LCQ12: Regulating sale of pharmaceutical products
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     Following is a question by Dr the Hon David Lam and a written reply by the Secretary for Food and Health, Professor Sophia Chan, in the Legislative Council today (June 1):
 
Question:
 
     Drug retailers holding valid licences issued by the Pharmacy and Poisons Board of Hong Kong (the Board), including registered pharmacies and licensed medicine stores, are authorised by the Laws of Hong Kong to sell drugs of different categories. Of the two, only pharmacies may use the title of "Pharmacy/Dispensary" and the "Rx" logo, and may dispense prescription drugs as well as sell pharmacist-only controlled medicines under the supervision of a pharmacist in the shop. However, it has been reported that quite a number of shops of unlicensed drug retailers operating in the community with Chinese names comprising terms such as "藥坊", "藥業", "藥店" and "藥妝" (other drugstores) imitate the decoration design of pharmacies and use logos resembling the "Rx" logo in order to solicit business. As a result, members of the public have been misled and suffered monetary and health losses. In this connection, will the Government inform this Council:
 
(1) of the respective numbers of complaints against licensed drug retailers and other drugstores received by the Government in each of the past three years;
 
(2) whether it has studied if the laws should stipulate that only drug retailers holding valid licences issued by the Board may display the character "藥" in their Chinese names on the signboards, so as to protect members of the public from being misled;
 
(3) whether it has formulated effective measures to regulate the business practices of drug retailers, so as to prohibit shops with records of illegal sale and possession of unregistered medicines from carrying on business of sale of drugs; and
 
(4) whether it will step up public education to help members of the public identify licensed drug retailers and other drugstores; if so, of the details?
 
Reply:
 
President,

     According to the Pharmacy and Poisons Ordinance (Cap. 138) (the Ordinance), retailers authorised as Authorized Sellers of Poisons (ASPs) (commonly known as "pharmacies") by the Pharmacy and Poisons Board of Hong Kong (the Board) are allowed to conduct retail business involving poisons listed in Part 1 and Part 2 of the Poisons List at Schedule 10 to the Pharmacy and Poisons Regulations (Cap. 138A). For retailers that are not ASPs and wish to conduct retail business involving poisons listed in Part 2 of the Poisons List, they must obtain a licence of Listed Seller of Poisons (LSP) (commonly known as "medicine companies") issued by the Board. The Department of Health (DH) is responsible for providing technical and executive support to the Board.
 
     Having consulted the DH, the reply to the question raised by Dr the Hon David Lam is as follows:

(1) In the past three years, the number of complaint cases related to drug retailers (note 1) handled by the Drug Office of the DH were as follows:
 
Year Number of complaint cases
ASP LSP
2019 66 17
2020 54 24
2021 91 20
 
(2) and (3) Under the Ordinance, only ASPs may use terms such as "藥房", "pharmacy", "dispensary" and "drug-store" at their registered premises. 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.

     The DH has an established mechanism in place to conduct surprise inspections at ASPs and LSPs to ensure their compliance with relevant legislation, licence conditions and respective code of practice. In addition, the DH also conducts test purchases at drug retailers, including ASPs, LSPs and other retailers, to monitor their compliance with relevant legislation and the requirements of applicable code of practice. If any contravention of the law is suspected, the DH will follow up and carry out enforcement action immediately. After seeking advice from the Department of Justice, prosecutions against relevant drug retailers or persons may be initiated. Convicted cases involving ASPs and LSPs will be submitted to the Board for consideration of disciplinary action against them. For drug retailers that have been convicted or are associated with frequent complaints, the DH will step up inspection and monitoring, and take enforcement action if contravention of the law is found.
 
     While retailers selling registered pharmaceutical products that contain uncontrolled medicinal ingredients are not required to be authorised as ASP by the Board or obtain a licence of LSP issued by the Board, the DH will carry out investigation immediately when it receives information suggesting that a retailer is suspected to have violated the Ordinance and its subsidiary legislation (including the illegal sale of medicines, the illegal use of restricted title "pharmacy" or the illegal display of the prescribed ASP logo, etc.). Joint operation with the Hong Kong Police Force or the Hong Kong Customs and Excise Department will be conducted when necessary.
 
     In the past three years, the number of convicted cases related to drug retailers handled by the Drug Office were as follows:
 
Year Number of convicted cases
ASP LSP Other retailers (note 2)
2019 14 7 13
2020 5 2 3
2021 13 1 5

(4) To cope with the increasing number of retailers engaged in the sale of drugs, the DH has stepped up its efforts in publicity and education to enhance public understanding of different types of drug retailers. These include publication of information titled "Do you know the differences between Pharmacy & Medicine Store?" and "Introduction to Drug Regulatory System in Hong Kong" on the website of the Drug Office, to assist members of the public to differentiate different types of drug retailers, and to better understand the legal requirements in respect of the regulation of drugs.
 
     In addition, the website of the Drug Office has listed the names and addresses of all licensees (including ASPs and LSPs) for public information. The website also provides a search engine for members of the public to enquire if a premise holds a relevant licence.
 
Note 1: The Drug Office does not maintain statistics of complaint cases related to other retailers that have not been authorised as ASP by the Board or obtained a licence of LSP issued by the Board.

Note 2: Other retailers refer to retailers that have not been authorised as ASP by the Board or obtained a licence of LSP issued by the Board.

Ends/Wednesday, June 1, 2022
Issued at HKT 15:35

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