LCQ14: Crackdown on illegal sale or possession of unregistered medicine
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Question:
It has been reported that some premises were recently uncovered to have offered customers "Wilms' tumour 1" (WT1), a vaccine which was claimed to be able to prevent multiple types of cancer, and that the Department of Health, together with the Police, earlier conducted raids at multiple premises across Hong Kong and seized a number of vials of unregistered injectable pharmaceutical products. In this connection, will the Government inform this Council:
(1) of the following since 2023: (i) the number of operations conducted by the Government to crack down on the illegal sale or possession of unregistered medicine (with a breakdown by proactive inspections and inspections conducted upon receipt of reports), (ii) the number of unregistered pharmaceutical products seized, (iii) the number and details of persons arrested and/or prosecuted (with a breakdown by healthcare professionals and non-healthcare professionals), and (iv) the number of complaints received from members of the public respectively; and among such cases, the number of cases involving WT1;
(2) of the respective details of the Government's screening of and enforcement against medical advertisements since 2023; and
(3) how the Government will step up public education and publicity, so as to prevent members of the public from seeking medical treatment through improper methods and channels?
Reply:
President,
Hong Kong has a stringent regulatory regime for pharmaceutical products. Any product which falls within the definition of "pharmaceutical product" under the Pharmacy and Poisons Ordinance (Cap. 138) must meet the criteria of safety, efficacy and quality, and be registered with the Pharmacy and Poisons Board of Hong Kong (Board) before it can be sold in Hong Kong. According to the Guidance Notes on Classification of Products as "Pharmaceutical Products" under the Pharmacy and Poisons Ordinance (Cap. 138) formulated by the Board, products intended for injection into the human body are classified as pharmaceutical products. Advanced therapy products, including gene therapy products, somatic cell therapy products and tissue engineered products, are also pharmaceutical products and are regulated under Cap. 138.
According to Cap. 138, any person who illegally sells (through any channel, including the Internet) or possesses unregistered pharmaceutical products or Part 1 poisons commits an offence and shall be liable, upon conviction, to a maximum penalty of a fine of $100,000 and imprisonment for two years. Furthermore, the import and export of pharmaceutical products are regulated under the Import and Export Ordinance (Cap. 60). Any person who imports or exports pharmaceutical products without the relevant licence commits an offence and shall be liable, upon conviction, to a maximum penalty of a fine of $500,000 and imprisonment for two years.
In consultation with the Department of Health (DH), the consolidated reply to the question raised by Professor the Hon Chan Wing-kwong is as follows:
(1) The DH has all along been rigorously combating the illegal possession or sale of unregistered pharmaceutical products. Its efforts include monitoring medicines sold in the market (including on the Internet) through its established mechanism, conducting investigations and follow-up actions upon receipt of intelligence, or taking proactive enforcement actions such as unannounced inspections and test purchase operations. Where necessary, the DH will also conduct joint enforcement operations with the relevant law enforcement departments, including the Hong Kong Police Force (Police) and the Hong Kong Customs (Customs).
From January 2023 to August 2026, the Drug Office of the DH conducted about 36 200 inspections relating to the regulation of pharmaceutical products, and handled 105 conviction cases involving the sale and/or possession of unregistered pharmaceutical products. The maximum penalty imposed in these cases was 10 months’ imprisonment or a fine of $242,000.
Regarding the case in which certain organisations allegedly claimed to be able to provide the "Wilms' tumour 1" (WT1) vaccine, the DH launched an investigation immediately upon receipt of relevant intelligence in July 2026 and conducted multiple unannounced inspections at the premises concerned. In early September 2026, the DH, together with the Police, raided a number of premises across the territory and seized over 1 600 vials of suspected unregistered injectable pharmaceutical products at four of these premises, although no product labelled as "WT1" was found. During the operations, three persons (including a registered medical practitioner) were arrested for suspected illegal possession of unregistered pharmaceutical products and Part 1 poisons.
WT1 is not a registered pharmaceutical product in Hong Kong, and so far, no registration record of the relevant pharmaceutical product has been found with the drug regulatory authorities of the Mainland or any overseas jurisdiction. The DH is tracing the source of the products and has notified Customs to follow up on the possible illegal importation of unregistered pharmaceutical products into Hong Kong involved in the case. As a registered medical practitioner and a nurse were suspected of having provided the WT1 vaccine to customers, the DH has referred the case to the Medical Council of Hong Kong and the Nursing Council of Hong Kong for follow-up. The Government will not tolerate anyone abusing his or her professional authority to endanger public health under the pretext of cancer prevention or treatment. The DH will continue to work with the relevant departments to closely monitor the situation and gather intelligence, and will take decisive enforcement action against illegal acts to safeguard public health.
(2) To prevent members of the public from seeking improper treatment for certain health conditions and thereby delaying proper diagnosis and treatment, the Undesirable Medical Advertisements Ordinance (Cap. 231) prohibits or restricts the publication of advertisements likely to lead to the use of any medicine, surgical appliance or treatment for the purpose of preventing or treating the diseases or conditions specified in Schedules 1 and 2 to Cap. 231 (including any benign or malignant tumour). Cap. 231 also prohibits or restricts the making of six groups of claims specified in Schedule 4 in advertisements for orally consumed products.
The DH has all along been screening medical advertisements based on its mechanism. From January 2023 to August 2026, the DH reviewed over 150 000 advertisements published across various media in Hong Kong, including newspapers, magazines, leaflets, signs, posters, as well as radio, television and internet advertisements. During the aforesaid period, the DH issued over 1 600 warning letters concerning advertisements suspected of contravening Cap. 231. Following the issuance of warning letters by the DH, the relevant advertisement contents were removed or deleted. For cases where the relevant advertisement contents are still not removed or deleted upon receipt of warning letters, the DH will initiate prosecution proceedings based on its mechanism. Upon first conviction, an offender is liable to a fine of $50,000 and imprisonment for six months; upon a subsequent conviction for the same offence, an offender is liable to a fine of $100,000 and imprisonment for one year.
Regarding the WT1 case mentioned above, the DH has issued warning letters to the organisations involved in accordance with the established procedures, requesting the removal of the relevant advertisement contents suspected of contravening Cap. 231. According to the DH's investigation, the relevant advertisements were removed after the issuance of the warning letters. As the advertisements concerned were also published on social media platforms on the Mainland, the DH has notified the relevant Mainland law enforcement authorities for follow-up.
(3) The DH has all along attached great importance to public education and publicity. It has repeatedly reminded members of the public that, for any queries about the prevention or treatment of diseases (including cancers), they should first consult a registered doctor, who will provide professional advice based on their individual health condition and the latest medical evidence, and that they should not blindly trust unproven medical claims to safeguard their own health. Regarding the case in which certain organisations allegedly claimed to be able to provide WT1, the DH has issued alerts through channels including press releases, media interviews and social media platforms, reminding the public that WT1 is not a registered pharmaceutical product in Hong Kong and that any advertisement claiming to provide the vaccine for cancer prevention is misleading and suspected of fraud. The DH has also urged members of the public not to believe advertisements or rumours hastily and receive injections of substances of unknown origin. In addition, the DH has issued letters to all doctors and private healthcare facilities in Hong Kong, reminding them that they must comply with the laws of Hong Kong and must not inject illegal pharmaceutical products to patients. Members of the public who suspect professional misconduct on the part of registered healthcare professionals may lodge complaints with the relevant professional regulatory bodies, such as the Medical Council of Hong Kong and the Nursing Council of Hong Kong. The DH has also prepared safety information on the purchase and use of medicines, including Be Cautious when Buying Medicines on Internet, General Knowledge on Registered Medicines and Be Cautious When Buying Medicines Overseas, for the public's reference.
The DH will continue to step up public education through a multi-pronged approach, including through the websites of the Drug Office and the Centre for Health Protection, social media and video clips, to educate members of the public on how to identify registered pharmaceutical products (e.g. by checking the registration number in the format of "HK-XXXXX" on the product packaging, and by searching for information on registered pharmaceutical products on the Drug Office's website). Members of the public may also use the "Licence Scanner" function of the DH's mobile application to verify whether a private healthcare facility is licensed or has been issued with a letter of exemption, and check whether a service provider is a registered healthcare professional through the registers of the relevant healthcare professional boards or councils. Furthermore, the Government will establish the Hong Kong Centre for Medical Products Regulation within this year to further raise the regulatory standards for drugs and medical devices, thereby safeguarding public health.
Ends/Wednesday, October 7, 2026
Issued at HKT 12:42
Issued at HKT 12:42
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