LC: Speech by SFH on Pharmacy and Poisons Ordinance
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     Following is the speech (English translation) by the Secretary for Food and Health, Dr York Chow, in moving the motion on Pharmacy and Poisons (Amendment) (No. 3) Regulation 2009 and Poisons List (Amendment) (No. 3) Regulation 2009 under the Pharmacy and Poisons Ordinance in the Legislative Council today (October 21):

President,

     I move that the motion under my name, as printed on the Agenda, be passed.  

     Currently, we regulate the sale and supply of pharmaceutical products through a registration and monitoring 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.  Pharmaceutical products put on different parts of the Poisons List and different Schedules are subject to 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, including 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.  The sale of some pharmaceutical products must be authorised by prescription from a registered medical practitioner, dentist or veterinary surgeon.

     Arising from an application for registration of two pharmaceutical products, the Pharmacy and Poisons Board proposes to add the following two substances to Part I of the Poisons List and the First and Third Schedules to the Pharmacy and Poisons Regulations:

(a) Dexketoprofen; its salts; and
(b) Thiotic acid; its salts; its derivatives, when contained in pharmaceutical products.

     Pharmaceutical products and formulations containing the above substances must then be sold in pharmacies under the supervision of registered pharmacists and in their presence, with the support of prescriptions.

     In addition, the Pharmacy and Poisons Board proposes to relax the control of "orlistat when contained in pharmaceutical products the recommended daily dose of which contains not more than 60mg of orlistat or its salts to be taken three times a day."  Upon detailed research, these pharmaceutical products have been shown to be sufficiently safe and effective for use in the management of weight reduction without doctor's supervision.  Therefore, we propose to re-classify "orlistat when contained in pharmaceutical products the recommended daily dose of which contains not more than 60mg of orlistat or its salts to be taken three times a day" from Part I of the Poisons List and the First and Third Schedules to the Pharmacy and Poisons Regulations to Part I of the Poisons List only.  Subject to regulation under the relevant provision, these pharmaceutical products must be sold in pharmacies in the presence and under the supervision of registered pharmacists.

     In response to the recent emergence of products marketed for weight reduction or for enhancement of sexual function in men which were found on analysis to contain analogues of poisons subject to regulation under the Pharmacy and Poisons Regulations, the Pharmacy and Poisons Board also proposes to amend four existing entries in Part I of the Poisons List and in the First and Third Schedules to the Pharmacy and Poisons Regulations by adding a chemical description after each entry describing the analogues of each poison, such that the analogues are also subject to the controls applicable to the four poisons themselves. The four poisons are "Sibutramine; its salts", "Sildenafil; its salts", "Tadalafil; its salts" and "Vardenafil; its salts."

     We propose that these amendment regulations take immediate effect upon gazettal on October 23, 2009 to allow early control of pharmaceutical products containing these substances.  

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

     With these remarks, President, I move the motion.

Ends/Wednesday, October 21, 2009
Issued at HKT 16:53

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