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Following is a question by the Dr Hon Kwok Ka-ki and a written reply by the Secretary for Food and Health, Dr Ko Wing-man, in the Legislative Council today (October 28):
Question:
At present, only authorised sellers of poisons (ASPs) (commonly known as pharmacies) are allowed to sell drugs which require doctors' prescriptions. It has been reported that some pharmacies are selling drugs, including the anti-cancer drug Herceptin and Sovaldi for the treatment of hepatitis C, to members of the public without doctors' prescriptions. These pharmacies sell these drugs at very low prices (e.g. around HK$20,000 only for Sovaldi, which is sold at the price of HK$650,000 in the United States), raising suspicion as to whether these drugs are fake. Regarding law enforcement by the authorities on the sale of drugs, will the Government inform this Council:
(1) whether it has compiled statistics on the current number of shops which are not ASPs but with their Chinese names comprising the character "藥"; if it has, of the number; if not, the reasons for that;
(2) of the respective numbers of inspections conducted by the authorities in the past five years on shops whose Chinese names comprise (i) the term "藥房", (ii) the term "藥行" and (iii) the character "藥" but not the terms "藥房" or "藥行", as well as the respective numbers of cases in which the persons concerned were prosecuted and convicted for contravention of the law, and among the convicted persons, the respective numbers of those who were (i) registered pharmacists and (ii) ASPs;
(3) of the respective numbers of complaints or reports about the sale of fake or spurious drugs received by the authorities in the past five years, as well as the respective numbers of prosecutions and convictions in connection with them;
(4) of the respective numbers of patients who fell sick and were admitted to hospitals for treatment in the past five years after taking (i) prescription drugs bought from pharmacies without doctors' prescriptions and (ii) drugs that were fake or spurious; and
(5) whether it will review and amend the existing legislation to raise the penalties for selling prescription drugs without doctors' prescriptions and for selling fake or spurious drugs; whether it will require that only shops which are ASPs are allowed to use Chinese names comprising the character "藥", so as to avoid causing confusion to members of the public?
Reply:
The regulation of "pharmaceutical products" and "medicine" is governed by the Pharmacy and Poisons Ordinance (Cap. 138) (PPO) and its subsidiary legislation (including the Pharmacy and Poisons Regulations (Cap. 138A) (PPR)). The relevant ordinance and regulations adopt a risk-based approach in laying down a set of comprehensive and stringent control measures to regulate the manufacture, import and wholesale, and retail of pharmaceutical products and drugs. The Department of Health (DH) is responsible for the enforcement of the PPO and the PPR.
As stipulated by the relevant ordinance and regulations, only persons authorised by the Pharmacy and Poisons Board (PPB) as "Authorised Sellers of Poisons" (ASPs) are allowed to conduct the relevant retail business of selling poisons (including poisons listed in Part I and Part II of the Poisons List at the Tenth Schedule to the PPR). Moreover, those who wish to conduct retail business of selling poisons listed in Part II of the Poisons List should obtain a licence for "Listed Seller of Poisons" (LSP) issued by the PPB.
The PPO stipulates that the terms "pharmacy", "dispensary", "drug-store" or the Chinese term "藥房" used in connection with premises shall be deemed to be calculated to suggest that such premises are premises registered under the PPO as premises of an ASP and are under the control of a registered pharmacist. The PPO restricts the use of the title "藥房", which 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.
Furthermore, under the Trade Descriptions Ordinance (Cap. 362), any person who imports, exports, sells or manufactures goods (including medicines) to which a forged trade mark is applied commits an offence. The Customs and Excise Department (C&ED) is responsible for enforcing the relevant provisions. Prosecution will be instituted if there is sufficient evidence. Cases will be brought before a Magistrate's Court for trial and upon summary conviction, an offender is liable to a maximum penalty of a fine of $100,000 and imprisonment for two years. Serious cases may be referred to the District Court for trial and upon conviction on indictment, an offender is liable to a maximum penalty of a fine of $500,000 and imprisonment for five years.
In consultation with the Commerce and Economic Development Bureau, the DH and the Hospital Authority (HA), our reply is as follows:
(1) The website of the Drug Office of the DH has set out in details the names of ASPs and LSPs, and the addresses of their premises. Moreover, members of the public can check whether a shop is an ASP or LSP by entering the name or the address of the shop on the "Search Drug Dealers" link of the website. The DH also educates members of the public how to identify ASPs and LSPs through the above-mentioned website. The DH does not maintain statistics on the number of shops which are not ASPs but have the character "藥" in their Chinese names.
(2) During the period between 2011 and August 2015, the Drug Office of the DH conducted 5 588 inspections to ASPs and 35 320 inspections to LSPs, during the same period there were a total of 34 convicted cases involving LSPs and 135 convicted cases involving ASPs (including 77 cases in which the ASPs were convicted for illegal sale of prescription drugs). For the cases involving ASPs, three registered pharmacists were convicted. Detailed figures of inspection and prosecution are set out in Annex 1.
Furthermore, in the same period, the Drug Office of the DH processed a total of nine convicted cases involving illegal display or use of a prescribed logo, emblem or the term "藥房" by medicine retailers. All nine cases involved retail shops without a licence.
(3) The C&ED received 469 complaints and reports involving counterfeit pharmaceutical products in the past five years. Upon investigation and analysis, including requesting the trade mark owners to verify the authenticity of the products in question, the C&ED detected 133 cases, in which 92 persons or companies were convicted. The details are set out in Annex 2.
(4) Upon investigation, the DH found that among the cases reported by the HA between 2011 and August 2015, there were 78 cases involving people taking prescription drugs bought from ASPs without doctors' prescriptions. For each case, the DH will carry out epidemiological investigation immediately and, if there was doubt about whether the drug was fake or spurious, the case will be referred to the C&ED for follow-up action. Separately, the DH made referrals of three non-ASP cases involving fake or spurious drugs containing western medicine ingredients during the above-mentioned period.
(5) Since counterfeit pharmaceutical products may be hazardous to public health, the Government attaches great importance to the problem of such products. Various departments have adopted the following measures to tackle the problem:
(a) the DH has an established mechanism in place to carry out surprise inspections to licensed ASPs and LSPs to check whether they are in compliance with the relevant legislations and licensing conditions. It also conducts test purchases at ASPs and LSPs from time to time to combat the illegal sale of prescription drugs;
(b) if the DH receives information suggesting that someone is suspected to have violated the PPO and its subsidiary legislation (including the suspected illegal sale of prescription drugs by ASPs and LSPs, or by other retail premises), it will carry out investigation immediately. Joint operation with the Hong Kong Police Force and the C&ED will be conducted when necessary;
(c) any act of alleged misconduct by an ASP may be subject to inquiry by Disciplinary Committees appointed by the PPB. The PPB will make decisions which include disqualifying the ASP for a period of time, removing its premises from the register of premises, and serving a written warning on it. In addition, the PPB may also, according to the circumstances, disqualify or temporarily suspend the licence of any LSP which contravenes the relevant provisions under the PPO and its subsidiary legislation;
(d) to cope with the increasing number of retail premises engaged in the retail sale of drugs, the DH has stepped up its publicity and educational efforts 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;
(e) the C&ED intercepts the import of counterfeit pharmaceutical products into Hong Kong, and conducts blitz operations from time to time at shops selling pharmaceutical products across the territory to check if counterfeit pharmaceutical products are sold. If a shop is found selling counterfeit pharmaceutical products, the C&ED will take enforcement actions promptly and investigate all parties involved, including the salesperson(s), the person-in-charge and the licensee of the shop; and
(f) the C&ED maintains close collaboration with the pharmaceutical industry and trade mark proprietors in market surveillance. In addition, the C&ED has introduced reward schemes with trade mark proprietors to encourage the public to report activities involving counterfeit and fake pharmaceutical products, with a view to combating such crimes more effectively.
The enforcement agencies will continue to take measures to combat illegal activities.
Ends/Wednesday, October 28, 2015
Issued at HKT 15:35
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