Pharmaceutical advertising regulation and medical device advertising in Hong Kong

The primary source of legislation in Hong Kong that governs both advertisements of medicines and medical devices is the Undesirable Medical Advertisements Ordinance (Cap. 231) (“UMAO”). Further, the Public Health and Municipal Services Ordinance (Cap. 132) (“PHMSO”) governs the advertisement of drugs.  Broadly speaking, the Trade Descriptions Ordinance (Cap. 362) (“TDO”) and the Unsolicited Electronic Messages Ordinance (Cap. 593) (“UEMO”) are also applicable to all kinds of advertising activities, including those of medicines and medical devices.

Advertisements on medicines and medical devices that involve broadcast media and radio must also comply with the relevant regulations, namely, the Generic Code of Practice on Television Advertising Standards and the Radio Code of Practice on Advertising Standards of Ancillary Visual Service.

The Code of Practice of the Hong Kong Association of the Pharmaceutical Industry (“HKAPI Code”) sets out the acceptable marketing practices of its members pharmaceutical companies and organisations in Hong Kong when advertising for medicines and medical devices.

The Department of Health also issues the Code of Practice for Listed Local Manufacturers of Medical Devices and Code of Practice for Listed Importers of Medical Devices, which govern only listed local manufacturers and importers who registered themselves with the Medical Device Division of Hong Kong. Such registration, although voluntary, is required for public tenders. The said Codes of Practice have specific requirements on the advertisements for those manufactured / imported medical devices.

The Hong Kong Medical and Healthcare Device Industries Association has also published the Medical Device Marketing Practice Guideline (“MD Guideline”) that binds its members, which covers design houses, components manufacturers, traders and companies which provide testing and certification services of medical devices.

There are no licenses/approvals/fees required for advertisements of medicines and medical devices.

No, Hong Kong law does not regulate the advertising of prescription-only and over-the-counter medicines differently.

The main restrictions are set out in the UMAO, which prohibits the following advertisements of medicines and medical devices to be published or caused to be published:

• advertisements that are likely to lead to the use of any medicine, surgical appliance, or treatment for:
  • the purpose of treating human beings for, or preventing them from contracting any disease or condition specified in column 1 of Schedule 1 (except for a purpose specified in column 2 of the Schedule) to UMAO; or 
  • treating human beings for any purpose specified in Schedule 2 to UMAO. 
• Any advertisement:
  • offering to procure a miscarriage of women; 
  • canvassing, inviting, or inducing the procuration of miscarriage of women; or
  • referring to any thing in terms which are calculated to lead to the use of that thing for the procuration of miscarriage of women

Please refer to the answers for question 5. However, it should be noted that if the advertisement is made only in a publication of a technical character intended for circulation mainly among certain medical professionals, such advertisement will not be prohibited.

Advertising medical devices imported by Listed Importers shall include a statement to the effect that:

• the listing of an importer carries no implication that its medical devices are listed; and
• clearly state whether any of the medical devices presented in the same articles are listed under the Medical Device Administrative Control System.

The HKAPI Code also specifies that all advertisements of medicine issued by their members to health professionals should include the following information:

• Name of the product (normally the brand name); 
• The name, address and telephone number of the manufacturer or the manufacturer’s authorised agent, or the business name and address of the  part of the manufacturer’s business responsible for the sale of the product;
• The active ingredient(s), using approved names where such exist, or other non-proprietary names; alternatively, the non-proprietary name of the product if it is the subject of an accepted monograph. The generic name should be in close proximity to the trade name; and
• Abbreviated prescribing information which should include an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications, precautions, and side effects;
• Date of approval (i.e. year and month).
  Information provided in the advertisement must be up-to-date and valid according to the respective registration details in the applicable city.

Please refer to the answers for question 7.

There is no specific requirement for scientific data indicated in advertisements. However, such data stated in the advertisement must not be false.

The HKAPI Code provides that comparative advertisements / claims of medicines should be based on data from adequate and well-controlled clinical studies and should be consistent with other clinical data.

• Non-clinical comparative studies on antibiotics are acceptable provided the tests adhere to well-established scientific and evidence based standards used in the medical community.
• Statements based on animal models or in-vitro data must be identified clearly.
• The claimed differences between pharmaceutical products should be statistically significant.
• Comparative statements should mention the pharmaceutical product under comparison.

The MD Guideline provides that comparative claims should be well founded on data from adequate and 
well-controlled clinical studies and should be consistent with the evidence of other clinical data.

• Non-clinical comparative studies are acceptable provided the tests are well-established scientific and evident based standards activity used in the medical community. 
• Statements based on animal models or in-vitro data must be identified clearly. Such data may be used only if human data are not available.
• The claimed differences between medical devices should only be made if statistically significant. 
• Comparative statements should mention the comparison medical device. The use of a competitor product brand name requires written consent from that company.

No, there are no specific provisions for advertisement of medicines and medical devices on the internet/ social media postings.

As Hong Kong does not have a comprehensive legislation regulating all advertising of medicines / medical devices, such advertisements are regulated by different bodies.

UMAO

The Department of Health is responsible for the enforcement of UMAO. A person who fails to comply with the prohibition set out in the UMAO shall be guilty of an offence and shall be liable upon a first conviction to a fine of $50,000 and imprisonment for 6 months and upon a second or subsequent conviction for an offence under the same offence to a fine of $100,000 and imprisonment for 1 year.

PHMSO

The Department of Health is also responsible for the enforcement of PHMSO in respect of drugs. The maximum penalty for false advertisement of drugs is a fine of HK$50,000 and imprisonment for 6 months as set out in the Ninth Schedule of the PHMSO.

TDO

The enforcement of the TDO is exercised by the Customs & Excise Department. It is a criminal offence to (1) apply a false trade description to any goods or services; or (2) supply or offer to supply any goods or services to which a false trade description is applied. Any person who commits any offence above shall be liable on conviction on indictment, to a fine of HK$500,000 and to imprisonment for 5 years; and on summary conviction, to a fine of HK$100,000 and to imprisonment for 2 years.

UEMO

For any non-compliance with the UEMO, the Communications Authority will first serve an enforcement notice in writing on that person. A person who contravenes an enforcement notice commits an offence and is liable on a first conviction, to a fine at HK$100,000; and on a second or subsequent conviction, to a fine of HK$500,000, and, in the case of a continuing offence, to a further daily fine of HK$1,000 for each day during which the offence continues.

The Hong Kong government has launched the voluntary Medical Device Administrative Control System (MDACS) since November 2004, in which the responsible governmental body, the Medical Device Division, has issued two Codes of Practice that regulate the advertising of medical devices by listed local manufacturers and listed importers. However, it is expected that Hong Kong will eventually develop an appropriate regulatory system to control the advertising of medical devices in Hong Kong.