Replies to LegCo questions
LCQ4: Regulation of pharmaceutical products and proprietary Chinese medicines
Following is a question by the Hon Chan Kam-lam and a reply by the Secretary for
Food and Health, Dr Ko Wing-man, in the Legislative Council today (June 1):
Question:
Under the law, all pharmaceutical products must be registered with the Pharmacy
and Poisons Board before they are put up for sale in the market. Medicines under
Categories 1 and 2 may be dispensed and sold only by Authorised Sellers of
Poisons, commonly known as "pharmacies", under the supervision of registered
pharmacists, and medicines under Category 1 (i.e. prescription medicines) are
required to be sold on a doctor's prescription. Listed Sellers of Poisons,
commonly known as "medicine companies", are only allowed to sell medicines under
Category 3 (e.g. medicines for common cold and antipyretics). People engaged in
retail business of Chinese herbal medicines are required to obtain the relevant
licence issued by the Chinese Medicine Council of Hong Kong. It has been
reported that recently some shops which are not medicine retailers (e.g. shops
selling household and baby products) have been found selling unregistered
medicines, some of which contain prescription medicine ingredients such as
antibiotics, steroids. In addition, some people sell medicinal herbal packs,
weight-loss drugs and psychedelic drugs through Internet social networking
platforms. Some people even sell a medicine for rheumatism which is subject to a
recall order issued by the authorities and deliver the products to buyers at MTR
stations. In this connection, will the Government inform this Council:
(1) how the authorities monitor the compliance of pharmacies and medicine
companies with the relevant legislation at present; whether the authorities
instituted any prosecution in the past 12 months against persons after they had
been found to have sold or possessed unregistered medicines; if they did, of the
number of such cases;
(2) whether the authorities have taken enforcement actions against the illegal
sale of medicines in shops which are not medicine retailers and at random
locations; if they have, of the number and details of such cases cracked by the
authorities in the past 12 months; and
(3) how the authorities combat the illegal sale of pharmaceutical products and
medicines on the Internet at present, and whether they will review the relevant
legislation to curb such activities?
Reply:
President,
"Pharmaceutical products" and "Medicine" are regulated by the Pharmacy and
Poisons Ordinance (Cap. 138) (PPO) and its subsidiary legislation. Products
which fall within the definition of "pharmaceutical products" under the PPO must
meet the requirements specified therein as regards their safety, quality and
efficacy, and be registered with the Pharmacy and Poisons Board (PPB) before
they can be sold in Hong Kong.
Medicines classified as Part 1 poisons under the PPO can only be sold at sellers
authorised by the PPB to carry on a business of retail sale of poisons (i.e.
Authorised Sellers of Poisons (ASPs) (commonly known as pharmacies or
dispensaries)) by registered pharmacists or in the presence and under the
supervision of registered pharmacists. Among these medicines:
Part 1 First Schedule poisons can only be sold at the ASPs by registered
pharmacists or in the presence and under the supervision of registered
pharmacists, and the relevant sales information (such as name of medicine, name
and identity card number of purchaser) must be recorded;
Part 1 Third Schedule poisons (such as oral steroids) are prescription
medicines. They can only be sold at the ASPs by registered pharmacists or in the
presence and under the supervision of registered pharmacists in accordance with
the prescriptions given by medical practitioners, dentists or veterinary
surgeons.
Medicines classified as Part 2 poisons under the PPO can be sold at the ASPs and
Listed Sellers of Poisons (LSPs) (commonly known as medicine companies).
Any person who illegally sells (through any channel, including the Internet)
Part 1 poisons or unregistered pharmaceutical products, or possesses them for
the purpose of sale commits an offence and shall be liable, upon conviction, to
a maximum penalty of a fine of $100,000 and two years' imprisonment.
The public may check the details of the registered pharmaceutical products, such
as whether a product is registered in Hong Kong and its sales requirements (e.g.
prescription medicines), from the "Search Drug Database" function of the website
of the Drug Office of the Department of Health (DH) by entering the English name
of the product or its Hong Kong registration number. All registered
pharmaceutical products shall bear the Hong Kong registration number on their
package. Moreover, the public should seek advice from healthcare professionals
before taking any medicine.
As regards the regulation of proprietary Chinese medicines (pCms), according to
the Chinese Medicine Ordinance (Cap. 549), any persons who wish to engage in the
business of retail or wholesale of Chinese herbal medicines, as well as
wholesale or manufacturing of pCms, must apply for the relevant licence from the
Chinese Medicines Board (CMB) under the Chinese Medicine Council of Hong Kong
(CMCHK). They can only commence the business after they have obtained the
licence. Moreover, products that fall within the definition of pCms must be
registered by the CMB before they can be imported, or manufactured or sold in
Hong Kong. Any person who contravenes the above provisions shall be liable, upon
conviction, to a maximum penalty of a fine of $100,000 and two years'
imprisonment. A list of pCms which meet the CMB's requirements has been uploaded
to the website of the CMCHK for public reference.
All along, the DH has been carrying out promotional activities through various
channels such as websites, Announcements in the Public Interest (API) and
leaflets to enhance the understanding of the statutory provisions among the
public, industry players and other stakeholders. Relevant work includes issuing
newsletters to the industry, distributing leaflets to the public, broadcasting
TV API, holding annual consultation sessions/briefings and organising
district-based roving exhibitions.
Our reply to the Hon Chan Kam-lam's question is as follows:
(1) Regarding the monitoring of the ASPs and the LSPs, the DH has put in place
an established mechanism to conduct unannounced inspections as well as test
purchases of medicines at licensed ASPs and LSPs, in order to check whether they
are in compliance with the relevant legislation and licensing conditions.
Besides, if the DH receives information regarding any suspected violation of the
legislation on drugs (including suspected illegal sale of prescription drugs by
licensed drug dealers), it will carry out investigation immediately and take
joint enforcement action together with the Police where necessary. Should there
be any contravention of the relevant legislation, the DH will take appropriate
action deemed necessary.
From 2015 to March 2016, the Drug Office of the DH conducted 9 726 and 1 510
inspections against the LSPs and ASPs respectively, and handled 17 convicted
cases registered against LSPs and 35 convicted cases registered against ASPs.
Among them, there were nine convicted cases registered against ASPs and LSPs for
illegal sale or possession of unregistered pharmaceutical products for the
purpose of sale.
As for the regulation of Chinese medicines, the DH has put in place a
comprehensive market surveillance system to check if there is any sale of
unregistered pCms on the market or operation of Chinese medicine business
without a licence. The DH also conducts routine inspections and checking of
premises of local Chinese medicine traders to ensure their compliance with the
requirements of the relevant legislation and practising guidelines. The DH has
also established a mechanism for reporting adverse incidents relating to
medicines, so that information can be collated through different channels to
facilitate risk assessment, management and reporting. Moreover, the DH has been
working closely with other Government departments, such as the Hong Kong Police
Force, the Customs and Excise Department, the Government Laboratory and the
Consumer Council, for the exchange of intelligence and the conduct of joint
operation when necessary.
From 2015 to March 2016, the Chinese Medicine Division (CMD) of the DH conducted
a total of 6 226 inspections against retailers of Chinese herbal medicines.
During the same period, the CMD handled one convicted case involving the
possession of unregistered pCm by retailer of Chinese herbal medicines.
(2) and (3) The DH has put in place an established mechanism to monitor the
health products and drugs sold in the market (including shops which are not
medicine retailers, at random locations and the Internet). Should there be any
contravention of the relevant legislation (including illegal sale or possession
of unregistered pharmaceutical products or prescription medicines), the DH will
commence investigation immediately and where necessary, conduct joint
enforcement operation with the Police and take appropriate action deemed
necessary. If auction websites are involved, the DH will ask the webmasters
concerned to delete the relevant product information from their websites.
From 2015 and March 2016, the Drug Office of the DH handled a total of 68 cases
convicted of sale or possession of unregistered pharmaceutical products
(involving neither LSPs nor ASPs), 10 of which involved Internet sellers. The
highest fine imposed among these 68 cases was $82,000 (the total fine for all
counts of offence). Apart from fines, a convicted person was sentenced to two
months' imprisonment (suspended for 24 months).
In addition, from 2015 to March 2016, the CMD of the DH handled six convicted
cases involving the sale of Chinese herbal medicines without licence and 10
convicted cases involving the sale or possession of unregistered pCms. In these
16 cases, the highest fine imposed was $20,000 (the total fine for all counts of
offence). Apart from fines, a convicted person was sentenced to two months'
imprisonment (suspended for 24 months). There were no Internet sellers involved.
To combat the above situation, the DH will continue to conduct unannounced
inspections and test purchases, and review the relevant measures from time to
time.
Ends/Wednesday, June 1, 2016
Issued at HKT 16:04
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