EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2014 (NO. 6)

Subsection 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2014 (No. 6) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).

The Listing Notice has the effect of requiring that therapeutic goods that contain ‘alfadex’ as a therapeutically active ingredient, subject to certain conditions, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.

The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included on the Register before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act).  Medicines are registered or listed on the Register, depending on the ingredients they contain and the therapeutic claims that are being made.

In general, products that contain low risk ingredients are referred to as listed medicines in Australia.  Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.

Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the Register for listed goods.  Part 1 of Schedule 4 does not currently include goods containing ‘alfadex’ as a therapeutically active ingredient.

Subsection 9A(5) of the Act authorises the Minister for Health to publish a notice in the Commonwealth of Australia Gazette requiring that specified goods be included in the part of the Register for listed goods.  Such notices generally require that goods containing particular ingredients be included in that part of the Register.  Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.

If Part 1 of Schedule 4 to the Regulations is amended to require goods that are the subject of a subsection 9A(5) notice to be included in the part of the Register for listed goods, the notice ceases to have effect (subsection 9A(6) of the Act).

A person can apply for a new ingredient or substance to be specified in a notice under subsection 9A(5).  The TGA evaluates such applications, and the supporting data provided by the applicant, on the basis of safety and quality.  The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines, and the quality-focussed element characterises the precise and correct nature of the ingredient or substance.

‘Alfadex’

‘Alfadex’, also known as ‘alpha-cyclodextrin’, is a cone-shaped glucose-based molecule manufactured from starch via an enzymatic process and purified prior to its use as an ingredient.

‘Alfadex’ is added as a dietary fibre to a variety of foods including bakery products, dairy products, beverages and cereals. Currently, ‘alfadex’ is used as a non-active ingredient in registered prescription medicines. In 2004, ‘alfadex’ gained a self-affirmed Generally Recognized as Safe (GRAS) status in the USA without assessment by the Food and Drug Administration (FDA). In 2007, an assessment by the European Food Safety Authority identified no safety concerns with the use of ‘alfadex’ as a dietary fibre ingredient in foods. In Canada, ‘alfadex’ is available as an ingredient in natural health products.

A review of clinical studies relating to ‘alfadex’ by the TGA has identified a potential for experiencing gastrointestinal complaints when ‘alfadex’ is taken at doses of more than 6 g per day.

As such, the TGA considers ‘alfadex’ suitable for use in listed medicines subject to conditions, including in relation to the potential for gastrointestinal complaints with higher doses.

To that end, the delegate of the Minister has determined that therapeutic goods containing ‘alfadex’ as a therapeutically active ingredient be included in the part of the Register for listed goods, when:
 

• the preparations are for oral use only; and  

• the preparations provide not more than 6 g of alfadex per daily dose; and

• the preparations are presented in a therapeutic dosage form for therapeutic use.

CONSULTATION

Consultation was not undertaken in relation to the making of the Listing Notice, as the notice is considered to be minor and machinery in nature, with low compliance costs for affected industry.

The making of the Notice does not involve any new regulatory steps for industry, but rather provides a basis for products containing this ingredient to access the listing process rather than registration, a significant benefit for sponsors.

The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to Listing Notices (OBPR Ref. 14416).

The effect of the Listing Notice is that sponsors wishing to use ‘alfadex’ as a therapeutically active ingredient in a medicine can list that medicine on the Register rather than registering it.  Applications for new registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to inclusion on the Register, a process that is considerably more expensive and lengthy than the listing process.

In relation to compatibility with human rights, it is considered that the Listing Notice is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is set out below.

SUPPLEMENTARY MATERIAL – STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods (Listing) Notice 2014 (No. 6) – ‘Alfadex’

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Bill/Legislative Instrument

Therapeutic Goods (Listing) Notice 2014 (No. 6) (the Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act). The effect of the Notice is to allow sponsors of orally ingested therapeutic goods containing ‘alfadex’ as a therapeutically active ingredient to list, rather than register, those goods in the Australian Register of Therapeutic Goods (the Register) (registration being a considerably more expensive and lengthy process than listing). Once the Notice has commenced, persons can apply to list goods containing this ingredient as a therapeutically active ingredient on the Register.

Human rights implications

This legislative instrument does not engage any of the applicable rights or freedoms.

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

Professor John Skerritt, delegate of the Minister for Health