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Following is a question by the Dr Hon Kwok Ka-ki and a written reply by the Secretary for Health, Welfare and Food, Dr York Chow, in the Legislative Council today (January 11):
Question:
Early last month, some medical groups and private clinics were discovered to have given several hundred residents injections with influenza vaccines imported from the Mainland but unregistered in Hong Kong. The incident has aroused grave concern in the community. In this connection, will the Government inform this Council:
(a) how the authorities monitor issues relating to the provision of influenza vaccines, including the places of origin, distribution, registration and import of such vaccines;
(b) whether the relevant Mainland authorities and vendors have been contacted concerning this incident; if so, of the relevant details; of the plans to strengthen communication with the relevant Mainland authorities; whether it will consider introducing legislative amendments to prevent unauthorized vaccines from entering Hong Kong; and
(c) whether it knows the existing channels through which medical groups and private clinics acquire vaccines, and whether it plans to step up its monitoring efforts?
Reply:
Madam President,
(a) Influenza vaccines are pharmaceutical products, the registration and import of which are subject to regulation by the Pharmacy and Poisons Ordinance (the Ordinance). Registration of pharmaceutical products is necessary to ensure the products meet the safety, efficacy and quality standard for administration/consumption. In making an application for registration, applicants are required to submit information including the place of origin of the pharmaceutical products.
According to the Ordinance, all pharmaceutical products must be registered by the Pharmacy and Poisons Board (the Board) before a company holding a licence for wholesalers of pharmaceutical products can apply for import licences. The Board is the issuing authority of licences for wholesalers of pharmaceutical products, which are granted to applicants possessing suitable experience and equipment for the transportation and distribution of pharmaceutical products. The Department of Health (DH) is the issuing authority of import licences, which will only be issued upon confirmation that the applicant holds a wholesale poisons licence and the pharmaceutical products to be imported have been registered in Hong Kong.
(b) DH has maintained close liaison with the Mainland on pharmaceutical products. When it came to DH's notice last month that some clinics used unregistered vaccines originating from the Mainland, DH immediately approached the relevant Mainland authorities and manufacturers to gather further information, while at the same time notifying the Mainland's State Food and Drug Administration of the incident.
Under current legislation, all pharmaceutical products must be registered prior to import into Hong Kong by a licensed importer. In addition, the importer is also required to apply for an import licence for every batch of pharmaceutical products to be imported. Sale or possession for the purposes of sale, distribution or other use of any unregistered pharmaceutical product is an offence, anyone guilty of which is liable on conviction to a fine of $100,000 and to imprisonment for 2 years. The Administration considers the current legislation adequate in achieving the regulatory intent and will continue to maintain liaison with the Mainland on the import of pharmaceutical products into Hong Kong.
(c) To the best of DH's knowledge, medical groups and private clinics acquire their influenza vaccines from four local importers of influenza vaccines. Should there be reports of, or complaints about, the use of unregistered pharmaceutical products, the Administration would immediately commence investigations and require these service providers to furnish information about the acquisition and use of such pharmaceutical products for public health protection. The Administration considers the existing regulatory mechanism adequate in achieving the intended objectives.
Ends/Wednesday, January 11, 2006
Issued at HKT 14:31
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