MH 78:04/4-2_V15
HSA 006:02/03
1 December 2022
PROVISION OF INFORMATION ON HEALTH PRODUCTS BY PHMCA / HCSA LICENSEES AND TELEMEDICINE SERVICE PROVIDERS AND ACTIONS TO BE TAKEN The Ministry of Health (MOH) and the Health Sciences Authority (HSA) have received an increasing number of feedback on healthcare institutions (HCI) and telemedicine (TM) service providers publishing information on health products, which include therapeutic products and medical devices, on their websites and/or social media platforms. Some of the information is published in a manner considered as advertisements promoting the use of certain health products. Such advertisements and publications are not allowed as they contravene the advertisement regulations within the Health Products Act (HPA).
2. MOH and HSA would like to remind all PHMCA and HCSA licensees, and TM service providers, to comply with the requirements under the relevant regulations, such as HPA and PHMCA. Advertisement Controls of Health Products
3. Health product advertisements are regulated by HSA under the HPA and its subsidiary legislation, namely the Health Products (Advertisement of Specified Health Products) Regulations [for therapeutic products and cell, tissue or gene therapy products] and the Health Products (Medical Devices) Regulations [for medical devices]. Publication of any information that promotes the sale or use of a health product directly or indirectly is deemed as an advertisement under the HPA. This includes information published in any media including digital media (such as electronic direct mailers, corporate or healthcare institution’s websites and social media platforms, including blogs, Facebook and Instagram).
4. Therapeutic products1 that are Prescription Only Medicines, unregistered therapeutic products as well as Professional Use Only medical devices , and cell, tissue or gene therapy products are not allowed to be advertised to the public. The appropriate use of these products requires clinical assessment of the patient’s medical condition, and informed discussion between healthcare professionals and their patients. Hence, PHMCA, HCSA licensees, and TM service providers should not advertise or promote the sale or use of these products directly to members of the public.
5. Notwithstanding the above, the legal framework is not intended to restrict factual or educational information that serves to inform consumers on diseases, medical conditions, and available treatments. Such information is allowed, provided they are not misleading, and do not create unjustified expectations of the treatments, results by, or promote the use of specific health products. On the other hand, information that focuses on or draws attention to a specific product may be considered as an advertisement of the product as it could encourage individuals to request for the specific product from their healthcare professionals. Such materials will be subject to the prescribed controls. For avoidance of doubt, these controls would also apply to materials featuring specific products jointly produced by PHMCA/HCSA licensed healthcare institutions and the industry. PHMCA/HCSA Licensees and TM service providers are therefore reminded that they and the companies are responsible in ensuring that these materials published comply with the prescribed requirements.
6. Please refer to Annex 1 for the Guidance for PHMCA/HCSA Licensees and Telemedicine Service Providers on Advertisement Controls of Health Products and Provision of Non-Promotional Information to the Public. The detailed requirements can be found in HSA’s guidance documents available on the HSA website (www.hsa.gov.sg).
Actions required 7. PHMCA/HCSA Licensees and TM service providers are given a grace period of up to 31 March 2023 to review your current published materials regarding health products, including product features on your websites and other digital media pages to ensure compliance with the prescribed requirements. Following the grace period, enforcement action may be taken for non-compliances by licensees. For TM service providers that continue to contravene prevailing advertising requirements for health products, this may be taken into consideration during your application for a HCSA licence in mid 2023 and may also result in delisting from MOH’s Voluntary Listing of Direct Telemedicine Service Providers.
8. Under the HPA, anyone who contravenes the prescribed requirements may be subject to penalties on conviction, which include a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or both. In addition, HSA may also direct the advertiser to take corrective measures such as issuance of a corrective advertisement.
A/PROF KENNETH MAK
DIRECTOR OF MEDICAL SERVICES
MINISTRY OF HEALTH
DR CHOONG MAY LING,MIMI
CHIEF EXECUTIVE OFFICER
HEALTH SCIENCES AUTHORITY
The full documents may be downloaded below:
Download [.pdf, 407KB]Annex