Introduction
Chinese medicine is widely accepted by the community and plays an important role in the health care system of Hong Kong . According to the General Household Survey conducted in mid 2002, about 20% of doctor consultations were provided by CM practitioners. An earlier survey also showed that about 60% of Hong Kong people had resorted to the use of Chinese medicines.
Government Policy on Chinese Medicine
Preparation for regulation of CM started in August 1989, when the Hong Kong Government set up the Working Party on Chinese Medicine. It was tasked to review the use and practice of CM in Hong Kong, and advise on measures to promote the proper use and good practice of CM. Following the Working Party's recommendation, a Preparatory Committee on Chinese Medicine was appointed by the then Secretary for Health and Welfare in 1995 to make recommendations on the regulation and development of CM. The Committee finalised its recommendations and submitted its report to the Government in March 1997.
A public consultation exercise was conducted from November to December 1997. Based on the Preparatory Committee's recommendations and submissions received during the consultation exercise, the Chinese Medicine Bill was introduced to the Legislative Council in February 1999.
Legal Basis and Government Policy
The Basic Law provides that the Hong Kong Special Administrative Region (HKSAR) Government shall, on its own, formulate policies to develop western and traditional Chinese medicine.
In his 1997 and 1998 Policy Addresses, the Chief Executive set forth the vision to develop Hong Kong into an international centre of CM and announced that for the protection of public health, a statutory framework would be established to recognise the professional status of CM practitioners, to monitor their standards of practice, and to regulate the use, manufacture and trading of Chinese medicines.
The Statutory Regulatory Framework
The Chinese Medicine Ordinance was enacted in July 1999 to provide for a comprehensive regulatory framework for CM. The Chinese Medicine Council of Hong Kong (the Council), established in September 1999, was a statutory body to devise and implement the regulatory systems.
Regulation on Chinese Medicine Practitioners
CM practitioners are regulated through a system of examination, registration and discipline. In the long run, only registered CM practitioners are allowed to practise in Hong Kong. To become a registered CM practitioner, one must have completed a recognised undergraduate degree course in CM practice and pass the licensing examination conducted by the Council. They must also comply with the code of practice and meet the requirements on continuing education.
The CM Ordinance provides for transitional arrangements for CM practitioners who were practising CM in Hong Kong on or before 3 January 2000. They could apply to become listed CM practitioners.
With effect from 1 March 2002, any unqualified person (person neither a registered nor listed CM practitioner) who practises CM in Hong Kong contravenes the Chinese Medicine Ordinance.
In 2003, the Council conducted the Registration Assessment for listed CM practitioners and the first universal Licensing Examination. At present, there are over 4,700 registered CM practitioners and 3,200 listed CM practitioners in Hong Kong.
Regulation of Chinese Medicines
Chinese medicines are regulated through a licensing system for traders and a registration system for proprietary Chinese medicines (pCm).
Wholesalers and retailers of Chinese herbal medicines listed in Schedule 1 and Schedule 2 of the CM Ordinance as well as wholesalers and manufacturers of pCm must obtain a licence for their business. The licensing requirements focus on personnel, facilities and hygienic conditions of premises. Proper packaging, labelling and keeping of sales records are also required to facilitate audit trail and recall in case of adverse reactions.
To help the traders meet the future regulatory standards, the CM Council has prepared practising guidelines for each type of these traders. In addition, guidelines on Good Manufacturing Practice and Good Clinical Practice have been drawn up.
All pCm need to be registered before they are allowed to be on sale or manufactured in Hong Kong. Having extensively consulted the trade, the Council set out the registration requirements for pCm based on the criteria of safety, quality and efficacy.
The subsidiary legislation on Chinese medicines was passed by the Legislative Council in January 2003. Applications for license of Chinese medicine traders and registration of proprietary Chinese medicines began in May and December 2003 respectively. So far, about 6,900 applications for trader license have been received and they are now being processed.
Like CM practitioners, transitional arrangements are provided for Chinese medicines traders who were in the business on 3 January 2000 and pCm which were manufactured or sold in Hong Kong on 1 March 1999. A transitional licence or transitional registration of pCm will be granted if an application was made during the specified period (5 May to 15 July 2003 for transitional licence for traders or 19 December 2003 to 30 June 2004 for transitional registration of pCm).
Hong Kong Chinese Materia Medica Standards (HKCMMS)
To safeguard public health, objective safety and quality regulatory standards of Chinese herbal medicines are required. The Department of Health is committed to developing regulatory standards for 60 commonly used herbs. To take the initiative forward, a HKCMMS office with experts recruited from the Mainland and an International Advisory Board comprising of renowned local, Mainland and overseas experts were established. A scientific committee has also been formed to provide technical advice and to monitor progress on the development of HKCMMS.
Laboratory and research work is being conducted and validated in collaboration with local universities and research institutions from the Mainland and overseas. Preliminary results of the first 8 herbs are now available for deliberation at the second International Advisory Board meeting scheduled in February 2004. The next stage of work involving 24 herbs will commence in early 2004.
The development of HKCMMS, alongside the regulatory and other infra-structural developments, will support the modernisation and globalisation of Chinese medicines, paving way for Hong Kong to develop into an international centre for Chinese medicine.
Chinese Medicine Division
Department of Health
We will collaborate with universities and research institutes to collect and authenticate raw materials. Specimens will be retained and archived at local universities. In phytochemistry, our laboratory carries out extract preparation and adopts chemical techniques and bioactivity-guided isolation to purify CM active fractions and ingredients. The quality of CM is based on good quality assurance and quality control. We use state-of-the-art technologies to develop consistent and reproducible analytical methods and markers for quality profiling of CM. Our approach will contribute towards meeting technical requirements of regulations on safety and quality and achieving intellectual property protection. Our sample bank comprises good quality standard extracts, chemical markers (including active ingredients and specific markers) and associated technical information and documentation. Through this laboratory, we will be able to offer technical advice and support on quality evaluation of CM to government offices, research organisations and the industry.
Furthermore, the establishment of this laboratory helps to centralise co-ordination for effective project management, use of resources and sharing of related technical information. To advance CM development, we will develop collaborations with research-based organisations in the area of Chinese medicine or natural product research within and outside Hong Kong to share latest research findings.
