LCQ7: Development of proprietary Chinese medicine manufacturing industry
Following is a question by the Hon Vincent Fang and a written reply by the Secretary for Commerce and Economic Development, Mr Gregory So, in the Legislative Council today (June 13):
Some members of the proprietary Chinese medicine (pCm) manufacturing industry have reflected that Macao has confirmed the construction of the Guangdong-Macao Traditional Chinese Medicine Science and Technology Industrial Park in Hengqin, and to use preferential policies to attract members of the industry to establish business there, and although the pCm manufacturing industry has a long history of development in Hong Kong, with many famous brands produced, there is a lack of government support for the industry. They have pointed out that the Government has indicated that it will implement the Good Manufacturing Practice in respect of Proprietary Chinese Medicines (GMP-pCm) step by step, but at present no uniform standard has been established yet. Further, they have pointed out that as Hong Kong lacks plants which can meet the requirements under GMP-pCm and consultants with relevant experience, the demand can hardly be met, and pharmaceutical manufacturers also need to make big investments so as to comply with GMP-pCm, thus so far only six of the 300-odd pCm manufacturers across the territory have obtained the certificate for compliance with GMP-pCm, and some manufacturers need to find pharmaceutical manufacturers in other places which comply with GMP-pCm to produce products of their pCm brands on their behalf, thereby hindering the development of the industry in Hong Kong. In this connection, will the Government inform this Council:
(a) whether it knows the number of pCm brands produced by pCm manufacturers in Hong Kong; the number of their factories in Hong Kong, their scale of operation and the number of employees; Hong Kong's pCm brands which had ceased production in the past 10 years; whether the Government has planned to support and help such brands which had ceased production to resume production and supplies to the market; if it has, of the plan; if not, the reasons for that;
(b) whether it has drawn reference from GMP of other countries or regions in formulating the GMP-pCm for Hong Kong; the current number of consultancy firms and personnel possessing the relevant professional knowledge in Hong Kong; whether the Government has any plan in place to provide professional training relating to GMP-pCm so as to satisfy the development needs of the industry;
(c) whether the Government will study how to help solve the aforesaid problem of the lack of suitable plants; whether it will set aside sites at existing industrial estates for the development of the pCm manufacturing industry; whether it will consider constructing plants that meet the pCm GMP standards for use by the industry; whether it will convert existing factory buildings for use by small and medium-sized manufacturers;
(d) whether it has compiled statistics on the manpower resources needed for the implementation of GMP-pCm by the pCm manufacturing industry; whether it knows if there are vocational training courses on pCm production at present; if so, of the number of such courses in the past three years; the number of people who had completed such courses, and whether they have joined the industry upon graduation; if not, whether it will design and introduce relevant training courses to meet the development needs of the industry; and
(e) whether the Government will draw reference from the practice of the Macao Special Administrative Region Government and set up a traditional Chinese medicine science and technology industrial park exclusively for the development of the pCm manufacturing industry, and introduce preferential policies to assist in the development of the industry; if it will, of the details; if not, whether it has assessed if enterprises which produce local pCm brands will move to Hengqin for developing their business?
The question touches on various areas such as regulation of Chinese medicines (CM), vocational and manpower training relating to the CM industry, and the work and infrastructure in support of the development of the proprietary Chinese medicines (pCm) manufacturing industry. The Innovation and Technology Commission (ITC) under the Commerce and Economic Development Bureau promotes CM research and development (R&D). The Hong Kong Science and Technology Parks Corporation (HKSTPC), supported by ITC, operates the Hong Kong Science Park (Science Park) and the Industrial Estates (IEs), which respectively provides research facilities to promote CM R&D and infrastructure for the CM manufacturing industry. Regulation of CM in Hong Kong falls under the policy area of the Food and Health Bureau (FHB), whereas CM-related vocational and manpower training are under the purview of the Education Bureau (EDB). We have consulted FHB and EDB and incorporated their inputs in preparing this reply.
Our reply to the Hon Vincent Fang's question is as follows:
(a) There are at present 295 proprietary Chinese medicine (pCm) manufacturers in Hong Kong who, in accordance with the Chinese Medicine Ordinance (Cap 549) (CMO), hold licences issued by the Chinese Medicines Board (CMB) under the Chinese Medicine Council (CMC) of Hong Kong. Most of them are small and medium enterprises (i.e. with less than 100 employees). According to statistics on the Chinese medicine sector in Hong Kong from the Census and Statistics Department, the number of persons engaged in the local CM manufacturing industry was about 1 900 in 2009. On the other hand, among the pCm registered under the CMO to be manufactured or sold in Hong Kong, more than 6 000 are manufactured by local pCm manufacturers. It is a business decision of pCm manufacturers whether the pCm are actually manufactured or sold in Hong Kong. CMC currently does not maintain statistics on the number of pCm/brands of pCm available in the market.
(b) At present, the Good Manufacturing Practice (GMP) requirement in respect of pCm in Hong Kong is not mandatory. Manufacturers holding a pCm manufacturer licence may apply to CMB for a Certificate for Manufacturer, certifying that they follow the requirements of good practices in manufacture and quality control of pCm. CMB issued the "Hong Kong GMP Guidelines for Proprietary Chinese Medicines" in 2003 with reference to the relevant GMP guidelines published by the World Health Organization and the Pharmacy and Poisons Board of Hong Kong. There are now eight pCm manufacturers who have been awarded with GMP Certificates.
To ensure the quality and safety of pCm, the Chief Executive announced in his 2010-11 Policy Address that a timetable for mandatory compliance with GMP for manufacture of pCm would be worked out, to keep up with international trends of developing GMP for medicines. Having taken reference of the development of GMP in other countries and regions in the world, CMB recommended in May 2011 adoption of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP standard as a licensing requirement for local pCm manufacturers. Since May 2011, CMB has been in wide consultation with the Chinese medicines trade to gather the views of the trade through various channels on the timetable and specific arrangements, including the conduct of a series of briefings through the Department of Health (DH) and attending meetings with Chinese medicine associations and various pCm manufacturers. Local and Mainland experts have also been invited to brief the Chinese medicines traders on the GMP requirements, training and consultancy services; as well as to share experiences in the implementation of GMP. DH has provided information on the proposed GMP implementation plan to all licensed Chinese medicines traders through the Chinese Medicines Traders Newsletter. All relevant information is available online for reference and comment by the trade.
To assist pCm manufacturers in the implementation of GMP, DH will meet with manufacturers who are interested in the implementation of GMP and already have preliminary designs of their factory premises, to explain to them the requirements of the current GMP guidelines.
In addition to assistance provided by the Government, Chinese medicine manufacturers may also engage suitable consultant companies or GMP professionals to assist in staff training, in accordance with their own needs and requirements. At present, GMP training is available in Hong Kong, the Mainland and overseas. The Government will continue to liaise closely with the trade and offer assistance to enable them to secure the relevant information. The Government also welcomes views from the trade, facilitating compliance with GMP requirements for manufacture of pCm to be implemented in a gradual and progressive manner.
(c) The three IEs in Tai Po, Yuen Long and Tseung Kwan O managed by HKSTPC provide land for industries which would upgrade our manufacturing bases, but could not be operated in traditional multi-storey industrial buildings (including the CM manufacturing industry). About 95% of the IE greenfield sites have been granted so far. As at May 2012, there were over 160 organisations operating in the three IEs, over 10 of which were related to CM manufacturing, including one situated in the GMP Centre of Tai Po IE. To support the long-term development of the high technology industry, we have invited HKSTPC to explore the feasibility of expanding the Yuen Long IE by about 16 hectares. If the consultancy study confirms the feasibility of the plan, we will further explore ways to support the development of high technology industry in the site and create synergy with the existing companies in the Estate. CM manufacturing will be amongst the industries to be considered. On the other hand, HKSTPC will continue to encourage grantees that are not fully utilising their IE sites to consider assigning the sites to new users who meet the prevailing admission criteria of IEs. We especially welcome projects involving advanced technology, high investment, high value-added and more technical personnel to move into IEs. There have been successful cases of assignment of sites originally granted for traditional manufacturing projects to CM manufacturing projects. HKSTPC will further enhance the revitalisation of IEs to release precious land for high technology projects.
(d) The manpower resources required for full implementation of mandatory GMP requirements for manufacture of pCm depend on various factors, such as the number of pCm manufacturers that will implement GMP, as well as manpower savings arising from the adoption of mechanised manufacturing technology due to the implementation of GMP. As regards training of personnel, a number of institutions in Hong Kong (including the Hong Kong Baptist University, HKU School of Professional and Continuing Education, School of Continuing and Professional Studies of The Chinese University of Hong Kong and the Vocational Training Council, etc.) have offered a total of eight diploma and degree programmes or on-the-job training courses relating to CM manufacturing, pCm and pharmacy in CM in the recent three academic years, and about 650 participants have already completed these programmes/courses. In addition, DH has attended meetings of the Employees Retraining Board to put forward suggestions on training targeted at the Chinese medicines trade. Besides, some local R&D and technology consultancy organisations, such as the Hong Kong Institute of Biotechnology and Hong Kong Productivity Council, will organise GMP-related training courses and provide technical consulting services in response to market demand.
(e) As different economies are unique in their development of Chinese medicine, the Administration will draw on the experience of different places and devise an appropriate plan in promoting the future development of Chinese medicine in Hong Kong in light of the characteristics, needs and views of stakeholders in Hong Kong. While the Government currently does not have any plan to set up a traditional Chinese medicine science and technology industrial park exclusively for the development of the pCm manufacturing industry, we will examine in detail the local industry's need for such infrastructure, evaluate the sustainability and cost-effectiveness of different development plans, and review the existing operation of the Science Park and IEs to see how we should facilitate development and provide support in this regard.
The Government has been attaching great importance to CM development in Hong Kong and striving to promote the sustainable development of the local CM industry on various fronts:
(i) On R&D, the Government provides funding support to the local CM industry to conduct applied research projects relating to CM R&D and testing through various funding support programmes under the Innovation and Technology Fund. Among these programmes, the Innovation and Technology Support Programme and the University-Industry Collaboration Programme aim to encourage companies to jointly carry out R&D projects with the universities by leveraging their expertise. The Small Entrepreneur Research Assistance Programme provides funding support for small and medium-sized enterprises to conduct CM R&D so as to facilitate their business development. The General Support Programme provides funding support for projects which can enhance and facilitate the CM industry development such as conferences/exhibitions, workshops, research and surveys.
(ii) Regarding testing and certification of CM, the Government has been promoting the development of the testing and certification industry in Hong Kong, including enhancing the local CM testing capabilities in the aspects of technology and manpower training. At present, there are over 10 accredited laboratories in Hong Kong providing testing services for Chinese herbal medicines and pCm, which will help the CM trade in product quality assurance.
(iii) As for infrastructure, in addition to the three IEs mentioned above, the Science Park under HKSTPC provides the industry with research infrastructure, including the two biotechnology buildings established in Science Park Phase Two as well as laboratory facilities for companies in the Park. The biotechnology industry (including CM and western pharmaceuticals) will be further promoted in the Phase Three development.
(iv) To more effectively orchestrate efforts of Government, industry, the academic and R&D sectors in promoting the development of R&D and testing of CM to meet the future needs of Hong Kong, the Government set up the Committee on Research and Development of Chinese Medicines (the Committee) last December to explore the strategies of promoting R&D and testing of CM in Hong Kong and to join hands with all sectors to promote work in these areas. For instance, the Committee will organise a large-scale seminar in September this year and representatives from relevant organisations and experts in the fields of CM regulation, R&D, testing and certification, and clinical services will be invited to exchange ideas with the industry.
Wednesday, June 13, 2012