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Summary & response: Evidence required to support indications for Listed medicines

Summary of broad issues reported and TGA's response

13 July 2012

The following table sets out in brief the broad issues identified from the submissions received and the TGA's response.

Issue Summary of issue TGA response
1 The requirements appear to be new or more complex, onerous and prescriptive than the existing Guidelines for levels and kinds of evidence to support indications and claims document without explanation.

Sponsors of listed complementary medicines are currently required to hold evidence to support the indications.

From the information collected in the post-listing compliance reviews conducted during specific periods in 2009-2010, 57% of the listed complementary medicines reviewed for evidence (n=89) failed to meet evidence requirements.

The Auditor General's report into the regulation of complementary medicines asks the TGA to update key guidance material. In addition, the Informal Working Group on Complementary Medicines, which included representatives from consumers, health professionals and industry considered the challenges for the Australian public and the TGA as a result of low compliance rates for listed complementary medicines. The group subsequently recommended that the Evidence document be updated to improve evidence compliance and thus improve the public's confidence in listed complementary medicines.  The Government agreed to these recommendations, as set out in the TGA reforms: A blueprint for TGA's future ("the Blueprint").

2 The Evidence document does not highlight the role of the document in the wider context of monitoring, enforcement, sanctions, other incentives to improve regulatory compliance and other TGA reforms. Improvements in compliance (including evidence requirements) are an important part of improving the public's confidence in listed complementary medicines. However, the TGA recognises that in order to obtain compliance improvements, a multi-faceted approach is required including improvements in the approach to post-market review through the use of risk profiles. These reforms are underway.
3 It is unclear how the requirements in the Evidence document will be implemented. The TGA wished to obtain advice from stakeholders on appropriate implementation activities before developing an implementation plan for the Evidence document. The TGA will take information provided in the submissions into account in developing an implementation plan.

The document is largely silent on homeopathic products and there are difficulties obtaining conventional scientific evidence that clearly shows efficacy of homeopathic products.

The majority of homeopathic prescriptions are single remedies of a standard content and preparation that are prepared by, and sourced directly from, homeopathic pharmacies in Australia. It would be prohibitive for individual manufacturers and retailers to be required to undertake this listing and evidence process for each of our thousands of medicines.

As set out in the Executive Summary to the Evidence document:

This document outlines the requirements for evidence held by sponsors to support indications for listed medicines.

The Evidence document applies to all complementary medicines that require listing on the ARTG. Where specific medicines require specific attention, this has been mentioned in the document.

5 Active ingredients with established credibility and high levels of evidence will be significantly disadvantaged and the amount of work required to list will be disproportionate with the risk of the medicine.

The TGA will amend the document to propose an approach where sponsors can use established sources of evidence to support indications for established ingredients. When established sources of evidence are not available a systematic review will be required to ensure that:

  • all the evidence/studies possibly relevant to the indications/claims for the product are identified
  • these evidence/studies are screened appropriately to identify those that should be subjected to further analysis
  • analysis regarding statistical and clinical significance is conducted appropriately.

These steps are necessary to establish a comprehensive and accurate efficacy profile of the medicine. The same approach is required for all ingredients - established or otherwise - to ensure that there is supporting evidence for the ingredient and its proposed use.

6 Several respondents argued that the Evidence document incorrectly accepts scientific and traditional methods of evaluation as equivalent despite the differences in principles between the two methods. This is not compatible with the commitment of the Government to take decisions on the basis of the best scientific evidence in health. The TGA will further clarify as it was not intended to convey a message that scientific evidence and traditional evidence can provide equivalent levels of assurance regarding efficacy. The intention is to adopt a transparent approach where the context of traditional indications is explicitly provided to consumers with the promise of efficacy.

Acceptable qualifications for an 'expert' as the model proposed in the Evidence document does not appear to be appropriate or have considered all the options available.

Respondents also identified some of the barriers that industry would face in engaging suitably qualified experts.

The TGA understands that, while welcomed by consumers, the requirement to use experts to prepare reports for listed complementary medicines has caused concern for industry.

The TGA acknowledges the importance of following the steps in the process of evaluating the evidence and that achieving a high quality outcome is not dependent on the qualifications of the person undertaking the review.

Where the TGA conducts a post-market review of a product to confirm that the sponsor has the required evidence to support the indications/claims, the TGA will determine if:

  • the sponsor has followed the requirements in relation to preparation of a report, and
  • the evidence meets the stated requirements.
8 The draft appears to require the preparation of a scientific systematic review of every ingredient and/or every indication for every product carrying scientific indications. This would severely affect sponsors, through an additional cost burden, without apparent benefit. The TGA proposal to allow a review of the sources of established evidence available will reduce the burden on sponsors but still assist them to ensure that they have appropriate evidence to support their listed medicine (see issue 5).
9 A number of respondents have proposed that information regarding the efficacy of the complementary medicine (or a summary of that information) be provided to the TGA at the time of applying for listing (although not necessarily evaluated). Summary information could then be made available to the public.

Although it is evident that a significant number of listed complementary medicines are found to have non-compliance issues, the TGA believes that it is possible to continue with the existing model (i.e. listed complementary medicines can be included on the ARTG via the Electronic Listing Facility (ELF) with no premarket regulatory oversight by the TGA, provided that certain conditions are met).

The TGA is expecting that non-compliance rates will improve on implementation of:

10 For registered OTC medicines, indications for active ingredients can be based on evidence found in standard reference texts. The requirements of a systematic review in every case for substantiation of the indications for use of listed medicines make this a stricter requirement than for these types of registered OTC medicines. The TGA will amend the document to propose an approach where sponsors can use established sources of evidence to support indications for established ingredients (see issue 5).
11 There will be additional costs to industry engaging experts and undertaking systematic reviews.

The TGA will amend the document to propose an approach where sponsors can use established sources of evidence to support indications for established ingredients instead of engaging experts and undertaking systematic reviews (see issue 5).

As noted above, sponsors currently have a responsibility to the Australian public, as set out under the therapeutic goods legislation, to ensure that they hold the appropriate evidence that supports the efficacy of the product in the context in which it is marketed.

The Evidence document provides further clarity on the sound scientific principles that the TGA currently expects sponsors to employ to assess evidence and ensure that they hold appropriate evidence of the efficacy profile of the medicine, including any safety issues.

Therefore, the costs involved should not significantly increase if sponsors' existing arrangements are appropriate.

12 Many of the submissions received from industry expressed concern at the limited length of consultation period and the need for minimal impact on products already listed. The TGA notes that the Evidence document was not developed in isolation from industry (refer to issue 1 above for background). Also, as noted above, this document provides further clarity on the sound scientific principles that the TGA currently expects sponsors to employ to assess evidence and ensure that they hold appropriate evidence of the efficacy profile of the medicine. Nonetheless, the TGA will consider these concerns when developing an implementation plan for the Evidence document.