In February 2017, the Therapeutic Goods Administration (TGA) released a consultation paper, Reforms to the Regulatory Framework for Complementary Medicines (Consultation Paper), in which extensive reforms are proposed to the manner in which complementary medicines are regulated in Australia.1
If the reforms proceed, complementary medicines will be much more tightly regulated in Australia with the reforms impacting significantly on the way in which sponsors apply for the listing of complementary medicines on the Australian Register of Therapeutic Goods (ARTG) and the claims which may be made in respect of complementary medicines.
The TGA is requesting feedback about proposals to:
- implement a three-tiered risk-based framework to regulate complementary medicines. This would include a new pathway which sits between listed, lowrisk medicines and high-risk registered medicines being introduced;
- list those permitted indications, which must be used by low-risk listed complementary medicines;
- permit sponsors to make claims that their complementary medicines have been assessed for efficacy by the TGA where those complementary medicines have undergone pre-market evaluation by the TGA; and
- incentivise innovation in the complementary medicines sector by introducing new mechanisms such as greater protections for efficacy data and new ingredients.
The proposed reforms implement various recommendations contained in the Review of Medicines and Medical Devices Regulation (Review) which was released in October 2016.2
The Review considered that Australia’s existing regulatory framework for complementary medicines does not align regulatory protections with risks in an appropriate manner. With this in mind, the reforms have various objectives including:
- for sponsors to improve the standard of evidence regarding efficacy;
- to provide sponsors with the ability to use higher level indications than are currently appropriate for listed products;
- to prevent consumers being misled by indications on labels; and
- to reduce the number of non-compliant indications being included on the ARTG.
The current pathway for listing low-risk complementary medicines on the ARTG will remain the same except that only those indications, which are on an approved list, will be able to be used. The free text field in the TGA’s Electronic Listing Field which is used to enter indications will be removed. The requirements of self-assessment and self-certification by the sponsor will remain the same.
An intermediate pathway (Intermediate Pathway) for complementary medicines will be available where these medicines:
- contain only permitted ingredients, and are manufactured under GMP conditions;
- make indications which fall outside the list of permitted indications and which remain appropriate for listed medicines (as opposed to registered medicines); and
- have scientific evidence considered acceptable by the TGA to support the proposed indications. This evidence will be assessed by the TGA before any marketing in Australia of the complementary medicine can commence.
As with low-level complementary medicines, the Intermediate Pathway application process will involve self-certification by the sponsor. Complementary medicines, which only have evidence based on a history of traditional use, will be excluded from the Intermediate Pathway unless the sponsor also has acceptable scientific evidence.
The registered medicines pathway will remain the same.
The TGA anticipates that the list of permitted indications for low-risk complementary medicines will only include those indications referring to general health maintenance; health enhancement; the prevention of deficiencies in diet; or which imply a benefit for a non-serious disease or condition. Examples referred to in the Consultation Paper include “helps stimulate digestive function”, “helps relieve muscle aches and pains” and “may support healthy lung function”.
To enable market differentiation, the TGA anticipates that sponsors would be allowed to vary the wording of permitted indications where neither the intent nor the meaning of the indication is changed. The TGA seeks feedback on the proposed criteria for including an indication on the permitted list. In particular:
- whether the criteria is appropriate; and
- the way in which permitted indications are structured, including whether a list of core permitted indications should be available which can be modified with qualifiers (which have also been approved).
Where a complementary medicine is assessed by the TGA and meets the requirements of the new Intermediate Pathway, sponsors will be able to claim that the efficacy of their products has been assessed. The TGA has referred to this claim as a “claimer”.
The TGA seeks feedback on whether the use of a claimer will have unintended consequences; whether it should be represented by a visual identifier (as well as a statement); and whether other considerations should be taken into account.
Incentives to Encourage Innovation
The Consultation Paper refers to a range of possible incentives to encourage innovation in the complementary medicines sector, including providing:
- a limited period of two years market exclusivity, which would be granted to applicants who apply successfully for new ingredient approval; and
- a three year data protection period to applicants whose products include new ingredients, which are supported by clinical data directly relating to the formulation of the finished products.
Timeframe for Reforms
The TGA proposes a transitional period of three years from the commencement of the legislation mandating the reforms. During the transitional period, sponsors would be required to:
- in respect of products with low level indications, transition the indications to those indications on the permitted list; and
- in respect of products with intermediate indications, either transition to the Intermediate Pathway or select low level permitted indications.
The TGA anticipates that sponsors will be able to keep existing AUST L numbers and, if they update their ARTG entries within the first 18 months of the transition period, no fee will be payable.
If you are interested in making a submission, the deadline is 28 March 2017. Information about how to make a submission is available on the TGA’s website.3
The TGA will then release feedback after it has had an opportunity to review the submissions.