Panel on Health Services
Meeting on 14 September 1998
Report on the Legislation of Chinese Medicine
This paper sets out the present position on the proposal to legislate for the regulation of the practice, use and trading of Chinese medicine.
2. In March this year, we briefed Members of the Health Panel of the Provisional Legislative Council on our proposal to regulate Chinese medicine in Hong Kong. In the past few months, details of the proposal were discussed at the meetings of the Preparatory Committee on Chinese Medicine and its Sub-committees, and continuing consultations were made with Chinese medicine practitioners and traders. We are now preparing the draft Chinese Medicine Bill (the Bill) based on the feedback received. Key areas to be covered by the Bill are briefly described in ensuing paragraphs.
The Proposed Regulatory Framework
3. The Bill provides for the establishment of a regulatory structure comprising one Council, two Boards and six Committees. The Chinese Medicine Council oversees the entire regulatory system for Chinese medicine and advises the Government on relevant policy matters. The Council will be underpinned by two Boards, namely, the Chinese Medicine Practitioners (CMP) Board and the Chinese Medicines (CM) Board, set up to regulate the two main areas of Chinese medicine respectively. Under each of the two Boards, three Committees will be formed to take up different aspects of the regulatory work, including registration, licensing and discipline.
4. Membership of the Council, Boards and Committees will consist mainly of persons from the Chinese medicine sectors to reflect the principle of "self-regulation" by the profession. Representatives from the Government and other sectors of the community will also be included to ensure that the regulatory body is accountable to the public.
The Regulation of Chinese Medicine Practitioners
Statutory Registration System
5. The Bill will establish a statutory registration system for CM practitioners to ensure that only persons with the required standard of knowledge and practice experience will be allowed to practise Chinese medicine. The registration requirement covers all Chinese medicine practitioners in general practice, bone-setting, and acupuncture.
6. To assess the competency of the applicants for registration, a licensing examination will be introduced. Only those who have passed the examination will be allowed to register as a CM practitioner.
7. On the other hand, taking into account the large number (about 7,000) of CM practitioners now practising in Hong Kong, we propose that the Bill should provide a transitional arrangement whereby practising CM practitioners can register with the Council without the need to sit for the licensing examination. After extensive consultation with the Chinese medicine profession, we propose the following transitional arrangements :-
- those with a minimum of 15 years of continuous practice experience in Hong Kong can be registered without sitting for the licensing examination;
- those with less than 15 years but more than 10 years of continuous practice experience in Hong Kong and possessing a qualification in Chinese medicine practice acceptable to the CMP Board can be registered without sitting for the licensing examination;
- those with less than 15 years but more than 10 years of continuous practice experience in Hong Kong but who do not possess an acceptable qualification can be exempted from sitting for the licensing examination provided they pass a registration assessment by the CMP Board;
- those with less than 10 years of continuous practice experience in Hong Kong but possessing an acceptable qualification can be exempted from sitting for the licensing examination provided they pass the registration assessment by the CMP Board; and
- those with less than 10 years of practice experience and who have not obtained any acceptable qualification will be required to sit for the licensing examination.
8. All applicants for registration who fall outside the transitional arrangements must take the licensing examination. To be eligible to take the licensing examination, they must first satisfy the CMP Board that they have satisfactorily completed a course of training in Chinese medicine practice of the type approved by the Board. The curriculum, format, standard of assessment and other related matters in respect of the licensing examination will be determined by the Board.
9. The Bill will provide for limited registration to be approved by the CMP Board, whereby a CM practitioner who is engaged by an education institution to carry out primarily clinical teaching and research work may be allowed to register for a limited period of time, provided he has the necessary qualification and experience, and his application is supported by the institution concerned.
Practising Certificate and Continuing Education
10. Following registration, a CM practitioner must apply and obtain a practising certificate before he is allowed to practise Chinese medicine. The certificate is renewable, but the CMP Board may, in the interest of maintaining the standard of practice, require the certificate holder to show proof of having taken part in continuing education in Chinese medicine as a condition of renewal. The CMP Board will determine the requirements relating to continuing education in Chinese medicine, including the accreditation of courses and seminars.
11. A disciplinary system for CM practitioners will be established to handle any alleged malpractice or misconduct in the Chinese medicine profession. The CMP Board will make inquiry into any case of alleged malpractice or misconduct by a registered CM practitioner and take appropriate disciplinary action, where necessary.
The Regulation of Chinese Medicine
Chinese Herbal Medicines
12. We propose that the Chinese Medicine Council should specify for regulatory purpose a list of commonly dispensed Chinese herbal medicines and a list of potent herbal Chinese medicines which can only be sold or dispensed on prescription. The lists will exclude those Chinese herbal medicines which are widely used as ingredients in common dishes and herbal soups, such as dried mushrooms and lotus seeds.
13. Retailers and wholesalers/importers of the listed Chinese herbal medicines are subject to licensing control. The licensing conditions will be prescribed by the CM Board. The controls are envisaged to cover such areas as storage, labelling, and packaging of Chinese herbal medicines. The holder of a retail licence will be required to nominate a competent and experienced person to be in charge of the dispensing of Chinese herbal medicines.
Proprietary Chinese Medicines
14. The Bill will require all proprietary Chinese medicines manufactured or offered for sale in Hong Kong to be registered with the CM Board. Registration of imported medicines will be made by either the importers or local representatives/agents of the manufacturers outside Hong Kong. In the case of medicines being manufactured in Hong Kong, the responsibility for registration lies with the local manufacturers.
15. In determining an application for registration of a proprietary Chinese medicine, the CM Board will take into consideration the safety, quality and efficacy of the medicine. For a proprietary Chinese medicine to be imported, the Board will also take into account the methods, standards and conditions of manufacture of the medicine. The CM Board may also require undertakings to be given by the manufacturer of the imported proprietary Chinese medicine to permit inspection of the manufacturing facilities and operation, and to comply with any conditions that may be imposed by the CM Board.
16. Similar to the one for the Chinese herbal medicines, a licensing system will be introduced for the licensing of manufacturers and wholesalers/importers of proprietary Chinese medicines. Licensing of retailers, however, will not be required as the proprietary Chinese medicines for sale have already been registered. The licensing conditions will be prescribed by the CM Board. The controls will cover such areas as the hygiene of the warehouses and factories, quality control of the manufacturing operation and proper packaging and labelling of the medicines.
Transitional Registration and Licensing
17. To minimise disruption to the trade when the legislation is first enacted, there will be provisions in the Bill to allow for transitional registration and licensing. Provided an application for registration or licence has been made to the CM Board within a prescribed time period, the traders will be allowed to carry on their business as if the registration or licence have been obtained until such time when the application is approved or rejected.
Other Provisions for the Regulation of Chinese Medicines
18. The Bill will also contain provisions governing such matters as the labelling and marking requirements of containers and packages containing Chinese medicines, the issue of clinical trial certificates or medicinal test certificates for proprietary Chinese medicines, and the issue of free sale certificates for the purpose of exporting proprietary Chinese medicines.
Legislative and Implementation Timetable
19. We are presently proceeding according to the following timetable:-
|Introduction of the Bill into the Legislative Council
||First quarter of 1999
|Enactment of subsidiary legislation
||1999/2000 legislative session
|Registration of Chinese Medicine Practitioners
||Commence in 2000
|Regulation of Chinese Medicines
||Implemented by phases, starting from 2000
Health and Welfare Bureau