As we reported in October 2018, significant legislative changes have been made to the Therapeutic Goods Act 1989 (TG Act) in respect of the regulation of complementary medicines in Australia.
In this paper, we consider the changes relating to indications that are permitted for use in respect of complementary medicines listed on the Australian Register of Therapeutic Goods (ARTG).
Before 6 March 2018, sponsors were permitted to enter “free text” in relation to listed medicines.
However, by 6 March 2021, sponsors must replace any “free text” with permitted indications that are prescribed by the Therapeutic Goods (Permissible Indications) Determination (No.1) 2019 (Cth) (PID).
Importantly, there is a “fee free” period for sponsors to transition to using permitted indications in respect of their listed medicines. The “fee free” period ends on 6 September 2019.
Summary of changes in respect of permitted indications
The relevant section of the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 (Cth) (the TG Amendment Act) came into effect on 6 March 2018.
The TG Amendment Act establishes a 3 year transition period for sponsors of listed medicines to comply with changes made in respect of indications.
During the transition period, sponsors:
- must select those indications set out in the PID which are most relevant to their listed medicines;
- must not enter any "free text" in respect of indications for listed medicines; and
- may apply for new indications to be added to the PID.
The table below sets out the key dates in the transition period.
6 March 2018
The PID reform came into effect and commencement of the "fee free" period for sponsors to transition existing listed medicines to comply with the PID.
6 September 2019
6 March 2021
End of the transition period for listed medicines to comply with the PID. ARTG entries that are non-compliant with the PID will be cancelled.
6 September 2019 is a key date in the transition period. After this date, any changes made to indications in respect of listed medicines will incur a fee.
Background for listed medicines, indications and the implementation of the PID
Listed complementary medicines (for example: vitamins and minerals) are considered to be "low risk" medicines with "low risk" ingredients. Each active ingredient is, generally, unscheduled and has a substantial history of safe use.
Indications are statements that describe the therapeutic use of a complementary medicine. In other words, they represent the claimed purpose or health benefit for the complementary medicine. Indications can be specific or non-specific in nature. Examples include the specific claim: “relieves coughs” and the non-specific claim: “for general health and wellbeing”.
Prior to the TG Amendment Act, sponsors could draft their own indications. These indications could be recorded as "free text" entries in the ARTG in respect of any listed complementary medicine. Following the commencement of the TG Amendment Act, any indication that is now used in respect of a listed medicine must be selected from the PID. In other words, sponsors are no longer permitted to draft their own indications.
Sponsors of listed complementary medicines will still be required to hold evidence of the efficacy of their products at all times. Each sponsor must still hold evidence that substantiates the indication(s) relating to a complementary medicine listed on the ARTG.
Importantly, a listed medicine cannot include any indication that refers to the prevention, cure or alleviation of any diseases, ailments, defects or injuries. Further, indications must not refer to prohibited representations or restricted representations, as specified in Part 4 of the Therapeutic Goods Advertising Code (Code).
How are "permitted indications" determined?
Listed medicines may only comprise low level indications that are consistent with their "low risk" status. Currently, a number of permitted indications have been determined by the TGA subject to specific criteria; others can be added.
The TGA will consider a possible indication for entry onto the PID if the indication is:
- a "low level" indication;
- consistent with a treatment paradigm (i.e. based on scientific or traditional evidence);
- capable of complying with the Code and the TG Act; and
- not included in a "non-permitted" indication list (should one exist).
It is open to sponsors or others to apply for new indications to be included in future editions of the PID on the basis that they meet the relevant criteria and are approved by the TGA.
Use of permitted indications on medicine labels and advertising
Sponsors do not need to replicate permitted indication entries on the ARTG for their products, "word for word", on any product packaging or labelling (absent any specific requirement to do so). That said, the wording of indications utilised on the product packaging/labelling must convey the same meaning as the permitted indication detailed on the ARTG.
In other words, the ARTG entry and the product packaging/labelling must have an equivalent therapeutic target and action. In this respect, a sponsor may amend the order or structure of the elements of a permitted indication and use therapeutic action terms such as "maintain" or "support" interchangeably.
Permitted indications and treatment paradigms
All permitted indications must accord with the relevant treatment paradigm. In other words, scientific indications must not adopt traditional medicine terminology and vice versa. This is particularly relevant to sponsors of complementary medicines. In this case, traditional indications (or indications supported by evidence of traditional use) must not:
- adopt terminology that belongs to a different paradigm or conventional medicine;
- use terminology that requires scientific substantiation;
- reference diagnostic findings or biological or pharmacological effects that are not reasonably contemplated by that paradigm; and/or
- refer to conditions that a paradigm is incapable of properly diagnosing.
Sponsors of complementary medicines must ensure that any references to permitted indications, particularly when referring to a combination of any permitted indications, accord with the PID and the relevant ARTG entry (or entries) for the relevant product and are consistent with the relevant treatment paradigm.
Impact on Your Business
Up until 6 September 2019, sponsors have the ability to transition existing listed medicines to comply with the PID for no fee. Any listed medicine that transitions after this date will incur a fee. Accordingly, businesses should be proactive in ensuring that listed medicines comply with the PID before this date to minimise costs.
Importantly, any ARTG entry that is non-compliant with the PID on 6 March 2021 (the end of the transition period) will be cancelled. The cancellation of an ARTG entry is likely to be detrimental to a sponsor’s business in Australia.