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The following is the speech by the Acting Secretary for Health and Welfare, Mr Gregory Leung, in moving the resolution under the Pharmacy and Poisons Ordinance in the Legislative Council today (Friday):

Madam President,

I move that the Poisons List (Amendment) Regulation 1999 and the Pharmacy and Poisons (Amendment) Regulation 1999 as set out under my name in the paper circulated to Members be approved.

Currently, we regulate the sale and supply of pharmaceutical products through a registration and inspection system set up in accordance with the Pharmacy and Poisons Ordinance. The Ordinance maintains a Poisons List under the Poisons List Regulations and several Schedules under the Pharmacy and Poisons Regulations. Subject to where they are listed, pharmaceutical products are put under different levels of control in regard to the conditions of sale and keeping of records.

For the protection of public health, some pharmaceutical products can only be sold in pharmacies under the supervision of registered pharmacists and in their presence. For certain pharmaceutical products, proper records of the particulars of the sale must be kept, which should include the date of sale, the name and address of the purchaser, the name and quantity of the medicine and the purpose for which it is required. Some of the sale must be supported by prescription from a registered medical practitioner, a registered dentist or a registered veterinary surgeon. Some pharmaceutical products are also subject to specific labelling requirements.

The Amendment Regulations now before Members seek to amend the Poisons List in the Poisons List Regulations and the Schedules to the Pharmacy and Poisons Regulations, for the purpose of imposing or updating control on a number of medicines.

102 medicines are proposed to be added to Part I of the Poisons List and the First and Third Schedules to the Pharmacy and Poisons Regulations so that pharmaceutical products containing any of them must be sold in pharmacies under the supervision of registered pharmacists and in their presence, with the support of prescriptions.

Another 4 medicines are proposed to be added only to Part I of the Poisons List, requiring pharmaceutical products containing any of them to be sold in pharmacies under the supervision of registered pharmacists and in their presence. Prescriptions are not required.

In addition to the above revisions, the control of 2 other medicines are proposed to be upgraded and that of another 3 medicines to be relaxed. The name of one medicine is proposed to be changed to tie with the internationally accepted nomenclature for that medicine. 2 other medicines are proposed to be exempted from some specific labelling requirement.

The Pharmacy and Poisons (Amendment) Regulation 1999 also includes an amendment to clarify which medicines are subject to the record keeping requirement imposed by section 22 of the Pharmacy and Poisons Ordinance.

The Amendment Regulations are proposed by the Pharmacy and Poisons Board. The latter is a statutory authority established under section 3 of the Ordinance to regulate the registration and control of pharmaceutical products. The Board comprises members engaged in the pharmacy, medical and academic professions. The Board considers these amendments related to the control of pharmaceutical products necessary in view of the potency, toxicity and potential side-effects of the medicines concerned.

With these remarks, I move the motion.

END/Friday, July 16, 1999

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