Pharmaceutical advertising regulation and medical device advertising in Singapore

In Singapore, a few legislations, regulations and guidelines regulate the advertising of medicines and medical devices.

1.1 Medicines 

Together, the Medicines Act 1975, the Medicines (Medical Advertisement) Regulations, the Health Products Act 2007, and the Health Products (Advertisement of Specified Health Products) Regulations regulate the advertising of medicines in Singapore. 

1.2 Medical devices 

Both the Health Products Act 2007 and the Health Products (Medical Devices) Regulations govern the advertising of medical devices in Singapore. 

There are various codes of conduct and guidance that govern the advertising of medicines and medical devices in Singapore. Examples include the Singapore Code of Advertising Practice which regulates advertising generally across industries. Regulatory guidance documents are also periodically released by Singapore’s Health Science Authority (“HSA”). 

Examples of guidance includes: the Guide on Advertisements and Sales Promotion of Medicinal Products; the Explanatory Guidance to the Health Products (Advertisement of Specified Health Products) Regulations 2016; and Guidance for Licensees under the Private Hospitals and Medical Clinics Act and Healthcare Services Act. 

While these codes and guidelines do not have the force of law, they are treated as clarificatory and guiding principles that govern the advertising of medicines and medical devices in Singapore. 

Medicines

Medicines in Singapore are generally split into two categories: (1) Therapeutic Products (“TPs”); and (2) Medicinal Products (“MPs”).

TPs are intended for use by and in humans for a therapeutic, preventive, palliative, or diagnostic purpose. TPs do not require prior approval from Singapore’s Health Science Authority. However, advertisements must comply with the principles and requirements laid out in the Health Products Act and the Regulations. 

MPs are referred to in the Medicines Act 1975 to include: Chinese Proprietary Medicines; Traditional Medicines; Homeopathic Medicines; Quasi-medicinal products (such as medicated soaps; beverages; etc.); and Medicated Oil and Balms. 

MPs require prior approval from Singapore’s Health Science Authority. Prior to issuing any medical advertisements or conducting any sales promotion activities directed to the general public, you must ensure that the advertisement or sales promotion has a valid permit from the HSA. Applications for a permit may be done via HSA’s website, upon which a permit will remain valid for 1 year from the date of issuance of the permit. Permits may be renewed on a yearly basis. 

A table detailing the relevant application fees is produced below (effective 09 October 2023): 

 Medical devices

Advertisements of Medical Devices do not require prior approval by the Singapore’s Health Science Authority. However, advertisements of medical devices must comply with the requirements stated in the Health Products Act and the Regulations. 

Yes. Prescription only medicines are treated differently from over-the-counter medicines in Singapore. Prescription-only medicines generally refers to medicines that can only be obtained from a doctor or dentist. The conditions that these medicines treat usually require a diagnosis from a doctor. Examples of Prescription-only medicines include medicine for chronic disease (e.g., amlodipine), cancer drugs, sexual dysfunction drugs, and aesthetic medicines. 

Advertisements of prescription-only medicines directed to the general public is prohibited under Regulation 7 of the Health Products (Advertisement of Specified Health Products) Regulations 2016. Advertisements of prescription only medicines must not be made in public places. The reason for this prohibition is because such medicines are often dependent on the clinical judgment of medical doctors and requires informed discussions with their patients. 

Medicines that are not prescription only (i.e., pharmacy-only medicines and general sales list medicines) may be advertised to the general public, provided the advertisements comply with the principles and requirements under the Health Products Act and relevant Regulations.  

A person may not advertise a health product in a false or misleading way. Advertisements of TPs must not directly or indirectly cause the reader to self-diagnose or self-treat any serious diseases. Advertising of TPs must also not encourage inappropriate or excessive use of the TP. Furthermore, advertisements must not directly or indirectly cause fear, alarm, distress to the consumers or abuse the trust, exploit the lack of knowledge of any consumer in advertisements. 

The restrictions for Medical Devices are similar. For example, advertisements for medical devices must not give any false information concerning the Medical Device or create any erroneous impression regarding the components, composition, specification, quality, safety, efficacy or uses of the Medical Device. Advertisements for Medical Devices also should not directly or indirectly cause the reader to self-diagnose or self-treat any serious diseases.

In addition to the general restrictions mentioned above, a few restrictions specifically apply to advertisements of medicines and medical devices to healthcare professionals. 

Healthcare professionals are specified in the First Schedule of the Health Products (Advertisement of Specified Health Products) Regulations 2016 to include:

1. Qualified practitioners,
2. Registered pharmacists
3. Enrolled nurses
4. Registered nurses and registered midwives; and
5. Persons undergoing training with a view to becoming qualified practitioners, registered pharmacists, enrolled nurses, registered nurses or registered midwives.

For instance, advertisements that were intended solely for the abovementioned classes of persons must be restricted in circulation and not freely available to or accessible by the general public. Advertising materials relating to unregistered TPs or unapproved uses of registered TPs are allowed to be disseminated only at pharmaceutical trade fairs / exhibitions or scientific conferences / forums, only where attendance is not opened to the general public. 

Although there are no requirements stating that certain types of information must appear in advertisements directed to healthcare professionals, all advertisements concerning medicines and medical devices must generally include proper substantiation of facts or assertions. 

Medicines 

Where advertisements of a TP contain any statement, assertion, certification, award or feature of uniqueness or prominence differentiating the TP from any other competing or similar TP, the statement, assertion, certification, award or feature must be substantiated by facts or evidence.

Medical devices 

Where advertisements of a medical device contain any statement, assertion, certification, award or feature of uniqueness or prominence differentiating the medical device from any other competing or similar medical device, the statement, assertion, certification, award or feature must be substantiated by facts or evidence. 

The facts or evidence required for substantiation vis-à-vis medical devices include: (1) in relation to a certification or an award, the identity of the certifying or awarding body and the date the certification or award was granted; and (2) in relation to any claim of historical precedence in the use or administration of the medical device for the purpose of medical treatment, information on the outcome of that use or administration of the medical device. Any facts or evidence mentioned in (1) above must be indicated on the face of the advertisement. 

8.1 Medicines

See point 7 above.  

8.2 Medical devices

See point 7 above.  

Where medical devices are concerned, advertisements should not exploit the ignorance and credulity of the public by including scientific data that the general public cannot verify or validate. Advertisements should not misuse research results or make unnecessary quotations from technical and scientific publications. 

Although no specific provisions govern the use of scientific data in advertisements for medicine, Regulation 4 of the Health Products (Advertisement of Specified Health Products) Regulations 2016 states that an advertisement involving a TP must not exploit the lack of knowledge of consumers. This requirement is bolstered by the Singapore Code of Advertising Practice (a document approved by the HSA) which states that all advertisements should not abuse the trust of the consumer or exploit his lack of experience, expertise or knowledge.

Medicines

Under Regulation 4(f) of the Health Products (Advertisement of Specified Health Products) Regulations 2016, an advertisement for a TP must not compare or contrast the specified TP with any other named TP or a brand thereof. For instance, advertisements directed to members of the public should not contain comparative claims against another TP or brand, for example, by saying the TP “works faster or more effective than Brand xxx.”  However, comparison among products within the same brand by the same company to highlight difference between products is allowed.

Medical devices

Similar restrictions apply for advertisements concerning medical devices. Advertisements for medical devices should not denigrate or attack unfairly any other products, goods or services or other sectors of the industry. Furthermore, any comparative statements features must not mislead the public about the product being advertised or about any other product which it is compared with.

The definition of “advertisement” is broad and includes all forms of advertisement in any media. This includes digital interactive platforms, social media channels / platforms and blogs. Advertisements of medicines or medical devices that are made on such social media channels or platforms are subject to the same restrictions and requirements found in the Health Products Act and the relevant regulations. 

In general, where you have advertised any medicines and/or medical devices or caused any medicines and/or medical devices to be advertised in contravention of the Health Products Act, Singapore’s Health Science Authority has the power to: 

1. Stop the advertisement with immediate effect;
2. To take such measures as may be reasonable and necessary in the circumstances to remove the advertisements that have already been published;
3. To publish a corrective advertisement in such manner and containing such information as may be specified by the Health Sciences Authority. 

The above is in addition to penalties that may be imposed under the Health Products Act. Penalties for infractions of the Health Products Act vary from offence to offence but generally involve monetary fines or imprisonment sanctions.  

By way of example, a person who advertises a health product in a false or misleading wayshall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

Similarly, a person who advertises any product to be a health product where the product is not a health product shall be guilty of an offence and liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.  

With regard to the advertising of medicines and medical devices, no future developments are envisaged.