Speeches
LC: Speech by SFH on Pharmacy and Poisons Ordinance
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. 4) Regulation 2008 and Poisons List (Amendment) (No. 4)
Regulation 2008 under the Pharmacy and Poisons Ordinance (Cap. 138) in the
Legislative Council today (October 22):
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 six pharmaceutical products,
the Pharmacy and Poisons Board proposes to add the following six substances
to Part I of the Poisons List and the First and Third Schedules to the
Pharmacy and Poisons Regulations:
(a) Anidulafungin; its salts; its esters; their salts;
(b) Etravirine ;
(c) Fosaprepitant; its salts;
(d) Fulvestrant;
(e) Idursulfase; and
(f) Palonosetron; its salts.
Pharmaceutical products containing these six 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
gum and lozenges intended to be used in nicotine replacement therapy which
contain not more than 4mg of Nicotine per piece as well as patches (for
external application) intended to be used in nicotine replacement therapy.
At present, they are classified in Part I of the Poisons List, and can only
be sold in pharmacies in the presence and under the supervision of a
registered pharmacist. These products have been studied in detail and have
been found to be sufficiently safe to be available for self-selection by
smokers who wish to quit smoking. As such, we propose reclassifying gum and
lozenges intended to be used in nicotine replacement therapy which contain
not more than 4mg of Nicotine per piece and patches (for external
application) intended to be used in nicotine replacement therapy as Part II
poisons, so that they can be sold by pharmacies as well as medicine
companies, and their sale would not be required to be conducted in the
presence and under the supervision of registered pharmacists.
We propose that these amendment regulations take immediate effect upon
gazettal on October 24, 2008 to allow early control and sale of the relevant
medicine.
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 22, 2008
Issued at HKT 14:53
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