Background
In November 2024, the HSA issued its Guidance on Disease Awareness Campaigns. At that time, the HSA required companies to obtain pre-approvals and advertisement permits to advertise therapeutic products (this is no longer a requirement). The HSA’s guidance in 2024 stipulated that DACs were exempt from such pre-approval and advertisement permit requirements. This guidance was thereafter decommissioned, and there was no further mention of DACs in the HSA’s guidance documents.
Instead, the Singapore Association of Pharmaceutical Industries (SAPI) included a section on DACs in its SAPI Code of Conduct dated 1 February 2021. The section explains what DACs are and sets out industry best practices for its member companies to follow when conducting DACs. SAPI also explained the broader implication that noncompliant DACs may potentially constitute an infringement of the HSA’s Health Products Act 2016 (note that the SAPI Code is drafted only for member companies’ compliance and does not have the force of law). This section continues to subsist within the latest version of the SAPI Code of Conduct dated April 2025.
In more detail
The HSA has clarified that when providing information on diseases and managing or conducting DACs, companies should adhere to the following:
- Avoid direct or indirect references to therapeutic products when providing information on treatment options involving such therapeutic products. Information on treatment options must be presented as a balanced overview that includes relevant disease information, the full range of treatment options (without reference to any therapeutic product), and information on their associated risks and benefits. Where therapeutic products are mentioned, the information must be limited to therapeutic class, active ingredients or generic terms relating to the technology and/or treatments.
- If limited treatment options are available, which may potentially draw attention to a single therapeutic product, companies must focus on the disease rather than on the products.
- Emphasis should not be placed on any single therapeutic product, e.g., by mentioning the brand name, using a large font or using promotional terms.
- Direct or indirect therapeutic or safety comparative claims with the intent to induce the use of any single product should not be made between specific ingredients or treatment options.
- Patients should be directed to seek advice from a healthcare professional.
Information that does not align with the abovementioned criteria and that focuses on or draws attention to a therapeutic product may be considered an advertisement under the therapeutic product advertising regulations. Such information will be subject to the advertising requirements under legislation.
Key takeaways
There is a spotlight on patient engagement/interaction, with regulators and industry associations closely scrutinizing such trends. In March 2024, we published a client alert on SAPI’s guidelines on patient interactions. The HSA’s introduction of a section on DACs in its therapeutic product advertising guidance illustrates that the HSA is aware of the trending developments and companies’ increased use of DACs. It may indicate that the HSA would be more active in its surveillance of and enforcement against noncompliant DACs.
The penalty for breaching the applicable therapeutic product advertising regulatory requirements is a fine of up to SGD 20,000, imprisonment for up to 12 months, or both. There may also be enhanced penalties for companies and officer liability. Companies should ensure that their DACs and published information that they may deem nonpromotional are fully aligned with the abovementioned criteria to avoid potential enforcement.
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