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LCQ18: Regulating the sale of pharmaceutical products
     Following is a question by the Hon Chan Hoi-yan and a written reply by the Secretary for Food and Health, Professor Sophia Chan, in the Legislative Council today (November 6):
     Under the Pharmacy and Poisons Ordinance (Cap. 138), only "authorized sellers of poisons" may carry on a business of retail sale of pharmaceutical products containing poisons (including those in Parts 1 and 2 of the Poisons List), and only registered premises of such type of sellers (pharmacies) may use Chinese names comprising the term "藥房". Apart from such type of sellers, operators of shops holding a "listed seller of poisons" licence (medicine stores) may also sell pharmaceutical products containing poisons in Part 2 of the Poisons List. Some pharmacists have relayed that retail shops with Chinese names comprising terms such as "藥坊", "藥店" and "藥粧" (other drugstores) have mushroomed in recent years. While a majority of those stores are not operated by the aforementioned two types of sellers, their names easily lead members of the public and tourists into mistaking them for being authorised to sell controlled pharmaceutical products, resulting in a lack of protection for consumers' rights and interests. In this connection, will the Government inform this Council:
(1) of (i) the respective year-end numbers of pharmacies and medicine stores and (ii) the respective numbers of pharmacies and medicine stores which were opened and closed down, in each of the past 10 years (with a breakdown by District Council district);
(2) of the respective numbers of complaints against pharmacies and medicine stores received by the Department of Health in each of the past five years;
(3) whether it has compiled statistics on the current number of other drugstores; if so, of the details; if not, the reasons for that and the difficulty involved;
(4) of the number of prosecutions instituted in each of the past five years by the authorities against operators of retails shops selling medicines, with a breakdown by type (i.e. pharmacies, medicine stores and other drugstores) and the offence involved; and
(5) whether it will consider amending the legislation to step up the regulation of other drugstores, including prohibiting them from using Chinese names comprising the character "藥", so as to avoid causing confusion to members of the public and tourists; if so, of the details; if not, the reasons for that?
     Under the Pharmacy and Poisons Ordinance (Cap. 138) (the Ordinance) and its subsidiary legislation, the Pharmacy and Poisons Regulation (Cap. 138A), pharmaceutical products must meet the requirements of safety, efficacy and quality, and must be registered with the Pharmacy and Poisons Board of Hong Kong (the Board) before they can be sold or distributed in Hong Kong. The Department of Health (DH), in accordance with relevant legislation, adopts a risk-based approach in laying down a set of comprehensive and stringent control measures to regulate the manufacture, import, wholesale and retail of pharmaceutical products. 
     Having consulted the DH, reply to the question raised by the Hon Chan Hoi-yan is as follows:
(1) The number of licences (as at the end of each year), new licences and  applications for withdrawing licences of Authorized Sellers of Poisons (ASP), commonly known as "pharmacies", and Listed Sellers of Poisons (LSP), commonly known as "medicine companies", in the past ten years are as follows:
Year Number of licences Number of new licences Number of applications for withdrawing licences
2010 546 3 499 67 272 38 170
2011 557 3 572 47 283 36 211
2012 570 3 827 45 377 32 162
2013 597 3 907 106 701 79 621
2014 605 3 951 39 311 31 267
2015 607 4 012 34 277 32 216
2016 604 3 937 29 231 32 306
2017 614 3 937 37 258 27 258
2018 641 3 937 50 264 23 264
(January to September)
665 4 299 48 545 24 183
     The DH does not have the breakdown of number of licences of ASP and LSP by District Council districts. As at end-September 2019, the number of ASP and LSP on Hong Kong Island, in Kowloon and in the New Territories are as follows:
  Hong Kong Island Kowloon New Territories Total
ASP 128 261 276 665
LSP 828 1 513 1 958 4 299
(2) and (4) The DH conducts surprise inspections of premises of ASP and LSP, as well as test purchases of controlled medicines, with a view to monitoring their compliance with the law and respective code of practice.
     Should there be any contravention of the relevant legislation by drug retailers, the DH will take follow-up actions immediately and, on the advice of the Department of Justice, institute prosecution when there is sufficient evidence. Convictions by licensed retailers would be submitted to the Board for consideration of disciplinary action. Convictions by ASP usually involve illegal sale of Part 1 poisons and prescription medicines; whereas convictions by LSP or other premises usually involve illegal possession and sale of unregistered pharmaceutical products and Part 1 poisons.
     The number of enforcement actions by the DH against ASP and LSP, and relevant complaints received by the DH in the past five years are as follows:
Year Number of inspections Number of test purchases Number of convicted cases Number of complaints
2015 1 214 7 977 4 136 3 008 24 3 5 86 36
2016 1 209 7 956 3 955 4 021 15 4 4 82 27
2017 1 220 7 874 4 329 3 229 13 5 4 103 34
2018 1 212 7 814 4 194 3 350 14 5 3 100 22
(January to September)
759 5 538 3 036 2 460 10 6 7 58 17

(3) Under the Ordinance, only persons authorised by the Board as ASP are allowed to conduct relevant retail business of selling poisons (including poisons listed in Part 1 and Part 2 of the Poisons List at the Schedule 10 to the Regulation). In addition, persons who wish to conduct relevant retail business of selling poisons listed in Part 2 of the Poisons List must obtain a licence of LSP issued by the Board.
     The Ordinance stipulates that terms such as "藥房", "pharmacy", "dispensary" and "drug-store" used in connection with premises will be deemed to be calculated to suggest that such premises are premises registered under the Ordinance as premises of an ASP and are under the control of a registered pharmacist. The Ordinance restricts the use of the title "藥房" that can only be used for premises registered by an ASP.  Failure to do so may constitute an offence. Upon conviction of this offence, a person is liable to a maximum penalty of a fine of $100,000 and imprisonment for two years.
     Retailers of registered pharmaceutical products that contain uncontrolled ingredients do not require a licence. The DH does not have figures on these premises.
(5) Although retailers of registered pharmaceutical products that contain uncontrolled ingredients do not require a licence, the DH has implemented the following measures to regulate medicine retailers based on existing legislation and to enhance public education:
(a) the DH has an established mechanism in place to conduct test purchases at drug retailers, including ASP, LSP and other retail premises, to monitor their compliance on illegal sale of controlled drugs. Prosecutions would be initiated if contraventions of the laws are found;
(b) if the DH receives information suggesting that someone is suspected to have violated the Ordinance and its subsidiary legislation (including the suspected illegal sale of medicines, the use of restricted title "pharmacy" or the display of the prescribed pharmacy logo), investigation will be carried out immediately. Joint operation with the Hong Kong Police Force and the Hong Kong Customs and Excise Department will be conducted when necessary;
(c) to cope with the increasing number of retail premises engaged in the retail sale of drugs, the DH has stepped up its efforts in publicity and education to enhance public understanding of different types of drug retailers. Over 10 000 copies of education pamphlets on drug retailers and registered pharmaceutical products have been published for distribution to inbound tourists through the Hong Kong Tourism Board and the Travel Industry Council of Hong Kong, and to arriving passengers through sea, land and air control points; and
(d) the website of the Drug Office of the DH has listed out the name and address of all licensees (including ASP and LSP) for public information. The website also provides a search engine for members of the public to enquire if a premises holds a relevant licence.
Ends/Wednesday, November 6, 2019
Issued at HKT 15:02
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