LC Paper No. CB(2) 1599/98-99
(These minutes have been
seen by the Administration)
Ref : CB2/BC/18/98
Bills Committee on Chinese Medicine Bill
Members present :
Minutes of meeting
held on Thursday, 4 March 1999 at 10:45 am
in the Chamber of the Legislative Council Building
Prof Hon NG Ching-fai (Chairman)
Hon David CHU Yu-lin
Hon Cyd HO Sau-lan
Hon Mrs Selina CHOW LIANG Shuk-yee, JP
Hon CHAN Yuen-han
Dr Hon LEONG Che-hung, JP
Hon CHOY So-yuk
Members Absent :
Hon HO Sai-chu, JP
Hon Michael HO Mun-ka
Hon LEE Kai-ming, JP
Dr Hon LUI Ming-wah, JP
Hon Ronald ARCULLI, JP
Dr Hon Philip WONG Yu-hong
Hon YEUNG Yiu-chung
Hon Ambrose LAU Hon-chuen, JP
Dr Hon TANG Siu-tong, JP
Hon SZETO Wah
Hon LAW Chi-kwong, JP
Public Officers Attending :
Clerk in Attendance :
- Mr Gregory LEUNG Wing-lup, JP
- Deputy Secretary for Health and Welfare 1
- Miss Eliza YAU
- Principal Assistant Secretary for Health and Welfare (Medical) 1
- Miss Miranda NG
- Senior Assistant Law Draftsman
Department of Justice
- Dr LEUNG Ting-hung
- Assistant Director of Health (Traditional Chinese Medicine)
Staff in Attendance :
- Ms Doris CHAN
- Chief Assistant Secretary (2) 4
- Mr LEE Yu-sung
- Senior Assistant Legal Adviser
- Ms Joanne MAK
- Senior Assistant Secretary (2) 4
I. Election of Chairman
Nominated by Dr LEONG Che-hung and seconded by Mr David CHU Yu-lin, Miss CHAN Yuen-han and Miss CHOY So-yuk, Prof. NG Ching-fai was elected Chairman of the Bills Committee.
II. Meeting with the Administration
(LC Papers Nos. CB(3) 1165/98-99 and LS 107/98-99; and LegCo Brief (Ref. HW CR1/3911/98)
Briefing by the Administration
Objectives of the Bill
2. Deputy Secretary for Health and Welfare 1 (DS(HW)1) said that the Bill sought to -
- ensure the standards of practice of the Chinese medicine practitioners and establish a statutory registration system for them ; and
- to regulate the use, manufacture and trading of Chinese medicines. The control mechanism would include licensing of retailers and wholesalers of Chinese herbal medicine, licensing of wholesalers and manufacturers of proprietary Chinese medicines, and the registration of individual proprietary Chinese medicines.
The Chinese Medicine Council
3. DS(HW)1 pointed out that the Bill provided for the setting up of a Chinese Medicine Council to be responsible for implementing various control measures in relation to Chinese medicine. It would be responsible for ensuring adequate standards of practice and conduct in the profession of Chinese medicine practitioners and the proper use of Chinese medicines. The membership of the Chinese Medicine Council and its boards/committees would consist mainly of persons from different Chinese medicine sectors as well as representatives from the Administration and other sectors of the community to ensure that public interest would be fully reflected.
Chinese medicine practitioners
4. DS(HW)1 pointed out that the registration requirement covered all Chinese medicine practitioners in general practice, bone-setting and acupuncture. The registration framework would operate through a system of examination, registration and discipline. With reference to paragraph 5(a) to (c) of the LegCo Brief, DS(HW)1 briefed members on details of the Licensing Examination, the practising certificates and conditions of its renewal as well as the limited registration arrangement as provided for in the Bill.
5. DS(HW)1 then briefed members on the transitional arrangements for the existing 7 000 Chinese medicine practitioners, details of which had been set out in Annex B of the LegCo Brief. In brief, depending on the applicants' level of experience, knowledge and skills, they might be exempted from the Licensing Examination and be allowed to register, or allowed to register subject to a registration assessment conducted by the Practitioners Board. DS(HW)1 pointed out that, in accordance with clause 90 of the Bill, the practising Chinese medicine practitioners, who had to pass a registration assessment or the Licensing Examination before they would be allowed to register, would still be permitted to continue to practise Chinese medicine provisionally. They would need to meet the registration standard and be registered before a cut-off date to be specified and promulgated by the Secretary for Health and Welfare by notice in the Gazette.
Chinese herbal medicine
6. DS(HW)1 informed members that a list of 31 potent Chinese herbal medicines and a list of 574 commonly dispensed Chinese herbal medicine were specified in Schedules 1 and 2 of the Bill respectively. Retailers and wholesalers of the listed Chinese herbal medicines would have to obtain a licence from the Medicines Board. For the 31 potent Chinese herbal medicines in Schedule 1, they could only be sold or dispensed on prescription by registered Chinese medicine practitioners.
Proprietary Chinese medicine
7. DS(HW)1 informed members that the Bill required all proprietary Chinese medicines manufactured or offered for sale in Hong Kong to be registered with the Medicines Board. It also required the licensing of manufacturers and wholesalers of proprietary Chinese medicines. DS(HW)1 explained that in determining an application for registration of a proprietary Chinese medicine, the Medicines Board would consider the safety, quality and efficacy of the proprietary Chinese medicine concerned.
8. In a bid to minimize disruption to the trade when the legislation was enacted, DS(HW)1 said that provisions had been made in the Bill to allow for transitional registration and licensing. He said that provided an application for registration or licence was made to the Medicines Board within a prescribed time period, the traders would be allowed to carry on their business as if the registration or licence had been obtained until such time when the application was approved or rejected. The relevant proposed transitional arrangements were spelt out in clauses 118, 128 and 138 of the Bill.
9. DS(HW)1 pointed out that there were no provisions in the Bill for the registration of dispensers. However, the Administration would encourage them to take part in relevant training. DS(HW)1 further pointed out that it would probably be made a licensing condition for the holder of a retail licence to nominate a competent and experienced person to oversee and supervise the dispensing of Chinese herbal medicines in the retail outlet.
Questions raised by members
10. Miss CHOY So-yuk enquired whether the Practitioners Board would be responsible for setting the questions of the Licensing Examination and how it would ensure that the questions asked would not be focusing on only a certain aspect of Chinese medicine. In response, Assistant Director of Health (Traditional Chinese Medicine) (AD(TCM)) said that the Practitioners Board would be responsible for setting the questions and determining the curriculum and standard of assessment in respect of the Licensing Examination. He informed members that the Board would consider appointing academic staff with relevant knowledge and Chinese medicine experts outside Hong Kong to advise on related matters in respect of the Examination.
|11. Miss CHOY So-yuk noted that, as announced by the Financial Secretary in his Budget Speech on 3 March 1999, the Administration intended to remove immigration restrictions on scientists and highly-skilled technologists from the Mainland entering Hong Kong to work. She enquired whether the policy would be extended to cover persons in the Mainland identified by a local educational/research institution as suitable to perform clinical teaching/research work in Chinese medicine for the institution. DS(HW)1 agreed to take note of Miss CHOY's suggestion and follow it up as and when necessary.
|12. Dr LEONG Che-hung declared interest as a member of the Preparatory Committee on Chinese Medicine. He was concerned as to whether the provisions for limited registration would be exploited by Chinese medical practitioners outside Hong Kong to come to work here under the guise of "conducting clinical teaching or research work". He urged the Administration to take measures to prevent abuses of the limited registration system in order to safeguard the interest of the local Chinese medicine practitioners. In reply, DS(HW)1 said that the future Chinese Medicine Council would scrutinize every application very carefully to avoid abuse. He considered that it would be difficult or impossible for the Administration to lay down every single detail in the principal legislation regarding what conditions should be met for limited registration. He assured members that the future Chinese Medicine Council would be requested to prevent such abuses by defining clearly the requirements for limited registration.
Regulation of dispensers
|13. Miss CHOY So-yuk enquired if the Administration would stipulate certain kinds of essential training which a dispenser must undertake within a prescribed period of time in order to qualify himself for dispensing work of Chinese herbal medicine. She further suggested that while the dispenser was taking part in the necessary training, he should be allowed to continue in his job. In response, DS(HW)1 explained that priority was given to handling the registration of Chinese medicine practitioners and establishing statutory control of Chinese medicine. In response to a suggestion that, subject to availability of adequate training facilities, it could be made a licensing condition in the future to require that retailers of Chinese medicine could only employ those dispensers who had completed the required training, DS(HW)1 said that the Administration would take note of the suggestion and explore if it could be implemented in the long run.
14. Mrs Selina CHOW, however, took the view that dispensers in the Chinese medicine field in general were quite experienced and had really little need for further training on the subject. She considered that with the establishment of the licensing control of retailers of Chinese herbal medicine, it could be made as a licensing condition that the retailers were obliged to ensure the standards of the dispensers under their employment.
|15. Dr LEONG Che-hung considered that inexperienced dispensers of Chinese herbal medicine did exist in the field since there were no particular restrictions on the entry to the profession. He supported that there should be a mechanism to regulate the standards of dispensers in order to safeguard the public interest. Miss CHOY So-yuk recalled that there had been dispensing errors at general out-patient clinics before which called for the need to step up the monitoring of dispensaries in out-patient clinics. In response, DS(HW)1 said that he noted members' concerns and agreed to prepare a paper on this subject for the next meeting.
Schedule 2 of the Bill
16. Mrs Selina CHOW considered that some of the Chinese herbal medicines specified in Schedule 2 were so commonly used that they were sold in supermarkets. She expressed doubt as to the need for imposing restrictions on the sale of these medicines as proposed in clause 111 of the Bill. She was worried that the proposal would cause much inconvenience to consumers and affect the sale of these medicines if they were required to be sold in licensed Chinese herbal medicine retail shops. In reply, AD(TCM) pointed out that Schedule 2 had been devised after careful consideration and it had already excluded those Chinese herbal medicines which were widely used as ingredients in common dishes and herbal soups, such as dried mushrooms and lotus seeds. Dr LEONG Che-hung questioned why "Radix Ginseng" and "Cordyceps" were also included in Schedule 2 as these two items were also commonly dispensed and could be bought in supermarkets. AD(TCM) explained that it was based on the advice of some Chinese medicine practitioners that these items were "medicines" and that they were unlike dried mushrooms which caused no harm to consumers even if they were taken everyday. DS(HW)1 supplemented that by clause 111, the retailers selling the listed Chinese herbal medicines would be required as a licensing condition to make special arrangements for the storage and packaging of these medicines which could help to preserve their potency and the arrangement would be beneficial to the consumers.
|17. At the request of Mrs Selina CHOW, DS(HW)1 agreed to provide the following information -
- the Chinese herbal medicines in Schedule 2 which were now being sold in supermarkets; and
- a list of the common food items which contained ingredients of the listed Chinese herbal medicines and to confirm whether their sale would be also subject to control as spelt out in clause 111.
Chinese proprietary medicines
18. Regarding the registration of proprietary Chinese medicines, Mrs Selina CHOW suggested that since they were largely manufactured in the Mainland, the Administration, in determining an application for registration of a proprietary Chinese medicine, could take into consideration the results of tests already conducted for the medicines by the authorities concerned in the Mainland. In this way, it would help to save manpower and resources for the future regulatory authority. In response, AD(TCM) explained that in determining such an application, the Medicines Board would basically consider the safety, quality and efficacy of the proprietary Chinese medicine concerned and all the three criteria must be met. He stressed that it was not recommended that clinical trials should be conducted for the proprietary Chinese medicines which had been on sale for a long time and were widely used. It was believed that from the experiences of the public in consuming these long-existed medicines, the level of safety and efficacy of the medicines should have been adequately reflected. He said that in fact the World Health Organization also recommended that thorough clinical tests should be conducted only for new medicines. Therefore, he believed that there would be different approaches adopted by the Chinese Medicine Council in handling long-existed proprietary Chinese medicines and new medicines. AD(TCM) added that the results of clinical trials conducted by the country of origin for the medicines concerned or information showing that the medicines had been registered with any authorities would be taken into consideration by the Medicines Board in determining the applications for registration of the products.
19. Mrs Selina CHOW and the Chairman were concerned about the standards applied for assessment of the safety of a proprietary Chinese medicine. AD(TCM) replied that for new proprietary Chinese medicines, clinical trials could be done to check whether they were safe for use. However, for those proprietary Chinese medicines which had been on sale for a long time and were widely used, the consumers' feedback in using the medicines could be relied upon for assessment of safety of the medicines. Furthermore, the proprietary Chinese medicines would be tested for excessive heavy metal components and/or pesticides. The Chairman enquired whether clinical trials had been conducted for "Wong Lo Kat herbal tea". In response, AD(TCM) said that the safety of such products was ensured by examining whether the prescription used for the product was in compliance with the theories advocated in Chinese medicine. It was also ensured on the basis of the consumers' feedback and the results of sample tests.
20. Mrs Selina CHOW took the view that as long as a proprietary Chinese medicine had been proved to be safe for use, it should be allowed for sale. She considered that a proprietary Chinese medicine should not be banned from sale just because it was not found as efficacious as it claimed to be. She pointed out that in fact a medicine might be efficacious to some persons but not to the others depending on the physical conditions of individuals. Dr LEONG Che-hung shared the view that efficacy of a medicine was difficult to determine in some cases and quoted examples to illustrate this point.
21. Dr LEONG Che-hung stressed that the medical sector including himself were supportive of conducting clinical trials for every new proprietary Chinese medicine to ensure that it was safe for use, and that the ingredients did not include any ingredients of western medicines. However, he concurred that while the safety of medicines was the primary concern, the Administration should explore some cost-effective ways to implement the controlling measures provided for in the Bill and to avoid causing too much disruption to the trade.
22. In response to Dr LEONG Che-hung's enquiry, DS(HW)1 said that the proprietary Chinese medicines sold in Hong Kong before 1 March 1999 would be allowed to continue to be sold, subject to an application for registration to be submitted within a prescribed period, and pending completion of the registration procedure. AD(TCM) estimated that it would take two years to finish examining these medicines sold in Hong Kong before 1 March 1999.
23. Miss Cyd HO noted that the British Pharmacopoeia had been an important reference for the western medicine sector in Hong Kong. She enquired which pharmacopoeia would be used as the basis in examining the proprietary Chinese medicines. In reply, AD(TCM) said that, in devising Schedule 2, the Administration had made reference mainly to the "Pharmacopoeia of the People's Republic of China" (the Pharmacopoeia), the "Chinese Materia Medica" and information provided by local Chinese medicine practitioners. He said that the Chinese Medicine Council would further decide whether it would compile its own pharmacopoeia depending on the needs.
24. For the purpose of achieving cost-effectiveness, Miss Cyd HO suggested that the Medicines Board in considering an application for registration of a proprietary Chinese medicine could make reference to the Pharmacopoeia instead of taking all the steps to test the medicine. In reply, AD(TCM) said that the Administration had relied not only on this reference but also the "Chinese Materia Medica" because the Pharmacopoeia covered only some 500 kinds of Chinese herbal medicine and a few hundred kinds of proprietary Chinese medicine. He reiterated that he was of the view that clinical trials should be only conducted for new proprietary Chinese medicines to confirm their safety and efficacy and not for those which were already widely used and had been on sale for a long time.
|25. Miss CHOY So-yuk pointed out that in China there were some kinds of prepared soluble Chinese medicine. The products were safe for use but often did not have the efficacy as they claimed. She asked the Administration what position it took on this kind of products. In response, AD(TCM) explained that under the current proposal, health food products or medicines containing ingredients of any Chinese herbal materials including the listed Chinese herbal medicines, would be subject to registration control. In determining an application for registration, the Medicines Board would examine the description of ingredients of the product and, based on theories of Chinese medicine, decide whether it was possible for the product to have the efficacy as it claimed. In this connection, Dr LEONG Che-hung urged the Administration to formulate its policy on the control of general health food sold in Hong Kong.
Transitional arrangements for Chinese medicine practitioners
26. Miss Cyd HO enquired whether the Chinese medicine practitioners under the transitional arrangements would be required to display their licences to let their clients know whether they were required to pass the Licensing Examination or the registration assessment in order to be registered. In reply, DS(HW)1 pointed out that those who would have to undergo the registration assessment or Licensing Examination in order to be registered would be called Chinese medicine practitioners. As for those who had been registered, they would be called registered Chinese medicine practitioners. Clients would know by the title the level of experience and qualifications of the practitioner concerned.
27. Miss Cyd HO enquired whether after enactment of the Chinese Medicine Ordinance, the premises used by the (registered) Chinese medicine practitioners for their practice would be subject to statutory control. In response, Principal Assistant Secretary for Health and Welfare (Medical) 1 (PAS(HW)1) said that based on the information that the Administration had obtained, most Chinese medicine practitioners were affiliated with Chinese herbal medicine retail shops and only a few of them practised in their own premises. In the latter case, the practitioners had to obtain commercial registration licences and the premises were likely to be in commercial buildings, which were also subject to requirements imposed by relevant authorities such as with regard to fire safety and building requirements. PAS(HW)1 suggested that in the future when the Chinese medicine practitioners applied for registration, they would be reminded of the need to observe fire safety requirements for the premises where they practised.
Licensing of retailers in Chinese herbal medicines
28. In response to Dr LEONG Che-hung's enquiries, AD(TCM) said that details of the licensing requirements for the retailers would be specified in the relevant subsidiary legislation. He said that the requirements were mainly related to the facilities and hygiene of the Chinese herbal medicine retail shops and factories, proper custody of records for the medicine and so on. As proposed in the Bill, all retailers of Chinese herbal medicines who obtained a licence would be allowed to sell the listed items specified in Schedules 1 and 2.
Membership of the Chinese Medicine Council
29. Mrs Selina CHOW noted that there were different groups within the Chinese medicine sector, such as the groups of manufacturing, wholesaling, retailing and import. She referred to the composition of the Chinese Medicine Council and enquired whether the five persons from the trade of Chinese medicines would include representatives from each of the groups. In response, DS(HW)1 said that the Administration was aware of the existence of various groups within the sector and would accommodate as far as possible each of the groups to be represented in the Chinese Medicine Council.
30. Dr LEONG Che-hung noted that the membership of the Chinese Medicine Council would include two persons from educational institutions in Hong Kong. He considered in the future Chinese medicine out-patient consultation service might be available in the public hospitals under the management of the Hospital Authority (HA). Therefore, he strongly suggested that the membership of the Chinese Medicine Council should include a representative from HA. In response, DS(HW)1 explained that the Administration did not see the need at the moment and pointed out that, where necessary, a member of HA could be appointed under the "lay person" category.
Invitation of written submissions from interested parties
31. Members discussed and agreed to place an advertisement in newspapers to invite written submissions from interested parties regarding the Bill. Members noted that the Bills Committee had already received some written submissions which would be circulated to members for reference.
(Post-meeting note : An advertisement was placed in the South China Morning Post and Ming Pao Daily on 8 March 1999 to invite written submissions from interested parties.)
III. Date(s) of Next Meeting(s)
32. Members agreed to schedule the next three meetings on the following dates -
- Tuesday, 30 March 1999 at 10:45 am;
- Wednesday, 7 April 1999 at 8:30 am; and
- Tuesday, 13 April 1999 at 8:30 am (for meeting deputations).
|33. Mrs Selina CHOW suggested that those parties in the Chinese medicine sector which had been consulted by the Administration regarding the Bill should be invited to attend meetings with Bills Committee. She considered that the Secretariat should contact the Administration to obtain details of the parties and invite them to the meetings.
34. The meeting ended at 12:45 pm.
Legislative Council Secretariat
29 March 1999