************************************************************
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
NNNN
