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Outcomes: Options for the implementation of a claimer for efficacy assessed non-prescription medicines

24 September 2018

Background

The TGA sought comments from interested parties on the use of a claimer for efficacy assessed non-prescription medicines to address the Government-agreed Recommendation 45 from the Review of Medicines and Medical Devices Regulation (MMDR).

A public consultation was conducted along with consumer usability testing to confirm whether the TGA proposals would meet the objectives of the reform. The outcomes of both consultative processes are outlined below.

Public consultation

A total of 63 submissions were received in response to the public consultation, which comprised:

  • 29 submissions from industry
  • 8 submissions from peak industry bodies
  • 4 submissions from healthcare professional bodies
  • 6 submissions from consumer and other professional bodies
  • 5 submissions from practitioners
  • 8 submissions from individuals
  • 3 submissions from government agencies.

Of the 63 respondents, 18 submitted electronic submissions via the TGA website or email and 45 completed an online survey. Responses to the public consultation have been published on the TGA website.

Outcomes of the public consultation

Submissions received in response to the consultation showed overall stakeholder support for TGA's proposed approach for the implementation of the claimer.

However, there were differences of opinions between some industry groups, particularly between complementary and OTC medicine sponsors. Complementary medicine sponsors supported the introduction of a claimer for all non-prescription medicines, whereas the OTC medicine sector did not support its implementation.

Consumer usability testing

The TGA also conducted qualitative usability testing on the concept of the claimer and the prototype designs proposed in the consultation paper. The Consumer Health Forum of Australia assisted in the planning, conducting and review of this research. Usability testing involved in-depth interviews with 24 consumers and 5 pharmacy assistants to gain an understanding of consumer's responses to and understanding of the claimer.

The broad insights and recommendations made as a result of this external research are summarised below.

Outcomes of the consumer usability testing

There were five broad insights as a result of the consumer usability testing. This included:

  1. A majority of participants were not familiar with TGA or TGA's regulatory role.
  2. Participants were unsure about what the TGA had assessed and how they had assessed it.
  3. Some of the terminology used in the proposed options for the symbol and the claimer (such as 'efficacy') were unfamiliar and caused confusion among participants.
  4. Participants saw the value of the claimer, noting it could be a positive influence if they knew more about TGA.
  5. The use of the symbol was more useful for consumers as it was more recognisable on product labels.

The external consultancy conducting the usability testing made four recommendations to the TGA to help ensure that intent of the recommendation could be achieved:

  1. Use language that is more familiar with the wider community (e.g. avoid using the word 'efficacy').
  2. Use a symbol to draw attention to the scheme and increase recognition.
  3. Referencing an Australian Government body such the TGA is more likely to provide greater consumer confidence in the validity of the claimer, provided they have awareness of the TGA.
  4. Support understanding of the symbol, claimer and the TGA through education. Suggestions included:
    • Utilising pharmacists and pharmacist assistants to educate consumers on the meaning behind the symbol and claimer.
    • Develop simple communication resources for use by consumers.
    • Improve the usability and information provided on the TGA website for consumers.

TGA response to the public consultation and consumer usability testing

Stakeholder feedback from the public consultation and consumer usability testing has informed our proposed position. The changes resulting from the feedback are summarised in the Outcome Summary below noting further targeted feedback will be sought in some cases.

Further information on implementation arrangements and guidance documentation for reforms in this consultation will be included on the TGA website in the coming months.

Outcome summary

Summary of changes resulting from consumer and public consultation on options for a claimer of efficacy

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The public consultation sought views on whether stakeholders supported the introduction of a claimer.

Stakeholder comment

There was a high level of support for the implementation of a claimer from consumers and healthcare professionals.

However there were mixed views from industry stakeholders. The complementary medicines sector strongly supports its introduction, whereas the OTC medicines sector was not supportive. They instead suggested that the TGA should utilise the current system of medicine identification (AUST L, AUST L(A) and AUST R) to educate consumers about the TGA and the level of pre-market assessment for classes of medicines.

Consumer usability testing suggested that consumers have limited understanding about the TGA and how we regulate therapeutic goods. However, it did suggest that once they were educated about the regulatory scheme, they did see the value of the claimer.

Outcome

Noting the high level of support for the introduction of the claimer, particularly from the complementary medicines sector and consumers, the TGA will implement the claimer alongside a consumer education campaign.

Implementation of the claimer will:

  • support consumers to make better informed purchasing decisions by improving the transparency about the status of efficacy claims for certain medicines (see below)
  • improve consumer awareness about the medicines regulatory framework and the different levels of assessment undertaken by the TGA
  • provide an incentive for product sponsors to lift the standards of evidence and extend the evidence base for certain medicines (see below)

The use of a claimer and/or label statement will be optional for the product sponsor.

The public consultation sought views on whether the claimer should be extended beyond assessed listed medicines and registered complementary medicines to include all pre-market assessed non-prescription medicines, including OTC products.

Stakeholder comment

A majority of complementary medicine industry stakeholders and consumers felt that a claimer should apply to all efficacy assessed non-prescription medicines.

The OTC medicines sector remained opposed to implementation of the claimer, even if it were extended to OTC medicines. Although the claimer would be optional, their view was that it would complicate efforts to harmonise product labels internationally.

Furthermore, if it was made available to sunscreens, it would also have the potential to create confusion for consumers if some sunscreens had a claimer and others did not.

Similarly, OTC medicines stakeholders also expressed concerns that implementation of a claimer on complementary medicines may encourage consumers to select assessed listed medicines (using a claimer) over OTC medicines (without a claimer) which are also assessed by the TGA for efficacy.

Outcome

The claimer will be introduced for assessed listed medicines (which may include complementary and OTC medicines) and registered complementary medicines only. This is consistent with the original intent of the MMDR recommendation, which was aimed at improving the transparency around the efficacy of complementary medicines and awareness of the different levels of assessment undertaken by the TGA.

To meet the objective of the scheme 'Grandfathered' registered complementary medicines which have not previously undergone pre-market assessment by the TGA will not be eligible for a claimer, unless the sponsor applies to the TGA for assessment of the products efficacy.

Following consideration of the concerns expressed by the OTC medicines sector, the claimer will not be available for Registered OTC medicines or sunscreens. In relation to sunscreens, it is also noted that the efficacy of sunscreen products supplied in Australia is already assumed by the requirement for these products to comply with the Sunscreen Standard (AS/NZS 2604:2012). Accordingly, there is little scope to extend the evidence base for sunscreens.

We considered the OTC sector's concerns about the potential impacts of the claimer for OTC products. However, we note that complementary medicines are generally separated from OTC products in the retail outlets where they are purchased and furthermore, that there does not appear to be a significant overlap between the therapeutic uses for OTC and complementary medicines.

The education campaign supporting the introduction of the claimer will aim to address the OTC industry's concerns by providing clear information about the different assessment processes undertaken for listed, assessed listed, registered complementary medicines and registered OTC medicines.

The public consultation and usability testing sought views on a range of prototype designs for the claimer.

Stakeholder comment

Stakeholders expressed a significant preference for the text-based symbol 'TGA Assessed' and the label statement 'Evidence for the approved indications has been assessed by the TGA' (see below). They felt that these options provided the most accurate description of the evaluation work undertaken by the TGA.

Consumers participating in the usability testing also preferred the language in these options as words like 'efficacy' were not easily understood.

There was also a high-level of support in response to the public consultation for the TGA proposals for the size and colour restrictions of the claimer. However, we noted industry concerns about availability of space on medicine labels and that there should be flexibility for sponsors to choose the claimer location.

Outcome

The claimer will be implemented via:

  • An optional label statement (Option 2, shown below), and
Chosen claimer label statement Mocked-up label with chosen claimer label statement
'Evidence for the approved indications has been assessed by the TGA' picture of a mocked-up label showing the claimer label statement
  • An optional text based symbol (Option 1, shown below).
Chosen claimer symbol Mocked-up label with chosen claimer symbol
Claimer symbol: TGA assessed picture of a mocked-up label showing the claimer symbol

As identified through the consumer usability testing, the use of a text based symbol specifically referencing the TGA is more likely to leverage consumer confidence, trust and familiarity when done in concert with an education campaign. These options are also simpler and use language that is more familiar to consumers.

To ensure consistency with existing TGA labelling requirements, the colour, size and location limitations for the claimer will be as follows:

  • The visual claimer must be presented in black ink on a white background and surrounded by a black outline.
  • The size of the claimer text must not be smaller than 1.5mm and no larger than the text size for the names and amounts of active ingredients.
  • Sponsors will have the option of including the claimer on the main label or primary pack.