide relevant quality certification documents to reduce the relative testing costs.
Ends/Wednesday, July 16, 2025
Issued at HKT 18:25
Issued at HKT 18:25
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