Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which laws apply when it comes to promoting medicines and medical devices?

• Undesirable Medical Advertisements Ordinance (Cap. 231) (“UMAO”)
• Public Health and Municipal Services Ordinance (Cap. 132) (“PHMSO”)
• Trade Descriptions Ordinance (Cap. 362) (“TDO”)
• Unsolicited Electronic Messages Ordinance (Cap. 593) (“UEMO”)

2. What are self-regulatory codes of conduct?

Several self-regulatory codes of conduct complement the legal framework:

Hong Kong Association of the Pharmaceutical Industry (HKAPI) Code of Practice

Sets out acceptable marketing practices for member pharmaceutical companies and organizations in Hong Kong when advertising medicines and medical devices.

Department of Health Codes of Practice

• Code of Practice for Listed Local Manufacturers of Medical Devices
• Code of Practice for Listed Importers of Medical Devices

These codes govern only listed local manufacturers and importers registered with the Medical Device Division of Hong Kong. Although voluntary, registration is required for public tenders and these codes have specific advertising requirements for manufactured/imported medical devices.

Hong Kong Medical and Healthcare Device Industries Association (HKMHDIA)

Medical Device Marketing Practice Guideline binds its members, including design houses, component manufacturers, traders, and companies providing testing and certification services for medical devices.

3. Licenses, Approvals, and Fees

There are no specific licenses, approvals, or fees required for advertising medicines and medical devices to the general public and healthcare professionals in Hong Kong. However, advertisements must comply with the relevant laws and codes of practice.

4. Prescription-only vs. Over-the-Counter Medicines

Hong Kong law does not differentiate between the advertising regulations for prescription-only medicines and over-the-counter medicines. Both categories are subject to the same regulatory framework.

5. Restrictions on Advertising to the General Public

The main restrictions are set out in the UMAO, which prohibits:

• Advertisements likely to lead to the use of any medicine, surgical appliance, or treatment for treating or preventing diseases specified in Schedule 1 (except permitted purposes).
• Advertisements for purposes specified in Schedule 2 to UMAO.
• Advertisements offering, inducing, or referring to procuring a miscarriage.

6. Advertising to Healthcare Professionals

Restrictions under the UMAO also apply to advertisements directed at healthcare professionals. However, advertisements published only in technical publications intended mainly for medical professionals are not prohibited.

7. Information Required in Advertisements for Healthcare Professionals

Advertisements must clearly state whether medical devices are listed under the Medical Device Administrative Control System and that listing of an importer does not imply device listing.

HKAPI Code Requirements

• Product name (brand name)
• Name, address, and telephone number of manufacturer or authorized agent
• Active ingredient(s) using approved or non-proprietary names
• Abbreviated prescribing information
• Date of approval (year and month)
• Up-to-date and valid information per registration details

8. General Advertising Requirements

• Product name (brand name)
• Manufacturer or authorized agent details
• Active ingredient(s) or non-proprietary name
• Abbreviated prescribing information
• Date of approval
• Up-to-date and valid registration information

9. Scientific Data in Advertisements

There is no specific requirement to include scientific data. However, any data used must not be false or misleading and should be accurate, credible, and supported by adequate clinical studies or reliable sources.

10. Comparative Advertising Rules

Medicines (HKAPI Code)

• Claims must be based on well-controlled clinical studies
• Non-clinical studies allowed if scientifically valid
• Animal or in-vitro data must be clearly identified
• Differences must be statistically significant
• Comparator product must be mentioned

Medical Devices

• Claims must be supported by clinical data
• Non-clinical studies allowed if scientifically sound
• Comparator device must be identified
• Competitor brand name requires written consent

11. Internet and Social Media Advertising

No specific provisions exist for online or social media advertising. General advertising laws such as UMAO, PHMSO, TDO, and UEMO apply.

12. Enforcement Mechanisms and Legal Consequences

UMAO

• Enforcement: Department of Health
• First conviction: HK$50,000 fine and 6 months imprisonment
• Subsequent conviction: HK$100,000 fine and 1 year imprisonment

PHMSO

• Enforcement: Department of Health
• Penalty: HK$50,000 fine and 6 months imprisonment

TDO

• Enforcement: Customs & Excise Department
• Indictment: HK$500,000 fine and 5 years imprisonment
• Summary conviction: HK$100,000 fine and 2 years imprisonment

UEMO

• Enforcement: Communications Authority
• First conviction: HK$100,000 fine
• Subsequent conviction: HK$500,000 fine plus daily penalties

13. Future Developments in Hong Kong

Since November 2004, the Medical Device Administrative Control System (MDACS) regulates advertising of medical devices through Codes of Practice. A comprehensive regulatory system is expected in the future.

How Can OMC Help?

• Professional review of marketing and advertising materials
• Support for obtaining authority approvals
• Professional translation services certified under ISO 17100