Proposed Amendments to Regulation 23 of the Health Products (Therapeutic Products) Regulations

Introduction

The Health Sciences Authority (HSA), a statutory board of the Ministry of Health (MOH), invites public feedback on the proposed amendments to the Health Products (Therapeutic Products) Regulations 2016 (“Regulations”). The consultation period has been updated and is open from 1 March 2024 to 12 April 2024.

2Under regulation 23 of the Regulations, HSA must consider whether a patent under the Patents Act 1994 is in force in respect of the therapeutic product for which registration is sought. The applicant seeking to register a therapeutic product is required to make and furnish a patent declaration to HSA. This legislative mechanism was implemented to fulfil Singapore’s obligation under the US-Singapore Free Trade Agreement. It seeks to facilitate timely resolution of any potential patent disputes prior to the grant of registration, whereby the patent proprietor will be notified if a registration application for a therapeutic product that is subject to a patent is made during the patent term, without the consent or acquiescence of the proprietor.   

3The current regulation provides for the applicant to assess and determine any patent that needs to be declared in the registration application. HSA has considered the feedback from industry stakeholders that the requirements lacked clarity and may cause uncertainty on the types of patents that must be listed in the patent declaration, resulting in potential inappropriate use of the mechanism. This may also lead to challenges faced by the industry when making registration applications. 

4To enhance clarity of application requirements and ensure a system that facilitates registration applications, HSA initiated a comprehensive review of regulation 23 in consultation with the relevant Government ministries and agencies¹ taking into consideration the relevant alignment with US’ system². 

Proposed Health Products (Therapeutic Products) (Amendment) Regulations 2024

5The objectives of the proposed Health Products (Therapeutic Products) (Amendment) Regulations 2024 are:

i. To provide clarity to industry stakeholders on the types of patents that must be considered when making an application for registration of a therapeutic product, and for which the provisions under regulation 23 apply.

ii. To ensure a system that facilitates all industry stakeholders in making registration applications and minimise any potential indiscriminate use of the mechanism under regulation 23.

Key proposed legislative changes

(A) The types of patents to be considered under regulation 23

6Regulation 23 will be amended to apply to the following categories of patents that are in force in respect of the therapeutic product to which the application for registration relates:

i. a patent containing a claim for an active ingredient of that therapeutic product;

ii. a patent containing a claim for a formulation or composition of that therapeutic product;

iii. a patent containing a claim for the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use.

Patents that are in force in respect of the therapeutic product but which do not fall under the abovementioned categories are not subject to the requirements under regulation 23.

(B) Consequent amendments to regulations 24 and 25

7Regulations 24 and 25 will be updated to reflect the jurisdiction under which patent infringement matters reside and clarify the offences related to making a false declaration, respectively.   

Views sought

8HSA welcomes feedback on the proposed Health Products (Therapeutic Products) (Amendment) Regulations 2024. 

9The public consultation document and draft legislation are available at https://go.gov.sg/hptp-reg-amend and REACH portal.

10Please provide your name, name of the organisation you represent, contact number and email address. We may contact you to clarify your enquiries if necessary. Where possible, you should highlight the provisions in the proposed draft Regulations for which you are providing feedback.

11Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence and not be published, if the information is proprietary, confidential, or commercially sensitive. HSA will respond to you, if needed, in confidence.

12Please provide your feedback using the following online form:

¹Ministry of Health, Ministry of Law, Ministry of Trade and Industry, and Intellectual Property Office of Singapore.

²US Drug Price Competition and Patent Term Restoration Act of 1984.