Legislation

Health Products Bill 2007 (B3/2007)
On 22 January 2007, the Health Products Bill 2007 (B3/2007) (the 'Bill') was tabled for first reading in the Parliament.

The Bill aims to amalgamate the existing controls for regulating medicines, which currently reside in various pieces of legislation, into one omnibus Act. This proposal follows from industry feedback that having the regulatory controls fragmented and spread out in different Acts makes them confusing and difficult to understand. Furthermore, there are areas in which the existing four separate pieces of legislation overlap. The overlapping of controls in some areas sometimes makes compliance with the legal requirements unnecessarily complicated.

Medicines and health-related products are currently regulated under four separate pieces of legislation, namely:

1 the Medicines Act;
2 the Medicines (Advertisement and Sale) Act;
3 the Poisons Act; and
4 the Sale of Drugs Act.

The Health Sciences Authority (the 'HSA') conducted a public consultation between 15 June 2005 and 31 July 2005 to seek comments on the draft text of the Bill.

The Bill will be administered by the HSA.

Scope of the Health Products Act
The Bill seeks to regulate the manufacture, import, supply, presentation and advertisement of 'health products'.

'Health product' is defined in s 2 of the Bill to mean any substance, preparation or device that falls within any of the categories of health products specified in the First Schedule of the Health Products Act (when it is enacted) (the 'Act') and:

1 is represented for use by humans;
2 whether because of its presentation or otherwise, is likely to be taken for use by humans; or
3 is included in a class of substances, preparations or devices which are or are ordinarily intended for use by humans,
4 solely or principally for a health-related purpose.

'Health-related purpose' means a therapeutic, preventive, palliative, diagnostic or cosmetic purpose, or any other purpose for the promotion or preservation of human health and well-being, and includes the following:

1 preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or the symptoms thereof, in humans;
2 compensating for any injury or handicap in humans;
3 investigating, modifying or replacing any part of the human anatomy or any physiological process in humans;
4 testing the susceptibility of humans to any disease, disorder or ailment;
5 influencing, controlling or preventing conception in humans;
6 testing for pregnancy in humans;
7 inducing anaesthesia in humans;
8 destroying or inhibiting micro-organisms that may be harmful to humans; and
9 cleansing, fragrancing, deodorising, beautifying, preserving, improving, altering or restoring the complexion, skin, hair, nails or teeth of humans.

The breadth of the definition of 'health products' is intended to extend the coverage of the Act to health supplements (like vitamins) as well as to capture all sorts of health products which are available in the market that do not fall within the ambit of the existing legislation. A product that fits into the definition of 'health product' per se is not subject to the Act unless it is specified in the First Schedule to the Act. s 4 of the Bill provides that the Act will apply only in relation to the categories of health products that are specified and described in the first and second columns of the First Schedule of the Act to the extent prescribed in the third column thereof.
Currently, 'medical device' is the only category of health product specified in the First Schedule to the Bill.

A new s 77 will be inserted in the Medicines Act to deal with the transfer of the regulation of medicinal products from the Medicines Act to the Bill. By virtue of the new s 77, when any medicinal product being regulated under the Medicines Act has been categorised as a health product and is being regulated under the Bill, the Minister for Health will, by an order published in the Gazette, declare that the Medicines Act will cease to apply to that medicinal product. This will avoid duplicity of regulation. The Medicines Act will be repealed by a separate Bill when all medicinal products currently being regulated under that Act have been categorised as health products and are being regulated under the Bill. No time frame is indicated for the transfer.

Activities Regulated Under the Act
All health products that are specified in the First Schedule to the Act must be registered under the Act before they can be manufactured, imported and sold in Singapore. Health products are registered in accordance with the categories specified in the First Schedule to the Act.

The Bill regulates dealings concerning health products that are specified in the First Schedule to the Act as follows:

1 manufacturer's licence is required for a person who manufactures any health product ;
2 importer's licence is required for a person who imports any health product;
3 wholesaler's licence is required for a person who supplies any health product by wholesale; and
4 supply of health products must be carried out in accordance with prescribed requirements in the Act.

There are also prohibitions against the manufacturing, importing or supplying of adulterated, counterfeit, unwholesome health products or health products that have been tampered with.

Presentation (for example, labelling, packaging and naming of health products) and advertisement of health products are also governed under the Bill.

Elizabeth Wong
Allen & Gledhill