EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2015 (NO. 1)
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2015 (No. 1) (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 revoking Therapeutic Goods (Listing) Notice 2012 (No.3 ) and requiring that therapeutic goods that contain ‘Ubiquinol-10’ 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 ‘Ubiquinol-10’ 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 changes to certain conditions associated with an ingredient specified in a notice under subsection 9A(5). The TGA evaluates such applications, 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.
‘UBIQUINOL-10’
Ubiquinol-10 is the reduced form of what is commonly known as 'coenzyme Q10' (CoQ10). In the mammalian body, including in humans, CoQ10 is a key component for energy production in all cells and also has other functions, including antioxidant properties. It is synthesised by the body and may be obtained through the diet, mainly through foods such as meat, poultry and fish.
Both the fully reduced (ubiquinol-10) and the fully oxidised (ubidecarenone/ ubiquinone-10) forms of CoQ10 exist in the body, where they are fully convertible. Ubiquinol-10 is the dominant form of CoQ10 found in the healthy human body.
In Australia, Therapeutic Goods (Listing) Notice 2012 (No. 3) permitted the use of ubiquinol-10 as an active ingredient in listed medicines for oral use subject to certain conditions, including that the maximum daily dose be restricted to 150 mg, and that a label advisory statement is required to warn against potential interaction with warfarin containing medicines.
In 2014, the TGA further considered the available information relating to ubiquinol-10, and an up-to-date safety risk assessment for ubiquinol-10 concluded that a maximum daily dose of 300 mg be of sufficiently low risk for use in listed medicines. The risk assessment also concluded that there is no impediment to the approval of combined use of ubiquinol-10 and ubidecarenone as an oral ingredient in listed therapeutic goods, provided that the total maximum daily dose of the two substances does not exceed 300 mg.
This daily limit is consistent with the daily dose considered safe by Health Canada for nutritional supplements containing ubiquinol-10 in its jurisdiction. Further, noting that ubiquinol-10 readily converts in the body to ubidecarenone, this daily limit acknowledges the interconversion of ubiquinol-10 and ubidecarenone.
While the risk assessment for ubiquinol-10 found that there is evidence to support the safe use of ‘ubiquinol-10’ as a therapeutically active ingredient, there is a potential that ubiquinol-10 may interact with warfarin-containing medicines. As such, the TGA considers ubiquinol-10 suitable for use in listed medicines, subject to a label warning statement that is also required for listed medicines containing ubidecarenone.
To that end, the delegate of the Minister has determined that therapeutic goods containing ubiquinol-10 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 300 mg ubiquinol-10 per daily dose; and
when used in combination with ubidecarenone, the preparations provide not more than 300 mg of ubiquinol-10 and ubidecarenone combined per daily dose; and
- the container, and any other packaging, for the preparation is labelled with the following warning:
“Not to be taken, if on warfarin therapy, without medical advice”.
The current Listing Notice therefore replaces and revokes Therapeutic Goods (Listing) Notice 2012 (No. 3).
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 this Listing Notice is that sponsors wishing to use ‘ubiquinol-10’ 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 2015 (No. 1) – ‘ubiquinol-10’
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 2015 (No. 1) (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 ‘ubiquinol-10’ 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