Between 27 October 2014 and 23 November 2014, the Health Sciences Authority (the “HSA”) conducted a public consultation on the proposal to transfer existing regulatory controls of pharmaceutical products from the Medicines Act and Poisons Act to the Health Products Act (the “HPA”). This will provide greater clarity to relevant stakeholders as they would only need to refer to a single legislation.
The HPA provides the legislative and licensing framework for different categories of health products which span a wide range from low to high risk products. Medical devices and cosmetic products are examples of recent health products which have been brought under the HPA.
The relevant fundamental controls for pharmaceutical products under the existing laws which remain sound and relevant will be retained and transferred to the HPA. Pharmaceutical products will be introduced as “therapeutic products” in the First Schedule to the HPA and defined as a category of health products intended for a therapeutic, preventive, palliative or diagnostic purpose. The scope of therapeutic products will include chemical and biologic drugs.
As part of the public consultation, the HSA has issued draft versions of the following subsidiary legislation in relation to controls of advertisements of therapeutic products and licensing of retail pharmacies:
- Health Products (Advertisement of Therapeutic Products) Regulations 2015
- Health Products (Licensing of Retail Pharmacies) Regulations 2015
The HSA expects to conduct another public consultation later in 2014 on a further two sets of subsidiary legislation which would focus on the licensing regime of therapeutic products and its dealers, as well as that of clinical trial controls.
Key proposed changes
Health Products (Advertisement of Therapeutic Products) Regulations 2015
The following are the key changes relating to advertisement control of therapeutic products under the draft Health Products (Advertisement of Therapeutic Products) Regulations 2015:
- The current pre-publish permit system for advertisements and sales promotion of pharmaceutical products under the Medicines Act will be removed and the industry will be allowed to self-regulate based on a set of rules and guiding principles.
- The controls for the conduct of sales promotions will be stipulated in the regulations for better clarity and transparency.
- There will be strict prohibitions against objectionable claims as well as certain types of advertisements. For instance, any reference to the 19 diseases or conditions, such as cancer, diabetes, infertility and impotency, listed in the Second Schedule to the regulations is prohibited. The prohibition extends to the reference to any sign or symptom clinically attributable with any of the specified diseases/conditions.
- All direct to consumer advertisements of pharmacy-only medicines must feature advisories and warnings as directed by the HSA.
- The advertisement control under the HPA encompasses those on Internet and social media platforms.
Health Products (Licensing of Retail Pharmacies) Regulations 2015
Set out below is a summary of the key changes relating to the licensing of retail pharmacies:
- There will be a change in licence name from the existing “Certificate of Registration of a Pharmacy” to “Retail Pharmacy Licence”.
- Form A Poisons Licence will no longer be required for wholesaling of pharmaceutical products containing a listed poison under the HPA licensing regime. However, Form A Poisons Licence will still be required to handle active pharmaceutical ingredients, laboratory reagents and/or veterinary products containing listed poisons under the Poisons Act.
- The provisions on telepharmacy service will be prescribed in the proposed regulations for better clarity and transparency.
There will be no change to the licensing fees for retail pharmacies under the HPA.
The following materials are available from the HSA website www.hsa.gov.sg:
- Press release
- Draft Health Products (Advertisements for Therapeutic Products) Regulations 2015
- Explanatory Guidance to the Health Products (Advertisements of Therapeutic Products) Regulations 2015
- Summary of Proposed Changes for Advertisements for Therapeutic Products
- Draft Health Products (Licensing of Retail Pharmacies) Regulations 2015
- Summary of Proposed Changes for Licensing of Retail Pharmacies